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Human Subjects Research and Investigation

Overview

The Ikoku Foundations are committed to fostering and conducting the most beneficial, humane and respectful modes of research and investigation involving human subjects.

Therefore, persons and entities engaged in activity within, for, on behalf of, in reference to and more generally pertaining to The Ikoku Foundations are expected to uphold the following:

Your Agreement

— With respect to the Agreement you enter into with The Ikoku Foundations via the Policy on Human Subjects Research and Investigation, you understand and adhere to the following:

[su_accordion class=””][su_spoiler title=”Persons Adhering to Agreement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that the Policy on Human Subjects Research and Investigation is to be adhered to by a wide range of associated individuals and communities ― including but not limited to board and committee members, leadership, management, officers, staff, employees, volunteers, representatives, agents, collaborators, partners, and visitors and users ― as they work in their capacity to establish, further develop, operate, collaborate with, carry out the mission and purposes of, and also visit, use and participate in the offerings of The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Applicability and Governance of Agreement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that the Policy on Human Subjects Research and Investigation governs any and all of your access, actions, activity, communication, operations, participation or other use in, with, for, on behalf of, in reference to or otherwise pertaining to The Ikoku Foundations, their divisions, series, subsidiaries and affiliates, and their Products and Services, including the Sites.[/su_spoiler][su_spoiler title=”Entry and Continuation of Agreement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that whenever you engage in any access, action, activity, communication, operation, participation or other use in, with, for, on behalf of, in reference to or otherwise pertaining to The Ikoku Foundations, their divisions, series, subsidiaries or affiliates, and their Products and Services, including the Sites — directly or indirectly as further described below — you are agreeing to the Policy on Human Subjects Research and Investigation as well as the associated Codes and Policies that collectively constitute The Ikoku Foundations User Agreement and Code of Conduct, as they are amended from time to time.[/su_spoiler][su_spoiler title=”Direct and Indirect Entry and Continuation of Agreement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that whenever you engage in the above described activities directly or indirectly — whether engaged in through The Ikoku Foundations, their divisions, series, subsidiaries or affiliates, and their Products and Services, including the Sites; or through persons and entities working with The Ikoku Foundations, their divisions, series, subsidiaries or affiliates, and their Products and Services, including the Sites; or working with such engaged activities and resulting media, materials or otherwise — you are also agreeing to the Policy on Human Subjects Research and Investigation as well as the associated Codes and Policies that collectively constitute The Ikoku Foundations User Agreement and Code of Conduct, as they are amended from time to time.[/su_spoiler][su_spoiler title=”Binding Nature and Validity of Agreement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that you are also thus indicating that you understand the Policy on Human Subjects Research and Investigation and the Codes and Policies, that you intend them to be the legal equivalent of a signed, written contract, equally binding, and that you accept such Policy on Human Subjects Research and Investigation and Codes and Policies and agree to be legally bound by them (your “Agreement”).[/su_spoiler][su_spoiler title=”Agreement On Behalf of Organization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that if you are engaging in any of the above described activities, communication or uses for or on behalf of an organization, you are agreeing to this Agreement on behalf of that organization, and represent and warrant that you can do so.[/su_spoiler][su_spoiler title=”In Case of Non-Agreement or Inability to Honor” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that you will not engage in any of the above described activities, communication or uses if you do not agree to all of the Policy on Human Subjects Research and Investigation or the Codes and Policies or if your jurisdiction will not honor them.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Your Consent to The Policy

With respect to your ability to agree and consent to the Policy on Human Subjects Research and Investigation, you represent and warrant the following:

[su_accordion class=””][su_spoiler title=”Your Power and Authority” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that you have the power and authority to enter into the agreement entailed in the Policy on Human Subjects Research and Investigation, including, where applicable, the power and authority to enter into the agreement on behalf of an organization.[/su_spoiler][su_spoiler title=”Required Age or Permission and Supervision” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that you are at least eighteen (18) years old or if younger at least thirteen (13) years old and engage in activity, communication, operation, participation, visit or other use in relation to The Ikoku Foundations, their divisions, series, subsidiaries and affiliates, or their Products and Services, including the Sites with the permission and supervision of an adult parent or guardian.[/su_spoiler][su_spoiler title=”Reading and Understanding” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that you have read and understood the Policy on Human Subjects Research and Investigation.[/su_spoiler][su_spoiler title=”Voluntary Nature of Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that you understand your consent to be voluntary in nature.[/su_spoiler][su_spoiler title=”Agreement and Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that you consented to and agreed to be legally bound by the Policy on Human Subjects Research and Investigation.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products and Services, including the Sites, you accept and agree that your consent meets the conditions, principles and requirements for consent, as delineated and described in a these Codes and Policies — for the specific purpose of consenting to this Policy, the Agreement and the Codes and Policies.

Your Abiding by The Policies

You represent, warrant and covenant that, given the above attestation about your consent to the Policy on Human Subjects Research and Investigation, you have read, understood, consented to and agreed to be legally bound by and abide by the Policy on Human Subjects Research and Investigation and the Codes and Policies, as they are amended from time to time, and in their entirety without modification.

— You represent, warrant and covenant that, given the above attestation about your consent and adherence to the Policy on Human Subjects Research and Investigation, you have also read, understood, consented to and agreed to be legally bound by and abide by understandings of human subjects research and investigation as defined in all applicable law and regulation, by The Ikoku Foundations in the Codes and Polices, and as further delineated below, to be respected and not misused or unethically conducted, in any way, by you.

Your Understanding of Biospecimens, Data and Information

— You represent, warrant and covenant that, given the above attestation about your consent and adherence to the Policy on Human Subjects Research and Investigation, you have also read, understood, consented to and agreed to be legally bound by and abide by understandings of biospecimens, data and information as defined in all applicable law and regulation, by The Ikoku Foundations in the Codes and Polices, and as further delineated below, to be respected and not misused or unethically processed, in any way, by you.

Your Understanding of Human Subjects Research Principles and Rights

— You represent, warrant and covenant that, given the above attestation about your consent and adherence to the Policy on Human Subjects Research and Investigation, you have also read, understood, consented to and agreed to be legally bound by and abide by understandings of human subjects research principles and of human subjects research rights as defined in all applicable law and regulation, by The Ikoku Foundations in the Codes and Polices, and as further delineated below, to be respected and not infringed or violated, in any way, by you.

Your Understanding of Human Subjects Research Protections

— You represent, warrant and covenant that, given the above attestation about your consent and adherence to the Policy on Human Subjects Research and Investigation, you have also read, understood, consented to and agreed to be legally bound by and abide by protections for human subjects, for human subjects research, for biospecimens, data and information, for human subjects principles and for human subjects rights, as they are provided for and defined in all applicable law and regulation, by The Ikoku Foundations in the Codes and Polices, and as further delineated below, to be fulfilled and respected and not breached or violated, in any way, by you.

Your Commitment to the Understandings

— You also represent, warrant and covenant that, given the aforementioned attestation, your commitment to these understandings of human subjects, of human subjects research, of biospecimens, data and information, of human subjects principles, of human subjects rights, and of their protections shall entail the following:

[su_accordion class=””][su_spoiler title=”Basis for Your Actions, Activity and Decisions” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]its basis for any human subjects research activity you engage in with respect to The Ikoku Foundations — including their divisions, series, subsidiaries and affiliates, as well as their Products and Services — and that any such actions and decisions you engage in shall be free of any incompatibility with, inconsistency with or violation of this Policy on Human Subjects Research and Investigation and all applicable laws, protections and regulations.[/su_spoiler][su_spoiler title=”Commitment to Informed Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that this commitment include but not be limited to ensuring and maintaining for every human research subject concerned at The Ikoku Foundations reasonably informed consent and informing consent process before, during and after the conduct of activities involving research and biospecimens, data and information.[/su_spoiler][su_spoiler title=”Commitment to Care and Safety” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that this commitment include but not be limited to ensuring and maintaining for every human research subject concerned at The Ikoku Foundations protections of their care and safety before, during and after the conduct of activities involving research and biospecimens, data and information.[/su_spoiler][su_spoiler title=”Commitment to Confidentiality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that this commitment include but not be limited to ensuring and maintaining for every human research subject concerned at The Ikoku Foundations protections of confidentiality before, during and after the conduct of activities involving research and confidential, personal, private and sensitive biospecimens, data and information.[/su_spoiler][su_spoiler title=”Commitment to Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that this commitment include but not be limited to ensuring and maintaining for every human research subject concerned at The Ikoku Foundations protections of privacy before, during and after the conduct of activities involving research and confidential, personal, private and sensitive biospecimens, data and information.[/su_spoiler][su_spoiler title=”Commitment to Necessary Limitations” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that this commitment include but not be limited to ensuring and maintaining for every person concerned at The Ikoku Foundations the limiting of processing of confidential, personal, private and sensitive data and information to what is strictly necessary for the research activity, communication, operation, product, service or other use and purposes consented to by the owner of the confidential, personal, private and sensitive data and information.[/su_spoiler][su_spoiler title=”Commitment to Protections Following From and Ahead of the Law” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that you also respectfully assist and in no way interfere with or impede the reasonable efforts taken by The Ikoku Foundations to obtain, keep current and comply with required human subjects research guidelines, law and regulation, as they pertain to applicable local, state, national and international jurisdictions, including but also often beyond what the law provides for and protects with respect to human research subjects — especially, the Belmont ReportDeclaration of HelsinkiNuremburg Code, United States Health Insurance Portability and Accountability ActUnited States Policy for Protection of Human Research Subjects, and United Nations Declaration of Bioethics and Human Rights, as well as The Ikoku Foundations’s Policy on Data and Information, itself further informed by the California Consumer Privacy Act and European Union General Data Protection Regulation and a number of privacy protections in California, including the constitutional right to privacy provided for in the State Constitution of California.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Accordance with Ethics

— that The Ikoku Foundations ensure following the above principles further remains in accordance with the Codes and Policies and especially the Founding and Governing Code of Ethics.

Further Considerations

Your Knowledge and Agreement

The Ikoku Foundations strongly recommend you develop and maintain your knowledge of all the Codes and Policies, and so asks that you read, understand and regularly visit this page and other communications regarding the Policy on Human Subjects Research and Investigation, as well as the Codes and Policies. The Ikoku Foundations take your continued visiting and use of their Products and Services, including the Sites, as active indication of your knowledge, understanding, legally binding acceptance and agreement.

Your Duty to Corporate Integrity

To protect the corporate and organizational integrity of The Ikoku Foundations — as well as the properties, rights and protections of the corporations and their official persons — The Ikoku Foundations require all natural and legal persons concerned to read, understand, abide by and, where applicable, sign contracts and agreements delineated and described in the Policy on Corporate Integrity.

The Ikoku Foundations remind you that the Policy on Corporate Integrity forms part of The Ikoku Foundations User Agreement and Code of Conduct. Thus, The Ikoku Foundations take your continued visiting and use of their Products and Services, including the Sites, as active indication of your legally binding acceptance of this Policy as well as the Codes and Policies.

Your Questions and Feedback

Please contact policies@ikokufoundations.org with any feedback, issues or questions — which will be addressed by the President and CEO, Alvan Azinna Chibuzo Ikoku.

Your Reporting of Violations

If you detect, notice or are informed of a possible breach or violation of this Policy or any of these Codes and Policies, please contact policies@ikokufoundations.org with any details you have — which will be addressed by the President, CEO and Chair, Alvan Azinna Chibuzo Ikoku.

The Definitions

As with all official documents, materials, policies and statements of The Ikoku Foundations, definitions for terms used here can be found in the main Codes and Policies page.

The Policy Details

Provision

Along with the above key principles, the Policy on Human Subjects Research and Investigation requires attention to correlative principles, rights and responsibilities delineated below, and strongly recommended steps for enhancing compliance.

A — Basic Principles

The Principles of Research and Investigation

There are fifteen (15) overarching principles of human subjects research and investigation. The Ikoku Foundations shall fulfill such principles before, during and after conducting human subjects research and investigation, especially when accessing or otherwise process biospecimens, data and information attributable to, identifying, or relating to you. The Policy will elaborate in some detail upon each of these principles as you proceed on this page. In the meantime do keep in mind that, as much as feasibly and reasonably possible, The Ikoku Foundations endeavor to have each instance of human subjects research and investigation fulfill all of the following:

[su_accordion class=””][su_spoiler title=”Applicability” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that any activity at The Ikoku Foundations that constitutes or involves human subjects research and investigation should be identified and administered as such, and thus made subject to this Policy.[/su_spoiler][su_spoiler title=”Approval and Certification” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that any such human subjects research and investigation should be reviewed, then either not approved or certified as approved by an internal review board (the “IRB”), as described in this Policy.[/su_spoiler][su_spoiler title=”Beneficence” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should be beneficent with respect to you — as the human subject under study — then with respect to the field and community where the study is conducted.[/su_spoiler][su_spoiler title=”Non-Maleficence” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should be non-maleficent with respect to you — as the human subject under study — then with respect to the field and community where the study is conducted.[/su_spoiler][su_spoiler title=”Justice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should be just with respect to you — as the human subject under study — then with respect to the field and community where the study is conducted.[/su_spoiler][su_spoiler title=”Lawfulness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should be lawful with respect to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Research and Investigation Purpose” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should have and adhere to an explicit, legitimate and specific purpose for such research or investigation, clearly understood by you — as the human subject under study — prior to, during and after the research or investigation.[/su_spoiler][su_spoiler title=”Respect for Autonomy via Informed Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should show and maintain respect for the autonomy of human subjects, by obtaining and maintaining your informed consent — as the human subject under study — to the specific activity, purpose and study, prior to, during and after the research or investigation.[/su_spoiler][su_spoiler title=”Necessity and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should be conducted by means that are necessary for its consented purpose.

— and biospecimens, data and information processed should be the minimum necessary for such research, its consented means and its consented purpose.[/su_spoiler][su_spoiler title=”Non-Identification” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should be conducted by means that ensure your non-identification — as the human subject under study — to the most feasible and reasonable extent.

— and biospecimens, data and information should be processed by means that ensure your non-identification — as the human subject under study — to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Privacy and Confidentiality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should be conducted by means that maintain your privacy and confidentiality — as the human subject under study.

— and biospecimens, data and information should be processed by means that maintain your privacy and confidentiality — as the human subject under study.[/su_spoiler][su_spoiler title=”Protection and Security” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should be conducted by means that maintain your protection and security — as the human subject under study.

— and biospecimens, data and information should be processed by means that maintain your protection and security — as the human subject under study.[/su_spoiler][su_spoiler title=”Sensitivity and Sensitive Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation involving the processing of sensitive biospecimens, data and information should be prohibited, except as delineated and described in these Codes and Policies.[/su_spoiler][su_spoiler title=”Transparency, Informing and Facilitating Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should be preceded and accompanied by transparent communication and notification reasonably informing you — as the human subject under study.

— and that human subjects research and investigation should, upon your reasonable request, be accompanied by transparent communication and notification to you — as the human subject under study — helping you exercise your human subjects research and investigation rights.[/su_spoiler][su_spoiler title=”Commensurability” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that human subjects research and investigation should be accompanied by a process to ensure commensurability is reached in good faith during the review and approval of human subjects research and investigation, as well as cases with apparent inadequacies in the fulfillment of principles, rights and responsibilities of human subjects research and investigation.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Principle of Applicability

Below are subsequent criteria The Ikoku Foundations shall follow to determine the applicability of this Policy to any activity or operation within, for, on behalf of, in reference to and more generally pertaining to The Ikoku Foundations, as well as such activities and operations seeking funding or support of The Ikoku Foundations. It should be understood that The Ikoku Foundations determine such activity or operation to constitute human subjects research or human subjects investigation when all three of the following apply:

[su_accordion class=””][su_spoiler title=”Distinction Between Practice and Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the conductors or proposers of any given activity or operation make and maintain adequate distinctions between practice — designed solely to deliver or provide an action or benefit with reasonable expectation of success — and research or investigation — designed to inquire, to test an hypothesis or thesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.[/su_spoiler][su_spoiler title=”Determination of Research and Investigation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the activity or operation constitutes research or investigation — meaning a systematic study designed to contribute to or develop generalizable knowledge, with such study including research design, development, evaluation and testing. Activities that meet this definition constitute research or investigation for purposes of this Policy, whether or not they are conducted or supported under a program that is considered research or investigation for other purposes.[/su_spoiler][su_spoiler title=”Determination of Human Subject” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and the research or investigation involves a human subject — meaning a living individual about or from whom a researcher or investigator (whether professional, non-professional or student) conducting research or investigation:

— (a) obtains biospecimens, data or information through interaction or intervention with the individual, and analyzes, studies, uses or otherwise processes the biospecimens, data or information; or

— (b) analyzes, generates, obtains, studies, uses or otherwise process identifiable biospecimens, identifiable private or sensitive data, or identifiable private or sensitive information.[/su_spoiler][su_spoiler title=”Culmination in Narrow Applicability” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and, with the above met, this Policy only applies to actions, activities and operations constituting research or investigation on human subjects — including when involving the access and other processing of biospecimens, data and information attributable to, identifying or otherwise relating to a specific natural person — as conducted by persons employed, funded, managed or otherwise directed or supported by The Ikoku Foundations, narrowly defined, engaging or functioning in an allowed, approved and authorized area, capacity and manner.[/su_spoiler][/su_accordion]

Research and Investigation Activities Not Exempt Under Policy: Contrary to certain guidelines on human subjects research — and due to past and recent abuse of such protocols — the following activities and operations are not exempt from this Policy and rigorous review:

[su_accordion class=””][su_spoiler title=”Academic, Historical, Journalistic and Scholarly Activities” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]research or investigation conducted as part of, in support of, or for the purposes of academic, historical, journalistic and scholarly activity (such as biography, cultural and social studies, humanistic and religious studies, journalism, legal research, literary criticism, news, nonfiction, oral history and historical scholarship) that focuses directly on specific living individuals about whom data and information are accessed, gathered or otherwise processed — such research and investigation remain subject to this Policy.[/su_spoiler][su_spoiler title=”Benign Interactions or Interventions Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]research and investigation conducted on benign interactions or interventions — such research and investigation remain subject to this Policy, and should adhere to further regulations to be found in the section, Additional Specific Guidelines.[/su_spoiler][su_spoiler title=”Educational Settings Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]research or investigation conducted in commonly accepted or established educational settings — such research and investigation remain subject to this Policy, and should adhere to further regulations to be found in the section, Additional Specific Guidelines.[/su_spoiler][su_spoiler title=”Educational Testing Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]research and investigation conducted on interactions involving educational tests — such research and investigation remain subject to this Policy, and should adhere to further regulations to be found in the section, Additional Specific Guidelines.[/su_spoiler][su_spoiler title=”Health Care Operations Activities” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]research or investigation conducted as part of, in support of, or for the purposes of health care operations and health care operations research — such research and investigation remain subject to this Policy, and should adhere to further regulations to be found in the section, Additional Specific Guidelines.[/su_spoiler][su_spoiler title=”Public Benefit and Service Programs Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]research, investigation and demonstration projects conducted or supported by a government or public authority — or otherwise subject to the approval of government or public authority — that are designed to evaluate, improve, study or otherwise examine public benefit or service programs — such research and investigation remain subject to this Policy, and should adhere to further regulations to be found in the section, Additional Specific Guidelines.[/su_spoiler][su_spoiler title=”Public Health Surveillance Activities” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]research or investigation conducted as part of, in support of, or for the purposes of public health surveillance activities — such research and investigation remain subject to this Policy, and should adhere to further regulations to be found in the section, Additional Specific Guidelines.[/su_spoiler][su_spoiler title=”Public Security and Criminal Justice Activities” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]research or investigation conducted as part of, in support of, or for the purposes of criminal justice or criminal investigative purposes, defense, homeland security, intelligence or other national security missions — such research and investigation remain subject to this Policy.[/su_spoiler][su_spoiler title=”Secondary Research Activities and Uses” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]research or investigation conducted as part of, in support of, or for the purposes of secondary research activities or uses on identifiable biospecimens, identifiable data, or identifiable information, whether or not publicly available, whether or not confidential, identifying, personal, private or sensitive, and including storage and maintenance activities — such research and investigation remain subject to this Policy.[/su_spoiler][su_spoiler title=”Taste, Food Quality and Consumer Acceptance Studies” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]research and investigation conducted as part of, in support of, or for the purposes of taste and food quality evaluation and consumer acceptance studies — such research and investigation remain subject to this Policy, and should adhere to further regulations to be found in the section, Additional Specific Guidelines.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Principle of Approval and Certification

Below are subsequent criteria The Ikoku Foundations shall follow to review — and either not approve or certify for approval — projects, proposals, protocols and studies in human subjects research and investigation. It should be understood that The Ikoku Foundations determine a given research or investigation study to be adequately reviewed only if and to the extent that all of the following apply:

[su_accordion class=””][su_spoiler title=”Founder and Internal Review Board” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the Founder, Alvan Azinna Chibuzo Ikoku, as part of the internal review board of The Ikoku Foundations (the “IRB”) initially then continually or periodically reviews, approves or disapproves all research or investigation activities and studies covered by this Policy, before, during and after they are conducted.[/su_spoiler][su_spoiler title=”Requests for Review and Approval” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the Founder, Alvan Azinna Chibuzo Ikoku, as part of the IRB, requires submission of projects, proposals, protocols and studies concerning proposed, ongoing or reported research and investigation activities; requires modifications in such materials and research and investigation activities (to secure approval or compliance); and where applicable, observes the consent process and any appropriate aspects of proposed, ongoing or reported research and investigation activities.[/su_spoiler][su_spoiler title=”Review for Minimization of Risk” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the IRB assesses for and determines risks to you — as the human subject under study — are minimized.

— and in evaluating risk minimization, the IRB considers and strongly recommends (even restricts approval to) procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and

— whenever appropriate, the IRB considers and strongly recommends (even restricts approval to) procedures already being performed on you and other human subjects for diagnostic or treatment purposes.[/su_spoiler][su_spoiler title=”Review for Reasonable Benefit-Risk Relation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the IRB assesses for and determines risks to you — as the human subject under study — are reasonable in relation to anticipated benefits, if any, to you, and the importance of the knowledge that may reasonably be expected to result.

— and in evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies you would receive even if not participating in the research).

— and the IRB does not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.[/su_spoiler][su_spoiler title=”Review for Equitable Research Subjects Selection” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the IRB assesses for and determines the selection of human subjects is equitable.

— and in making this assessment the IRB does not take into account the purposes of the research and the setting in which the research will be conducted.

— and the IRB remains particularly cognizant of the special problems of research that involves a category of human subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.[/su_spoiler][su_spoiler title=”Review for Informing and Documented Consent Process” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the IRB assesses for and determines the consent process adequately informs you — as the human subject under study — and informed consent is sought from each prospective human subject, in accordance with this Policy.

— and in making this determination the IRB confirms appropriate documentation of consent process and informed consent.[/su_spoiler][su_spoiler title=”Review for Assessment and Monitoring of Activities and Methods” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where applicable, the IRB assesses for and determines adequate provision for monitoring the research or investigation activities and methods — including any interactions, interventions, and processing of biospecimens, data and information — to ensure the fulfillment of principles, rights and responsibilities of human subjects research to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Review for Monitoring of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where applicable, the IRB assesses for and determines adequate provision for monitoring the biospecimens, data and information that are accessed or otherwise processed to ensure the fulfillment of principles, rights and responsibilities of human subjects research, especially the confidentiality, privacy, safety, security and sensitivity protections against risks to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Review for Privacy and Confidentiality of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where appropriate, the IRB assesses for and determines adequate provision to obtain, maintain and protect the privacy and confidentiality of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Possible Further Review” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]research or investigation approved by the IRB may be subject to further appropriate review (and approval or disapproval) by authorized officials of The Ikoku Foundations — including the possibility of a recommended rejection of IRB decisions on grounds of anticipated or confirmed creation of difficult legal or policy problems — though such officials cannot approve the research or investigation if it has not been approved by the IRB.[/su_spoiler][su_spoiler title=”Certification on Approval” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]all IRB approvals of research or investigation activities covered by this Policy are confirmed then certified by expressly written instrument signed and sealed of the Founder, Alvan Azinna Chibuzo Ikoku, .[/su_spoiler][su_spoiler title=”Periodic Review and Termination” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the IRB periodically reviews and has authority to suspend or terminate approval of any research or investigation study that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to you or any other human subjects under study.

— and any suspension or termination of approval includes a written statement of the reasons for the IRB action and is reported promptly to the investigator and appropriate institutional and regulatory officials.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Principle of Beneficence

Below are subsequent criteria The Ikoku Foundations shall follow to determine beneficence before, during and after human subjects research and investigation. It should be understood that The Ikoku Foundations determine such research and investigation to be beneficent only if and to the extent that all of the following apply:

[su_accordion class=””][su_spoiler title=”Obligation to Maximize Benefit of Interaction or Intervention” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to maximize the benefits of any given interaction or intervention for you — as the human subject under study.[/su_spoiler][su_spoiler title=”Obligation to Maximize Benefit of Research and Investigation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to maximize the benefits of the research and investigation for you — as the human subject under study.[/su_spoiler][su_spoiler title=”Obligation to Maximize Benefit to Field of Knowledge” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that the researcher or investigator conduct research and investigation activities by means that meet the ethical obligation to maximize the benefits of the research and investigation to the field of knowledge in which the research and investigation are conducted.[/su_spoiler][su_spoiler title=”Obligation to Maximize Benefit to Community and Society” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to maximize the benefits of the research and investigation to the community and society to which the human subject under study belongs, and in which the research and investigation are conducted.[/su_spoiler][su_spoiler title=”Obligation to Maximize Benefit to Environment” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to maximize the benefits of the research and investigation to the biosphere and physical and vegetative environments.[/su_spoiler][su_spoiler title=”Obligation to Prioritize Human Subject over Community and Society” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to prioritize the interests and welfare of you — as the human subject under study — over the interests of the field, community, environment and society in which the research and investigation are conducted.[/su_spoiler][su_spoiler title=”Obligation to Avoid Undue Inducement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to avoid the use of benefits as undue inducement to elicit research and investigation participation of you — as a potential human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Principle of Non-Maleficence

Below are subsequent criteria The Ikoku Foundations shall follow to determine non-maleficencebefore, during and after human subjects research and investigation. It should be understood that The Ikoku Foundations determine such research and investigation to be non-maleficent only if and to the extent that all of the following apply:

[su_accordion class=””][su_spoiler title=”Obligation to Minimize Harm of Interaction or Intervention” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to minimize the harms of any given interaction or intervention for you — as the human subject under study.[/su_spoiler][su_spoiler title=”Obligation to Minimize Harm of Research and Investigation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to minimize the harms of the research and investigation for you — as the human subject under study.[/su_spoiler][su_spoiler title=”Obligation to Minimize Harm to Field of Knowledge” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to minimize the harms of the research and investigation to the field of knowledge in which the research and investigation are conducted.[/su_spoiler][su_spoiler title=”Obligation to Minimize Harm to Community and Society” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to minimize the harms of the research and investigation to the community and society to which the human subject under study belongs, and in which the research and investigation are conducted.[/su_spoiler][su_spoiler title=”Obligation to Minimize Harm to Environment” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to minimize the harms of the research and investigation to the biosphere and physical and vegetative environments.[/su_spoiler][su_spoiler title=”Obligation to Prioritize Human Subject over Community and Society” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to prioritize the interests and welfare of you — as the human subject under study — over the interests of the field, community, environment and society in which the research and investigation are conducted.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Principle of Justice

Below are subsequent criteria The Ikoku Foundations shall follow to determine justice before, during and after human subjects research and investigation. It should be understood that The Ikoku Foundations determine such research and investigation to be just only if and to the extent that all of the following apply:

[su_accordion class=””][su_spoiler title=”Obligation to Attend to and Protect Vulnerable Populations” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to account for, attend to and protect vulnerable populations.[/su_spoiler][su_spoiler title=”Obligation to Account for a History of Vulnerable Populations” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to account for a history of vulnerable populations, and to not repeat patterns of unethical conduct pertinent to the field, community and society in which the research and investigation are conducted.[/su_spoiler][su_spoiler title=”Obligation to Avoid Discriminatory Bias or Effects or Stigma” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to avoid discriminatory bias or effects or stigma on the human subjects, their selection or in the research and investigation, including, for instance, confidentiality and privacy protections against disclosure of participation or personal data and information; and attention to whether patterns in human subjects selection has more to do with ease of coercion or recruitment than for reasons directly related to the hypothesis, problem or question being studied.[/su_spoiler][su_spoiler title=”Obligation to Avoid Abrogation or Infringement and Civil and Fundamental Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to avoid abrogation or infringements of civil liberties, civil rights and fundamental freedoms of human subjects.[/su_spoiler][su_spoiler title=”Obligation to Not Take Advantage of Less Strict Regulation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to not take advantage of absent, fewer, lapsed, lax, lesser, lower or other differences in regulation of human subjects research and investigation.[/su_spoiler][su_spoiler title=”Obligation to Maximize Benefits and Minimize Harms Across Populations” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the researcher or investigator conducts research and investigation activities by means that meet the ethical obligation to maximize the benefits, minimize the harms and more equitably distribute the burdens of the research and investigations across the fields, communities, populations and states in which the research and investigation are conducted.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Principle of Lawfulness

Below are subsequent criteria The Ikoku Foundations shall follow to determine and ensure the lawfulness of human subjects research and investigation, especially when processing biospecimens, data and information attributable to, identifying or otherwise relating to you. It should be understood that The Ikoku Foundations determine such research and investigation to be lawful only if and to the extent that all of the following apply:

[su_accordion class=””][su_spoiler title=”Human Subject Informed by Transparent Communication” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]you — as the human subject under study — are provided transparent communication and notification reasonably informing you about the research or investigation study and its activities, including any processing of biospecimens, data and information.[/su_spoiler][su_spoiler title=”Informed and Unrevoked Consent of Human Subject” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and you — as the human subject under study— have also given and not revoked informed consent to the research or investigation study and its activities, including any processing of biospecimens, data and information, for an explained, explicit, legitimate and specific purpose.[/su_spoiler][su_spoiler title=”Necessity for Consented or Assented Purpose” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including any processing of biospecimens, data and information, are conducted by means that are necessary to fulfill the explained, explicit, legitimate and specific purpose consented (or assented) to by you — as the human subject under study.[/su_spoiler][su_spoiler title=”Proportionate to Consented or Assented Purpose” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including any processing of biospecimens, data and information, are conducted by means that are proportionate — or appropriate, effective and commensurate with fulfilling the explained, explicit, legitimate and specific purpose consented (or assented) to by you — as the human subject under study.[/su_spoiler][su_spoiler title=”Accordance with Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including any processing of biospecimens, data and information, are conducted by means that are in accordance with and do not abrogate or diminish the civil liberties or basic, civil or fundamental rights of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Accordance with Law” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including any processing of biospecimens, data and information, are conducted by means that are in accordance with and do not violate applicable guidelines, law or regulations.[/su_spoiler][su_spoiler title=”Accordance with Ethics” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including any processing of biospecimens, data and information, are conducted by means that are in accordance with and do not violate ethics codes, policies and regulations, especially the approval and review process of the IRB, these Codes and Policies, and the Founding Code of Ethics.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Principle of Purpose

Below are subsequent criteriaThe Ikoku Foundations shall follow to determine and ensure the quality of the purposes for human subjects research and investigation. It should be understood that The Ikoku Foundations determine a purpose for research or investigation to be appropriate, ethical and respectful only if and to the extent that allof the following apply:

[su_accordion class=””][su_spoiler title=”Purpose Should be Explicit” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where the purpose for the research or investigation is explicit, or clearly explained to you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Purpose Should be Specific” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where the purpose for the research or investigation is specific, or clearly defined, delineated and specified to you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Purpose Should be Legitimate” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where the purpose for the research or investigation is legitimate, or has a reasonable basis that is clear, expected and understandable to you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Purpose Should be Consented” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where the purpose for the research or investigation is consented to by you — as the human subject under study — before, during and after the research or investigation study.

— or, with the above given precedence and good faith opportunity, but where consent cannot be freely given or meaningful, only if the research or investigation has been assented to by you — as described in these Codes and Policies — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Where Added or Changed, then Limited, Compatible and Reviewed for Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and, where the purpose has been changed from or added to the original purpose for research or investigation, only if such changed or new purpose is also limited and compatible — or has an association to the original purpose that you would consider to be close, compatible and in keeping with your consent, and so you would reasonably expect the addition or change.

— and, if so, that the expectation is also confirmed as soon as reasonably possible, by having the changed or new purpose reviewed and consented to by you — as the human subject under study — or otherwise assented.[/su_spoiler][/su_accordion]

Furthermore, The Ikoku Foundations determine a purpose to be legitimate only if and to the extent that the above and all of the following apply:

[su_accordion class=””][su_spoiler title=”Reasonably Expected by Human Subject Given Relationship and Understanding” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the nature of the purpose is reasonably expected by you — as the human subject under study — given your relationship to and understanding of the research or investigation study.[/su_spoiler][su_spoiler title=”Reasonably Expected by Human Subject Given Proportionality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the scope of the purpose is reasonably expected by you, given your understanding that such purposes be proportionate — or appropriate, effective and commensurate with your relationship to and understanding of the research or investigation study.[/su_spoiler][su_spoiler title=”Reasonably Expected by Human Subject Given Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the purpose is reasonably expected by you — as the human subject under study‘ — given your understanding that such purposes be in keeping with the protection of your rights and freedoms, and the fulfillment of the principles, rights and responsibilities of human subjects research and investigation.[/su_spoiler][su_spoiler title=”Reasonably Expected by Field Given Prior Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the purpose is acceptable, sound and reasonably expected by the field of knowledge or practice in which the research or investigation is conducted — given prior research or investigation and published papers, reports, results or scholarship.[/su_spoiler][su_spoiler title=”Legal and Law-Abiding” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the purpose is legal and law-abiding with respect to you — as the human subject under study — but also with respect to applicable local, regional, national and international law.[/su_spoiler][su_spoiler title=”Ethical and Approved” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and the purpose is ethical with respect to you — as the human subject under study — but also with respect to requirements and standards set out for its approval and authorization by The Ikoku Foundations — as delineated and described in applicable guidelines, protocols and regulations, the Founding Codes of Ethics, and these Codes and Policies.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Principle of Informed Consent

Below are subsequent criteria The Ikoku Foundations shall follow in determining and ensuring informed consent before, during and after human subjects research and investigation. It should be understood that The Ikoku Foundations determine your informed consent to be adequately addressed via a five-part evaluation.

The first part consists of a statement of community standards The Ikoku Foundations uphold with respect to consent and their subsequent ethics requirements:

[su_accordion class=””][su_spoiler title=”Consent as Fundamental Basis” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your consent is and remains a fundamental basis for actions you conduct within and in relation to communities and societies, and it is also a fundamental basis of your presence within and in relation to those communities and societies.[/su_spoiler][su_spoiler title=”Participation in Research as Subject to Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your participation in research or investigation is an important aspect of your conduct and presence within and in relation to communities and societies — and so such participation should be subject to your consent.[/su_spoiler][su_spoiler title=”Biospecimens, Data and Information as Subject to Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]any biospecimens, data and information attributable to, identifying or otherwise relating to you are important aspects of your conduct and presence within and in relation to communities and societies — and so such biospecimens, data and information, including their processing, should be subject to your consent.[/su_spoiler][su_spoiler title=”Human Subjects Should be Treated as Individual, Freely Deciding Persons” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]human subjects should be treated as individual persons with the ability to freely make decisions — which requires The Ikoku Foundations to acknowledge their personhood by providing ample opportunities for their informed consent to a proposed research or investigation study.[/su_spoiler][su_spoiler title=”Human Subjects with Diminished Freedom to Decide Should be Protected” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]human subjects with diminished ability to freely make decisions should still be treated as individual decision-making persons but also be protected — which requires The Ikoku Foundations to acknowledge their personhood and situation by providing ample opportunities for their informed assent, as well as safeguards and at times non-approval of research and investigation studies.[/su_spoiler][/su_accordion]

The second part consists of the standard The Ikoku Foundations shall follow in asking for and maintaining consent before, during and after human subjects research and investigation. It should be understood that The Ikoku Foundations determine consent to be given and maintained only if and to the extent that the following standard has been met:

[su_accordion class=””][su_spoiler title=”Consent Warranting Respect” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]consent should not be a matter for coercion, confusion, deception, force or trickery — it should be a matter for respect, when asked, given, or withdrawn.[/su_spoiler][su_spoiler title=”Consent, Ethical and Legally Effective Standard” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]so consent with respect to research or investigation should be affirmative, clear, freely given, reasonably informed, meaningful, revocable, unambiguous and written by you — as the human subject under study — and furthermore expressly indicated for an explicit, legitimate and specific purpose for the research or investigation study, for the study’s activities and methods, and where applicable, also for processing biospecimens, data and information attributable to, identifying or otherwise relating to you — as these purposes are delineated and explained in an accessible, clear, easily legible and understandable, informing and written form, page or request.[/su_spoiler][/su_accordion]

As you may already be able to tell from the paragraph above, consent is a high-quality standard, and an important basis for the work The Ikoku Foundations do regarding human subjects research and investigation. The Ikoku Foundations wish for you to be educated as well as informed during your decisions to give or withdraw consent. And to do that the Policy will start here to break consent into its essential components and explain each one.

So the third part of our evaluation concerns making sure you are in a situation where your consent can be freely given and meaningful.

[su_accordion class=””][su_spoiler title=”Where Consent Can Be Freely Given and Meaningful” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]for consent pertaining to human subjects research and investigation to be freely given and meaningful, the consent process should involve your free or genuine choice — without coercion, confusion, deception, force, misunderstanding, trickery or undue inducement (paying you too much) — and your ability to refuse or withdraw such consent without unfair detriment, non-enjoyment of or non-participation in an authorized part of The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Where Consent Cannot Be Freely Given or Meaningful” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]meanwhile, consent cannot be presumed to be freely given or meaningful if the asker or requester for your consent is in a position to compel consent from you; where you have no reasonable option but to give consent; where you were made to understand that you needed to consent when you did not; or where you are not able to proceed with an expected standard of living without engaging in an activity that presumes your consent.[/su_spoiler][su_spoiler title=”Classic Situations of Consent Not Freely Given or Meaningful” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]therefore consent pertaining to human subjects research and investigation cannot be presumed to be freely given or meaningful — and it is unlikely to be ethical or legally effective — if the asker or requester is a public authority, public office or government official or a judiciary representative with a subpoena or warrant; or if you are offered too much money or too high a benefit for you to reasonably refuse; or if you are a child and need your next of kin to take your wishes into account in providing assent to the research or investigation; or if the asker or requester presents consent pertaining to research or investigation as necessary or required where it is not (e.g. asking consent to a research study as though necessary for the performance of an agreement or contract, or the provision of a product or service, when such research is not necessary for such performance or such provision).[/su_spoiler][su_spoiler title=”The Goal is Freely Given and Meaningful, Of Course” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the goal, when The Ikoku Foundations ask for your consent, is to have any positive decision on your part be freely given and meaningful — so to anticipate and avoid or detect and eliminate any of the above scenarios or their equivalent, sometimes by not approving a study for you or anyone — and where this is not possible the equally important goal is to reasonably inform you of that situation, so that you are reasonably aware of the quality of any consent — or assent — given, or any alternative grounds upon which you may become or be asked to become a human subject for research or investigation.[/su_spoiler][/su_accordion]

The next part of the Policy evaluation has to do with making sure the consent process reasonably informs you — as the potential human subject under study. That typically occurs when the form, page, part, presentation or request for consent fulfills requirements for reasonably transparent communication and notification regarding human subjects research and investigation. It should be understood that The Ikoku Foundations determine the consent process to be reasonably informing only if and to the extent that all of the following apply:

[su_accordion class=””][su_spoiler title=”Reasonably Informing, Ethical Standard” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification provide to you — as the human subject under study — all the key information, in sufficient detail, that a reasonable person would want to have in order to make an informed decision about whether to participate as a human subject in the research or investigation study, and an opportunity to discuss that information.

— and so the informing process does not merely provide lists of isolated facts, but is instead organized in a manner most likely to assist you — as a potential human subject under study — in understanding the reasons why you might or might not want to participate in the study.[/su_spoiler][su_spoiler title=”Informing, Confirmation of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification provide to you — as the human subject under study — confirmation that the study you are participating in involves research or investigation, the approximate number of human subjects involved in the study, whether the study involves an interaction or intervention as part of its methods, and whether biospecimens, data or information attributable to, identifying or otherwise relating to you will be accessed or otherwise processed.[/su_spoiler][su_spoiler title=”Informing, Purposes of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — the explicit, legitimate and specific purpose for the research or investigation, and where applicable the explicit, legitimate and specific purpose for which biospecimens, data or information attributable to, identifying or otherwise relating to you will be accessed or otherwise processed.[/su_spoiler][su_spoiler title=”Informing, Duration of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — the period of time during which the research or investigation will be conducted, the duration of your participation as human subject under study, and where applicable the period of time during which biospecimens, data or information attributable to, identifying or otherwise relating to you will be accessed or otherwise processed.[/su_spoiler][su_spoiler title=”Informing, Methods of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — the means, measures and methods by which, as well as the extent to which, the research or investigation will be conducted, including descriptions of any interaction or intervention.

— also clearly confirm and explain procedures that you — as the human subject under study — will be asked to follow.

— also clearly identify and explain any methods or procedures that are experimental.

— and where applicable, clearly confirm and explain the means, measures and methods by which, as well as the extent to which, biospecimens, data or information attributable to, identifying or otherwise relating to you will be accessed or otherwise processed.[/su_spoiler][su_spoiler title=”Informing, Recipients of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where applicable, such communication and notification clearly explain to you — as the human subject under study — what recipients and categories of recipients will receive biospecimens, data or information attributable to, identifying or otherwise relating to you — including any transfers to any third party, third country, governmental office or international organization.[/su_spoiler][su_spoiler title=”Informing, Content of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where applicable, such communication and notification clearly explain to you — as the human subject under study — what categories, content and nature of biospecimens, data or information attributable to, identifying or otherwise relating to you will be accessed or otherwise processed.[/su_spoiler][su_spoiler title=”Informing, Processes of Non-Identification” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — whether and how identifiers shall be removed from any biospecimens, data or information accessed, gathered or otherwise processed about or from you.

— and clearly confirm and explain, whether or not other processes of non-identification are to be employed, including periodic re-identification, and if so under what circumstances and to what extent.[/su_spoiler][su_spoiler title=”Informing, Future Research and Processing of Content” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly confirm to you — as the human subject under study —  that whether or not such processes of non-identification are conducted, the biospecimens, data or information shall not be used for future research studies or distributed to another researcher or investigator for future research studies, unless with additional informed consent from you.[/su_spoiler][su_spoiler title=”Informing, Commercial Research and Processing of Content” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly confirm to you — as the human subject under study —  that whether or not such processes of non-identification are conducted, the biospecimens, data or information shall not be used for commercial profit or equivalent benefit without your explicit consent and agreement to terms.[/su_spoiler][su_spoiler title=”Informing, Genomic Research and Processing of Content” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly confirm to you — as the human subject under study — whether the research or investigation will or might include whole genome sequencing of biospecimens accessed, gathered or otherwise processed about or from you, particularly if sequencing a human germline or somatic specimen with the intent to generate the genome or exome sequence of that biospecimen.

— and such communication and notification clearly confirm to you — as the human subject under study — that whether or not processes of non-identification are conducted, the biospecimens, data or information shall not undergo or be used for genetic testing, genomic sequencing or their equivalent processing without your explicit consent and agreement to terms.[/su_spoiler][su_spoiler title=”Informing, Costs and Discomforts of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — any additional costs or discomforts to you that may reasonably be expected from the research or investigation.

— and where applicable, clearly confirm and explain any costs or discomforts to you — as the human subject under study — that may reasonably be expected from the provision of such biospecimens, data or information that will be accessed or otherwise processed.[/su_spoiler][su_spoiler title=”Informing, Benefits of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — any benefits to you or to others that may reasonably be expected from the research or investigation.

— and where applicable, clearly confirm and explain any benefits to you — as the human subject under study —  or to others that may reasonably be expected from the provision of biospecimens, data and information that will be accessed or otherwise processed.[/su_spoiler][su_spoiler title=”Informing, Risks of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — any risks to you or to others that may reasonably be expected from the research or investigation.

— and where applicable, clearly confirm and explain any risks to you — as the human subject under study — or to others that may reasonably be expected from the provision of biospecimens, data and information that will be accessed or otherwise processed.

— and where applicable, clearly confirm and explain the particular research or investigation methods, procedures or treatment possibly involving risks to you — as the human subject under study — or to an embryo or fetus (if you are or may become pregnant) that are currently unforeseeable.[/su_spoiler][su_spoiler title=”Informing, Alternatives to Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — appropriate alternative research or investigation procedures or courses of treatment, if any, that might be advantageous to you.

— and where applicable, clearly confirm and explain appropriate alternative methods or procedures, if any, that might be advantageous to you — as the human subject under study — for the provision, accessing, gathering or other processing of such biospecimens, data or information.[/su_spoiler][su_spoiler title=”Informing, Protections and Safeguards” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — protections and safeguards advantageous to you during and after your participation in the research or investigation, including, where applicable, protections and safeguards during and after accessing, gathering or otherwise processing any biospecimens, data or information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Informing, Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — your rights with respect to your participation in the research or investigation study, and where applicable, with respect to the access, gathering or other processing of biospecimens, data or information attributable to, identifying or otherwise relating to you, as well as the means and procedures for exercising your rights in relation to such participation and such processing.[/su_spoiler][su_spoiler title=”Informing, Disclosures During Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — whether clinically relevant research results, including individual results, are to be disclosed to you, and if so, under what conditions.

— and clearly confirm and explain whether significant new findings developed during the course of the research or investigation that may relate to your willingness to continue your participation — as the human subject under study — are to be provided to you.[/su_spoiler][su_spoiler title=”Informing, Early Termination or Withdrawal” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — anticipated circumstances under which your participation may be terminated by the researcher or investigator without regard to your consent or assent.

— and clearly describe and explain the consequences of your decision to withdraw your participation — as the human subject under study — and procedures for orderly termination of participation by your decision.[/su_spoiler][su_spoiler title=”Informing, Ideally Voluntary Nature of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — that participation should be voluntary, that refusal to participate should involve no penalty or loss of benefits to which you are otherwise entitled, and that you should be able to discontinue your participation at any time without penalty or loss of benefits to which you are otherwise entitled.[/su_spoiler][su_spoiler title=”Informing, Any Compulsory Nature of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]nevertheless, such communication and notification clearly confirm to you — as the human subject under study — whether your participation in the research or investigation study is a contractual or statutory requirement, or a requirement necessary to enter into an agreement or contract, as well as whether you are obliged to participate in the research or investigation study, and the possible consequences of failure to participate in the research or investigation study.

— and where applicable, clearly confirm whether the provision of such biospecimens, data or information is a contractual or statutory requirement, or a requirement necessary to enter into an agreement or contract, as well as whether you are obliged to provide the biospecimens, data or information, and the possible consequences of failure to provide such biospecimens, data or information.[/su_spoiler][su_spoiler title=”No Exculpatory Language” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification contain no exculpatory language through which you — as the potential human subject under study — are made to waive or appear to waive any of your legal rights, or release or appear to release the researcher or investigator, sponsor, institution or any of their agents from liability for negligence.[/su_spoiler][su_spoiler title=”Informing, Injury Compensation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where there is more than minimal risk, such communication and notification clearly explain to you — as the human subject under study — whether any compensation and medical treatments are available to you if injury occurs and, if so, what they consist of, or where further information may be obtained.[/su_spoiler][su_spoiler title=”Informing, Communication about Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — the procedures for obtaining confirmation and communication with respect to the research or investigation, and where applicable, with respect to the accessing, gathering and other processing of biospecimens, data or information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Informing, Responsible Entity, Offices or Persons” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification provide to you — as the human subject under study — the identity and contact information of the entity, office or persons responsible for the research or investigation study, and the identity and contact information of the entity, office or persons responsible for the processing of any biospecimens, data or information, including whom you are to contact for answers to pertinent questions, and in the event of a research-related injury to you.[/su_spoiler][su_spoiler title=”Informing, Period of Discussion and Consideration” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and most importantly, such communication and notification reasonably provide to you — as the human subject under study — sufficient period of time and opportunity to ask questions, discuss and finally consider — with minimal possibility of coercion or undue influence — whether or not to participate in the research or investigation study, as well as how you may withdraw consent after entry.[/su_spoiler][su_spoiler title=”Given No Adverse Effects on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that such communication and notification to you — as the human subject under study — whether pertaining to the research, investigation, biospecimens, data and information or their processing, do not adversely affect the civil liberties and basic, civil and fundamental rights of others — particularly those of other human subjects under study and natural or legal persons concerned, including The Ikoku Foundations and their Founder, Alvan Azinna Chibuzo Ikoku.[/su_spoiler][su_spoiler title=”Given Necessity, Non-Identification and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that such communication and notification to you — as the human subject under study — whether pertaining to the research, investigation, biospecimens, data and information or their processing, adhere to and fulfill the principles of necessity, non-identification and data-minimization.[/su_spoiler][su_spoiler title=”Given Adherence to Founding Mission and Code of Ethics” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that such communication and notification adhere to and not be incompatible with the founding of The Ikoku Foundations, originating mission and purposes, and Founding and Governing Code of Ethics, most especially our concern and protections for confidentiality and privacy.[/su_spoiler][/su_accordion]

The fifth and final component has to do with establishing clarity, identity and understanding during the consent process itself. It is best to explain this component of consent as the Policy places all five parts together. It should thus be clearer, now, when the Policy states that The Ikoku Foundations endeavor to achieve and maintain a quality of informed consent meeting the above standard, by having all of the following apply:

[su_accordion class=””][su_spoiler title=”Authorized and Identified Parties to Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the consent process is between an accurately, appropriately, clearly, correctly and securely authorized and identified employee or part of The Ikoku Foundations and an accurately, appropriately, clearly, correctly and securely identified natural or legal person who is a potential or prospective human subject for a research on investigation study.[/su_spoiler][su_spoiler title=”Written and Documentable Consent Process” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the form, page, part or request for consent is in writing, written communication or a written instrument.

— and such written communication or instrument is documentable or preservable as part of the records of The Ikoku Foundations, to be later reproducible in legible, physical and written form wherever there is need to demonstrate the actions and decisions of the consent process.[/su_spoiler][su_spoiler title=”Accessible and Understandable Consent Process ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the form, page, part or request for consent is easily accessible and easy to understand for you — as the human subject under study — and clear and plain language be used in such writing, written communication or written instrument.[/su_spoiler][su_spoiler title=”Explicit, Legitimate and Specific Purpose” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the form, page, part or request for consent clearly delineates, describes and explains to you — as the human subject under study — an explicit, legitimate and specific purpose for which your consent is being ascertained.[/su_spoiler][su_spoiler title=”Ethical and Lawful Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the form, page, part or request for consent clearly delineates, describes and explains to you — as the human subject under study — the expectations and safeguards for ethical and lawful research or investigation, and where applicable, ethical and lawful processing of biospecimens, data or information.[/su_spoiler][su_spoiler title=”Reasonably Informing Consent Process” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]as delineated and described above, the form, page, part or request for consent, and the consent process itself, reasonably informs you — as the human subject under study.[/su_spoiler][su_spoiler title=”Freely Given and Meaningful Full, Partial or No Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the form, page, part or request for consent clearly indicates, where appropriate, fair, and non-disruptive, how you — as the human subject under study — could freely and meaningfully give full, partial or no consent to different purposes and processes — and also explains the effect of such consent on your enjoyment of or participation in an agreement, contract, product, service, site or authorized part of The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Good Faith Opportunity Where Consent Cannot be Freely Given or Meaningful” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the form, page, part or request for consent clearly discloses and explains to you — as the human subject under study — both where consent cannot be freely given or meaningful and the reasons for such a determination — then also provides a good faith opportunity for you to (a) confirm your own understanding of the nature of the consent and the determination; (b) decide whether to proceed with the informing consent process and, perhaps eventually, the research or investigation study, and where applicable the processing of biospecimens, data or information in question; (c) decide not to proceed at all; or (d) opt for any alternative research or investigation study, and where applicable the processing of biospecimens, data or information that may fulfill the same or equivalent purposes and where consent can be freely given and meaningful.[/su_spoiler][su_spoiler title=”Procedures for Withdrawal” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the form, page, part or request for consent includes a clear written statement informing you — as the human subject under study — of your right to revoke or withdraw consent at any time; the easily accessible, comprehensible and implementable procedures for revoking or withdrawing consent; and the effect of revoking or withdrawing consent on the lawfulness of the research or investigation conducted, and where applicable the processing conducted on biospecimens, data or information during the period in which your consent was given.[/su_spoiler][su_spoiler title=”Attestation and Confirmation of Identity” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the form, page, part or request for consent includes a means by which you — as the human subject under study — can accurately, clearly and unambiguously attest to and confirm your identity, appropriateness and authorization for giving, revoking or withdrawing consent.[/su_spoiler][su_spoiler title=”Attestation and Confirmation of Understanding” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the form, page, part or request for consent includes a means by which you — as the human subject under study — can accurately, clearly and unambiguously attest to and confirm your understanding and your being reasonably informed of the consent process and the terms of giving, revoking or withdrawing consent.[/su_spoiler][su_spoiler title=”Affirmative, Clear and Unambiguous” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the form, page, part or request for consent includes a means by which you — as the human subject under study — can provide an affirmative, clear and unambiguous indication of your consent decisions pertaining to research or investigation study, and where applicable the processing of biospecimens, data or information.

— note that such means should be by means of signature on a written instrument (as always required in biomedical, clinical or therapeutic research as well as any research involving biospecimens), but in certain instances could include, for example, clicking a button or ticking a box when visiting an internet website, choosing privacy and technical settings for products and services, or other conduct or statements that are defined or described to clearly indicate in this context the acceptance of proposed purposes and processes for the research on investigation study and the biospecimens, data or information.

— therefore The Ikoku Foundations understand inactivity, inference, pre-ticked boxes, presumption, silence, ambiguous, unclear or unintended language or sound and their equivalent to not constitute consent.[/su_spoiler][su_spoiler title=”Freely Given, Meaningful and Revocable” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the form, page, part or request for consent includes a means by which you — as the human subject under study — can accurately, clearly and unambiguously attest to and confirm the fact that any consent you provide is freely given, meaningful and revocable.[/su_spoiler][/su_accordion]

Addendum — What About Assent?: Then there are situations — as the Policy alluded to earlier — where the consent you give cannot be considered freely given and meaningful, or you may not be able to properly give consent at all — or to all that you and the researcher prospectively envision will develop during the research or investigation study. Here, The Ikoku Foundations still insist on treating you as a human being and individual as much as possible, and so aftercarrying out the informing consent process in good faith, the policy evaluation shall proceed through the order below and determine your assent to have been fulfilled when one of the following applies:

[su_accordion class=””][su_spoiler title=”Assent Where Necessary for Protection of Vital Interests” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]with the above given precedence and good faith opportunity, but where consent cannot be freely given or meaningful, The Ikoku Foundations ascertain your likely assent with substantial protections for you only if the research or investigation is still necessary to protect vital interests that are imminently essential to the life of you — as the human subject under study — with the standard being a medically-proven and imminently life-saving or benefiting procedure or treatment.

— in such contexts (especially where children are involved) the informed permission is frequently also required of another natural or legal person (for instance, a parent, guardian, advocate or legal representative). All persons asked and giving consent, assent or permission are to be provided the complete informing consent process to the fullest extent possible, and the standards for both affirmative indication (or withdrawal) and documentation remain the same as they are for informed consent.[/su_spoiler][su_spoiler title=”Assent Where Necessary for Protection of Rights and Associated Interests” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]or, with the above given precedence and good faith opportunity, but where consent cannot be freely given or meaningful, The Ikoku Foundations ascertain your likely assent with substantial protections for you only if the research or investigation is still necessary to protect the legal rights and associated interests of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Assent Where Necessary for Agreement or Contract” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]or, with the above given precedence and good faith opportunity, but where consent cannot be freely given or meaningful, The Ikoku Foundations ascertain your likely assent with substantial protections for you only if the research or investigation is stillnecessary for the performance of an agreement or contract of The Ikoku Foundations to which you — as the human subject under study — are a consented party.[/su_spoiler][su_spoiler title=”Assent Where Necessary for Compliance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]or, with the above given precedence and good faith opportunity, but where consent cannot be freely given or meaningful, The Ikoku Foundations ascertain your likely assent with substantial protections for you only if the research or investigation is still necessary for compliance with legal obligations to which The Ikoku Foundations are subject, as those obligations are described in the Codes and Policies and our other official governance documents.[/su_spoiler][su_spoiler title=”Assent Where Necessary for Corporate Duties and Functions” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]or, with the above given precedence and good faith opportunity, but where consent cannot be freely given or meaningful, The Ikoku Foundations ascertain your likely assent with substantial protections for you only if the research or investigation is still necessary for the performance of a duty or function carried out in the exercise of corporate authority vested in The Ikoku Foundations, as such authority, duties and functions are described in the Codes and Policies and our other official governance documents.[/su_spoiler][su_spoiler title=”Prospective Assent Where Agreement to Include Deception” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]or, with the above given precedence and guaranteed, but where the research or investigation study also involves as part of its approved methods deceptionregarding its nature or purpose, only if you — as the human subject under study — have, in addition to consent, authorized any deception through a prospective agreement to participate in research or investigation where subjects are informed that they will be unaware of or misled regarding the nature or purposes of the research.[/su_spoiler][su_spoiler title=”Given Complete Informing Consent Process” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that you — as the human subject under study — undergo the complete informed consent process.[/su_spoiler][su_spoiler title=”Given High Evidentiary Basis for Activity, Method and Measure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that establishes a high evidentiary basis for the rationale for recourse to assent and a high evidentiary basis for each activity, measure, method and operation conducted pursuant to assent — with the standard being that developed for evidence-based medicine.[/su_spoiler][su_spoiler title=”Given Benign Interactions or Interventions” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects) confirming that any proposed and active interaction or intervention is benign, that it will and does not adversely affect or impact human subjects, and is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject; and

— (f) neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Given Highly Favorable and Protective Benefit-Risk Assessment” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that there is rigorous assessment and confirmation (from the IRB and processor) that establishes the relation between benefit and risk to you — as the human subject under study — of the research or investigation activities, and the research processing of biospecimens, data and information, is highly favorable and highly protective.[/su_spoiler][su_spoiler title=”Given Strict Elimination of Risk of Adverse Effect or Impact on Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that there is rigorous assessment and confirmation (from the IRB and processor) that processing of biospecimens, data and information is conducted in a manner that eliminates any disclosure that would place you — as the human subject under study — at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Human Subjects and Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification and the identity of the human subjects cannot be ascertained, directly or indirectly through identifiers linked to the human subjects.*[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Human Subjects and Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that whenever biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of the human subjects can be ascertained, directly or indirectly through identifiers linked to the human subjects, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

*As a clarifying indication of how highly protective measures should be under conditions of informed assent (or consent): note that applying the principles of necessity, non-identification, minimization and sensitivity insists that mechanisms for performance and security-related review or testing at The Ikoku Foundations should still normally be developed and conducted without resorting to personal profiling, surveillance or tracking.

Principles of Necessity and Minimization

Below are subsequent criteria The Ikoku Foundations shall follow to determine and ensure necessityand minimization before, during and after human subjects research and investigation, especially when processing biospecimens, data and information attributable to, identifying or otherwise relating to you. It should be understood that The Ikoku Foundations determine necessity and minimization to be adequately addressed only if and to the extent that allof the following apply:

[su_accordion class=””][su_spoiler title=”Research Necessary for Consented or Assented Purposes” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation activities — including interactions and interventions — are conducted by means that are appropriate, expected and necessary to fulfill the explained, explicit, legitimate and specific purposes consented (or assented) to by you — as the human subject under study.[/su_spoiler][su_spoiler title=”Necessary Biospecimens, Data and Information for Consented or Assented Purpose” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the biospecimens, data and information accessed or otherwise processed are appropriate, expected and necessary to fulfill the explained, explicit, legitimate and specific purpose consented (or assented) to by you  — as the human subject under study.[/su_spoiler][su_spoiler title=”Necessary Processing for Consented or Assented Purpose” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the processing of biospecimens, data and information is conducted by means that are appropriate, expected and necessary to fulfill the explained, explicit, legitimate and specific purpose consented (or assented) to by you  — as the human subject under study.[/su_spoiler][su_spoiler title=”Minimal Biospecimens, Data and Information for Consented or Assented Purpose” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the biospecimens, data and information accessed or otherwise processed are in amounts and ranges that are minimally necessary to fulfill the explained, explicit, legitimate and specific purpose consented (or assented) to by you  — as the human subject under study.[/su_spoiler][su_spoiler title=”Minimal Processing for Consented or Assented Purposes” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the processing of biospecimens, data and information is conducted at frequencies and to the extent minimally necessary to fulfill the explained, explicit, legitimate and specific purpose consented (or assented) to by you  — as the human subject under study.[/su_spoiler][su_spoiler title=”Minimal Risk and Assessment from Prior Studies” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where possible and appropriate, prior research or investigation studies — equivalent in activity, interaction, intervention, method or human subjects — are conducted or consulted to assess anticipated risks to you, and to ascertain measures that would ensure “minimal risk” for you — as the human subject under study.[/su_spoiler][su_spoiler title=”Least Risk Necessary for Consented or Assented Purpose” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation activities — including interactions and interventions and the processing of biospecimens, data and information —are conducted by means that carry the least risk necessary to fulfill the explained, explicit, legitimate and specific purpose consented (or assented) to by you — as the natural or legal person concerned.

— and the biospecimens, data and information attributable to, identifying or otherwise relating to you carry the least risk necessary to fulfill the explained, explicit, legitimate and specific purpose consented (or assented) to by you — as the natural or legal person concerned.[/su_spoiler][su_spoiler title=”No Reasonable Alternative Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]there is a review of biospecimens, data and information to ensure that the explained, explicit, legitimate and specific purpose consented (or assented) to by you — as the human subjects under study — cannot reasonably be fulfilled by any other biospecimens, data and information.[/su_spoiler][su_spoiler title=”No Reasonable Alternative Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]there is a review of the processing of biospecimens, data and information to ensure that the explained, explicit, legitimate and specific purpose consented (or assented) to by you — as the natural or legal person concerned — cannot reasonably be fulfilled by any other means of processing.[/su_spoiler][su_spoiler title=”No Further Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]there is also monitoring of the processing of biospecimens, data and information to ensure such biospecimens, data and information are not further processed by means or for purposes other than those necessary to fulfill the explicit, legitimate and specific purposes consented (or assented) to by you — as the human subject under study.[/su_spoiler][su_spoiler title=”Adequacy, Relevance and Limitation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]there is monitoring of the processing of biospecimens, data and information to ensure that the biospecimens, data and information are adequate, relevant and limited to what is necessary for the means and purposes consented (or assented) to by you — as the human subject under study.[/su_spoiler][su_spoiler title=”Strict Minimum Period” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]there is monitoring of the processing of biospecimens, data and information to ensure that the period for which the biospecimens, data and information are accessed, gathered, stored or otherwise processed is limited to a strict minimum.[/su_spoiler][su_spoiler title=”Time Limits for Periodic Review” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]there is monitoring of the processing of biospecimens, data and information to ensure that time limits are established for periodic review and then for any appropriate, respectful ethics decision as to their continued processing, including maintenance, storage or destruction.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Principle of Non-Identification

Below are subsequent criteria The Ikoku Foundations shall follow to determine and maintain non-identification before, during and after human subjects research and investigation, especially when processing biospecimens, data or information attributable to, identifying or otherwise relating to you. It should be understood that The Ikoku Foundations determine non-identification to be adequately addressed via a two-part evaluation.

The first consists of a statement of The Ikoku Foundations’ preferred (or normative) approach to methods designwhen it comes to handling biospecimens, data and information:

[su_accordion class=””][su_spoiler title=”Statement of Preferred or Normative Non-Identifying Design” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where appropriate, possible and reasonable — and certainly where necessary or required — any access or other processing of biospecimens, data and information should be done by means that do not permit or require the identification of you or any other human subject under study.[/su_spoiler][su_spoiler title=”Non-Identifying Nature of Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]note that adhering to the above statement should at the very least lead The Ikoku Foundations toward measures and methods that — by design — generate biospecimens, data and information that are non-identifying in nature. Such preferred processing methods typically entail taking biospecimens, data and information through steps known as de-identification, pseudonymization, pseudo-anonymization, anonymization and irreversible anonymization.

— But they may also include initial access or other processing methods that result in non-personal biospecimens, data and information from the outset or very soon after, with little or no ability or possibility of attributing to, identifying or otherwise relating to a human subject or natural person. For instance, protocols designed and set to detect only resolutely anonymous data and information (still, though, with your consent).[/su_spoiler][su_spoiler title=”Non-Identifying Processing of Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]note, too, that adhering to the above statement should also lead The Ikoku Foundations to implement non-identifying processing measures and methods that — by design — do not need to identify you to be conducted. The goal of these design choices is to greatly reduce our need for identification of human subjects or natural persons to carry out a given research or investigation activity or operation.[/su_spoiler][su_spoiler title=”Critical for Achieving Protection by Design” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and note that the above approach, preferences and methods are critical for attaining and maintaining standards for human subject, biospecimen, data and information protection by design — one of two key principles for our protection of you and other human subjects under study.*[/su_spoiler][/su_accordion]

The second part of the evaluation for non-identification is a statement of our methods default (or normative) position when handling biospecimens, data and information that are no longer identifying:

[su_accordion class=””][su_spoiler title=”Default and Normative Position to Maintain Non-Identifying State” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where any research or investigation activity or study, or any processing of biospecimens, data and information, does not permit or require, or no longer permits or requires, the identification of you or another human subject under study, The Ikoku Foundations should not be obliged to acquire, maintain or process additional information in order to identify you or another human subject under study.[/su_spoiler][su_spoiler title=”Notion of You as Supposedly a Human Subject Under Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]note, at the end of that above statement, the description of you as effectively unidentified, and the attendant notion that you are now among persons who were earlier (supposedly) identifiable by the biospecimens, data or information.[/su_spoiler][su_spoiler title=”Exception to Default Position Only on Your Request ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the above notion is important, because the policy evaluation will maintain the default position, unless The Ikoku Foundations receive a consented request from you — as a (supposed) human subject under study — that also meets all of the following three requirements:[/su_spoiler][su_spoiler title=”Request to Exercise Personal Data Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]there is a request by you — as a (supposed) human subject under study — to exercise any of your human subjects research rights with respect to the non-identifying biospecimens, data or information in question.[/su_spoiler][su_spoiler title=”Offer to Provide Additional Identifying Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]as part of the request to exercise your human subjects research rights, you — as a (supposed) human subject under study — offer to provide additional information identifying you and connecting you to the non-identifying biospecimens, data or information.

— and where provided, The Ikoku Foundations should accept and process such information in order to support the exercise of your rights.[/su_spoiler][su_spoiler title=”Nature of Additional Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such additional information provided by you also include authenticating and matching credentials for identification and security mechanisms and protocols approved by the IRB for the research or investigation study.[/su_spoiler][su_spoiler title=”Given No Adverse Effects on Rights to Be Informed and to Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that such fulfillment of principles for non-identification — whether pertaining to the research, investigation, biospecimens, data and information or their processing — does not adversely affect the rights to being informed and to consent of others concerned — particularly those of other human subjects under study and natural or legal persons concerned, including The Ikoku Foundations and their Founder, Alvan Azinna Chibuzo Ikoku.[/su_spoiler][su_spoiler title=”Given No Adverse Effects on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that such fulfillment of principles for non-identification does not adversely affect the civil liberties and basic, civil and fundamental rights of other natural or legal persons concerned, including The Ikoku Foundations and their Founder, Alvan Azinna Chibuzo Ikoku.[/su_spoiler][su_spoiler title=”Given Adherence to Founding Mission and Code of Ethics” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that such fulfillment of principles for non-identification adheres to and is not incompatible with the founding of The Ikoku Foundations, originating mission and purposes, and Founding and Governing Code of Ethics, most especially our concern and protections for confidentiality and privacy.[/su_spoiler][su_spoiler title=”Critical for Achieving Protection by Default” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the above position and strict requirements for exception are critical for attaining and maintaining standards for human subject, biospecimen, data and information protection by default — also understood as one of our key principles for protection of you and other human subjects under study.*[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

*you may learn more about the principles of protection and security by design and by default on this Policy page under Principles of Protection and Security; similarly, you may learn more about the principles of confidentiality and privacy by design and by default on this Policy page under Principles of Confidentiality and Privacy.

Principles of Privacy and Confidentiality

Below are subsequent criteria The Ikoku Foundations shall follow to maintain privacy and confidentialitybefore, during and after human subjects research and investigation, especially when processing biospecimens, data or information attributable to, identifying or otherwise relating to you. It should be understood that The Ikoku Foundations determine privacy and confidentiality to be adequately addressed only if and to the extent that allof the following apply:

[su_accordion class=””][su_spoiler title=”Privacy and Confidentiality as Absolute Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]all involved understand the rights to privacy and confidentiality as themselves fundamental and absolute rights with respect to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Research that Respects Privacy and Confidentiality of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including the processing of biospecimens, data and information, protect and respect the privacy and confidentiality of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Privacy and Confidentiality as Effect via Methods Neutrality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including the processing of biospecimens, data and information, confer, as an effect, privacy and confidentiality with respect to you — as the human subject under study — that is methods neutral, sought and ensured to the same and equivalent extent, regardless of the means, measures and methods involved.[/su_spoiler][su_spoiler title=”Privacy and Confidentiality as Effect via Purpose Neutrality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including the processing of biospecimens, data and information, confer, as an effect, privacy and confidentiality with respect to you — as the human subject under study — that is purpose neutral, sought and ensured to the same and equivalent extent, regardless of the purposes.[/su_spoiler][su_spoiler title=”Protection from Risks to Privacy and Confidentiality of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]also, the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted by means that account for, protect and secure against risks to the privacy and confidentiality of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Privacy and Confidentiality as Limitation and Safeguard on Means and Purposes” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]therefore, the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted only for purposes that respect and protect the privacy and confidentiality of you — as the human subject under study.

— and the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted only by means and measures that account for and accordingly protect the privacy and confidentiality of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Privacy and Confidentiality by Design” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and the processing of biospecimens, data and information defined or described as confidential, private or sensitive is conducted only by means that, by design, strictly adhere to and fulfill principles of necessity, non-identification, minimization and sensitivity with respect to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Privacy and Confidentiality by Default” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and the processing of biospecimens, data and information defined or described as confidential, private or sensitive is conducted only by means that, by default, strictly ensure such biospecimens, data and information are not made accessible to any number of natural or legal persons without the consent (if permitted) and request of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Harmonization of Confidentiality and Privacy Expectations and Standards” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted across areas, systems and technologies where the harmonization of expectations and standards for privacy and confidentiality is developed to the fullest possible and reasonable extent, as described in these Codes and Policies.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Principles of Protection and Security

Below are subsequent criteria The Ikoku Foundations shall follow to determine and ensure adequate levels of protection and security before, during and after human subjects research and investigation, especially when processing biospecimens, data or information attributable to, identifying or otherwise relating to you. It should be understood that The Ikoku Foundations determine protection and security to be adequately addressed only if and to the extent that all of the following apply:

[su_accordion class=””][su_spoiler title=”Protection as Basic Right of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]all involved understand research, human subject, biospecimen, data and information protection as themselves a basic right with respect to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Protection of Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including the processing of biospecimens, data and information, protect and respect the rights of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Protection as Effect via Methods Neutrality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including the processing of biospecimens, data and information, confer, as an effect, the protection of the rights of you — as the human subject under study — that is methods neutral, sought and ensured to the same and equivalent extent, regardless of the means, measures and methods involved.[/su_spoiler][su_spoiler title=”Protection as Effect via Purpose Neutrality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including the processing of biospecimens, data and information, confer, as an effect, the protection of the rights of you — as the human subject under study — that is purpose neutral, sought and ensured to the same and equivalent extent, regardless of the purposes involved.[/su_spoiler][su_spoiler title=”Protection from Risks to Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted by means that account for, protect and secure against risks to the rights of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Protection as Limitation and Safeguard on Means and Purposes” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]therefore, the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted only for purposes that respect and protect the rights of you — as the human subject under study.

— and the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted only by means and measures that account for the risks to and accordingly protect the rights of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Protection by Design” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted only by means that, by design, adhere to and fulfill principles of necessity, non-identification, minimization and sensitivity with respect to you — as the human subject under study.*[/su_spoiler][su_spoiler title=”Protection by Default” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted only by means that, by default, require that biospecimens, data and information are not made accessible to an indefinite number of natural or legal persons, unless with the request and consent of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Protection and Security of Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted on biospecimens, data and information sets that are themselves protected and secured, and enjoy the above protections, via adequate and effective measures and safeguards.[/su_spoiler][su_spoiler title=”Protection and Security of Means and Methods” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted by means that are themselves protected and secured, and enjoy the above protections, via adequate and effective measures and safeguards.[/su_spoiler][su_spoiler title=”Assessment of Protection and Security Measures” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the measures developed and implemented to ensure the above protection and security are assessed for their adequacy and effectiveness, including with respect to assessments made of anticipated risks and minimal risk to you — the human subject under study.[/su_spoiler][su_spoiler title=”Harmonization of Protections and Security” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the research or investigation study and its activities, including the processing of biospecimens, data and information, are conducted across areas, systems and technologies where the harmonization of protections and security is developed to the fullest possible and reasonable extent, as described in these Codes and Policies.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

*As a clarifying indication of how highly protective measures should be, even under conditions of informed consent (or assent): note that applying the principles of necessity, non-identification, minimization and sensitivity insists that mechanisms for performance and security-related review or testing at The Ikoku Foundations should still normally be developed and conducted without resorting to personal profiling, surveillance or tracking.

Principle of Sensitivity

Below are subsequent criteria that The Ikoku Foundations shall follow to determine and ensure stricter protections for sensitivity before, during and after human subjects research and investigation, especially when processing sensitive biospecimens, data and information attributable to, identifying or otherwise relating to you. It should be understood that The Ikoku Foundations determine sensitivity to be adequately addressed via a four-part evaluation.

The first consists of a definition of sensitivity — which helps us determine or decide whether and what to treat as sensitive biospecimens, data and information:

[su_accordion class=””][su_spoiler title=”Determination of Sensitivity via Risks to Freedoms, Liberties and Rights of Persons” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]“sensitive biospecimens, data and information” include identifiable or personal biospecimens, data and information where a breach in protection or security of the biospecimens, data and information — or of their processing — produces an especially high risk to the civil liberties and rights and fundamental freedoms and rights of the human subject under study.

— note that this determination is often legal and situational in nature, since it derives from political contexts and various societies’ laws to protect people from discriminatory effects. [/su_spoiler][su_spoiler title=”Determination of Sensitivity via Risks for Identity Theft” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]“sensitive biospecimens, data and information” include identifiable or personal biospecimens, data and information where a breach in protection or security of the biospecimens, data and information — or of their processing — produces an especially high risk and capacity for harm to the human subject under study in the case of identity theft.

— note that this determination is often focused on authentication, financial and government-issued credential data and information, for reasons of the likely impact of identity theft using such materials.[/su_spoiler][su_spoiler title=”Determination of Sensitivity via Genomic or Vital Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]“sensitive biospecimens, data and information” include identifiable or personal biospecimens, data and information that are of genomic significance or of vital importance to the life of the human subject under study — where either the very processing or a breach in protection or security of the biospecimens, data and information produces an especially high risk and capacity for harm to the human subject under study.

— note that this determination is often focused on either the source importance of biospecimens — such as a vital, non-regenerating organ — or the intent of biospecimen processing — as where it includes genetic material and whole genome sequencing, or the sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen.[/su_spoiler][su_spoiler title=”Determination of Sensitivity via Risks of Private and Confidential Access” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]“sensitive biospecimens, data and information” include personal biospecimens, data and information derived from points of access that produce an especially high risk of, or themselves constitute, a breach or violation of privacy and confidentiality for the human subject under study or other person.

— note that this determination is often focused on means of access and other processing that either by definition cannot, or are highly unlikely to, avoid violating our strict protections for privacy and confidentiality — and so a human subject under study is not permitted to consent to research or investigation, including the processing of biospecimens, data and information, through such points of access. For this reason, no research, investigation or processing activities shall be conducted at the personal homes or equivalent spaces of the human subject under study. Nor shall a human subject’s personal computers and equivalent devices or personal homes and equivalent spaces be considered extensions of the research offices and administration, management and operations sections of The Ikoku Foundations. And finally, none of the research offices and administration, management and operations sections of The Ikoku Foundations, or its official computers and devices, shall be considered public or open to the public.[/su_spoiler][su_spoiler title=”Determination of Sensitivity via Demarcation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]we also confer a determination of sensitivity for identifiable or personal biospecimens, data and information demarcated, described or discussed as “confidential,” “private” or “sensitive” — as we define under Confidentiality and Privacy on the main Policies page.[/su_spoiler][su_spoiler title=”Working List of Sensitive Data” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and for a working list of biospecimens, data and information we have determined to be sensitive see those delineated under Sensitive Data and Information on the main Policies page.[/su_spoiler][/su_accordion]

The second part of the evaluation for sensitivity and for the protection of sensitive biospecimens, data and information is a statement of our default (or normative) position — which is to prohibit the processing of sensitive biospecimens, data and information attributable to, identifying or otherwise relating to you:

[su_accordion class=””][su_spoiler title=”Default Prohibition of Processing Sensitive Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that any access or other processing of “sensitive biospecimens,” “sensitive data” and “sensitive information” — as they are defined and delineated in these Codes and Policies — is prohibited.[/su_spoiler][su_spoiler title=”Critical for Confidentiality, Privacy and Protection by Default” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]note that the above prohibition, as well as the very narrow exception this Policy will later describe, are critical for attaining and maintaining standards for biospecimens, data and information protection, privacy and confidentiality by default — one of two key principles for ensuring adequate protections of you and other natural and legal persons concerned.*[/su_spoiler][/su_accordion]

The third part of the evaluation for sensitivity and for the protection of sensitive biospecimens, data and information is a statement of the narrow exception The Ikoku Foundations shall be expected to consider and possibly allow, as well as the conditions for such review:

[su_accordion class=””][su_spoiler title=”Exception to Prohibition of Processing Sensitive Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]The Ikoku Foundations shall be expected to consider and allow the processing of sensitive biospecimens, data and information only if and where all of the following threerequirements are met:[/su_spoiler][su_spoiler title=”Where Your Giving Consent is Permitted” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where there is no applicable guideline, law or regulation prohibiting you — as the human subject under study — from giving your consent to the processing of the sensitive biospecimens, data and information, for the explicit, legitimate, specific purpose for which your consent is being asked or renewed.[/su_spoiler][su_spoiler title=”Human Subjects Research Principles, Rights and Responsibilities Fulfilled” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where all of the principles, rights and responsibilities of personal data and information and human subjects research are and will remain fulfilled.[/su_spoiler][su_spoiler title=”Rigorous Risks Assessment and Protections” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where there is, especially, rigorous assessment of anticipated risks, then protections implemented to ensure, as much as possible, minimal risk to you — the human subject under study.[/su_spoiler][su_spoiler title=”Protections Against Undue Coercion or Inducement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where there is also rigorous assessment of anticipated risks of undue coercion or inducement, then protections implemented to eliminate or minimize the prospect of offering direct or indirect benefits of such a magnitude as to impair your ability to weigh the risks of the research or investigation against the value of your participation — as the human subject under study.[/su_spoiler][su_spoiler title=”Protections Against Risks on Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where there is, too, rigorous assessment of anticipated risks, then protections implemented to minimize any harms upon breach or disclosure, including those which place you — as the human subject under study — at risk of civil or criminal liability, of stigmatization and ostracization, or of damage to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Rigorous Non-Identification of Human Subjects Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification — with irreversible anonymization and aggregation preferred — so the identity of the human subjects cannot readily be ascertained, directly or indirectly through identifiers linked to the human subjects.[/su_spoiler][su_spoiler title=”Rigorous Re-Identification of Human Subjects Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or indirectly through identifiers linked to the human subjects, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Then Permitted For Research of Direct or Vital Benefit to You” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and also where the processing of sensitive biospecimens, data and information are necessary and expressly made accessible by you — as the human subject under study — to a researcher or investigator for consented, explicit, legitimate and specific research purposes of direct or vital benefit to you or your life.[/su_spoiler][su_spoiler title=”A High and Protective Bar” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]note the comparatively high and protective bar being set — to first make certain that we can fulfill all principles, rights, responsibilities; to then make sure you are even permitted to consent; and then to — initially — restrict the purposes for which you can consent to processing the sensitive biospecimens, data and information.[/su_spoiler][/su_accordion]

The fourth part of the evaluation for sensitivity and for the protection of sensitive biospecimens, data and information consists of a set of request situations The Ikoku Foundations expect to receive, asking to be added to the above narrow exception, and our further expectation that we shall typically decide to either (a) insist on review and consent via the conditions delineated above or (b) insist on review and consent via the conditions delineated above and additional regulation:

[su_accordion class=””][su_spoiler title=”Where Academic Research is Overriding or Primary” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where an academic argument, interest, need or purpose is the overriding or primary purpose for human subjects research and investigation, The Ikoku Foundations shall determine that such argumentation, interests, needs and purposes cannot themselves be considered lawful or legitimate and so cannot overridethe consent decisions, interests or protections of you — as the human subject under study who is identifiable by the sensitive biospecimens, data or information. The Ikoku Foundations therefore strictly prohibit any processing of sensitive biospecimens, data and information — as well as funding or supporting such processing — for solely such purposes.[/su_spoiler][su_spoiler title=”Where News or Journalism Research is Overriding or Primary” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where a news or journalism or broad or specific public argument, interest, need or purpose is the overriding or primary purpose for human subjects research and investigation, The Ikoku Foundations shall determine that such argumentation, interests, needs and purposes cannot themselves be considered lawful or legitimate and so cannot override the consent decisions, interests or protections of you — as the human subject under study who is identifiable by the sensitive biospecimens, data and information. The Ikoku Foundations therefore strictly prohibit any processing of sensitive biospecimens, data and information — as well as funding or supporting such processing — for solely such purposes.[/su_spoiler][su_spoiler title=”Where Public Benefit Research is Overriding or Primary” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where a broad or specific public benefit argument, interest, need or purpose is the overriding or primary purpose for human subjects research and investigation, The Ikoku Foundations shall determine that such argumentation, interests, needs and purposes cannot themselves be considered lawful or legitimate and so cannot override the consent decisions, interests or protections of you — as the human subject under study who is identifiable by the sensitive biospecimens, data and information. The Ikoku Foundations therefore strictly prohibit any processing of sensitive biospecimens, data and information — as well as funding or supporting such processing — for solely such purposes.[/su_spoiler][su_spoiler title=”Where Public Health Research is Overriding or Primary” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where a public health argument, benefit, interest, need or purpose is the overriding or primary purpose for human subjects research and investigation, The Ikoku Foundations shall determine that such argumentation, benefit, interests, needs and purposes cannot themselvesbe considered lawful or legitimate and so cannot override the consent decisions, interests or protections of you — as the human subject under study who is identifiable by the sensitive biospecimens, data and information. The Ikoku Foundations therefore strictly prohibit any processing of sensitive biospecimens, data and information — as well as funding or supporting such processing — for solely such purposes. The Ikoku Foundations further strongly urge — on successful review and consent under the above narrow exception conditions — that every possible measure be taken to conduct and apply for and receive funding for such public health work without recourse to accessing or otherwise processing sensitive biospecimens, data and information, and where such access or other processing proves necessary, to meet additional and more restrictive requirements via federally-mandated ethical or internal review board policies, processes and practices that the Founder, Alvan Azinna Ikoku, and The Ikoku Foundations shall develop, authorize and provide, as described in this Policy.[/su_spoiler][su_spoiler title=”Where Health, Medical or Scientific Research is Overriding or Primary” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where health, medical or scientific research is the overriding or primary purpose for human subjects research and investigation, The Ikoku Foundations shall determine that such argumentation, benefit, interests, needs and purposes cannot themselves be considered lawful or legitimate and so cannot override the consent decisions, interests or protections of you — as the human subject under study who is identifiable by the sensitive biospecimens, data and information. The Ikoku Foundations therefore strictly prohibit any processing of sensitive biospecimens, data and information — as well as funding or supporting such processing — for solely such purposes. The Ikoku Foundations further strongly urge — on successful review and consent under the above narrow exception conditions — that every possible measure be taken to conduct and apply for and receive funding for such health, medical and scientific research without recourse to accessing or otherwise processing sensitive biospecimens, data and information, and where such access or other processing proves necessary, to meet additional and more restrictive requirements via federally-mandated ethical or internal review board policies, processes and practices that the Founder, Alvan Azinna Ikoku, and The Ikoku Foundations shall develop, authorize and provide, as described in this Policy.[/su_spoiler][su_spoiler title=”Where Health or Medical Services Research is Overriding or Primary” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where health or medical operations or services research is the overriding or primary purpose for human subjects research and investigation, The Ikoku Foundations shall determine that such argumentation, benefit, interests, needs and purposes cannot themselvesbe considered lawful or legitimate and so cannot override the consent decisions, interests or protections of you and the assent processes for you — as the human subject under study who is identifiable by the sensitive biospecimens, data and information. The Ikoku Foundations therefore strictly prohibit any processing of sensitive biospecimens, data and information — as well as funding or supporting such processing — for solely such purposes. The Ikoku Foundations further strongly urge — on successful review and consent under the above narrow exception conditions — that every possible measure be taken to conduct and apply for and receive funding for such health and medical care and services without recourse to accessing or otherwise processing sensitive biospecimens, data and information, and where such access or other processing proves necessary, to meet additional and more restrictive requirements via federally-mandated ethical or internal review board policies, processes and practices that the Founder, Alvan Azinna Ikoku, and The Ikoku Foundations shall develop, authorize and provide, as described in this Policy.[/su_spoiler][su_spoiler title=”Where Legal or Social Services Research is Overriding or Primary” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where legal or social work, operations or services research is the overriding or primary purpose for human subjects research and investigation, The Ikoku Foundations shall determine that such argumentation, benefit, interests, needs and purposes cannot themselves be considered lawful or legitimate and so cannot override the consent decisions, interests or protections of you — as the human subject under study who is identifiable by the sensitive biospecimens, data and information. The Ikoku Foundations therefore strictly prohibit any processing of sensitive biospecimens, data and information — as well as funding or supporting such processing — for solely such purposes. The Ikoku Foundations further strongly urge — on successful review and consent under the above narrow exception conditions — that every possible measure be taken to conduct and apply for and receive funding for such legal and social work and service without recourse to accessing or otherwise processing sensitive biospecimens, data and information, and where such access or other processing proves necessary, to meet additional and more restrictive requirements via federally-mandated ethical or internal review board policies, processes and practices that the Founder, Alvan Azinna Ikoku, and The Ikoku Foundations shall develop, authorize and provide, as described in this Policy.[/su_spoiler][su_spoiler title=”Where NonProfit Civic Liberties and Rights Research is Overriding or Primary” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where nonprofit civic liberties and rights work, operations or services research is the overriding or primary purpose for human subjects research and investigation, The Ikoku Foundations shall determine that such argumentation, benefit, interests, needs and purposes cannot themselves be considered lawful or legitimate and so cannot override the consent decisions, interests or protections of you — as the human subject under study who is identifiable by the sensitive biospecimens, data and information. The Ikoku Foundations therefore strictly prohibit any processing of sensitive biospecimens, data and information — as well as funding or supporting such processing — for solely such purposes. The Ikoku Foundations further strongly urge — on successful review and consent under the above narrow exception conditions — that every possible measure be taken to conduct and apply for and receive funding for such nonprofit civic liberties and rights service without recourse to accessing or otherwise processing sensitive biospecimens, data and information, and where such access or other processing proves necessary, to meet additional and more restrictive requirements via federally-mandated ethical or internal review board policies, processes and practices that the Founder, Alvan Azinna Ikoku, and The Ikoku Foundations shall develop, authorize and provide, as described in this Policy.[/su_spoiler][su_spoiler title=”Where Employment, Services or Volunteering Contract is Overriding or Primary” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where there is an agreement, arrangement, contract or employment for work, volunteering or other third-party contractorship or services to be rendered, The Ikoku Foundations shall determine that any attendant argumentation, benefit, interests, needs and purposes cannot themselves be considered lawful or legitimate and so cannot override the consent decisions, interests or protections of you and assent processes by you — as the human subject under study who is identifiable by the sensitive biospecimens, data and information. The Ikoku Foundations therefore strictly prohibit any human subjects research and investigation involving processing of sensitive biospecimens, data and information — as well as funding or supporting such processing — for solely such purposes. The Ikoku Foundations further strongly urge — on successful review and consent under the above narrow exception conditions — that every possible measure be taken to make and request such agreement, contract, employment, independent contractorship, third party arrangement or volunteering considerations without recourse to accessing or otherwise processing sensitive biospecimens, data and information, and where such access or other processing proves necessary, to meet additional and more restrictive requirements via federally-mandated ethical or internal review board policies, processes and practices that the Founder, Alvan Azinna Ikoku, and The Ikoku Foundations shall develop, authorize and provide, as described in this Policy.[/su_spoiler][su_spoiler title=”An Even Higher and More Protective Bar” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]note, now, two aspects of our response to the above situations — that almost all requests to avoid asking for and respecting your informed consent decisions are denied; and further that a special set of request situations concern purposes (health, science, human research) that compel additional regulation, even stricter protections of you as they ask for and respect your consent decisions. Several of these situations are addressed in this Policy, under the section Additional Guidelines. Our approach here — and the even higher and more protective bar it sets — is in keeping with many long-standing discussions and concerns about how best to continue to maintain the same level of protection in effect from anticipated risks to you and your rights, even when sensitive biospecimens, data and information are at issue.[/su_spoiler][su_spoiler title=”Critical for Confidentiality, Privacy and Protection by Default” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]our approach to handling these request situations, as well as our insistence on the very narrow exception, are all the more critical for attaining and maintaining our standards for data and information protection, confidentiality and privacy by default — one of two key principles for ensuring adequate protections of you and other human subjects under study.*[/su_spoiler][su_spoiler title=”Also Critical for Confidentiality, Privacy and Protection by Design” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]important, too, is that our approach — and response in certain of the above request situations — result in additional regulation and pressures on the means, measures and methods of research, investigation and processing, all the more critical for attaining and maintaining our standards for human subject, biospecimen, data and information protection, confidentiality and privacy by design — also one of two key principles for ensuring adequate protections of you and other natural and legal persons concerned.*[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

*you may learn more about the principles of protection and security by design and by default on this Policy page under Principles of Protection and Security; similarly, you may learn more about the principles of confidentiality and privacy by design and by default on this Policy page under Principles of Privacy and Confidentiality.

Principle of Transparency

Below are the subsequent criteria The Ikoku Foundations shall follow when addressing any communication or notification to the public or to you regarding human subjects research and investigation. It should be understood that The Ikoku Foundations determine such communication and notification to be reasonably transparent only if and to the extent that all of the following apply:

[su_accordion class=””][su_spoiler title=”Easy Accessibility” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification are easily accessible for you — as the human subject under study.[/su_spoiler][su_spoiler title=”Easy Understanding” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification are as concise and easy to understand as possible for you — as the human subject under study.[/su_spoiler][su_spoiler title=”Clear and Plain Language and Visuals” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification use clear and plain language and, additionally, where appropriate, clear visualization.[/su_spoiler][su_spoiler title=”In Writing, Electronic Form” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification are provided in writing, including where appropriate in electronic form (such as a public website).[/su_spoiler][su_spoiler title=”Given Feasibility and Reasonableness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that — and as part of the commitment to reasonable transparency — your requests and the responses of The Ikoku Foundations are both feasible and reasonable with respect to cost, frequency, number, proportionate effort, technical limits and concerns for the rights of other human subjects under study and natural or legal persons concerned, including The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Given No Adverse Effects on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that such communication and notification to you do not adversely affect the fundamental freedoms, civil liberties and rights of others — particularly those of other human subjects under study and natural or legal persons concerned, including The Ikoku Foundations and their Founder, Alvan Azinna Chibuzo Ikoku.[/su_spoiler][su_spoiler title=”Given Necessity, Non-Identification and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that such communication and notification to you adhere to and fulfill the principles of necessity, non-identification and data-minimization.[/su_spoiler][su_spoiler title=”Given Adherence to Founding Mission and Code of Ethics” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that such communication and notification adhere to and not be incompatible with the founding of The Ikoku Foundations, originating mission and purposes, and Founding and Governing Code of Ethics, most especially the concern and protections for confidentiality and privacy.[/su_spoiler][/su_accordion]

Furthermore, where any such communication and notification is addressed to you — specifically regarding any human subjects research or investigation involving your participation and any biospecimens, data and information attributable to, identifying or otherwise relating to you — The Ikoku Foundations determine such communication and notification to be fulland transparent only if and to the extent that all of the following also apply:

[su_accordion class=””][su_spoiler title=”Reasonably Informing, Ethical Standard” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification provide to you — as the human subject under study — all the key information, in sufficient detail, that a reasonable person would want to have in order to make an informed decision about whether to begin, continue or withdraw participation as a human subject in the research or investigation study, and an opportunity to discuss that information.

— and so that the informing process does not merely provide lists of isolated facts, but is instead organized in a manner most likely to assist you — as a potential human subject under study — in understanding the reasons why you might or might not want to participate in the study.[/su_spoiler][su_spoiler title=”Informing, Confirmation of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification provide to you — as the human subject under study — confirmation that the study you are participating in involves research or investigation, the approximate number of human subjects involved in the study, whether the study involves an interaction or intervention as part of its methods, and whether biospecimens, data or information attributable to, identifying or otherwise relating to you have been, are or will be accessed or otherwise processed.[/su_spoiler][su_spoiler title=”Informing, Purposes of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — the explicit, legitimate and specific purpose for the research or investigation, and where applicable the explicit, legitimate and specific purpose for which biospecimens, data or information attributable to, identifying or otherwise relating to you have been, are or will be accessed or otherwise processed.[/su_spoiler][su_spoiler title=”Informing, Duration of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — the period of time during which the research or investigation will be conducted, the duration of your participation as human subject under study, and where applicable the period of time during which biospecimens, data or information attributable to, identifying or otherwise relating to you have been, are or will be accessed, stored or otherwise processed, or how that period of time for access, processing and any storage is determined.[/su_spoiler][su_spoiler title=”Informing, Methods of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — the means, measures and methods by which, as well as the extent to which, the research or investigation will be conducted, including descriptions of any interaction or intervention.

— also clearly confirm and explain procedures that you — as the human subject under study — have been, are or will be asked to follow.

— also clearly identify and explain any methods or procedures that are experimental.

— and where applicable, clearly confirm and explain the means, measures and methods by which, as well as the extent to which, biospecimens, data or information attributable to, identifying or otherwise relating to you have been, are or will be accessed or otherwise processed.

— and that, where such processing entails automated decision-making, including profiling, The Ikoku Foundations also provides you meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for you — as the human subject under study. Please also do learn more about your rights during such processing under the section, Rights Concerning Research via Automation.[/su_spoiler][su_spoiler title=”Informing, Content of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where applicable, such communication and notification clearly explain to you — as the human subject under study — what categories, content and nature of biospecimens, data or information attributable to, identifying or otherwise relating to you have been, are or will be accessed or otherwise processed.

— and where applicable, clearly confirm the records and sources of the biospecimens, data and information and whether those records and sources are themselves to be processed, secured or publicly accessible.[/su_spoiler][su_spoiler title=”Informing, Recipients of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where applicable, such communication and notification clearly explain to you — as the human subject under study — the recipients and categories of recipients of biospecimens, data or information attributable to, identifying or otherwise relating to you have been, are or will be accessed or otherwise processed — including any transfers to any third party, third country, governmental office or international organization.[/su_spoiler][su_spoiler title=”Informing, Non-Identification of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — whether and how identifiers shall be removed from any biospecimens, data or information accessed, gathered or otherwise processed about or from you.

— and clearly confirm and explain, whether or not other processes of non-identification are to be employed, including periodic re-identification, and if so under what circumstances and to what extent.[/su_spoiler][su_spoiler title=”Informing, Future Research and Processing of Content” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly confirm to you — as the human subject under study —  that whether or not such processes of non-identification are conducted, the biospecimens, data or information shall not be used for future research studies or distributed to another researcher or investigator for future research studies, unless with additional informed consent from you.[/su_spoiler][su_spoiler title=”Informing, Commercial Research and Processing of Content” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly confirm to you — as the human subject under study —  that whether or not such processes of non-identification are conducted, the biospecimens, data or information shall not be used for commercial profit or equivalent benefit without your explicit consent and agreement to terms.[/su_spoiler][su_spoiler title=”Informing, Genomic Research and Processing of Content” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly confirm to you — as the human subject under study — whether the research or investigation will or might include whole genome sequencing of biospecimens accessed, gathered or otherwise processed about or from you, particularly if sequencing a human germline or somatic specimen with the intent to generate the genome or exome sequence of that biospecimen.

— and such communication and notification clearly confirm to you — as the human subject under study — that whether or not processes of non-identification are conducted, the biospecimens, data or information shall not undergo or be used for genetic testing, genomic sequencing or their equivalent processing without your explicit consent and agreement to terms.[/su_spoiler][su_spoiler title=”Informing, Benefits of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — any benefits to you or to others that may reasonably be expected from the research or investigation.

— and where applicable, clearly confirm and explain any benefits to you — as the human subject under study —  or to others that may reasonably be expected from the provision of biospecimens, data and information that have been, are or will be accessed or otherwise processed.[/su_spoiler][su_spoiler title=”Informing, Costs and Discomforts of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — any additional costs or discomforts to you that may reasonably be expected from the research or investigation.

— and where applicable, clearly confirm and explain any costs or discomforts to you — as the human subject under study — that may reasonably be expected from the provision of such biospecimens, data or information that have been, are or will be accessed or otherwise processed.[/su_spoiler][su_spoiler title=”Informing, Risks of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — any risks to you or to others that may reasonably be expected from the research or investigation.

— and where applicable, clearly confirm and explain any risks to you — as the human subject under study — or to others that may reasonably be expected from the provision of biospecimens, data and information that have been, are or will be accessed or otherwise processed.

— and where applicable, clearly confirm and explain the particular research or investigation methods, procedures or treatment possibly involving risks to you — as the human subject under study — or to an embryo or fetus (if you are or may become pregnant) that are currently unforeseeable.[/su_spoiler][su_spoiler title=”Informing, Alternatives to Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — appropriate alternative research or investigation procedures or courses of treatment, if any, that might be advantageous to you.

— and where applicable, clearly confirm and explain appropriate alternative methods or procedures, if any, that might be advantageous to you — as the human subject under study — for the provision, accessing, gathering or other processing of such biospecimens, data or information.[/su_spoiler][su_spoiler title=”Informing, Protections and Safeguards” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — protections and safeguards advantageous to you during and after your participation in the research or investigation, including, where applicable, protections and safeguards during and after accessing, gathering or otherwise processing any biospecimens, data or information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Informing, Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — your rights with respect to your participation in the research or investigation study, and where applicable, with respect to the access, gathering or other processing of biospecimens, data or information attributable to, identifying or otherwise relating to you, as well as the means and procedures for exercising your rights in relation to such participation and such processing.[/su_spoiler][su_spoiler title=”Informing, Disclosures During Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — whether clinically relevant research results, including individual results, are to be disclosed to you, and if so, under what conditions.

— and clearly confirm and explain whether significant new findings developed during the course of the research or investigation that may relate to your willingness to continue your participation — as the human subject under study — are to be provided to you.[/su_spoiler][su_spoiler title=”Informing, Early Termination or Withdrawal” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — anticipated circumstances under which your participation may be terminated by the researcher or investigator without regard to your consent or assent.

— and clearly describe and explain the consequences of your decision to withdraw your participation — as the human subject under study — and procedures for orderly termination of participation by your decision.[/su_spoiler][su_spoiler title=”Informing, Ideally Voluntary Nature of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — that participation should be voluntary, refusal to participate should involve no penalty or loss of benefits to which you are otherwise entitled, and that you should discontinue your participation at any time without penalty or loss of benefits to which you are otherwise entitled.[/su_spoiler][su_spoiler title=”Informing, Any Compulsory Nature of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]nevertheless, such communication and notification clearly confirm to you — as the human subject under study — whether your participation in the research or investigation study is a contractual or statutory requirement, or a requirement necessary to enter into an agreement or contract, as well as whether you are obliged to participate in the research or investigation study, and the possible consequences of failure to participate in the research or investigation study.

— and where applicable, clearly confirm whether the provision of such biospecimens, data or information is a contractual or statutory requirement, or a requirement necessary to enter into an agreement or contract, as well as whether you are obliged to provide the biospecimens, data or information, and the possible consequences of failure to provide such biospecimens, data or information.[/su_spoiler][su_spoiler title=”No Exculpatory Language” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification contain no exculpatory language through which you — as the potential human subject under study — are made to waive or appear to waive any of your legal rights, or release or appear to release the researcher or investigator, sponsor, institution or any of their agents from liability for negligence.[/su_spoiler][su_spoiler title=”Informing, Injury Compensation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where there is more than minimal risk, such communication and notification clearly explain to you — as the human subject under study — whether any compensation and medical treatments are available to you if injury occurs and, if so, what they consist of, or where further information may be obtained.[/su_spoiler][su_spoiler title=”Informing, Communication about Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification clearly explain to you — as the human subject under study — the procedures for obtaining confirmation and communication with respect to the research or investigation, and where applicable, with respect to the accessing, gathering and other processing of biospecimens, data or information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Informing, Responsible Entity, Offices or Persons” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification provide to you — as the human subject under study — the identity and contact information of the entity, office or persons responsible for the research or investigation study, and the identity and contact information of the entity, office or persons responsible for the processing of any biospecimens, data or information, including whom you are to contact for answers to pertinent questions, and in the event of a research-related injury to you.[/su_spoiler][su_spoiler title=”Informing, Period of Discussion and Consideration” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and most importantly, such communication and notification reasonably provide to you — as the human subject under study — sufficient period of time and opportunity to ask questions, discuss and finally consider — with minimal possibility of coercion or undue influence — whether or not to participate in the research or investigation study, as well as how you may withdraw consent after entry.[/su_spoiler][su_spoiler title=”In Writing, Electronic Form” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]such communication and notification be provided in writing, and where appropriate, in electronic form (such as a public website), and are further attentive to situations where the complexity and number of researchers or investigators as well as research activities, interactions, interventions and processing may make it difficult for human subjects to learn, understand, track and verify all involved in the research or investigation and processing biospecimens, data and information.[/su_spoiler][su_spoiler title=”Given Feasibility and Reasonableness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that — and as part of the commitment to reasonable transparency — your requests and the responses of The Ikoku Foundations are both feasible and reasonable with respect to cost, frequency, number, proportionate effort, technical limits and concerns for the rights of other human subjects under study and persons concerned, including The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Given No Adverse Effects on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that such communication and notification to you — as the human subject under study — whether pertaining to the research, investigation, biospecimens, data and information or their processing, do not adversely affect the civil liberties and basic, civil and fundamental rights of others — particularly those of other human subjects under study and natural or legal persons concerned, including The Ikoku Foundations and their Founder, Alvan Azinna Chibuzo Ikoku.[/su_spoiler][su_spoiler title=”Given Necessity, Non-Identification and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that such communication and notification to you — as the human subject under study — whether pertaining to the research, investigation, biospecimens, data and information or their processing, adhere to and fulfill the principles of necessity, non-identification and data-minimization.[/su_spoiler][su_spoiler title=”Given Adherence to Founding Mission and Code of Ethics” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that such communication and notification adhere to and not be incompatible with the founding of The Ikoku Foundations, originating mission and purposes, and Founding and Governing Code of Ethics, most especially the concern and protections for confidentiality and privacy.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Principle of Commensurability

The principle of commensurability and its criteria delineated below are followed by The Ikoku Foundations in recognition of the likelihood that contexts will arise where it seems that two or more interests, persons, principles, rights or responsibilities render the fulfillment of human subjects research and investigation policies incommensurable, when they do not. The Ikoku Foundations feel that where it is asserted that there is no common basis for the comparison of policy claims or injunctions, other much less fair or ideal approaches take the place vacated by prior information and notice, managed expectations, analysis and deliberation, consideration, discernment, judgment and respect. It is better, therefore, to assert the existence of, and clarify a rubric for, just such a common basis at The Ikoku Foundations. It consists of the following:

[su_accordion class=””][su_spoiler title=”Prior Agreement as Starting Point” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]on the part of every natural and legal person and human subject involved, there is a prior Agreement — as delineated and described in these Codes and Policies — to use or visit, partake of, participate in, benefit from, be supported by or work for any part or section of The Ikoku Foundations, and such Agreement is the starting point of any activity under review.[/su_spoiler][su_spoiler title=”Prior Agreement to Not Violate Protections of The Ikoku Foundations or their Founder” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and on the part of every natural and legal person and human subject involved, there is an attendant prior Agreement — also delineated and described in these Codes and Policies — to not violate the rights and protections of The Ikoku Foundations or their Founder, Alvan Azinna Chibuzo Ikoku in any activity, operation or decision during review, and where so, have remedying such violations be critically important, prioritized and conducted to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Prior Approval and Authorization of Proceedings” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and on the part of every natural and legal person and human subject involved, there is an attendant prior Agreement — also delineated and described in these Codes and Policies — that any action, activity, operation, or proceeding pertaining to commensurability or equivalent resolution have prior written approval and authorization of the Founder of The Ikoku Foundations, Alvan Azinna Chibuzo Ikoku, and that no such action, activity, operation, or proceeding may be begun, conducted, supervised or otherwise administered by an external or independent entity.[/su_spoiler][su_spoiler title=”Prior Limitation of Scope” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and on the part of every natural and legal person and human subject involved, there is an attendant prior Agreement — also delineated and described in these Codes and Policies — to limit the scope of any action, activity, operation, or proceeding pertaining to commensurability or equivalent resolution only to questions of human subjects research and investigation, and any handling of biospecimens, data and information, narrowly defined — namely, issues involving the conduct of research and investigation actions, activities, operations and studies on (as well as the access and other processing of personal data and information attributable to, identifying or otherwise relating to) a specific natural person, as conducted by persons employed, funded, managed or otherwise directed or supported by The Ikoku Foundations, narrowly defined, engaging or functioning in an allowed, approved and authorized area, capacity and manner — and to not have the scope of such proceedings entail other issues, matters, questions, remedies or rights.[/su_spoiler][su_spoiler title=”Reasonable Transparency and Being Informed” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]with all of the above sufficiently met, The Ikoku Foundations proceed by determining that communication and notification regarding the activities of human subjects research and investigation — including the provision and processing of biospecimens, data and information — are themselves reasonably transparent and informing before, during and after your participation, and thus fulfill the principles of transparency and your rights to being informed, permitting, among other things, opportunities for informed consent and for later reviewing consent decisions by you — as the human subject under study.[/su_spoiler][su_spoiler title=”Broad Prohibition for Improperly Consented Activity” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]The Ikoku Foundations also proceed by ensuring there is a broad prohibition of improperly — or not reasonably informed — consented activity before, during and after human subjects research and investigation, and where so, have remedying such situations be prioritized and conducted to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Broad Prohibition and Narrow Exceptions for Unconsented Activity” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]The Ikoku Foundations follow the above principle of broad prohibition with very narrow and strict exceptions for the conduct of human subjects research and investigation without consent — and so The Ikoku Foundations subject all such activities and operations involving or otherwise relating to human subjects to reasonably informing consent and assent processes — and where there is any inadequacy in this regard, has remedying such situations be prioritized and conducted to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Broad Prohibition for Unlawfulness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]The Ikoku Foundations also proceed by ensuring the activities of human subjects research and investigation — including the provision and processing of biospecimens, data and information — are themselves lawful before, during and after your participation, and thus fulfill the protective principles, rights and responsibilities of human subjects research and investigation, especially those pertaining to purposes, non-identification, minimization, necessity and sensitivity as well as beneficence, non-maleficence and justice — and where there is any inadequacy in this regard, has remedying such situations be prioritized and conducted to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Broad Prohibition for Diminished Protections” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]The Ikoku Foundations also proceed by ensuring the activities of human subjects research and investigation — including the provision and processing of biospecimens, data and information — are themselves protective before, during and after your participation, and thus fulfill the protective principles, rights and responsibilities of human subjects research and investigation, especially those pertaining to purposes, non-identification, minimization, necessity and sensitivity as well as beneficence, non-maleficence and justice — and where there is any inadequacy in this regard, has remedying such situations be prioritized and conducted to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Prohibition of Violations of Privacy and Confidentiality Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]The Ikoku Foundations ascertain that there are no violations of privacy or confidentiality rights of human subjects under study in any human subjects research or investigation activities, including the processing of biospecimens, data and information — and where so, has remedying such violations be prioritized and conducted to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Prohibition of Violations of Civil and Fundamental Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]The Ikoku Foundations ascertain that there are no violations of civil liberties or basic or fundamental rights of human subjects under study — especially the principles for sensitivity — in any human subjects research or investigation activities, including the processing of biospecimens, data and information — and where so, has remedying such violations be prioritized and conducted to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Prohibition of Violations of Property and Proprietary Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]The Ikoku Foundations ascertain that there are no violations of property and proprietary rights of human subjects under study in any human subjects research or investigation activities, including the processing of biospecimens, data and information — and where so, has remedying such violations be prioritized and conducted to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Limitation and Minimization Where Harm is Established or Imminent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]throughout any review, The Ikoku Foundations ascertain that no harm to any natural or legal person is established or imminent in any human subjects research or investigation activities, including the processing of biospecimens, data and information — and where so, has eliminating and remedying such harm and its imminence be critically important, prioritized and conducted to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Errors, Violations and Fruits of the Poisonous Tree” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where errors or violations are determined, remedying them involves prioritized attention to historical order of error, offense or violation and then — to the extent appropriate and feasible — application of the “fruit of the poisonous tree” concept, entailing a depositing of research or investigation materials, including biospecimens, data and information with The Ikoku Foundations to provide opportunities for The Ikoku Foundations and the human subject under study to make consented decisions and exercise their human subjects research rights; the depositing, too, with The Ikoku Foundations of any benefits accrued via the erroneous or violating research or investigation activity or processing of biospecimens, data and information; and where the violation is intentional, a relinquishing by the violator of any role in the remedying process.[/su_spoiler][su_spoiler title=”Where Non-Identification is Resolving” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]with the above taking precedence and guaranteed, but where review of cases with supposed incommensurability is still needed, The Ikoku Foundations also ascertain whether and how commensurability can be had via processes of necessity, minimization and non-identification — and where so, has the processes of further minimization and non-identification (ideally up to irreversible anonymization and aggregation) be conducted to the most feasible and reasonable extent with the written agreement and consent of all the primary natural or legal persons concerned.[/su_spoiler][su_spoiler title=”Given Adherence to Founding Mission and Code of Ethics” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that any actions, decisions, determinations and processing pertaining to human subjects research and investigation or biospecimens, data and information, including during review for commensurability, adhere to and not be incompatible with the founding of The Ikoku Foundations, originating mission and purposes, and Founding and Governing Code of Ethics, and these Codes and Policies.[/su_spoiler][su_spoiler title=”Incentives Toward Ethical, Respectful and Non-Identifying Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that the remedying of such cases result in incentives and disincentives toward the enjoyment of respect for persons — as described in these Codes and Policies — which includes, where appropriate, adopting respectful minimization and non-identification methods that (a) are and were never personal; (b) are encrypted; (c) have undergone immediate or soon-after irreversible anonymization and aggregation; (d) are under secured pseudonymization; or (d) are under secured de-identification.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

B — Basic Rights

The Rights of Research and Investigation

The above principles of human subjects research and investigation also provide you — as the human subject under study — fifteen (15) overarching rights of human subjects research and investigation. The Ikoku Foundations should fulfill, respect and help you exercise such rights when conducting research or investigation on, about or otherwise relating you, and when processing biospecimens, data and information attributable to, identifying, or otherwise relating to you. The Policy will elaborate in some detail upon each of these rights as you proceed on this page. In the meantime do keep in mind two opening points to be made here.

First, that the exercising of any freedoms, liberties or rights — and the fulfillment of any principles and responsibilities — shall not confer or entail any right of access to The Ikoku Foundations or The Ikoku Foundations Administration (or any correlative rights, duties and obligations concerning any equivalent access, level of openness or transparency) to any natural or legal person other than the Founder, Alvan Azinna Chibuzo Ikoku.

And second, that, given the aforementioned, and as much as feasibly and reasonably possible, The Ikoku Foundations endeavor to have human subjects research and investigation fulfill all of your following rights:

[su_accordion class=””][su_spoiler title=”Rights to Be Informed” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to be reasonably informed regarding the research or investigation study and about biospecimens, data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Rights Concerning Research and Processing On and About Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to be reasonably informed regarding research or investigation study conducted on, about or otherwise relating to you, and regarding the processing of biospecimens, data and information from, about or otherwise relating to you.[/su_spoiler][su_spoiler title=”Rights Concerning Research and Processing via Automation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to not be subject to research or investigation study or processing of biospecimens, data and information by means of automation and automated methods, including automated individual decision-making and profiling.

— and to be reasonably informed when such automated means are used to conduct research or investigation study or processing of biospecimens, data and information on, from, about or otherwise relating to you.[/su_spoiler][su_spoiler title=”Rights to Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to consent and to the reasonably informing consent process.[/su_spoiler][su_spoiler title=”Rights to Confidentiality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to confidentiality, to the confidentiality of confidential, identifiable and sensitive biospecimens, data and information, and absolute rights to confidential conversation.[/su_spoiler][su_spoiler title=”Rights to Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to privacy, to the privacy of identifiable, private and sensitive biospecimens, data and information, and absolute rights to private conversation and to private thoughts.[/su_spoiler][su_spoiler title=”Rights to Protection, Safety and Security” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to have research or investigation study and processing of biospecimens, data and information conducted by means that ensure adequate protection, safety and security.[/su_spoiler][su_spoiler title=”Rights to Ensure and Verify” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to reasonably ensure and verify the fulfillment of principles, rights and responsibilities with respect to research, investigation and processing of biospecimens, data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Rights of Access” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to reasonable access to public or published reports or results of research, investigation and processing of biospecimens, data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Rights to Portability” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to reasonable portability of public or published reports or results of research, investigation and processing of biospecimens, data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Rights to Object” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to reasonable objections and stoppage with respect to research, investigation and processing of biospecimens, data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Rights to Restrict Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to reasonable restriction of research, investigation and processing of biospecimens, data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Rights to Removal” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to reasonable removal or yourself and records of your participation in research, investigation or processing of biospecimens, data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Rights to Remedy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to reasonable remedy during review of research, investigation or processing of biospecimens, data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Rights to Notification” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]rights to reasonable notification of other persons upon decisions to remove or restrict research, investigation or processing of biospecimens, data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Be Informed

As the human subject under study, you shall have the rights to be reasonably informed regarding research or investigation studies and activities conducted in relation to you. And your rights to be reasonably informed are also regarding biospecimens, data and information attributable to, identifying or otherwise relating to you. Such rights therefore include all of the following:

[su_accordion class=””][su_spoiler title=”Research and Processing on and about Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that reasonably informs you — as the human subject under study — regarding research and investigation activities that have been, are or will be conducted on you.

— and your right to receive transparent communication that reasonably informs you — as the human subject under study — regarding biospecimens, data and information that have been, are or will be processed from you.[/su_spoiler][su_spoiler title=”Research and Processing about Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that reasonably informs you — as the human subject under study — regarding research and investigation activities that have been, are or will be conducted about or relating to you.

— and your right to receive transparent communication that reasonably informs you — as the human subject under study — regarding biospecimens, data and information that have been, are or will be processed about or relating to you.[/su_spoiler][su_spoiler title=”Research and Processing via Automation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that reasonably informs you — as the human subject under study — regarding research and investigation activities that have been, are or will be conducted from or about you by means of automation and automated methods, including but not limited to automated individual decision-making and profiling.

— and your right to receive transparent communication that reasonably informs you — as the human subject under study — regarding biospecimens, data and information that have been, are or will be processed from or about you by means of automated decision-making, including profiling.[/su_spoiler][su_spoiler title=”Human Subjects Research and Investigation Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that reasonably informs you — as the human subject under study — about all your human subjects research and investigation rights, and the means and procedures for exercising those rights.[/su_spoiler][su_spoiler title=”Facilitating Exercising of Human Subjects Research and Investigation Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that helps you — as the human subject under study — exercise your human subjects research and investigation rights.[/su_spoiler][su_spoiler title=”Where Non-Identification is Confirmed” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive such reasonably transparent communication unless we demonstrate that we cannot identify you or connect you to the research and investigation study or the biospecimens, data and information in question.

— where non-identification is confirmed, your right to receive notification of the situation — as the potential or supposed human subject under study.

— upon receiving the above notification, your right to be given an opportunity to provide additional information that identifies you and connects you to the research and investigation study or the biospecimens, data and information in question.

— and upon providing such information, your right to have The Ikoku Foundations proceed as described under the section, Principle of Non-Identification.[/su_spoiler][su_spoiler title=”Progress in Exercising Human Subjects Research and Investigation Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that reasonably updates you — as the human subject under study — without unreasonable delay, on progress in the exercising of your human subjects research and investigation rights.[/su_spoiler][su_spoiler title=”Decisions in Exercising Human Subjects Research and Investigation Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive such communication that reasonably informs you — as the human subject under study — about decisions as to (a) whether any action is being taken upon your request to exercise a human subjects research and investigation right; (b) if so, the action taken and the reasons or rationale; (c) if not, the action not taken and the reason or rationale; and (d) in either case, possibilities for acceptance and closure, appeal, complaint, further review or otherwise seeking remedy.[/su_spoiler][su_spoiler title=”Frequency and Period of Informing Process” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have this reasonably and transparently informing process available to you — as the human subject under study — without cost twice every twelve (12) months, and that the above reasonably transparent communication cover clearly demarcated periods of research, investigation and biospecimen, data and information processing that include the twelve (12) preceding months.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights Concerning Research On or About Human Subjects

As the human subject under study, you shall have the rights to be reasonably informed regarding research or investigation studies and activities conducted in relation to you. And your rights to be reasonably informed are also regarding research biospecimens, data and information attributable to, identifying or otherwise relating to you.

You shall have such rights to be thusly informed where such research or investigation activities are conducted directly on, about and relating to you; and also where such biospecimens, data and information are provided by you and processed from, about and relating to you. Such rights therefore include all of the following:

[su_accordion class=””][su_spoiler title=”Reasonably Informing, Confirmation of Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that confirms to you — as the human subject under study — that research or investigation activities have been, are or will be conducted on, about or otherwise relating to you.[/su_spoiler][su_spoiler title=”Reasonably Informing, Confirmation of Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that confirms to you — as the human subject under study — that biospecimens, data and information attributable to, identifying or otherwise relating to you have been, are or will be processed.[/su_spoiler][su_spoiler title=”Reasonably Informing, All Aspects of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that reasonably informs you — as the human subject under study — regarding all aspects of the research and processing, as delineated and described under the section Principles for Transparency.[/su_spoiler][su_spoiler title=”Informing, Method of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that confirms to you — as the human subject under study — whether research, investigation or processing entails automation or automated methods, and where so, your right to have The Ikoku Foundations further inform you as described under the section Rights Concerning Research via Automation.[/su_spoiler][su_spoiler title=”Informing, Risks of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that confirms to you — as the human subject under study — whether The Ikoku Foundations’ assessment of risks from research, investigation or processing leads to a determination of high risk, and if so, your right to have The Ikoku Foundations such research, investigation or processing, unless a research and processing risks assessment has been specifically conducted, with concerns addressed and risks minimized, as described under the section Responsibilities for Risk.[/su_spoiler][su_spoiler title=”Informing, Further Communication, Discussion and Contact ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that provides you — as the human subject under study — sufficient period of time and opportunity to ask questions and discuss concerns, the means for ongoing communication and notification, and the identity and contact details of the offices, persons and representatives responsible for the research, investigation and processing of biospecimens, data and information concerning you.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights Concerning Research via Automation

As the human subject under study, you shall have the rights — to not be subject to —and also to be reasonably informed regarding research and investigation activities conducted on or about you by means of automation or automated methods. And your rights to be reasonably informed are also regarding research biospecimens, data and information processed from or about you by means of automation or automated methods.

You shall have such rights to thusly refuse and to be thusly informed especially where such uses of automation and automated methods have a legal or similarly significant effect concerning you. Such rights therefore include all of the following:

[su_accordion class=””][su_spoiler title=”Reasonably Informing, Confirmation of Research via Automation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication confirming to you — as the human subject under study — whether research or investigation activities have been, are or will be conducted on, about or otherwise relating to you by means of automation and automated methods.[/su_spoiler][su_spoiler title=”Reasonably Informing, Confirmation of Processing via Automation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication confirming to you — as the human subject under study — whether biospecimens, data and information attributable to, identifying or otherwise relating to you have been, are or will be processed by means of automation and automated methods.[/su_spoiler][su_spoiler title=”Reasonably Informing, All Aspects of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication reasonably informing you — as the human subject under study — regarding all aspects of such research and processing, as delineated and described under the section Principle of Transparency.[/su_spoiler][su_spoiler title=”Informing, Confirmation of Absence of a Child” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication confirming to you — as the human subject under study — the absence and non-involvement of a child (including yourself) in the above proposed or reported research, investigation or processing activities by means of automation and automated methods.

— and where a child is involved, your right to further confirmation to you that such research, investigation or processing is strictly prohibited, to notification of its stoppage, to remedy where applicable, and to further communication pertaining to your rights to ensure and verify and to object and stop such research, investigation and processing.[/su_spoiler][su_spoiler title=”Informing, Confirmation of Absence of Sensitivity” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication confirming to you — as the human subject under study — the absence of sensitive biospecimens, data and information from, about or otherwise relating to you in the above proposed or reported research, investigation or processing activities by means of automation and automated methods.

— and where such sensitive biospecimens, data and information are involved, your right to further confirmation that such research, investigation or processing is prohibited, unless you are permitted to consider and give informed consent, as described under the section Principle of Sensitivity.

— and where the above also entails extensive or systematic review of natural persons or special categories of natural persons, your right to further confirmation that such research, investigation or processing is prohibited, unless a research and processing risks assessment has also been specifically conducted, with concerns addressed and risks minimized, as delineated and described under the section, Responsibilities for Risk.[/su_spoiler][su_spoiler title=”Informing, Methods of Research and Processing via Automation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication delineating and describing to you — as the human subject under study — the methods of the above proposed or reported research, investigation or processing activities by means of automation and automated methods — containing meaningful information about the algorithm or equivalent logic involved, as well as the significance and envisaged consequences of employing the algorithm or equivalent logic for you.

— and where the logic, measures or methods involved are new, the right to further confirmation that such research, investigation or processing is prohibited, unless a research and processing risks assessment has been specifically conducted, with concerns addressed and risks minimized, as described under the section Responsibilities for Risk.[/su_spoiler][su_spoiler title=”Informing, Publicly Accessible Areas” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication confirming to you — as the human subject under study — whether the above proposed or reported research, investigation or processing by means of automation and automated methods involves publicly accessible areas.

— and where so, your right to further confirmation that such research, investigation or processing is prohibited, unless a research and processing risks assessment has been specifically conducted, with concerns addressed and risks minimized, as described under the section Responsibilities for Risk.[/su_spoiler][su_spoiler title=”Informing, Significant Legal Effects of Research and Processing via Automation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication confirming, delineating and describing to you — as the human subject under study — any legal or similarly significant effects with respect to you of conducting the above proposed or reported research, investigation or processing activities by means of automation and automated methods.

— and where there are such effects, the right to further confirmation that such research, investigation or processing is prohibited, unless a research and processing risks assessment has been specifically conducted, with concerns addressed and risks minimized, as described under the section Responsibilities for Risk.[/su_spoiler][su_spoiler title=”Informing, Scale of Research and Processing via Automation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication delineating and describing to you — as the human subject under study — the scale and size of the above proposed or reported research, investigation or processing activities by means of automation and automated methods, and the scale and size of the biospecimens, data and information themselves attributable to, identifying or otherwise relating to you.

— and where large-scale, the right to further confirmation that such research, investigation or processing is prohibited, unless a research and processing risks assessment has been specifically conducted, with concerns addressed and risks minimized, as described under the section Responsibilities for Risk.[/su_spoiler][su_spoiler title=”Informing, Risks of Research and Processing via Automation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication confirming, delineating and describing to you — as the human subject under study — the risks to you of conducting the above proposed or reported research, investigation or processing activities by means of automation and automated methods.

— and if high risk is determined, the right to further confirmation that such research, investigation or processing is prohibited, unless a research and processing risks assessment has been specifically conducted, with concerns addressed and risks minimized, as described under the section Responsibilities for Risk.[/su_spoiler][su_spoiler title=”Informing, Consent to Research and Processing via Automation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication specifically affording you — as the human subject under study — sufficient time and opportunity to give and withdraw consent, as described in these Codes and Policies, to prior, present or future research, investigation or processing activities relating to you conducted on, from, about or otherwise relating to you by means of automation and automated methods, including but not limited to automated individual decision-making and profiling.[/su_spoiler][su_spoiler title=”Informing, Decisions of Research and Processing via Automation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication describing and explaining to you — as the human subject under study — any decisions made or reached concerning you during research, investigation or processing conducted on, from, about or otherwise relating to you by means of automation and automated methods, including but not limited to automated individual decision-making and profiling.

— and where so, your right to transparent communication specifically affording you sufficient time and opportunity to give and withdraw consent, as described in these Codes and Policies, to prior, present or future decisions made or reached concerning you during research, investigation or processing activities conducted on, from, about or otherwise relating to you by means of automation and automated methods, including but not limited to automated individual decision-making and profiling.[/su_spoiler][su_spoiler title=”Informing, Human Subjects Research Rights and Exercising Them” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication reasonably informing you — as the human subject under study — regarding the means and procedures to exercise all of your human subjects research rights in relation to the above proposed or reported research, investigation or processing activities on, from, about or otherwise relating to you by means of automation and automated methods, including but not limited to automated individual decision-making and profiling — as well as the following additional rights to (a) challenge any decisions made via such research, investigation or processing, (b) obtain human intervention, (c) express your point of view, and (d) have your point of view documented and added to the record.[/su_spoiler][su_spoiler title=”Informing, Further Communication, Discussion and Contact” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication specifically affording you — as the human subject under study — sufficient period of time and opportunity to ask questions and discuss concerns, the means for ongoing communication and notification, and the identity and contact details of the offices, persons and representatives responsible for the research, investigation and processing of biospecimens, data and information concerning you.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Consent

As the human subject under study, you shall have the rights to be asked, give and withdraw informed consent to participating in a research or investigation study and to the processing of biospecimens, data and information attributable to, identifying or otherwise relating to you. You shall also have the right to an informing consent process, and to your knowledge of and participation in an assent process concerning you. Such rights include all of the following:

[su_accordion class=””][su_spoiler title=”Autonomy, Dignity and Legal Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that protect and respect your autonomy, dignity and attendant legal rights.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that protect and respect your autonomy, dignity and attendant legal rights.[/su_spoiler][su_spoiler title=”Fulfillment of Informed Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that fulfill the requirements for informed consent, as described under the section Principle of Informed Consent.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that fulfill the requirements for informed consent, as described under the section Principle of Informed Consent.[/su_spoiler][su_spoiler title=”Respect for Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that protect and respect your consent, consent decisions and consent rights.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that protect and respect your consent, consent decisions and consent rights.[/su_spoiler][su_spoiler title=”Respect for Withdrawal” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that protect and respect your withdrawal of consent.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that protect and respect your withdrawal of consent.[/su_spoiler][su_spoiler title=”Invalidity of Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that protect and respect your rights to be informed of the invalidity or non-binding nature of consent asked, given or presumed.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that protect and respect your rights to be informed of the invalidity or non-binding nature of consent asked, given or presumed.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Confidentiality

As the human subject under study, you shall have the rights to confidentiality before, during and after The Ikoku Foundations conducts research or investigation on, about or otherwise relating to you, and before, during and after The Ikoku Foundations process biospecimens, data and information attributable to, identifying or otherwise relating to you. You shall also have the absolute rights to confidential conversation. Such rights include all of the following:

[su_accordion class=””][su_spoiler title=”Autonomy, Dignity and Legal Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that protect and respect your autonomy, dignity and attendant legal rights.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that protect and respect your autonomy, dignity and attendant legal rights.[/su_spoiler][su_spoiler title=”Fulfillment of Confidentiality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that fulfill the requirements for confidentiality and sensitivity, as described under the section Principles for Privacy and Confidentiality.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that fulfill the requirements for confidentiality and sensitivity, as described under the section Principles for Privacy and Confidentiality.[/su_spoiler][su_spoiler title=”Fulfillment of Sensitivity” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that fulfill the requirements for sensitivity, as described under the section Principles for Sensitivity.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that fulfill the requirements for sensitivity, as described under the section Principles for Sensitivity.[/su_spoiler][su_spoiler title=”Protection of Confidentiality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that protect and respect your confidentiality and confidentiality rights.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that protect and respect your confidentiality and confidentiality rights.[/su_spoiler][su_spoiler title=”Breaches and Violations of Confidentiality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that reasonably informs you — as the human subject under study — of confirmed breaches or violations of your confidentiality.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Privacy

As the human subject under study, you shall have the rights to privacy before, during and after The Ikoku Foundations conducts research or investigation on, about or otherwise relating to you, and before, during and after The Ikoku Foundations process biospecimens, data and information attributable to, identifying or otherwise relating to you. You shall also have the absolute rights to private conversation and to private thought. Such rights require that all of the following apply:

[su_accordion class=””][su_spoiler title=”Autonomy, Dignity and Legal Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that protect and respect your autonomy, dignity and attendant legal rights.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that protect and respect your autonomy, dignity and attendant legal rights.[/su_spoiler][su_spoiler title=”Fulfillment of Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that fulfill the requirements for privacy, as described under the section Principles of Privacy and Confidentiality.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you be processed by means that fulfill the requirements for privacy, as described under the section Principles of Privacy and Confidentiality.[/su_spoiler][su_spoiler title=”Fulfillment of Sensitivity” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that fulfill the requirements for sensitivity, as described under the section Principle of Sensitivity.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that fulfill the requirements for sensitivity, as described under the section Principle of Sensitivity.[/su_spoiler][su_spoiler title=”Protection of Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that protect and respect your privacy and privacy rights, especially your absolute rights to private conversation and private thought.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that protect and respect your privacy and privacy rights, especially your absolute rights to private conversation and private thought.[/su_spoiler][su_spoiler title=”Breaches and Violations of Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that reasonably informs you — of confirmed breaches or violations of your privacy.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Protection, Safety and Security

As the human subject under study, you shall have the rights to adequate protection, safety and security of yourself and biospecimens, data and information attributable to, identifying or otherwise relating to you — before, during and after their processing and any research or investigation conducting on, about or relating to you. You shall also have the rights to protect your intellectual, real and organizational property and proprietary rights before, during and after such research and such processing. Such rights include all of the following:

[su_accordion class=””][su_spoiler title=”Protection as Basic Right of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have all involved understand research, human subject, biospecimen, data and information protection as a basic right with respect to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Protection, Safety and Security of Human Subject” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that ensure adequate levels of protection, safety and security against harms and risks to your body, mind and self.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that ensure adequate levels of protection, safety and security against harms and risks to your body, mind and self.[/su_spoiler][su_spoiler title=”Protection, Safety and Security of Human Subject Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that ensure adequate levels of protection, safety and security against harms and risks to your rights.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that ensure adequate levels of protection, safety and security against harms and risks to your rights.[/su_spoiler][su_spoiler title=”Protection, Safety and Security of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that ensure adequate levels of protection, safety and security against harms and risks to the research and investigation.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that ensure adequate levels of protection, safety and security against harms and risks to the biospecimens, data and information.[/su_spoiler][su_spoiler title=”Protection of Intellectual Property” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that support you in protecting your intellectual property and intellectual property and proprietary rights, including but not limited to copyrights, patents, trademarks and trade secrets.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that support you in protecting your intellectual property and intellectual property and proprietary rights, including but not limited to copyrights, patents, trademarks and trade secrets.[/su_spoiler][su_spoiler title=”Protection of Real Property” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — conducted by means that support you in protecting your real property and real property rights, including but not limited to reasonable prevention or remediation against exposure, leakage, loss, theft, trespassing and vandalism.

— and your right to have biospecimens, data and information attributable to, identifying or otherwise relating to you processed by means that support you in protecting your real property and real property rights, including but not limited to reasonable prevention or remediation against exposure, leakage, loss, theft, trespassing and vandalism.[/su_spoiler][su_spoiler title=”Organizational Functioning, Integrity and Property as Entities” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have research and investigation on, about or otherwise relating to you — as the human subject under study — as well as any processing of biospecimens, data and information attributable to, identifying or otherwise relating to you conducted by means that support you in protecting your organizational functioning, integrity and property and attendant rights as an entity.

— and such rights shall include but not be limited to those pertaining to administration, coordination and management; data, information and network security; development and operations for products and services; safe-keeping of accounts, books and records; and restriction of access to headquarters, offices, operations or organizational spaces or sites that are physical, technical, telecommunicative or virtual in nature.[/su_spoiler][su_spoiler title=”Breaches and Violations of Protection, Safety and Security” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to receive transparent communication that reasonably informs you — as the human subject under study — of confirmed breaches or violations of your rights to protection, safety and security as well as your property and proprietary rights.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Ensure and Verify

As the human subject under study, you shall have the rights to reasonably ensure and verify the fulfillment of principles of human subjects research and investigation conducted on, about or otherwise relating to you, and of research processing of biospecimens, data and information attributable to, identifying or otherwise relating to you. Such rights include all of the following:

[su_accordion class=””][su_spoiler title=”Process in Writing and Documentable” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have your request to ensure or verify, its response and any further communication proceed in writing and be accessible, documentable and reproducible in standardly legible form.[/su_spoiler][su_spoiler title=”Reasonably Transparent Communication” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have the above communication fulfill the principles, rights and responsibilities for transparency with respect to the process to ensure and verify, to the research or investigation activities and study, and to the biospecimens data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Informing and Consenting” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have the above communication fulfill the principles, rights and responsibilities for consent and being informed with respect to the process to ensure and verify, to the research or investigation activities and study, and to the biospecimens, data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Facilitating the Exercise of Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have the above communication fulfill the principles, rights and responsibilities for supporting you in exercising all of your human subjects research and investigation rights with respect to the process to ensure and verify, to the research or investigation activities and study, and to the biospecimens, data and information attributable to, identifying or otherwise relating to you.[/su_spoiler][su_spoiler title=”Responsive and Updating Communication” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have the above communication be responsive to reasonable requests without undue delay, and be as reasonably informing as possible regarding progress, updates and any decisions reached, including clear reasoning or rationale.[/su_spoiler][su_spoiler title=”Reaching Commensurability” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have further communication pertaining to the process to ensure and verify, to the research or investigation activities and study, and to the biospecimens, data and information, ensure commensurability is reached in good faith upon any supposed conflict of claims, interests or purposes.[/su_spoiler][su_spoiler title=”Further Process” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have further communication pertaining to the process to ensure and verify, to the research or investigation activities and study, and to the biospecimens, data and information, clearly explain decisions and determinations reached, delineate actions taken, and inform you — as the human subject under study — of the possibilities and means for acceptance and closure, appeal, complaint, further review or otherwise seeking remedy.[/su_spoiler][su_spoiler title=”Given Feasibility and Reasonableness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that your requests are both feasible and reasonable with respect to cost, frequency, number, proportionate effort, technical limits and concerns for the rights of other persons concerned, including The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Given No Adverse Effect on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that exercising these rights does not adversely affect the civil liberties and basic, civil and fundamental rights of others — especially where those others are also human subjects under study or other natural persons concerned.[/su_spoiler][su_spoiler title=”Given Necessity, Non-Identification and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that all such communication and ensure and verify process granted to you — as the human subject under study — whether pertaining to the research or investigation activities and study, to the biospecimens, data and information, or to their processing, adhere to and fulfill the principles of necessity, non-identification and minimization.*[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

*to offer a clarifying example of reasonably transparent communication with these principles in mind: a good response to a request to ensure and verify may include written confirmation that a limited-scope but deep review has shown specified categories of data and information collected from specified categories or users, over the past year, have been and continue to be irreversibly anonymized.

Rights to Access

As the human subject under study, you shall have the rights to reasonable access to public or published reports of human subjects research and investigation attributable to, identifying or otherwise relating to you. Such rights shall include all of the following:

[su_accordion class=””][su_spoiler title=”Request and Obtain Access to Public or Published Reports” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to request and obtain access to authorized and public or published articles, papers and reports of research or investigation conducted on about or otherwise relating to you and involving processing of biospecimens, data and information attributable to, identifying or relating to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Request and Obtain Copy of Public or Published Reports” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to request and obtain a copy of authorized and public or published articles, papers and reports of research or investigation conducted on about or otherwise relating to you and involving processing of biospecimens, data and information attributable to, identifying or relating to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Reasonably Transparent Communication” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have The Ikoku Foundations provide you — as the human subject under study — reasonably transparent communication regarding progress and decisions pertaining to your access or copy requests.[/su_spoiler][su_spoiler title=”Given Feasibility and Reasonableness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that your requests are both feasible and reasonable with respect to cost, frequency, number, proportionate effort, technical limits and concerns for the rights of other persons concerned, including The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Given No Adverse Effect on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that exercising these rights does not adversely affect the civil liberties and basic, civil and fundamental rights of others — especially where those others are also human subjects under study or natural and legal persons concerned.[/su_spoiler][su_spoiler title=”Given Necessity, Non-Identification and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that all such communication and notification and access granted to you — as the human subject under study — whether pertaining to the research or investigation activities and study, to the biospecimens, data and information, or to their processing, adhere to and fulfill the principles of necessity, non-identification and minimization.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Portability

As the human subject under study, you shall have the rights to reasonable portability of public or published results of human subjects research and investigation attributable to, identifying or otherwise relating to you. Such rights shall include all of the following:

[su_accordion class=””][su_spoiler title=”Request and Receive the Report in Readable Format” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to request and receive, in a structured, commonly used and computer-readable format, authorized and public or published articles, papers and reports of research or investigation conducted on, about or otherwise relating to you and involving research processing of biospecimens, data and information attributable to, identifying or relating to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Reasonably Transparent Communication” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have The Ikoku Foundations provide you — as the human subject under study — reasonably transparent communication regarding progress and decisions pertaining to your portability requests.[/su_spoiler][su_spoiler title=”Given Feasibility and Reasonableness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that your requests are both feasible and reasonable with respect to cost, frequency, number, proportionate effort, other technical limits and concerns for the rights of other persons concerned, including The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Given No Adverse Effect on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that exercising these rights does not adversely affect the civil liberties and basic, civil and fundamental rights of others — especially where those others are also human subjects under study or natural and legal persons concerned.[/su_spoiler][su_spoiler title=”Given Necessity, Non-Identification and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that all such communication and portability granted to you — as the human subject under study — whether pertaining to the research or investigation activities and study, to the biospecimens, data and information, or to their processing, adhere to and fulfill the principles of necessity, non-identification and minimization.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Object and Stop

As the human subject under study, you shall have the rights to reasonably object to and have stopped, on grounds relating to your particular situation, at any time, any or all human subjects research and investigation — including access or other processing of biospecimens, data and information — specifically attributable to, identifying or otherwise relating to you. You shall have such rights especially, but not limited to, when any of the following applies:

[su_accordion class=””][su_spoiler title=”Harmful, Unethical, Unlawful, Without Consent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where the research, investigation or processing of the biospecimens, data and information was, is, or will be harmful, unconsented, unethical or unlawful or otherwise not adhering to or fulfilling the policies, principles and rights for human subjects research and investigation.[/su_spoiler][su_spoiler title=”Research or Processing for Non-Direct and Public Benefit Reasons” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where the research, investigation or processing of the biospecimens, data and information was, is, or will be conducted solely for archival, care, research or statistical purposes, including health, historical, medical or scientific, or for reasons of public benefit or public interest.[/su_spoiler][su_spoiler title=”Processing for Marketing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where the research, investigation or processing of the biospecimens, data and information was, is, or will be conducted solely for direct marketing or other advertising or marketing purposes.[/su_spoiler][su_spoiler title=”Reasonably Transparent Communication” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that The Ikoku Foundations provide you — as the human subject under study — reasonably transparent communication and notification regarding progress and decisions pertaining to your objection or stoppage requests.[/su_spoiler][su_spoiler title=”Given Feasibility and Reasonableness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that your requests are both feasible and reasonable with respect to cost, frequency, number, proportionate effort, technical limits and concerns for the rights of other persons concerned, including The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Given No Adverse Effect on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that exercising these rights does not adversely affect the civil liberties and basic, civil and fundamental rights of others — especially where those others are also human subject under study or natural and legal persons concerned.[/su_spoiler][su_spoiler title=”Given Necessity, Non-Identification and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that all such communication and objection or stoppage granted to you — as the human subject under study — whether pertaining to the research or investigation activities and study, to the biospecimens, data and information, or to their processing, adhere to and fulfill the principles of necessity, non-identification and data-minimization.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Restrict Research

As the human subject under study, you shall have the rights to reasonably obtain from The Ikoku Foundations, at any time, a restriction of any and all human subjects research and investigation — including access or other processing of biospecimens, data and information — specifically attributable to, identifying or otherwise relating to you. You shall have such rights especially, but not limited to, when any of the following applies:

[su_accordion class=””][su_spoiler title=”When Contesting Consent or Assent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where you — as the human subject under study — contest the validity of the consent or assent or the consent process pertaining to the research, investigation or processing, for a period enabling The Ikoku Foundations to verify the validity of the consent or assent or the consent process.[/su_spoiler][su_spoiler title=”When Contesting Harm or Benefit-Risk Relation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where you — as the human subject under study — contest the adequacy of harm avoidance or minimization or assessment of appropriate benefit-risk relations pertaining to the research, investigation or processing, for a period enabling The Ikoku Foundations to verify the adequacy of harm avoidance or minimization or assessment of appropriate benefit-risk relations.[/su_spoiler][su_spoiler title=”When Contesting Ethics or Lawfulness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where you — as the human subject under study — contest the ethics or lawfulness of the research, investigation or processing and particularly the fulfillment of the principles of human subjects research, for a period enabling The Ikoku Foundations to verify the ethics or lawfulness of the research, investigation or processing.[/su_spoiler][su_spoiler title=”When Exercising Rights to Object” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where you — as the human subject under study — exercise your rights to object on any of the legitimate grounds delineated and described in these Codes and Policies, for a period enabling The Ikoku Foundations to verify the validity of the grounds for objection.[/su_spoiler][su_spoiler title=”When Harmful, Unconsented, Unethical or Unlawful Research is Established but not Removal” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where you — as the human subject under study — and The Ikoku Foundations have established an inadequacy in consent, ethics, harmfulness or lawfulness of the research, investigation or processing — or have determined that other grounds for objection are valid — but you decide against removal, deletion, destruction or erasure and instead request the restriction of purposes, research, investigation or processing.[/su_spoiler][su_spoiler title=”When Legal Claims are being Established, Exercised or Defended” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where you — as the human subject under study — requests the preservation and storage of the identifiable biospecimens, data and information for your own establishing, exercising or defense of legal claims, though The Ikoku Foundations establish that it no longer has need for the identifiable biospecimens, data and information or any of its processing for research or investigation.[/su_spoiler][su_spoiler title=”Reasonably Transparent Communication” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that The Ikoku Foundations provide you — as the human subject under study — reasonably transparent communication and notification regarding progress and decisions pertaining to your restriction requests.[/su_spoiler][su_spoiler title=”Given Need for Consent for Processing Beyond Storage” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that, where restriction of research, investigation or processing is decided, any research, investigation of processing beyond storage of biospecimens, data and information relating to you — as the human subject under study — requires your informed consent.[/su_spoiler][su_spoiler title=”Given Notice on Lifting of Restriction” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that, where restriction of research, investigation or processing occurs, you — as the human subject under study — are informed without undue delay if andbefore the restriction of research, investigation or processing is lifted.[/su_spoiler][su_spoiler title=”Given Feasibility and Reasonableness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that your requests are both feasible and reasonable with respect to cost, frequency, number, proportionate effort, technical limits and concerns for the rights of other persons concerned, including The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Given No Adverse Effect on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided as well that exercising these rights does not adversely affect the civil liberties and basic, civil and fundamental rights of others — especially where those others are also human subjects under study or natural and legal persons concerned.[/su_spoiler][su_spoiler title=”Given Necessity, Non-Identification and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that all such communication and restriction granted to you — as the human subject under study — whether pertaining to the research or investigation activities and study, to the biospecimens, data and information, or to their processing, adhere to and fulfill the principles of necessity, non-identification and minimization.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Removal

As the human subject under study, you shall have the rights, upon confirmed decision to object, restrict, stop or withdraw, to have reasonably removed — including deleted, destroyed or erased — yourself and records of your participation in the study as well as biospecimens, data and information attributable to, identifying or otherwise relating to solely you. Such rights shall include all of the following:

[su_accordion class=””][su_spoiler title=”Request and Confirm Removal of Self” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have — upon confirmed review and approval by The Ikoku Foundations of your request and decision to object, restrict, stop or withdraw — yourself and your participation in the research or investigation study — as the human subject under study — reasonably removed, and confirmed as such without undue delay.[/su_spoiler][su_spoiler title=”Request and Confirm Removal of Records” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have — upon confirmed review and approval by The Ikoku Foundations of your request and decision to object, restrict, stop or withdraw — any permitted records of your participation in the study as well as biospecimens, data and information attributable to, identifying or relating to you — as the human subject under study — reasonably removed, including deleted, destroyed or erased, and confirmed as such without undue delay.[/su_spoiler][su_spoiler title=”Inform Other Recipients” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right — where the records of your participation in the study as well as biospecimens, data and information permitted for removal have been made accessible or public or transferred to other recipients or third parties, and where financially and technically feasible — to have The Ikoku Foundations inform such other recipients of the request for their removal as well as the removal of any related links, copies or replications.[/su_spoiler][su_spoiler title=”Reasonably Transparent Communication” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right to have The Ikoku Foundations provide you — as the human subject under study — reasonably transparent communication and notification regarding progress and decisions pertaining to your removal requests.[/su_spoiler][su_spoiler title=”Given Feasibility and Reasonableness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that your requests are both feasible and reasonable with respect to cost, frequency, number, proportionate effort, technical limits and concerns for the rights of other persons concerned, including The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Given No Adverse Effect on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that exercising these rights does not adversely affect the civil liberties and basic, civil and fundamental rights of others — especially where those others are also also human subjects under study or natural and legal persons concerned.[/su_spoiler][su_spoiler title=”Given Necessity, Non-Identification and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that all such communication and removal granted to you — as the human subject under study — whether pertaining to the research or investigation activities and study, to the biospecimens, data and information, or to their processing, adhere to and fulfill the principles of necessity, non-identification and minimization.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Remedy

As the human subject under study, you shall have the rights to reasonable remedy following an ethics review of human subjects research and investigation conducted on, about or otherwise relating to you, and of research processing of biospecimens, data and information attributable to, identifying or otherwise relating to you. Such rights shall require all of the following:

[su_accordion class=””][su_spoiler title=”Remedy upon Unethical Finding” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that where you — as the human subject under study — and The Ikoku Foundations have established an inadequacy in consent, ethics, harmfulness or lawfulness of the research, investigation or processing, or have determined that other grounds for objection are valid, The Ikoku Foundations provide you the opportunity to seek and receive reasonable remedy via processes to reach commensurability in good faith, with IRB approval and review and authorization of the Founder, Alvan Azinna Chibuzo Ikoku.[/su_spoiler][su_spoiler title=”Reasonably Transparent Communication” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and that The Ikoku Foundations provide you — as the human subject under study — reasonably transparent communication and notification regarding progress and decisions pertaining to your remedy requests.[/su_spoiler][su_spoiler title=”Given Feasibility and Reasonableness” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that your requests are both feasible and reasonable with respect to cost, frequency, number, proportionate effort, technical limits and concerns for the rights of other persons concerned, including The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Given No Adverse Effect on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that exercising these rights does not adversely affect the civil liberties and basic, civil and fundamental rights of others — especially where those others are also human subjects under study or natural and legal persons concerned.[/su_spoiler][su_spoiler title=”Given Necessity, Non-Identification and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that all such communication and remedy granted to you — as the human subject under study — whether pertaining to the research or investigation activities and study, to the biospecimens, data and information, or to their processing, adhere to and fulfill the principles of necessity, non-identification and minimization.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Rights to Notification

As the human subject under study, you shall have the rights to reasonable notification of persons following decisions and actions taken during an ethics review of human subjects research and investigation conducted on, about or otherwise relating to you, and of research processing of biospecimens, data and information attributable to, identifying or otherwise relating to you. Such rights shall include all of the following:

[su_accordion class=””][su_spoiler title=”Recipients upon Removal” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right, upon any decision for removal, to have The Ikoku Foundations provide reasonably transparent communication and notification to each recipient to whom the removed records, biospecimens, data and information have been disclosed or transferred.[/su_spoiler][su_spoiler title=”Recipients upon Restriction of Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]your right, upon any decision to restrict the research, investigation or processing, to have The Ikoku Foundations provide reasonably transparent communication and notification to each recipient to whom the restricted research records, biospecimens, data and information have been disclosed or transferred.[/su_spoiler][su_spoiler title=”Reasonably Transparent Communication” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and your right to have The Ikoku Foundations provide you — as the human subject under study — reasonably transparent communication and notification regarding progress and decisions pertaining to your notification requests, and on your reasonable additional request, to have The Ikoku Foundations inform you about those recipients.[/su_spoiler][su_spoiler title=”Given Feasibility and Reasonableness ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that your requests are both feasible and reasonable with respect to cost, frequency’, number, proportionate effort, technical limits and concerns for the rights of other persons concerned, including The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Given Expected Reductions in Obligation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided specifically that the obligation is reasonably reduced where notification proves impossible or involves disproportionate effort.[/su_spoiler][su_spoiler title=”Given No Adverse Effect on Rights of Others” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that exercising these rights does not adversely affect the civil liberties and basic, civil and fundamental rights of others — especially where those others are also human subjects under study or natural and legal persons concerned.[/su_spoiler][su_spoiler title=”Given Necessity, Non-Identification and Minimization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that all such communication and notification granted to you — as the human subject under study — whether pertaining to the research or investigation activities and study, to the biospecimens, data and information, or to their processing, adhere to and fulfill the principles of necessity, non-identification and minimization.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

C — Central Responsibilities

The Responsibilities of Research Administration

The above principles of human subjects research and investigation — and their attendant rights of human subjects research and investigation — also incur ten (10) central responsibilities for the administration and management of human subjects research and investigation. The Ikoku Foundations shall fulfill and retain such responsibilities with respect to all human subjects research and investigation it conducts and supports, especially when accessing or otherwise processing biospecimens, data and information attributable to, identifying, or otherwise relating to you. The Policy will elaborate in some detail upon each of these responsibilities as you proceed on this page. In the meantime do keep in mind two opening points to be made here.

First, that The Ikoku Foundations and specifically their Founder, Alvan Azinna Chibuzo Ikoku, consider these responsibilities to be under the purview of Property Rights — and so take any attempts to abrogate, diminish, disrupt, reduce or weaken their capacity to fulfill, maintain or retain such responsibilities very seriously, directing you to the notice on Your Duty to Corporate Integrity at the top of this Policy page.

And second, that, given the aforementioned, it should be understood that The Ikoku Foundations and their Founder shall have human subjects research and investigation conducted under all of the following conditions:

[su_accordion class=””][su_spoiler title=”Responsibilities for Studies” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder have and retain full responsibilities for determining and accounting for the characteristics, parameters and qualities of research studies.[/su_spoiler][su_spoiler title=”Responsibilities for Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder have and retain full responsibilities for determining and accounting for the characteristics, parameters and qualities of human subjects groups and selection.[/su_spoiler][su_spoiler title=”Responsibilities for Biospecimens, Data and Information and Their Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder have and retain full responsibilities for determining and accounting for the characteristics, parameters and qualities of biospecimens, data and information, and of their processing.[/su_spoiler][su_spoiler title=”Responsibilities for Measures and Methods” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder have and retain full responsibilities for developing and implementing computational, organizational and technical measures and methods for research activities and studies, biospecimens, data and information, their processing and the administration and management of research and investigation.[/su_spoiler][su_spoiler title=”Responsibilities for Assessing and Minimizing Risks” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder have and retain full responsibilities for assessing and minimizing risks to the rights of you and other human subjects under study.[/su_spoiler][su_spoiler title=”Responsibilities for Protections, Safety and Security” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder have and retain full responsibilities for developing, implementing and revising protection, safety and security measures for research activities and studies, biospecimens, data and information, their processing and the administration and management of research and investigation.[/su_spoiler][su_spoiler title=”Responsibilities for Approval, Authorization and Transfer” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, during all of the above, The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — have and retain all responsibilities for approval, authorization and transfer pertaining to research activities and studies, biospecimens, data and information, their processing and the administration and management of research and investigation.[/su_spoiler][su_spoiler title=”Responsibilities for Records” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, during all of the above, The Ikoku Foundations and their Founder have and retain all responsibilities for creating, maintaining and safekeeping books and records for research activities and studies, biospecimens, data and information, their processing and the administration and management of research and investigation.[/su_spoiler][su_spoiler title=”Responsibilities for Communication and Notification” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, during all of the above, The Ikoku Foundations and their Founder have and retain all responsibilities for full and transparent communication with and notification of you — as the natural or legal person concerned — upon any breach or violation of the above.[/su_spoiler][su_spoiler title=”Responsibilities for Review, Accordance with and Adherence to Codes, Policies and Regulations” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder have and retain full responsibilities for reviewing, updating and ensuring that computational, organizational and technical measures and methods are adequate, appropriate and effective for research activities and studies, biospecimens, data and information, their processing and the administration and management of research and investigation.

— and that, during all of the above, The Ikoku Foundations and their Founder have and retain all responsibilities for ensuring research activities and studies, biospecimens, data and information, their processing and the administration and management of research and investigation are and remain in accordance with Founder and IRB approval procedures, with these Codes and Policies, with their delineated and described principles, rights and responsibilities, and with applicable guidelines, law and regulation.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Responsibilities for Study

The Ikoku Foundations — when conducting research and investigation on, about or otherwise relating to you — shall have the responsibilities for determining and accounting for the conception, purposes and design, parameters, primary fields and forms of studies in human subjects research and investigation. The Ikoku Foundations are responsible for assessing and deciding, for instance, their content, context, nature and scope as well as their focus of inquiry or testing, mode of inquiry or testing, null hypothesis or thesis, interactions, interventions and primary procedures. Such responsibilities require that all of the following apply:

[su_accordion class=””][su_spoiler title=”Focus of Inquiry or Testing of Research Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the focus of inquiry or testing for studies in human subjects research and investigation, including but not limited to deciding and authorizing the objectives or purposes, research problem or question, interaction, intervention or method under evaluation, inquiry or testing, null hypothesis or thesis, and contributory field of generalizable knowledge for such research and investigation.[/su_spoiler][su_spoiler title=”Nature of Research Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the nature of studies in human subjects research and investigation, including but not limited to deciding and authorizing the primary mode of inquiry or testing and form of investigation, such as archival research and humanistic analysis, data analysis, observational study, randomized control trial.[/su_spoiler][su_spoiler title=”Scope of Research Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the scope of studies in human subjects research and investigation, including but not limited to deciding and authorizing the field, range, scale, size and time of such research and investigation.[/su_spoiler][su_spoiler title=”Context of Research Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the context of studies in human subjects research and investigation, including but not limited to deciding and authorizing certain areas, parts, products, sections, services and sites of The Ikoku Foundations, as well as communities, populations and societies for such research and investigation.[/su_spoiler][su_spoiler title=”Content of Research Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the content of studies in human subjects research and investigation, including but not limited to deciding and authorizing the biospecimens, data and information to be accessed or otherwise processed during such research and information.[/su_spoiler][su_spoiler title=”Accounting for Research Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, with the above taking precedence and guaranteed, The Ikoku Foundations and their Founder be the primary administrator and manager accounting for, proposing, reevaluating, reporting on, reviewing and revising protocols for human subjects research and investigation projects and studies themselves, including but not limited to their overall design, execution and accordance with fulfilling the principles, rights and responsibilities of human subjects research and investigation.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Responsibilities for Subjects

The Ikoku Foundations — when conducting research and investigation on, about or otherwise relating to you — shall have the responsibilities for determining and accounting for the characteristics, parameters and qualities of the human subjects groups and their selection in human subjects research and investigation. The Ikoku Foundations are responsible for deciding and controlling, for instance, their cultural, demographic or physical nature, their diversity or similarity along selected factors, their communities, location or situations as well as their random or equitable selection, protections, safety and security during such research and investigation. Such responsibilities require that all of the following apply:

[su_accordion class=””][su_spoiler title=”Selection of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the selection of human subjects for human subjects research and investigation activities and studies, including but not limited to deciding and authorizing their random and equitable selection or their selection and subsequent diversities and similarities along characteristics of interest for such research and investigation.[/su_spoiler][su_spoiler title=”Context of Human Subjects Participation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the context in which human subjects participate in research and investigation activities and studies, including but not limited to deciding and authorizing certain areas, parts, products, sections, services and sites of The Ikoku Foundations, as well as communities, populations and societies for such research and investigation.[/su_spoiler][su_spoiler title=”Scope of Human Subjects Participation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the scope of human subjects participation in research and investigation activities and studies, including but not limited to deciding and authorizing the depth, extent, frequency, invasive or demanding nature, scale, size and time of their participation in such research and investigation.[/su_spoiler][su_spoiler title=”Protections, Safety and Security of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the level and quality of protections afforded the human subjects during research and investigation activities and studies, including but not limited protections for confidentiality, privacy, reduction of harms, safety and security.[/su_spoiler][su_spoiler title=”Accounting for Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, with the above taking precedence and guaranteed, The Ikoku Foundations and their Founder be the primary administrator and manager accounting for, proposing, reevaluating, reporting on, reviewing and revising protocols for human subjects selection, participation and protections, especially with respect to their overall design, execution and accordance with fulfilling the principles, rights and responsibilities of human subjects research and investigation.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Responsibilities for Processing

The Ikoku Foundations — when conducting research and investigation on, about or otherwise relating to you — shall have the responsibilities for determining and accounting for the characteristics, parameters, qualities and processing of biospecimens, data and information in human subjects research and investigation. The Ikoku Foundations are responsible for deciding and controlling, for instance, their nature and scope, as well as context, purposes and content.

With respect to the biospecimens, data and information themselves, such responsibilities require that all of the following apply:

[su_accordion class=””][su_spoiler title=”Content of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the content of biospecimens, data and information for such research and investigation.[/su_spoiler][su_spoiler title=”Nature of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the nature of biospecimens, data and information, including but not limited to deciding and authorizing the form, genre, language, medium, personal or identifying capacity, sensitivity and type of biospecimens, data and information.[/su_spoiler][su_spoiler title=”Scope of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the scope of biospecimens, data and information, including but not limited to deciding and authorizing the field, range, scale, size and time of biospecimens, data and information.[/su_spoiler][su_spoiler title=”Context of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the context of biospecimens, data and information, including but not limited to deciding and authorizing certain areas, parts, products, services and sites of The Ikoku Foundations for the biospecimens, data and information.[/su_spoiler][su_spoiler title=”Accounting for Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, with the above taking precedence and guaranteed, The Ikoku Foundations and their Founder be the primary administrator and manager accounting for, reevaluating, reviewing and revising the content, context, nature and scope for biospecimens, data and information in our fulfillment of human subjects research principles, rights and responsibilities.[/su_spoiler][/su_accordion]

With respect to the processing of such biospecimens, data and information, the above responsibilities also require that allof the following apply:

[su_accordion class=””][su_spoiler title=”Content of Biospecimens, Data and Information Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the content of research processing of biospecimens, data and information.[/su_spoiler][su_spoiler title=”Nature of Biospecimens, Data and Information Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the nature of research processing for biospecimens, data and information, including but not limited to deciding and authorizing computation, equipment, filing system, means, mechanisms, methods, procedures and technologies for such processing.[/su_spoiler][su_spoiler title=”Purposes of Biospecimens, Data and Information Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the purposes for research processing of biospecimens, data and information, including but not limited to deciding and authorizing actual or proposed applications, benefits, ends, impacts, interests, objectives, recipients and uses for biospecimens, data and information via such processing.[/su_spoiler][su_spoiler title=”Scope of Biospecimens, Data and Information Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the scope of research processing for biospecimens, data and information, including but not limited to deciding and authorizing field, range, scale, size and time of each application, method, process or utilization for such processing.[/su_spoiler][su_spoiler title=”Context of Biospecimens, Data and Information Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the context for research processing of biospecimens, data and information, including but not limited to deciding and authorizing certain areas, parts, products, services and sites of The Ikoku Foundations for such processing.[/su_spoiler][su_spoiler title=”Accounting for Biospecimens, Data and Information Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, with the above taking precedence and guaranteed, The Ikoku Foundations and their Founder be the primary administrator and manager accounting for, reevaluating, reviewing and revising the content, context, nature, purposes and scope for research processing of biospecimens, data and information in our fulfillment of human subjects research principles, rights and responsibilities.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Responsibilities for Measures and Methods

The Ikoku Foundations — when conducting research and investigation on, about or otherwise relating to you — shall have the responsibilities for assessing and determining the computational, organizational and technical measures and methods of human subjects research and investigation. The Ikoku Foundations are responsible for deciding and controlling, for instance, the adequacy, appropriateness and effectiveness of such measures and methods for specific research and investigation purposes, study designs, human subjects groups, as well as biospecimens, data and information and their processing. Such responsibilities require that all of the following apply:

[su_accordion class=””][su_spoiler title=”Methods Under Inquiry” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager assessing and determining the methods, interactions or interventions to be evaluated or tested during human subjects research and investigation, including but not limited to deciding and authorizing the actions, methodologies, procedures, questionnaires or surveys, techniques, theories, therapies and treatments to be administered, utilized and evaluated during such research and information.[/su_spoiler][su_spoiler title=”Measures Accounting for Research Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing and implementing computational, organizational and technical measures that are adequate, appropriate and effective specifically for the content, context, design, nature, scope, as well as null hypothesis or thesis, research objective, purpose, problem or question, focus of inquiry or testing, mode of inquiry or testing, and interactions, interventions and procedures of the research and investigation study.[/su_spoiler][su_spoiler title=”Measures Accounting for Methods Under Inquiry” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing and implementing computational, organizational and technical measures that are adequate, appropriate and effective specifically for the characteristics, parameters and qualities as well as context, nature, scope and frequency and extent of administration or application of methods under inquiry.[/su_spoiler][su_spoiler title=”Measures Accounting for Research Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing and implementing computational, organizational and technical measures that are adequate, appropriate and effective specifically for the characteristics and parameters of selection, context, nature and scope of participation, as well as protections, safety and security of the human subjects.[/su_spoiler][su_spoiler title=”Measures Accounting for Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing and implementing computational, organizational and technical measures that are adequate, appropriate and effective specifically for the content, context, nature and scope of the biospecimens, data and information.[/su_spoiler][su_spoiler title=”Measures Accounting for Biospecimens, Data and Information Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing and implementing computational, organizational and technical measures that are adequate, appropriate and effective specifically for the context, nature, purposes and scope for the processing of biospecimens, data and information.[/su_spoiler][su_spoiler title=”Measures Meeting Best Practices Standards” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing and implementing computational, organizational and technical measures that meet best practices standards, to the most reasonable extent possible, in keeping with expectations for research and investigation purposes, study design, subjects groups, methods, biospecimens, data and information, as well as their processing.[/su_spoiler][su_spoiler title=”Measures Meeting Codes and Policies Standards” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, during all of the above, The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing and implementing computational, organizational and technical measures that are furthermore compatible with standards set via our human subjects research and investigation principles, rights and responsibilities.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Responsibilities for Risk

The Ikoku Foundations — when conducting research and investigation on, about or otherwise relating to you — shall have the responsibilities for assessing and minimizing risks to you and to your rights as the human subject under study. The Ikoku Foundations are responsible for anticipating and reducing risks, for instance, of varying likelihood, number, origin and severity, as well as assessing and ensuring favorable relations between benefit and risk, as found in a specific proposed then reviewed study, with particular attention to study design, human subjects groups, sets of methods, sets of biospecimens, data and information, and their processing.

The assessment of risk is among the most important responsibilities The Ikoku Foundations can carry out for you. Such responsibilities therefore entail a one- or three-part evaluation, depending on the level of risk we discern. The first part of the evaluation, which every proposed research or investigation undergoes, requires that all of the following apply:

[su_accordion class=””][su_spoiler title=”Early Definition and Determination of Risk” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager defining and determining the factors leading to, likelihood, number, origin and severity of risks of the human subjects research and investigation activities or study to you and also to your rights — as the human subject under study.[/su_spoiler][su_spoiler title=”Risk Determination Accounting for Aspects of Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager conducting the above early determination of risk while accounting for content, context, nature, purposes and scope of the research or investigation study.[/su_spoiler][su_spoiler title=”Risk Determination Accounting for Aspects of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager conducting the above early determination of risk while accounting for characteristics and parameters of selection, context, nature and scope of participation, as well as anticipated vulnerabilities of human subjects group and specific human subjects.[/su_spoiler][su_spoiler title=”Risk Determination Accounting for Aspects of Methods” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager conducting the above early determination of risk while accounting for context, nature, purposes and scope of methods.[/su_spoiler][su_spoiler title=”Risk Determination Accounting for Aspects of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager conducting the above early determination of risk while accounting for content, context, nature and scope of biospecimens, data and information.[/su_spoiler][su_spoiler title=”Risk Determination Accounting for Aspects of Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager conducting the above early determination of risk while accounting for content, context, nature, purposes and scope of the research processing of biospecimens, data and information.[/su_spoiler][su_spoiler title=”Early and Objective Establishment of Risk” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations complete the above early determination of risk on the basis of an objective assessment that establishes whether the research or investigation study — and the research processing of biospecimens, data and information — involves no risk, a risk, low risk or high risk.[/su_spoiler][su_spoiler title=”Early and Effective Mitigation of Risk” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager responding to the early determination and establishment of risk by developing and implementing adequate, appropriate and effective measures for mitigating risks identified, including best practices methods with respect to factors for, likelihood, number, origin and severity of risks and with respect to aspect of research study, subjects group, methods, biospecimens, data and information, and their processing.[/su_spoiler][su_spoiler title=”Early and Objective Establishment of Benefit-Risk Relation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations also conclude the above early determination of risk with an objective assessment that establishes the relation between benefit and risk of the research or investigation study — and of the research processing of biospecimens, data and information — to you as the human subject under study.[/su_spoiler][su_spoiler title=”Early and Effective Comparison for Favorable Benefit-Risk Relation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager responding to the early determination and establishment of the benefit-risk relation by assessing whether such relation is favorable to you — as the human subject under study — and developing effective comparisons with benefit-risk relations of alternative research or investigation activities and studies similar in objectives, purposes and other aspects of study, subjects group, methods, biospecimens, data and information, or their processing.[/su_spoiler][su_spoiler title=”Decision on Research and Processing Risks Assessment” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where the above risk definition and determination process results in (a) the identification of new activities, methods, procedures or technologies or (b) the establishment of high risk, The Ikoku Foundations decide to conduct a research and processing risks assessment, as described below.[/su_spoiler][/su_accordion]

The second part of the evaluation occurs when a research and processing risks assessment is indicated. Understanding when that is required shall entail the anticipation and assessment of the level of risk to you and the level of difficulty you may or will likely have in exercising your human subjects research and investigation rights — as the human subject under study. The Ikoku Foundations shall therefore conduct such a research and processing risks assessment where there is any of the following:

[su_accordion][su_spoiler title=”Automation or Automated Methods with Legal Effects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where the research, investigation or processing primarily involves automation or automated methods — including but not limited to automated individual decision-making and profiling — that produces legal or similarly significant effects on you — as the human subject under study.[/su_spoiler][su_spoiler title=”Research and Processing on a Large Scale with Sensitivity” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where the research, investigation or processing is conducted on a large scale with sensitive biospecimens,  data and information (or with data or information containing or revealing convictions and offenses or other criminal- or security-related information), thus potentially affecting large numbers of human subjects under study who may not easily exercise their human subjects research and investigation rights.[/su_spoiler][su_spoiler title=”Research and Processing on a Publicly Accessible Area” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research, investigation or processing is conducted in, on or to systematically assess, evaluate, monitor or test a publicly accessible area.[/su_spoiler][/su_accordion]

The final part of the research and processing risks assessment shall first entail, as in the early determination of risk above, a delineation and description of the factors for, likelihood, number, origin and severity of risks. And then the assessment shall include all of the following:

[su_accordion][su_spoiler title=”Systematic Description of Research and Processing Operations and Purposes” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]a systematic description and explanation of the proposed research and processing activities, operations and their purposes, including aspects of study design, human subjects groups, methods, biospecimens, data and information, and their processing.[/su_spoiler][su_spoiler title=”Assessment of Necessity and Proportionality of Activities and Methods” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]a systematic assessment of the necessity and proportionality of the research, investigation and processing activities and methods in relation to the purposes of such research, investigation and processing and to the biospecimens, personal data and information.[/su_spoiler][su_spoiler title=”Assessment of Necessity and Proportionality of Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]a systematic assessment of the necessity and proportionality of aspects of the study design in relation to the purposes of the research, investigation or processing.[/su_spoiler][su_spoiler title=”Assessment of Necessity and Proportionality of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]a systematic assessment of the necessity and proportionality of aspects of the human subjects groups in relation to the purposes of the research, investigation or processing.[/su_spoiler][su_spoiler title=”Assessment of Necessity and Proportionality of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]a systematic assessment of the necessity and proportionality of the biospecimens, personal data and information in relation to the purposes of the research, investigation or processing.[/su_spoiler][su_spoiler title=”Assessment from Similar Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]a systematic comparative assessment drawing careful and selective insights from similar research, investigation and processing activities and studies — including attention to aspects of study, subjects groups, methods, biospecimens, data and information, and their processing — to the degree that all compared research, investigation and processing activities and studies are highly similar with respect to the above aspects as well as to the factors for, likelihood, number, origin and severity of risks.[/su_spoiler][su_spoiler title=”Review of Measures for Protections of Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]with the above completed and taken into account, a systematic review to ensure the use of adequate and appropriate organizational and technical measures and to specifically minimize factors and risks that result in reduction in the level or protections for the research, investigation and processing, including protections pertaining to accuracy, confidentiality, privacy, rights and freedoms, safety and security.[/su_spoiler][su_spoiler title=”Review of Measures for Protections of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]with the above completed and taken into account, a systematic review to ensure the use of adequate and appropriate organizational and technical measures and to specifically minimize factors and risks that result in reduction in the level or protections for the biospecimens, data and information, including protections pertaining to accuracy, confidentiality, privacy, rights and freedoms, safety and security.[/su_spoiler][su_spoiler title=”Review of Measures for Protections of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]with the above completed and taken into account, a systematic review to ensure the use of adequate and appropriate organizational and technical measures and to specifically minimize factors and risks that result in reduction in the level or protections for the human subjects under study, including protections pertaining to accuracy, confidentiality, privacy, rights and freedoms, safety, security and stigmatization and discriminatory effects.[/su_spoiler][su_spoiler title=”Review of Computational and Equivalent Procedures” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]with the above completed and taken into account, a systematic review to ensure the use of adequate and appropriate logic and computational, mathematical or statistical procedures in the setting of human subjects research and investigation — most especially where automation and automated methods are significantly involved, including but not limited to automated decision-making and profiling.[/su_spoiler][su_spoiler title=”Review of Such Procedures for Accuracy, Efficacy and Ethics of Decision-Making” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]with the above completed and taken into account, a systematic review to ensure the use of adequate and appropriate computational, organizational and technical measures and to specifically minimize factors and risks that result in inaccurate, inappropriate, ineffective, harmful, unlawful or unethical decision-making where automation and automated methods — including but not limited to automated decision-making and profiling — are significantly involved in human subjects research and investigation.[/su_spoiler][su_spoiler title=”Review of Such Procedures for Risks to Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]with the above completed and taken into account, a systematic review to ensure the use of adequate and appropriate computational, organizational and technical measures and to specifically take into account and minimize factors that result in risks to rights of human subjects where automation and automated methods — including but not limited to automated decision-making and profiling — are significantly involved in human subjects research and investigation.[/su_spoiler][su_spoiler title=”Review of Such Procedures for Prevention of Discrimination and Stigmatization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]with the above completed and taken into account, a systematic review to ensure the use of adequate and appropriate computational, organizational and technical measures and to specifically prevent, inter alia, discriminatory and stigmatizing effects on human subjects where automation and automated methods — including but not limited to automated decision-making and profiling — are significantly involved in human subjects research and investigation.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Responsibilities for Protections, Safety and Security

The Ikoku Foundations — when conducting research and investigation on, about or otherwise relating to you — shall have the responsibilities for developing and ensuring protections, safety and security for human subjects research and investigation. The Ikoku Foundations shall have such protections responsibilities to ensure measures are commensurate with the specificities of research activities and studies, biospecimens, data and information, their processing, and the administration and management of research and investigation. Such responsibilities require that all of the following apply:

[su_accordion class=””][su_spoiler title=”Measures Ensuring Protections Against Anticipated and Established Risk” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing, implementing and reviewing adequate and appropriate computational, organizational and technical measures to ensure protections commensurate with the specified aspects of the research study and its established risks.[/su_spoiler][su_spoiler title=”Specific Attention to Protection by Design” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing, implementing and reviewing computational, organizational and technical measures with specific attention to fulfilling the principles of necessity, non-identification and minimization to the most feasible and reasonable extent.[/su_spoiler][su_spoiler title=”Specific Attention to Protection by Default” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing, implementing and reviewing computational, organizational and technical measures with specific attention to fulfilling the principles of protection by default, which further requires that identifiable and personal biospecimens, data and information are not made accessible to an indefinite number of natural or legal persons without the consent, intervention and request of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Ensuring Confidentiality of Research and Processing Systems and Services” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing, implementing and reviewing organizational and technical measures that are appropriate and effective to ensure, where applicable, the ongoing confidentiality of the research and investigation study, of biospecimens, data and information, of their processing, of research and processing systems and services, and of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Ensuring Privacy of Research and Processing Systems and Services” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing, implementing and reviewing organizational and technical measures that are appropriate and effective to ensure, where applicable, the ongoing privacy of the research and investigation study, of biospecimens, data and information, of their processing, of research and processing systems and services, and of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Ensuring Safety of Research and Processing Systems and Services” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing, implementing and reviewing organizational and technical measures that are appropriate and effective to ensure, where applicable, the ongoing safety of the research and investigation study, of biospecimens, data and information, of their processing, of research and processing systems and services, and of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Ensuring Security of Research and Processing Systems and Services” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing, implementing and reviewing organizational and technical measures that are appropriate and effective to ensure the ongoing security of the research and investigation study, of biospecimens, data and information, of their processing, of research and processing systems and services — including but not limited to encrypting, protecting and securing against exposure, leakage, loss, theft, and unauthorized access, disclosure or use, as well as appropriately informing, and limiting adverse impacts on, pertinent individuals and entities in the event of exposure, leakage, loss, theft, or unauthorized access, disclosure or use.[/su_spoiler][su_spoiler title=”Ensuring Integrity of Research and Processing Systems and Services” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing, implementing and reviewing organizational and technical measures that are appropriate and effective to ensure the ongoing integrity of the research and investigation study, of biospecimens, data and information, of their processing, of research and processing systems and services.[/su_spoiler][su_spoiler title=”Ensuring Resilience of Research and Processing Systems and Services” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing, implementing and reviewing organizational and technical measures that are appropriate and effective to ensure the ongoing resilience of research, investigation and processing systems and services.[/su_spoiler][su_spoiler title=”Ensuring Availability of Research and Processing Systems and Services” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager designing, developing, implementing and reviewing organizational and technical measures that are appropriate and effective to ensure the service availability of research, investigation and processing systems and services, including the ability to restore availability and access to authorized researchers and investigators of such systems and services in a timely manner in the event of a physical or technical incident.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Responsibilities for Notification

The Ikoku Foundations — when conducting research and investigation on, about or otherwise relating to you — shall have all responsibilities for reasonably transparent communication and notification upon any breach or violation in human subjects research and investigation. The Ikoku Foundations shall have such notification responsibilities when intended recipient is you, any other human subject or natural or legal persons concerned, and any applicable regulatory authority. Such responsibilities require that all of the following apply:

[su_accordion class=””][su_spoiler title=”Decision to Notify on Recognition of Breach or Violation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, upon recognition of a breach or violation pertaining to the research or investigation study, biospecimens, data and information, or their processing, The Ikoku Foundations conduct a competent and rigorous evaluation determining whether the breach or violation results in a risk to the rights and associated interests of you — as the human subject under study — on the basis of an objective assessment that establishes the likelihood, number, origin and severity or risks and whether the breach or violation involves no risk, a risk, low risk or high risk.

— that if no risk, The Ikoku Foundations may decide not to notify you.

— that if an unlikely risk or low risk, The Ikoku Foundations may decide not to notify you only if it promptly conducts the mitigation measures described below.

— that if high risk, The Ikoku Foundations should notify you and promptly conduct the mitigation measures described below.[/su_spoiler][su_spoiler title=”Time to Notify on Recognition of Breach or Violation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, within seventy-two (72) hours of becoming aware of a breach or violation of high risk pertaining to the research or investigation study, biospecimens, data and information, or their processing, The Ikoku Foundations send reasonably transparent communication and notification to you — as the human subject under study — and to any applicable regulatory authority.[/su_spoiler][su_spoiler title=”Delay to Notify on Recognition of Breach or Violation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, if such notification above is sent afterseventy-two (72) hours of becoming aware of a breach or violation pertaining to the research or investigation study, biospecimens, data and information, or their processing, The Ikoku Foundations also sends explanation of reasons for the delay to you — as the human subject under study — and to any applicable regulatory authority.

— where it is not possible to provide the required full details of the breach or violation all at once, or at the same time, that The Ikoku Foundations provide the required details in phases without undue further delay.

— and where such a delay was due to reasonable time requested for necessary investigation, including in coordination with law enforcement, that The Ikoku Foundations provide as much detail it can first in phases, then without undue delay after the investigation period is completed.[/su_spoiler][su_spoiler title=”Nature of Breach or Violation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, upon recognition of a breach or violation pertaining to the research or investigation study, biospecimens, data and information, or their processing, The Ikoku Foundations have the reasonably transparent communication and notification above describe the nature of the breach or violation, including where possible, the categories and approximate number of human subject under study, the categories and approximate number of research participation, biospecimens, data and information records, and the categories and number of recipients.[/su_spoiler][su_spoiler title=”Consequences of Breach or Violation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, upon recognition of a breach or violation pertaining to the research or investigation study, biospecimens, data and information, or their processing, The Ikoku Foundations have the reasonably transparent communication and notification above describe the consequences of the breach or violation, including where applicable, risks to the rights of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Measures to Mitigate Breach or Violation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, upon recognition of a breach or violation pertaining to the research or investigation study, biospecimens, data and information, or their processing, The Ikoku Foundations have the reasonably transparent communication and notification above describe the measures The Ikoku Foundations have taken or proposed to address the breach or violation, including, where appropriate, measures to mitigate risks to and possible adverse effects on you — as the human subject under study.[/su_spoiler][su_spoiler title=”Personal Measures to Prevent and Reduce Risks and Adverse Effects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, upon recognition of a breach or violation pertaining to the research or investigation study, biospecimens, data and information, or their processing, The Ikoku Foundations have the reasonably transparent communication and notification above describe, explain and recommend measures that you — as the human subject under study — should promptly take to prevent and reduce any possible adverse effects or risks that could arise from the breach or violation.[/su_spoiler][su_spoiler title=”Responsible Entity, Office or Persons” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that the reasonably transparent communication and notification above include the identity and contact information of The Ikoku Foundations and the office or persons responsible for such research or investigation study, biospecimens, data and information, or their processing.[/su_spoiler][su_spoiler title=”Ensuring Mitigation of Adverse Effects and Risks” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager promptly assessing, characterizing and establishing the risks and adverse effects resulting from the breach or violation pertaining to the research or investigation study, biospecimens, data and information, or their processing, and then developing and implementing appropriate and effective measures for mitigating risks identified, including best practices methods with respect to factors for, likelihood, number, origin and severity of risks; also with respect to aspects of the research study, human subjects groups, methods, biospecimens, data and information, and their processing; and with respect to the content, context, nature, scope and extent of the breach or violation.[/su_spoiler][su_spoiler title=”Ensuring Adherence to Reasonably Transparent Communication” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager creating, securing and transmitting such notification above in a manner that ensures the adherence to the principles for transparency and requirements for reasonably transparent communication.[/su_spoiler][su_spoiler title=”Ensuring Privacy and Confidentiality of Communication and Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager creating, securing and transmitting such communication and notification above in a manner that ensures the adherence to principles, protections, rights and requirements for privacy and confidentiality of research and of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Ensuring Documentation of Breach, Violation and Communication and Notification” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager creating, maintaining and transmitting books, documentation and records of the breach or violation and of the communication and notification above, in a manner that ensures their limited reproducibility and availability, upon necessity and reasonable request, specifically for demonstration of compliance with standards.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Responsibilities for Records

The Ikoku Foundations — when conducting research and investigation on, about or otherwise relating to you — shall have all responsibilities for creating, maintaining and safekeeping accurate books and records for human subjects research and investigation. The Ikoku Foundations shall have such books and records responsibilities for proposals, protocols and projects, research activities and studies, biospecimens, data and information, their processing, and the administration and management of research and investigation. Such responsibilities require that all of the following apply:

[su_accordion class=””][su_spoiler title=”Ensuring Adherence to Principles of Transparency ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager creating, maintaining, safekeeping and transmitting accurate books and records for the research or investigation study, biospecimens, data and information, and their processing in a manner that ensures the adherence to principles for transparency and requirements for reasonably transparent communication.[/su_spoiler][su_spoiler title=”Ensuring Privacy and Confidentiality of Books and Records” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations be the sole administrator and manager creating, maintaining, safekeeping and transmitting accurate books and records for the research or investigation study, biospecimens, data and information, and their processing in a manner that ensures the adherence to principles, rights and requirements for privacy and confidentiality.[/su_spoiler][su_spoiler title=”Ensuring Integrity and Security of Books and Records” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager creating, maintaining, safekeeping and transmitting books and records for the research or investigation study, biospecimens, data and information, and their processing in a manner that ensures their integrity and the adherence to principles, rights and requirements for protections, safety and security.[/su_spoiler][su_spoiler title=”Where Needed, Ensuring Availability and Reproducibility of Books and Records” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager creating, maintaining, safekeeping and transmitting books and records for the research or investigation study, biospecimens, data and information, and their processing in a manner that ensures their limited reproducibility and availability, upon necessity and reasonable request, specifically for demonstration of processing and compliance with standards.[/su_spoiler][/su_accordion]

The Ikoku Foundations shall create, maintain and safely keep all books and records for the research or investigation study, biospecimens, data and information, and their processing, including where appropriate and possible in a manner adhering to Principles of Non-Identification and Transparency, and so where appropriate and possible in versions of records that are de-identified and de-personalized via their categorization, making sure they contain all of the following:

[su_accordion class=””][su_spoiler title=”Purposes for Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the purposes for the research or investigation activities and study.[/su_spoiler][su_spoiler title=”Purposes for Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the purposes for the processing of the biospecimens, data and information.[/su_spoiler][su_spoiler title=”Categories or Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the categories of processing of the biospecimens, data and information.[/su_spoiler][su_spoiler title=”Categories of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the categories of biospecimens, data and information.[/su_spoiler][su_spoiler title=”Categories of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the categories of human subjects under study, and with respect to the biospecimens, data and information and their processing.[/su_spoiler][su_spoiler title=”Categories of Recipients” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the categories of recipients to whom the biospecimens, data and information have been, are or will be disclosed or transferred, including any recipients in third countries or international organizations.[/su_spoiler][su_spoiler title=”Erasure of Categories of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where possible, the envisaged time limits for erasure of the different categories of biospecimens, data and information.[/su_spoiler][su_spoiler title=”Transfers of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]any transfers of the biospecimens, data and information to a third country, third party or international organization, including the identification of the third country, third party or international organization and documentation of appropriate safeguards.[/su_spoiler][su_spoiler title=”Transmission of Record” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]any request and authorized transmission of any such record of processing, including the time and reason for the request and communication, person who authorized the communication, the identification of the recipients, and documentation of appropriate safeguards.[/su_spoiler][su_spoiler title=”Measures for Protection and Security” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where possible, a general description of the computational, technical and organizational security measures taken to ensure the protection and security of the records of the research or investigation study, biospecimens, data and information, and their processing.[/su_spoiler][su_spoiler title=”Responsible Entity, Office or Persons” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the identity and contact information of The Ikoku Foundations and the office or persons responsible for such records of the research or investigation study, biospecimens, data and information, and their processing.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Responsibilities for Approval, Authorization and Transfer

The Ikoku Foundations — when conducting research and investigation on, about or otherwise relating to you — shall have all responsibilities for approval, authorization, assignment, delegation and transfer pertaining to human subjects research and investigation. The Ikoku Foundations shall have all such authorization and oversight responsibilities for research activities and studies, biospecimens, data and information, their processing and the administration and management of research and investigation. The Ikoku Foundations shall also have all such authorization and oversight responsibilities internally and externally, including for any partner, third party, third country or international organization. Such responsibilities therefore require that all of the following apply:

[su_accordion class=””][su_spoiler title=”Sole Approval and Authorization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and their Founder be the sole administrator and manager approving and authorizing any research, investigation or processing, and their administration and management.[/su_spoiler][su_spoiler title=”Sole Approval and Authorization of Access and Actions” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and their Founder be the sole administrator and manager approving and authorizing access, activities, measures, operations and any equivalent actions pertaining to any research, investigation or processing, and their administration and management.[/su_spoiler][su_spoiler title=”Sole Approval and Authorization of Communications and Transparency” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo be the sole administrator and manager approving and authorizing communications, notifications, reports, transparency and any equivalent correspondence pertaining to any research, investigation or processing, and their administration and management.[/su_spoiler][su_spoiler title=”Sole Approval and Authorization of Persons and Third Parties” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and their Founder be the sole administrator and manager approving and authorizing persons, entities, offices, partners and any equivalent third parties pertaining to any research, investigation or processing, and their administration and management.[/su_spoiler][su_spoiler title=”Assigned or Delegated Administration, Management, Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that any research, investigation or processing, or their administration or management assigned or delegated to persons and third parties not proceed or continue except on explicit, legitimate and specific instructions and purposes from The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — as given via the required approval and authorization.[/su_spoiler][su_spoiler title=”Ensuring Adherence to Requirements for Approvals and Authorizations” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and their Founder be the sole administrator and manager ensuring all approvals and authorizations pertaining to any research, investigation or processing, and their administration and management adhere to definitions and requirements for written approval and authorization, as delineated and described in these Codes and Policies.[/su_spoiler][su_spoiler title=”Ensuring Adherence to Requirements for Communication and Notification” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and their Founder be the sole administrator and manager ensuring all approvals and authorizations pertaining to any research, investigation or processing, and their administration and management adhere to definitions and requirements for written communication and notification, as delineated and described in these Codes and Policies.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Codes and Policies” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and their Founder be the sole administrator and manager ensuring all approvals and authorizations pertaining to any research, investigation or processing, and their administration and management are and remain in accordance with these Codes and Policies.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Founding, Mission and Code of Ethics” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and their Founder be the sole administrator and manager ensuring all approvals and authorizations pertaining to any research, investigation or processing, and their administration and management are and remain in accordance with the founding, mission and Code of Ethics of The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Applicable Guidelines, Law and Regulation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and their Founder be the sole administrator and manager ensuring all approvals and authorizations pertaining to any research, investigation or processing, and their administration and management are and remain in accordance with applicable guidelines, law and regulation.[/su_spoiler][/su_accordion]

Furthermore, where there is the assignment or delegation of any research, investigation or processing, or their administration or management, there should also be a contract or equivalent legal instrument — between The Ikoku Foundations and the person or third party to receive the assignment or delegation (the “assignee” or “delegate”) — written, approved, agreed to and signed by all parties, and containing all of the following:

[su_accordion class=””][su_spoiler title=”Sole Approval and Authorization” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and their Founder be the sole administrator and manager approving and authorizing any research, investigation or processing, and their administration and management.[/su_spoiler][su_spoiler title=”Explicit, Legitimate and Specific Instructions and Purposes” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above shall carry out only the explicit, legitimate and specific instructions and purposes delineated and described in the contract or equivalent legal instrument, including but not limited to content, context, nature, purpose, scope and time duration any research, investigation or processing, and their administration and management, and the human subjects under study and other natural and legal persons concerned.[/su_spoiler][su_spoiler title=”Explicit, Legitimate and Specific Recipients and Transfers” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above shall follow only documented instructions with respect to transfers of any biospecimens, data and information to recipients, categories of recipients, a third party, a third country or an international organization, and ensure the appropriate safeguards.[/su_spoiler][su_spoiler title=”Commitment to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above are and remain committed to confidentiality and privacy, confidentiality and privacy protections, and confidentiality privacy rights, as delineated and described in these Codes and Policies.[/su_spoiler][su_spoiler title=”Measures for Protection and Security” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above shall implement approved and authorized computational, organizational and technical measures that ensure the protection and security of any research, investigation or processing, their administration and management, and biospecimens, data and information, as delineated and described in these Codes and Policies.[/su_spoiler][su_spoiler title=”Measures for Rights and Interests of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above shall implement approved and authorized computational, organizational and technical measures that ensure the fulfillment, protection and respect of the rights of human subjects under study and other persons concerned, as well as facilitate the exercising of such rights, as delineated and described in these Codes and Policies.[/su_spoiler][su_spoiler title=”Reasonably Transparent Communication and Notification” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above shall implement approved and authorized computational, organizational and technical measures that ensure the fulfillment of principles, rights and responsibilities for reasonable transparency and for communication and notification, as delineated and described in these Codes and Policies.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Responsibilities for Books and Records” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above shall implement approved and authorized computational, organizational and technical measures that ensure accordance with the responsibilities and standards for book and records, as delineated and described in these Codes and Policies.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Codes and Policies” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above shall implement computational, operational and technical measures that ensure accordance with these Codes and Policies.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Founding, Mission and Code of Ethics” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above shall implement computational, operational and technical measures that ensure accordance with the founding, mission and Code of Ethics of The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Applicable Guidelines, Law and Regulation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above shall implement computational, operational and technical measures that ensure accordance with applicable guidelines, law and regulation.[/su_spoiler][su_spoiler title=”Further Assignment, Delegation or Engagement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above shall not further assign, delegate or engage another person or party, except where given prior written approval and authorization by The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — as well as another written contract or equivalent legal instrument meeting these standards and protections for human subjects research and investigation principles, rights and responsibilities, as described here and in these Codes and Policies.[/su_spoiler][su_spoiler title=”Validity, Legal Binding and Liabilities” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the contract or equivalent legal instrument and conditions as described above shall be valid.

— also that the contract or equivalent legal instrument shall legally bind the assignee or delegate above with respect to The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — including but not limited to liabilities to The Ikoku Foundations.

— and that such validity, binding, conditions and liabilities shall continue even where the assignee or delegate above further assigns, delegate or engages another person or party.[/su_spoiler][su_spoiler title=”Erasure or Return at the End of Assignment or Delegation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the assignee or delegate above shall, on the choice and request of The Ikoku Foundations, delete, erase or return all records or participation, biospecimens, data and information and their copies, upon cessation, completion or end of the assignment or delegation.[/su_spoiler][su_spoiler title=”Responsible Entities, Offices and Persons” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]the identity and contact information — for all parties involved — of the entities, offices and persons, or their representatives, responsible for the research, investigation or processing; their administration, management; biospecimens, data and information; and any assignment, delegation or transfer.[/su_spoiler][/su_accordion]

In addition to the above provisions, where there is a transfer of research, investigation or processing, their administration or management, or biospecimens, data and information to a third party, third country or international organization, there should also be a contract or equivalent legal instrument — between The Ikoku Foundations and the third party or third country or international organization to receive the transfer (the “transferee”) — written, approved, agreed to and signed by all parties, and containing all of the following:

[su_accordion class=””][su_spoiler title=”Substitution of Transferee for Assignee or Delegate” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]all of the above provisions for the contract or equivalent legal instrument, but where applicable substituting “transferee” for “assignee” or “delegate.”[/su_spoiler][su_spoiler title=”Description of the Overarching Arrangement and Purposes for Transfer” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where applicable, a description of the overarching or ongoing arrangement, activity or relationship under which the transfer is conducted, as well as a description of the legitimate purposes for any transferred research, investigation, processing of biospecimens, data and information, as well as management or administration; and a systematic evaluation of the regulatory environment of the transferee with respect to standards and protections for human subjects research and investigation principles, rights and responsibilities, as described here and in these Codes and Policies.[/su_spoiler][su_spoiler title=”Accordance with Codes, Policies and Regulations” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the transferee fully comply with this Data and Information Policy, with applicable provisions of these Codes and Policies, and with applicable guidelines, law and regulation.[/su_spoiler][su_spoiler title=”Measures and Safeguards for Above Compliance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the transferee shall have and implement additional transferee-owned and rigorously reviewed measures and safeguards to ensure the full compliance with this Policy on Human Subjects Research and Investigation, with applicable provisions of these Codes and Policies, and with applicable guidelines, law and regulation.[/su_spoiler][su_spoiler title=”Specific Safeguards for Protection of Rights of Persons” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]agreement and attestation by all parties that the transferee shall have and implement additional transferee-owned and rigorously reviewed measures and safeguards to ensure the fulfillment, protection and respect of the rights of human subjects under study, as well as facilitate the exercising of such rights, as delineated and described in these Codes and Policies.[/su_spoiler][su_spoiler title=”Where a Request for Portability Rights” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]in addition to the above, where a human subject under study is exercising rights to portability, reasonably informed consent of the human subject under study, if consent is permitted, as described in these Codes and Policies.[/su_spoiler][su_spoiler title=”Where Transfer is Single Action Without Ongoing Arrangement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and where the transfer is a single-occurrence action without an ongoing arrangement with The Ikoku Foundations — as in the case of a simple exercise of rights to portability rights — agreement and attestation by all parties that the transferee shall assume all liability for any breach or violation of standards and protections for human subjects research and investigation principles, rights and responsibilities, as delineated and described in this Policy on Human Subjects Research and Investigation, these Codes and Policies, and applicable guidelines, law and regulation.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Responsibilities for Review

The Ikoku Foundations — when conducting research and investigation on, about or otherwise relating to you — shall have all responsibilities for ensuring that the research and investigation studies, biospecimens, data and information, their processing, and the administration and management of research and investigation are and remain in accordance with internal and external standards. The Ikoku Foundations shall have all such responsibilities with respect to IRB and Founder review procedures, the Policy on Human Subjects Research and Investigation, its principles, rights and responsibilities, our Codes and Policies, as well as applicable field-specific guidelines, law and mandatory regulations. Such responsibilities therefore require that all of the following apply:

[su_accordion class=””][su_spoiler title=”Ensuring Administration of and Accordance with IRB” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager designing, developing, implementing and reviewing computational, organizational and technical measures to ensure all research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of research and investigation undergo adequate and periodic review, recommendation, approval and disapproval procedures of the IRB and remain in accordance with the decisions of the IRB process.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Human Subjects Research Policy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager designing, developing, implementing and reviewing computational, organizational and technical measures to ensure all research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of research and investigation are and remain in accordance with this Policy on Human Subjects Research and Investigation.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Human Subjects Research Principles, Rights and Responsibilities” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager designing, developing, implementing and reviewing computational, organizational and technical measures to ensure all research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of research and investigation are and remain in accordance with the exercising and fulfillment of human subjects research and investigation principles, rights and responsibilities.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Codes and Policies” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager designing, developing, implementing and reviewing computational, organizational and technical measures to ensure all research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of research and investigation are and remain in accordance with these Codes and Policies.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Founding, Mission and Code of Ethics” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager designing, developing, implementing and reviewing computational, organizational and technical measures to ensure all research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of research and investigation are and remain in accordance with the founding, mission and Code of Ethics of The Ikoku Foundations.[/su_spoiler][su_spoiler title=”Ensuring Accordance with Applicable Guidelines, Law and Regulation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager designing, developing, implementing and reviewing computational, organizational and technical measures to ensure all research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of research and investigation are and remain in accordance with applicable local, regional, national, international and field-specific guidelines, law and regulation.[/su_spoiler][su_spoiler title=”Communication and Cooperation with Compliance, Regulatory and Public Authorities ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the sole administrator and manager communicating, cooperating, coordinating and ensuring accordance of all research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of research and investigation with compliance, regulatory and public authorities, including but not limited to offices dedicated to guidelines, law and legislation, licensing, professions matters, public and occupational health, public and occupational safety, regulations, security, and taxes, fees and other financial matters.[/su_spoiler][/su_accordion]

The Ikoku Foundations shall also have the responsibilities for reviewing and updating computational, organizational and technical measures, including methods, of human subjects research and investigation. The Ikoku Foundations are responsible for ensuring that such measures and methods are optimally adequate, appropriate and effective for the research or investigation study, biospecimens, data and information, their processing, and the administration and management of research and investigation. Such responsibilities require that all of the following apply:

[su_accordion class=””][su_spoiler title=”Ensuring Best Practices Standards for Review Measures” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager ensuring that the assessing, evaluating, testing and updating involved in the reviewing of measures meet best practices standards, to the most reasonable extent possible, in keeping with expectations for research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of such research and investigation.[/su_spoiler][su_spoiler title=”Reviewing Measures for Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager reviewing and updating computational, organizational and technical measures to be adequate and effective for the research or investigation and processing of biospecimens, data and information, and for the fulfillment of principles, rights and responsibilities of such research and such processing.[/su_spoiler][su_spoiler title=”Reviewing Measures for Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager reviewing and updating computational, organizational and technical measures to be adequate and effective in particular for the human subjects groups.[/su_spoiler][su_spoiler title=”Reviewing Measures for Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager reviewing and updating computational, organizational and technical measures to be adequate and effective in particular for the biospecimens, data and information.[/su_spoiler][su_spoiler title=”Reviewing Measures for Privacy and Confidentiality” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager reviewing and updating computational, organizational and technical measures to be adequate and effective for ensuring the privacy and confidentiality of research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of such research and investigation.[/su_spoiler][su_spoiler title=”Reviewing Measures for Protection and Security” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager reviewing and updating computational, organizational and technical measures to be adequate and effective for ensuring the protection and security of research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of such research and investigation.[/su_spoiler][su_spoiler title=”Reviewing Measures for Communication and Notification” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager reviewing and updating computational, organizational and technical measures to be adequate and effective for fulfilling principles for transparency, rights to being informed, and requirements and responsibilities of reasonably transparent communication and notification.[/su_spoiler][su_spoiler title=”Reviewing Measures for Books and Records” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager reviewing and updating computational, organizational and technical measures to be adequate and effective for fulfilling standards commensurate with the responsibilities for books and records of research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of such research and investigation.[/su_spoiler][su_spoiler title=”Reviewing Measures for Approval, Authorization and Transfer” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager reviewing and updating computational, organizational and technical measures to be adequate and effective for fulfilling standards commensurate with the responsibilities for approval, authorization and transfer regarding research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of such research and investigation.[/su_spoiler][su_spoiler title=”Reviewing Measures for Regulation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that The Ikoku Foundations and their Founder be the primary administrator and manager reviewing and updating computational, organizational and technical measures to be adequate and effective for ensuring research and investigation activities and studies, biospecimens, data and information, their processing, and the administration and management of such research and investigation are and remain in accordance with IRB approval procedures and standards, this Policy, these Codes and Policies, and with applicable guidelines, law and regulation.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

D — Additional Guidelines

The Contexts for Additional Requirements

The overarching principles, rights and responsibilities of human subjects research and investigation — as well as the processes and standards of IRB and Founder review — necessitate the consideration of twenty (20) expected contexts of human subjects research and investigation that incur additional ethics requirements. The Ikoku Foundations shall meet such requirements before, during and after conducting human subjects research and investigation in these contexts, especially when accessing or otherwise processing biospecimens, data and information attributable to, identifying, or otherwise relating to you.

The contexts for additional requirements tend to arise from two recurring situational concerns. First, where the nature of consent is at issue — as when the research subject is a person vulnerable to coercion — and there is need to place protective restrictions on the kind of research to ask consent (or assent) for, as well as the conditions under which that consent request should be made. Second, when the risks assessment The Ikoku Foundations carries out determines an anticipated high risk of difficulty for you and other human subjects to effectively exercise your human subjects research and investigation rights. Think, for instance, of research on children, prisoners and students, or research conducted by public officials or social scientists on communities, public programs or transit spaces.

The Policy will elaborate in some detail upon each of these contexts as we proceed on this Policies page. In the meantime do keep in mind that, as much as feasibly and reasonably possible, The Ikoku Foundations endeavor to have each instance of human subjects research and investigation — as well as IRB and Founder review — pay specific ethics attention to all of the following:

[su_accordion class=””][su_spoiler title=”Archival and Humanistic Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of archival and humanistic research.[/su_spoiler][su_spoiler title=”Artistic and Creative Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of artistic and creative expression and research.[/su_spoiler][su_spoiler title=”Benign Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted on or utilizing benign interactions, interventions or procedures.[/su_spoiler][su_spoiler title=”Civil Liberties and Civil Rights Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of civil liberties, civil rights and associated services research, especially when involving legal and legal services research.[/su_spoiler][su_spoiler title=”Commercial, Financial and Marketing Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of commercial, financial and direct or indirect marketing research.[/su_spoiler][su_spoiler title=”Criminal Justice Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, is or will be conducted as part of, in support of, or for the purposes of criminal justice and criminal justice research, especially when involving vulnerable human subjects under court order, surveillance and equivalently significant legal effects.[/su_spoiler][su_spoiler title=”Deception Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted on or utilizing methods or modes of deception, especially those where human subjects are not to be informed of the purposes of the study, an interaction, intervention or procedure.[/su_spoiler][su_spoiler title=”Demographic and Public Opinion Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of demographic and public opinion research.[/su_spoiler][su_spoiler title=”Educational Settings Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of education research in commonly accepted or established educational settings.[/su_spoiler][su_spoiler title=”Educational Testings Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of education testing research and on interactions involving educational tests.[/su_spoiler][su_spoiler title=”Ethnographic and Social Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of anthropological, ethnographic or social sciences research, especially in communities and settings where such research is conducted.[/su_spoiler][su_spoiler title=”Genetic and Genomic Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of genetic and genomic research, especially when involving genetic, pluripotential and reproductive materials.[/su_spoiler][su_spoiler title=”Health Care Operations Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of health care operations and health care operations research.[/su_spoiler][su_spoiler title=”News, Journalism and Public Interest Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of news, journalism and public interest research.[/su_spoiler][su_spoiler title=”Obstetrics and Neonatal Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of obstetrics and neonatal research, especially when involving pregnant parents and recently born infants.[/su_spoiler][su_spoiler title=”Pediatrics Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, is or will be conducted as part of, in support of, or for the purposes of pediatrics research, especially when involving children and childhood.[/su_spoiler][su_spoiler title=”Prisoner and Penal Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of penal and prison research, especially when involving prisons, prisoners, detainees and convicts.[/su_spoiler][su_spoiler title=”Public Benefit and Public Services Programs Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of public benefit programs and public services programs.[/su_spoiler][su_spoiler title=”Public Health Surveillance Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of public health surveillance.[/su_spoiler][su_spoiler title=”Taste and Food Quality Evaluation and Consumer Acceptance Studies ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]where research and investigation have been, are or will be conducted as part of, in support of, or for the purposes of taste and food quality evaluation and consumer acceptance studies.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Archival and Humanistic Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research and investigation activities as part of, in support of, or for the purposes of archival and humanistic research. The Ikoku Foundations recognizes that such research or investigation conducted on, about or otherwise relating to you — as well as for knowledge and publication in the archival sciences and humanities — requires rigorous ethics attention to ensure consistent expectations and protections for you — as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Limitation to Archival and Humanities Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to archival and humanistic disciplines, studies and scholarship.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Distinction Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from practices associated with artistic expression and processing materials for archives and library collections.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator andhuman subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Data and Information Processed” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and attestation (from the IRB, researcher or investigator and you) that the data and information are not biospecimens and that any disclosure of your responses — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification Specific to Field of Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that, where applicable and appropriate, the processes of non-identification include methods and modes of recording, reporting, narrating and analysis that — to the degree that ethical obligations to you and other human subjects require — abstract identifiable details or personas from data and information; rename persons, places and contexts; fictionalize aspects of persons, places and contexts; and create personas via the amalgamation of relevant aspects, details and events from human subjects, collected data and information, and the contexts of the interviewing, research, investigation and processing.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given Acknowledgment, Citation and Intellectual and Publicity Rights ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that there is acknowledgment, citation and proper ascertainment and respect of intellectual and publicity rights in the reporting and publishing of data and information from, about or otherwise relating to you — as the human subject under study — especially where there is clear consent to reveal your identity and agreed upon details of responses, data and information.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Archival and Humanistic Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research and investigation activities as part of, in support of, or for the purposes of archival and humanistic research. The Ikoku Foundations recognizes that such research or investigation conducted on, about or otherwise relating to you — as well as for knowledge and publication in the archival sciences and humanities — requires rigorous ethics attention to ensure consistent expectations and protections for you — as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Limitation to Archival and Humanities Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to archival and humanistic disciplines, studies and scholarship.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Distinction Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from practices associated with artistic expression and processing materials for archives and library collections.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator andhuman subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification Specific to Field of Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that, where applicable and appropriate, the processes of non-identification include methods and modes of recording, reporting, narrating and analysis that — to the degree that ethical obligations to you and other human subjects require — abstract identifiable details or personas from data and information; rename persons, places and contexts; fictionalize aspects of persons, places and contexts; and create personas via the amalgamation of relevant aspects, details and events from human subjects, collected data and information, and the contexts of the interviewing, research, investigation and processing.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given Acknowledgment, Citation and Intellectual and Publicity Rights ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that there is acknowledgment, citation and proper ascertainment and respect of intellectual and publicity rights in the reporting and publishing of data and information from, about or otherwise relating to you — as the human subject under study — especially where there is clear consent to reveal your identity and agreed upon details of responses, data and information.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Artistic and Creative Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research and investigation activities as part of, in support of, or for the purposes of artistic and creative research. The Ikoku Foundations recognizes that research or investigation significantly focusing on your person or life, or conducted on artistic or creative material, data and information from, about or otherwise relating to you requires rigorous ethics attention to ensure consistent expectations and protections for you — as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Clear Prospective Agreement as to Relationship Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its relationship to the arts and to artistic, creative and expressive practices.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification Specific to Field of Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that, where applicable and appropriate, the processes of non-identification include methods and modes of recording, reporting, narrating and analysis that — to the degree that ethical obligations to you and other human subjects require — abstract identifiable details or personas from data and information; rename persons, places and contexts; fictionalize aspects of persons, places and contexts; and create personas via the amalgamation of relevant aspects, details and events from human subjects, collected data and information, and the contexts of the interviewing, research, investigation and processing.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given Acknowledgment, Citation and Intellectual and Publicity Rights ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that there is acknowledgment, citation and proper ascertainment and respect of intellectual and publicity rights in the reporting and publishing of data and information from, about or otherwise relating to you — as the human subject under study — especially where there is clear consent to reveal your identity and agreed upon details of responses, data and information.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Benign Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research and investigation activities on, about or otherwise relating to you in a manner, via methods and with data and information described or understood as benign. The Ikoku Foundations recognizes that the designation of research as benignrequires rigorous ethics attention to ensure consistent expectations and protections for you — as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described as benign will and does not adversely affect or impact human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Deception” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation entails deception of you — as the human subject under stayed — regarding its nature or purpose, you attest, first that you are an adult and, second, that, in addition to consent, you authorize any future deception of yourself during such research through a prospective agreement to participate in research where subjects are informed that they will be unaware of or misled regarding the nature or purposes of the research.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot readily be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that whenever biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can readily be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that biospecimens, data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you or other human subjects under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Civil Liberties and Civil Rights Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of civil liberties and civil rights research. The Ikoku Foundations recognizes such rights research to require rigorous ethics attention to ensure consistent protections for you and other vulnerable human subjects, especially when undergoing forms of discrimination, disenfranchisement, marginalization, persecution, stigmatization and other violations of or infringements on rights. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Protection as Fundamental Rights of Vulnerable Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all involved understand the rights to human subject, biospecimen, data and information protection as themselves fundamental rights with respect to you — as the human subject under study — irrespective of forms of discrimination, disenfranchisement, marginalization, persecution, stigmatization and other violations of or infringements on rights.[/su_spoiler][su_spoiler title=”Likelihood of Coerced Participation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all involved also understand that the constraints of being subject to violations of or infringements on rights or other equivalently significant legal effects may likely affect your ability to make a truly voluntary and uncoerced decision whether or not to participate as a human subject in research or investigation, requiring us to ensure the above level of protection, safety and security via additional requirements and safeguards.[/su_spoiler][su_spoiler title=”Risks Acceptable to Broader Community of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]therefore, that there is rigorous assessment and written attestation (by the IRB, researcher or investigator and human subjects) that the risks involved in the research or investigation study are commensurate with risks that would be accepted by a broader community or randomly selected groups of volunteers to participate as human subjects under study.[/su_spoiler][su_spoiler title=”Rigorous Protections Against Undue Inducement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is also rigorous assessment and written attestation (by the IRB, researcher or investigator and human subjects) that any possible advantages accruing to you through participation in the research or investigation study — when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings — are not of such a magnitude as to impair your ability to weigh the risks of the research or investigation against the value of such advantages.

— and that equivalently rigorous assurances exist that courts, law enforcement offices, government agencies and authorities and their equivalent will not take into account your participation in the research or investigation — especially when making decisions regarding asylum or citizenship status, discrimination, disenfranchisement, persecution, stigmatization or other equivalent legal effects — and you are clearly informed in advance that participation in the research will have no effect on your situation.[/su_spoiler][su_spoiler title=”Rigorous Protections Against Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any biospecimens, data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you or other human subjects under study.[/su_spoiler][su_spoiler title=”No Monitoring, Tracking or Surveillance as Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that such research and investigation not entail, include or involve activities or operations that follow, monitor, track or otherwise place under surveillance you — as the human subject under study — or any other human subject or individual or natural person.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information  are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that biospecimens, data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you or other human subjects under study.[/su_spoiler][su_spoiler title=”Permitted Research of Causes, Co-Factors, Effects and Processes” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation on the possible causes, co-factors, effects and processes of discrimination, disenfranchisement, marginalization, persecution, stigmatization and other violations of or infringements on rights as well as asylum, citizenship, deportation, residence or other equivalent situation or status, provided that the study presents no more than minimal risk and no more than inconvenience to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Permitted Research of Institutional and Procedural Structures” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation of institutional and procedural structures resulting in or reducing discrimination, disenfranchisement, marginalization, persecution, stigmatization and other violations of or infringements on rights as well as asylum, citizenship, deportation, residence or other equivalent situation or status, provided that the study presents no more than minimal risk and no more than inconvenience to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Permitted Research of Conditions Affecting Vulnerable Subjects as Class” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation of conditions particularly affecting you and other vulnerable human subjects in the above situations as a class, provided that the study presents no more than minimal risk and no more than inconvenience to you.[/su_spoiler][su_spoiler title=”Permitted Research on Practices Offering Direct Health Benefit” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of you — as the human subject under study — provided that the study presents no more than minimal risk and no more than inconvenience to you.[/su_spoiler][su_spoiler title=”No Other Permitted Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, apart from the above, no other research or investigation objectives, purposes or studies may be approved by the IRB — or conducted, funded or supported — when involving the above vulnerable human subjects.[/su_spoiler][su_spoiler title=”Not Authorization of Vulnerable as Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and that nothing in this Policy shall be understood as indicating compliance with or fulfillment of its principles, rights and responsibilities authorizes — in itself — research or investigation involving you and other such vulnerable human subjects, to the extent that such research or investigation is barred or limited by any applicable local or national guidelines, laws or regulation.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Commercial, Financial and Direct Marketing Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of commercial, financial and marketing research. The Ikoku Foundations recognizes research in fields with clear and immediate for-profit applications requires rigorous ethics attention to ensure consistent protections for you and other human subjects under study, especially when such research potentially involves sensitive data and information. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities  — all of the following:

[su_accordion class=””][su_spoiler title=”Limitation to Commerce, Finance and Marketing Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to commerce, finance and marketing.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Distinction Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from practices carried out to directly accomplish or conduct for-profit commerce, finance and marketing.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator andhuman subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Criminal Justice Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of criminal justice and criminal justice research. The Ikoku Foundations recognizes criminal justice research to require rigorous ethics attention to ensure consistent protections for you and other vulnerable human subjects, especially when under court order, surveillance or other equivalently significant legal effects. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Protection as Fundamental Rights of Vulnerable Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all involved understand the rights to human subject, biospecimen, data and information protection as themselves fundamental rights with respect to you — as the human subject under study — irrespective of arrest, conviction, detention, incarceration, probation, parole, probable suspicion, monitoring, tracking or other criminal or surveillance status.[/su_spoiler][su_spoiler title=”Likelihood of Coerced Participation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all involved also understand that the constraints of court order, surveillance or other equivalently significant legal effects may likely affect your ability to make a truly voluntary and uncoerced decision whether or not to participate as a human subject in research or investigation, requiring us to ensure the above level of protection, safety and security via additional requirements and safeguards.[/su_spoiler][su_spoiler title=”Risks Acceptable to Broader Community of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]therefore, that there is rigorous assessment and written attestation (by the IRB, researcher or investigator and human subjects) that the risks involved in the research or investigation study are commensurate with risks that would be accepted by a broader community or randomly selected groups of volunteers to participate as human subjects under study.[/su_spoiler][su_spoiler title=”Rigorous Protections Against Undue Inducement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is also rigorous assessment and written attestation (by the IRB, researcher or investigator and human subjects) that any possible advantages accruing to you through participation in the research or investigation study — when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings — are not of such a magnitude as to impair their ability to weigh the risks of the research or investigation against the value of such advantages.

— and that equivalently rigorous assurances exist that courts, law enforcement offices, parole boards, surveillance authorities and their equivalent will not take into account your participation in the research or investigation — especially when making decisions regarding court order, parole, probation, surveillance or other equivalent legal effects — and you are clearly informed in advance that participation in the research will have no effect on your situation.[/su_spoiler][su_spoiler title=”No Monitoring, Tracking or Surveillance as Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that such research and investigation not entail, include or involve activities or operations that follow, monitor, track or otherwise place under surveillance you — as the human subject under study — or any other human subject or individual or natural person.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information  are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that biospecimens, data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you or other human subjects under study.[/su_spoiler][su_spoiler title=”Permitted Research of Causes, Co-Factors, Effects and Processes” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation on the possible causes, co-factors, effects and processes of arrest, conviction, detention, incarceration, probation, parole, probable suspicion, stoppage or other equivalent situation or status as well as being placed under court order, surveillance or other equivalently significant legal effects, provided that the study presents no more than minimal risk and no more than inconvenience to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Permitted Research of Institutional and Procedural Structures” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation of institutional and procedural structures resulting in or reducing arrest, conviction, detention, incarceration, probation, parole, probable suspicion or other equivalent situation or status as well as being placed on court order, surveillance or other equivalently significant legal effects, provided that the study presents no more than minimal risk and no more than inconvenience to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Permitted Research of Conditions Affecting Vulnerable Subjects as Class” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation of conditions particularly affecting you and other vulnerable human subjects in the above situations as a class, provided that the study presents no more than minimal risk and no more than inconvenience to you.[/su_spoiler][su_spoiler title=”Permitted Research on Practices Offering Direct Health Benefit” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of you — as the human subject under study — provided that the study presents no more than minimal risk and no more than inconvenience to you.[/su_spoiler][su_spoiler title=”No Other Permitted Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””] and that, apart from the above, no other research or investigation objectives, purposes or studies may be approved by the IRB — or conducted, funded or supported — when involving the above vulnerable human subjects.[/su_spoiler][su_spoiler title=”Not Authorization of Vulnerable as Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that nothing in this Policy shall be understood as indicating compliance with or fulfillment of its principles, rights and responsibilities authorizes — in itself — research or investigation involving you and other such vulnerable human subjects, to the extent that such research or investigation is barred or limited by any applicable local or national guidelines, laws or regulation.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Deception Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research and investigation activities on, about or otherwise relating to you in a manner, including using methods of deception, that does not permit you to know the nature or purpose of the study. The Ikoku Foundations recognizes that deception research requires rigorous ethics attention to ensure consistent protections for you — as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Necessity Limitation of Deception Studies” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all deception research and investigation studies are limited to those research purposes that require deception as primary methodology, and that allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to such research purposes.[/su_spoiler][su_spoiler title=”Necessity Limitation of Deception Activities” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to carry out the specified deception, and that allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to the aforementioned research purposes.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Deception” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation entails deception of you — as the human subject under study — regarding its nature or purpose, you attest, first that you are an adult and, second, that, in addition to consent, you have prospectively authorized any deception of yourself during the research or investigation through a prospective agreement to participate in research where subjects are informed that they will be unaware of or misled regarding the nature or purposes of the research.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that all biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and attestation (from the IRB and researcher or investigator) that biospecimens, data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you or other human subjects under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Demographic and Public Opinion Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of demographic and public opinion research. The Ikoku Foundations recognizes such population and polling research requires rigorous ethics attention to ensure consistent protections for you and other vulnerable human subjects, especially when such research potentially involves sensitive data and information. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Limitation to Demographic and Public Opinion Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to demographic, polling and public opinion studies and scholarship.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Difference Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from practices of administering and providing government censuses and civic participation and voting services.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Educational Settings Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of education research in commonly accepted and established settings of teaching and learning. The Ikoku Foundations recognizes such education settings research to require rigorous ethics attention to ensure consistent expectations and protections for you and your education. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Limitation to Education Research Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to education, learning and teaching disciplines, studies and scholarship, including but not limited to most benign research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional curricula, techniques or classroom management methods.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Difference Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from practices of education, learning, teaching and education services.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”No Adverse Impact on Students, their Learning and Educator Assessment” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there has been a rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects) confirming that the studied educational practices will not, or are unlikely to, adversely impact students, their opportunities to learn or the assessment of educators who provide instruction.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator andhuman subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Educational Testing Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of educational testing research. The Ikoku Foundations recognizes research conducted on, about or otherwise relating to you — but primarily for improving educational testing itself — requires rigorous ethics attention to ensure consistent expectations and protections for you and your opportunities for educational evaluation. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Limitation to Educational Testing Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to educational testing disciplines, studies and scholarship, including but not limited to most benign research involving tests for achievement, aptitude, cognitive abilities, diagnosis, disability, intelligence and personality; interview and survey procedures; and observation of public education or learning behavior, especially where utilizing auditory or visual recording.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Difference Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from practices of administering and providing educational tests and educational testing services.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”No Adverse Impact on Students, their Testing and Educator Assessment” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there has been a rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects) confirming that the studied educational testing practices will not, or are unlikely to, adversely impact students or test-takers, their opportunities for learning, testing and assessment, and the assessment of educators and proctors who provide instruction and testing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Ethnographic and Social Science Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of ethnographic and social research. The Ikoku Foundations recognizes that such research or investigation conducted on, about or otherwise relating to you — as well as for knowledge and publication in anthropology, ethnography and social sciences — requires rigorous ethics attention to ensure consistent expectations and protections for you as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Limitation to Social Sciences Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to anthropological, ethnographic and social sciences disciplines, studies and scholarship.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Distinction Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from cultural, health or healing, political and social practice.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification Specific to Field of Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that, where applicable and appropriate, the processes of non-identification include methods and modes of recording, reporting, narrating and analysis that — to the degree that ethical obligations to you and other human subjects require — abstract identifiable details or personas from data and information; rename persons, places and contexts; fictionalize aspects of persons, places and contexts; and create personas via the amalgamation of relevant aspects, details and events from human subjects, collected data and information, and the contexts of the interviewing, research, investigation and processing.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given Acknowledgment, Citation and Intellectual and Publicity Rights ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that there is acknowledgment, citation and proper ascertainment and respect of intellectual and publicity rights in the reporting and publishing of data and information from, about or otherwise relating to you — as the human subject under study — especially where there is clear consent to reveal your identity and agreed upon details of responses, data and information.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Genetic and Genomic Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of genetic and genomic research. The Ikoku Foundations recognizes such research involving material of high genetic, pluripotent and reproductive importance to require rigorous ethics attention to ensure consistent expectations and protections for you as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the principles, rights and responsibilities of human subjects research and investigation — all of the following:

[su_accordion class=””][su_spoiler title=”Limitation to Genetic and Genomic Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to genetic and genomic disciplines, studies and scholarship.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Difference Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from (or relationship to) caring, clinical, counseling, curative, diagnostic, preventative and screening practices of genetic and genomic medicine.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Consent to Specific Purposes” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) first that you are an adult and, second, that, in addition to informed consent, you prospectively agree to the specific purposes for the research or investigation study, and to the specific purposes for biospecimens, data and information accessed, gathered or otherwise processed about or from you — as the human subject under study — with adequate genetic counseling before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Non-Identification” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, you receive and prospectively agree to transparent communication clearly confirming and explaining to you — as the human subject under study — whether and how identifiers shall be removed from any biospecimens, data or information accessed, gathered or otherwise processed about or from you.

— and such communication clearly confirms and explains, whether or not other processes of non-identification are to be employed, including periodic re-identification, and if so under what circumstances and to what extent.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Genetic and Genomic Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that such communication and notification clearly confirm to you — as the human subject under study — whether the research or investigation will or might include whole genome sequencing of biospecimens accessed, gathered or otherwise processed about or from you, particularly if sequencing a human germline or somatic specimen with the intent to generate the genome or exome sequence of that biospecimen.

— and that such communication and notification clearly confirm to you — as the human subject under study — that whether or not processes of non-identification are conducted, the biospecimens, data or information shall not undergo or be used for genetic testing, genomic or exome sequencing or equivalently significant research or processing (including but not limited to stem cell research) without your explicitly informed consent and agreement to terms.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement with Aid of Genetic Counseling” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, were there are research or investigation activities for the purposes of genetic and genomic or equivalently significant research or processing (including but not limited to stem cell research), that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of each specific proposed activity, interaction, intervention, test, biospecimen, data and information and method and plan for their processing, including but not limited to expectations and protections with respect to decision-making and responses subsequent to having such results provided to you — as the human subject under study — as well as direct or indirect benefit, donation, past, present and future implications, range and limitations of associated or proposed therapeutics and other equivalent clinical, ethical and personal concerns — all accompanied by adequate genetic counseling before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Permitted Genetic and Genomic Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, were there are research or investigation activities for the purposes of genetic and genomic or equivalently significant research or processing (including but not limited to stem cell research), that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) confirming that research, investigation and processing activities on biospecimens, data and information attributable to, identifying or otherwise relating to you — as the human subject under study — shall be conducted only in accord with any specifically applicable local, state, national and international guidelines, laws and regulations regarding such activities and biospecimens.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Future Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that such communication and notification clearly confirm to you — as the human subject under study —  that whether or not such processes of non-identification are conducted, the biospecimens, data or information shall not be used for future research studies or distributed to another researcher or investigator for future research studies, unless with additional informed consent from you.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Commercial Research and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that such communication and notification clearly confirm to you — as the human subject under study —  that whether or not such processes of non-identification are conducted, the biospecimens, data or information shall notbe used for commercial profit or equivalent benefit without your explicit consent and agreement to terms.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Benefit-Risk Relations Assessment” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations, guidelines and protections of accounting for the relations between benefits and risks with respect to you — as the human subject under study — of the research or investigation study and its activities, methods and procedures.[/su_spoiler][su_spoiler title=”Risk Assessment from Preclinical Studies” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where scientifically appropriate, preclinical studies — involving equivalent activities, interactions, interventions, methods or human subjects — have been conducted and provide data for assessing potential risks to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Where Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where an assurance is made that procedures are benign, there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described as benign will and does not adversely affect or impact human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Where No Greater Than Minimal Risk” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where the research or investigation study poses no greater than minimal risk to you — as the human subject under study — the additional requirement be undergoing a reasonably informing consent process specific to the genetic and genomic research activities  and procedures to be conducted on you.[/su_spoiler][su_spoiler title=”Where Greater than Minimal Risk but with Direct Benefit” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where the research or investigation study poses more than minimal risk to you — as the human subject under study — but also holds out the prospect of direct benefit for you or is likely to contribute to your well-being, the additional requirements be undergoing a reasonably informing consent process specific to the genetic and genomic research activities  and procedures to be conducted on you as well as:

— (a) ensuring the risk is justified by the anticipated benefit to you; and

— (b) ensuring the relation of anticipated benefit to risk is as favorable or better to you than the benefit-risk relation of available alternative approaches or procedures.[/su_spoiler][su_spoiler title=”Where Greater than Minimal Risk and No Direct Benefit” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where the research or investigation study poses more than minimal risk to you — as the human subject under study — but holds out no prospect of direct benefit for you or is not likely to contribute to your well-being, the additional requirements be undergoing a reasonably informing consent process specific to the genetic and genomic research activities  and procedures to be conducted on you as well as:

— (a) ensuring the risk represents a minor increase over minimal risk;

— (b) ensuring the research or investigation study presents experiences to you that are reasonably commensurate with those inherent in your actual or expected clinical or medical situation; and

— (c) ensuring the research or investigation study is likely to yield generalizable knowledge about your disorder or condition which is of vital importance for the understanding or amelioration of your disorder or condition.[/su_spoiler][su_spoiler title=”Where Risk Assessment Include Pregnancy, Fetus or Child” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where the above risk assessment entails concern for pregnancy, fetus, newborn or a child, the additional requirements follow those delineated and described under section for Obstetrics and Neonatal Research and Pediatrics Research.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever boiospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any processing of biospecimens, data and information is conducted to pose no (or very low) risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study — and other natural persons concerned, including but not limited to specific concerns about discriminatory and stigmatizing effects, and the probability that disclosure of sensitive biospecimens, data and information may place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation..[/su_spoiler][su_spoiler title=”Adequate Provision for Follow-up Care, Counseling or Examination” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where the IRB finds there may be a need for follow-up care, genetic counseling or examination of you as the human subject under study after the end of your participation, adequate provision is made for such care, genetic counseling or examination, taking into account the varying lengths, likelihoods and severities of conditions and prognoses associated with genetic diagnoses and results, and for informing you and other participants of this fact.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Health Care Operations Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of health care operations research. The Ikoku Foundations recognizes that such research or investigation conducted on, about or otherwise relating to you — as well as for evaluating and improving operations of health care services — requires rigorous ethics attention to ensure consistent expectations and protections for you as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the principles, rights and responsibilities of human subjects research and investigation — all of the following:

[su_accordion class=””][su_spoiler title=”Limitation to Health Care Operations Assessment” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects or conditions of specific and evidenced importance to health care operations disciplines, studies and scholarship.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Difference Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from practices of health care delivery, management, production, regulation, reimbursement and insurance and services.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

News and Journalism Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of media, news and journalism research. The Ikoku Foundations recognizes that such research or investigation conducted on, about or otherwise relating to you — as well as for knowledge and publication pertaining to media, news, journalism and the public interest — requires rigorous ethics attention to ensure consistent expectations and protections for you as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Limitation to Media and Journalism Studies Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to media, news, journalism and public interest studies and scholarship.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Distinction Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from media, news and journalism practice.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification Specific to Field of Study” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that, where applicable and appropriate, the processes of non-identification include methods and modes of recording, reporting, narrating and analysis that — to the degree that ethical obligations to you and other human subjects require — abstract identifiable details or personas from data and information; rename persons, places and contexts; fictionalize aspects of persons, places and contexts; and create personas via the amalgamation of relevant aspects, details and events from human subjects, collected data and information, and the contexts of the interviewing, research, investigation and processing.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given Acknowledgment, Citation and Intellectual and Publicity Rights ” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that there is acknowledgment, citation and proper ascertainment and respect of intellectual and publicity rights in the reporting and publishing of data and information from, about or otherwise relating to you — as the human subject under study — especially where there is clear consent to reveal your identity and agreed upon details of responses, data and information.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Obstetrics and Neonatal Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of obstetrics and neonatal research. The Ikoku Foundations recognizes that research or investigation conducted on, about or otherwise relating to you during pregnancy — as well as with respect to your fetus and newborn — requires rigorous ethics attention to ensure consistent expectations around consent and assent and protections for both human subjects under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Protection as Fundamental Rights of Pregnant, Fetal and Neonatal Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all involved understand the rights to human subject, biospecimen, data and information protection as themselves fundamental rights with respect to you, if pregnant, and to the fetus or neonate — as the human subjects under study.[/su_spoiler][su_spoiler title=”Limitation to Obstetrics and Neonatal Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to obstructs and neonatal disciplines, studies and scholarship.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Difference Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from (or relationship to) caring, clinical, curative, diagnostic and preventative practices of obstetrics and neonatal medicine.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Consent, Assent and Permission” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of consent, assent and any required parental or guardian permission with respect to you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as to Benefit-Risk Relations Assessment” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations, guidelines and protections of accounting for the relations between benefits and risks with respect to you — as the human subject under study — of the research or investigation study and its activities, methods and procedures.[/su_spoiler][su_spoiler title=”Assent, Consent and Permissions Where Pregnant Child Subject” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where you — as the human subject under study — are both pregnant and a child, your reasonably informing assent is obtained and maintained, along with the required permission of parents or guardians, and each and every natural and legal person involved is reasonably and transparently informed.[/su_spoiler][su_spoiler title=”Risk Assessment from Preclinical Studies” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where scientifically appropriate, preclinical studies — involving equivalent activities, interactions, interventions, methods or human subjects — have been conducted and provide data for assessing potential risks to the pregnant parent and fetus.[/su_spoiler][su_spoiler title=”Least Possible Risk” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that any risk is the least possible for achieving the objectives and purposes of the research or investigation study.[/su_spoiler][su_spoiler title=”Where Greater than Minimal Risk to Fetus then Direct Benefit to Fetus or Parent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that any greater than minimal risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the pregnant parent or the fetus.[/su_spoiler][su_spoiler title=”Where Direct Benefit to Pregnant Parent” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that where the research or investigation study holds out the prospect of direct benefit to the pregnant parent, the informed consent of the pregnant parent is to be obtained and maintained.[/su_spoiler][su_spoiler title=”Where Direct Benefit to Pregnant Parent and Fetus” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that where the research or investigation study holds out the prospect of direct benefit both to the pregnant parent and the fetus, the informed consent of the pregnant parent is to be obtained and maintained.[/su_spoiler][su_spoiler title=”Where No Direct Benefit to Pregnant Parent or Fetus” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that where the research or investigation study holds out no prospect of benefit for the pregnant parent nor the fetus, the risk to the fetus is to be no greater than minimal, and the purpose of the research should be the development of important biomedical knowledge that cannot be obtained by any other means.[/su_spoiler][su_spoiler title=”Where Direct Benefit Only to Fetus” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that where the research or investigation study holds out the prospect of direct benefit solely to the fetus, the informed consent of all parents involved is to be obtained and maintained.

— except where the non-pregnant parent is unable to consent because of unavailability, incompetence or temporary incapacity, or where the pregnancy resulted from rape or incest, then the informed consent of the pregnant parent is to be obtained and maintained.[/su_spoiler][su_spoiler title=”No Inducements to Terminate a Pregnancy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that no inducements, monetary or otherwise, are offered to terminate a pregnancy.[/su_spoiler][su_spoiler title=”No Researchers Involvement in Decision to Terminate Pregnancy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that natural and legal persons engaged in the research or investigation study have no part in any decisions as to the timing, method or procedures used to terminate a pregnancy.[/su_spoiler][su_spoiler title=”No Researchers Involvement in Viability Assessment of Neonate” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that natural and legal persons engaged in the research or investigation study have no part in determining the viability of a neonate (or “newborn”) after delivery.[/su_spoiler][su_spoiler title=”Where Research Permitted on Neonates of Uncertain Viability” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, until the viability of a neonate is ascertained, the neonate may not be involved in research or investigation unless all of the following apply:

— that the research or investigation study holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective.

— or that the purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research.

— and there is the legally effective informed consent of either parent of the neonate, or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent’s legally authorized representative, or, if the pregnancy resulted from rape or incest, the legally effective informed consent of the parent who gave birth to the neonate.[/su_spoiler][su_spoiler title=”Where Research Permitted on Nonviable Neonates” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that a neonate determined after delivery to be nonviable may not be involved in research or investigation unless all of the following apply:

— the vital functions of the neonate will not be artificially maintained.

— the research or investigation will not terminate the heartbeat or respiration of the neonate.

— there will be no added risk to the neonate resulting from the research.

— the purpose of the research or investigation study is the development of important biomedical knowledge that cannot be obtained by other means.

— and there is the legally effective informed consent of both parents of the neonate, or, if one parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of the other parent, or, if the pregnancy resulted from rape or incest, the legally effective informed consent of the parent who gave birth to the neonate.[/su_spoiler][su_spoiler title=”Where Research Permitted on Viable Neonates” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that a neonate determined after delivery to be viable — specifically, able to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration — may be included in research or investigation only to the extent permitted by and in accordance with the principles, rights and responsibilities of human subjects research and the additional requirements for children.[/su_spoiler][su_spoiler title=”Where Research Permitted on Post-Delivery Material” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that any research or investigation study involving, after delivery, the placenta, dead fetus, macerated fetal material, or cells, tissue or organs excised from a dead fetus, is approved and conducted only in accordance with applicable guidelines, law and regulations regarding such research activities and studies.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any biospecimens, data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Pediatrics Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of pediatrics research. The Ikoku Foundations recognizes that research or investigation conducted on, about or otherwise relating to you during childhood requires rigorous ethics attention to ensure consistent expectations around consent and assent and protections for you — as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Protection as Fundamental Rights of Child Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all involved understand the rights to human subject, biospecimen, data and information protection as themselves fundamental rights with respect to you, the child — as the human subject under study — irrespective of age and decision-making capacity.[/su_spoiler][su_spoiler title=”Limitation to Childhood Care and Pediatrics Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to pediatrics disciplines, studies and scholarship.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Difference Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from (or relationship to) caring, clinical, curative, diagnostic and preventative practices of pediatrics and childhood care.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the child subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Consent, Assent and Permission” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of consent, assent and any required parental or guardian permission with respect to you — as the child subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the child subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are child in the care of a parent or equivalent guardian and, second, that, in addition to assent (and consent), you and the parent or equivalent guardian prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Benefit-Risk Relations Assessment” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations, guidelines and protections of accounting for the relations between benefits and risks with respect to you — as the child subject under study — of the research or investigation study and its activities, methods and procedures.[/su_spoiler][su_spoiler title=”Risk Assessment from Preclinical Studies” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where scientifically appropriate, preclinical studies — involving equivalent activities, interactions, interventions, methods or human subjects — have been conducted and provide data for assessing potential risks to you — as the child subject under study.[/su_spoiler][su_spoiler title=”Where No Greater Than Minimal Risk” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where the research or investigation study poses no greater than minimal risk to you — as the child subject under study — the additional requirement be obtaining and maintaining your informed assent and the informed permission of one or all your parents or guardians.[/su_spoiler][su_spoiler title=”Where Greater than Minimal Risk but with Direct Benefit” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where the research or investigation study poses more than minimal risk to you — as the child subject under study — but also holds out the prospect of direct benefit for you or is likely to contribute to your well-being, the additional requirements be obtaining and maintaining your informed assent and the informed permission of one or all your parents or guardians as well as:

— ensuring the risk is justified by the anticipated benefit to you; and

— ensuring the relation of anticipated benefit to risk is as favorable or better to you than the benefit-risk relation of available alternative approaches.[/su_spoiler][su_spoiler title=”Where Greater than Minimal Risk and No Direct Benefit” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where the research or investigation study poses more than minimal risk to you — as the child subject under study — but holds out no prospect of direct benefit for you or is notlikely to contribute to your well-being, the additional requirements be obtaining and maintaining your informed assent and the informed permission of all your parents or guardians as well as:

— (a) ensuring the risk represents a minor increase over minimal risk;

— (b) ensuring the research or investigation study presents experiences to you that are reasonably commensurate with those inherent in your actual or expected dental, educational, medical, psychological or social situation; and

— (c) ensuring the research or investigation study is likely to yield generalizable knowledge about your disorder or condition which is of vital importance for the understanding or amelioration of your disorder or condition.[/su_spoiler][su_spoiler title=”Where Child Subject is a Ward” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where you are a child and ward of the state or any other agency, institution or entity and are to participate in any of the above permitted research or investigation scenarios — as the child subject under study — the additional requirements be what is required above, obtaining and maintaining your informed assent and the informed permission of all your parents or guardians as well as:

— (a) ensuring the research or investigation study and purpose is related to your status as a ward; or

— (b) ensuring the research or investigation study is conducted in camps, hospitals, institutions, schools or similar settings in which the majority of children involved as human subjects are not wards; and

— (c) appointing an advocate for you and each other ward and child, in addition to any other individual acting on behalf of the child as guardian or in loco parentis.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the child subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever boiospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the child subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Child Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any biospecimens, data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the child subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Prisoner and Penal Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities conducted as part of, in support of, or for the purposes of penal, prisons and prisoners research. The Ikoku Foundations recognizes that research or investigation conducted on, about or otherwise relating to you while detained or incarcerated requires rigorous ethics attention to ensure consistent expectations around consent and assent and protections for you as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities  — all of the following:

[su_accordion class=””][su_spoiler title=”Protection as Fundamental Rights of Prisoner Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all involved understand the rights to human subject, biospecimen, data and information protection as themselves fundamental rights with respect to you — as the human subject under study — irrespective of arrest, conviction, detention, imprisonment, incarceration or other criminal or prison status.[/su_spoiler][su_spoiler title=”Likelihood of Coerced Participation” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all involved understand that the constraints of incarceration likely affect your ability to make a truly voluntary and uncoerced decision whether or not to participate as a human subject in research or investigation, requiring us to ensure the above level of protection, safety and security via additional requirements and safeguards.[/su_spoiler][su_spoiler title=”Risks Acceptable to Nonprisoner Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]therefore, that there is rigorous assessment and written attestation (by the IRB, researcher or investigator and human subjects) that the risks involved in the research or investigation study are commensurate with risks that would be accepted by a broader community or randomly selected groups of nonprisoner volunteers to participate as human subjects under study.[/su_spoiler][su_spoiler title=”Rigorous Protections Against Undue Inducement” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is also rigorous assessment and written attestation (by the IRB, researcher or investigator and human subjects) that any possible advantages accruing to you through participation in the research or investigation study — as the human subject under study — when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison — are not of such a magnitude as to impair their ability to weigh the risks of the research or investigation against the value of such advantages in the limited choice environment of the prison.

— and that equivalently rigorous assurances exist that parole boards will not take into account your participation in the research or investigation — as the human subject under study — especially when making decisions regarding parole, and you and each other prisoner are clearly informed in advance that participation in the research will have no effect on parole.[/su_spoiler][su_spoiler title=”Rigorous Protections of Human Subjects Selection” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]therefore, that there is rigorous assessment and written attestation (by the IRB, researcher or investigator and human subjects) that procedures for selection of you and other human subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners.

— and that control subjects are selected randomly from the group of available prisoners who meet the characteristics needed for the particular research or investigation study — unless the researcher or investigator provides to the IRB written justification for following other selection procedures and potential human subjects are reasonably informed of this procedural departure.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given No Risk to Human Subjects on Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your responses — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided too that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][su_spoiler title=”Adequate Provision for Follow-up Examination or Care” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where the IRB finds there may be a need for follow-up examination or care of you — as the human subject under study — after the end of your participation, adequate provision is made for such examination or care, taking into account the varying lengths of your and other individual prisoners’ sentences, and for informing you and other participants of this fact.[/su_spoiler][su_spoiler title=”Permitted Research of Incarceration and Behaviors” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation on the possible causes, effects and processes of incarceration and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Permitted Research of Prisoners as Incarcerated Persons” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Permitted Research of Prisons as Institutional Structures” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation of prisons as institutional structures, provided that the study presents no more than minimal risk and no more than inconvenience to you — as the human subject under study.[/su_spoiler][su_spoiler title=”Permitted Research of Conditions Affecting Prisoners as a Class” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation of conditions particularly affecting prisoners as a class, provided that the study presents no more than minimal risk and no more than inconvenience to you and the study may proceed only after national government consultation with appropriate experts (including in penology medicine and ethics) and subsequent published notice — in the Federal Register or equivalent online and publicly accessible site — of intent to approve such research.[/su_spoiler][su_spoiler title=”Permitted Research on Practices Offering Direct Health Benefit” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, among the highly limited and restricted research or investigation purposes approvable by the IRB, a researcher or investigator may submit a proposal for research or investigation on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of you — as the human subject under study — provided that the study presents no more than minimal risk and no more than inconvenience to you and the study may proceed only after national government consultation with appropriate experts (including in penology medicine and ethics) and subsequent published notice — in the Federal Register or equivalent online and publicly accessible site — of intent to approve such research.[/su_spoiler][su_spoiler title=”No Other Permitted Research” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, apart from the above, no other research or investigation objectives, purposes or studies may be approved by the IRB — or conducted, funded or supported — when involving you and other prisoners as human subjects.[/su_spoiler][su_spoiler title=”Not Authorization of Prisoners as Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and that nothing in this Policy shall be understood as indicating compliance with or fulfillment of its principles, rights and responsibilities authorizes — in itself — research or investigation involving you and other prisoners as human subjects, to the extent that such research or investigation is barred or limited by any applicable local or national guidelines, laws or regulation.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Public Benefit and Public Service Programs Research

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of public benefit and public services research. The Ikoku Foundations recognizes that such research or investigation conducted on, about or otherwise relating to you — as well as for evaluating and improving public benefit and public service programs — requires rigorous ethics attention to ensure consistent expectations and protections for you as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Appropriate Authority or Office as Sponsor” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research, investigation and demonstration projects activities are also continually subject to approval, authorized, conducted, regulated, sponsored and supported by an appropriate government, public benefit or service and public authority.[/su_spoiler][su_spoiler title=”Limitation to Public Benefit or Service Programs” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research, investigation and demonstration projects activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to public benefit and public services service programs and their studies, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.[/su_spoiler][su_spoiler title=”Publication of Research, Investigation and Demonstration Projects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that each government, public benefit, public service and public authority department or agency conducting or supporting the research, investigation and demonstration projects establish, on a publicly accessible government and public office online website — and prior to commencing the research involving human subjects — a list of research, investigation and demonstration projects that the government, public benefit, public service and public authority department or agency conducts or supports under this Policy.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Difference Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from practices of providing public benefit, public services, and their benefit and services programs.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Public Health Surveillance

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of public health and public health surveillance research. The Ikoku Foundations recognizes that such research or investigation conducted on, about or otherwise relating to you — as well as for surveillance and decision-making pertaining to population-wide disease and health — requires rigorous ethics attention to ensure consistent expectations and protections for you — as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Appropriate Authority or Office as Sponsor” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are also authorized, conducted, regulated, sponsored and supported by an appropriate medical, public health and public authority.[/su_spoiler][su_spoiler title=”Limitation to Public Health Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to public health disciplines, studies and scholarship, such as potential public health signals, onsets of disease outbreaks, patterns in diseases, risk factors, and trends in injuries from using consumer products.[/su_spoiler][su_spoiler title=”Limitation to Public Health Awareness and Priorities Setting” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary and associated with providing timely situational awareness and priority setting during the course of an event or crisis — including a natural or man-made disaster — that threatens public health.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Distinction Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its relationship to the caring, clinical, curative, diagnostic and directly preventative practices of public health.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Taste, Food Quality and Community Acceptance Studies

Below are additional ethics requirements The Ikoku Foundations shall meet when conducting research or investigation activities as part of, in support of, or for the purposes of taste and food quality evaluation and consumer acceptance studies. The Ikoku Foundations recognizes that such research or investigation conducted on, about or otherwise relating to you — as well as for knowledge pertaining to consumption, quality and taste of foods — requires rigorous ethics attention to ensure consistent expectations and protections for you — as the human subject under study. The Ikoku Foundations shall therefore have such research or investigation fulfill — in addition to the aforementioned principles, rights and responsibilities — all of the following:

[su_accordion class=””][su_spoiler title=”Limitation to Consumer, Quality and Taste Importance” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to those necessary to allow the authorized and IRB-approved researcher or investigator to study aspects of specific and evidenced importance to taste, food quality and consumer acceptance studies and scholarship.[/su_spoiler][su_spoiler title=”Limitation to Wholesome Foods” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to the consumption of wholesome foods without additives.[/su_spoiler][su_spoiler title=”Limitation of Ingredients to Safe Levels and Uses” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to the consumption of foods containing food ingredients at or below levels found to be safe and for uses found to be safe by pertinent government, public and regulatory authorities.[/su_spoiler][su_spoiler title=”Limitation of Contaminants to Safe Levels” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that all research and investigation activities are limited to the consumption of foods containing agricultural, chemical or environmental contaminants at or below levels found to be safe by pertinent government, public and regulatory authorities.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Difference Between Research and Practice” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and purposes of the research or investigation study and its distinction from practices of agricultural, beverage and food production, preparation and services.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as to Confidentiality and Privacy” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is clear prospective agreement and attestation (from the IRB, researcher or investigator and you) about the expectations and protections of confidentiality and privacy for you — as the human subject under study — before, during and after the research or investigation study.[/su_spoiler][su_spoiler title=”Clear Prospective Agreement as well as Consent to Specific Data and Processing” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that, where such research or investigation is in conjunction with the collection or other processing of biospecimens, data and information from you — as the human subject under study — including through interactions, interventions, procedures, tests and equivalent activities, as well as through audiovisual recording, verbal or written responses and data entry, you attest, first that you are an adult and, second, that, in addition to consent, you prospectively agree only to the specific research interactions and interventions, the specific biospecimens, data and information, and their specific manner or methods of access and other processing.[/su_spoiler][su_spoiler title=”Benign Nature of Method or Procedure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]that there is rigorous assessment and written attestation (from the IRB, researcher or investigator and human subjects), including where appropriate review and citation of studies with relevant similarities, confirming that any proposed and active interaction, intervention, method or procedure described is benign, will and does not adversely affect or impact you and any other human subjects, and also is:

— (a) brief in duration;

— (b) harmless;

— (c) painless;

— (d) not physically invasive,

— (e) not likely to have a significant adverse lasting impact on the human subject;

— (f) and neither offensive nor embarrassing.[/su_spoiler][su_spoiler title=”Benign Nature of Biospecimens, Data, Information and Disclosure” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that there is rigorous assessment and confirmation (from the IRB and researcher or investigator) that any disclosure of your participation in the research, your responses, or your biospecimens, data and information — as the human subject under study — outside the research or investigation would not reasonably place you at risk of criminal or civil liability or be damaging to your educational advancement, employability, financial standing or reputation.[/su_spoiler][su_spoiler title=”Given Rigorous Non-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided also that all biospecimens, data and information obtained are accessed and otherwise processed by the researcher or investigator in such a manner that rigorously fulfills the principle of non-identification, so that the identity of you — as the human subject under study — cannot be ascertained, directly or indirectly through identifiers linked to you.[/su_spoiler][su_spoiler title=”Given Rigorous Re-Identification of Biospecimens, Data and Information” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]provided that whenever biospecimens, data and information are accessed and otherwise processed by the researcher or investigator in such a manner that the identity of you — as the human subject under study — can be ascertained, directly or indirectly through identifiers linked to you, the researcher or investigator rigorously adheres to protective protocols reviewed by the IRB specifically for the research or investigation study prior to its approval and inception.[/su_spoiler][su_spoiler title=”Given No Adverse Risk to the Rights of Human Subjects” open=”no” style=”default” icon=”folder-1″ anchor=”” class=””]and provided that there is rigorous assessment and confirmation (from the IRB, researcher or investigator and you) that any data and information, and their processing, poses no risk to the fundamental freedoms, civil liberties and rights of you — as the human subject under study.[/su_spoiler][/su_accordion]

And furthermore, by using or visiting, in any way, The Ikoku Foundations, any area, part, section or properties of The Ikoku Foundations, any area, part, section or properties of their divisions, series, subsidiaries or affiliates, as well as any of the Products or Services, including the Sites, you accept and agree to the terms, conditions and requirements described above, and in these Codes and Policies, in their entirety without modification.

Child Looking Up Among Adult Celebrants
Child at Ceremony, Ikorodu, Nigeria, 2016 (Oshomah Abubakar)
Boy Smiling While Showing Hand String Game
Boy Playing Hand Game, 2017 (Alexander Radelich)
Child in Costume Looking at Camera
Niño, Cusco, Peru, 2018 (Ben Ostrower)
Tatooed Map on Outstretched Arm
Map on Arm, Dayton, US, 2017 (Don Ross III)
Woman with Arm on Head, Smiling
Woman in Joy, Kolkota, India, 2017 (Loren Joseph)
Boy Among Chidlren in Class, Looking at Camera
Children in Classroom, Nakasaki District, Kampala, Uganda, 2017 (Bill Wegener)
Woman Seated on Mat on Floor, Holding Fan
Seated by Kpone Katamanso District Assembly Office, Tema, Ghana, 2017 (Nathaniel Tetteh)
Girl Kneeling in Busy Street
Tibetan Girl, 2017 (Journey Yang)

Central and Associated Policies

Provision

As stated earlier, The Ikoku Foundations User Agreement and Code of Conduct consist of several Codes and Policies that collectively govern all of your activity with, within, for, in reference to and otherwise pertaining to The Ikoku Foundations. By continuing, you indicate that you understand that these Codes and Policies include — but are not limited to — the Founding and Governing Code of Ethics, the Policy on Privacy and Confidentiality, the Terms and Conditions of Use and Service, and the Acceptable Use Policy along with all Associated Codes and Policies. Access to the aforementioned is provided below.

Founding Code of Ethics

Founding Code of Ethics (HTML and PDF)

Privacy and Confidentiality

Policy on Privacy and Confidentiality (HTML and PDF)

Terms and Conditions

Terms and Conditions of Use and Service (HTML and PDF)

Acceptable Use Policy

Acceptable Use Policy (HTML and PDF)

All Associated Policies

All Associated Policies (HTML and PDF)

*Note

*Note: Please see the main Policies page for notice on conditions incompatible with the founding and mission of The Ikoku Foundations.

Ethics at The Foundations

The establishment of The Ikoku Foundations entails a set of core emphases that ensure and reflect the originating charitable mission and purposes. These emphases inform each instance of commitment, effort and work to achieve benefit, impact and success. And they furthermore produce three features evident in the resulting governance structure, operations and most importantly, communities:

01.

Governace Suited to Local and Global Philanthropy

The governing structure of The Ikoku Foundations have been designed to be attentive to needs and operations at the local and global level, as well as across the complex states and societies where the served communities reside, living shared, interdependent lives.

02.

With Respect Being Central to Ethics

At the core of the Founding and Governing Code of Ethics is a commitment to the most robust conceptions of respect and humanity, including and beyond what the law has protected and provided for, as The Ikoku Foundations fulfill their mission to serve the public interest in Africa, its global diasporas and the full range of shared societies.

03.

To Ensure a Just and Shared Future for Many

The Ikoku Foundations are inspired by peoples who have contributed to the foundations and development of their societies, despite a history of systemic difficulties. Who maintain an unyielding belief that the betterment of their human condition will foster the betterment of those living around them, and will enhance the futures of the regularly underserved, marginalized, disenfranchised. The Foundations draw from these examples a vision of the public good and common community that is their hope and objective.

More About Us

The Ikoku Foundations

The Ikoku Charitable Trusts and The Ikoku Foundations are independent, private, non-profit organizations that serve the public interest in Africa and its global diasporas — by advancing education and research and by also supporting creative ideas, civic endeavors and emerging communities, organizations and societies.

— About Us

Nature, Scope, Means

The Ikoku Foundations’ founding mission and ongoing emphases of support are for good works that help the public understand Africa's essential place in a global future, one that is to be more knowledgeable, environmentally sound, equitable and of deep benefit across communities in shared societies.

— Founding & Overview

Charitable Mission, Purposes, Goals

To this end, The Ikoku Charitable Trusts and The Ikoku Foundations are governed by a Board of Trustees and two differently dedicated Advisory Boards of Directors — a three-board system set out and defined in the original Declaration of Trust, where the Founding and Governing Code of Ethics is also delineated.

— Governance

Leadership, Boards, Documents

The policies provided on these Sites collectively constitute the User Agreement and Code of Conduct, which govern all activity and work in and for, access to and use of, association with and reference to The Ikoku Charitable Trusts and The Ikoku Foundations. Please read them attentively.

— Policies

Codes, Conditions, Terms

Take a look, and follow The Ikoku Charitable Trusts and The Ikoku Foundations. Follow, too, media events and the coverage that precedes them or ensues. You may also sign up for newsletters, which will update you about developments at these organizations and the communities they serve.

— Communications

Press, Newsletters, Reports

Join The Ikoku Charitable Trusts and The Ikoku Foundations as a potential leader, staff, board or committee member, researcher or educator, contributor, volunteer, partner or collaborator. A career of contributing to and helping define the greater good through these organizations may be the perfect fit for you.

— Careers at the Foundations

Jobs, Volunteer, Collaboration