Human Subjects | Research – The Ikoku Foundations

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Codes &

Policies

The Ikoku Foundations derive their codes and policies from the Founding Declaration of Trust and Code of Ethics — which guide and govern all activities conducted with, within, for, on behalf of, in reference to and otherwise pertaining to The Ikoku Foundations, as well as their programs, services and sites.

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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:

Persons Adhering to Agreement

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.

Applicability and Governance of Agreement

that the Policy on Human Subjects Research and Investigation governs any and all of your access, actions, activity, communication, operation, participation, or other use in, with, for, on behalf of, in reference to, or otherwise pertaining to The Ikoku Foundations, the divisions, series, subsidiaries, and affiliates, and the Products and Services.

Entry and Continuation of Agreement

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, the divisions, series, subsidiaries, or affiliates, and the Products and Services — 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.

Direct and Indirect Entry and Continuation of Agreement

that whenever you engage in the above described activities directly or indirectly — whether engaged in through The Ikoku Foundations, the divisions, series, subsidiaries, or affiliates, and the Products and Services; or through persons and entities working with The Ikoku Foundations, the divisions, series, subsidiaries, or affiliates, and the Products and Services; 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.

Binding Nature and Validity of Agreement

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”).

Agreement On Behalf of Organization

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.

In Case of Non-Agreement or Inability to Honor

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.

And furthermore, by engaging in any activity engaging, involving, referring to, relating to, or otherwise pertaining to The Ikoku Foundations, any activities, affairs, areas, assets, offices, parts, properties, sections, or equivalent of The Ikoku Foundations, any activities, affairs, areas, assets, offices, parts, properties, sections, or equivalent of the divisions, series, subsidiaries, or affiliates, as well as any activities, affairs, areas, assets, offices, parts, properties, sections, or equivalent of the Products or Services, you accept and agree to the terms, conditions, and requirements described above, and in the 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:

Your Power and Authority

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.

Required Age or Permission and Supervision

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, the divisions, series, subsidiaries, and affiliates, or the Products and Services with the permission and supervision of an adult parent or guardian.

Reading and Understanding

that you have read and understood the Policy on Human Subjects Research and Investigation.

Voluntary Nature of Consent

that you understand your consent to be voluntary in nature.

Agreement and Consent

that you consented to and agreed to be legally bound by the Policy on Human Subjects Research and Investigation.

And furthermore, by engaging in any activity engaging, involving, referring to, relating to, or otherwise pertaining to The Ikoku Foundations, any activities, affairs, areas, assets, offices, parts, properties, sections, or equivalent of The Ikoku Foundations, any activities, affairs, areas, assets, offices, parts, properties, sections, or equivalent of the divisions, series, subsidiaries, or affiliates, as well as any activities, affairs, areas, assets, offices, parts, properties, sections, or equivalent of the Products or Services, you accept and agree that your consent meets the conditions, principles, and requirements for consent, as delineated and described in a the 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, in their entirety without modification, including as they are amended from time to time by The Ikoku Foundations.

Your Understanding of Human Subjects Research

— 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 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:

Basis for Your Actions, Activity and Decisions

its basis for any human subjects research activity you engage in with respect to The Ikoku Foundations — including the divisions, series, subsidiaries, and affiliates, as well as the 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 the Policy on Human Subjects Research and Investigation or any equivalent or applicable guidelines, laws, policies, provisions, or regulations.

Commitment to Informed Consent

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.

Commitment to Care and Safety

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.

Commitment to Confidentiality

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.

Commitment to Privacy

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.

Commitment to Necessary Limitations

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.

Commitment to Respectful and Protective Practices

that you respectfully assist solely by duties described below in this Policy and in no way interfere with or impede the reasonable efforts taken by The Ikoku Foundations to translate the above commitments into practices for developing and maintaining protections pertaining to human subjects research; for determining compliance with those protections; and for fulfilling, respecting, and safeguarding human research subjects, biospecimens, data, and information resulting from human subjects research, persons, properties, and interests relating to human subjects research, human subjects research processes, human subjects research principles, human subjects research rights, and their protections, including but not limited to those delineated in this Policy and the Codes and Policies.

Commitment to Protections Following and Ahead of the Law

that you also respectfully assist solely by duties described below in this Policy 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 and biospecimens, data, and information resulting from human subjects research — such as basic standards for human subjects research rights and protections set in the Belmont Report, the Declaration of Helsinki, the Nuremburg Code, the United States Policy for Protection of Human Research Subjects, and the United Nations Declaration of Bioethics and Human Rights, as well as several privacy laws in California and the constitutional right to privacy provided for in the State Constitution of California.

Your Duty to the Policy

— With respect to your duty to the Policy on Human Subjects Research and Investigation, you represent and warrant that you understand and shall adhere to such duty by way of the following:

Refraining from Any Intentional Breach or Violation

avoiding, refraining from, and stopping any access, action, activity, communication, operation, or other use and any collaboration, collusion, coordination, planning, or other preparation you or any person engage in that may encourage, result in, or otherwise foster any intentional breach or violation of the Policy on Human Subjects Research and Investigation; any intentional breach, diminishment, disruption, impediment, interference, or pertaining to human subjects research guidelines, laws, policies, provisions, or regulations, or other human subjects research protections or rights of The Ikoku Foundations; and any intentional breach, diminishment, disruption, impediment, interference, or other violation pertaining to the independent and executive control and determination of the above by the sole Founder, Chair, and President, Alvan Azinna Chibuzo Ikoku.

Refraining from Any Unintentional Breach or Violation

avoiding, refraining from, and stopping any access, action, activity, communication, operation, or other use and any collaboration, collusion, coordination, planning, or other preparation you or any person engage in that may encourage, result in, or otherwise foster any unintentional breach or violation of the Policy on Human Subjects Research and Investigation; any unintentional breach, diminishment, disruption, impediment, interference, or pertaining to human subjects research guidelines, laws, policies, provisions, or regulations, or other human subjects research protections or rights of The Ikoku Foundations; and any intentional breach, diminishment, disruption, impediment, interference, or other violation pertaining to the independent and executive control and determination of the above by the sole Founder, Chair, and President, Alvan Azinna Chibuzo Ikoku.

Reporting Any Intentional Breach or Violation

reporting — directly and specifically to Alvan Azinna Chibuzo Ikoku, the Founder, Owner, and President of The Ikoku Foundations — any access, action, activity, communication, operation, or other use and any collaboration, collusion, coordination, planning, or other preparation you or any person engage in that may encourage, result in, or otherwise foster any intentional breach or violation of the Policy on Human Subjects Research and Investigation; any intentional breach, diminishment, disruption, impediment, interference, or pertaining to human subjects research guidelines, laws, policies, provisions, or regulations, or other human subjects research protections or rights of The Ikoku Foundations; and any intentional breach, diminishment, disruption, impediment, interference, or other violation pertaining to the independent and executive control and determination of the above by the sole Founder, Chair, and President, Alvan Azinna Chibuzo Ikoku.

Reporting Any Unintentional Breach or Violation

reporting — directly and specifically to Alvan Azinna Chibuzo Ikoku, sole Founder, Owner, and President of The Ikoku Foundations — any access, action, activity, communication, operation, or other use and any collaboration, collusion, coordination, planning, or other preparation you or any person engage in that may encourage, result in, or otherwise foster any unintentional breach or violation of the Policy on Human Subjects Research and Investigation; any unintentional breach, diminishment, disruption, impediment, interference, or pertaining to human subjects research guidelines, laws, policies, provisions, or regulations, or other human subjects research protections or rights of The Ikoku Foundations; and any intentional breach, diminishment, disruption, impediment, interference, or other violation pertaining to the independent and executive control and determination of the above by the sole Founder, Chair, and President, Alvan Azinna Chibuzo Ikoku.

Determination of Compliance

not diminishing or interfering with, in any way, the ability, opportunity, and sole discretion and rights of The Ikoku Foundations and the sole Founder, Chair, and President, Alvan Azinna Chibuzo Ikoku, to determine compliance with the Policy on Human Subjects Research and Investigation and to have their decision be final and binding and not subject to challenge or appeal.

Your Accordance with Ethics

Your Accordance with Mission

— You represent, warrant, and covenant that, given the above attestation about your consent to this Policy, you ensure that your abiding by and adhering to its conditions, policies, principles, requirements, and rights shall further remain in accordance with the founding mission and purposes of The Ikoku Foundations, without incompatibility, as described and delineated in the Codes and Policies and the Founder’s Declaration of Trust.

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 section 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 the Products and Services, as active indication of your knowledge, understanding, and legally binding acceptance of and agreement to this Policy as well as the Codes and Policies.

Your Duty to Organizational Integrity

With respect to your attendant duty to organizational integrity — and your legally binding agreement to not diminish, interfere, or violate, in any way, its principles, protections, requirements, or rights — you represent and warrant that you understand and shall adhere to the following:

Your Duty to Policy

To protect the organizational integrity of The Ikoku Foundations — as well as the properties, rights, and protections of the corporation and its 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.

Your Acceptance of Policy

The Ikoku Foundations remind you that the Policy on Organizational Integrity forms part of The Ikoku Foundations User Agreement and Code of Conduct. Thus, The Ikoku Foundations take your continued engagement in any activity involving, referring, relating, or otherwise pertaining to The Ikoku Foundations as active indication of your legally binding acceptance of this Policy as well as the Codes and Policies.

Your Acceptance of Administration

Furthermore, you represent, warrant, and covenant that, given the above, your continuation in using or visiting, in any way, The Ikoku Foundations, any activities, affairs, areas, assets, offices, parts, properties, sections, or equivalent of The Ikoku Foundations, any activities, affairs, areas, assets, offices, parts, properties, sections, or equivalent of the divisions, series, subsidiaries, or affiliates, as well as any activities, affairs, areas, assets, offices, parts, properties, sections, or equivalent of the Products or Services, is an active indication of your legally binding acceptance of the executive administration, control, and management of The Ikoku Foundations by the Founder, Alvan Azinna Chibuzo Ikoku, as further described in the Policy on Corporate Integrity.

And you further legally accept and agree that no application, interpretation, judgment, or other compliance, proceeding, or reading from, of, with, or otherwise relating to the Founding Ethics, the Codes and Policies, or any equivalent code, policy, or other document or material shall, in any way, entail any abrogation, diminishment, interference, or violation pertaining to any of the terms, conditions, principles, requirements, rights — including the attendant properties and protections — of corporate and organizational integrity.

Your Questions and Feedback

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

Your Reporting of Violations

If you detect, notice, become aware of, or are informed of a possible breach or violation of this Policy or any of the Codes and Policies, please contact policies@ikokufoundations.org with any details you have — to be addressed to and 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 section.

LekkiIkoyiBridgeLagosNigeriaBabatundeOlajideFeb2019 — Lekki-Ikoyi Link Bridge, Lagos, Nigeria, February 23 2019 (Babatunde Olajide)

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 section. 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:

Applicability

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.

Approval and Certification

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.

Beneficence

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.

Non-Maleficence

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.

Justice

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.

Lawfulness

that human subjects research and investigation should be lawful with respect to you — as the human subject under study.

Research and Investigation Purpose

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.

Respect for Autonomy via Informed Consent

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.

Necessity and Minimization

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.

Non-Identification

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.

Privacy and Confidentiality

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.

Protection and Security

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.

Sensitivity and Sensitive Biospecimens, Data and Information

that human subjects research and investigation involving the processing of sensitive biospecimens, data, and information should be prohibited, except as delineated and described in the Codes and Policies.

Transparency, Informing and Facilitating Rights

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.

Commensurability

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.

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:

Distinction Between Practice and Research

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.

Determination of Research and Investigation

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.

Determination of Human Subject

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.

Culmination in Narrow Applicability

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.

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:

Academic, Historical, Journalistic and Scholarly Activities

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.

Benign Interactions or Interventions Research

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.

Educational Settings Research

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.

Educational Testing Research

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.

Health Care Operations Activities

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.

Public Benefit and Service Programs Research

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.

Public Health Surveillance Activities

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.

Public Security and Criminal Justice Activities

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.

Secondary Research Activities and Uses

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.

Taste, Food Quality and Consumer Acceptance Studies

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.

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:

Founder and Internal Review Board

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.

Requests for Review and Approval

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.

Review for Minimization of Risk

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.

Review for Reasonable Benefit-Risk Relation

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.

Review for Equitable Research Subjects Selection

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.

Review for Informing and Documented Consent Process

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.

Review for Assessment and Monitoring of Activities and Methods

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.

Review for Monitoring of Biospecimens, Data and Information

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.

Review for Privacy and Confidentiality of Human Subjects

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.

Possible Further Review

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.

Certification on Approval

all IRB approvals of research or investigation activities covered by this Policy are confirmed then certified by express written instrument signed and sealed of the Founder, Alvan Azinna Chibuzo Ikoku, .

Periodic Review and Termination

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.

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:

Obligation to Maximize Benefit of Interaction or Intervention

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.

Obligation to Maximize Benefit of Research and Investigation

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.

Obligation to Maximize Benefit to Field of Knowledge

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.

Obligation to Maximize Benefit to Community and Society

Obligation to Maximize Benefit to Environment

Obligation to Prioritize Human Subject over Community and Society

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.

Obligation to Avoid Undue Inducement

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.

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:

Obligation to Minimize Harm of Interaction or Intervention

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.

Obligation to Minimize Harm of Research and Investigation

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.

Obligation to Minimize Harm to Field of Knowledge

Obligation to Minimize Harm to Community and Society

Obligation to Minimize Harm to Environment

Obligation to Prioritize Human Subject over Community and Society

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:

Obligation to Attend to and Protect Vulnerable Populations

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.

Obligation to Account for a History of Vulnerable Populations

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.

Obligation to Avoid Discriminatory Bias or Effects or Stigma

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.

Obligation to Avoid Abrogation or Infringement and Civil and Fundamental Rights

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.

Obligation to Not Take Advantage of Less Strict Regulation

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.

Obligation to Maximize Benefits and Minimize Harms Across Populations

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.

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:

Human Subject Informed by Transparent Communication

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.

Informed and Unrevoked Consent of Human Subject

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.

Necessity for Consented or Assented Purpose

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.

Proportionate to Consented or Assented Purpose

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.

Accordance with Rights

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.

Accordance with Law

Accordance with Ethics

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, the Codes and Policies, and the Founding Code of Ethics.

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:

Purpose Should be Explicit

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.

Purpose Should be Specific

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.

Purpose Should be Legitimate

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.

Purpose Should be Consented

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 the Codes and Policies — before, during and after the research or investigation study.

Where Added or Changed, then Limited, Compatible and Reviewed for Consent

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.

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:

Reasonably Expected by Human Subject Given Relationship and Understanding

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.

Reasonably Expected by Human Subject Given Proportionality

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.

Reasonably Expected by Human Subject Given Rights

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.

Reasonably Expected by Field Given Prior Research

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.

Legal and Law-Abiding

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.

Ethical and Approved

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 the Codes and Policies.

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:

Consent as Fundamental Basis

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.

Participation in Research as Subject to Consent

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.

Biospecimens, Data and Information as Subject to Consent

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.

Human Subjects Should be Treated as Individual, Freely Deciding Persons

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.

Human Subjects with Diminished Freedom to Decide Should be Protected

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.

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:

Consent Warranting Respect

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.

Consent, Ethical and Legally Effective Standard

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.

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.

Where Consent Can Be Freely Given and Meaningful

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.

Where Consent Cannot Be Freely Given or Meaningful

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.

Classic Situations of Consent Not Freely Given or Meaningful

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).

The Goal is Freely Given and Meaningful, Of Course

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.

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:

Reasonably Informing, Ethical Standard

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.

Informing, Confirmation of Research and Processing

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.

Informing, Purposes of Research and Processing

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.

Informing, Duration of Research and Processing

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.

Informing, Methods of Research and Processing

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.

Informing, Recipients of Research and Processing

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.

Informing, Content of Research and Processing

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.

Informing, Processes of Non-Identification

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.

Informing, Future Research and Processing of Content

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.

Informing, Commercial Research and Processing of Content

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.

Informing, Genomic Research and Processing of Content

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.

Informing, Costs and Discomforts of Research and Processing

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.

Informing, Benefits of Research and Processing

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.

Informing, Risks of Research and Processing

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.

Informing, Alternatives to Research and Processing

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.

Informing, Protections and Safeguards

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.

Informing, Rights

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.

Informing, Disclosures During Research

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.

Informing, Early Termination or Withdrawal

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.

Informing, Ideally Voluntary Nature of Research and Processing

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.

Informing, Any Compulsory Nature of Research and Processing

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.

No Exculpatory Language

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.

Informing, Injury Compensation

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.

Informing, Communication about Processing

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.

Informing, Responsible Entity, Offices or Persons

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.

Informing, Period of Discussion and Consideration

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.

Given No Adverse Effects on Rights of Others

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 the Founder, Alvan Azinna Chibuzo Ikoku.

Given Necessity, Non-Identification and Minimization

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.

Given Adherence to Founding Mission and Code of Ethics

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.

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:

Authorized and Identified Parties to Consent

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.

Written and Documentable Consent Process

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.

Accessible and Understandable Consent Process

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.

Explicit, Legitimate and Specific Purpose

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.

Ethical and Lawful Research and Processing

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.

Reasonably Informing Consent Process

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.

Freely Given and Meaningful Full, Partial or No Consent

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.

Good Faith Opportunity Where Consent Cannot be Freely Given or Meaningful

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.

Procedures for Withdrawal

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.

Attestation and Confirmation of Identity

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.

Attestation and Confirmation of Understanding

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.

Affirmative, Clear and Unambiguous

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.

Freely Given, Meaningful and Revocable

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.

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:

Assent Where Necessary for Protection of Vital Interests

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.

Assent Where Necessary for Protection of Rights and Associated Interests

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.

Assent Where Necessary for Agreement or Contract

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.

Assent Where Necessary for Compliance

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.

Assent Where Necessary for Corporate Duties and Functions

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.

Prospective Assent Where Agreement to Include Deception

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.

Given Complete Informing Consent Process

provided that you — as the human subject under study — undergo the complete informed consent process.

Given High Evidentiary Basis for Activity, Method and Measure

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.

Given Benign Interactions or Interventions

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.

Given Highly Favorable and Protective Benefit-Risk Assessment

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.

Given Strict Elimination of Risk of Adverse Effect or Impact on Disclosure

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.

Given Rigorous Non-Identification of Human Subjects and Data and Information

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.*

Given Rigorous Re-Identification of Human Subjects and Data and Information

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.

*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:

Research Necessary for Consented or Assented Purposes

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.

Necessary Biospecimens, Data and Information for Consented or Assented Purpose

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.

Necessary Processing for Consented or Assented Purpose

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.

Minimal Biospecimens, Data and Information for Consented or Assented Purpose

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.

Minimal Processing for Consented or Assented Purposes

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.

Minimal Risk and Assessment from Prior Studies

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.

Least Risk Necessary for Consented or Assented Purpose

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.

No Reasonable Alternative Biospecimens, Data and Information

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.

No Reasonable Alternative Processing

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.

No Further Processing

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.

Adequacy, Relevance and Limitation

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.

Strict Minimum Period

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.

Time Limits for Periodic Review

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.

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:

Statement of Preferred or Normative Non-Identifying Design

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.

Non-Identifying Nature of Data and Information

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).

Non-Identifying Processing of Data and Information

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.

Critical for Achieving Protection by Design

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.*

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:

Default and Normative Position to Maintain Non-Identifying State

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.

Notion of You as Supposedly a Human Subject Under Study

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.

Exception to Default Position Only on Your Request

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:

Request to Exercise Personal Data Rights

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.

Offer to Provide Additional Identifying Information

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.

Nature of Additional Information

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.

Given No Adverse Effects on Rights to Be Informed and to Consent

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 the Founder, Alvan Azinna Chibuzo Ikoku.

Given No Adverse Effects on Rights of Others

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 the Founder, Alvan Azinna Chibuzo Ikoku.

Given Adherence to Founding Mission and Code of Ethics

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.

Critical for Achieving Protection by Default

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.*

*you may learn more about the principles of protection and security by design and by default on this Policy section 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 section 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:

Privacy and Confidentiality as Absolute Rights of Human Subjects

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.

Research that Respects Privacy and Confidentiality of Human Subjects

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.

Privacy and Confidentiality as Effect via Methods Neutrality

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.

Privacy and Confidentiality as Effect via Purpose Neutrality

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.

Protection from Risks to Privacy and Confidentiality of Human Subjects

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.

Privacy and Confidentiality as Limitation and Safeguard on Means and Purposes

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.

Privacy and Confidentiality by Design

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.

Privacy and Confidentiality by Default

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.

Harmonization of Confidentiality and Privacy Expectations and Standards

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 the Codes and Policies.

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:

Protection as Basic Right of Human Subjects

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.

Protection of Rights of Human Subjects

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.

Protection as Effect via Methods Neutrality

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.

Protection as Effect via Purpose Neutrality

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.

Protection from Risks to Rights of Human Subjects

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.

Protection as Limitation and Safeguard on Means and Purposes

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.

Protection by Design

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.*

Protection by Default

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.

Protection and Security of Data and Information

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.

Protection and Security of Means and Methods

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.

Assessment of Protection and Security Measures

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.

Harmonization of Protections and Security

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 the Codes and Policies.

*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:

Determination of Sensitivity via Risks to Freedoms, Liberties and Rights of Persons

“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.

Determination of Sensitivity via Risks for Identity Theft

“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.

Determination of Sensitivity via Genomic or Vital Importance

“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.

Determination of Sensitivity via Risks of Private and Confidential Access

“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.

Determination of Sensitivity via Demarcation

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 section.

Working List of Sensitive Data

and for a working list of biospecimens, data, and information The Ikoku Foundations have determined to be sensitive see those delineated under Sensitive Data and Information on the main Policies section.

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:

Default Prohibition of Processing Sensitive Data and Information

that any access or other processing of “sensitive biospecimens,” “sensitive data” and “sensitive information” — as they are defined and delineated in the Codes and Policies — is prohibited.

Critical for Confidentiality, Privacy and Protection by Default

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.*

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:

Exception to Prohibition of Processing Sensitive Data and Information

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:

Where Your Giving Consent is Permitted

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.

Human Subjects Research Principles, Rights and Responsibilities Fulfilled

where all of the principles, rights, and responsibilities of personal data and information and human subjects research are and will remain fulfilled.

Rigorous Risks Assessment and Protections

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.

Protections Against Undue Coercion or Inducement

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.

Protections Against Risks on Disclosure

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.

Rigorous Non-Identification of Human Subjects Data and Information

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.

Rigorous Re-Identification of Human Subjects Data and Information

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.

Then Permitted For Research of Direct or Vital Benefit to You

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.

A High and Protective Bar

note the comparatively high and protective bar being set — to first make certain that The Ikoku Foundations 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.

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 The Ikoku Foundations 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:

Where Academic Research is Overriding or Primary

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.

Where News or Journalism Research is Overriding or Primary

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.

Where Public Benefit Research is Overriding or Primary

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.

Where Public Health Research is Overriding or Primary

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.

Where Health, Medical or Scientific Research is Overriding or Primary

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.

Where Health or Medical Services Research is Overriding or Primary

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.

Where Legal or Social Services Research is Overriding or Primary

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.

Where NonProfit Civic Liberties and Rights Research is Overriding or Primary

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.

Where Employment, Services or Volunteering Contract is Overriding or Primary

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.

An Even Higher and More Protective Bar

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.

Critical for Confidentiality, Privacy and Protection by Default

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.*

Also Critical for Confidentiality, Privacy and Protection by Design

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.*

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:

Easy Accessibility

such communication and notification are easily accessible for you — as the human subject under study.

Easy Understanding

such communication and notification are as concise and easy to understand as possible for you — as the human subject under study.

Clear and Plain Language and Visuals

such communication and notification use clear and plain language and, additionally, where appropriate, clear visualization.

In Writing, Electronic Form

such communication and notification are provided in writing, including where appropriate in electronic form (such as a public website).

Given Feasibility and Reasonableness

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.

Given No Adverse Effects on Rights of Others

provided also that such communication and notification to you do not adversely affect the civil and fundamental liberties and rights of others — particularly those of other human subjects under study and natural or legal persons concerned, including The Ikoku Foundations and the Founder, Alvan Azinna Chibuzo Ikoku.

Given Necessity, Non-Identification and Minimization

provided too that such communication and notification to you adhere to and fulfill the principles of necessity, non-identification and data-minimization.

Given Adherence to Founding Mission and Code of Ethics

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.

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:

Reasonably Informing, Ethical Standard

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.

Informing, Confirmation of Research and Processing

Informing, Purposes of Research and Processing

Informing, Duration of Research and Processing

Informing, Methods of Research and Processing

— 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 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.

Informing, Content of Research and Processing

— 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.

Informing, Recipients of Research and Processing

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.

Informing, Non-Identification of Research and Processing

Informing, Future Research and Processing of Content

Informing, Commercial Research and Processing of Content

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.

Informing, Genomic Research and Processing of Content

Informing, Benefits of Research and Processing

Informing, Costs and Discomforts of Research and Processing

Informing, Risks of Research and Processing

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.

Informing, Alternatives to Research and Processing

Informing, Protections and Safeguards

Informing, Rights

Informing, Disclosures During Research

Informing, Early Termination or Withdrawal

Informing, Ideally Voluntary Nature of Research and Processing

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.

Informing, Any Compulsory Nature of Research and Processing

No Exculpatory Language

Informing, Injury Compensation

Informing, Communication about Processing

Informing, Responsible Entity, Offices or Persons

Informing, Period of Discussion and Consideration

In Writing, Electronic Form

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.

Given Feasibility and Reasonableness

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.

Given No Adverse Effects on Rights of Others

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 the Founder, Alvan Azinna Chibuzo Ikoku.

Given Necessity, Non-Identification and Minimization

Given Adherence to Founding Mission and Code of Ethics

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.

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:

Prior Agreement as Starting Point

on the part of every natural and legal person and human subject involved, there is a prior Agreement — as delineated and described in the 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.

Prior Agreement to Not Violate Protections of The Ikoku Foundations or the Founder

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 the Codes and Policies — to not violate the rights and protections of The Ikoku Foundations or the 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.

Prior Approval and Authorization of Proceedings

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 the 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.

Prior Limitation of Scope

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 the 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.

Reasonable Transparency and Being Informed

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.

Broad Prohibition for Improperly Consented Activity

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.

Broad Prohibition and Narrow Exceptions for Unconsented Activity

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.

Broad Prohibition for Unlawfulness

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.

Broad Prohibition for Diminished Protections

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.

Prohibition of Violations of Privacy and Confidentiality Rights

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.

Prohibition of Violations of Civil and Fundamental Rights

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.

Prohibition of Violations of Property and Proprietary Rights

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.

Limitation and Minimization Where Harm is Established or Imminent

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.

Errors, Violations and Fruits of the Poisonous Tree

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.

Where Non-Identification is Resolving

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.

Given Adherence to Founding Mission and Code of Ethics

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 the Codes and Policies.

Incentives Toward Ethical, Respectful and Non-Identifying Research

and provided that the remedying of such cases result in incentives and disincentives toward the enjoyment of respect for persons — as described in the 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.

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 section. 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:

Rights to Be Informed

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.

Rights Concerning Research and Processing On and About Human Subjects

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.

Rights Concerning Research and Processing via Automation

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.

Rights to Consent

rights to consent and to the reasonably informing consent process.

Rights to Confidentiality

rights to confidentiality, to the confidentiality of confidential, identifiable and sensitive biospecimens, data, and information, and absolute rights to confidential conversation.

Rights to Privacy

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.

Rights to Protection, Safety and Security

rights to have research or investigation study and processing of biospecimens, data, and information conducted by means that ensure adequate protection, safety, and security.

Rights to Ensure and Verify

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.

Rights of Access

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.

Rights to Portability

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.

Rights to Object

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.

Rights to Restrict Processing

rights to reasonable restriction of research, investigation and processing of biospecimens, data, and information attributable to, identifying or otherwise relating to you.

Rights to Removal

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.

Rights to Remedy

rights to reasonable remedy during review of research, investigation or processing of biospecimens, data, and information attributable to, identifying or otherwise relating to you.

Rights to Notification

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.

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:

Research and Processing on and about Human Subjects

— 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.

Research and Processing about Human Subjects

Research and Processing via Automation

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.

Human Subjects Research and Investigation Rights

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.

Facilitating Exercising of Human Subjects Research and Investigation Rights

your right to receive transparent communication that helps you — as the human subject under study — exercise your human subjects research and investigation rights.

Where Non-Identification is Confirmed

your right to receive such reasonably transparent communication unless we demonstrate that The Ikoku Foundations 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.

Progress in Exercising Human Subjects Research and Investigation Rights

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.

Decisions in Exercising Human Subjects Research and Investigation Rights

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.

Frequency and Period of Informing Process

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.

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:

Reasonably Informing, Confirmation of Research

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.

Reasonably Informing, Confirmation of Processing

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.

Reasonably Informing, All Aspects of Research and Processing

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.

Informing, Method of Research and Processing

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.

Informing, Risks of Research and Processing

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.

Informing, Further Communication, Discussion and Contact

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.

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:

Reasonably Informing, Confirmation of Research via Automation

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.

Reasonably Informing, Confirmation of Processing via Automation

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.

Reasonably Informing, All Aspects of Research and Processing

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.

Informing, Confirmation of Absence of a Child

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.

Informing, Confirmation of Absence of Sensitivity

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.

Informing, Methods of Research and Processing via Automation

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.

Informing, Publicly Accessible Areas

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.

Informing, Significant Legal Effects of Research and Processing via Automation

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.

Informing, Scale of Research and Processing via Automation

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.

Informing, Risks of Research and Processing via Automation

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.

Informing, Consent to Research and Processing via Automation

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 the 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.

Informing, Decisions of Research and Processing via Automation

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 the 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.

Informing, Human Subjects Research Rights and Exercising Them

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.

Informing, Further Communication, Discussion and Contact

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.

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:

Autonomy, Dignity and Legal Rights

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.

Fulfillment of Informed Consent

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.

Respect for Consent

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.

Respect for Withdrawal

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.

Invalidity of Consent

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.

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:

Autonomy, Dignity and Legal Rights

Fulfillment of Confidentiality

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.

Fulfillment of Sensitivity

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.

Protection of Confidentiality

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.

Breaches and Violations of Confidentiality

your right to receive transparent communication that reasonably informs you — as the human subject under study — of confirmed breaches or violations of your confidentiality.

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:

Autonomy, Dignity and Legal Rights

Fulfillment of Privacy

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.

Fulfillment of Sensitivity

Protection of Privacy

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.

Breaches and Violations of Privacy

your right to receive transparent communication that reasonably informs you — of confirmed breaches or violations of your privacy.

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:

Protection as Basic Right of Human Subjects

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.

Protection, Safety and Security of Human Subject

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.

Protection, Safety and Security of Human Subject Rights

Protection, Safety and Security of Research and Processing

Protection of Intellectual Property

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.

Protection of Real Property

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.

Organizational Functioning, Integrity and Property as Entities

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.

Breaches and Violations of Protection, Safety and Security

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.

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:

Process in Writing and Documentable

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.

Reasonably Transparent Communication

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.

Informing and Consenting

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.

Facilitating the Exercise of Rights

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.

Responsive and Updating Communication

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.

Reaching Commensurability

Further Process

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.

Given Feasibility and Reasonableness

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.

Given No Adverse Effect on Rights of Others

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.

Given Necessity, Non-Identification and Minimization

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.*

*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:

Request and Obtain Access to Public or Published Reports

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.

Request and Obtain Copy of Public or Published Reports

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.

Reasonably Transparent Communication

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.

Given Feasibility and Reasonableness

Given No Adverse Effect on Rights of Others

Given Necessity, Non-Identification and Minimization

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.

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:

Request and Receive the Report in Readable Format

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.

Reasonably Transparent Communication

Given Feasibility and Reasonableness

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.

Given No Adverse Effect on Rights of Others

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.

Given Necessity, Non-Identification and Minimization

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.

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:

Harmful, Unethical, Unlawful, Without Consent

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.

Research or Processing for Non-Direct and Public Benefit Reasons

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.

Processing for Marketing

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.

Reasonably Transparent Communication

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.

Given Feasibility and Reasonableness

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.

Given No Adverse Effect on Rights of Others

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.

Given Necessity, Non-Identification and Minimization

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.

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:

When Contesting Consent or Assent

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.

When Contesting Harm or Benefit-Risk Relation

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.

When Contesting Ethics or Lawfulness

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.

When Exercising Rights to Object

where you — as the human subject under study — exercise your rights to object on any of the legitimate grounds delineated and described in the Codes and Policies, for a period enabling The Ikoku Foundations to verify the validity of the grounds for objection.

When Harmful, Unconsented, Unethical or Unlawful Research is Established but not Removal

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.

When Legal Claims are being Established, Exercised or Defended

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.

Reasonably Transparent Communication

Given Need for Consent for Processing Beyond Storage

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.

Given Notice on Lifting of Restriction

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.

Given Feasibility and Reasonableness

Given No Adverse Effect on Rights of Others

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.

Given Necessity, Non-Identification and Minimization

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.

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:

Request and Confirm Removal of Self

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.

Request and Confirm Removal of Records

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.

Inform Other Recipients

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.

Reasonably Transparent Communication

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.

Given Feasibility and Reasonableness

Given No Adverse Effect on Rights of Others

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.

Given Necessity, Non-Identification and Minimization

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.

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:

Remedy upon Unethical Finding

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.

Reasonably Transparent Communication

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.

Given Feasibility and Reasonableness

Given No Adverse Effect on Rights of Others

Given Necessity, Non-Identification and Minimization

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.

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:

Recipients upon Removal

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.

Recipients upon Restriction of Processing

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.

Reasonably Transparent Communication

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.

Given Feasibility and Reasonableness

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.

Given Expected Reductions in Obligation

provided specifically that the obligation is reasonably reduced where notification proves impossible or involves disproportionate effort.

Given No Adverse Effect on Rights of Others

Given Necessity, Non-Identification and Minimization

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.

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 section. In the meantime do keep in mind two opening points to be made here.

First, that The Ikoku Foundations and specifically the 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 Organizational Integrity at the top of this Policy section.

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

Responsibilities for Studies

that The Ikoku Foundations and the Founder have and retain full responsibilities for determining and accounting for the characteristics, parameters and qualities of research studies.

Responsibilities for Subjects

that The Ikoku Foundations and the Founder have and retain full responsibilities for determining and accounting for the characteristics, parameters and qualities of human subjects groups and selection.

Responsibilities for Biospecimens, Data and Information and Their Processing

that The Ikoku Foundations and the 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.

Responsibilities for Measures and Methods

that The Ikoku Foundations and the 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.

Responsibilities for Assessing and Minimizing Risks

that The Ikoku Foundations and the Founder have and retain full responsibilities for assessing and minimizing risks to the rights of you and other human subjects under study.

Responsibilities for Protections, Safety and Security

that The Ikoku Foundations and the 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.

Responsibilities for Approval, Authorization and Transfer

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.

Responsibilities for Records

that, during all of the above, The Ikoku Foundations and the 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.

Responsibilities for Communication and Notification

that, during all of the above, The Ikoku Foundations and the 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.

Responsibilities for Review, Accordance with and Adherence to Codes, Policies and Regulations

that The Ikoku Foundations and the 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 the 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 the Codes and Policies, with their delineated and described principles, rights, and responsibilities, and with applicable guidelines, law, and regulation.

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:

Focus of Inquiry or Testing of Research Study

that The Ikoku Foundations and the 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.

Nature of Research Study

that The Ikoku Foundations and the 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.

Scope of Research Study

that The Ikoku Foundations and the 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.

Context of Research Study

that The Ikoku Foundations and the 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.

Content of Research Study

that The Ikoku Foundations and the 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.

Accounting for Research Study

that, with the above taking precedence and guaranteed, The Ikoku Foundations and the 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.

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:

Selection of Human Subjects

that The Ikoku Foundations and the 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.

Context of Human Subjects Participation

that The Ikoku Foundations and the 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.

Scope of Human Subjects Participation

that The Ikoku Foundations and the 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.

Protections, Safety and Security of Human Subjects

that The Ikoku Foundations and the 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.

Accounting for Human Subjects

that, with the above taking precedence and guaranteed, The Ikoku Foundations and the 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.

Responsibilities for Processing

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

Content of Biospecimens, Data and Information

that The Ikoku Foundations and the Founder be the primary administrator and manager assessing and determining the content of biospecimens, data, and information for such research and investigation.

Nature of Biospecimens, Data and Information

that The Ikoku Foundations and the 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.

Scope of Biospecimens, Data and Information

that The Ikoku Foundations and the 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.

Context of Biospecimens, Data and Information

that The Ikoku Foundations and the 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.

Accounting for Biospecimens, Data and Information

that, with the above taking precedence and guaranteed, The Ikoku Foundations and the 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.

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

Content of Biospecimens, Data and Information Processing

that The Ikoku Foundations and the Founder be the primary administrator and manager assessing and determining the content of research processing of biospecimens, data, and information.

Nature of Biospecimens, Data and Information Processing

that The Ikoku Foundations and the 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.

Purposes of Biospecimens, Data and Information Processing

that The Ikoku Foundations and the 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.

Scope of Biospecimens, Data and Information Processing

that The Ikoku Foundations and the 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.

Context of Biospecimens, Data and Information Processing

that The Ikoku Foundations and the 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.

Accounting for Biospecimens, Data and Information Processing

that, with the above taking precedence and guaranteed, The Ikoku Foundations and the 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.

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:

Methods Under Inquiry

that The Ikoku Foundations and the 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.

Measures Accounting for Research Study

that The Ikoku Foundations and the 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.

Measures Accounting for Methods Under Inquiry

that The Ikoku Foundations and the 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.

Measures Accounting for Research Subjects

that The Ikoku Foundations and the 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.

Measures Accounting for Biospecimens, Data and Information

Measures Accounting for Biospecimens, Data and Information Processing

Measures Meeting Best Practices Standards

that The Ikoku Foundations and the 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.

Measures Meeting Codes and Policies Standards

that, during all of the above, The Ikoku Foundations and the 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.

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 The Ikoku Foundations discern. The first part of the evaluation, which every proposed research or investigation undergoes, requires that all of the following apply:

Early Definition and Determination of Risk

that The Ikoku Foundations and the 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.

Risk Determination Accounting for Aspects of Study

that The Ikoku Foundations and the 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.

Risk Determination Accounting for Aspects of Human Subjects

that The Ikoku Foundations and the 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.

Risk Determination Accounting for Aspects of Methods

that The Ikoku Foundations and the Founder be the primary administrator and manager conducting the above early determination of risk while accounting for context, nature, purposes and scope of methods.

Risk Determination Accounting for Aspects of Biospecimens, Data and Information

Risk Determination Accounting for Aspects of Processing

Early and Objective Establishment of Risk

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.

Early and Effective Mitigation of Risk

that The Ikoku Foundations and the 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.

Early and Objective Establishment of Benefit-Risk Relation

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.

Early and Effective Comparison for Favorable Benefit-Risk Relation

that The Ikoku Foundations and the 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.

Decision on Research and Processing Risks Assessment

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.

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:

Automation or Automated Methods with Legal Effects

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.

Research and Processing on a Large Scale with Sensitivity

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.

Research and Processing on a Publicly Accessible Area

where research, investigation or processing is conducted in, on or to systematically assess, evaluate, monitor or test a publicly accessible area.

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:

Systematic Description of Research and Processing Operations and Purposes

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.

Assessment of Necessity and Proportionality of Activities and Methods

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.

Assessment of Necessity and Proportionality of Study

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.

Assessment of Necessity and Proportionality of Human Subjects

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.

Assessment of Necessity and Proportionality of Biospecimens, Data and Information

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.

Assessment from Similar Research and Processing

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.

Review of Measures for Protections of Research and Processing

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.

Review of Measures for Protections of Biospecimens, Data and Information

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.

Review of Measures for Protections of Human Subjects

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.

Review of Computational and Equivalent Procedures

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.

Review of Such Procedures for Accuracy, Efficacy and Ethics of Decision-Making

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.

Review of Such Procedures for Risks to Rights of Human Subjects

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.

Review of Such Procedures for Prevention of Discrimination and Stigmatization

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.

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:

Measures Ensuring Protections Against Anticipated and Established Risk

that The Ikoku Foundations and the 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.

Specific Attention to Protection by Design

Specific Attention to Protection by Default

that The Ikoku Foundations and the 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.

Ensuring Confidentiality of Research and Processing Systems and Services

Ensuring Privacy of Research and Processing Systems and Services

Ensuring Safety of Research and Processing Systems and Services

Ensuring Security of Research and Processing Systems and Services

that The Ikoku Foundations and the 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.

Ensuring Integrity of Research and Processing Systems and Services

Ensuring Resilience of Research and Processing Systems and Services

Ensuring Availability of Research and Processing Systems and Services

that The Ikoku Foundations and the 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.

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:

Decision to Notify on Recognition of Breach or Violation

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.

Time to Notify on Recognition of Breach or Violation

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.

Delay to Notify on Recognition of Breach or Violation

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.

Nature of Breach or Violation

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.

Consequences of Breach or Violation

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.

Measures to Mitigate Breach or Violation

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.

Personal Measures to Prevent and Reduce Risks and Adverse Effects

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.

Responsible Entity, Office or Persons

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.

Ensuring Mitigation of Adverse Effects and Risks

that The Ikoku Foundations and the 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.

Ensuring Adherence to Reasonably Transparent Communication

that The Ikoku Foundations and the 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.

Ensuring Privacy and Confidentiality of Communication and Human Subjects

that The Ikoku Foundations and the 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.

Ensuring Documentation of Breach, Violation and Communication and Notification

that The Ikoku Foundations and the 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.

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:

Ensuring Adherence to Principles of Transparency

that The Ikoku Foundations and the 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.

Ensuring Privacy and Confidentiality of Books and Records

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.

Ensuring Integrity and Security of Books and Records

that The Ikoku Foundations and the 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.

Where Needed, Ensuring Availability and Reproducibility of Books and Records

that The Ikoku Foundations and the 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.

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:

Purposes for Research

the purposes for the research or investigation activities and study.

Purposes for Processing

the purposes for the processing of the biospecimens, data, and information.

Categories or Processing

the categories of processing of the biospecimens, data, and information.

Categories of Biospecimens, Data and Information

the categories of biospecimens, data, and information.

Categories of Human Subjects

the categories of human subjects under study, and with respect to the biospecimens, data, and information and their processing.

Categories of Recipients

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.

Erasure of Categories of Biospecimens, Data and Information

where possible, the envisaged time limits for erasure of the different categories of biospecimens, data, and information.

Transfers of Biospecimens, Data and Information

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.

Transmission of Record

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.

Measures for Protection and Security

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.

Responsible Entity, Office or Persons

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.

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:

Sole Approval and Authorization

that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and the Founder be the sole administrator and manager approving and authorizing any research, investigation or processing, and their administration and management.

Sole Approval and Authorization of Access and Actions

that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and the 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.

Sole Approval and Authorization of Communications and Transparency

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.

Sole Approval and Authorization of Persons and Third Parties

that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and the 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.

Assigned or Delegated Administration, Management, Research and Processing

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.

Ensuring Adherence to Requirements for Approvals and Authorizations

that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and the 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 the Codes and Policies.

Ensuring Adherence to Requirements for Communication and Notification

that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and the 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 the Codes and Policies.

Ensuring Accordance with Codes and Policies

that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and the 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 Codes and Policies.

Ensuring Accordance with Founding, Mission and Code of Ethics

that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and the 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.

Ensuring Accordance with Applicable Guidelines, Law and Regulation

that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and the 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.

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:

Sole Approval and Authorization

agreement and attestation by all parties that The Ikoku Foundations — specifically the Founder, Alvan Azinna Chibuzo Ikoku — and the Founder be the sole administrator and manager approving and authorizing any research, investigation or processing, and their administration and management.

Explicit, Legitimate and Specific Instructions and Purposes

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.

Explicit, Legitimate and Specific Recipients and Transfers

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.

Commitment to Confidentiality and Privacy

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 the Codes and Policies.

Measures for Protection and Security

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 the Codes and Policies.

Measures for Rights and Interests of Human Subjects

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 the Codes and Policies.

Reasonably Transparent Communication and Notification

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 the Codes and Policies.

Ensuring Accordance with Responsibilities for Books and Records

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 the Codes and Policies.

Ensuring Accordance with Codes and Policies

agreement and attestation by all parties that the assignee or delegate above shall implement computational, operational and technical measures that ensure accordance with the Codes and Policies.

Ensuring Accordance with Founding, Mission and Code of Ethics

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.

Ensuring Accordance with Applicable Guidelines, Law and Regulation

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.

Further Assignment, Delegation or Engagement

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 the Codes and Policies.

Validity, Legal Binding and Liabilities

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.

Erasure or Return at the End of Assignment or Delegation

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.

Responsible Entities, Offices and Persons

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.

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:

Substitution of Transferee for Assignee or Delegate

all of the above provisions for the contract or equivalent legal instrument, but where applicable substituting “transferee” for “assignee” or “delegate.”

Description of the Overarching Arrangement and Purposes for Transfer

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 the Codes and Policies.

Accordance with Codes, Policies and Regulations

agreement and attestation by all parties that the transferee fully comply with this Data and Information Policy, with applicable provisions of the Codes and Policies, and with applicable guidelines, law, and regulation.

Measures and Safeguards for Above Compliance

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 the Codes and Policies, and with applicable guidelines, law, and regulation.

Specific Safeguards for Protection of Rights of Persons

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 the Codes and Policies.

Where a Request for Portability Rights

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 the Codes and Policies.

Where Transfer is Single Action Without Ongoing Arrangement

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, the Codes and Policies, and applicable guidelines, law, and regulation.

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:

Ensuring Administration of and Accordance with IRB

that The Ikoku Foundations and the 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.

Ensuring Accordance with Human Subjects Research Policy

that The Ikoku Foundations and the 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.

Ensuring Accordance with Human Subjects Research Principles, Rights and Responsibilities

that The Ikoku Foundations and the 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.

Ensuring Accordance with Codes and Policies

that The Ikoku Foundations and the 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 Codes and Policies.

Ensuring Accordance with Founding, Mission and Code of Ethics

that The Ikoku Foundations and the 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.

Ensuring Accordance with Applicable Guidelines, Law and Regulation

that The Ikoku Foundations and the 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.

Communication and Cooperation with Compliance, Regulatory and Public Authorities

that The Ikoku Foundations and the 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.

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:

Ensuring Best Practices Standards for Review Measures

that The Ikoku Foundations and the 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.

Reviewing Measures for Research and Processing

that The Ikoku Foundations and the 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.

Reviewing Measures for Human Subjects

Reviewing Measures for Biospecimens, Data and Information

Reviewing Measures for Privacy and Confidentiality

that The Ikoku Foundations and the 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.

Reviewing Measures for Protection and Security

that The Ikoku Foundations and the 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.

Reviewing Measures for Communication and Notification

that The Ikoku Foundations and the 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.

Reviewing Measures for Books and Records

that The Ikoku Foundations and the 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.

Reviewing Measures for Approval, Authorization and Transfer

that The Ikoku Foundations and the 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.

Reviewing Measures for Regulation

that The Ikoku Foundations and the 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, the Codes and Policies, and with applicable guidelines, law, and regulation.

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 you proceed through this Policy section. 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:

Archival and Humanistic Research

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.

Artistic and Creative Research

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.

Benign Research

where research and investigation have been, are or will be conducted on or utilizing benign interactions, interventions or procedures.

Civil Liberties and Civil Rights Research

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.

Commercial, Financial and Marketing Research

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.

Criminal Justice Research

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.

Deception Research

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.

Demographic and Public Opinion Research

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.

Educational Settings Research

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.

Educational Testings Research

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.

Ethnographic and Social Research

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.

Genetic and Genomic Research

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.

Health Care Operations Research

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.

News, Journalism and Public Interest Research

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.

Obstetrics and Neonatal Research

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.

Pediatrics Research

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.

Prisoner and Penal Research

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.

Public Benefit and Public Services Programs Research

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.

Public Health Surveillance Research

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.

Taste and Food Quality Evaluation and Consumer Acceptance Studies

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.

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:

Limitation to Archival and Humanities Importance

Clear Prospective Agreement as to Distinction Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

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.

Clear Prospective Agreement as well as Consent to Specific Data and Processing

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.

Benign Nature of Method or Procedure

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.

Benign Nature of Data and Information Processed

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.

Given Rigorous Non-Identification of Data and Information

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.

Given Rigorous Non-Identification Specific to Field of Study

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.

Given Rigorous Re-Identification of Data and Information

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.

Given Acknowledgment, Citation and Intellectual and Publicity Rights

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.

Given No Adverse Risk to the Rights of Human Subjects

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 civil and fundamental liberties and rights of you — as the human subject under study.

Archival and Humanistic Research

Limitation to Archival and Humanities Importance

Clear Prospective Agreement as to Distinction Between Research and Practice

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Method or Procedure

— (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.

Benign Nature of Biospecimens, Data, Information and Disclosure

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.

Given Rigorous Non-Identification of Biospecimens, Data and Information

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.

Given Rigorous Non-Identification Specific to Field of Study

Given Rigorous Re-Identification of Biospecimens, Data and Information

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.

Given Acknowledgment, Citation and Intellectual and Publicity Rights

Given No Adverse Risk to the Rights of Human Subjects

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:

Clear Prospective Agreement as to Relationship Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Method or Procedure

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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Non-Identification Specific to Field of Study

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given Acknowledgment, Citation and Intellectual and Publicity Rights

Given No Adverse Risk to the Rights of Human Subjects

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:

Benign Nature of Method or Procedure

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.

Clear Prospective Agreement as well as Consent to Deception

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.

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

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.

Given Rigorous Re-Identification of Biospecimens, Data and Information

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.

Given No Adverse Risk to the Rights of Human Subjects

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 civil and fundamental liberties and rights of you or other human subjects under study.

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:

Protection as Fundamental Rights of Vulnerable Subjects

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.

Likelihood of Coerced Participation

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.

Risks Acceptable to Broader Community of Human Subjects

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.

Rigorous Protections Against Undue Inducement

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.

Rigorous Protections Against Risk to the Rights of Human Subjects

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 civil and fundamental liberties and rights of you or other human subjects under study.

No Monitoring, Tracking or Surveillance as Research

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.

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

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.

Given Rigorous Re-Identification of Biospecimens, Data and Information

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.

Given No Adverse Risk to the Rights of Human Subjects

Permitted Research of Causes, Co-Factors, Effects and Processes

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.

Permitted Research of Institutional and Procedural Structures

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.

Permitted Research of Conditions Affecting Vulnerable Subjects as 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.

Permitted Research on Practices Offering Direct Health Benefit

No Other Permitted Research

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.

Not Authorization of Vulnerable as Human Subjects

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.

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:

Limitation to Commerce, Finance and Marketing Importance

Clear Prospective Agreement as to Distinction Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Method or Procedure

— (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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given No Adverse Risk to the Rights of Human Subjects

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:

Protection as Fundamental Rights of Vulnerable Subjects

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.

Likelihood of Coerced Participation

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.

Risks Acceptable to Broader Community of Human Subjects

Rigorous Protections Against Undue Inducement

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 equivalently significant legal effects — and you are clearly informed in advance that participation in the research will have no effect on your situation.

No Monitoring, Tracking or Surveillance as Research

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given No Adverse Risk to the Rights of Human Subjects

Permitted Research of Causes, Co-Factors, Effects and Processes

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.

Permitted Research of Institutional and Procedural Structures

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.

Permitted Research of Conditions Affecting Vulnerable Subjects as 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.

Permitted Research on Practices Offering Direct Health Benefit

No Other Permitted Research

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.

Not Authorization of Vulnerable as Human Subjects

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.

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:

Necessity Limitation of Deception Studies

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.

Necessity Limitation of Deception Activities

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.

Clear Prospective Agreement as well as Consent to Deception

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.

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Method or Procedure

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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

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.

Given Rigorous Re-Identification of Biospecimens, Data and Information

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.

Given No Adverse Risk to the Rights of Human Subjects

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 civil and fundamental liberties and rights of you or other human subjects under study.

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:

Limitation to Demographic and Public Opinion Importance

Clear Prospective Agreement as to Difference Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Method or Procedure

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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given No Adverse Risk to the Rights of Human Subjects

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:

Limitation to Education Research Importance

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.

Clear Prospective Agreement as to Difference Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

No Adverse Impact on Students, their Learning and Educator Assessment

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.

Benign Nature of Method or Procedure

— (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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given No Adverse Risk to the Rights of Human Subjects

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:

Limitation to Educational Testing Importance

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.

Clear Prospective Agreement as to Difference Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

No Adverse Impact on Students, their Testing and Educator Assessment

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.

Benign Nature of Method or Procedure

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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given No Adverse Risk to the Rights of Human Subjects

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:

Limitation to Social Sciences Importance

Clear Prospective Agreement as to Distinction Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Method or Procedure

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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Non-Identification Specific to Field of Study

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given Acknowledgment, Citation and Intellectual and Publicity Rights

Given No Adverse Risk to the Rights of Human Subjects

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:

Limitation to Genetic and Genomic Importance

Clear Prospective Agreement as to Difference Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as to Consent to Specific Purposes

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.

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Clear Prospective Agreement as well as Consent to Non-Identification

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.

Clear Prospective Agreement as well as Consent to Genetic and Genomic Research

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.

Clear Prospective Agreement with Aid of Genetic Counseling

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.

Clear Prospective Agreement as to Permitted Genetic and Genomic Research

Clear Prospective Agreement as well as Consent to Future Research and Processing

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.

Clear Prospective Agreement as well as Consent to Commercial Research and Processing

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.

Clear Prospective Agreement as to Benefit-Risk Relations Assessment

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.

Risk Assessment from Preclinical Studies

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.

Where Benign Nature of Method or Procedure

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.

Where No Greater Than Minimal Risk

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.

Where Greater than Minimal Risk but with Direct Benefit

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.

Where Greater than Minimal Risk and No Direct Benefit

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.

Where Risk Assessment Include Pregnancy, Fetus or Child

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.

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

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.

Given No Adverse Risk to the Rights of Human Subjects

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 civil and fundamental 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..

Adequate Provision for Follow-up Care, Counseling or Examination

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.

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:

Limitation to Health Care Operations Assessment

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.

Clear Prospective Agreement as to Difference Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Method or Procedure

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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given No Adverse Risk to the Rights of Human Subjects

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:

Limitation to Media and Journalism Studies Importance

Clear Prospective Agreement as to Distinction Between Research and Practice

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Method or Procedure

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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Non-Identification Specific to Field of Study

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given Acknowledgment, Citation and Intellectual and Publicity Rights

Given No Adverse Risk to the Rights of Human Subjects

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:

Protection as Fundamental Rights of Pregnant, Fetal and Neonatal Subjects

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.

Limitation to Obstetrics and Neonatal Importance

Clear Prospective Agreement as to Difference Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as to Consent, Assent and Permission

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.

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Clear Prospective Agreement as well as to Benefit-Risk Relations Assessment

Assent, Consent and Permissions Where Pregnant Child Subject

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.

Risk Assessment from Preclinical Studies

Least Possible Risk

that any risk is the least possible for achieving the objectives and purposes of the research or investigation study.

Where Greater than Minimal Risk to Fetus then Direct Benefit to Fetus or Parent

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.

Where Direct Benefit to Pregnant Parent

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.

Where Direct Benefit to Pregnant Parent and Fetus

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.

Where No Direct Benefit to Pregnant Parent or Fetus

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.

Where Direct Benefit Only to Fetus

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.

No Inducements to Terminate a Pregnancy

that no inducements, monetary or otherwise, are offered to terminate a pregnancy.

No Researchers Involvement in Decision to Terminate Pregnancy

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.

No Researchers Involvement in Viability Assessment of Neonate

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.

Where Research Permitted on Neonates of Uncertain Viability

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.

Where Research Permitted on Nonviable Neonates

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.

Where Research Permitted on Viable Neonates

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.

Where Research Permitted on Post-Delivery Material

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.

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given No Adverse Risk to the Rights of Human Subjects

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 civil and fundamental liberties and rights of you — as the human subject under study.

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:

Protection as Fundamental Rights of Child Subjects

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.

Limitation to Childhood Care and Pediatrics Importance

Clear Prospective Agreement as to Difference Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

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.

Clear Prospective Agreement as to Consent, Assent and Permission

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.

Clear Prospective Agreement as well as Consent to Specific Data and Processing

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.

Clear Prospective Agreement as to Benefit-Risk Relations Assessment

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.

Risk Assessment from Preclinical Studies

Where No Greater Than Minimal Risk

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.

Where Greater than Minimal Risk but with Direct Benefit

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.

Where Greater than Minimal Risk and No Direct Benefit

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

Where Child Subject is a Ward

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.

Given Rigorous Non-Identification of Biospecimens, Data and Information

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.

Given Rigorous Re-Identification of Biospecimens, Data and Information

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.

Given No Adverse Risk to the Rights of Child Subjects

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:

Protection as Fundamental Rights of Prisoner Subjects

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.

Likelihood of Coerced Participation

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.

Risks Acceptable to Nonprisoner Human Subjects

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.

Rigorous Protections Against Undue Inducement

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.

Rigorous Protections of Human Subjects Selection

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.

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Biospecimens, Data, Information and Disclosure

Given No Risk to Human Subjects on Disclosure

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.

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given No Adverse Risk to the Rights of Human Subjects

Adequate Provision for Follow-up Examination or Care

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.

Permitted Research of Incarceration and Behaviors

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.

Permitted Research of Prisoners as Incarcerated Persons

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.

Permitted Research of Prisons as Institutional Structures

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.

Permitted Research of Conditions Affecting Prisoners as a 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.

Permitted Research on Practices Offering Direct Health Benefit

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.

No Other Permitted Research

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.

Not Authorization of Prisoners as Human Subjects

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.

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:

Appropriate Authority or Office as Sponsor

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.

Limitation to Public Benefit or Service Programs

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.

Publication of Research, Investigation and Demonstration Projects

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.

Clear Prospective Agreement as to Difference Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Method or Procedure

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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given No Adverse Risk to the Rights of Human Subjects

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:

Appropriate Authority or Office as Sponsor

that all research and investigation activities are also authorized, conducted, regulated, sponsored and supported by an appropriate medical, public health and public authority.

Limitation to Public Health Importance

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.

Limitation to Public Health Awareness and Priorities Setting

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.

Clear Prospective Agreement as to Distinction Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Method or Procedure

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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given No Adverse Risk to the Rights of Human Subjects

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:

Limitation to Consumer, Quality and Taste Importance

Limitation to Wholesome Foods

that all research and investigation activities are limited to the consumption of wholesome foods without additives.

Limitation of Ingredients to Safe Levels and Uses

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.

Limitation of Contaminants to Safe Levels

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.

Clear Prospective Agreement as to Difference Between Research and Practice

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.

Clear Prospective Agreement as to Confidentiality and Privacy

Clear Prospective Agreement as well as Consent to Specific Data and Processing

Benign Nature of Method or Procedure

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.

Benign Nature of Biospecimens, Data, Information and Disclosure

Given Rigorous Non-Identification of Biospecimens, Data and Information

Given Rigorous Re-Identification of Biospecimens, Data and Information

Given No Adverse Risk to the Rights of Human Subjects

Actor in Macbeth Costume — Macbeth, Undated (New York Public Library)

Wide Staircase with Statue and Urns on First Landing — Stairs, British Museum, London, United Kingdom, 2018 (Monty Lov)

Girl Kneeling in Busy Street — Tibetan Girl, 2017 (Journey Yang)

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 the Codes and Policies include — but are not limited to — the Founding and Mission Statement, the Founding and Governing Code of Ethics, the Policy on Privacy and Confidentiality, the Terms and Conditions of Use and Service, and the Acceptable Uses Policy along with all Associated Codes and Policies. Access to the aforementioned is provided below.

Founding and Mission

Statement on Founding and Mission of The Ikoku Foundations (HTML)

Founding Code of Ethics

Founding Code of Ethics (HTML)

Privacy and Confidentiality

Policy on Privacy and Confidentiality (HTML)

Terms and Conditions

Terms and Conditions of Use and Service (HTML)

The Acceptable Uses Policy

Acceptable Use Policy (HTML)

All Policies

All Policies (HTML)

Woman Bending Down to Tend Crops — Sierra Leone, 2017 (Annie Spratt)

Child in Costume Looking at Camera — Niño, Cusco, Peru, 2018 (Ben Ostrower)

Woman Seated on Mat on Floor, Holding Fan — Seated by Kpone Katamanso District Assembly Office, Tema, Ghana, 2017 (Nathaniel Tetteh)

People Holding Peace Banner and Respect Sign — Women's March, Boston, USA, 2017, (Alice Donovan Rouse)

Also at The Foundations

As stated earlier, The Ikoku Foundations are dedicated to fostering philanthropy and good works concerning Africa, its global diasporas and a range of shared societies — toward the betterment of lives across the globe. And so in accordance with the above, The Foundations provide the following:

Nonprofits Dedicated to Africa

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.

II.

Support for a Global and Just Future

A founding mission and ongoing emphases of support for good works that help the public understand Africa’s essential place in a global future, one that is to be more knowledgeable, environmentally sustainable, equitable and of benefit across communities in just societies.

III.

A Vision of the Public Good

A vision of the public good that accounts for the past while ensuring a just and shared future. That draws inspiration from peoples who, despite a history of systemic difficulties, maintain an unyielding belief that the betterment of their human condition will foster the betterment of those living around them and will enhance the present and futures of the regularly disenfranchised, marginalized and underserved.

More About Us

The Ikoku Foundations

About Us • Governance • Policies

Past

Present

Future

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