Conditions
Introduction
The Policy on Human Subjects Research delineates the conditions, principles, and protections for human subjects research that are integral to the Agreement you enter into whenever — and wherever — you commence or continue any conduct or service relating in any way, directly or indirectly, to Publiks. Please, therefore, take the time to read what follows carefully.
Your Policy Agreements
Section 14.1.0. First, with respect to the Human Subjects Research Policy you enter into via your Agreement with the Codes and Policies, you understand and agree to abide by the following:
14.1.1. Policy, Name, Nature
that the name of this Policy is the “Policy on Human Subjects Research of Publiks Inc and The Publiks Group” (the “Human Subjects Research Policy,” the “Human Research Policy,” and the “Human Subjects Policy”) and that the nature of this Policy is to serve as the policy on human subjects research of Publiks Inc and The Publiks Group;
14.1.2. Policy, Composition
that the Human Subjects Research Policy consists of all conditions, principles, protections, and equivalent provisions for human subjects research in the Codes and Policies of Publiks Inc and The Publiks Group (the “Codes and Policies” and the “Policies”) and the Publiks Conduct and Service Agreement (the “Agreement”), which therefore include, but are not limited to, those delineated below;
14.1.3. Policy, Agreement
that you understand the Human Subjects Research Policy to be an integral part of the Codes and Policies and the Agreement you enter into with Publiks;
14.1.4. Policy, Consent
that your consent to the Codes and Policies and the Agreement includes your legally equivalent consent to the Human Subjects Research Policy;
14.1.5. Policy, Duties
that your duties to the Codes and Policies and the Agreement includes your legally equivalent duties to the Human Subjects Research Policy;
14.1.6. Policy, Entry
that your entry into the Agreement includes your legally equivalent entry into the Human Subjects Research Policy, and similarly occurs whenever you commence or continue any conduct or service at, by, for, in, on, with or otherwise relating to Publiks;
14.1.7. Policy, Legally Abiding
that your attestation about your reading, understanding, consenting and agreeing to legally abide by the Codes and Policies and the Agreement includes your legally attestation about your reading, understanding, consenting and agreeing to legally abide by the Human Subjects Research Policy, in its entirety without modification or severability, as amended from time to time solely by the Founder;
14.1.8. Policy, Legally Binding
that your attestation about your reading, understanding, consenting and agreeing to be legally bound by the Codes and Policies and the Agreement includes your legally equivalent attestation about your reading, understanding, consenting and agreeing to be legally bound by the Human Subjects Research Policy, in its entirety without modification or severability, as amended from time to time solely by the Founder;
14.1.9. Policy, Knowledge
that your attestation about your awareness and acceptance of your responsibility to keep informed and update your knowledge of the Codes and Policies and the Agreement includes your legally equivalent awareness and acceptance of your responsibility to keep informed and update your knowledge of the Human Subjects Research Policy, in its entirety without modification or severability, as amended from time to time solely by the Founder.
Your Policy Understandings
Section 14.2.0. Second, with respect to your understandings of the Human Subjects Research Policy, you covenant, represent, and warrant the following:
14.2.1. Policy Understandings
that you have read, understood, consented to, and agreed to be legally bound by and abide by applicable understandings of human subjects research as they are normally operative and reasonably interpreted in law, policy, and society;
14.2.1.1. Policy Understandings, A
the above including such understandings of human subjects protecting, providing for, and otherwise pertaining to individuals about whom a researcher (academic, commercial, professional, student, technological or equivalent) collects, generates, or otherwise processes biospecimens, data, or information that are often identifiable and personal, and often through interaction or intervention with the individuals, for analysis, study, or other research-based use;
14.2.1.2. Policy Understandings, B
the above including such understandings of research protecting, providing for, and otherwise pertaining to a systematic inquiry or investigation, including development, evaluation, and testing, that is designed to contribute to or develop generalizable knowledge;
14.2.2. Policy Understandings, Conditions
that you have read, understood, consented to, and agreed to be legally bound by and abide by understandings of human subjects research conditions as they are defined and provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation, to be fulfilled and respected and not breached or violated, in any way, by you;
14.2.3. Policy Understandings, Definitions
that you have read, understood, consented to, and agreed to be legally bound by and abide by understandings of human subjects research definitions as they are defined and provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation, to be fulfilled and respected and not breached or violated, in any way, by you;
14.2.4. Policy Understandings, Practices
that you have read, understood, consented to, and agreed to be legally bound by and abide by understandings of human subjects research practices as they are defined and provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation, to be fulfilled and respected and not breached or violated, in any way, by you;
14.2.5. Policy Understandings, Principles
that you have read, understood, consented to, and agreed to be legally bound by and abide by understandings of human subjects research principles as they are defined and provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation, to be fulfilled and respected and not infringed or violated, in any way, by you;
14.2.6. Policy Understandings, Processes
that you have read, understood, consented to, and agreed to be legally bound by and abide by understandings of human subjects research processes as they are defined and provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation, to be fulfilled and respected and not breached or violated, in any way, by you;
14.2.7. Policy Understandings, Rights
that you have read, understood, consented to, and agreed to be legally bound by and abide by understandings of human subjects research rights as they are defined and provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation, to be fulfilled and respected and not infringed or violated, in any way, by you;
14.2.8. Policy Understandings, Safeguards
that you have read, understood, consented to, and agreed to be legally bound by and abide by understandings of human subjects research safeguards and resulting protections as they are defined and provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation, to be fulfilled and respected and not breached or violated, in any way, by you;
14.2.9. Policy Understandings, Violations
that you have read, understood, consented to, and agreed to be legally bound by and abide by understandings of human subjects research breach, diminishment, incompatibility, infringement, and violation as they are defined and provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation, to not be brought about, in any way, by you.
Your Policy Commitments
Section 14.3.0. Third, with respect to your commitments to the Human Subjects Research Policy, you understand and agree to abide by the following:
14.3.1. Policy Commitments, Basis
that your commitment is the basis for any conduct or service at, by, for, in, on, with, or otherwise relating to Publiks that you commence or continue — including via any of the Products or Services, or the divisions, series, subsidiaries, or affiliates — and that any such conduct or service is free of any infringement of the most humane, protective and respectful interpretations of human subjects research, the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation;
14.3.2. Policy Commitments, Conditions
that this commitment include but not be limited to upholding for every person at Publiks the most humane, protective and respectful interpretations of human subjects research conditions, including as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation;
14.3.3. Policy Commitments, Definitions
that this commitment include but not be limited to upholding for every person at Publiks the most humane, protective and respectful interpretations of human subjects research definitions, including as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation;
14.3.4. Policy Commitments, Principles
that this commitment include but not be limited to upholding for every person at Publiks the most humane, protective and respectful interpretations of human subjects research principles, including as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation;
14.3.5. Policy Commitments, Processes
that this commitment include but not be limited to upholding for every person at Publiks the most humane, protective and respectful interpretations of human subjects research processes, including as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation;
14.3.6. Policy Commitments, Rights
that this commitment include but not be limited to upholding for every person at Publiks the most humane, protective and respectful interpretations of human subjects research rights, including as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation;
14.3.7. Policy Commitments, Safeguards
that this commitment include but not be limited to upholding for every person at Publiks the most humane, protective and respectful interpretations of human subjects research safeguards and resulting protections, including as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation;
14.3.8. Policy Commitments, Practices
that you respectfully assist solely via Your Duties as described in the Codes and Policies and the Human Subjects Research Policy and in no way interfere with or impede the reasonable efforts authorized and executed solely by the Founder to translate the aforementioned commitments into practices for adopting and applying policies pertaining to human subjects research; for adjudicating and determining compliance with the policies; and for fulfilling Publiks’s own duties pertaining to human subjects research, human subjects research conditions, human subjects research definitions, human subjects research principles, human subjects research processes, human subjects research rights, and human subjects research safeguards and their resulting protections, including as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation;
14.3.9. Policy Commitments, Protections
that you also respectfully assist solely via Your Duties as described in the Codes and Policies and the Human Subjects Research Policy and in no way interfere with or impede the reasonable efforts authorized and executed solely by the Founder to develop and enforce human subjects research protections derived from, first, applicable law and regulation, and second, from advances in human subjects research that protect persons in ways that go beyond what such law and regulation currently provides.
Principles
Provision
The Policy on Human Subjects Research requires your adherence to the conditions above and correlative conditions and principles delineated below.
A — On Biospecimens
Conditions for Biospecimens
Section 14.5.0. With respect to conditions for biospecimens and biospecimens administration, you understand and agree to abide by the following:
14.5.1. Biospecimens Conditions
that, in addition to your Agreement, you do not infringe, in any way, the ensuing conditions for biospecimens and biospecimens administration;
14.5.2. Biospecimens Conditions, Administration
that the biospecimens and biospecimens administration of Publiks and provisions attendant to such biospecimens and biospecimens administration — as administered solely by the Founder, and executed solely via the Founder’s authorization — are attained, maintained and protected, and not infringed in any way;
14.5.3. Biospecimens Conditions, Areas
that biospecimens and biospecimens administration in areas, offices, parts, properties, sections, and equivalent of Publiks — and attendant principles and provisions for such biospecimens and biospecimens administration — are attained, maintained and protected, and not infringed in any way;
14.5.4. Biospecimens Conditions, Founder
that biospecimens and biospecimens administration for the Founder and Founder-related activities, administration, conduct, and service — and attendant principles and provisions for such biospecimens and biospecimens administration — are attained, maintained and protected, and not infringed in any way;
14.5.5. Biospecimens Conditions, Ownership
that the biospecimens ownership of Publiks and Publiks Administration and the rights attendant to such biospecimens ownership — including that providing for and otherwise pertaining to the biospecimens interests-, share-, stake- and stock-holding, ownership, and equivalent of Publiks and Publiks Administration, solely and wholly by the Founder, Alvan Azinna Chibuzo Ikoku — are attained, maintained and protected, and not infringed in any way;
14.5.6. Biospecimens Conditions, Practices
that practices for ensuring biospecimens and biospecimens administration at Publiks, including through its conduct and service — and attendant principles and provisions for such practices — are attained, maintained and protected, and not infringed in any way;
14.5.7. Biospecimens Conditions, Reporting
that measures for reporting actual, anticipated or apparent infringement related to biospecimens and biospecimens administration at Publiks — and attendant principles and provisions for such reporting — are attained, maintained and protected, and not infringed in any way;
14.5.8. Biospecimens Conditions, Understanding
with the understanding that the aforementioned and other conditions for biospecimens and biospecimens administration at Publiks are authorized, administered and adjudicated for compliance solely by the Founder, and executed solely via the Founder’s authorization.
Duties for Biospecimens
Section 14.6.0. With respect to duties for biospecimens and biospecimens administration, you understand and agree to abide by the following:
14.6.1. Biospecimens Duties
that, in addition to your Agreement, you fulfill and do not infringe, in any way, the ensuing duties for biospecimens and biospecimens administration;
14.6.2. Biospecimens Duties, Activity
that you have a duty to maintain and not infringe, in any way, the biospecimens and biospecimens administration of an act or activity of Publiks;
14.6.3. Biospecimens Duties, Agent
that you have a duty to maintain and not infringe, in any way, the biospecimens and biospecimens administration of an agent, party, or other person of Publiks;
14.6.4. Biospecimens Duties, Arrangement
that you have a duty to maintain and not infringe, in any way, the biospecimens and biospecimens administration of an arrangement of Publiks;
14.6.5. Biospecimens Duties, Conduct, Service
that you have a duty to maintain and not infringe, in any way, the biospecimens and biospecimens administration of a conduct or service of Publiks;
14.6.6. Biospecimens Duties, Entity, Organization
that you have a duty to maintain and not infringe, in any way, the biospecimens and biospecimens administration of Publiks Inc and The Publiks Group, including as proprietary and protective organizations and as entities of proprietary and protective administration;
14.6.7. Biospecimens Duties, Expectation
that you have a duty to consider and not infringe, in any way, an expectation pertaining to biospecimens and biospecimens administration at Publiks that is meaningful and reasonable;
14.6.8. Biospecimens Duties, Material
that you have a duty to maintain and not infringe, in any way, the biospecimens and biospecimens administration of a material of Publiks;
14.6.9. Biospecimens Duties, Matter
that you have a duty to maintain and not infringe, in any way, the biospecimens and biospecimens administration of a matter of Publiks;
14.6.10. Biospecimens Duties, Procedure
that you have a duty to maintain and not infringe, in any way, the biospecimens and biospecimens administration of a procedure, proceeding, or process of Publiks;
14.6.11. Biospecimens Duties, Relation
that you have a duty to maintain and not infringe, in any way, the biospecimens and biospecimens administration of a relation or relationship of Publiks;
14.6.12. Biospecimens Duties, Request
that you have a duty to consider and not infringe, in any way, a request pertaining to biospecimens and biospecimens administration at Publiks that is meaningful and reasonable;
14.6.13. Biospecimens Duties, Understanding
with the understanding that your sole means of fulfilling the aforementioned and other duties for biospecimens and biospecimens administration is by refraining from and reporting — via fully informing communication directly to the Founder — any infringement of biospecimens and biospecimens administration, and furthermore, not in any way diminishing or hindering the Founder’s sole discretion and powers to adjudicate and remedy such infringements.
Rights for Biospecimens
Section 14.7.0. With respect to rights for biospecimens and biospecimens administration, you understand and agree to abide by the following:
14.7.1. Biospecimens Rights
that, in addition to your Agreement, you respect and do not infringe, in any way, the ensuing rights for biospecimens and biospecimens administration;
14.7.2. Biospecimens Rights, Civil
that you respect and do not infringe, in any way, rights for biospecimens and biospecimens administration accorded to persons at Publiks by their applicable state or territorial governments;
14.7.3. Biospecimens Rights, Legal
that you respect and do not infringe, in any way, rights for biospecimens and biospecimens administration accorded to persons at Publiks by applicable law and regulation;
14.7.4. Biospecimens Rights, Entity, Organization
that you respect and do not infringe, in any way, rights for biospecimens and biospecimens administration of Publiks, including rights of biospecimens and biospecimens administration accorded to Publiks Inc and The Publiks Group, as proprietary and protective organizations and entities of proprietary and protective administration, via the Codes and Policies;
14.7.5. Biospecimens Rights, Human
that you respect and do not infringe, in any way, human and natural rights for biospecimens and biospecimens administration accorded to natural persons at Publiks via the Codes and Policies, including absolute rights for biospecimens and biospecimens administration of a human’s inner being, body, brain, as well as inner self, soul, spirit;
14.7.6. Biospecimens Rights, Understanding
with the understanding that your sole means of respecting the aforementioned and other rights for biospecimens and biospecimens administration is by refraining from and reporting — via fully informing communication directly to the Founder — any infringement of biospecimens and biospecimens administration, and furthermore, not in any way diminishing or hindering the Founder’s sole discretion and powers to adjudicate and remedy such infringements.
Safeguards for Biospecimens
Section 14.8.0. With respect to rights for biospecimens and biospecimens administration, you understand and agree to abide by the following:
14.8.1. Biospecimens Safeguards
that, in addition to your Agreement, you maintain and do not infringe, in any way, the ensuing safeguards for biospecimens and biospecimens administration;
14.8.2. Biospecimens Safeguards, Activity
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the biospecimens and biospecimens administration of an act or activity of Publiks;
14.8.3. Biospecimens Safeguards, Agent
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the biospecimens and biospecimens administration of an agent, party, or other person of Publiks;
14.8.4. Biospecimens Safeguards, Arrangement
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the biospecimens and biospecimens administration of an arrangement of Publiks;
14.8.5. Biospecimens Safeguards, Conduct, Service
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the biospecimens and biospecimens administration of a conduct or service of Publiks;
14.8.6. Biospecimens Safeguards, Entity, Organization
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the biospecimens and biospecimens administration of Publiks Inc and The Publiks Group, including as proprietary and protective organizations and as entities of proprietary and protective administration;
14.8.7. Biospecimens Safeguards, Expectation
that you consider and not infringe, in any way, an expectation to safeguard biospecimens and biospecimens administration at Publiks that is meaningful and reasonable;
14.8.8. Biospecimens Safeguards, Material
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the biospecimens and biospecimens administration of a material of Publiks;
14.8.9. Biospecimens Safeguards, Matter
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the biospecimens and biospecimens administration of a matter of Publiks;
14.8.10. Biospecimens Safeguards, Procedure
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the biospecimens and biospecimens administration of a procedure, proceeding, or process of Publiks;
14.8.11. Biospecimens Safeguards, Relation
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the biospecimens and biospecimens administration of a relation or relationship of Publiks;
14.8.12. Biospecimens Safeguards, Request
that you consider and not infringe, in any way, a request to safeguard biospecimens and biospecimens administration at Publiks that is meaningful and reasonable;
14.8.13. Biospecimens Safeguards, Rights
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard rights for biospecimens and biospecimens administration, including rights to such safeguards;
14.8.14. Biospecimens Safeguards, Understanding
with the understanding that your sole means of maintaining the aforementioned and other safeguards for biospecimens and biospecimens administration is by refraining from and reporting — via fully informing communication directly to the Founder — any infringement of biospecimens and biospecimens administration, and furthermore, not in any way diminishing or hindering the Founder’s sole discretion and powers to adjudicate and remedy such infringements.
B — On Human Subjects
Conditions for Human Subjects
Section 14.9.0. With respect to conditions for human subjects and human subjects administration, you understand and agree to abide by the following:
14.9.1. Human Subjects Conditions
that, in addition to your Agreement, you do not infringe, in any way, the ensuing conditions for human subjects and human subjects administration;
14.9.2. Human Subjects Conditions, Administration
that the human subjects and human subjects administration of Publiks and provisions attendant to such human subjects and human subjects administration — as administered solely by the Founder, and executed solely via the Founder’s authorization — are attained, maintained and protected, and not infringed in any way;
14.9.3. Human Subjects Conditions, Areas
that human subjects and human subjects administration in areas, offices, parts, properties, sections, and equivalent of Publiks — and attendant principles and provisions for such human subjects and human subjects administration — are attained, maintained and protected, and not infringed in any way;
14.9.4. Human Subjects Conditions, Founder
that human subjects and human subjects administration for the Founder and Founder-related activities, administration, conduct, and service — and attendant principles and provisions for such human subjects and human subjects administration — are attained, maintained and protected, and not infringed in any way;
14.9.5. Human Subjects Conditions, Practices
that practices for ensuring human subjects and human subjects administration at Publiks, including through its conduct and service — and attendant principles and provisions for such practices — are attained, maintained and protected, and not infringed in any way;
14.9.6. Human Subjects Conditions, Reporting
that measures for reporting actual, anticipated or apparent infringement related to human subjects and human subjects administration at Publiks — and attendant principles and provisions for such reporting — are attained, maintained and protected, and not infringed in any way;
14.9.7. Human Subjects Conditions, Understanding
with the understanding that the aforementioned and other conditions for human subjects and human subjects administration at Publiks are authorized, administered and adjudicated for compliance solely by the Founder, and executed solely via the Founder’s authorization.
Duties for Human Subjects
Section 14.10.0. With respect to duties for human subjects and human subjects administration, you understand and agree to abide by the following:
14.10.1. Human Subjects Duties
that, in addition to your Agreement, you fulfill and do not infringe, in any way, the ensuing duties for human subjects and human subjects administration;
14.10.2. Human Subjects Duties, Activity
that you have a duty to maintain and not infringe, in any way, the human subjects and human subjects administration of an act or activity of Publiks;
14.10.3. Human Subjects Duties, Agent
that you have a duty to maintain and not infringe, in any way, the human subjects and human subjects administration of an agent, party, or other person of Publiks;
14.10.4. Human Subjects Duties, Arrangement
that you have a duty to maintain and not infringe, in any way, the human subjects and human subjects administration of an arrangement of Publiks;
14.10.5. Human Subjects Duties, Conduct, Service
that you have a duty to maintain and not infringe, in any way, the human subjects and human subjects administration of a conduct or service of Publiks;
14.10.6. Human Subjects Duties, Entity, Organization
that you have a duty to maintain and not infringe, in any way, the human subjects and human subjects administration of Publiks Inc and The Publiks Group, including as proprietary and protective organizations and as entities of proprietary and protective administration;
14.10.7. Human Subjects Duties, Expectation
that you have a duty to consider and not infringe, in any way, an expectation pertaining to human subjects and human subjects administration at Publiks that is meaningful and reasonable;
14.10.8. Human Subjects Duties, Material
that you have a duty to maintain and not infringe, in any way, the human subjects and human subjects administration of a material of Publiks;
14.10.9. Human Subjects Duties, Matter
that you have a duty to maintain and not infringe, in any way, the human subjects and human subjects administration of a matter of Publiks;
14.10.10. Human Subjects Duties, Procedure
that you have a duty to maintain and not infringe, in any way, the human subjects and human subjects administration of a procedure, proceeding, or process of Publiks;
14.10.11. Human Subjects Duties, Relation
that you have a duty to maintain and not infringe, in any way, the human subjects and human subjects administration of a relation or relationship of Publiks;
14.10.12. Human Subjects Duties, Request
that you have a duty to consider and not infringe, in any way, a request pertaining to human subjects and human subjects administration at Publiks that is meaningful and reasonable;
14.10.13. Human Subjects Duties, Understanding
with the understanding that your sole means of fulfilling the aforementioned and other duties for human subjects and human subjects administration is by refraining from and reporting — via fully informing communication directly to the Founder — any infringement of human subjects and human subjects administration, and furthermore, not in any way diminishing or hindering the Founder’s sole discretion and powers to adjudicate and remedy such infringements.
Rights for Human Subjects
Section 14.11.0. With respect to rights for human subjects and human subjects administration, you understand and agree to abide by the following:
14.11.1. Human Subjects Rights
that, in addition to your Agreement, you respect and do not infringe, in any way, the ensuing rights for human subjects and human subjects administration;
14.11.2. Human Subjects Rights, Civil
that you respect and do not infringe, in any way, rights for human subjects and human subjects administration accorded to persons at Publiks by their applicable state or territorial governments;
14.11.3. Human Subjects Rights, Legal
that you respect and do not infringe, in any way, rights for human subjects and human subjects administration accorded to persons at Publiks by applicable law and regulation;
14.11.4. Human Subjects Rights, Entity, Organization
that you respect and do not infringe, in any way, rights for human subjects and human subjects administration of Publiks, including rights of human subjects and human subjects administration accorded to Publiks Inc and The Publiks Group, as proprietary and protective organizations and entities of proprietary and protective administration, via the Codes and Policies;
14.11.5. Human Subjects Rights, Human
that you respect and do not infringe, in any way, human and natural rights for human subjects and human subjects administration accorded to natural persons at Publiks via the Codes and Policies, including absolute rights for human subjects and human subjects administration of a human’s inner being, body, brain, as well as inner self, soul, spirit;
14.11.6. Human Subjects Rights, Understanding
with the understanding that your sole means of respecting the aforementioned and other rights for human subjects and human subjects administration is by refraining from and reporting — via fully informing communication directly to the Founder — any infringement of human subjects and human subjects administration, and furthermore, not in any way diminishing or hindering the Founder’s sole discretion and powers to adjudicate and remedy such infringements.
Safeguards for Human Subjects
Section 14.12.0. With respect to rights for human subjects and human subjects administration, you understand and agree to abide by the following:
14.12.1. Human Subjects Safeguards
that, in addition to your Agreement, you maintain and do not infringe, in any way, the ensuing safeguards for human subjects and human subjects administration;
14.12.2. Human Subjects Safeguards, Activity
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the human subjects and human subjects administration of an act or activity of Publiks;
14.12.3. Human Subjects Safeguards, Agent
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the human subjects and human subjects administration of an agent, party, or other person of Publiks;
14.12.4. Human Subjects Safeguards, Arrangement
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the human subjects and human subjects administration of an arrangement of Publiks;
14.12.5. Human Subjects Safeguards, Conduct, Service
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the human subjects and human subjects administration of a conduct or service of Publiks;
14.12.6. Human Subjects Safeguards, Entity, Organization
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the human subjects and human subjects administration of Publiks Inc and The Publiks Group, including as proprietary and protective organizations and as entities of proprietary and protective administration;
14.12.7. Human Subjects Safeguards, Expectation
that you consider and not infringe, in any way, an expectation to safeguard human subjects and human subjects administration at Publiks that is meaningful and reasonable;
14.12.8. Human Subjects Safeguards, Material
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the human subjects and human subjects administration of a material of Publiks;
14.12.9. Human Subjects Safeguards, Matter
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the human subjects and human subjects administration of a matter of Publiks;
14.12.10. Human Subjects Safeguards, Procedure
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the human subjects and human subjects administration of a procedure, proceeding, or process of Publiks;
14.12.11. Human Subjects Safeguards, Relation
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the human subjects and human subjects administration of a relation or relationship of Publiks;
14.12.12. Human Subjects Safeguards, Request
that you consider and not infringe, in any way, a request to safeguard human subjects and human subjects administration at Publiks that is meaningful and reasonable;
14.12.13. Human Subjects Safeguards, Rights
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard rights for human subjects and human subjects administration, including rights to such safeguards;
14.12.14. Human Subjects Safeguards, Understanding
with the understanding that your sole means of maintaining the aforementioned and other safeguards for human subjects and human subjects administration is by refraining from and reporting — via fully informing communication directly to the Founder — any infringement of human subjects and human subjects administration, and furthermore, not in any way diminishing or hindering the Founder’s sole discretion and powers to adjudicate and remedy such infringements.
C — On Research
Conditions for Research
Section 14.13.0. With respect to conditions for research and research administration, you understand and agree to abide by the following:
14.13.1. Research Conditions
that, in addition to your Agreement, you do not infringe, in any way, the ensuing conditions for research and research administration;
14.13.2. Research Conditions, Administration
that the research and research administration of Publiks and provisions attendant to such research and research administration — as conducted solely by the Founder, and executed solely via the Founder’s authorization — are attained, maintained and protected, and not infringed in any way;
14.13.3. Research Conditions, Areas
that research and research administration in areas, offices, parts, properties, sections, and equivalent of Publiks — and attendant principles and provisions for such research and research administration — are attained, maintained and protected, and not infringed in any way;
14.13.4. Research Conditions, Founder
that research and research administration for the Founder and Founder-related activities, administration, conduct, and service — and attendant principles and provisions for such research and research administration — are attained, maintained and protected, and not infringed in any way;
14.13.5. Research Conditions, Ownership
that the research ownership of Publiks and Publiks Administration and the rights attendant to such research ownership — including that providing for and otherwise pertaining to the research interests-, share-, stake- and stock-holding, ownership, and equivalent of Publiks and Publiks Administration, solely and wholly by the Founder, Alvan Azinna Chibuzo Ikoku — are attained, maintained and protected, and not infringed in any way;
14.13.6. Research Conditions, Practices
that practices for ensuring research and research administration at Publiks, including through its conduct and service — and attendant principles and provisions for such practices — are attained, maintained and protected, and not infringed in any way;
14.13.7. Research Conditions, Reporting
that measures for reporting actual, anticipated or apparent infringement related to research and research administration at Publiks — and attendant principles and provisions for such reporting — are attained, maintained and protected, and not infringed in any way;
14.13.8. Research Conditions, Understanding
with the understanding that the aforementioned and other conditions for research and research administration at Publiks are authorized, administered and adjudicated for compliance solely by the Founder, and executed solely via the Founder’s authorization.
Duties for Research
Section 14.14.0. With respect to duties of research and research administration, you understand and agree to abide by the following:
14.14.1. Research Duties
that, in addition to your Agreement, you fulfill and do not infringe, in any way, the ensuing duties for research and research administration;
14.14.2. Research Duties, Activity
that you have a duty to maintain and not infringe, in any way, the research and research administration of an act or activity of Publiks;
14.14.3. Research Duties, Agent
that you have a duty to maintain and not infringe, in any way, the research and research administration of an agent, party, or other person of Publiks;
14.14.4. Research Duties, Arrangement
that you have a duty to maintain and not infringe, in any way, the research and research administration of an arrangement of Publiks;
14.14.5. Research Duties, Conduct, Service
that you have a duty to maintain and not infringe, in any way, the research and research administration of a conduct or service of Publiks;
14.14.6. Research Duties, Entity, Organization
that you have a duty to maintain and not infringe, in any way, the research and research administration of Publiks Inc and The Publiks Group, including as proprietary and protective organizations and as entities of proprietary and protective administration;
14.14.7. Research Duties, Expectation
that you have a duty to consider and not infringe, in any way, an expectation pertaining to research and research administration at Publiks that is meaningful and reasonable;
14.14.8. Research Duties, Material
that you have a duty to maintain and not infringe, in any way, the research and research administration of a material of Publiks;
14.14.9. Research Duties, Matter
that you have a duty to maintain and not infringe, in any way, the research and research administration of a matter of Publiks;
14.14.10. Research Duties, Procedure
that you have a duty to maintain and not infringe, in any way, the research and research administration of a procedure, proceeding, or process of Publiks;
14.14.11. Research Duties, Relation
that you have a duty to maintain and not infringe, in any way, the research and research administration of a relation or relationship of Publiks;
14.14.12. Research Duties, Request
that you have a duty to consider and not infringe, in any way, a request pertaining to research and research administration at Publiks that is meaningful and reasonable;
14.14.13. Research Duties, Understanding
with the understanding that your sole means of fulfilling the aforementioned and other duties for research and research administration is by refraining from and reporting — via fully informing communication directly to the Founder — any infringement of research and research administration, and furthermore, not in any way diminishing or hindering the Founder’s sole discretion and powers to adjudicate and remedy such infringements.
Rights for Research
Section 14.15.0. With respect to rights for research and research administration, you understand and agree to abide by the following:
14.15.1. Research Rights
that, in addition to your Agreement, you respect and do not infringe, in any way, the ensuing rights for research and research administration;
14.15.2. Research Rights, Civil
that you respect and do not infringe, in any way, rights for research and research administration accorded to persons at Publiks by their applicable state or territorial governments;
14.15.3. Research Rights, Legal
that you respect and do not infringe, in any way, rights for research and research administration accorded to persons at Publiks by applicable law and regulation;
14.15.4. Research Rights, Entity, Organization
that you respect and do not infringe, in any way, rights for research and research administration of Publiks, including rights of research and research administration accorded to Publiks Inc and The Publiks Group, as proprietary and protective organizations and entities of proprietary and protective administration, via the Codes and Policies;
14.15.5. Research Rights, Human
that you respect and do not infringe, in any way, human and natural rights for research and research administration accorded to natural persons at Publiks via the Codes and Policies, including absolute rights for research and research administration of a human’s inner being, body, brain, as well as inner self, soul, spirit;
14.15.6. Research Rights, Understanding
with the understanding that your sole means of respecting the aforementioned and other rights for research and research administration is by refraining from and reporting — via fully informing communication directly to the Founder — any infringement of research and research administration, and furthermore, not in any way diminishing or hindering the Founder’s sole discretion and powers to adjudicate and remedy such infringements.
Safeguards for Research
Section 14.16.0. With respect to safeguards for research and research administration, you understand and agree to abide by the following:
14.16.1. Research Safeguards
that, in addition to your Agreement, you maintain and do not infringe, in any way, the ensuing safeguards for research and research administration;
14.16.2. Research Safeguards, Activity
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the research and research administration of an act or activity of Publiks;
14.16.3. Research Safeguards, Agent
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the research and research administration of an agent, party, or other person of Publiks;
14.16.4. Research Safeguards, Arrangement
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the research and research administration of an arrangement of Publiks;
14.16.5. Research Safeguards, Conduct, Service
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the research and research administration of a conduct or service of Publiks;
14.16.6. Research Safeguards, Entity, Organization
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the research and research administration of Publiks Inc and The Publiks Group, including as proprietary and protective organizations and as entities of proprietary and protective administration;
14.16.7. Research Safeguards, Expectation
that you consider and not infringe, in any way, an expectation to safeguard research and research administration at Publiks that is meaningful and reasonable;
14.16.8. Research Safeguards, Material
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the research and research administration of a material of Publiks;
14.16.9. Research Safeguards, Matter
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the research and research administration of a matter of Publiks;
14.16.10. Research Safeguards, Procedure
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the research and research administration of a procedure, proceeding, or process of Publiks;
14.16.11. Research Safeguards, Relation
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard the research and research administration of a relation or relationship of Publiks;
14.16.12. Research Safeguards, Request
that you consider and not infringe, in any way, a request to safeguard research and research administration at Publiks that is meaningful and reasonable;
14.16.13. Research Safeguards, Rights
that you maintain and not infringe, in any way, practices, processes, protections, and other provisions to safeguard rights for research and research administration, including rights to such safeguards;
14.16.14. Research Safeguards, Understanding
with the understanding that your sole means of maintaining the aforementioned and other safeguards for research and research administration is by refraining from and reporting — via fully informing communication directly to the Founder — any infringement of research and research administration, and furthermore, not in any way diminishing or hindering the Founder’s sole discretion and powers to adjudicate and remedy such infringements.
D — On Processes
— of Administration
Section 14.17.0. With respect to powers and responsibilities pertaining to personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following:
14.17.1. Administration
that Publiks — and specifically the Founder, Alvan Azinna Chibuzo Ikoku — have and retain all powers and responsibilities pertaining to personal biospecimens, data and information, human subjects research, and the administration of both, executed solely via the Founder’s authorization, without liability, and with absolute, complete, sole discretion.
14.17.2. Administration, Authorizer
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole authorizer of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.3. Administration, Access, Actions
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer of access, actions, activities, conduct, service, and equivalent involving or pertaining to personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.4. Administration, Applicability
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure the applicability of the Human Subjects Research Policy to a given conduct or service, including any activity, agent, or arrangement, or involved material or matter.
14.17.5. Administration, Appropriateness
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure the appropriateness of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.6. Administration, Approval
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate approval and certification of a given conduct or service subject to the Human Subjects Research Policy.
14.17.7. Administration, Assignment
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate assignment, delegation, and transfer of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.8. Administration, Care
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate care in personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.9. Administration, Categorization
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate categorization and classification of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.10. Administration, Communication
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate communication and notification pertaining to personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.11. Administration, Confidentiality
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate confidentiality of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.12. Administration, Consent
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate consent for personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.13. Administration, Documentation
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate documentation of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.14. Administration, Infringement
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate mitigation and notification of an infringement of personal biospecimens, data and information, human subjects research, or the administration of either.
14.17.15. Administration, Integrity
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate integrity of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.16. Administration, Lawfulness
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure the lawfulness of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.17. Administration, Minimization
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate minimization of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.18. Administration, Necessity
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate necessity of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.19. Administration, Neutrality
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate neutrality of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.20. Administration, Non-Identification
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate non-identification of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.21. Administration, Privacy
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate privacy of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.22. Administration, Protection
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate protection of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.23. Administration, Safety
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate safety of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.24. Administration, Security
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate security of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.25. Administration, Sensitivity
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate sensitivity of personal biospecimens, data and information, human subjects research, and the administration of both.
14.17.26. Administration, Standardization
that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the sole administrator and authorizer with powers and responsibilities to determine and ensure adequate standardization of personal biospecimens, data and information, human subjects research, and the administration of both.
— of Applicability
Section 14.18.0. With respect to determining and ensuring the applicability of the Human Subjects Research Policy to a given conduct or service, you understand and agree to abide by the following criteria:
14.18.1. Applicability, Distinction
that the Human Subjects Research Policy is applicable where the conduct or service — including any activity, agent, or arrangement, or involved material or matter — entail, require, or result in distinctions between what is “personal” and what is “non-personal,” as defined in the Codes and Policies.
14.18.2.1. Applicability, Human Subject
that the Human Subjects Research Policy is applicable where the conduct or service — including any activity, agent, or arrangement, or involved material or matter — specifically relates to a “human subject concerned,” as defined in the Codes and Policies.
14.18.2.2. Applicability, Personal, Biospecimen
that the Human Subjects Research Policy is applicable where the conduct or service involves “personal biospecimens, data and information,” as defined in the Codes and Policies.
14.18.2.3. Applicability, Research
that the Human Subjects Research Policy is applicable where the conduct or service constitutes “investigation,” “research,” or “study,” as defined in the Codes and Policies, and where the conduct or service is not merely a practice, process, or procedure — designed solely to deliver or provide an action or benefit with reasonable expectation of success — but rather, entails an action — including an inquiry, interaction, or intervention — designed to pursue a problem, question, or topic; test an hypothesis or thesis; result in conclusions drawn; and thereby contribute to or develop generalizable knowledge.
14.18.3. Applicability, Specification
and with all of the above met, further specification that the Human Subjects Research Policy applies only to conduct or service relating to an authorized and recognized person, partner, party, research subject, user, visitor, or other consumer or customer of Publiks, narrowly defined, engaging in an activity, area, capacity, and manner authorized solely via the Founder’s authorization.
— of Appropriateness
Section 14.19.0. With respect to determining and ensuring the appropriateness of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following:
14.19.1. Appropriateness, Basis
that the aspects, characteristics, and parameters of personal biospecimens, data and information, human subjects research, and the administration of both are appropriate and efficacious for their authorized and consented purpose.
14.19.2. Appropriateness, Compliance
that personal biospecimens, data and information, human subjects research, and the administration of both are appropriately and efficaciously compliant with policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.19.3. Appropriateness, Content
that the content of personal biospecimens, data and information, human subjects research, and the administration of both is appropriate and efficacious for their authorized and consented purpose.
14.19.4. Appropriateness, Context
that the context of personal biospecimens, data and information, human subjects research, and the administration of both — e.g. area, device, office, place, product, service, site, space, and equivalent — is appropriate and efficacious for the authorized and consented biospecimens, data and information, research, administration, and purpose.
14.19.5. Appropriateness, Means
that the means of personal biospecimens, data and information, human subjects research, and the administration of both — e.g. administrative, disciplinary, organizational and technical measure, mechanism, method, modeling, procedure, system, technology, and equivalent — is appropriate and efficacious for the authorized and consented biospecimens, data and information, research, administration, and purpose.
14.19.6. Appropriateness, Nature
that the nature of personal biospecimens, data and information, human subjects research, and the administration of both — e.g. category, design, discipline, form, genre, language, medium, model, personal or identifying capacity, sensitivity, type, and equivalent — is appropriate and efficacious for the authorized and consented biospecimens, data and information, research, administration, and purpose.
14.19.7. Appropriateness, Person
that the person relating to personal biospecimens, data and information, human subjects research, and the administration of both — e.g. agent, conductor, customer, effector, facilitator, processor, provider, recipient, servicer, source, subject, user, visitor, and equivalent as well as the selection of the human subject — is appropriate and efficacious for the authorized and consented biospecimens, data and information, research, administration, and purpose.
14.19.8. Appropriateness, Purpose
that the purpose for personal biospecimens, data and information, human subjects research, and the administration of both — e.g. application, benefit, end, focus of inquiry or testing, generalizable knowledge, goal, hypothesis, impact, interaction or intervention under evaluation, interest, objective, problem, question, thesis, use, and equivalent — is appropriate and efficacious as well as compliant with human subjects research policies, principles, and protections.
14.19.9. Appropriateness, Quality
that the quality of personal biospecimens, data and information, human subjects research, and the administration of both — e.g. accuracy, availability, definition, completeness, consistency, integrity, organization, precision, timeliness, uniqueness, validity, and equivalent — is appropriate and efficacious for the authorized and consented biospecimens, data and information, research, administration, and purpose.
14.19.10. Appropriateness, Scope
that the scope of personal biospecimens, data and information, human subjects research, and the administration of both — e.g. duration, field, frequency, period, range, scale, size, volume, and equivalent — is appropriate and efficacious for the authorized and consented biospecimens, data and information, research, administration, and purpose.
— of Approval
Section 14.20.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service subject to the Human Subjects Research Policy, you understand and agree to abide by the following criteria:
14.20.1. Approval, Basis
that the research review board of Publiks (the “RRB”), including the Founder, Alvan Azinna Chibuzo Ikoku, initially then continually or periodically reviews and either approves or disapproves all conduct and service subject to the Human Subjects Research Policy, before, during and after any access or collection of biospecimens, data and information, human subjects research, and the administration of both.
14.20.2. Approval, Application
that prior to any access or collection of biospecimens, data and information, human subjects research, and the administration of both, the RRB requires (a) submission of application detailing the aspects, characteristics, and parameters of the aforementioned; (b) where appropriate, modifications in such application to secure approval or compliance; and (c) where appropriate, RRB observation of the consent process and other processes pertaining to the biospecimens, data and information, human subjects research, and the administration of both.
14.20.3. Approval, Adherence
that the RRB requires the above application to demonstrate adherence to and compliance with the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation prior to any possible approval.
14.20.4.1. Approval, Assessment, Benefit, Risk
that the RRB assesses for and determines the actual and anticipated benefits for and risks to you — as the human subject concerned — of the conduct or service, biospecimens, data and information, research, and administration, including, where appropriate and feasible, review and citation of studies involving equivalent activities, human subjects, interactions, interventions, and other aspects, characteristics, and parameters of biospecimens, data and information, research, and administration.
14.20.4.2. Approval, Assessment, Benign
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — including, where appropriate, review and citation of studies with relevant similarities, confirming that any actual, anticipated and proposed interaction, intervention, method, procedure as well as such biospecimens, data and information, research, and administration are benign, as defined and provided for in the Codes and Policies.
14.20.4.3. Approval, Assessment, Consent
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — that your consent is required, with no recourse to assent alone (that is, without your continually and fully informed knowledge, authorization, and attendant consent), and that all policies, principles, and protections for informed consent are fulfilled, as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.20.4.4. Approval, Assessment, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from practice, as defined and provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.20.4.5. Approval, Assessment, Limitation
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — including, where appropriate, review and citation of studies with relevant similarities, confirming that all research and investigation activities are limited to those necessary to allow the authorized and RRB-approved researcher or investigator to study aspects of evidenced and specific importance to the identified type of research and its associated disciplines, fields, studies, and scholarship.
14.20.4.6. Academic, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — confirming that any involved or studied interaction, intervention, practice, setting, testing, or equivalent will not adversely impact any human subjects, their opportunities or prospects, or their physical or psychological condition or state.
14.20.4.7. Approval, Assessment, Non-Controversy
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — including, where appropriate, review and citation of studies with relevant similarities, confirming that none of the actual, anticipated and proposed biospecimens, data and information, research, or administration are controversial, a cause for concern, a subject of debate or call for new regulation, or equivalent, within the field associated with the research, the applicable governmental, judicial or regulatory bodies, or the general public.
14.20.4.8. Approval, Assessment, Non-Identification
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — including, where appropriate, review and citation of studies with relevant similarities, confirming that fulfillment of non-identification includes methods that abstract, codify, fictionalize, mask, obscure, recode, recombine, recreate, remove, or rename attributable or identifiable aspects, details, names, places, or equivalent, so as to preclude or prevent re-identification.
14.20.4.9. Approval, Assessment, Non-Novelty
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — including, where appropriate, review and citation of studies with relevant similarities, confirming that none of the actual, anticipated and proposed biospecimens, data and information, research, or administration are new, novel, non-standard, unestablished, unregulated, unresearched, untested or equivalent.
14.20.4.10. Approval, Assessment, Non-Sensitivity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — including, where appropriate, review and citation of studies with relevant similarities, confirming that none of the actual, anticipated and proposed biospecimens, data and information, research, or administration are sensitive, as defined and provided for in the Codes and Policies.
14.20.4.11. Approval, Assessment, Risk Minimization
that the RRB assesses for means to ensure the actual and anticipated risks to you — as the human subject concerned — are minimized; and that in evaluating risk minimization, the RRB considers and strongly recommends (even restricts approval to) biospecimens, data and information, research, and administration that are consistent with protective and sound design, that do not unnecessarily expose you and other persons concerned to risk, that are necessary for the study under review, and that already being performed on you and other human subjects for diagnostic or treatment purposes.
14.20.4.12. Approval, Assessment, Risk Relation
that the RRB assesses for and determines the actual and anticipated risks to you — as the human subject concerned — are reasonable in relation to anticipated benefits, if any, to you, and the importance of the knowledge that may reasonably be expected to result.
14.20.4.13. Approval, Assessment, Risk Relation, Specified
that, in evaluating for the benefit-risk relation, the RRB considers only those benefits and risks that may result from the involved biospecimens, data and information, research, and administration (as distinguished from benefits and risks of therapies you would receive even if not participating in the research).
14.20.4.14. Approval, Assessment, Risks, Obstetric, Pediatric
that, where the above risk assessment entails concern for pregnancy, fetus, newborn, or a child, the RRB assesses for and ensures fulfillment of additional criteria and requirements, as provided for under Obstetric and Pediatric Research in the Human Subjects Research Policy.
14.20.4.15. Approval, Assessment, Risk Relation, Unspecified
that, in evaluating for the benefit-risk relation, the RRB does not consider any possible long-range effects of knowledge (e.g. its application or effects on public policy) gained from the involved biospecimens, data and information, research, and administration as among those benefits and risks that fall within the purview of its responsibility.
14.20.4.17. Approval, Assessment, Selection
the RRB assesses for and determines the selection of human subjects is equitable.
14.20.4.16. Approval, Assessment, Selection, Specified
that, in evaluating for equitable selection, the RRB 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.
14.20.4.18. Approval, Assessment, Selection, Unspecified
that, in evaluating for equitable selection, the RRB does not take into account the purposes of the research or the setting in which the research will be conducted.
14.20.5.1. Approval, Monitoring, Consent
that the RRB assesses for and determines adequate provision for monitoring the consent process to ensure it adequately informs you — as the human subject concerned — and informed consent is sought from each prospective person concerned, in accordance with the Human Subjects Research Policy, and via such monitoring the RRB confirms appropriate documentation of the consent process and informed consent.
14.20.5.2. Approval, Monitoring, Biospecimens
that the RRB assesses for and determines adequate provision for monitoring the involved biospecimens, data and information to ensure adherence to and fulfillment of policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation, with respect to you — as the human subject concerned.
14.20.5.3. Approval, Monitoring, Research
that the RRB assesses for and determines adequate provision for monitoring human subjects research to ensure adherence to and fulfillment of policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation, with respect to you — as the human subject concerned.
14.20.5.4. Approval, Monitoring, Research Administration
that the RRB assesses for and determines adequate provision for monitoring the administration of human subjects research and biospecimens, data and information to ensure adherence to and fulfillment of policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation, with respect to you — as the human subject concerned.
14.20.6.1. Approval, Review, Certification
that, where the above criteria are adequately met, any RRB approvals of biospecimens, data and information, human subjects research, and administration of both are confirmed then certified solely via the Founder’s authorization.
14.20.6.2. Approval, Review, Periodic
that the RRB periodically reviews and has authority to suspend or terminate approval of any biospecimens, data and information, human subjects research, or administration of either that is not being conducted in accordance with RRB requirements or that has been associated with unexpected serious harm to you or any other person concerned — and any suspension or termination of approval includes a written statement of the reasons for the RRB action and is reported promptly to Publiks, the Founder, and appropriate regulatory officials mandated by applicable law and regulation.
14.20.6.3. Approval, Review, Post
that where appropriate, biospecimens, data and information, human subjects research, and administration of both approved by the RRB may be subject to further post-RRB review (and approval or disapproval) by authorized official persons of Publiks — including the possibility of a recommended rejection of RRB decisions on grounds of actual or anticipated creation of difficult ethical, legal or policy problems — though such official persons cannot confer approval if the RRB has decided against approval.
—— of Approval of Academic
Section 14.21.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails academic research, you understand and agree to abide by the following additional criteria:
14.21.1. Academic, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to academia whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or academic research are administered.
14.21.2. Academic, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such academic research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.21.3. Academic, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from academic administration, education, or other academic practice and service.
14.21.4. Academic, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Archival
Section 14.22.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails archival research, you understand and agree to abide by the following additional criteria:
14.22.1. Archival, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to archives whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or archive-related research are administered.
14.22.2. Archival, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such archival research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.22.3. Archival, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from archival and library practice and science.
14.22.4. Archival, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Artistic
Section 14.23.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails art, artistic or creative research, you understand and agree to abide by the following additional criteria:
14.23.1. Artistic, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to the arts whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or art-related research are administered.
14.23.2. Artistic, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such artistic research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.23.3. Artistic, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from art, artistic and creative composition, expression, performance, and practice.
14.23.4. Artistic, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Civil, Criminal Justice
Section 14.24.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails civil and criminal justice research, you understand and agree to abide by the following additional criteria:
14.24.1. Justice, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to civil or criminal justice whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or justice-related research are administered.
14.24.2. Justice, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such civil and criminal justice research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.24.3. Justice, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from activist, advocacy, law and legal practices and services.
14.24.4.1. Justice, Consent
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about well-established expectations that the constraints of being subject to civil, criminal, judicial or state order, process, record, or status or to asylum, deportation, discrimination, harassment, infringement, persecution, or violation, or other equivalently significant legal effects likely affect your ability to make an uncoerced and thus freely given, meaningful and truly voluntary decision whether or not to participate as a human subject in research or investigation, requiring the RRB to ensure additional protections against legally defective consent and risks to you and your interests and rights.
14.24.4.2. Justice, Consent, Acceptability
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring 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.
14.24.4.3. Justice, Consent, Inducement
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that (a) any possible advantages accruing to you through participation in the research or investigation study, when compared to the care, catering, conditions, and opportunities generally available to others in situations similar to yours, 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 in such limited choice situations; and (b) government, judicial, and law enforcement agencies, authorities, bodies, and officials will not take into account your participation in the research or investigation, and you and each other prisoner are clearly informed in advance that participation in the research will have no effect on decisions regarding appeal, asylum, compensation, deportation, due process, harm, injury, judgments, probation, rights violation, sentencing, surveillance, tort, or equivalent matters.
14.24.4.4. Penal, Consent, Selection
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that (a) procedures for selection of you and other human subjects sharing your situation are fair to all others and immune from arbitrary intervention by authorities or other persons; and (b) control subjects are selected randomly from the group of available participants who meet the characteristics needed for the particular research or investigation study; unless (c) the researcher or investigator provides to the RRB written justification for following other selection procedures and potential human subjects are reasonably informed of this procedural departure.
14.24.5. Justice, Follow-Up Care
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that, where the RRB finds there may be a need for follow-up examination or care of you after the end of your participation, adequate provision is made for such examination or care, and for informing you and other participants of this determined need and provision.
14.24.6. Justice, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — confirming that the studied civil and criminal justice interaction, intervention, practice, setting, testing, or equivalent will not adversely impact any such vulnerable persons, including their opportunities for activist, advocacy, law and legal practice and service, and their physical and psychological condition and state.
14.24.7. Justice, Non-Surveillance
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that such research and investigation will not entail, include, or involve activities or operations that eavesdrop on, follow, monitor, spy on, trace, or otherwise track you or place you under any form of surveillance.
14.24.8. Justice, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
14.24.9.1. Justice Research Permissible
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that any proposed research or investigation is for limited and restricted research or investigation purposes permissible according to applicable law and regulation, specifically, penal research on (a) arrest, conviction, court order, detention, probation, parole, probable suspicion, stoppage, surveillance, or other equivalent situation or status, including their causes, effects, institutions, and processes; (b) asylum, deportation, discrimination, disenfranchisement, harassment, marginalization, persecution, rights infringement or violation, stigmatization, or other equivalent situation or status, including their causes, effects, institutions, and processes; (c) conditions particularly affecting you and other vulnerable human subjects in the above and equivalently legally significant situations as a class; and (f) practices, both accepted and innovative, which have the intent and reasonable probability of improving the health or well-being of you and other vulnerable human subjects in the above and equivalently legally significant situations.
14.24.9.2. Justice, Research Permitted
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that civil and criminal justice research or investigation is approved, authorized and permitted only for the aforementioned research purposes, provided that the research or investigation presents no more than minimal risk and no more than inconvenience to you — as the human subject under study.
14.24.9.3. Justice, Research Unpermitted
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that (a) apart from the aforementioned research purposes, no other research or investigation objectives or purposes, or attendant activities or studies, are approved by the RRB, or conducted, funded or supported as research, when involving you or other equivalently vulnerable persons as human subjects; and (b) nothing in the Human Subjects Research Policy authorizes — in itself — research or investigation involving you and other equivalently vulnerable persons as human subjects, to the extent that such research or investigation is barred or limited by any applicable law or regulation.
14.24.10. Justice, Rights
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that your particular rights as a vulnerable person are of high importance and priority and are rigorously protected and fulfilled, irrespective of (a) any arrest, conviction, detention, imprisonment, incarceration, parole, probable cause or suspicion, surveillance, or other criminal, prison or probation status associated with you; and (b) any forms of asylum, deportation, discrimination, disenfranchisement, marginalization, persecution, stigmatization, or other rights infringement or violation you have experienced.
—— of Approval of Commercial
Section 14.25.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails commercial, financial or marketing research, you understand and agree to abide by the following additional criteria:
14.25.1. Commercial, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to commerce whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or commerce-related research are administered.
14.25.2. Commercial, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such commercial, financial or marketing research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.25.3. Commercial, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from commercial, financial, marketing or other business and for-profit conduct, practice, or service.
14.25.4. Commercial, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Deception
Section 14.26.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails deception research, you understand and agree to abide by the following additional criteria:
14.26.1. Deception, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service involving deception whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or deception-related research are administered.
14.26.2. Deception, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such deception research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.26.3. Deception, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from deception practice, including that entailed in film, fraud, magic, music, performance, theater, or video.
14.26.4. Deception, Necessity Limitation
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — that all deception activities and research are limited to those research purposes that require deception as primary methodology, and are further limited to that which is necessary for the authorized and RRB-approved researcher or investigator to study aspects of evidenced and specific importance to such research purposes.
14.26.5. Deception, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — confirming that the involved or studied deception interaction, intervention, practice, setting, testing, or equivalent will not adversely impact any human subjects or their physical or psychological condition or state.
14.26.6. Deception, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Demographic
Section 14.27.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails demographic research, you understand and agree to abide by the following additional criteria:
14.27.1. Demographic, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to demographics whenever (a) its activity or design focuses directly on specific living individuals or populations (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or demography-related research are administered.
14.27.2. Demographic, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such demographic research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.27.3. Demographic, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from civic, census, demographic, policy and equivalent governmental, political and population practice, procedure, process, or service.
14.27.4. Demographic, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Educational
Section 14.28.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails education and educational settings and testing research, you understand and agree to abide by the following additional criteria:
14.28.1. Educational, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to education whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or education-related research are administered.
14.28.2. Educational, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such education and educational settings and testing research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.28.3. Educational, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from educational, pedagogical and teaching practice or service.
14.28.4. Educational, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — confirming that the studied educational interaction, intervention, practice, setting, testing, or equivalent will not adversely impact educators, learners, proctors, students, teachers, or test-takers, including their assessment, their opportunities for educating, learning, or testing, and their physical and psychological condition and state.
14.28.5. Educational, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Ethnographic
Section 14.29.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails ethnographic research, you understand and agree to abide by the following additional criteria:
14.29.1. Ethnographic, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service involving ethnography whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or culture-related research are administered.
14.29.2. Ethnographic, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such ethnographic research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.29.3. Ethnographic, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from cultural or ethnographic practice.
14.29.4. Ethnographic, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — confirming that the studied cultural or ethnographic interaction, intervention, practice, setting, testing, or equivalent will not adversely impact any human subjects, their opportunities for cultural practice, or their physical or psychological condition or state.
14.29.5. Ethnographic, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Food
Section 14.30.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails agricultural, beverage, food or nutritional research, you understand and agree to abide by the following additional criteria:
14.30.1. Food, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to agriculture, beverage, food, or nutrition whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or food-related research are administered.
14.30.2. Food, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such agricultural, food and nutritional research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.30.3. Food, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from agricultural, beverage, food or nutritional production, preparation, practice, and service.
14.30.4.1. Food, Limitation, Importance
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that all research, investigation and demonstration project activities are limited to those necessary to study aspects of evidenced and specific importance to agricultural, beverage, food and nutritional disciplines, studies, and scholarship, such as consumption, quality and taste of beverage and food, evaluation and improvement of agricultural practices and processes, and provable effects of nutrition on health and performance.
14.30.4.2. Food, Limitation, Ingestion
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that, where ingestion by human subjects is involved, the beverage, food, or other ingestible material is limited to (a) wholesome foods without additives; (b) foods containing ingredients at or below levels found to be safe and for uses found to be safe by pertinent government, public and regulatory authorities; and (c) foods containing agricultural, chemical or environmental contaminants at or below levels found to be safe by pertinent government, public and regulatory authorities.
14.30.5. Food, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — confirming that the studied agricultural, beverage, food or nutritional interaction, intervention, practice, setting, testing, or equivalent will not adversely impact any human subjects, their opportunities for agricultural, food or nutritional practice, or their physical or psychological condition or state.
14.30.6. Food, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Genetic
Section 14.31.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails genetic and genomic research, you understand and agree to abide by the following additional criteria:
14.31.1. Genetic, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service involving genes, genetics, or genomics whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or gene-related research are administered.
14.31.2. Genetic, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such genetic and genomic research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.31.3. Genetic, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from care, clinical, counseling, curative, diagnostic, preventative and screening practices of genetic and genomic medicine.
14.31.4.1. Genetic, Informed, Commercial
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that informing communication and notification confirms to you that, whether or not processes of non-identification are conducted, the biospecimens, data and information will not be used for commercial profit or equivalent benefit without your explicitly informed consent and agreement to additional and expressly specified terms.
14.31.4.2. Genetic, Informed, Sequencing I
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that informing communication and notification confirms to you that, whether or not processes of non-identification are conducted, the biospecimens, data and information will not undergo or be used for genomic or exome sequencing or equivalently significant research or processing without your explicitly informed consent and agreement to additional and expressly specified terms.
14.31.4.3. Genetic, Informed, Sequencing II
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that informing communication and notification confirms to you (a) whether the research or investigation may or will include whole genome sequencing of biospecimens accessed, collected or otherwise processed; and (b) whether the research or investigation may or will include sequencing a human germline or somatic specimen with the intent to generate the genome or exome sequence of that biospecimen.
14.31.4.4. Genetic, Informed, Stem Cell
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that informing communication and notification confirms to you that, whether or not processes of non-identification are conducted, the biospecimens, data and information will not undergo or be used for stem cell research or equivalently significant research or processing without your explicitly informed consent and agreement to additional and expressly specified terms.
14.31.4.5. Genetic, Informed, Testing
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that informing communication and notification confirms to you that, whether or not processes of non-identification are conducted, the biospecimens, data and information will not undergo or be used for genetic testing or equivalently significant research or processing without your explicitly informed consent and agreement to additional and expressly specified terms.
14.31.5.1. Genetic, Minimal Risk Exception, Direct Benefit
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that, where the research or investigation study poses more than minimal risk to you but also holds out the prospect of direct benefit for you or is likely to contribute to your well-being, (a) the risk is justified by the anticipated benefit to you; and (b) 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.
14.31.5.2. Genetic, Minimal Risk Exception, No Direct Benefit
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that, where the research or investigation study poses more than minimal risk to you but holds out no prospect of direct benefit for you or is not likely to contribute to your well-being, (a) the risk represents a minor increase over minimal risk; (b) the research or investigation study presents experiences to you that are reasonably commensurate with those inherent in your actual or anticipated clinical or medical situation; and (c) the research or investigation study is likely to yield generalizable knowledge about your care, condition, or disorder that is of vital importance for the amelioration or understanding of your care, condition, or disorder.
14.31.6. Genetic, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — confirming that the studied genetic and genomic interaction, intervention, practice, setting, testing, or equivalent will not adversely impact any carers, patients, practitioners, or providers, including their assessment, their opportunities for clinical, health and medical care, practice, and treatment, and their physical and psychological condition and state.
14.31.7. Genetic, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
14.31.8. Genetic, Results
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and protections with respect to any results of the genetic and genomic research activities, including (a) decision-making and responses subsequent to having such results provided to you; (b) 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; and (c) direct provision to you, where appropriate, of adequate follow-up care, counseling, or examination before, during and after your participation in the research or investigation study, taking into account the varying lengths, likelihoods, and severities of conditions and prognoses associated with genetic diagnoses and results, and for providing you and other human subjects with such information.
—— of Approval of Health
Section 14.32.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails health, health care, health operations or health policy research, you understand and agree to abide by the following additional criteria:
14.32.1. Health, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to health whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or health-related research are administered.
14.32.2. Health, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such health, health care, health operations and health policy research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.32.3. Health, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from practices of clinical, health and medical care, delivery, insurance, management, operations, policy, production, regulation, reimbursement, and services.
14.32.4. Health, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — confirming that the studied health interaction, intervention, practice, setting, testing, or equivalent will not adversely impact any carers, patients, practitioners, or providers, including their assessment, their opportunities for clinical, health and medical care, operation, practice, and treatment, and their physical and psychological condition and state.
14.32.5. Health, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Media
Section 14.33.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails journalism, media or news research, you understand and agree to abide by the following additional criteria:
14.33.1. Media, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to journalism, media, or news whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or media-related research are administered.
14.33.2. Media, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such journalism, media or news research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.33.3. Media, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from academic administration, education, or other practice.
14.33.4. Media, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Obstetric
Section 14.34.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails obstetric and neonatal research, you understand and agree to abide by the following additional criteria:
14.34.1. Obstetric, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to pregnancy whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or pregnancy-related research are administered.
14.34.2. Obstetric, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such obstetric and neonatal research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.34.3. Obstetric, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from care, clinical, counseling, curative, diagnostic, preventative and screening practices of obstetric and neonatal medicine.
14.34.4.1. Obstetric, Minimal Risk Exception, Direct Benefit
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that, where the research or investigation study poses more than minimal risk to the pregnant person, fetus, or neonate but also holds out the prospect of direct benefit for the pregnant person, fetus, and neonate or is likely to contribute to their well-being, (a) the risk is justified by the anticipated benefit to the pregnant person, fetus, and neonate; and (b) the relation of anticipated benefit to risk is as favorable or better to the pregnant person, fetus, and neonate than the benefit-risk relation of available alternative approaches or procedures.
14.34.4.2. Obstetric, Minimal Risk Exception, No Direct Benefit
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that, where the research or investigation study poses more than minimal risk to the pregnant person, fetus, or neonate but holds out no prospect of direct benefit for the pregnant person, fetus, or neonate or is not likely to contribute to their well-being, (a) the risk represents a minor increase over minimal risk; (b) the research or investigation study presents experiences to the pregnant person, fetus, and neonate that are reasonably commensurate with those inherent in their actual or anticipated clinical or medical situation; and (c) the research or investigation study is likely to yield generalizable knowledge about their care, condition, or disorder that is of vital importance for the amelioration or understanding of their care, condition, or disorder.
14.34.5. Obstetric, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — confirming that the studied obstetric and neonatal interaction, intervention, practice, setting, testing, or equivalent will not adversely impact any carers, patients, practitioners, or providers, including their assessment, their opportunities for clinical, health and medical care, practice, and treatment, and their physical and psychological condition and state.
14.34.6.1. Obstetric, Neonatal, Viability, Decisions
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that (a) persons engaged in the research or investigation study have no part in determining the viability of a pregnancy or a fetus before delivery; (b) persons engaged in the research or investigation study have no part in determining the viability of a neonate after delivery; (c) persons engaged in the research or investigation study have no part in determine whether to terminate a pregnancy or in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and (d) no inducements, monetary or otherwise, are offered to terminate a pregnancy.
14.34.6.2. Obstetric, Neonatal, Viability, Definite
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring 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 compliance with human subjects research policies, principles, and protections, and additional requirements for children and pediatric research, as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.34.6.3. Obstetric, Neonatal, Viability, Indefinite
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that, until the viability of a neonate is ascertained, the neonate may not be involved in research or investigation unless (a) 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 (b) 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 (c) 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.
14.34.6.4. Obstetric, Neonatal, Viability, None
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that a neonate determined after delivery to be nonviable may not be involved in research or investigation unless (a) the vital functions of the neonate will not be artificially maintained; (b) the research or investigation will not terminate the heartbeat or respiration of the neonate; (c) there will be no added risk to the neonate resulting from the research; (d) the purpose of the research or investigation study is the development of important biomedical knowledge that cannot be obtained by other means; and (e) 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.
14.34.7. Obstetric, Post-Delivery Material
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that any research or investigation study involving, after delivery, a dead fetus, cells, tissue, or organs excised from a dead fetus, macerated fetal material, or the placenta is approved and conducted only in accordance with applicable law and regulation regarding such research activities and studies.
14.34.8. Obstetric, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
14.34.9. Obstetric, Rights
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that, where applicable, the particular rights of any pregnant person, fetus, or neonate involved are of high importance and priority and are rigorously protected and fulfilled.
—— of Approval of Pediatric
Section 14.35.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails pediatric and childcare research, you understand and agree to abide by the following additional criteria:
14.35.1. Pediatric, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to children whenever (a) its activity or design focuses directly on specific living individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or children-related research are administered.
14.35.2. Pediatric, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the child human subject concerned — that such pediatric and childcare research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.35.3. Pediatric, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the child human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from care, clinical, counseling, curative, diagnostic, preventative and screening practices of pediatric and childcare medicine.
14.35.4.1. Pediatric, Minimal Risk Exception, Direct Benefit
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the child human subject concerned — ensuring that, where the research or investigation study poses more than minimal risk to you but also holds out the prospect of direct benefit for you or is likely to contribute to your well-being, (a) the risk is justified by the anticipated benefit to you; and (b) 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.
14.35.4.2. Pediatric, Minimal Risk Exception, No Direct Benefit
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the child human subject concerned — ensuring that, where the research or investigation study poses more than minimal risk to you but holds out no prospect of direct benefit for you or is not likely to contribute to your well-being, (a) the risk represents a minor increase over minimal risk; (b) the research or investigation study presents experiences to you that are reasonably commensurate with those inherent in your actual or anticipated clinical or medical situation; and (c) the research or investigation study is likely to yield generalizable knowledge about your care, condition, or disorder that is of vital importance for the amelioration or understanding of your care, condition, or disorder.
14.35.5. Pediatric, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the child human subject concerned — confirming that the studied pediatric and childcare interaction, intervention, practice, setting, testing, or equivalent will not adversely impact any carers, patients, practitioners, or providers, including their assessment, their opportunities for clinical, health and medical care, practice, and treatment, and their physical and psychological condition and state.
14.35.6. Pediatric, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the child human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the child human subject concerned — especially where there is clear consent by you to reveal your identity.
14.35.7. Pediatric, Rights
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the child human subject concerned — ensuring that your particular rights as a child are of high importance and priority and are rigorously protected and fulfilled.
14.35.8. Pediatric, Ward
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the child human subject concerned — ensuring that, where you are a child ward of the state or any other agency, entity, or institution and are to participate in any of the above permitted research or investigation scenarios, (a) the research or investigation purpose and study are related to your status as a ward; or (b) 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) an advocate is appointed for you and each other child ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis.
—— of Approval of Penal
Section 14.36.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails penal, prisons and prisoners research, you understand and agree to abide by the following additional criteria:
14.36.1. Penal, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to prisons or prisoners whenever (a) its activity or design focuses directly on specific living individuals or institutions or programs involved in imprisoning such individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or prison-related research are administered.
14.36.2.Penal, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such penal, prisons and prisoners research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.36.3.Penal, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from imprisonment, prisons and prisoner practices and services.
14.36.4.1. Penal, Consent
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about well-established expectations that the constraints of incarceration likely affect your ability to make an uncoerced and thus freely given, meaningful and truly voluntary decision whether or not to participate as a human subject in research or investigation, requiring the RRB to ensure additional protections against legally defective consent and risks to you and your interests and rights.
14.36.4.2. Penal, Consent, Acceptability
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring 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.
14.36.4.3. Penal, Consent, Inducement
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that (a) any possible advantages accruing to you through participation in the research or investigation study, when compared to the care, catering, conditions, and opportunities generally available in the prison, 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 in the limited choice environment of the prison; and (b) parole boards will not take into account your participation in the research or investigation, and you and each other prisoner are clearly informed in advance that participation in the research will have no effect on parole decisions.
14.36.4.4. Penal, Consent, Selection
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that (a) 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 (b) control subjects are selected randomly from the group of available prisoners who meet the characteristics needed for the particular research or investigation study; unless (c) the researcher or investigator provides to the RRB written justification for following other selection procedures and potential human subjects are reasonably informed of this procedural departure.
14.36.5. Penal, Follow-Up Care
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that, where the RRB finds there may be a need for follow-up examination or care of you 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’s sentences, and for informing you and other participants of this determined need and provision.
14.36.6. Penal, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — confirming that the studied penal or prison interaction, intervention, practice, setting, testing, or equivalent will not adversely impact any prisoners or prison staff, including their assessment, their opportunities for prison care and practice, and their physical and psychological condition and state.
14.36.7. Penal, Non-Surveillance
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that such research and investigation will not entail, include, or involve activities or operations that eavesdrop on, follow, monitor, spy on, trace, or otherwise track you or place you under any form of surveillance.
14.36.8. Penal, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
14.36.9.1. Penal, Research Permissible
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that any proposed research or investigation is for limited and restricted research or investigation purposes permissible according to applicable law and regulation, specifically, penal research on (a) criminal and incarcerable behavior, including their causes and effects; (b) incarceration, including their causes, effects, and processes; (c) prisoners as incarcerated persons; (d) prisons as institutions and institutional structures; (e) conditions particularly affecting prisoners as a class; and (f) practices, both accepted and innovative, which have the intent and reasonable probability of improving the health or well-being of prisoners.
14.36.9.2. Penal, Research Permitted
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that penal research or investigation is approved, authorized and permitted only for the aforementioned research purposes, provided that (a) the research or investigation presents no more than minimal risk and no more than inconvenience to you — as the human subject under study; and (b) 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 and conduct such research.
14.36.9.3. Penal, Research Unpermitted
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that (a) apart from the aforementioned research purposes, no other research or investigation objectives or purposes, or attendant activities or studies, are approved by the RRB, or conducted, funded or supported as research, when involving you or other prisoners as human subjects; and (b) nothing in the Human Subjects Research Policy 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 law or regulation.
14.36.10. Penal, Rights
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that the particular rights of any actual or former prisoner under study are of high importance and priority and are rigorously protected and fulfilled, irrespective of arrest, conviction, detention, imprisonment, incarceration, or other criminal, prison or probation status.
—— of Approval of Public Health
Section 14.37.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails public health research, you understand and agree to abide by the following additional criteria:
14.37.1. Public Health, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to public health whenever (a) its activity or design focuses directly on specific living individuals or populations (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or public health-related research are administered.
14.37.2. Public Health, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such public health research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.37.3. Public Health, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from the care, clinical, curative, diagnostic and directly preventative practices of public health.
14.37.4. Public Health, Limitation
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that all research, investigation and demonstration project activities are limited to those necessary to study aspects of evidenced and specific importance to public health disciplines, studies, and scholarship, such as disability or disease epidemiology, man-made or natural crisis or disaster prediction and response, outbreak detection and response, occupational hazard and injury trends, and provable environmental and health effects of consumer behaviors and products.
14.37.5. Public Health, Public Sponsor
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that all research and investigation activities are associated with, sponsored and supported by an appropriate government, public or state agency, authority, department, or office, whose purview includes administration of the public health activity or program under study.
14.37.6. Public Health, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring (a) acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity; and (b) that each government, public or state agency, authority, department, or office sponsoring or supporting the research and investigation establish, on a publicly accessible government and public office online website — and prior to commencing the research involving human subjects — a list of research and investigation activities that the government, public or state agency, authority, department, or office sponsors or supports under this Policy.
—— of Approval of Public Opinion
Section 14.38.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails public opinion research, you understand and agree to abide by the following additional criteria:
14.38.1. Public Opinion, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to opinion whenever (a) its activity or design focuses directly on specific living individuals or populations (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or opinion-related research are administered.
14.38.2. Public Opinion, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such public opinion research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.38.3. Public Opinion, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from campaign, election, focus group, participation, polling, voting and other political and public opinion practice, procedure, process, or service.
14.38.4. Public Opinion, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity.
—— of Approval of Public Program
Section 14.39.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails public benefit and public service program research, you understand and agree to abide by the following additional criteria:
14.39.1. Public Program, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to public benefit or service whenever (a) its activity or design focuses directly on specific living individuals or programs directly serving such individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or public program-related research are administered.
14.39.2. Public Program, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such public benefit and public service program research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.39.3. Public Program, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from the practice of providing public benefit, public service, and their programs.
14.39.4. Public Program, Limitation
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that all research, investigation and demonstration project activities are limited to those necessary to study aspects of evidenced and specific importance to public benefit and public services programs and their studies, such as the evaluation and improvement of such programs, including their benefit- or service-provision procedures, their operations, their personnel, and their possible alternatives.
14.39.5. Public Program, Public Sponsor
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring that all research, investigation and demonstration project activities are associated with, sponsored and supported by an appropriate government, public or state agency, authority, department, or office, whose purview includes administration of the public benefit or service program under study.
14.39.6. Public Program, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring (a) acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity; and (b) that each government, public or state agency, authority, department, or office sponsoring or supporting the research, investigation, and demonstration project 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 or state agency, authority, department, or office sponsors or supports under this Policy.
—— of Approval of Spiritual
Section 14.40.0. With respect to determining and ensuring adequate approval and certification of a given conduct or service that entails religion, spirituality or theology research, you understand and agree to abide by the following additional criteria:
14.40.1. Spirituality, Applicability
that there is determination of applicability of the Human Subjects Research Policy to conduct or service pertaining to religion, spirituality or theology whenever (a) its activity or design focuses directly on specific living individuals or programs directly serving such individuals (b) about or from whom biospecimens, data and information are accessed, collected or otherwise processed; (c) on whom research methods — including inquiries, interactions, and interventions — are conducted; and (d) concerning whom biospecimens, data and information, their processing, or spirituality-related research are administered.
14.40.2. Spirituality, Compliance
that there is clear, prospective and written agreement and attestation by all parties and persons — including the RRB, researcher or investigator, and you, as the human subject concerned — that such religion, spirituality and theology research and its attendant conduct or service are subject to the Human Subjects Research Policy and to initial, then periodic and rigorous review for compliance with its principles, protections, and provisions.
14.40.3. Spirituality, Distinction
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — about the expectations and purposes of the research or investigation study and its distinction from the practice of providing public benefit, public service, and their programs.
14.40.4. Spirituality, Non-Adversity
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — confirming that the studied religious, spiritual or theological interaction, intervention, practice, setting, testing, or equivalent will not adversely impact any human subjects, their opportunities for religious, spiritual or theological practice, or their physical or psychological condition or state.
14.40.5. Spirituality, Publication
that there is assessment and clear, prospective and written agreement and attestation — by the RRB, researcher or investigator, and you, as the human subject concerned — ensuring (a) acknowledgment, citation, and proper ascertainment and respect of intellectual and publicity rights in any publication, reporting, or equivalent sharing of aspects of the research relating to you — as the human subject concerned — especially where there is clear consent by you to reveal your identity; and (b) that each government, public or state agency, authority, department, or office sponsoring or supporting the research, investigation, and demonstration project 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 or state agency, authority, department, or office sponsors or supports under this Policy.
— of Assignment
Section 14.41.0. With respect to determining and ensuring adequate assignment, delegation, and transfer of biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following:
14.41.1. Assignment, Authorization
that non-personal and personal biospecimens, data and information, human subjects research, and administration of both may be assigned, delegated or transferred to authorized and official persons external to Publiks — specifically, third-country and third-party entities, offices, and persons — only with explicit, legitimate and specific instructions and purposes from Publiks, as given via the RRB’s approval and Founder’s authorization.
14.41.2. Assignment, Attestation
that such assignment, delegation, or transfer is accompanied by an authorized and written contract or equivalent legal instrument — between Publiks and the recipient of the assignment, delegation, or transfer (the “assignee,” “delegate,” or “transferee”) — agreed to and signed by all parties and containing all of the following attestations.
14.41.2.1. Assignment, Attestation, Administration, Authorization
agreement and attestation by all parties that Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — is the primary administrator and sole authorizer of the biospecimens, data and information, human subjects research, and administration of both.
14.41.2.2. Assignment, Attestation, Arrangement, Purposes
agreement and attestation by all parties to (a) the overarching or ongoing arrangement, activity, or relationship under which the assignment, delegation, or transfer is conducted; (b) the authorized, consented, explicit, legitimate and specific purposes for the biospecimens, data and information, human subjects research, and administration of both; and (c a systematic evaluation of the regulatory environment of the assignee, delegate, or transferee with respect to standards for human subjects research policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.41.2.3. Assignment, Attestation, Communication, Notification
agreement and attestation by all parties that the assignee, delegate, or transferee will implement authorized administrative, organizational and technical measures to adequately, appropriately and efficaciously ensure reasonably informing communication and notification pertaining to the biospecimens, data and information, human subjects research, and administration of both to all persons concerned.
14.41.2.4. Assignment, Attestation, Compliance
agreement and attestation by all parties that the assignee, delegate, or transferee will implement authorized administrative, organizational and technical measures to adequately, appropriately and efficaciously ensure the biospecimens, data and information, human subjects research, and administration of both are complaint with the policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.41.2.5. Assignment, Attestation, Instructions, Purposes
agreement and attestation by all parties that the assignee, delegate, or transferee will carry out and fulfill only the explicit, legitimate and specific instructions and purposes delineated and described in the contract or equivalent legal instrument, including but not limited to specifications as to appropriate aspects, characteristics, and parameters of biospecimens, data and information, human subjects research, and administration of both.
14.41.2.6. Assignment, Attestation, Recipients, Operational
agreement and attestation by all parties that the assignee, delegate, or transferee will follow only documented instructions with respect to operational transfers of the data and information to recipients, categories of recipients, a third party, a third country or an international organization, and ensure the appropriate safeguards.
14.41.2.7. Assignment, Attestation, Recipients, Subsequent
agreement and attestation by all parties that the assignee, delegate, or transferee will not further or subsequently engage — including assign, delegate, or transfer any of the biospecimens, data and information, human subjects research, or administration of either to — another party, person, or recipient, except where given prior written approval and authorization by Publiks, specifically the Founder, Alvan Azinna Chibuzo Ikoku, as well as an additional written contract or equivalent legal instrument meeting these attestation standards and safeguard measures for principles, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.41.2.8. Assignment, Attestation, Recordation
agreement and attestation by all parties that the assignee, delegate, or transferee will implement authorized administrative, organizational and technical measures to adequately, appropriately and efficaciously ensure compliance with and fulfillment of policies, principles, and protections for documentation pertaining to biospecimens, data and information, human subjects research, and administration of both.
14.41.2.9. Assignment, Attestation, Responsible Persons
the identity and contact information — for all parties involved — of the entities, offices, and persons, or their representatives, responsible for the biospecimens, data and information, human subjects research, administration of both, as well as their assignment, delegation, or transfer.
14.41.2.10. Assignment, Attestation, Single Action
where the transfer is a single-occurrence action without an ongoing arrangement with Publiks — as in the case of a single fulfillment of a request for data portability or interoperable transfer — agreement and attestation by all parties that the transferee has the informed consent of all persons concerned and will assume all liability for any breach, infringement, or violation of policies, principles, or protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.41.2.11. Assignment, Attestation, Termination
agreement and attestation by all parties that the assignee, delegate, or transferee will, on the decision and request of Publiks, delete, erase, or return all data and information and their copies, upon cessation, completion, end, or termination of the assignment, delegation, or transfer or its attendant contract or relationship.
14.41.2.12. Assignment, Attestation, Validity, Liability
agreement and attestation by all parties that the contract or equivalent legal instrument and the aforementioned conditions will be valid; will legally bind the assignee, delegate, or transferee with respect to Publiks — specifically the Founder, Alvan Azinna Chibuzo Ikoku — including but not limited to liabilities to Publiks; and will continue to be valid and legally bind even where the assignee, delegate, or transferee further assigns, delegates, engages, or transfers to another party, person, or recipient.
— of Aim, Purpose
Section 14.42.0. With respect to determining and ensuring adequate aims and purposes for personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.42.1. Purpose, Basis
that each aim, objective, or purpose for personal biospecimens, data and information, human subjects research, and the administration of both is appropriate and reasonable to a sufficient degree to serve as the basis of an Agreement between Publiks and you — as the human subject concerned — as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.42.2. Purpose, Consented
that such purpose is consented (or assented) to by you — as the human subject concerned.
14.42.3. Purpose, Ethical
that such purpose is ethical with respect to you — as the human subject concerned.
14.42.4. Purpose, Explicit
that such purpose is explicit, that is, clearly explained to you.
14.42.5. Purpose, Harm
that such purpose is not harmful to you — as the human subject concerned.
14.42.6. Purpose, Humane
that such purpose is humane, and not inhuman or inhumane, with respect to you — as the human subject concerned.
14.42.7. Purpose, Legal
that such purpose is law-abiding, lawful and legal with respect to you — as the human subject concerned.
14.42.8. Purpose, Legitimate
that such purpose is legitimate, that is, has a reasonable basis that is clear, expectable, transparent and understandable to you — as the human subject concerned.
14.42.8.1. Purpose, Legitimate, Activity
with legitimacy satisfied only where the purpose is not deceptive or misleading; not hidden or undisclosed; understood as integral to the activity being conducted or proposed; and thus reasonably clear, expectable, transparent and understandable to you — as the human subject concerned — given your understanding of the research activity, investigation, and study.
14.42.8.2. Purpose, Legitimate, Appropriateness
with legitimacy satisfied only where the purpose is, as described above, reasonably clear, expectable, transparent and understandable to you — as the human subject concerned — given your understanding that such purpose is to be appropriate for the research activity, investigation, and study.
14.42.8.3. Purpose, Legitimate, Efficacy
with legitimacy satisfied only where the purpose is, as described above, reasonably clear, expectable, transparent and understandable to you — as the human subject concerned — given your understanding that such purpose is to be efficacious for the research activity, investigation, and study.
14.42.8.4. Purpose, Legitimate, Necessity
with legitimacy satisfied only where the purpose is, as described above, reasonably clear, expectable, transparent and understandable to you — as the human subject concerned — given your understanding that such purpose is to be necessary for the research activity, investigation, and study.
14.42.8.5. Purpose, Legitimate, Proportion
with legitimacy satisfied only where the purpose is, as described above, reasonably clear, expectable, transparent and understandable to you — as the human subject concerned — given your understanding that such purpose is to be proportionate for the research activity, investigation, and study.
14.42.8.6. Purpose, Legitimate, Regulation
with legitimacy satisfied only where the purpose is, as described above, reasonably clear, expectable, transparent and understandable to you — as the human subject concerned — given your understanding that such purpose is to be compliant with the policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.42.8.7. Purpose, Legitimate, Relation
with legitimacy satisfied only where the purpose is, as described above, reasonably clear, expectable, transparent and understandable to you — as the human subject concerned — given your relationship to Publiks, for example, as an applicant, customer, employee, member of general public, participant, partner, third party, user, visitor, or volunteer.
14.42.8.8. Purpose, Legitimate, Research Standard
with legitimacy satisfied only where the purpose is acceptable and, as described above, reasonably clear, expectable, transparent and understandable, per the field of knowledge and practice of the research activity, investigation, and study — given standards established and informed by prior research or investigation and published papers, reports, results, or scholarship..
14.42.9. Purpose, Limited
and, where the purpose has been added to or altered from the original purpose, only if such new purpose is also limited, that is, close in nature to the original purpose, compatible and in keeping with your consent, and reasonably expected by you — as the human subject concerned — who will be informed of, review, and consent (or not consent) to the added or altered purpose as soon as reasonably possible.
14.42.10. Purpose, Protective
that such purpose is protective of and minimally risky to you — as the human subject concerned.
14.42.11. Purpose, Specific
that such purpose is specific, that is, clearly defined, delineated and specified to you — as the human subject concerned.
— of Care
Section 14.43.0. With respect to determining and ensuring adequate care in personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.43.1. Care, Basis
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that optimally fulfills the care and ethics principles of beneficence, equipoise, justice, and non-maleficence with respect to you — as the human subject concerned — and then, where applicable and appropriate, to the community, environs, and field of generalizable knowledge in which such biospecimens, data and information, research, and administration are conducted.
14.43.2. Care, Beneficence
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures beneficence by optimally maximizing benefit or utility to you — as the human subject concerned — via such biospecimens, data and information, research, or administration.
14.43.2.1. Care, Beneficence, Benefit Priority
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures beneficence by prioritizing maximization of benefit or utility to you — as the human subject concerned — over, where applicable and appropriate, the community, environs, and field of generalizable knowledge in which such biospecimens, data and information, research, and administration are conducted.
14.43.2.2. Care, Beneficence, Undue Inducement
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures beneficence by avoiding the use, or reducing the effect, of benefits as undue inducement to elicit the consent and research participation of you — as the human subject concerned.
14.43.3. Care, Equipoise
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures equipoise by not subjecting you — as the human subject concerned — to exploitative, substandard or unfavorable condition, outcome, or treatment via such biospecimens, data and information, research, or administration.
14.43.3.1. Care, Equipoise, Interest Priority
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures equipoise by prioritizing the interests and welfare of you — as the human subject concerned — over the interests of, where applicable and appropriate, the community, environs, and field of generalizable knowledge in which such biospecimens, data and information, research, and administration are conducted.
14.43.3.2. Care, Equipoise, Non-Burden
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures equipoise by refraining from inhumane, undue or unequal burden, treatment, or use on or of you — as the human subject concerned — via such biospecimens, data and information, research, or administration.
14.43.3.3. Care, Equipoise, Non-Instrumentality
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures equipoise by refraining from the instrumental use of you — as the human subject concerned — via such biospecimens, data and information, research, or administration.
14.43.3.4. Care, Equipoise, Non-Utilitarianism
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures equipoise by refraining from burdening, depriving, harming, imperiling, or sacrificing you — as the human subject concerned — for the greater good or the increased or maximal gain of a community, field, or state, via such biospecimens, data and information, research, or administration.
14.43.3.5. Care, Equipoise, Termination
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures equipoise by stopping or terminating wherever there is reason to believe, or even a remote possibility, that such exploitation, instrumentalization, non-prioritization, undue burden, or utilitarian use of you — as the human subject concerned — will result from such biospecimens, data and information, research, or administration.
14.43.4. Care, Justice
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures justice by not subjecting you — as the human subject concerned — to discriminatory or unlawful treatment via such biospecimens, data and information, research, or administration.
14.43.4.1. Care, Justice, Non-Bias
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures justice by not effecting or facilitating bias, discrimination, marginalization, or stigmatization against you — as the human subject concerned — via such biospecimens, data and information, research, or administration.
14.43.4.2. Care, Justice, Non-Expediency
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures justice by not effecting or facilitating compromise or expediency with respect to you — as the human subject concerned persons — for politics, profit, or public good, via such biospecimens, data and information, research, or administration.
14.43.4.3. Care, Justice, Non-Infringement, Law
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures justice by not infringing any human subjects research principles or protections with respect to you — as the human subject concerned — as provided for in applicable law and regulation.
14.43.4.4. Care, Justice, Non-Infringement, Policies
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures justice by not infringing any human subjects research principles or protections with respect to you — as the human subject concerned — as provided for in the Human Subjects Research Policy and the Codes and Policies.
14.43.4.5. Care, Justice, Non-Infringement, Rights
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures justice by not infringing any civil liberties or rights accorded by your polities to you — as the human subject concerned — via such biospecimens, data and information, research, or administration.
14.43.4.6. Care, Justice, Non-Vulnerability
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures justice by assessing for and protecting vulnerable persons — including by accounting for a history of vulnerable populations, and by not continuing or repeating the conduct of harmful, unethical or unprotective biospecimens, data and information, research, and administration of both relating to vulnerable populations.
14.43.5. Care, Non-Maleficence
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures non-maleficence by optimally minimizing harm to you — as the human subject concerned — via such biospecimens, data and information, research, or administration.
14.43.5.1. Care, Non-Maleficence, Harm Priority
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures non-maleficence by prioritizing minimization of harm to you — as the human subject concerned — over, where applicable and appropriate, the community, environs, and field of generalizable knowledge in which such biospecimens, data and information, research, and administration are conducted.
14.43.5.2. Care, Non-Maleficence, Undue Harm
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted in a manner that ensures non-maleficence by assessing for and protecting against anticipated, excessive, undue, unexpected, unexplained or unnecessary harm of and to such biospecimens, data and information, research, administration, and protections with respect to you — as the human subject concerned — and then, where applicable and appropriate, the community, environs, and field of generalizable knowledge in which such biospecimens, data and information, research, and administration are conducted.
— of Categorization
Section 14.44.0. With respect to determining and ensuring adequate categorization and classification of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following:
14.44.1. Categorization, Basis
that personal biospecimens, data and information, human subjects research, and the administration of both are accompanied by an adequate, appropriate and efficacious process of categorization and classification facilitating compliance with and fulfillment of policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Polices, and applicable law and regulation.
14.44.2.1. Categories, Biospecimens
that personal biospecimens, data and information, human subjects research, and the administration of both may involve up to six (6) categories and twenty-five (25) subcategories of data and information, personal and non-personal.
14.44.2.2. Categories, Biospecimen Sources
that personal biospecimens, data and information, human subjects research, and the administration of both may involve up to twelve (12) categories and thirty-six (36) subcategories of sources for such biospecimens, data and information, research, and administration.
14.44.2.3. Categories, Persons
that personal biospecimens, data and information, human subjects research, and the administration of both may involve up to ten (10) categories of persons concerned, that is, attributable to, identifiable by, or otherwise relating to such biospecimens, data and information, research, and administration.
14.44.2.4. Categories, Purposes
that personal biospecimens, data and information, human subjects research, and the administration of both may involve up to ten (10) categories of purposes for such biospecimens, data and information, research, and administration.
14.44.2.5. Categories, Recipients
that personal biospecimens, data and information, human subjects research, and the administration of both may involve up to eight (8) categories of recipients of such biospecimens, data and information, research, and administration.
—— of Categories of Biospecimens
Section 14.45.0. With respect to adequate categorization and classification of biospecimens, data and information, both personal and non-personal, you understand and agree to abide by the following:
14.45.1. Biographical —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve data and information categorized as biographical, including the subcategories below.
14.45.1.1. Biographical, Birth, Life
such biographical data and information relating to your birth, life events, and personal history, including their effect and influences on you and your surroundings.
14.45.1.2. Biographical, Family
such biographical data and information relating to your family events, history, members, relationships, structure, and status changes.
14.45.1.3. Biographical, Personal Communication
such biographical data and information relating to your personal and private communications, conversations, and correspondence.
14.45.1.4. Biographical, Schooling, Training, Work
such biographical data and information relating to your education, schooling, training, and work events, history, and records.
14.45.2. Econographical —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve data and information categorized as econographical, including the subcategories below.
14.45.2.1. Econographical, Accounts, Cards
such econographical data and information relating to your financial accounts, cards, instruments, and policies information and records.
14.45.2.2. Econographical, Assets, Properties
such econographical data and information relating to assets and intellectual and real properties you currently or previously acquire, borrow, develop, entrust, equip or furnish, insure, invest, lease, license, lien, occupy or reside in, own, pay taxes for, possess, register, rent or rent out, sell, or transact.
14.45.2.3. Econographical, Credit Capacity, Standing
such econographical data and information relating to your borrowing and credit capacity, records, reports, reputation, scores, standing, and worthiness.
14.45.2.4. Econographical, Earnings, Transactions
such econographical data and information relating to your earnings, income, philanthropic, tax and transactional activities, events, habits, history, and records.
14.45.3. Physiographical —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve biospecimens, data and information categorized as physiographical, including the subcategories below.
14.45.3.1. Physiographical, Bodily, Physical
such physiographical biospecimens, data and information relating to your specific bodily, genetic, phenotypic and physical abilities, aspects, alterations, characteristics, conditions, dimensions, markings, scars, and states.
14.45.3.2. Physiographical, Cultural, Ethnic
such physiographical biospecimens, data and information relating to your cultural, ethnic, political and “racial” heritages, genealogies, identities, languages, lineages, origins, and practices.
14.45.3.3. Physiographical, Demographic, Epidemiological
such physiographical biospecimens, data and information relating to demographic, epidemiological and socioeconomic characteristics, ranges, and traits you share with others in classifications, cohorts, and populations.
14.45.3.4. Physiographical, Health, Medical
such physiographical biospecimens, data and information relating to your health, medical, fitness and wellness care, condition, events, history, information, procedures, records, results, status, and therapies.
14.45.4. Psychographical —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve data and information categorized as psychographical, including the subcategories below.
14.45.4.1. Psychographical, Abstractions, Ideations
such psychographical data and information relating to your abstractions, apperceptions, conceptualizations, creativities, ideations, imaginations, inventions, narrations, and other conceptual events, relations, and states.
14.45.4.2. Psychographical, Affections, Associations
such psychographical data and information relating to your affections, affinities, associations, and other emotional instances, relations, and states.
14.45.4.3. Psychographical, Aptitudes, Knowledges
such psychographical data and information relating to your cognitive and mental abilities, aptitudes, intelligences, knowledges, learnings, and other epistemic instances, relations, and states.
14.45.4.4. Psychographical, Attentions, Experiences
such psychographical data and information relating to your attentions, awarenesses, experiences, memories, and other attentional events, relations, and states.
14.45.4.5. Psychographical, Attitudes, Intentions
such psychographical data and information relating to your attitudes, beliefs, convictions, dispositions, inclinations, intentions, interests, opinions, perspectives, preferences, proclivities, resolutions, tendencies and other attitudinal instances, relations, and states.
14.45.5. Sociographical —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve data and information categorized as sociographical, including the subcategories below.
14.45.5.1. Sociographical, Behavioral
such sociographical data and information relating to your behaviors, choices, habits, and other behavioral events, relations, and states.
14.45.5.2. Sociographical, Interpersonal
such sociographical data and information relating to your interpersonal activities, friendships, life, networks, orientation, relationships, and other interpersonal events, relations, and states.
14.45.5.3. Sociographical, Societal
such sociographical data and information relating to your communal, political, public, social and societal activities, engagement, life, practice, service, status, and other societal events, relations, and states.
14.45.5.4. Sociographical, State
such sociographical data and information relating to your governmental and state records of activities, citizenship, identification, offenses, proceedings, registrations, residences, services, statuses, travels, voting, and work.
14.45.6. Technographical —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve data and information categorized as technographical, including the subcategories below.
14.45.6.1. Technographical, Applications, Devices
such technographical data and information relating to applications, computers, devices, equipments, and other technologies that you specifically use.
14.45.6.2. Technographical, Contacts, Connections
such technographical data and information relating to your contacts, connections and network activities, addresses, events, history, information, records, and status via online, postal, technological, telecommunications and virtual means.
14.45.6.3. Technographical, Location, Motion
such technographical data and information relating to your geo- or positional location, motions, and movements, at any moment and over time, in and across a given area, block, building, city, country, county, distance, GPS coordinates, neighborhood, province, region, room, space, state, street, town, and village.
14.45.6.4. Technographical, Uniquely Identifying
such technographical data and information relating to identifiers that semi-uniquely or uniquely identifies you as part of either (a) private and authenticating activity, most often something only you or one other living person could access, know, or possess at a precise time; or (b) public and identifying activity, such as aliases, names, and usernames; biometric prints and recognition; government or institution-issued identification and numbers, handwriting and signatures, images, pictures, and video.
—— of Categories of Biospecimen Sources
Section 14.46.0. With respect to adequate categorization and classification of sources of biospecimens, data and information, both personal and non-personal, you understand and agree to abide by the following:
14.46.1. Account-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of data and information categorized as account-derivative.
14.46.1.1. Account-Derivate, Authenticating
account-derivative authenticating information and data (“accaids” or “acc-AIDs”) that are derived from authentication you enable, engage in, or engender during your access, creation, and other use of accounts, profiles, and equivalent.
14.46.1.2. Account-Derivate, Identifying
account-derivative identifying information and data (“accids” or “acc-IDs”) that are derived from identification you enable, engage in, or engender during your access, creation, and other use of accounts, profiles, and equivalent.
14.46.1.3. Account-Derivate, Tracing
account-derivative settings, tracings and trackings (“accssetts,” “acctraces,” or “acctracks”) that are derived from activities and specifications you enable, engage in, or engender during your access and other use of accounts, profiles, and equivalent.
14.46.2. Application-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of data and information categorized as app- or application-derivative.
14.46.2.1. Application-Derivate, Authenticating
app- or application-derivative authenticating information and data (“appaids” or “app-AIDs,” also “brows-AIDs” for browsers) that are derived from authentication you enable, engage in, or engender during your access, installation, and other use of applications, browsers, and equivalent.
14.46.2.2. Application-Derivate, Identifying
app- or application-derivative identifying information and data (“appids” or “app-IDs,” also “brows-IDs” for browsers) that are derived from identification you enable, engage in, or engender during your access, installation, and other use of applications, browsers, and equivalent.
14.46.2.3. Application-Derivate, Tracing
app- or application-derivative settings, tracings and trackings (“appssetts,” “apptraces,” or “apptracks” also browser-associated tracing, tracking and settings or “batts”) that are derived from activities and specifications you enable, engage in, or engender during your access and other use of applications, browsers, and equivalent.
14.46.3. Body-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of biospecimens, data and information categorized as body-derivative.
14.46.3.1. Body-Derivate, Authenticating
body-derivative authenticating information and data (“bodaids” or “body-AIDs”) — including biospecimens — that are derived from authentication you enable, engage in, or engender during access to or provision from your physical or physiological body.
14.46.3.2. Body-Derivate, Identifying
body-derivative identifying information and data (“bodids” or “body-IDs”) — including biospecimens — that are derived from identification you enable, engage in, or engender during access to or provision from your physical or physiological body.
14.46.3.3. Body-Derivate, Tracing
body-derivative settings, tracings and trackings (“bodyssetts,” “bodytraces,” or “bodytracks”) — including biospecimens — that are derived from activities and specifications you enable, engage in, or engender during access to or provision from your physical or physiological body.
14.46.4. Device-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of biospecimens, data and information categorized as dev- or device-derivative.
14.46.4.1. Device-Derivate, Authenticating
dev- or device-derivative authenticating information and data (“devaids” or “dev-AIDs”) — including biospecimens — that are derived from authentication you enable, engage in, or engender during your access, acquisition, and other use of computers, devices, equipment, and equivalent technologies.
14.46.4.2. Device-Derivate, Identifying
dev- or device-derivative identifying information and data (“devids” or “dev-IDs”) — including biospecimens — that are derived from identification you enable, engage in, or engender during your access, acquisition, and other use of computers, devices, equipment, and equivalent technologies.
14.46.4.3. Device-Derivate, Tracing
dev- or device-derivative settings, tracings and trackings (“devssetts,” “devtraces,” or “devtracks”) — including biospecimens — that are derived from activities and specifications you enable, engage in, or engender during your access and other use of computers, devices, equipment, and equivalent technologies.
14.46.5. Government-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of data and information categorized as gov- or government-derivative.
14.46.5.1. Government-Derivate, Authenticating
gov- or government-derivative authenticating information and data (“govaids” or “gov-AIDs”) that are derived from authentication you enable, engage in, or engender during your access, recognition by, and other use and visiting of government and state offices, services, and equivalent.
14.46.5.2. Government-Derivate, Identifying
gov- or government-derivative identifying information and data (“govids” or “gov-IDs”) that are derived from identification you enable, engage in, or engender during your access, recognition by, and other use and visiting of government and state offices, services, and equivalent.
14.46.5.3. Government-Derivate, Records
gov- or government-derivative records (“gov-RECs”) that are derived from records generated by your access, recognition by, and other use and visiting of government and state activities, areas, entities, offices, services, and equivalent.
14.46.6. Location-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of data and information categorized as geo- or location-derivative.
14.46.6.1. Location-Derivate, Authenticating
geo- or location-derivative authenticating information and data (“locaids” or “loc-AIDs”) that are derived from authentication you enable, engage in, or engender during your location, position, motion, movement, and equivalent activity.
14.46.6.2. Location-Derivate, Identifying
geo- or location-derivative identifying information and data (“locids” or “loc-IDs”) that are derived from identification you enable, engage in, or engender during your location, position, motion, movement, and equivalent activity.
14.46.6.3. Location-Derivate, Tracing
geo- or location-derivative settings, tracings and trackings (“locssetts,” “loctraces,” or “loctracks”) that are derived from activities and specifications you enable, engage in, or engender during your location, position, motion, movement, and equivalent activity.
14.46.7. Log-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of data and information categorized as log-derivative.
14.46.7.1. Log-Derivate, Authenticating
log-derivative authenticating information and data (“logaids” or “log-AIDs”) that are derived from authentication you enable, engage in, or engender during activity that generates or produces log files, server logs, temp records, and equivalent.
14.46.7.2. Log-Derivate, Identifying
log-derivative identifying information and data (“logids” or “log-IDs”) that are derived from identification you enable, engage in, or engender during activity that generates or produces log files, server logs, temp records, and equivalent.
14.46.7.3. Log-Derivate, Records
log-generated and -emanating records (“loggers” or “log-RECS”) that are derived from via any of your activity that generates, uses, or otherwise processes log files, server logs, temp records, and equivalent.
14.46.8. Party-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of biospecimens, data and information categorized as party-derivative.
14.46.8.1. Party-Derivate, Authenticating
party-derivative authenticating information and data (“partaids” or “part-AIDs”) — including biospecimens — that are derived from authentication you enable, engage in, or engender during activity via third-party partners, processors, providers, purchases, servicers, vendors, and equivalent.
14.46.8.2. Party-Derivate, Identifying
party-derivative identifying information and data (“partids” or “part-IDs”) — including biospecimens — that are derived from identification you enable, engage in, or engender during activity via third-party partners, processors, providers, purchases, servicers, vendors, and equivalent.
14.46.8.3. Party-Derivate, Records
party-generated and -emanating records (“pagers” or “part-RECS”) — including biospecimens — that are derived from via any of your activity that generates, uses, or otherwise processes records via third-party partners, processors, providers, purchases, servicers, vendors, and equivalent.
14.46.9. Product-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of data and information categorized as product-derivative.
14.46.9.1. Product-Derivate, Authenticating
product-derivative authenticating information and data (“prodaids” or “prod-AIDs”) that are derived from authentication you enable, engage in, or engender during your access, acquisition, and other use of products and equivalent.
14.46.9.2. Product-Derivate, Identifying
product-derivative identifying data and information (“prodids” or “prod-IDs”) that are derived from identification you enable, engage in, or engender during your access, acquisition, and other use of products and equivalent.
14.46.9.3. Product-Derivate, Tracing
product-derivative settings, tracings and trackings (“prodssetts,” “prodtraces,” or “prodtracks”) that are derived from activities and specifications you enable, engage in, or engender during your access and other use of products and equivalent.
14.46.10. Public-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of data and information categorized as public-derivative or publicly available.
14.46.10.1. Public, Authenticating
publicly available authenticating information and data (“pubaids” or “pub-AIDs”) that are derived from authentication you enable, engage in, or engender during your access, creation, and other use and visiting of openly and publicly available records, sources, and equivalent.
14.46.10.2. Public, Identifying
publicly available identifying information and data (“pubids” or “pub-IDs”) that are derived from identification you enable, engage in, or engender during your access, creation, and other use and visiting of openly and publicly available records, sources, and equivalent.
14.46.10.3. Public, Records
publicly available records and collections (“parcs” or “pub-RECS”) that are derived from records generated by your access, recognition by, and other use and visiting of publicly accessible and available activities, areas, entities, offices, services, and equivalent.
14.46.11. Service-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of biospecimens, data and information categorized as service-derivative.
14.46.11.1. Service-Derivate, Authenticating
service-derivative authenticating information and data (“servaids” or “serv-AIDs”) — including biospecimens — that are derived from authentication you enable, engage in, or engender during your access and other use of services, sites, and equivalent.
14.46.11.2. Service-Derivate, Identifying
service-derivative identifying information and data (“servids” or “serv-IDs”) — including biospecimens — that are derived from identification you enable, engage in, or engender during your access and other use of services, sites, and equivalent.
14.46.11.3. Service-Derivate, Tracing
service-derivative settings, tracings and trackings (“servsetts,” “servtraces,” or “servtracks”) — including biospecimens — that are derived from activities and specifications you enable, engage in, or engender during your access and other use of services, sites, and equivalent.
14.46.12. Storage-Derivate —
that personal biospecimens, data and information, human subjects research, and the administration of both may involve sources of data and information categorized as service-derivative.
14.46.12.1. Storage, Authenticating
storage-specific authenticating information and data (“storaids” or “stor-AIDs”) that are derived from authentication you enable, engage in, or engender during your access, creation, and other use of caches, datasets, servers, and equivalent storage.
14.46.12.2. Storage, Identifying
storage-specific identifying information and data (“storids” or “stor-IDs”) that are derived from identification you enable, engage in, or engender during your access, creation, and other use of caches, datasets, servers, and equivalent storage.
14.46.12.3. Storage, Records
storage-emenating records (“storers” or “stor-RECS”) that are derived from via any of your activity that generates, uses, or otherwise processes caches, datasets, servers, and equivalent storage.
—— of Categories of Persons
Section 14.47.0. With respect to adequate categorization and classification of persons concerned regarding biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following:
14.47.1. Account-Attributable
that personal biospecimens, data and information, human subjects research, and the administration of both may involve persons concerned categorized as account-attributable, that is, those attributable to or identifiable as actual, former or potential holders of accounts, profiles, and equivalent.
14.47.2. Application-Attributable
that personal biospecimens, data and information, human subjects research, and the administration of both may involve persons concerned categorized as application-attributable, that is, those attributable to or identifiable as actual, former or potential customers or users of applications, browsers, and equivalent.
14.47.3. Device-Attributable
that personal biospecimens, data and information, human subjects research, and the administration of both may involve persons concerned categorized as device-attributable, that is, those attributable to or identifiable as actual, former or potential customers or users of computers, devices, equipment, and equivalent smart technologies.
14.47.4. Organization-Attributable
that personal biospecimens, data and information, human subjects research, and the administration of both may involve persons concerned categorized as organization-attributable, that is, those attributable to or identifiable as actual, former or potential official persons of Publiks, including their beneficiaries and emergency contacts.
14.47.5. Party-Attributable
that personal biospecimens, data and information, human subjects research, and the administration of both may involve persons concerned categorized as party-attributable, that is, those attributable to or identifiable as actual, former or potential third parties of Publiks, including third-county and third-party partners, processors, providers, purchases, servicers, vendors, and equivalent.
14.47.6. Product-Attributable
that personal biospecimens, data and information, human subjects research, and the administration of both may involve persons concerned categorized as product-attributable, that is, those attributable to or identifiable as actual, former or potential customers or users of goods, products, and equivalent.
14.47.7. Profession-Attributable
that personal biospecimens, data and information, human subjects research, and the administration of both may involve persons concerned categorized as product-attributable, that is, those attributable to or identifiable as actual, former or potential members, officials, representatives, workers, or other agents of a field, guild, profession, or specialty, or a certifying, professional, or licensing body, entity, or office.
14.47.8. Public-Attributable
that personal biospecimens, data and information, human subjects research, and the administration of both may involve persons concerned categorized as public- or population-attributable, that is, those attributable to or identifiable as cohorts, communities, groups, members, representatives, samples, sectors, and equivalent of the general public and population.
14.47.9. Service-Attributable
that personal biospecimens, data and information, human subjects research, and the administration of both may involve persons concerned categorized as public- or population-attributable, that is, those attributable to or identifiable as actual, former or potential customers or users of services, sites, and equivalent.
14.47.10. State-Attributable
that personal biospecimens, data and information, human subjects research, and the administration of both may involve persons concerned categorized as public- or population-attributable, that is, those attributable to or identifiable as members, officials, representatives, or other agents of governmental, public, regulatory and equivalent bodies, entities, or offices.
—— of Categories of Purposes
Section 14.48.0. With respect to adequate categorization and classification of purposes for biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following:
14.48.1. Account-Focused
that personal biospecimens, data and information, human subjects research, and the administration of both may be for purposes categorized as account-focused, that is, for the purposes of administering, enhancing, as well as offering an account, profile, and equivalent.
14.48.2. Advertising-Focused
that personal biospecimens, data and information, human subjects research, and the administration of both may be for purposes categorized as ad- or advertising-focused, that is, for the purposes of advertising, marketing, and public relations.
14.48.3. Communication-Focused
that personal biospecimens, data and information, human subjects research, and the administration of both may be for purposes categorized as communication-focused, that is, for the purposes of communication and notification to persons relating to Publiks.
14.48.4. Compliance-Focused
that personal biospecimens, data and information, human subjects research, and the administration of both may be for purposes categorized as compliance-focused, that is, for the purposes of fulfilling and responding to compliance requests and requirements, as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.48.5. Development-Focused
that personal biospecimens, data and information, human subjects research, and the administration of both may be for purposes categorized as development-focused, that is, for the purposes of for the purposes of research, design, and development.
14.48.6. Feedback-Focused
that personal biospecimens, data and information, human subjects research, and the administration of both may be for purposes categorized as feedback-focused, that is, for the purposes of participation in feedback, focus groups, opinion polls, surveys, and equivalent means of ascertaining awareness, knowledge, and perspectives of persons.
14.48.7. Organization-Focused
that personal biospecimens, data and information, human subjects research, and the administration of both may be for purposes categorized as compliance-focused, that is, for the purposes of administration and fulfillment of the duties, functions, interests, and responsibilities of Publiks.
14.48.8. Product-Focused
that personal biospecimens, data and information, human subjects research, and the administration of both may be for purposes categorized as product-focused, that is, for the purposes of administering, enhancing, as well as offering the Products to actual, former and potential customers, users, and visitors.
14.48.9. Service-Focused
that personal biospecimens, data and information, human subjects research, and the administration of both may be for purposes categorized as service-focused, that is, for the purposes of administering, enhancing, as well as offering the Services to actual, former and potential customers, users, and visitors.
14.48.10. Support-Focused
that personal biospecimens, data and information, human subjects research, and the administration of both may be for purposes categorized as support-focused, that is, for the purposes of assistance, maintenance, troubleshooting, updating, and other support for persons relating to the Products and Services and to Publiks.
—— of Categories of Recipients
Section 14.49.0. With respect to adequate categorization and classification of recipients for biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following:
14.49.1. Ikoku Charitable Trusts-Receiving
that personal biospecimens, data and information, human subjects research, and the administration of both may involve recipients categorized as Ikoku Charitable Trusts-receiving, that is, authorized and recognized as official persons and recipients of The Chinyere and Chinelo Ikoku Charitable Trusts.
14.49.2. Ikoku Foundation-Receiving, C&C
that personal biospecimens, data and information, human subjects research, and the administration of both may involve recipients categorized as C&C Ikoku Foundation-receiving, that is, authorized and recognized as official persons and recipients of The Chinyere and Chinelo Ikoku Foundation.
14.49.3. Ikoku Foundation-Receiving, Alvan
that personal biospecimens, data and information, human subjects research, and the administration of both may involve recipients categorized as Alvan Ikoku Foundation-receiving, that is, authorized and recognized as official persons and recipients of The Alvan Azinna Chibuzo Ikoku Foundation.
14.49.4. Ikoku Center-Receiving
that personal biospecimens, data and information, human subjects research, and the administration of both may involve recipients categorized as Ikoku Center-receiving, that is, authorized and recognized as official persons and recipients of The Alvan Ikoku Center for Ethics.
14.49.5. Ikoku Institute-Receiving
that personal biospecimens, data and information, human subjects research, and the administration of both may involve recipients categorized as Ikoku Institute-receiving, that is, authorized and recognized as official persons and recipients of The Alvan Ikoku Institute for International Affairs.
14.49.6. Ikoku Philanthropies-Receiving
that personal biospecimens, data and information, human subjects research, and the administration of both may involve recipients categorized as Ikoku Philanthropies-receiving, that is, authorized and recognized as official persons and recipients of The Alvan Ikoku Philanthropies.
14.49.7. Ikoku University-Receiving
that personal biospecimens, data and information, human subjects research, and the administration of both may involve recipients categorized as Ikoku University-receiving, that is, authorized and recognized as official persons and recipients of Alvan Ikoku University.
14.49.8. Humana Sancta-Receiving
that personal biospecimens, data and information, human subjects research, and the administration of both may involve recipients categorized as Humana Sancta-receiving, that is, authorized and recognized as official persons and recipients of Humana Sancta.
14.49.9. Founder-Administering
with all of the aforementioned categories of recipients authorized and administered solely by the Founder, Alvan Azinna Chibuzo Ikoku, as executed solely via the Founder’s authorization.
— of Communication
Section 14.50.0. With respect to determining and ensuring adequate communication and notification pertaining to personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.50.1. Communication, Basis
that personal biospecimens, data and information, human subjects research, and the administration of both are accompanied by communication and notification that provides to you — as the human subject concerned — all the key information, in sufficient detail, that a reasonable person would need in order to make an informed decision about whether to permit, rectify, or terminate the personal biospecimens, data and information, human subjects research, or the administration of either; 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 in understanding the reasons why you may or may not decide to permit, rectify, or terminate such biospecimens, data and information, research, or administration.
14.50.2.1. Communication, Anticipated
that such communication or notification explicitly states and explains to you — as the human subject concerned — whether the study you are participating in involves research or investigation; whether the study involves an interaction or intervention as part of its methods; and whether biospecimens, data and information attributable to, identifying or otherwise relating to you will be accessed, collected or otherwise processed.
14.50.2.2. Communication, Aim, Purpose
that such communication or notification explicitly states and explains to you — as the human subject concerned — the explicit, legitimate and specific aim or purpose for such personal biospecimens, data and information, research, and administration.
14.50.2.3. Communication, Benefit
that such communication or notification explicitly states and explains to you — as the human subject concerned — the ethical, lawful and specific benefit to you or to others that may reasonably be expected from such personal biospecimens, data and information, research, and administration.
14.50.2.4. Communication, Cost, Discomfort
that such communication or notification explicitly states and explains to you — as the human subject concerned — the ethical, lawful and specific cost or discomfort to you that may reasonably be expected from such personal biospecimens, data and information, research, and administration.
14.50.2.5. Communication, Duration
that such communication or notification explicitly states and explains to you — as the human subject concerned — the ethical, lawful and specific duration or period of time for such personal biospecimens, data and information, research, and administration.
14.50.2.6. Communication, Extent, Scope
that such communication or notification explicitly states and explains to you — as the human subject concerned — the ethical, lawful and specific extent or scope of such personal biospecimens, data and information, research, and administration.
14.50.2.7. Communication, Manner
that such communication or notification explicitly states and explains to you — as the human subject concerned — the ethical, lawful and specific manner, means, measures, mechanisms, methods, or modes for such personal biospecimens, data and information, research, and administration, including (a) descriptions of any interaction or intervention; (b) explanations of any instructions that you will be asked to follow; and (c) explanations of any methods or procedures that are experimental.
14.50.2.7.1. Communication, Manner, Automation
that such communication or notification explicitly states and explains to you — as the human subject concerned — whether such personal biospecimens, data and information, research, and administration entail automation and automated methods, including but not limited to an algorithm or equivalent logic, automated individual decision-making, and profiling.
14.50.2.7.2. Communication, Manner, Automation, Absence, Child
that, if so, such communication or notification explicitly confirms and explains to you — as the human subject concerned — the absence and non-involvement of a child (including, where applicable, yourself) attributable to, identifiable by, or otherwise related to such personal biospecimens, data and information, research, and administration; and where a child is involved, further confirmation that such biospecimens, data and information, research, and administration are strictly prohibited, and where applicable, immediately ceased and remedied.
14.50.2.7.3. Communication, Manner, Automation, Absence, Public Areas
that, if so, such communication or notification explicitly states and explains to you — as the human subject concerned — the absence and non-involvement of publicly accessible areas; and where publicly accessible areas are involved, further confirmation that such biospecimens, data and information, research, and administration are strictly prohibited, and where applicable, immediately ceased and remedied, unless as provided for under the Principle of Protection.
14.50.2.7.4. Communication, Manner, Automation, Absence, Sensitivity
that, if so, such communication or notification explicitly confirms and explains to you — as the human subject concerned — the absence and non-involvement of sensitive biospecimens, data and information; and where sensitive biospecimens, data and information are involved, further confirmation that such biospecimens, data and information, research, and administration are strictly prohibited, and where applicable, immediately ceased and remedied, unless as provided for under the Principles of Protection and Sensitivity.
14.50.2.7.5. Communication, Manner, Automation, Decisions
that, if so, such communication or notification explicitly confirms and explains to you — as the human subject concerned — the nature of decisions made or reached via the proposed or reported automation or automated methods; and where such automated decision-making is involved, further confirmation of the means for you to challenge any such decisions and, where feasible and reasonable, to request human input or intervention.
14.50.2.7.6. Communication, Manner, Automation, Methods
that, if so, such communication or notification explicitly states and explains to you — as the human subject concerned — specific details as to the means of proposed or reported processing via automation or automated methods, including meaningful information about the logic, decision-making, profiling, or other methods involved, as well as the actual and envisaged consequences and significant effects for you of employing the specified methods; and if the methods involved are new, further confirmation that such biospecimens, data and information, research, and administration are prohibited, and where applicable, immediately ceased and remedied, unless as provided for under the Principle of Protection.
14.50.2.7.7. Communication, Manner, Automation, Risks
that, if so, such communication or notification explicitly states and explains to you — as the human subject concerned — the level and nature of risk to you of using the automation and automated methods; and if high risk, further confirmation that such biospecimens, data and information, research, and administration are prohibited, and where applicable, immediately ceased and remedied, unless as provided for under the Principle of Protection.
14.50.2.7.8. Communication, Manner, Automation, Scale
that, if so, such communication or notification explicitly states and explains to you — as the human subject concerned — the scale and size of such biospecimens, data and information, research, and administration; and if large-scale, further confirmation that such biospecimens, data and information, research, and administration are prohibited, and where applicable, immediately ceased and remedied, unless as provided for under the Principle of Protection.
14.50.2.7.9. Communication, Manner, Automation, Significance
that, if so, such communication or notification explicitly states and explains to you — as the human subject concerned — the legal or similarly significant effects of using the automation and automated methods; and if there are such effects, further confirmation that such biospecimens, data and information, research, and administration are prohibited, unless as provided for under the Principle of Protection.
14.50.2.8. Communication, Material
that such communication or notification explicitly states and explains to you — as the human subject concerned — the ethical, lawful and specific materials and categories, natures, and types of materials in such personal biospecimens, data and information, research, and administration.
14.50.2.9. Communication, Matter
that such communication or notification explicitly states and explains to you — as the human subject concerned — the ethical, lawful and specific matters and categories, natures, and types of matters in such personal biospecimens, data and information, research, and administration.
14.50.2.10. Communication, Minimization, Necessity
that such communication or notification explicitly states and explains to you — as the human subject concerned — the ethical, lawful and specific measures for ensuring that such personal biospecimens, data and information, research, and administration adhere to and fulfill the principles of minimization, necessity, and non-identification, as provided for in the Human Subjects Research Policy and the Codes and Policies.
14.50.2.11. Communication, Non-Identification
that such communication or notification explicitly states and explains to you — as the human subject concerned — whether and how identifiers will be removed from such personal biospecimens, data and information, research, and administration; whether or how other processes of non-identification are to be employed, including periodic re-identification, and if so under what circumstances and to what extent; and, whether or not such processes of non-identification are conducted, clearly confirm to you that the still personal biospecimens, data and information will not be involved in any future or other administration or processing, unless with additional informed consent from you.
14.50.2.12. Communication, Non-Personalization
that such communication or notification clearly provides you — as the human subject concerned — reasonable opportunity to consent to have such personal biospecimens, data and information become and remain non-personal via a combination of irreversible anonymization and further transformation (such as data aggregation), after which such data and information can be used for future or other administration or processing without additional informed consent from you.
14.50.2.13. Communication, Persons
that such communication or notification explicitly states and explains to you — as the human subject concerned — the ethical, lawful and specific persons and categories of persons involved in such personal biospecimens, data and information, research, and administration, including the approximate number of human subjects involved in the study and any assignments, delegations, or transfers to any recipient, third party, third country or international organization.
14.50.2.14. Communication, Research, Alternative
that, where applicable, such communication or notification explicitly states and explains to you — as the human subject concerned — alternative courses of treatment or alternatives to such biospecimens, data and information, research, or administration that might be appropriate and advantageous to you.
14.50.2.15. Communication, Research, Commercial
that such communication or notification explicitly states and confirms to you — as the human subject concerned — that whether or not processes of non-identification are conducted, such biospecimens, data and information, research, and administration will not be used for commercial profit or equivalent benefit without your explicit consent and agreement to additional and specified terms.
14.50.2.16. Communication, Research, Future
that such communication or notification explicitly states and confirms to you — as the human subject concerned — that whether or not processes of non-identification are conducted, such biospecimens, data and information, research, and administration will not be used for future research studies or distributed to another researcher or investigator for future research studies without your explicit consent and agreement to additional and specified terms.
14.50.2.17. Communication, Results Disclosure
that such communication or notification explicitly confirms and explains to you — as the human subject concerned — whether clinically relevant research results, including individual results, are to be disclosed to you, and if so, under what conditions; and whether significant new findings developed during the course of the research or investigation that may relate to your willingness to continue your participation are to be provided to you.
14.50.2.18. Communication, Rights
that such communication or notification explicitly states and explains to you — as the human subject concerned — your rights with respect to such personal biospecimens, data and information, research, and administration; the means and procedures for exercising your rights in relation to such biospecimens, data and information, processing, and administration; and that such biospecimens, data and information, processing, and administration do not infringe the locally accorded civil liberties or rights of you or of other persons concerned, including Publiks and the Founder, Alvan Azinna Chibuzo Ikoku.
14.50.2.19. Communication, Risks
that such communication or notification explicitly states and explains to you — as the human subject concerned — the ethical, lawful and specific risks to you that may reasonably be expected from such personal biospecimens, data and information, research, and administration; and where there is more than minimal risk, 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.
14.50.2.20. Communication, Safeguards
that such communication or notification explicitly states and explains to you — as the human subject concerned — policies, principles, and standards for such personal biospecimens, data and information, research, and administration; the protections and safeguards in relation to such biospecimens, data and information, research, and administration; and where applicable, further communication or notification reasonably informing you of any confirmed infringement of such protections and safeguards.
14.50.2.21. Communication, Sensitivity
that such communication or notification explicitly states and explains to you — as the human subject concerned — whether sensitive biospecimens, data and information attributable to, identifying or otherwise relating to you (especially biospecimens) has been, is being, or will be accessed or otherwise processed about or from you; and if so, that such communication also confirms and explains the consent process, protections, and safeguards provided to you specifically for such sensitivity.
14.50.2.22. Communication, Status
that such communication or notification explicitly states and explains to you — as the human subject concerned — the ethical, lawful and specific procedures of keeping you informed of the status of such personal biospecimens, data and information, research, and administration, including requests by you for such information, provided that your requests and the responses of Publiks are both feasible and reasonable with respect to cost, frequency, number, proportionate effort, technical limits, and risks to other persons concerned, especially Publiks and the Founder.
14.50.2.23. Communication, Termination, Withdrawal
that such communication or notification explicitly states and explains to you — as the human subject concerned — anticipated circumstances under which your participation may be terminated by the researcher or investigator without regard to your consent or assent; the consequences of any decision by you to withdraw your participation; and procedures for orderly termination of participation by your decision.
14.50.2.24. Communication, Voluntary
that such communication or notification explicitly states and explains to you — as the human subject concerned — that permission for such personal biospecimens, data and information, research, and administration is voluntary; that refusal to provide involves no penalty or punishment or loss of benefits to which you are otherwise entitled; and that you are able to discontinue to provide at any time without penalty, punishment, or loss of benefits to which you are otherwise entitled.
14.50.2.25. Communication, Where Compulsory
nevertheless, that such communication or notification explicitly states and explains to you — as the human subject concerned — whether such personal biospecimens, data and information, research, and administration is a compulsory, contractual, obligatory or statutory requirement, and the possible consequences of failure to conduct such personal biospecimens, data and information, research, and administration.
14.50.2.26. Communication, Who Responsible
that such communication or notification explicitly states and explains to you — as the human subject concerned — the identity and contact information of the entity, office, or person responsible for such personal biospecimens, data and information, research, and administration, including whom you are to contact for pertinent questions or requests.
14.50.3. Communication, With Opportunities
that such communication or notification explicitly states and provides to you — as the human subject concerned — sufficient opportunity and period of time to ask questions, discuss concerns, 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, with additional opportunities for discussion prior to, during and after conduct of such personal biospecimens, data and information, research, and administration.
14.50.3.1. Communication, With Opportunities, Confirmation
that such communication or notification explicitly states and provides to you — as the human subject concerned — the aforementioned sufficient opportunity to make feasible and reasonable requests to confirm that such personal biospecimens, data and information, research, and administration do not infringe any provisions of the Human Subjects Research Policy, the Codes and Polices, or applicable law or regulation.
14.50.3.2. Communication, With Opportunities, Copy
that such communication or notification explicitly states and provides to you — as the human subject concerned — the aforementioned sufficient opportunity to make feasible and reasonable requests for a copy of personal biospecimens, data and information that are appropriately and legally available to you, in a structured, commonly used and machine-readable format, with subsequent actions and decisions clearly confirmed and explained, without unreasonable delay.
14.50.3.3. Communication, With Opportunities, Disagreement
that such communication or notification explicitly states and provides to you — as the human subject concerned — the aforementioned sufficient opportunity to make feasible and reasonable requests to disagree with, dispute, or object to a particular personal biospecimen, data or information, human subjects research, or the administration of either, with subsequent actions and decisions clearly confirmed and explained, without unreasonable delay.
14.50.3.4. Communication, With Opportunities, Erasure
that such communication or notification explicitly states and provides to you — as the human subject concerned — the aforementioned sufficient opportunity to make feasible and reasonable requests to have a particular personal biospecimen, data or information, human subjects research, or the administration of either deleted or erased, with subsequent actions and decisions clearly confirmed and explained, without unreasonable delay.
14.50.3.5. Communication, With Opportunities, Rectification
that such communication or notification explicitly states and provides to you — as the human subject concerned — the aforementioned sufficient opportunity to make feasible and reasonable requests to have any discovered inaccuracies, inadequacies, incompleteness, infringements, insufficiencies, or equivalent in a particular personal biospecimen, data or information, human subjects research, or the administration of either rectified, with subsequent actions and decisions clearly confirmed and explained, without unreasonable delay.
14.50.3.6. Communication, With Opportunities, Restriction
that such communication or notification explicitly states and provides to you — as the human subject concerned — the aforementioned sufficient opportunity to make feasible and reasonable requests to have a particular personal biospecimen, data or information, human subjects research, or the administration of either limited or restricted, either permanently or temporarily, with subsequent actions and decisions clearly confirmed and explained, without unreasonable delay.
14.50.3.7. Communication, With Opportunities, Termination
that such communication or notification explicitly states and provides to you — as the human subject concerned — the aforementioned sufficient opportunity to make feasible and reasonable requests to have a particular personal biospecimen, data or information, human subjects research, or the administration of either stopped or terminated, with subsequent actions and decisions clearly confirmed and explained, without unreasonable delay.
14.50.3.8. Communication, With Opportunities, Update
that such communication or notification explicitly states and explains to you — as the human subject concerned — upon any pertinent decision by Publiks to erase, rectify, restrict, or terminate a particular personal biospecimen, data or information, human subjects research, or the administration of either, the subsequent feasible and reasonable efforts to send sufficiently informing notification to recipients of such personal biospecimens, data or information, research, or administration.
— of Confidentiality
Section 14.51.0. With respect to determining and ensuring adequate confidentiality of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.51.1. Confidentiality, Basis
that personal biospecimens, data and information, human subjects research, and the administration of both maintain confidentiality with respect to you — as the human subject concerned — as well as Publiks, and do not infringe any policies, principles, or protections for confidentiality, as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.51.2.1. Confidentiality, Biospecimens
that, where appropriate or required, the personal biospecimens, data and information are confidential with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.51.2.2. Confidentiality, Research
that, where appropriate or required, the human subjects research is conducted only in a manner that is confidential with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.51.2.3. Confidentiality, Research Administration
that, where appropriate or required, the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that is confidential with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.51.2.4. Confidentiality, Research Purpose
that, where appropriate or required, such personal biospecimens, data and information, research, and administration are conducted only for a purpose that is confidential with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.51.3. Confidentiality, Risks
that such personal biospecimens, data and information, research, and administration account for and protect against risks to confidentiality with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.51.3.1. Confidentiality, Risks Limitation, Biospecimens
that the personal biospecimens, data and information account for and protect against risks to confidentiality with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.51.3.2. Confidentiality, Risks Limitation, Research
that the human subjects research is conducted only in a manner that accounts for and protects against risks to confidentiality with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.51.3.3. Confidentiality, Risks Limitation, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that accounts for and protects against risks to confidentiality with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.51.3.4. Confidentiality, Risks Limitation, Research Purpose
that such personal biospecimens, data and information, research, and administration are conducted only for a purpose that accounts for and protects against risks to confidentiality with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.51.4.1. Confidentiality, Strict Default
that such personal biospecimens, data and information, research, and administration, by default, strictly adhere to and fulfill all policies, principles, and protections for confidentiality with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.51.4.2. Confidentiality, Strict Design
that such personal biospecimens, data and information, research, and administration, by design, strictly adhere to and fulfill all policies, principles, and protections for confidentiality with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.51.5. Confidentiality, Strict Review
that there is monitoring and periodic strict review to ensure the biospecimens, data and information, human subjects research, and the administration of both are confidential and maintain confidentiality, and where inadequacies or infringements are found, they are addressed and rectified without undue delay.
14.51.6. Confidentiality, Strict Review Period
that appropriate, minimum and necessary time considerations — such as duration, frequency, and length between instances — are established for such periodic and strict review for confidentiality and then for any appropriate and efficacious decision as to continued (or discontinued) administration, processing, rectification, restriction, storage, or termination.
— of Consent
Section 14.52.0. With respect to determining and ensuring adequate consent for personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following five-part evaluation:
14.52.1. Consent, Basis
that personal biospecimens, data and information, human subjects research, and the administration of both are subject to your consent, which is to be decided, given, informed and maintained to a sufficient degree to serve as the basis of an Agreement between Publiks and you — as the human subject concerned — for the duration of such biospecimens, data and information, research, and administration.
14.52.1.1. Consent, Basis, Activity
that such basis requires your consent for any research activity, conduct, or participation you engage in or undergo relating to Publiks.
14.52.1.2. Consent, Basis, Biospecimens
that such basis recognizes the frequent involvement of biospecimens, data and information attributable to, identifying or otherwise relating to you in such research activity, conduct, or participation — and thus requires your consent for such biospecimens, data and information, research, and administration.
14.52.1.3. Consent, Basis, Decision-Making
that such basis treats each human being as an individual person with decision-making abilities — even where such abilities are diminished and warrant protection — and thus requires adequate communication and opportunity for your informed consent, or assent, as well as safeguards and, at times, non-approval or prohibition of such biospecimens, data and information, research, and administration.
14.52.2. Consent, Definition
that consent with respect to personal biospecimens, data and information, human subjects research, and administration of both is adequate only when it is affirmative, clear, freely given, reasonably informed, meaningful, revocable, unambiguous and written by you — as the human subject concerned — and furthermore expressly indicated for an explicit, legitimate and specific purpose for such biospecimens, data and information, research, and administration — as this purpose is delineated and explained in an accessible, clear, easily legible and understandable, informing and written form, page, or request.
14.52.3. Consent, Meaningful
that such consent is freely given and meaningful only when and where the consent process involves your free and genuine decision to consent and your ability to refuse or revoke such consent.
14.52.3.1. Consent, Meaningful, Not
that such consent cannot be presumed to be freely given or meaningful (a) where the asker or requester is in a position to compel consent from you; (b) where the obtaining or maintaining of your consent entails coercion, confusion, deception, force, or trickery; (c) where you are presented with no reasonable option other than to give consent; and (d) where you were made to understand that you needed to consent when you did not or such consent was not necessary.
14.52.3.2. Consent, Meaningful, Not Situations
that such consent cannot, therefore, be presumed to be freely given or meaningful — and it is unlikely to suffice as a legally valid basis — (a) if the asker or requester is a government, public, regulatory or state agent, authority, entity, office, official, person or a judiciary representative with a subpoena or warrant; (b) or if the asker or requester presents such consent as necessary or required where it is not; e.g. for the performance of an activity, agreement, contract, conduct, or service; (c) or if you need a legal fiduciary, guardian, next of kin, parent, proxy, representative, or equivalent to take your wishes into account in providing assent; or (d) if the consent is obtained or presumed in a manner that has been determined to not be legally adequate, binding, meaningful, valid or equivalent by an official court or law of California, Delaware, a European Union member state, the United Kingdom, or the United States.
14.52.3.3. Consent, Meaningful, Opportunity
that the consent and informing process, including the form, page, part, or request for consent, clearly discloses and explains to you — as the human subject concerned — 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 biospecimens, data and information, research, and administration in question; (c) decide not to proceed at all; or (d) opt for any alternative biospecimens, data and information, research, or administration that may fulfill the same or equivalent purpose and where consent can be freely given and meaningful.
14.52.3.4. Consent, Meaningful, Options
that the consent and informing process, including the form, page, part, or request for consent, clearly indicates, where appropriate, options where you — as the human subject concerned — could freely and meaningfully give full, partial or no consent to a different purpose or process, and also explains the effect of such consent on your participation in or other use or visit of an authorized activity, agreement, contract, conduct, product, service, or equivalent of Publiks.
14.52.3.5. Consent, Meaningful, Revocation
that the consent and informing process, including the form, page, part, or request for consent, clearly informs you — as the human subject concerned — of your right to revoke or withdraw consent at any time; the easily accessible, comprehensible and implementable procedure for revoking or withdrawing consent; and the effect of revoking or withdrawing consent on the lawfulness of such biospecimens, data and information, research, and administration during the period in which your consent was given.
14.52.4. Consent, Informed
that such consent is informed only if the form, page, part, or request for consent provides to you — as the human subject concerned — all the key information, in sufficient detail, that a reasonable person would need in order to make an informed decision about whether to permit such biospecimens, data and information, research, and administration; and so only if the informing process does not merely provide lists of isolated facts, but is instead organized in a manner most likely to assist you in understanding the reasons why you may or may not decide to permit such biospecimens, data and information, research, and administration, fulfilling each requirement delineated under the Principle of Communication.
14.52.5. Consent, Process
that such consent is asked for, informed and otherwise processed via a process that meets the additional requirements below.
14.52.5.1. Consent, Process, Authorized Parties
that the consent and informing process is between an accurately, appropriately, clearly, correctly and securely authorized and identified official person or part of Publiks and an accurately, appropriately, clearly, correctly and securely identified person concerned who is attributable to, identifiable by, a subject of, or otherwise specifically related to the biospecimens, data and information, research, and administration.
14.52.5.2. Consent, Process, Accessible, Understandable
that the consent and informing process, including the form, page, part, or request for consent, is easily accessible and easy to understand for you — as the human subject concerned — is in writing, including where appropriate in electronic form, and is in clear, plain and written language, with, where appropriate, additional, assistive and clear visualization or vocalization.
14.52.5.3. Consent, Process, Affirmative, Clear, Unambiguous
that the consent and informing process, including the form, page, part, or request for consent, offers a means by which you — as the human subject concerned — can provide an affirmative, clear and unambiguous indication of your consent decisions pertaining to the biospecimens, data and information, research, and administration — for example, clicking a button, signing on a line, ticking a box, updating privacy or technical settings for a product or service — with the clear understanding that inactivity, inference, pre-selected or -ticked boxes, presumption, silence, sound, or other ambiguous, unclear or unintended communication or language does not constitute consent.
14.52.5.4. Consent, Process, Attestation, Identity
that the consent and informing process, including the form, page, part, or request for consent, offers a means by which you — as the human subject concerned — can accurately, clearly and unambiguously attest to and confirm your identity and ability and authorization to give, review, or revoke consent.
14.52.5.5. Consent, Process, Attestation, Informed
that the consent and informing process, including the form, page, part, or request for consent, offers a means by which you — as the human subject concerned — can accurately, clearly and unambiguously attest to and confirm your being reasonably informed of the consent process and the terms of giving, reviewing, and revoking consent.
14.52.5.6. Consent, Process, Attestation, Meaningful
that the consent and informing process, including the form, page, part, or request for consent, offers a means by which you — as the human subject concerned — can accurately, clearly and unambiguously attest to and confirm the fact that any consent you provide is freely given, meaningful and revocable.
14.52.5.7. Consent, Process, Attestation, Understanding
that the consent and informing process, including the form, page, part, or request for consent, offers a means by which you — as the human subject concerned — can accurately, clearly and unambiguously attest to and confirm your understanding of the consent process and the terms of giving, reviewing, and revoking consent.
14.52.5.8. Consent, Process, Documentable
that the consent and informing process, including the form, page, part, or request for consent, is documentable or preservable as part of the records of Publiks, to be later reproducible in legible, physical and written form wherever there is need to demonstrate the actions and decisions of the consent process.
14.52.5.9. Consent, Process, Protective
that the consent and informing process, including the form, page, part, or request for consent, does not infringe any policies, principles, or protections provided for in the Human Subjects Research Policy, the Codes and Policies, or applicable law or regulation.
14.52.5.10. Consent, Process, Written
that the consent and informing process, including the form, page, part, or request for consent, is in writing, via written communication and instrument, and not acceptable as consent — or informing — if indicated, provided, received or otherwise processed orally, vocally or via any form other than written.
—— of Consent via Assent
Section 14.53.0. With respect to determining and ensuring adequate assent for personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following:
14.53.1. Assent, Basis
that where the consent you indicate cannot be considered freely given and meaningful, or you may not be able to properly give consent at all, the consent process still treats you as a deciding human being and individual as much as possible, and fulfills the ensuing informed assent process.
14.53.2. Assent, Determination
that there is a legally valid determination that you — as the human subject concerned — do not have sufficient decision-making capacity to consent for the biospecimens, data and information, human subjects research, and the administration of both; that you are promptly informed of such determination via written communication; and that you are presented with adequate and ample opportunity to appeal such determination, including in a court of applicable law and regulation, prior to such biospecimens, data and information, research, or administration and any associated conduct or service.
14.53.3. Assent, Informed
that any assent process fulfill all requirements and standards for informed consent via written communication directly to you — as the human subject concerned — as well as to any other person determined to be included or required in the assent process (e.g. a legal fiduciary, guardian, next of kin, parent, proxy, or representative), as provided for in the Human Subjects Research Policy and the Codes and Policies.
14.53.4.1. Assent, Necessary, Vital Interests
that such assent process is limited to such biospecimens, data and information, research, and administration determined to be necessary for the purposes of protecting vital interests for you — as the human subject concerned — that are imminently essential to your life, with the standard being a medically-proven and imminently life-saving measure, procedure, or treatment.
14.53.4.2. Assent, Necessary, Vital Rights
that such assent process is limited to such biospecimens, data and information, research, and administration determined to be necessary for the purposes of protecting vital rights for you — as the human subject concerned — that are imminently essential to your life, with the standard being a life-associated right accorded to you by applicable law or regulation.
14.53.5.1. Assent, Protection, High Evidentiary Basis
that there is a rigorous RRB assessment and confirmation that establishes a high evidentiary basis for the rationale for recourse to assent and a high evidentiary basis for each activity, conduct, service, or involved measure or method conducted pursuant to assent, with the standard being that developed for evidence-based medicine.
14.53.5.2. Assent, Protection, Highly Favorable Ratio
that there is a rigorous RRB assessment and confirmation that establishes that the ratio or relation between benefit and risk to you — as the human subject concerned — of such biospecimens, data and information, research, and administration is highly favorable and highly protective.
14.53.5.3. Assent, Protection, Strict Risk Elimination
that there is a rigorous RRB assessment and confirmation that such biospecimens, data and information, research, and administration are conducted in a manner that eliminates any disclosure that would place you — as the human subject concerned — at risk of adverse effect or impact, including civil or criminal liability or damage to your educational advancement, employability, financial standing, or reputation; with such a strict standard requiring rigorous fulfillment of the policies, principles, and protections of minimization, necessity, non-indentification, and sensitivity.
14.53.6. Assent, Sufficiency
that any resulting assent with respect to personal biospecimens, data and information, human subjects research, and administration of both is adequate and legally sufficient only when it is affirmative, clear, freely given, reasonably informed, meaningful, revocable, unambiguous and written by you — as the human subject concerned — and by the additional person involved in the assent process, and furthermore expressly indicated for an explicit, legitimate and specific purpose for such biospecimens, data and information, research, and administration — as this purpose is delineated and explained in an accessible, clear, easily legible and understandable, informing and written form, page, or request.
— of Documentation
Section 14.54.0. With respect to determining and ensuring adequate documentation pertaining to personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following:
14.54.1. Documentation, Basis
that books, documents, files, records, and equivalent pertaining to personal biospecimens, data and information, human subjects research, and the administration of both are created, maintained, safeguarded, and, where applicable, transmitted in a manner that ensures compliance with and fulfillment of policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.54.2. Documentation, Approval
that such adequate books, documents, files, and records are created, maintained and safeguarded in fulfillment and service of RRB approval and authorization processes, including before, during and, where appropriate, subsequent to such processes.
14.54.3. Documentation, Assignment
that such adequate books, documents, files, and records are created, maintained and safeguarded in fulfillment and service of assignment, delegation and transfer processes, including before, during and, where appropriate, subsequent to such processes.
14.54.4. Documentation, Communication
that such adequate books, documents, files, and records are created, maintained and safeguarded in fulfillment and service of communication and notification processes, including before, during and, where appropriate, subsequent to such processes — and that such documentation remains compliant with policies, principles, and protections for informing communication and notification.
14.54.5. Documentation, Confidentiality
that, where reasonable or required, such adequate books, documents, files, and records are confidential, maintain confidentiality before, during and subsequent to confidential processes, and remain compliant with policies, principles, and protections for confidentiality.
14.54.6. Documentation, Consent
that such adequate books, documents, files, and records are created, maintained and safeguarded in fulfillment and service of consent processes, including before, during and, where appropriate, subsequent to such processes — and that such documentation remains compliant with policies, principles, and protections for informed consent.
14.54.7. Documentation, Infringement
that such adequate books, documents, files, and records are created, maintained and safeguarded in fulfillment and service of infringement detection, evaluation, mitigation and notification processes, including before, during and, where appropriate, subsequent to such processes.
14.54.8. Documentation, Integrity
that such adequate books, documents, files, and records are and remain accurate, available, complete, consistent, intact, and resilient with, where applicable and appropriate, verification from you — as the human subject concerned — in fulfillment and service of policies, principles, and protections for integrity.
14.54.9. Documentation, Privacy
that, where reasonable or required, such adequate books, documents, files, and records are private, maintain privacy before, during and subsequent to private processes, and remain compliant with policies, principles, and protections for privacy.
14.54.10. Documentation, Protection
that such adequate books, documents, files, and records are both protected and protective, confer and maintain protection throughout their creation, maintenance, safekeeping, and where applicable, transmission — including in service and fulfillment of policies, principles, and procedures for protection.
14.54.11. Documentation, Safety
that such adequate books, documents, files, and records are safe, confer and maintain safety throughout their creation, maintenance, safekeeping, and where applicable, transmission — including in service and fulfillment of policies, principles, and procedures for safety.
14.54.12. Documentation, Security
that such adequate books, documents, files, and records are both secure, confer and maintain security throughout their creation, maintenance, safekeeping, and where applicable, transmission — including in service and fulfillment of policies, principles, and procedures for security.
14.54.13. Documentation, Sensitivity
that, where applicable and required, such adequate books, documents, files, and records are treated as sensitive, maintain sensitivity before, during and subsequent to sensitive processes, and remain compliant with policies, principles, and protections for sensitivity.
14.54.14. Documentation, Transmission
that, where applicable and authorized, such adequate books, documents, files, and records are transmitted — primarily for administrative purposes internal to Publiks — in a limited and restricted manner that ensures compliance with and fulfillment of policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.54.15. Documentation, Transparency
that, where authorized and required, such adequate books, documents, files, and records are limitedly consulted, disclosed, reproduced, transmitted or otherwise made available by, for and to an entity, office or person external to Publiks, upon mandatory and reasonable request, specifically for transparency with respect to compliance with and fulfillment of the aforementioned policies, principles, and protections.
14.54.15.1. Documentation, Transparency, Non-Identifying
that, where such transparency is feasible and reasonable, it is conducted in a limited and restricted manner that ensures compliance with and fulfillment of the aforementioned policies, principles, and protections, with any disclosed or transmitted records being strictly non-identifying in nature and effect, revealing only the details below.
14.54.15.2. Documentation, Transparency, Non-Identifying, Categories, Biospecimens
the categories of personal biospecimens, data and information.
14.54.15.3. Documentation, Transparency, Non-Identifying, Categories, Research
the categories of processing of the personal biospecimens, data and information.
14.54.15.4. Documentation, Transparency, Non-Identifying, Categories, Biospecimen Sources
the categories of sources of the personal biospecimens, data and information.
14.54.15.5. Documentation, Transparency, Non-Identifying, Categories, Persons
the categories of persons concerned, with respect to such personal biospecimens, data and information, research, and administration.
14.54.15.6. Documentation, Transparency, Non-Identifying, Categories, Purposes
the categories of purposes for such personal biospecimens, data and information, research, and administration.
14.54.15.7. Documentation, Transparency, Non-Identifying, Categories, Recipients
the categories of recipients of the personal biospecimens, data and information, human subjects research, or the administration of either, including, where applicable, any assignment, delegation, or transfer to a third country, third party, or international organization.
14.54.15.8. Documentation, Transparency, Non-Identifying, Erasure
where feasible and reasonable, the envisaged time limits for erasure of the aforementioned categories details.
14.54.15.9. Documentation, Transparency, Non-Identifying, Protection
where feasible and reasonable, a general description of the administrative, organizational and technical measures taken to ensure the protection of such personal biospecimens, data and information, research, and administration.
14.54.15.10. Documentation, Transparency, Non-Identifying, Transmission
the context, reason, and time of transparency request, response, and transmission.
14.54.15.11. Documentation, Transparency, Non-Identifying, Transmitter
the contact information of the office or persons at Publiks responsible for such personal biospecimens, data and information, research, and administration; the authorizer and transmitter of the transparency response and transmission; and the disclosees and recipients of the transparency response and transmission.
— of Infringement
Section 14.55.0. With respect to determining and ensuring adequate mitigation and notification of an infringement of personal biospecimens, data and information, human subjects research, or the administration of either, you understand and agree to abide by the following:
14.55.1. Infringement, Assessment
that the detection of a breach, infringement, or violation pertaining to biospecimens, data and information, human subjects research, or the administration of either is promptly followed by a assessment determining whether the infringement results in an adverse effect on or risk to you — and any other persons concerned — on the basis of an objective evaluation that establishes the likelihood, number, origin, and severity of effects or risks and whether the infringement involves (a-i) no effect; (a-ii) low, minimal or unlikely effect; or (a-iii) high or significant effect and (b-i) no risk; (b-ii) low, minimal or unlikely risk; or (b-iii) high or significant risk.
14.55.2. Infringement, Mitigation
that such assessment is promptly followed by developing and implementing adequate, appropriate and efficacious measures for mitigating effects or risks identified, including best practices methods with respect to factors for, likelihood, number, origin, and severity of effects or risks and with respect to the aspects, characteristics, and parameters of the biospecimens, data and information, processing, administration, and their infringement.
14.55.3.1. Infringement, Notify
that such assessment is promptly followed by a decision whether to notify any persons concerned and any applicable regulatory authority; with the understanding that (a) if no effect or risk, Publiks may decide not to notify, (b) if low, minimal or unlikely effect or risk, Publiks may decide not to notify you only if it promptly conducts mitigation measures, and (c) if high or significant effect or risk, Publiks is to notify you and promptly conduct mitigation measures.
14.55.3.2. Infringement, Notify, Adherence
that any such notification adheres to and fulfills policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.55.3.3. Infringement, Notify, Description
that any such notification communicates to any persons concerned and any applicable regulatory authority a reasonably informing description of the infringement, including where possible, details as to its characteristics, nature, and the categories and approximate number of both persons concerned and personal biospecimens, data and information records.
14.55.3.4. Infringement, Notify, Effects
that any such notification communicates to any persons concerned and any applicable regulatory authority a reasonably informing description of the adverse effects, consequences, and risks of the infringement.
14.55.3.5. Infringement, Notify, Measures, Official
that any such notification communicates to any persons concerned and any applicable regulatory authority a reasonably informing description of the measures Publiks has conducted or proposed to address the infringement, including, where appropriate, measures to mitigate the adverse effects or risks.
14.55.3.6. Infringement, Notify, Measures, Personal
that any such notification communicates to any persons concerned and any applicable regulatory authority a reasonably informing description of the recommended measures that you — as the human subject concerned — should promptly take to prevent and reduce any possible adverse effects or risks that could arise from the infringement.
14.55.3.7. Infringement, Notify, Time
that any such notification is sent to any person concerned and any applicable regulatory authority within seventy-two (72) hours of detecting any infringement with high or significant effect or risk.
14.55.3.8. Infringement, Notify, Time Delay
that where such notification above is sent after seventy-two (72) hours of infringement detection, it is accompanied by explanation of reasons for the delay, with full required details, either all at once, in phases without further unreasonable delay, or where such a delay was due to reasonable time requested for necessary investigation, including in coordination with law enforcement, as much detail it can first in phases, then without undue delay after the investigation period is completed.
14.55.4. Infringement, Records
that documentation and records of the infringement and associated notification are created, maintained and safeguarded in a manner that ensures their limited availability, disclosure, and reproducibility, upon mandatory and reasonable request, specifically for demonstration of compliance with policies, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
— of Integrity
Section 14.56.0. With respect to determining and ensuring adequate integrity of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.56.1. Integrity, Basis
that personal biospecimens, data and information, human subjects research, and the administration of both maintain integrity with respect to you — as the human subject concerned — as well as Publiks, and do not infringe any policies, principles, or protections for integrity, as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.56.2.1. Integrity, Biospecimens
that the personal biospecimens, data and information are accurate, available, complete, consistent, intact, and resilient with, where applicable and appropriate, verification from you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.56.2.2. Integrity, Research
that the human subjects research is conducted only in a manner that is accurate, available, complete, consistent, intact, and resilient with, where applicable and appropriate, verification from you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.56.2.3. Integrity, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that is accurate, available, complete, consistent, intact, and resilient with, where applicable and appropriate, verification from you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.56.2.4. Integrity, Research Purpose
that such personal biospecimens, data and information, research, and administration are conducted only for a purpose that maintains integrity with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.56.3. Integrity, Risks
that such personal biospecimens, data and information, research, and administration account for and protect against risks to confidentiality with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.56.3.1. Integrity, Risks Limitation, Biospecimens
that the personal biospecimens, data and information account for and protect against risks to integrity with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.56.3.2. Integrity, Risks Limitation, Research
that the human subjects research is conducted only in a manner that accounts for and protects against risks to integrity with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.56.3.3. Integrity, Risks Limitation, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that accounts for and protects against risks to integrity with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.56.3.4. Integrity, Risks Limitation, Research Purpose
that such personal biospecimens, data and information, research, and administration are conducted only for a purpose that accounts for and protects against risks to integrity with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.56.4.1. Integrity, Strict Default
that such personal biospecimens, data and information, research, and administration, by default, strictly adhere to and fulfill all policies, principles, and protections for integrity with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.56.4.2. Integrity, Strict Design
that such personal biospecimens, data and information, research, and administration, by design, strictly adhere to and fulfill all policies, principles, and protections for integrity with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.56.5. Integrity, Strict Review
that there is monitoring and periodic strict review to ensure the biospecimens, data and information, human subjects research, and the administration of both are accurate, available, complete, consistent, intact, and resilient and maintain integrity, and where inadequacies or infringements are found, they are addressed and rectified without undue delay.
14.56.6. Integrity, Strict Review Period
that appropriate, minimum and necessary time considerations — such as duration, frequency, and length between instances — are established for such periodic and strict review for integrity and then for any appropriate and efficacious decision as to continued (or discontinued) administration, processing, rectification, restriction, storage, or termination.
— of Lawfulness
Section 14.57.0. With respect to determining and ensuring the lawfulness of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.57.1. Lawfulness, Basis
that personal biospecimens, data and information, human subjects research, and the administration of both are lawful and legal to a sufficient degree to serve as the basis of an Agreement between Publiks and you — as the human subject concerned — as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.57.2. Lawfulness, Communication
that personal biospecimens, data and information, human subjects research, and the administration of both are accompanied by communication and notification reasonably informing you — as the human subject concerned — in accordance with policies, principles, and protections for informing communication and notification.
14.57.3. Lawfulness, Consent
that personal biospecimens, data and information, human subjects research, and the administration of both are accompanied by informed consent (or assent) given and unrevoked by you — as the human subject concerned — in accordance with policies, principles, and protections for informed consent.
14.57.4. Lawfulness, Ethics
that personal biospecimens, data and information, human subjects research, and the administration of both are ethical with respect to you — as the human subject concerned — in accordance with policies, principles, and protections for ethics and ethical conduct and service.
14.57.5. Lawfulness, Law
that personal biospecimens, data and information, human subjects research, and the administration of both are law-abiding with respect to you — as the human subject concerned — in accordance with applicable law or regulation.
14.57.5.1. Lawfulness, Law, Illegal
with law-abiding lawfulness satisfied only where such personal biospecimens, data and information, research, and administration do not — in any way and in any jurisdiction — effect or facilitate a criminal or illegal act, breach, infringement, violation, or equivalent relating to human subjects research or any associated interests, protections, or rights, especially those pertaining to confidentiality and privacy, as determined or provided for in any official court or law of Canada, a European Union member state, the United Kingdom, or the United States.
14.57.5.2. Lawfulness, Law, Illiberal
with law-abiding lawfulness satisfied only where such personal biospecimens, data and information, research, and administration do not — in any way and in any jurisdiction — effect or facilitate a civil or illiberal breach, infringement, violation, or equivalent relating to human subjects research and associated civil liberties or rights, especially those pertaining to confidentiality and privacy, as determined or provided for in any official court or law of Canada, a European Union member state, the United Kingdom, or the United States.
14.57.5.3. Lawfulness, Law, Unconstitutional
with law-abiding lawfulness satisfied only where such personal biospecimens, data and information, research, and administration do not — in any way and in any jurisdiction — effect or facilitate an unconstitutional act, breach, infringement, violation, or equivalent relating to human subjects research or any associated interests, protections, or rights, especially those pertaining to confidentiality and privacy, as determined or provided for in any official court or law of Canada, a European Union member state, the United Kingdom, or the United States.
14.57.5.4. Lawfulness, Law, Unlawful
with law-abiding lawfulness satisfied only where such personal biospecimens, data and information, research, and administration do not — in any way and in any jurisdiction — effect or facilitate an “unlawful disclosure,” “unlawful gathering,” “unlawful processing,” or “wrongful collection” relating to human subjects research, or equivalent, as determined or provided for in any official court or law of Canada, a European Union member state, the United Kingdom, or the United States.
14.57.6. Lawfulness, Purpose
that personal biospecimens, data and information, human subjects research, and the administration of both are appropriate, efficacious, necessary and proportionate for fulfilling the explained, explicit, legitimate and specific purpose consented (or assented) to by you — as the human subject concerned.
— of Minimization
Section 14.58.0. With respect to determining and ensuring adequate minimization of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.58.1. Minimization, Basis
that the personal biospecimens, data and information, human subjects research, and the administration of both are minimized to that which carries “minimal risk” to you — as the human subject concerned — as well as that which is minimally necessary to fulfill an explained, explicit, legitimate and specific purpose consented (or assented) to by you.
14.58.2. Minimization, As Necessary
that such personal biospecimens, data and information, research, and administration are necessary, as provided for under the Principle of Necessity and in the Human Subjects Research Policy.
14.58.3.1. Minimization, Biospecimens
that the personal biospecimens, data and information are, in quantity and range, minimally necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.58.3.2. Minimization, Research
that human subjects research is conducted in a manner, including extent and frequency, minimally necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.58.3.3. Minimization, Research Administration
that the administration of human subjects research and biospecimens, data and information is conducted in a manner, including extent and frequency, minimally necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.58.3.4. Minimization, Research Retention
that the personal biospecimens, data and information are administered, processed and retained only for a time that is limited to what is minimally necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.58.4.1. Minimization, Minimal Risk
that where appropriate and possible, prior and periodic administration and processing — of data and information sets equivalent in aspects, characteristics, and parameters — are consulted to assess anticipated risks, and to ascertain measures that would ensure “minimal risk” for you — as the human subject concerned.
14.58.4.2. Minimization, Minimal Risk, Biospecimens
that the personal biospecimens, data and information carry only the “minimal risk” necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.58.4.3. Minimization, Minimal Risk, Research
that the human subjects research is conducted in a manner that carries only the “minimal risk” necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.58.4.4. Minimization, Minimal Risk, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted in a manner that carries only the “minimal risk” necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.58.4.5. Minimization, Minimal Risk, Research Retention
that the personal biospecimens, data and information are administered, processed and retained only for a time that carries only the “minimal risk” necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.58.5. Minimization, Strict Review
that there is monitoring and periodic strict review to ensure the biospecimens, data and information, human subjects research, and the administration of both are minimal and maintain minimization, and where inadequacies or infringements are found, they are addressed and rectified without undue delay.
14.58.6. Minimization, Strict Review Period
that appropriate, minimum and necessary time considerations — such as duration, frequency, and length between instances — are established for such periodic and strict review for minimization and then for any appropriate and efficacious decision as to continued (or discontinued) administration, processing, rectification, restriction, storage, or termination.
— of Necessity
Section 14.59.0. With respect to determining and ensuring adequate necessity of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.59.1. Necessity, Basis
that the personal biospecimens, data and information, human subjects research, and the administration of both are necessary to fulfill an explained, explicit, legitimate and specific purpose consented (or assented) to by you — as the human subject concerned.
14.59.2.1. Necessity, Alternative, Biospecimens
that prior and periodic assessment is done to ensure such consented purpose can reasonably be fulfilled only by personal biospecimens, data and information attributable to, identifying or otherwise relating to you — as the human subject concerned — and not by any alternative data and information, preferably non-personal.
14.59.2.2. Necessity, Alternative, Research
that prior and periodic assessment is done to ensure such consented purpose can reasonably be fulfilled only by a manner of human subjects research that identifies or otherwise relates specifically to you — as the human subject concerned — and not by any alternative manner of human subjects research, preferably non-personal.
14.59.2.3. Necessity, Alternative, Research Administration
that prior and periodic assessment is done to ensure such consented purpose can reasonably be fulfilled only by a manner of human subjects research administration that identifies or otherwise relates specifically to you — as the human subject concerned — and not by any alternative manner of human subjects research administration, preferably non-personal.
14.59.3.1. Necessity, Limitation, Biospecimens
that the personal biospecimens, data and information are limited to what is necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.59.3.2. Necessity, Limitation, Research
that human subjects research is conducted only in a manner that is limited to what is necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.59.3.3. Necessity, Limitation, Research Administration
that the administration of human subjects research and biospecimens, data and information is conducted only in a manner that is limited to what is necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.59.3.4. Necessity, Limitation, Research Purpose
that such personal biospecimens, data and information, research, and administration are not further conducted for purposes other than the purpose consented (or assented) to by you.
14.59.3.5. Necessity, Limitation, Research Retention
that the personal biospecimens, data and information are administered, processed and retained only for a time that is limited to what is necessary to fulfill the purpose consented (or assented) to by you — as the human subject concerned.
14.59.4. Necessity, Strict Review
that there is monitoring and periodic strict review to ensure the biospecimens, data and information, human subjects research, and the administration of both are necessary and maintain necessity, and where inadequacies or infringements are found, they are addressed and rectified without undue delay.
14.59.5. Necessity, Strict Review Period
that appropriate, minimum and necessary time considerations — such as duration, frequency, and length between instances — are established for such periodic and strict review for necessity and then for any appropriate and efficacious decision as to continued (or discontinued) administration, processing, rectification, restriction, storage, or termination.
— of Neutrality
Section 14.60.0. With respect to determining and ensuring adequate neutrality of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.60.1. Neutrality, Basis
that the personal biospecimens, data and information, human subjects research, and the administration of both confer, as an effect, fulfillment of human subjects research policies, principles, and protections with respect to you — as the human subject concerned — that is neutral, i.e., ensured to an equivalent or same extent, across feasible and reasonable options for biospecimens, data and information, human subjects research, and the administration of both.
14.60.2.1. Neutrality, Biospecimens
that the administration and human subjects research are conducted in manner conferring such protective effect to you — as the human subject concerned — that is biospecimen neutral, i.e., ensured to an equivalent or same extent, across feasible and reasonable options for data and information.
14.60.2.2. Neutrality, Research
that the human subjects research is conducted in manner conferring protective effect to you — as the human subject concerned — that is research neutral, i.e., ensured to an equivalent and same extent, across feasible and reasonable options for human subjects research.
14.60.2.3. Neutrality, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted in manner conferring protective effect to you — as the human subject concerned — that is administration neutral, i.e., ensured to an equivalent and same extent, across feasible and reasonable options for administering human subjects research and biospecimens, data and information.
14.60.2.4. Neutrality, Research Purpose
that the administration and human subjects research are conducted in manner conferring such protective effect to you — as the human subject concerned — that is purpose neutral, i.e., ensured to an equivalent or same extent, across feasible and reasonable options for purposes of biospecimens, data and information, human subjects research, and administration of both.
14.60.3. Neutrality, Evaluative Review
that where appropriate and possible, prior and periodic administration and processing — of data and information sets equivalent and dissimilar in aspects, characteristics, and parameters — are consulted to evaluate protective effects and measures that would ensure neutrality for you — as the human subject concerned.
14.60.4. Neutrality, Strict Review
that there is monitoring and periodic strict review to ensure the biospecimens, data and information, human subjects research, and the administration of both are neutral and maintain neutrality, and where inadequacies or infringements are found, they are addressed and rectified without undue delay.
14.60.5. Neutrality, Strict Review Period
that appropriate, minimum and necessary time considerations — such as duration, frequency, and length between instances — are established for such periodic and strict review for neutrality and then for any appropriate and efficacious decision as to continued (or discontinued) administration, processing, rectification, restriction, storage, or termination.
— of Non-Identification
Section 14.61.0. With respect to determining and ensuring adequate non-identification of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.61.1. Non-Identification, Basis
that where appropriate, feasible and reasonable — and certainly where necessary or required — biospecimens, data and information, human subjects research, and the administration of both do not permit or require attributing to, identifying or otherwise relating to you or any other person.
14.61.2.1. Non-Identification, Design, Biospecimens
that, where reasonable or required, biospecimens, data and information are accessed, collected or otherwise processed in a manner that — by design — generates biospecimens, data and information that are non-identifying in nature or effect, for instance, initially anonymous or non-personal biospecimens, data and information or subsequent processes of de-identification, pseudonymization, pseudo-anonymization, anonymization, and irreversible anonymization.
14.61.2.2. Non-Identification, Design, Research
that, where reasonable or required, the human subjects research is conducted in a manner that — by design — is non-identifying in nature or effect, for instance, absolute approaches to anonymous or non-personal processing, including encryption, and device-limited, task-limited and user-limited processing of de- and re-identified personal biospecimens, data and information.
14.61.2.3. Non-Identification, Design, Research Administration
that, where reasonable or required, the administration of the human subjects research and personal biospecimens, data and information is conducted in a manner that — by design — is non-identifying in nature or effect, for instance, absolute approaches to anonymous or non-personal administration, including encryption, and product-limited, service-limited and task-limited administration of de- and re-identified personal biospecimens, data and information.
14.61.2.4. Non-Identification, Design, Protection
that the above is and remains critical for attaining and maintaining standards for human subjects research protection by design.
14.61.3.1. Non-Identification, Default
that where any personal biospecimens, data and information, human subjects research, or the administration of either are non-identifying with respect to you — as the (supposed) person concerned — Publiks maintains a normative default position of refraining from accessing, maintaining, or otherwise processing any additional biospecimens, data and information attributable to, identifying or otherwise relating to you or another person.
14.61.3.2. Non-Identification, Default, Exception
that the default position will be rigorously maintained, except where Publiks receives a consented request from you — as the (supposed) person concerned — that meets the requirements below.
14.61.3.3. Non-Identification, Default, Exception, Additional Data
that, as part of the consented request, you — as the (supposed) person concerned — provide additional data and information identifying you and connecting you to the non-identifying personal biospecimens, data and information.
14.61.3.4. Non-Identification, Default, Exception, Authenticating Data
that such additional data and information include authenticating and matching credentials for digital or electronic identification and security mechanisms, for example, answers to identity or security questions, biometric data, login credentials, one-time codes for multi-factor or two-factor authentication, passkeys, or physical security keys.
14.61.3.5. Non-Identification, Default, Protection
that the above position and strict requirements for exception are and remain critical for attaining and maintaining standards for human subjects research protection by default.
14.61.4.1. Non-Identification, Process, At Origin, Onset
that, where reasonable or required, biospecimens, data and information are accessed, collected and otherwise processed in a manner that originates non-personal forms and states at or from the beginning, onset, origin, or source, with no ability or possibility of attributing to, identifying or otherwise relating to any person.
14.61.4.2. Non-Identification, Process, Early, Proximate
that, where reasonable or required, biospecimens, data and information are accessed, collected and otherwise processed in a manner that results in non-personal forms and states early in processing, immediately after or proximate to the beginning, onset, origin, or source, with no ability or possibility of attributing to, identifying or otherwise relating to any person.
14.61.4.3. Non-Identification, Process, Further, Subsequent
that, where reasonable or required, biospecimens, data and information are further accessed, collected and otherwise processed in a manner that results in non-personal forms and states subsequent to earlier processing, including further aggregation of non-personal biospecimens, data and information with multiple equivalently non-personal datasets in order to ensure the non-personal state; where all non-identification conditions are irreversibly met, such biospecimens, data and information may be safely treated as non-personal.
14.61.4.4. Non-Identification, Process, Irreversization
that previously personal biospecimens, data and information are to be treated as non-personal only if and to the extent that such further processing includes successful irreversible anonymization combined with aggregation (“irreversization” or “irreversibilization”), i.e. aggregation of newly anonymized data and information with multiple equivalently anonymized datasets to attain and ensure the non-personal state; where all such conditions are irreversibly met, such biospecimens, data and information may be safely treated as non-personal.
14.61.4.5. Non-Identification, Process, Preventive Aggregation
that the decision to safely treat de-identified or anonymized personal biospecimens, data and information as non-personal is based primarily on the possibility of re-identification, i.e. the ability to combine or cross-reference with any other identifying biospecimens, data and information that renders the anonymized or de-identified biospecimens, data and information effectively attributable to, identifying or otherwise directly relating to you or another person; currently, the best protection against such possibility is the processes of data summary and data transformation entailed in aggregation.
14.61.5.1. Non-Identification, Purposes
that, where reasonable or required, non-identifying and non-personal biospecimens, data and information, if priorly consented and in irreversibly anonymized and aggregated form, may be treated as non-personal biospecimens, data and information not further subject to the policies, principles, and protections for personal biospecimens, data and information, solely for purposes below.
14.61.5.2. Non-Identification, Purposes, Consented
for an explicit, legitimate and specific purpose consented to by you — as the person initially and supposedly concerned.
14.61.5.3. Non-Identification, Purposes, Organization
for consented, explicit, legitimate and specific purposes of administering as well as fulfilling the duties, functions, interests, legal obligations, policies, principles, protections, and responsibilities of Publiks, as an organizational entity, including as provided for in the Data and Information Policy and the Codes and Policies.
14.61.5.4. Non-Identification, Purposes, Personalization, None
for consented, explicit, legitimate and specific purposes of administering, engaging in, or offering a research activity or associated conduct, service, or study in a manner that is non-personalized.
14.61.5.5. Non-Identification, Purposes, Personalization, Pseudo
for consented, explicit, legitimate and specific purposes of administering, engaging in, or offering experiences, instances, or versions of a research activity or associated conduct, service, or study that are pseudo-personalized, that is, tailored to categories of persons via a non-identifying overlap of non-identifying data and information.
14.61.5.6. Non-Identification, Purposes, Personalization, Real
for consented, explicit, legitimate and specific purposes of administering, engaging in, or offering experiences, instances, or versions of a research activity or associated conduct, service, or study that are really or truly personalized, that is, tailored to specific persons via a re-identifying authentication or overlap of previously non-identifying data and information.
14.61.6.1. Non-Identification, Re-Identification
that you consent to re-identification whenever you permit the combination of previously anonymized, de-identified or non-identifying biospecimens, data and information with re-identifying biospecimens, data and information — in this case, such temporarily combined biospecimens, data and information is treated as personal for the duration, and thus subject to the policies, principles, and protections of personal biospecimens, data and information, until the combined form is reversed.
14.61.6.2. Non-Identification, Re-Identification, Authentication
that you are to take re-identification as a serious matter, endeavoring to protect yourself while participating in any research activity or associated conduct, service, or study involving biospecimens, data and information by, first, being thoughtful about your informed consent and the consent process, and second, making sure you are developing, protecting, and using Privately and Uniquely and Authenticating Data, as described below.
14.61.6.3. Non-Identification, Re-Identification, Only-You-Could-Know
making sure you are authenticating yourself with something only you or one other living person could access, know, or possess at any given and precise time.
14.61.6.4. Non-Identification, Re-Identification, Rarely Used, Written
where necessary, making sure that any names, pseudonyms, or usernames you offer or use to authenticate yourself are themselves rarely used, relatively undocumented and well-protected — for instance, given or taken during private rites or equivalently undocumented activities or events.
14.61.6.5. Non-Identification, Re-Identification, Well-Constructed, Changed
making sure you are authenticating yourself with passcodes and passwords that are also well-constructed (that is, gobbledygook and nonsensical), well-protected and regularly changed.
14.61.6.6. Non-Identification, Re-Identification, Well-Protected Answers
making sure you are authenticating yourself with answers to security clues, hints, or questions that are also hard to find or guess, not obvious, rarely used and well-protected.
14.61.6.7. Non-Identification, Re-Identification,With Passcode Authenticator
wherever it is possible, making sure you are also authenticating yourself with a well-protected authenticator device that generates a single-use and time-limited code to enter after you have inputted your passcode or password.
14.61.6.8. Non-Identification, Re-Identification, With Password Management
always and in every instance, making sure you are also authenticating yourself with passcodes and passwords kept in a highly privacy-preserving passcode and password management system, certainly those that use encryption and preferably those that do not require backup to another organization’s central server.
14.61.6.9. Non-Identification, Re-Identification, With Physically Inserted Key
wherever it is possible, making sure you are also authenticating yourself with a physical authenticating key that you must have in hand and insert to proceed with sensitive activity.
14.61.7.1. Non-Identification, Treatment, Personal
that, therefore, to the extent that biospecimens, data and information can be combined or cross-referenced to identify any person (also even by deduction or inference) or be reversibly de-anonymized, such de-identified, non-identifying or anonymized data and information are and remain personal at Publiks and are subject to requirements for fulfilling the policies, principles, and protections of personal biospecimens, data and information, to be treated as such (even confidential, private and sensitive) till their deletion, erasure, or irreversible destruction, if possible.
14.61.7.2. Non-Identification, Treatment, Personal, Temporary
that wherever non-personal biospecimens, data and information are combined with those that are personal the result is a combined form to be appropriately treated as personal, for as long as the combination remains intact.
14.61.8. Non-Identification, Strict Review
that there is monitoring and periodic strict review to ensure the biospecimens, data and information, human subjects research, and the administration of both are non-identifying and maintain non-identification, and where inadequacies or infringements are found, they are addressed and rectified without undue delay.
14.61.9. Non-Identification, Strict Review Period
that appropriate, minimum and necessary time considerations — such as duration, frequency, and length between instances — are established for such periodic and strict review for non-identification and then for any appropriate and efficacious decision as to continued (or discontinued) administration, processing, rectification, restriction, storage, or termination.
— of Privacy
Section 14.62.0. With respect to determining and ensuring adequate privacy of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.62.1. Privacy, Basis
that personal biospecimens, data and information, human subjects research, and the administration of both maintain privacy with respect to you — as the human subject concerned — as well as Publiks, and do not infringe any policies, principles, or protections for privacy, as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.62.2.1. Privacy, Biospecimens
that, where appropriate or required, the personal biospecimens, data and information are private with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.62.2.2. Privacy, Research
that, where appropriate or required, the human subjects research is conducted only in a manner that is private with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.62.2.3. Privacy, Research Administration
that, where appropriate or required, the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that is private with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.62.2.4. Privacy, Research Purpose
that, where appropriate or required, such personal biospecimens, data and information, research, and administration are conducted only for a purpose that is private with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.62.3. Privacy, Risks
that such personal biospecimens, data and information, research, and administration account for and protect against risks to privacy with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.62.3.1. Privacy, Risks Limitation, Biospecimens
that the personal biospecimens, data and information account for and protect against risks to privacy with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.62.3.2. Privacy, Risks Limitation, Research
that the human subjects research is conducted only in a manner that accounts for and protects against risks to privacy with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.62.3.3. Privacy, Risks Limitation, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that accounts for and protects against risks to privacy with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.62.3.4. Privacy, Risks Limitation, Research Purpose
that such personal biospecimens, data and information, research, and administration are conducted only for a purpose that accounts for and protects against risks to privacy with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.62.4.1. Privacy, Strict Default
that such personal biospecimens, data and information, research, and administration, by default, strictly adhere to and fulfill all policies, principles, and protections for privacy with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.62.4.2. Privacy, Strict Design
that such personal biospecimens, data and information, research, and administration, by design, strictly adhere to and fulfill all policies, principles, and protections for privacy with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.62.5. Privacy, Strict Review
that there is monitoring and periodic strict review to ensure the biospecimens, data and information, human subjects research, and the administration of both are private and maintain privacy, and where inadequacies or infringements are found, they are addressed and rectified without undue delay.
14.62.6. Privacy, Strict Review Period
that appropriate, minimum and necessary time considerations — such as duration, frequency, and length between instances — are established for such periodic and strict review for privacy and then for any appropriate and efficacious decision as to continued (or discontinued) administration, processing, rectification, restriction, storage, or termination.
— of Protection
Section 14.63.0. With respect to determining and ensuring adequate protection of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.63.1. Protection, Basis
that personal biospecimens, data and information, human subjects research, and the administration of both confer adequate protective effect with respect to you — as the human subject concerned — as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.63.1.1. Protection, Basis, Bias
with the understanding that such protective effect entails the mitigation of and protection against bias, discrimination, marginalization, or stigmatization against you — as the human subject concerned — to the most feasible and reasonable extent.
14.63.1.2. Protection, Basis, Harm
with the understanding that such protective effect entail the mitigation of and protection against harm, injury, or equivalent of you — as the human subject concerned — to the most feasible and reasonable extent.
14.63.1.3. Protection, Basis, Infringement, Biospecimens
with the understanding that such protective effect entails the mitigation of and protection against infringement of such personal biospecimens, data and information, research, and administration.
14.63.1.4. Protection, Basis, Infringement, Organization
with the understanding that such protective effect entails the mitigation of and protection against infringement of Publiks, as an organizational entity, and the administrative powers and responsibilities of the Founder, Alvan Azinna Chibuzo Ikoku.
14.63.1.5. Protection, Basis, Infringement, Policies
with the understanding that such protective effect entails the mitigation of and protection against infringement of polices, principles, and protections provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.63.1.6. Protection, Basis, Infringement, Rights
with the understanding that such protective effect entails the mitigation of and protection against infringement of civil liberties or rights accorded by your polities to you — as the human subject concerned — to the most feasible and reasonable extent.
14.63.1.7. Protection, Basis, Resulting Effect
with the understanding that such protective effect entails the mitigation of and protection against adverse effects on you — as the human subject concerned — resulting from any of the aforementioned, to the most feasible and reasonable extent.
14.63.1.8. Protection, Basis, Risks
with the understanding that such protective effect entails the mitigation of and protection against risks to you — as the human subject concerned — of any of the aforementioned occurring, to the most feasible and reasonable extent.
14.63.2.1. Protection, Biospecimens
that the human subjects research is conducted only on biospecimens, data and information that are protective with respect to you — as the human subject concerned — to the most feasible and reasonable extent.
14.63.2.2. Protection, Research
that the human subjects research is conducted only in a manner that is protective with respect to you — as the human subject concerned — to the most feasible and reasonable extent.
14.63.2.3. Protection, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that is protective with respect to you — as the human subject concerned — to the most feasible and reasonable extent.
14.63.2.4. Protection, Research Purpose
that personal biospecimens, data and information, human subjects research, and the administration of both are conducted only for a purpose that is protective with respect to you — as the human subject concerned — to the most feasible and reasonable extent.
14.63.3. Protection, Risks
that personal biospecimens, data and information, human subjects research, and the administration of both ascertain, assess, and protect against risks to you — as the human subject concerned — to the most feasible and reasonable extent.
14.63.4. Protection, Risks, Ascertainment
that personal biospecimens, data and information, human subjects research, and the administration of both is accompanied by a human subjects research risk ascertainment that conducts an objective evaluation detecting and defining actual and anticipated adverse effects and risks with respect to you — as the human subject concerned — and to the biospecimens, data and information.
14.63.4.1. Protection, Risks, Ascertainment, Definition
that, where adverse effects or risks are detected, such human subjects research risk ascertainment defines their characteristics, including the factors leading to, likelihood, number, origin, and severity of adverse effects or risks with respect to you — as the human subject concerned — and to the biospecimens, data and information.
14.63.4.2. Protection, Risks, Ascertainment, Definition, Biospecimens Aspects
that such human subjects research risk ascertainment defines such characteristics while accounting for and informing determinations as to the appropriate aspects, characteristics, and parameters of biospecimens, data and information, human subjects research, and the administration of both, as provided for in the Human Subjects Research Policy, under the Principle of Appropriateness.
14.63.4.3. Protection, Risks, Ascertainment, Establishment
that, subsequent to the definition of characteristics, such human subjects research risk ascertainment establishes whether the personal biospecimens, data and information, human subjects research, or the administration of either involves (a) no effect; low, minimal or unlikely effect; or high or significant effect and (b) no risk; low, minimal or unlikely risk; or high or significant risk.
14.63.4.4. Protection, Risks, Ascertainment, Mitigation
that, subsequent to the establishment of adverse effects and risks, such human subjects research risk ascertainment entails early implementation of adequate, appropriate and efficacious measures for mitigating adverse effects and risks identified, including best practices methods for the characteristics of adverse effects and risks and for the aspects, characteristics, and parameters of biospecimens, data and information, human subjects research, and the administration of both.
14.63.4.5. Protection, Risks, Ascertainment, Relation
that, subsequent to the early mitigation of adverse effects and risks, such human subjects research risk ascertainment entails the determination of relation between benefit and risk with respect to you — as the human subject concerned — of biospecimens, data and information, human subjects research, and the administration of both.
14.63.5. Protection, Risks, Assessment
that personal biospecimens, data and information, human subjects research, and the administration of both is accompanied by a human subjects research risk assessment where any of the following indications are found.
14.63.5.1. Protection, Risks, Assessment, Indication, High Risk
that, where the data and information ascertainment establishes a high or significant effect or risk, a subsequent human subjects research risk assessment is indicated and is conducted.
14.63.5.2. Protection, Risks, Assessment, Indication, Method, Automated
that, where the data and information ascertainment identifies administration or processing involvement of automation or automated methods, including automated individual decision-making and profiling, a subsequent human subjects research risk assessment is indicated and is conducted.
14.63.5.3. Protection, Risks, Assessment, Indication, Method, Large Scale
that, where the data and information ascertainment identifies administration or processing on a large scale, thus potentially affecting large numbers of persons who may not easily exercise their civil liberties or rights, a subsequent human subjects research risk assessment is indicated and is conducted.
14.63.5.4. Protection, Risks, Assessment, Indication, Method, New
that, where the data and information ascertainment identifies administration or processing via new methods or technologies, a subsequent human subjects research risk assessment is indicated and is conducted.
14.63.5.5. Protection, Risks, Assessment, Indication, Method, Publicly Accessible Area
that, where the data and information ascertainment identifies administration or processing involvement — including collection and systematic monitoring — of a publicly accessible area, a subsequent human subjects research risk assessment is indicated and is conducted.
14.63.5.6. Protection, Risks, Assessment, Indication, Sensitive Biospecimens
that, where the data and information ascertainment identifies the involvement of sensitive personal biospecimens, data and information, a subsequent human subjects research risk assessment is indicated and is conducted.
14.63.5.7. Protection, Risks, Assessment, Description
that, where indicated, the subsequent human subjects research risk assessment systematically describes and explains such personal biospecimens, data and information, research, and administration, including their aspects, characteristics, and parameters.
14.63.5.8. Protection, Risks, Assessment, Necessity
that, where indicated, the subsequent human subjects research risk assessment systematically assesses and ensures the appropriateness, minimization, necessity, and non-identification of such personal biospecimens, data and information, research, and administration.
14.63.5.9. Protection, Risks, Assessment, Review, Biospecimens
that, where indicated, the subsequent human subjects research risk assessment systematically reviews and ensures the use of adequate, appropriate and efficacious administrative, organizational and technical measures — for or on the personal biospecimens, data and information — to mitigate and protect against actual and anticipated adverse effects and risks resulting from such biospecimens, data and information.
14.63.5.10. Protection, Risks, Assessment, Review, Research Administration
that, where indicated, the subsequent human subjects research risk assessment systematically reviews and ensures the use of adequate, appropriate and efficacious administrative, organizational and technical measures — for the administration of the human subjects research and the personal biospecimens, data and information — to mitigate and protect against actual and anticipated adverse effects and risks resulting from such administration.
14.63.5.11. Protection, Risks, Assessment, Review, Research
that, where indicated, the subsequent human subjects research risk assessment systematically reviews and ensures the use of adequate, appropriate and efficacious administrative, organizational and technical measures — for the human subjects research — to mitigate and protect against actual and anticipated adverse effects and risks resulting from such research.
14.63.5.12. Protection, Risks, Assessment, Review, Decision-Making
that, where automated decision-making and methods are involved, the subsequent human subjects research risk assessment systematically reviews and ensures the use of adequate, appropriate and efficacious administrative, organizational and technical measures — including computational, logical, mathematical, profiling and statistical methods or procedures — to mitigate and protect against actual and anticipated adverse effects and risks resulting from such decision-making.
14.63.5.13. Protection, Risks, Assessment, Similar Sets
that, where indicated, the subsequent human subjects research risk assessment systematically draws careful and selective insights from highly similar samples and sets of personal biospecimens, data and information, human subjects research, and the administration of both — with degree of similarity based on data and information aspects, characteristics, and parameters and on characteristics of adverse effects and risks.
14.63.6.1. Protection, Risks Limitation, Biospecimens
that the human subjects research is conducted only on biospecimens, data and information that account and assess for, avoid, and protect against anticipated, excessive, unexpected, unexplained or unnecessary risks, as well as standard threats, with respect to you — as the human subject concerned.
14.63.6.2. Protection, Risks Limitation, Processing
that the human subjects research is conducted only in a manner that accounts and assesses for, avoid, and protects against anticipated, excessive, unexpected, unexplained or unnecessary risks, as well as standard threats, with respect to you — as the human subject concerned.
14.63.6.3. Protection, Risks Limitation, Purpose
that the human subjects research is conducted only for purposes that account and assess for, avoid, and protect against anticipated, excessive, unexpected, unexplained or unnecessary risks, as well as standard threats, with respect to you — as the human subject concerned.
14.63.7.1. Protection, Strict Default
that the human subjects research is strictly protective, by default, with respect to you — as the human subject concerned.
14.63.7.2. Protection, Strict Design
that the human subjects research is strictly protective, by design, with respect to you — as the human subject concerned.
14.63.8. Protection, Strict Review
that there is monitoring and periodic strict review to ensure the biospecimens, data and information, human subjects research, and the administration of both are protective and maintain protection, and where inadequacies or infringements are found, they are addressed and rectified without undue delay.
14.63.9. Protection, Strict Review Period
that appropriate, minimum and necessary time considerations — such as duration, frequency, and length between instances — are established for such periodic and strict review for protection and then for any appropriate and efficacious decision as to continued (or discontinued) administration, processing, rectification, restriction, storage, or termination.
— of Safety
Section 14.64.0. With respect to determining and ensuring adequate safety of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.64.1. Safety, Basis
that personal biospecimens, data and information, human subjects research, and the administration of both maintain safety with respect to you — as the human subject concerned — as well as Publiks, and do not infringe any policies, principles, or protections for safety, as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.64.2.1. Safety, Biospecimens
that the personal biospecimens, data and information are safe with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.64.2.2. Safety, Research
that the human subjects research is conducted only in a manner that is safe with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.64.2.3. Safety, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that is safe with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.64.2.4. Safety, Research Purpose
that such personal biospecimens, data and information, research, and administration are conducted only for a purpose that is safe with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.64.3. Safety, Risks
that such personal biospecimens, data and information, research, and administration account for and protect against risks to safety with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.64.3.1. Safety, Risks Limitation, Biospecimens
that the personal biospecimens, data and information account for and protect against risks to safety with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.64.3.2. Safety, Risks Limitation, Research
that the human subjects research is conducted only in a manner that accounts for and protects against risks to safety with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.64.3.3. Safety, Risks Limitation, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that accounts for and protects against risks to safety with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.64.3.4. Safety, Risks Limitation, Research Purpose
that such personal biospecimens, data and information, research, and administration are conducted only for a purpose that accounts for and protects against risks to safety with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.64.4.1. Safety, Strict Default
that such personal biospecimens, data and information, research, and administration, by default, strictly adhere to and fulfill all policies, principles, and protections for safety with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.64.4.2. Safety, Strict Design
that such personal biospecimens, data and information, research, and administration, by design, strictly adhere to and fulfill all policies, principles, and protections for safety with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.64.5. Safety, Strict Review
that there is monitoring and periodic strict review to ensure the biospecimens, data and information, human subjects research, and the administration of both are safe and maintain safety, and where inadequacies or infringements are found, they are addressed and rectified without undue delay.
14.64.6. Safety, Strict Review Period
that appropriate, minimum and necessary time considerations — such as duration, frequency, and length between instances — are established for such periodic and strict review for safety and then for any appropriate and efficacious decision as to continued (or discontinued) administration, processing, rectification, restriction, storage, or termination.
— of Security
Section 14.65.0. With respect to determining and ensuring adequate security of personal biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.65.1. Security, Basis
that personal biospecimens, data and information, human subjects research, and the administration of both maintain security with respect to you — as the human subject concerned — as well as Publiks, and do not infringe any policies, principles, or protections for safety, as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.65.2.1. Security, Biospecimens
that the personal biospecimens, data and information are secure with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.65.2.2. Security, Research
that the human subjects research is conducted only in a manner that is secure with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.65.2.3. Security, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that is secure with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.65.2.4. Security, Research Purpose
that such personal biospecimens, data and information, research, and administration are conducted only for a purpose that is secure with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.65.3. Security, Risks
that such personal biospecimens, data and information, research, and administration account for and protect against risks to security with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.65.3.1. Security, Risks Limitation, Biospecimens
that the personal biospecimens, data and information account for and protect against risks to security with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.65.3.2. Security, Risks Limitation, Research
that the human subjects research is conducted only in a manner that accounts for and protects against risks to security with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.65.3.3. Security, Risks Limitation, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that accounts for and protects against risks to security with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.65.3.4. Security, Risks Limitation, Research Purpose
that such personal biospecimens, data and information, research, and administration are conducted only for a purpose that accounts for and protects against risks to security with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.65.4.1. Security, Strict Default
that such personal biospecimens, data and information, research, and administration, by default, strictly adhere to and fulfill all policies, principles, and protections for security with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.65.4.2. Security, Strict Design
that such personal biospecimens, data and information, research, and administration, by design, strictly adhere to and fulfill all policies, principles, and protections for security with respect to you — as the human subject concerned — as well as Publiks, to the most feasible and reasonable extent.
14.65.5. Security, Strict Review
that there is monitoring and periodic strict review to ensure the biospecimens, data and information, human subjects research, and the administration of both are secure and maintain security, and where inadequacies or infringements are found, they are addressed and rectified without undue delay.
14.65.6. Security, Strict Review Period
that appropriate, minimum and necessary time considerations — such as duration, frequency, and length between instances — are established for such periodic and strict review for security and then for any appropriate and efficacious decision as to continued (or discontinued) administration, processing, rectification, restriction, storage, or termination.
— of Sensitivity
Section 14.66.0. With respect to determining and ensuring adequate sensitivity of sensitive biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.66.1. Sensitivity, Basis
that sensitive biospecimens, data and information, human subjects research, and the administration of both maintain sensitivity with respect to you — as the human subject concerned — and do not infringe any policies, principles, or protections for sensitivity, as provided for in the Human Subjects Research Policy, the Codes and Policies, and applicable law and regulation.
14.66.2.1. Sensitivity, Design, Biospecimens
that, where reasonable or required, biospecimens, data and information are accessed, collected or otherwise processed in a manner that — by design — generates biospecimens, data and information that are not sensitive in nature or effect.
14.66.2.2. Sensitivity, Design, Research
that, where reasonable or required, the human subjects research is conducted in a manner that — by design — is not sensitive in nature or effect.
14.66.2.3. Sensitivity, Design, Research Administration
that, where reasonable or required, the administration of personal biospecimens, data and information is conducted in a manner that — by design — is not sensitive in nature or effect.
14.66.2.4. Sensitivity, Design, Protection
that the above is critical for attaining and maintaining standards for sensitivity protection by design.
14.66.3.1. Sensitivity, Default, Biospecimens
that where any personal biospecimens, data and information may be sensitive with respect to you — as the (supposed) person concerned — Publiks maintains a normative default position of refraining from accessing, maintaining, or obtaining any such biospecimens, data and information.
14.66.3.2. Sensitivity, Default, Research
that where any human subjects research may be sensitive with respect to you — as the (supposed) person concerned — Publiks maintains a normative default position of refraining from such research.
14.66.3.3. Sensitivity, Default, Research Administration
that where any administration of personal biospecimens, data and information may be sensitive with respect to you — as the (supposed) person concerned — Publiks maintains a normative default position of refraining from such administration.
14.66.3.4. Sensitivity, Default, Exception
that the default position will be rigorously maintained, except where Publiks receives a consented request from you — as the (supposed) person concerned — that meets the requirements below.
14.66.3.5. Sensitivity, Default, Exception, Compliance
that there is a guarantee from you and Publiks that all policies, principles, and protections for personal biospecimens, data and information are and will remain fulfilled.
14.66.3.6. Sensitivity, Default, Exception, Consent
that there is no applicable law or regulation prohibiting you — as the human subject concerned — 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.
14.66.3.7. Sensitivity, Default, Exception, Non-Identification
that the sensitive biospecimens, data and information obtained are accessed and otherwise processed in a manner that rigorously fulfills the principle of non-identification — with irreversible anonymization and aggregation preferred — so your identity cannot be ascertained, directly or indirectly through identifiers linked to you.
14.66.3.8. Sensitivity, Default, Exception, Re-Identification
that whenever the sensitive biospecimens, data and information are accessed or otherwise processed in such a manner that your identity can be ascertained, directly or indirectly through identifiers, Publiks rigorously adheres to protective protocols reviewed by the RRB specifically for the processing prior to its approval.
14.66.3.9. Sensitivity, Default, Exception, Risks
that there is assessment of actual and anticipated risks, then protections implemented to ensure, as much as possible, minimal risk to you — person concerned — as well as mitigation and protection against such adverse risks.
14.66.3.10. Sensitivity, Default, Exception, Risks, Coercion
that there is assessment of actual and 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 against the benefits with respect to you — as the human subject concerned.
14.66.3.11. Sensitivity, Default, Exception, Risks, Disclosure
that there is assessment of actual and anticipated risks, then protections implemented to minimize any harms upon breach or disclosure, including those which place you — as the human subject concerned — at risk of civil or criminal liability, damage to your educational advancement, employability, financial standing or reputation, or ostracization or stigmatization.
14.66.3.12. Sensitivity, Default, Exception, Risks Limitation, Biospecimens
that the human subjects research is conducted only on biospecimens, data and information that account for and protect against risks of such sensitivity with respect to you — as the human subject concerned.
14.66.3.13. Sensitivity, Default, Exception, Risks Limitation, Research Administration
that the administration of human subjects research and personal biospecimens, data and information is conducted only in a manner that accounts for and protects against risks of such sensitivity with respect to you — as the human subject concerned.
14.66.3.14. Sensitivity, Default, Exception, Risks Limitation, Research
that the human subjects research is conducted only in a manner that accounts for and protects against risks of such sensitivity with respect to you — as the human subject concerned.
14.66.3.15. Sensitivity, Default, Exception, Risks Limitation, Research Purpose
that the human subjects research is conducted only for purposes that account for and protect against of such sensitivity with respect to you — as the human subject concerned.
14.66.3.16. Sensitivity, Default, Exception, Restricted Uses
that the sensitive personal biospecimens, data and information are expressly and manifestly made accessible or public by you — as the human subject concerned — only for your own consented, explicit and sole benefit, purposes, and uses.
14.66.3.17. Sensitivity, Default, Non-Exception, Where Academia
that where an academic argument, interest, need, or purpose is the overriding or primary purpose for the research,
14.66.3.18. Sensitivity, Default, Non-Exception, Where Journalism
and where a news or journalism or broad or specific public argument, interest, need, or purpose is the overriding or primary purpose for the research,
14.66.3.19. Sensitivity, Default, Non-Exception, Where Public Benefit
and where a broad or specific public benefit argument, interest, need, or purpose is the overriding or primary purpose for the research,
14.66.3.20. Sensitivity, Default, Non-Exception, Where Public Health
and where a public health argument, benefit, interest, need, or purpose is the overriding or primary purpose for the research,
14.66.3.21. Sensitivity, Default, Non-Exception, Where Research
and where health, medical or scientific research is the overriding or primary purpose for the research,
14.66.3.22. Sensitivity, Default, Non-Exception, Where Service, Care
and where care, health or medical services is the overriding or primary purpose for the research,
14.66.3.23. Sensitivity, Default, Non-Exception, Where Service, Legal, Social
and where legal or social work or service is the overriding or primary purpose for the research,
14.66.3.24. Sensitivity, Default, Non-Exception, Where Services, Liberties, Rights
and where nonprofit civic liberties and rights service is the overriding or primary purpose for the research,
14.66.3.25. Sensitivity, Default, Non-Exception, Where There is Agreement Expectation
and where there is an expectation or request for an agreement, arrangement, contract, employment, volunteering, or equivalent to be considered, made or offered,
14.66.3.26. Sensitivity, Default, Non-Exception, Where Therefore Prohibited
in the aforementioned circumstances, Publiks will determine that the aforementioned argumentation, benefit, interests, needs, and purposes cannot themselves be considered lawful or legitimate and so cannot override the consent (or assent) decisions, interests, processes, or protections for you — as the human subject concerned — and Publiks therefore strictly prohibits any human subjects research, as well as funding or supporting such research, for solely such purposes. Publiks further strongly urges — on successful review and consent under any of the aforementioned circumstances — that every possible measure be taken to make and request such consideration 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 institutional review board policies, processes, and practices that the Founder, Alvan Azinna Ikoku, and Publiks will develop, authorize, and provide.
14.66.4. Sensitivity, Default, Protection
that the above position and strict requirements for exception are critical for attaining and maintaining standards for sensitivity protection by default.
14.66.5. Sensitivity, Strict Review
that there is monitoring and periodic strict review to ensure the biospecimens, data and information, human subjects research, and the administration of both are sensitively handled and maintain sensitivity, and where inadequacies or infringements are found, they are addressed and rectified without undue delay.
14.66.6. Sensitivity, Strict Review Period
that appropriate, minimum and necessary time considerations — such as duration, frequency, and length between instances — are established for such periodic and strict review for sensitivity and then for any appropriate and efficacious decision as to continued (or discontinued) administration, processing, rectification, restriction, storage, or termination.
— of Standardization
Section 14.67.0. With respect to determining and ensuring adequate standardization of biospecimens, data and information, human subjects research, and the administration of both, you understand and agree to abide by the following criteria:
14.67.1. Standardization, Basis
that there is monitoring and periodic review of the personal biospecimens, data and information, human subjects research, and the administration of both to ensure centrality, commensurability and case resolution, compliance, and coordinated harmonization across activities, areas, and systems, and by these means, to standardize expectations and practices for human subjects research policies, principles, and protections to the most feasible and reasonable extent.
14.67.2. Standardization, Centrality
that such monitoring and review — including, where appropriate, administrative, organizational and technical measures — specifically ensures such personal biospecimens, data and information, research, and administration are conducted in a manner that maintains the centrality and unity as well as independence and integrity of Publiks, including the Founder, as provided for in the Codes and Policies.
14.67.3. Standardization, Commensurability
that there is a commensurability and conflict resolution process providing a common basis and rubric for adjudicating human subjects research policies, principles, or protections that seem in competition, conflict, or tension, or incommensurable, when they are not.
14.67.3.1. Standardization, Commensurability, Agreement
that such commensurability and conflict resolution process have as its starting point confirmation of a legally binding agreement on the part of every person concerned to Publiks Conduct and Service Agreement, as provided for in the Codes and Policies, especially the Conditions of Founding and the Conditions of Governance, and where discovered, any inadequacies are prioritized and remedied, with binding Agreement being determinative.
14.67.3.2. Standardization, Commensurability, Applicability
that, as a subsequent step, there is confirmation of an understanding among all persons concerned that the applicability of such process is limited to conduct or service narrowly subject to the Human Subjects Research Policy — and does not entail other claims, matters, properties, remedies, or rights, and where discovered, any inadequacies are prioritized and remedied, with narrow applicability being determinative.
14.67.3.3. Standardization, Commensurability, Authorization
that, as a subsequent step, there is confirmation that every aspect of such process — including the conduct or service, biospecimens, data and information, or human subjects research under review — have and maintain the Founder’s authorization and be conducted under the Founder’s administration, with the Founder’s decision and discretion being determinative.
14.67.3.4. Standardization, Commensurability, Communication
that, as a subsequent step, there is confirmation that there is informing communication and notification regarding every aspect of such process — including the conduct or service, biospecimens, data and information, or human subjects research under review — to and from all persons concerned, and where discovered, any inadequacies are prioritized and remedied to the most feasible and reasonable extent.
14.67.3.5. Standardization, Commensurability, Confidentiality, Privacy
that, as a subsequent step, there is confirmation that every aspect of such process — including the conduct or service, biospecimens, data and information, or human subjects research under review — has maintained and protected confidentiality and privacy with respect to all persons concerned, and where discovered, any inadequacies are prioritized and remedied to the most feasible and reasonable extent, with absolute or adequate confidentiality and privacy being determinative.
14.67.3.6. Standardization, Commensurability, Consent
that, as a subsequent step, there is confirmation that every aspect of such process — including the conduct or service, biospecimens, data and information, or human subjects research under review — has obtained and maintained informed consent (or assent) by all persons concerned, and where discovered, any inadequacies are prioritized and remedied to the most feasible and reasonable extent, with meaningful consent being determinative.
14.67.3.7. Standardization, Commensurability, Harm
that, as a subsequent step, there is confirmation that every aspect of such process — including the conduct or service, biospecimens, data and information, or human subjects research under review — has not effected or facilitated imminent harm or injury, of physical or psychological nature, to any of the persons concerned, and where discovered, any instances are prioritized and remedied to the most feasible and reasonable extent, with possibility or presence of imminent harm being determinative.
14.67.3.8. Standardization, Commensurability, Infringement
that, as a subsequent step, there is confirmation that every aspect of such process — including the conduct or service under review — has not effected or facilitated an infringement of the biospecimens, data and information, human subjects research, or their protections, with respect to any of the persons concerned, and where discovered, any inadequacies are prioritized and remedied to the most feasible and reasonable extent, with integrity and protection of the biospecimens, data and information and human subjects research being determinative.
14.67.3.9. Standardization, Commensurability, Infringement, Intentional
that, as a subsequent step, there is confirmation that every aspect of such process — including the conduct or service, biospecimens, data and information, or human subjects research under review — has not effected or facilitated an intentional infringement of the Human Subjects Research Policy, the Codes and Policies, or applicable law or regulation, with respect to any of the persons concerned, and where discovered, any inadequacies are prioritized and remedied to the most feasible and reasonable extent, with intent as well as infringement being determinative.
14.67.3.10. Standardization, Commensurability, Infringement, Unintentional
that, as a subsequent step, there is confirmation that every aspect of such process — including the conduct or service, biospecimens, data and information, or human subjects research under review — has not effected or facilitated an unintentional infringement of the Human Subjects Research Policy, the Codes and Policies, or applicable law or regulation, with respect to any of the persons concerned, and where discovered, any inadequacies are prioritized and remedied to the most feasible and reasonable extent, with mishandling, mistake, or misunderstanding as well as infringement being determinative.
14.67.3.11. Standardization, Commensurability, Property
that, as a subsequent step, there is confirmation that every aspect of such process — including the conduct or service, biospecimens, data and information, or human subjects research under review — has not effected or facilitated an infringement or violation of property or proprietariness with respect to any of the persons concerned, and where discovered, any inadequacies are prioritized and remedied to the most feasible and reasonable extent, with respected property attendant to data and information being determinative.
14.67.3.12. Standardization, Commensurability, Rights
that, as a subsequent step, there is confirmation that every aspect of such process — including the conduct or service, biospecimens, data and information, or human subjects research under review — has not effected or facilitated an infringement or violation of civil liberties or rights with respect to any of the persons concerned, and where discovered, any inadequacies are prioritized and remedied to the most feasible and reasonable extent, with respected rights attendant to human subjects research being determinative.
14.67.3.13. Standardization, Commensurability, Resolution Order
that, where inadequacies are discovered, remedying them involves prioritized attention to historical order of occurrence in combination with the aforementioned stepwise sequence of review, with, to the most feasible and reasonable extent, application of the “fruit of the poisonous tree” concept and depositing of any involved material or property, as well as any benefits accrued via such inadequacies, with Publiks and the Founder, Alvan Azinna Chibuzo Ikoku, for resolution via adjudicating decision at his absolute, complete and sole discretion.
14.67.4. Standardization, Compliance
that there is a compliance process — including, where appropriate, administrative, organizational and technical measures — specifically ensuring such personal biospecimens, data and information, research, and administration are conducted in a manner that adheres to and fulfills policies, principles, and protections as delineated in the RRB approval and provided for in the Human Subjects Research Policy, the Codes and Polices, and applicable law and regulation.
14.67.5. Standardization, Coordinated Harmonization
that there is a coordination and harmonization process specifically ensuring such personal biospecimens, data and information, research, and administration are optimally adequate, appropriate, efficacious and protective — across activities, areas, and systems — including, where appropriate, assessing, evaluating, testing, and updating administrative, organizational and technical measures and processes so that they meet best practices standards to the most feasible and reasonable extent.
E — On Protections
For Specific Persons
— For Entity
Section 14.68.0. With respect to human subjects research protections for Publiks as an entity, you understand and agree to abide by the following:
14.68.1. Protections, Entity
that Publiks holds protecting human subjects research for Publiks Inc and The Publiks Group as organizations to be a basic purpose and right of their establishment and existence as entities, thus of high importance;
14.68.2. Protections, Entity, Administration
that Publiks holds protecting such organizational human subjects research to be important to its formation, governance, and overall administration;
14.68.3. Protections, Entity, Areas
that Publiks holds protecting such organizational human subjects research to include that of its official areas, offices, parts, properties, sections, and equivalent, as well as any involved act, activity, agent, arrangement, asset, or material or matter;
14.68.4. Protections, Entity, Conduct, Service
that Publiks holds protecting such organizational human subjects research to include that of its official conduct and service, as well as any involved act, activity, agent, arrangement, asset, or material or matter;
14.68.5. Protections, Entity, Mission
that Publiks holds protecting such organizational human subjects research to be important to the fulfillment of its mission and purposes, and so enforces and fulfills attendant policies, principles, requirements, and rights to the fullest extent possible;
14.68.6. Protections, Entity, Non-Infringement
that you maintain and not infringe, in any way, such organizational human subjects research, as provided for in the Codes and Policies and applicable law and regulation;
14.68.7. Protections, Entity, Understanding
with the understanding that your primary means of maintaining such organizational human subjects research is to refrain from and report — via fully informing communication directly to the Founder — any actual, anticipated or apparent infringement of the Codes and Policies or applicable law or regulation.
— For Founder
Section 14.69.0. With respect to human subjects research protections for the Founder of Publiks, Alvan Azinna Chibuzo Ikoku, you understand and agree to abide by the following:
14.69.1. Protections, Founder
that Publiks holds protecting human subjects research for the Founder to be a basic purpose and right of its establishment and existence as an entity, thus of high importance;
14.69.2. Protections, Founder, Administration
that Publiks holds protecting such Founder human subjects research to be important to its formation, governance, and overall administration;
14.69.3. Protections, Founder, Areas
that Publiks holds protecting such Founder human subjects research to include the Founder’s official areas, offices, parts, properties, sections, and equivalent, as well as any involved act, activity, agent, arrangement, asset, material or matter;
14.69.4. Protections, Founder, Conduct, Service
that Publiks holds protecting such Founder human subjects research to include the Founder’s official conduct and service, as well as any involved act, activity, agent, arrangement, asset, material or matter;
14.69.5. Protections, Founder, Mission
that Publiks holds protecting such Founder human subjects research to be important to the fulfillment of its mission and purposes, and so enforces and fulfills attendant policies, principles, requirements, and rights to the fullest extent possible;
14.69.6. Protections, Founder, Non-Infringement
that you maintain and not infringe, in any way, such Founder human subjects research, as provided for in the Codes and Policies and applicable law and regulation;
14.69.7. Protections, Founder, Understanding
with the understanding that your primary means of maintaining such Founder human subjects research is to refrain from and report — via fully informing communication directly to the Founder — any actual, anticipated or apparent infringement of the Codes and Policies or applicable law or regulation.
— For Humans
Section 14.70.0. With respect to human subjects research protections for human beings, as individuals, you understand and agree to abide by the following:
14.70.1. Protections, Humans
that Publiks holds protecting human subjects research for humans, as individuals, at Publiks to be a basic purpose and right of its establishment and existence as an entity, thus of high importance;
14.70.2. Protections, Humans, Administration
that Publiks holds protecting such human human subjects research to be important to its formation, governance, and overall administration;
14.70.3. Protections, Humans, Areas
that Publiks holds protecting such human human subjects research to include individual-related areas, offices, parts, properties, sections, and equivalent, as well as any involved act, activity, agent, arrangement, asset, material or matter;
14.70.4. Protections, Humans, Being
that Publiks holds protecting such human human subjects research to include that pertaining to an individual’s inner being, body, and brain, as well as inner self, soul, and spirit;
14.70.5. Protections, Humans, Conduct, Service
that Publiks holds protecting such human human subjects research to include individual-related conduct and service, as well as any involved act, activity, agent, arrangement, asset, material or matter;
14.70.6. Protections, Humans, Mission
that Publiks holds protecting such human human subjects research to be important to the fulfillment of its mission and purposes, and so enforces and fulfills attendant policies, principles, requirements, and rights to the fullest extent possible;
14.70.7. Protections, Humans, Non-Infringement
that you maintain and not infringe, in any way, such human human subjects research, as provided for in the Codes and Policies and applicable law and regulation;
14.70.8. Protections, Humans, Understanding
with the understanding that your primary means of maintaining such human human subjects research is to refrain from and report — via fully informing communication directly to the Founder — any actual, anticipated or apparent infringement of the Codes and Policies or applicable law or regulation.
From Risks, Threats
— From Specific Risks
Section 14.71.0. With respect to protections of human subjects research from specific risks and threats, you understand and agree to abide by the following:
14.71.1. Protections, Cooptation
that Publiks protects itself and the Founder, as first priorities, then where reasonable, other natural persons from specifically relevant risks and threats to human subjects research resulting from attempts to coopt, takeover, or otherwise usurp the Founder’s administration, management, operation, ownership, or equivalent of Publiks, including attempts that are collectivist, communal, communist, cooperative, governmental, judicial, regulatory, socialist or statist, as provided for in the Codes and Policies and applicable law and regulation;
14.71.2. Protections, Disclosure
that Publiks protects itself and the Founder, as first priorities, then where reasonable, other natural persons from specifically relevant risks and threats to human subjects research resulting from infringing access, communication, human subjects research, disclosure, exposure, identification, leak, publicity, transparency, or equivalent, as provided for in the Codes and Policies and applicable law and regulation;
14.71.3. Protections, Non-Consent
that Publiks protects itself and the Founder, as first priorities, then where reasonable, other natural persons from specifically relevant risks and threats to human subjects research resulting from inadequacy, insufficiency, or other infringement of consent, as provided for in the Codes and Policies and applicable law and regulation;
14.71.4. Protections, Non-Provision
that Publiks protects itself and the Founder, as first priorities, then where reasonable, other natural persons from specifically relevant risks and threats to human subjects research resulting from non-provision of required and standard human subjects research administration, measure, practice, procedure, or equivalent, as provided for in the Codes and Policies and applicable law and regulation;
14.71.5. Protections, Understanding
with the understanding that the aforementioned determinations of specifically relevant risks and threats, and protections against them, are to be made solely by the Founder and executed solely via the Founder’s authorization.
— From Standard Risks
Section 14.72.0. With respect to protections of human subjects research from standard risks and threats, you understand and agree to abide by the following:
14.72.1. Protections, Incompatibility
that Publiks protects itself and the Founder, as first priorities, then where reasonable, other natural persons from standard risks and threats to human subjects research resulting from any incompatibility relating to Publiks, as provided for in the Codes and Policies;
14.72.2. Protections, Inconsistency
that Publiks protects itself and the Founder, as first priorities, then where reasonable, other natural persons from standard risks and threats to human subjects research resulting from any inconsistency relating to Publiks, as provided for in the Codes and Policies;
14.72.3. Protections, Infringement
that Publiks protects itself and the Founder, as first priorities, then where reasonable, other natural persons from standard risks and threats to human subjects research resulting from any infringement relating to Publiks, as provided for in the Codes and Policies;
14.72.4. Protections, Insecurity
that Publiks protects itself and the Founder, as first priorities, then where reasonable, other natural persons from standard risks and threats to human subjects research resulting from any insecurity relating to Publiks, as provided for in the Codes and Policies;
14.72.5. Protections, Interference
that Publiks protects itself and the Founder, as first priorities, then where reasonable, other natural persons from standard risks and threats to human subjects research resulting from any interference relating to Publiks, as provided for in the Codes and Policies;
14.72.6. Protections, Intrusion
that Publiks protects itself and the Founder, as first priorities, then where reasonable, other natural persons from standard risks and threats to human subjects research resulting from any intrusion relating to Publiks, as provided for in the Codes and Policies;
14.72.7. Protections, Invalidation
that Publiks protects itself and the Founder, as first priorities, then where reasonable, other natural persons from standard risks and threats to human subjects research resulting from any effective invalidation relating to Publiks, as provided for in the Codes and Policies;
14.72.8. Protections, Understanding
with the understanding that the aforementioned determinations of standard risks and threats, and protections against them, are to be made solely by the Founder and executed solely via the Founder’s authorization.
Policies
Provision
As stated earlier, the governance of Publiks Inc and The Publiks Group is, in important part, conducted via the Codes and Policies below:
Publiks Group Agreement
The Publiks Conduct and Service Agreement, which
Collectively Governing
consists of several Codes and Policies that collectively govern all conduct and service in any way relating to Publiks Inc and The Publiks Group.
Collectively Including
collectively include the Basic Policies — the Conditions and Terms of Founding, the Conditions and Terms of Governance, the Conditions and Terms of Conduct and Service, and the Founding and Governing Code of Ethics — as well as all other codes and policies, associated as the Correlative Policies.
Available Below
are made available further below.
Conditions of Founding
Conditions and Terms of Founding of Publiks (HTML)
Conditions of Governance
Conditions and Terms of Governance of Publiks (HTML)
Conditions of Service
Conditions and Terms of Conduct and Service (HTML)
Founding Ethics
Founding and Governing Code of Ethics (HTML)
All Policies
All Policies (HTML)
Conclusion
— Collectively, the Policy
— All of the aforementioned in this section constitutes the Policy on Human Subjects Research of Publiks Inc and The Publiks Group (the “Human Subjects Research Policy”) and forms an integral part of the Codes and Policies of Publiks Inc and The Publiks Group as well as the Publiks Conduct and Service Agreement you may enter into with Publiks Inc and The Publiks Group.
— Concerns and Questions
— Please report any concerns about code or policy violations, and send any questions you may have regarding the Policy on Human Subjects Research or the Publiks Conduct and Service Agreement, to policies@publiks.org.
— Concluding
— And as a concluding aviso and proviso, you are informed as well as reminded that by commencing or continuing any conduct or service relating to Publiks Inc or The Publiks Group — in any way, either directly or indirectly, and via any manner, means, method, or mode — you enter into the Publiks Conduct and Service Agreement and agree to abide by and be legally bound by the Policy conditions, principles, protections, and terms described above, and the Codes and Policies, in their entirety without modification or severability, as amended from time to time solely by the Founder.
Also at the Division
Publiks Inc and its partner, The Ikoku Group, are dedicated to developing, providing and safekeeping ideas and solutions — with the mission to foster care and creativity, culture and communities, ethics and innovation in lives and societies. And so in accordance with the above, The Ikoku Group and Publiks provide the following:
I.
A Company of Care and Community
A company and divisions committed to developing and ultimately providing ideas, practices, and products fostering care and community — for the benefit and service of people coexisting in local and global communities.
II.
A Company of Culture and Creativity
A company and divisions committed to developing and ultimately providing ideas, practices, and products fostering culture and creativity — for the benefit and enjoyment of people engaging in and with local and global communities.
III.
A Company of Ethics and Innovation
A company and divisions committed to developing and ultimately providing innovation that abides by ethics principles and protections — for the benefit and humane use of people employing our solutions for local and global concerns.