The HHS regulations (CFR45 Part 46) stipulate that the grantee organization(s), whether domestic or foreign, bears ultimate responsibility for safeguarding the rights and welfare of human subjects in HHS-supported activities (46.101(a) and 46.103(a)). Grantee institutions “engaged” in human subjects research must obtain a Federalwide Assurance (FWA) with the HHS Office for Human Research Protections (OHRP), and establish appropriate policies and procedures for the protection of human subjects. An institution is engaged in human subjects research if:
- the institution’s employees or agents intervene or interact with human subjects for research purposes;
- the institution’s employees or agents obtain individually identifiable private information about human subjects for research purposes; or
- the institution receives a direct HHS award to conduct human subjects research, even where all activities involving human subjects are carried out by a subcontractor or collaborator.
Each Institution must establish an Institutional Review Board (IRB) who will review and approve all research and related activities involving human participants. The board weighs the risks and benefits of participation to help protect the health and best interests of research participants. All review is completed prior to the beginning of research.
ETHICS CODES – BASES FOR REGULATIONS AND GUIDANCE
- The Nuremburg Code – First definition of legitimate medical research resulting from Nazi war crimes.
- Belmont Report – Respect for persons, beneficence, and justice.
- Declaration of Helsinki – Ethical principles developed by the World Medical Association.
- CIOMS – Applies the Declaration of Helsinki specifically to research in under-developed and low resource countries.
Office for Human Research Protections (OHRP) – HHS Policy for the Protection of Human Subjects. A base set of rules, with additional protections in place for research involving:
- Pregnant women, human fetuses, and neonates
Food & Drug Administration
The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. FDA regulations are published as part of chapter 21 of the CFR, and FDA’s human subject protection regulations are in parts 50, 56, 312 and 812.