The regulations apply to any clinical trial that involves an investigational drug, biological product, or other device that is regulated by the FDA under the Food, Drug, and Cosmetics Act - regardless of whether or not the trial receives Federal funding. If a trial is supported by the Department of Health and Human Services and involves an FDA-regulated drug or device, then it is subject to both organizations' regulations. (For more information, see Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors [fda.gov]).
Office for Human Research Protections (OHRP) [hhs.gov]:
The Office for Human Research Protections (OHRP) protects the rights, welfare, and well-being of subjects involved in research conducted or supported by the Department of Health and Human Services (HHS) and helps ensure that such research is carried out in accordance with the regulations described in the Code of Federal Regulations: Title 45, Part 46 [hhs.gov]; also referred to as 45 CFR 46 [hhs.gov]. Such research must abide by the Protection of Human Subjects requirements in 45 CFR 46.
Food and Drug Administration (FDA):
The U.S. Food and Drug Administration (FDA), through its Office of Health Affairs, has developed its own set of regulations on the protection of human subjects (Code of Federal Regulations: Title 21, Part 50 [accessdata.fda.gov] and Title 21, Part 56 [accessdata.fda.gov]; also referred to as 21 CFR 50, 56).
NIH Policy for Genome-Wide Association Studies (GWAS):
The NIH released the final "Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS)" in the NIH Guide and the Federal Register on August 28, 2007. Under this policy, investigators who are performing whole genome association studies conducted or supported by the NIH are expected to submit their data to the NIH GWAS data repository (currently dbGaP) for broad sharing with the research community.
Institutional Review Boards (IRBs): The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. Guidance regarding IRBs can be found at:
The National Institutes of Health (NIH): As a complement to the NIH GWAS Policy, the NIH has developed a Points to Consider[grants.nih.gov] document for IRBs and institutions in their review of data submission plans for institutional certifications under NIH's GWAS Policy.
The Office for Human Research Protections (OHRP): OHRP has developed an IRB Guidebook [hhs.gov] to help researchers and IRB members to understand the policies, principles, and issues that pertain to designing and reviewing research proposals. OHRP also has IRB information at the Human Research Questions & Answers [hhs.gov] resource.
The Department of Energy: The Department of Energy has a Human Subjects Protection Resource Book [humansubjects.energy.gov] that provides information for IRBs and their investigators. A chapter in this resource is dedicated to issues pertaining to genetics and genomics research.
Group Health Center for Health Studies
The Project to Review and Improve Study Materials (PRISM) is a Group Health Center for Health Studies initiative to improve the quality of print materials used in communication with research participants. The primary goal is to create written study materials that are readable and participant-centered through the PRISM Readability Toolkit [centerforhealthstudies.org]