IRB FAQs – Important Regulations and Governing Agencies
What is the Code of Federal Regulations (CFR) Title 21, Part 50 and Part 56?
Part 50 of the CFRare the regulations for clinical research which were established in 1980 by the Food and Drug Administration. Part 56 are the regulations that govern the IRB in reviewing research activities that involve humans.
What is the Common Rule?
In 1991, the Federal Policy for the Protection of Human Subjects was adopted, covering research supported by many other federal agencies and departments. Revisions to the Common Rule were issued by DHHS in January 2017 and became effective Jan. 21, 2019.
What is Office of Human Research Protections (OHRP)?
The Office of Human Research Protections (OHRP) was established within the U.S. Department of Health and Human Services. The OHRP provides leadership for all 17 federal agencies that carry out research involving humans under the Common Rule regulations. The office focuses entirely on protection of human participants in research and supervision of institutional review boards. OHRP has oversight and educational responsibilities wherever DHHS funds are used to conduct or support research involving human participants, and when the research institutions have included all research they conduct in their assurances filed with OHRP, regardless of the funding source. Find the OHRP online.
What is a federalwide assurance (FWA)?
According to DHHS regulations 45 CFR 46.103, every institution engaged in human research supported or conducted by DHHS must obtain an assurance of compliance approved by the OHRP. The FWA signatory official must be authorized to represent and commit the entire institution and all its components to a legally binding agreement.
- ECU’s FWA # is FWA00000658
- Vidant Medical Center’s FWA # is FWA00000652
The OHRP has also developed an IRB registration system. Registration of an IRB or independent ethics committee (IEC) with the OHRP is voluntary. However, registration is required for any institution or facility that receives federal funding. IRB registration is also mandatory for research that involves Food and Drug Administration articles that fall within its purview. The registration process is coordinated through the OHRP.
Both the Biomedical and Behavioral and Social Sciences IRBs at ECU are registered with OHRP and the FDA. The registration numbers for those committees are:
- IRB00000705 East Carolina U IRB #1 (Biomedical)
- IRB00003781 East Carolina U IRB #2 (Behavioral and Social Sciences)
Are there special requirements for FDA regulated research?
The Food and Drug Administration has separate regulations and policies concerning IRB review as set forth in 21 CFR 56.
The FDA has purview over regulations that must be followed when the research involves products such as drugs, devices and biologics. This includes research and marketing permits for drugs, biological products and medical devices for human use. The FDA is not concerned about whether the research is funded or what agency is funding it, if any. The regulations apply whenever the research involves the use of drugs, devices or biologics, whether investigational in nature or approved.
See the FDA’s Clinical Trials and Human Subject Protection webpage for information regarding good clinical practice for research studies involving human participants in FDA-regulated products.
Does a physician, in private practice, conducting research with an FDA regulated product, need to obtain IRB approval?
Yes. FDA regulations require IRB review and approval of regulated clinical investigations involving human participants no matter where the investigation is to occur.