U.S. Department of Health & Human Services
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What are the requirements for IRB membership?
The requirements for IRB membership are addressed in the HHS regulations at 45 CFR 46.107[Note: 45 CFR 46.304 requires a specialized IRB composition when research involving prisoners is being reviewed, including the presence of a prisoner representative].
An IRB must:
- have at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution;
- make every nondiscriminatory effort to ensure that the membership is not composed of entirely men or entirely women;
- include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas;
- include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution; and
- not allow any member to participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. Please see the regulations at 45 CFR 46.107 for complete information on all of the required qualifications to properly compose an IRB.
Last Reviewed: 01/20/2011
Related Questions:
- How do I determine the various categories of members for the IRB roster?
- Does a FWA have to be updated if an institution later relies on an IRB not included in the original FWA submission?
- Does registration mean that an IRB is in full compliance with the HHS regulations, 45 CFR part 46, or is otherwise meeting a particular standard of competence or expertise?
- When must an IRB registration be renewed or updated?
- What are the requirements for providing information on the number of protocols being reviewed by the IRB?
