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
