IRB members should be knowledgeable, diverse

By John Isidor, JD
CEO
Schulman Associates IRB
Cincinnati

Question: Does the Food and Drug Administration require that an IRB have a certain number of members?

Answer: The minimum number of members required is five (21 CFR 56.107; 45 CFR 46.107). The IRB must have one member whose primary concern is scientific and one member whose primary concern is nonscientific. The regulations do not define the terms "scientific" or "nonscientific." However, an IRB that regularly reviews biomedical research should have at least one physician at each meeting. Additionally, the IRB must have one person who is not affiliated with the institution.

IRBs should be diverse culturally, ethnically, racially, and in gender. The regulations also require members who are knowledgeable regarding institutional policies and procedures, applicable law, regulations and standards of professional conduct and practice, seemingly necessitating the presence of an attorney and a professional knowledgeable in the subject area of the research. If the IRB does not have such members, the regulations allow the IRB to use nonvoting consultants.

IRBs that regularly review research involving vulnerable subjects such as children, prisoners, or pregnant women should consider including members knowledgeable about the special concerns arising from participation of such subjects.

Finally, no IRB member who has a conflict of interest should participate in the review of research, except to provide information requested by the IRB.