IRB Membership
The HHS regulations (45 CFR 46.107) require that IRBs have at least 5 members from a variety of backgrounds. The experience, expertise and diversity of the IRB members should allow the IRB to provide a complete and adequate review of the research activities conducted at the institution.
Research may involve issues about which IRB members lack specific expertise. In these situations, IRBs should identify and invite individuals with specialized knowledge to assist in the review of applications and protocols where the expertise is required.
This issue was raised in the Respect for Persons section when discussing the HSS regulations for IRB membership when a study sought to enroll a vulnerable population (prisoners) in research. Another example of where specific expertise may be needed is a protocol proposing a study that recruits participants presenting to a hospital Emergency Department (ED) with acute appendicitis. If the IRB lacks expertise about protections for human subjects in emergency situations, the IRB Chair should ask an expert, such as the head of the ED to advise the IRB on the feasibility of the recruitment strategy.
