Which type of members must an IRB include as per the Common Rule?

An Institutional Review Board (IRB) is required by the Common Rule to include at least one member who is a nonscientist. This inclusion is vital to ensure that the IRB can consider ethical issues and perspectives that may not be adequately addressed through a purely scientific lens. A nonscientist member helps to bring a broader perspective to the review process, highlighting concerns that may relate to the welfare of participants, community implications, and ethical considerations that extend beyond scientific rigor. Such diversity in expertise promotes a more balanced assessment of research proposals, ensuring that human subjects’ rights and welfare are protected as required by federal regulations.

While other roles, such as an institutional official or community representative, may be beneficial for specific IRBs or institutional policies, the Common Rule specifically mandates the inclusion of at least one nonscientist to fulfill its requirements regarding the composition of the IRB.