B. IRB Expertise

IRBs should:

1. be familiar with Federal regulations, applicable state law, and institutional policies and procedures for the protection of human subjects.
2. have effective knowledge of subject populations and other factors that can foreseeably contribute to a determination of risks and benefits to subjects and subjects’ informed consent.
3. be able to judge the adequacy and accuracy of information in the informed consent document, advertising, and any other materials to be presented to subjects.
4. if regularly reviewing research that involves a vulnerable category of subjects such as children, prisoners, pregnant women, or handicapped or disabled persons, include in its membership one or more individuals who are knowledgeable about and experienced in working with these subjects.
5. have the professional competence necessary to review the research proposals presented for approval.