The composition of the IRB is specified in the Department of Health & Human Services (DHHS) regulations.107 The IRB must be comprised of male and female members from diverse backgrounds who possess the professional competence necessary to review the specific research activities submitted to the Board. In addition, the IRB should reflect an appropriate racial and cultural balance, as well as sensitivity to such issues as community attitudes toward medical research. At least one member of the IRB must be a lay community representative with no formal relationship with the Institution. Lay members of the IRB are not expected to possess the necessary technical expertise to review the scientific aspects of most medical protocols. They should, however, be competent to review the consent process and the consent form.
IRBs must have at least five members. Included in this group should be a least one scientist, one nonscientist, and one individual who has no personal or familial employment by the IRB. Further, membership by at least one attorney and one clergyman is generally recommended. In being certain that appropriate consent is provided, an IRB, by federal regulation, has the following obligations: (1) risks to subjects must be minimized by using procedures that are consistent with sound research design, and that do not necessarily expose subjects to risk and (2) risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result.