Institutional Review Board

An institutional review board (IRB), or ethics committee, reviews proposed and ongoing research conducted with human subjects. The purpose of the IRB review is to protect the rights and safety of human participants. The IRB review process was initiated in response to the Tuskegee Syphilis Study, in which subjects received substandard medical care without their consent. Initially focused on biomedical research, IRBs now review social science research and often liberal arts research as well (e.g., living history interviews). Institutions seeking federal funding must have an IRB, and the IRB must review and approve federally funded research studies. Most institutions require IRB approval for all research that [Page 545]involves human subjects, not just that funded by the federal government.

The IRB process begins before participants are recruited for a study. The study protocol must satisfy the three basic principles of the Belmont Report: that the study design provide sufficient beneficence (maximizes the benefits compared with the risks of participation), justice, and respect for persons. Once the study is approved, the IRB is charged with overseeing the research from an ethics perspective. This oversight is usually exercised through two mechanisms. First, it provides all participants a means of contacting the IRB directly if they have any concerns, and, second, the IRB conducts periodic reviews of the study to monitor the research progress and address any ethics concerns. The review process usually occurs annually. Although rarely used, the IRB can require additional reviews and actively conduct surprise inspections of research records.

IRBs for institutions receiving U.S. federal funds must have at least five members, and most have more. The IRB must include members who represent diverse bodies of knowledge relevant to the conduct of ethical research. In addition, members should be demographically and culturally diverse. Several specific membership criteria must be satisfied

• At least one member must be from the scientific community and knowledgeable about scientific research.
• At least one member must be outside the scientific community; this person should advocate for the nonscientific issues relevant to ethical conduct of research, such as legal issues and standards for professional conduct.
• At least one person must be from outside the institution; this person is usually a community member and represents the community standard for assessing the ethics of a study.

When the research proposed is outside the expertise of the IRB members, the IRB can invite experts in the research area to provide additional information in the review; however, these consultants are not allowed to vote. Most IRBs use a consensus approach (i.e., votes must be unanimous) to reach a decision, although some IRBs allow a majority vote. When a majority vote is used, the community member typically still has substantial power because most IRBs will not override the perspective of the community member. The administration of an institution (e.g., president of a university, director of a hospital) must allow the IRB to function independently, without undue influence related to funding pressures or other administration priorities.

The Office of Human Research Protections (OHRP) is responsible for the registration of IRBs and their oversight. The OHRP Web site provides substantial information about IRBs and the review process.

...