institutional review board

institutional review board (IRB), in the United States, ethics committee that reviews proposed and ongoing research involving human subjects. The institutional review board (IRB) exists to protect the rights and safety of human subjects who participate in research studies. The need for an IRB became apparent in the 1960s and 1970s, largely as a result of the Tuskegee Syphilis Study, in which human subjects received substandard medical care without their consent. The IRB system subsequently was established with the passage of the National Research Act of 1974. The Office of Human Research Protections, within the U.S. Department of Health and Human Services, is responsible for the registration of IRBs and their oversight.

Initially focused on biomedical research, IRBs later were also developed for research in the social sciences and liberal arts (e.g., for research involving 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 involves human subjects, not only 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 (a summary of ethical principles and guidelines for the conduct of research involving human subjects): 1) respect for persons, 2) beneficence (avoiding harm to subjects and maximizing the benefits compared with the risks of participation), and 3) justice. Once the study is approved, the IRB is charged with overseeing the research from an ethics perspective. This oversight usually is exercised through two mechanisms. First, participants are provided with a means of contacting the IRB directly if they have concerns, and, second, the IRB conducts periodic reviews of the study to monitor the research progress and address any ethical issues. The review process usually occurs annually. Although rarely used, the IRB can carry out additional reviews and actively conduct surprise inspections of research records.

IRBs for institutions receiving U.S. federal funds are required to have at least five members, though most institutions have more. The IRB must include members who represent diverse bodies of knowledge relevant to the conduct of ethical research. For example, at least one member must be from the scientific community and knowledgeable about scientific research, and there must be at least one member from 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. In addition, at least one person must be from outside the institution; this person (who may also serve as the nonscientific member) usually is 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 or director of a hospital) must allow the IRB to function independently, without undue influence related to funding pressures or other administration priorities.