Institutional review board

An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), Ethical Review Board (ERB), or Research Ethics Board (REB), is a type of committee used in research in the United States that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study.

History

The establishment of IRBs was initially mandated by the National Research Act in 1974, in response to public outrage over the Tuskegee Syphilis Study. The Act also created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was tasked with establishing the ethical guidelines for human research and identifying the basic principles that should underlie the conduct of biomedical and behavioral research involving human subjects.

Function

The primary function of an IRB is to protect the rights and welfare of human research subjects. This is achieved by reviewing research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure compliance with ethical standards and regulatory requirements. The IRB also has the authority to approve, require modifications in, or disapprove research.

Types of Review

IRBs conduct three types of review: full board review, expedited review, and exempt review. Full board review is required for research that presents more than minimal risk to subjects. Expedited review may be used for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. Exempt review is for research involving the least potential risk to subjects.

Composition

IRBs are composed of at least five members with varying backgrounds to promote complete and adequate review of research activities. The board must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, including considerations of their racial and cultural heritage and their sensitivity to issues such as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

Regulations

In the United States, IRBs are governed by Title 45 Code of Federal Regulations Part 46 (45 CFR 46), which is often referred to as the "Common Rule". The Common Rule outlines the basic provisions for IRBs, including requirements for membership, function, operations, review of research, and record keeping.

See Also

• Ethics Committee
• Clinical Trial
• Human Subject Research
• Informed Consent
• Research Ethics