IRB

IRB or Institutional Review Board is a committee 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 history of Institutional Review Boards (IRBs) dates back to the aftermath of the Nuremberg Trials, where the Nuremberg Code was established, setting forth the basic principles for conducting research involving human subjects. The Declaration of Helsinki further expanded on these principles. In the United States, the National Research Act of 1974 led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which developed the Belmont Report, a key document in the formation of IRB guidelines.

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 has the authority to approve, require modifications in, or disapprove research.

Types of Review

IRBs conduct three types of review: expedited review, full board review, and exempt review. The level of review is determined by the potential risk to the subject.

Composition

An IRB is 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.

Regulations

In the United States, IRBs are governed by Title 45, Part 46 of the Code of Federal Regulations. Other countries have their own regulations and guidelines governing the operation of IRBs.

See Also

• Ethics in research
• Clinical Trials
• Informed Consent

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