Institutional Review Board
Institutional Review Board (IRB) is a committee that is formally designated to review, approve, monitor, and propose modifications to biomedical and behavioral research involving humans. The primary purpose of an IRB is to protect the rights and welfare of human research subjects.
History[edit | edit source]
The concept of the Institutional Review Board originated in the United States in response to research abuses in the 20th century. The most notable of these was the Tuskegee Syphilis Study, which led to the development of the Belmont Report and the subsequent establishment of IRBs.
Function[edit | edit source]
The main function of an IRB is to review research proposals involving human subjects. This includes ensuring that the research is ethical, that the rights and welfare of the subjects are protected, and that any risks are minimized and are reasonable in relation to the potential benefits.
Types of Review[edit | edit source]
There are three types of review that an IRB can perform: expedited review, full board review, and exempt review.
Expedited Review[edit | edit source]
An expedited review is used for research that involves no more than minimal risk to the subjects. This type of review can be carried out by a single member of the IRB, rather than the full board.
Full Board Review[edit | edit source]
A full board review is required for research that involves more than minimal risk to the subjects. This type of review must be carried out by the full IRB.
Exempt Review[edit | edit source]
An exempt review is used for research that falls into one of the categories specified by the regulations as being exempt from the requirements for IRB review.
Composition[edit | edit source]
An IRB is composed of at least five members with varying backgrounds. This diversity helps to ensure the complete and adequate review of research activities.
Regulations[edit | edit source]
In the United States, IRBs operate under the regulations of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA).
See Also[edit | edit source]
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Contributors: Prab R. Tumpati, MD
