Institutional Review Boards (IRB)

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The FDA defines an IRB as an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and Investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

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About the Author
Proxima CRO Team
Bufo Areh
Clinical Research Associate

Nwabufo obtained his B.Sc. in Biotechnology with a minor in Business Administration from the Richard Stockton University, New Jersey. Nwabufo has over four years of global experience in a variety of therapeutic areas, including cardiovascular, oncology, ophthalmology, infectious diseases, CNS, and metabolic diseases as a clinical research associate.

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