ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Institutional Review Board (IRB)

IRBs review, approve, and monitor research involving human subjects in order to evaluating the ethical acceptability and the scientific validity of any such studies. An IRB is formally designated by an institution in which research takes places, such as a hospital or university. FDA regulations on IRB membership are quite strict. The IRB must be composed of at least five members including at least one scientific member, one nonscientific member, at least one person not affiliated with the research institution, no members with conflicts of interests, both genders if at all possible, and so forth. Research cannot begin until the IRB approves.

Publication Source: Committees on Human Research

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