45 CFR 46.304
§ 46.304 Composition of Institutional Review Boards where prisoners are involved.
United States · 45 CFR — Public Welfare · Status: effective
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- Citation
- 45 CFR 46.304, § 46.304 Composition of Institutional Review Boards where prisoners are involved, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/216358
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Full text
In addition to satisfying the requirements in § 46.107 of the pre-2018 Requirements or the 2018 Requirements, as applicable, an Institutional Review Board, carrying out responsibilities with respect to this subpart, shall also meet the following specific requirements:
(a) A majority of the Board (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the Board.
(b) At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a particular research project is reviewed by more than one Board only one Board need satisfy this requirement.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.