Can informed consent be waived or altered in research involving prisoners?

Yes. So long as the appropriately constituted IRB reviews the research and makes the appropriate findings regarding the waiver or alteration of informed consent requirements, research involving prisoners may be approved with a waiver or alteration of informed consent. However, even if informed consent is waived or altered, subpart C of 45 CFR part 46 still requires that the subjects be clearly informed in advance that participation in the research will have no effect on their parole, if such notification is relevant.

(45 CFR 46.305(a)(6)). Note that prisoners cannot be involved in emergency research where the requirement for informed consent has been waived by the Secretary under the authority of 45 CFR 46.101(i).

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