Proposed Waiver of the Applicability of Certain Provisions of Department of Health and Human Services Regulations for the Protection of Human Subjects for Department of Health and Human Services Epidemiologic Research Involving Prisoners as Subjects

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The Department of Health and Human Services (DHHS) is proposing to waive the applicability of certain provisions of Subpart C of 45 CFR part 46, the DHHS regulations for the protection of human subjects, to specific types of epidemiological research involving prisoners as subjects. Subpart C, entitled Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects, sets forth specific requirements for any research involving prisoners that is conducted or supported by DHHS. Pursuant to 45 CFR 46.101(i), the Secretary of Health and Human Services proposes waiving the applicability of 45 CFR 46.305(a)(1) and 46.306(a)(2) to allow DHHS to conduct or support certain important and necessary epidemiologic research that presents no more than minimal risk and no more than inconvenience to prisoner-subjects.