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

In a document published in the Federal Register on October 7, 2002 (67 FR 62432), the Secretary of Health and Human Services sought public comment on a proposed waiver of the applicability of certain requirements of the Department of Health and Human Services (DHHS or Department) regulations for the protection of human subjects, 45 CFR part 46, to allow DHHS to conduct or support certain important and necessary epidemiologic research on prisoners that presents no more than minimal risk and no more than inconvenience to the prisoner- subjects. Pursuant to his authority under 45 CFR 46.101(i), the Secretary proposed the waiver of Sec. Sec. 46.305(a)(l) and 46.306(a)(2) of the DHHS regulations for the protection of human subjects, which sections set forth specific requirements for any research involving prisoners that is conducted or supported by DHHS. After consideration of the public comments received, the Secretary is granting this waiver.