condition for receiving the federal funds. There are many rationales that would likely be sufficient justification for such legislation. For example, the federal government’s interest in “set[ting] uniform national standards in regulating health and safety,” as articulated in Gonzales v. Oregon, 126 S. Ct. 904, 923 (2006), and in particular, in ensuring reliable results from health sciences research, would be sufficient. This assisted suicide case addressed Congress’s more limited authority to directly impose requirements, but the interest articulated by the Court would be sufficient to impose conditional requirements. Additionally, the PREA was based in part on the federal government’s interest both in ensuring states do not violate prisoners’ federal civil and constitutional rights by their deliberate indifference to the problem of prison rape, and its interest in ensuring the “effectiveness and efficiency” of federally funded research and grant programs relating to health care and other prisoner-related research, which (Congress stated) were compromised (directly and indirectly) by state officials’ failure to monitor and address the problem of prison rape.54 Clearly these rationales would also support legislation requiring states to impose (at a minimum) the ethical limitations on research required by the DHHS as a condition of receiving the same federal funding.

The regulations could only be imposed in this manner if the states did in fact accept the federal funding. However, because the federal government only seeks to require the states to establish the same ethical regulations as those promulgated by the DHHS, and not to spend money on any new programs, the committee is confident that the states would choose simply to enact the DHHS regulations rather than foregoing substantial federal monies to avoid compliance.

Alternatives to Comprehensive Regulation

If a change in the statutory authority for these regulations is not possible (either constitutionally or practically), the DHHS might, at a minimum, work with the FDA (and perhaps the BOP) to develop regulations for research involving prisoners, which the FDA might then consider adopting (either in whole or in a modified form) for all research within its jurisdiction. The result would be uniform regulation by the FDA of all research relating to pharmaceuticals, medical devices, and other products within the FDA’s jurisdiction, both in state and federal prisons, supplemented by the DHHS’s regulation of federally supported research. Although not ideal, this framework may still reduce the amount of patchwork regulation applicable to research involving prisoners and be a step toward uniformity of ethical

54

42 U.S.C. § 15601 (13–14).



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