prisoners conducted in the United States). For the regulations to apply to other federally funded research, absent the consent of research institutions, it was necessary for every other department or agency funding such research to incorporate the DHHS-promulgated regulations into that department or agency’s own regulations. Sixteen other departments and agencies of the federal government adopted the generally applicable Common Rule regarding research with human subjects, thus partially accomplishing a goal of uniformity in the ethical regulations applicable to federally funded research.

However, perhaps because of the restrictiveness of the regulations, nearly all of the same departments or agencies did not adopt the additional protections for prisoners. At least one of the departments adopting the Common Rule, the Bureau of Prisons (BOP) at the Department of Justice (DOJ), instead adopted its own regulations that apply to all research with prisoners in BOP custody (not merely research that is funded by the DOJ). Additionally, the FDA promulgated its own rules, consistent to the extent practical with the Common Rule, governing clinical research associated with the products it regulates. However, the FDA’s attempt to adopt parallel regulations that were essentially the same as DHHS’s prisoner protections1 was the subject of a lawsuit brought by prisoners wishing to participate in such research. Therefore, the FDA does not have provisions comparable to DHHS Subpart C for prisoner populations.

Outside of DHHS and its agencies, only the Central Intelligence Agency (CIA) and the Social Security Administration (SSA) have adopted the DHHS’s prisoner protections (Figure 3-1).

In sum, regarding research involving prisoners as human research subjects, the applicable regulations are far from uniform and range from no protection at all (for research that is not funded by one of the 17 agencies that have adopted the Common Rule), to basic Common Rule protection, to heightened, overlapping, and possibly inconsistent regulations (e.g., for persons in BOP custody participating in therapeutic clinical trials). This chapter describes the components of the patchwork of regulations: the Common Rule, Subpart C (the DHHS’s protections for prisoners as research subjects), and the alternative regulations applied by other departments.

ADOPTION OF DHHS HUMAN SUBJECTS PROTECTION REGULATIONS

The first federal protections for human subjects were issued in 1966 by the NIH. This document, Clinical Investigations Using Human Subjects, served as the Public Health Service’s policy and was an initial attempt to

1

45 C.F.R. Part 46, Subpart C.



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