There have been notable discussions within scientific literature, bioethics
scholarship, and the popular press regarding the Institute of Medicine’s (IOM) 2006 recommendations to the Department of Health and Human Services to loosen federal restrictions on using prisoners in biomedical and behavioral research. Yet there has been little dialogue among legal scholars about the recommendations’ potential impact on administrative policy. Supporters point to the growing need for clinical trial participants, ethicists’ changing perspectives, and greater institutional protections, while opponents point to past abuses and their likelihood to reoccur.
Although certainly at odds, a common underlying theme in this debate is a focus on the possible outcomes produced by these recommendations rather than examining the argument made by the IOM Committee in proposing changes to 45 C.F.R. § 46, Subpart C. While valuable, this focus on possible outcomes might obscure a critical question that has thus far remained relatively unexamined: did the IOM come to this recommendation for a substantial shift in regulatory policy in a rigorous manner?
As part of a broader effort to think about ethics’ evolving relationship with administrative policy, this Article takes a closer look at the ethical framework used to justify these recommendations. Central to this inquiry is whether a proposed ethical framework that (a) is based upon a literature review of scholarship rather than an empirical examination of prison conditions, (b) treats prisoners’ vulnerability to abuse as solely a product of prison conditions without broader consideration of how profit motives within the research industry might exacerbate these concerns and (c) is isolated from other relevant normative commitments (such as human rights) can appropriately inform regulatory policy. This Article argues that it cannot. Before considering any changes to Subpart C, the Article argues that greater attention must be paid to how empirical methods can inform research ethics in prison, the different contexts that heighten prisoners’ vulnerability as human subjects, and the relevance of human rights to research ethics.
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