Human subjects research with prisoners: putting the ethical question in context

We write in response to the conversation initiated in Volume 24.1 of Bioethics, which focused on the role of prisoners in biomedical and behavioral research. As interdisciplinary legal scholars who have researched the history, ethics, and current practices of prison research in the United States, we write to encourage further dialogue about the Institute of Medicine's (IOM) recommendations to reform current standards for prisoners' participation as human subjects. Specifically, we challenge three critical assumptions, which underlie several articles in the Bioethics special issue.

First, we challenge the idea that a risk-benefit assessment applied to prisoner participants in research is too restrictive.¹ On the contrary, we argue that it is too permissive. The IOM's risk-benefit proposal – the most significant of its five main recommendations – is designed to relax current standards that categorically restrict prisoners' participation as human subjects to four narrow situations that directly benefit prisoners.² Current policies were implemented in response to substantial abuses directly connected to prisoners' vulnerability and deplorable prison conditions; a 1976 Commission concluded that widespread research in prisons should not be...