The Prisoner's Dilemma: The History, Ethical Dimensions, and Evolving Regulatory Landscape of Clinical Trials on Inmates
Citation
Caitlin Fitzpatrick, The Prisoner's Dilemma: The History, Ethical Dimensions, and Evolving Regulatory Landscape of Clinical Trials on Inmates (May 2012).Abstract
The history of research on prisoners in the United States is marred with a shameful pastof abuse and coercion. With the development of research ethics arising from the Nuremberg
Code and the Belmont Report, a critical light was shone on these oppressive practices. In 1974,
the Department of Health and Human Services commissioned a group to investigate the
conditions under which prisoners were used a research subjects and to formulate
recommendations to guide clinicians in the future. The results of this Commission Report paved
the way for Subpart C of the HHS regulations, which classifies prisoners as a vulnerable
population and created a de facto ban on the use of inmates in any research study that received
federal funding. What made this situation particularly noteworthy was the position of the FDA
following this eventful change in regulation. Initially, the FDA proposed a rule similar to that of
HHS which would have effectively barred the use of prisoners in all clinical research on FDAregulated
products, even that which was privately funded. This proposal was met with staunch
resistance, and a lawsuit filed by prisoners and a pharmaceutical company claimed that their
constitutional rights would be violated by this de facto ban. The FDA eventually settled the case,
and never again revisited the issue. But recently, the question of the propriety of using prisoners
in clinical trials has once again entered the public consciousness. The vast discrepancy in
approaches to this sensitive issue by the two major bodies tasked with its regulation yields
fruitful insight into the moral and ethical implications of research on prisoners. Strong advocates
on both sides of the issue insist that respect for persons, beneficence, and justice all weigh
heavily in their favor. These issues come most starkly into relief when viewed through an Eighth
Amendment paradigm of “cruel and unusual punishment,” as well as a Fourteenth Amendment
analysis under a “due process” and “equal protection” framework. The timeliness of this issue is
apparent given the recent developments in this area of bioethics which has been relatively
dormant for decades. A report by the Institute of Medicine in 2006, followed by an Advance
Notice of Proposed Rulemaking from the HHS in 2011, indicates that change is afoot. Now is
the critical moment to appraise the situation and strike the appropriate balance between
protecting prisoners from abuse, universalizing the regulatory landscape to promote medical
progress, and ensuring that the constitutional rights of prisoners as a class are defended.
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