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Prisoners and Clinical Trials

Cruel and Unusual Ethics?
by Osagie K. ObasogieGenetic Crossroads
June 29th, 2007

Government and private researchers used prisoners as test subjects up until the mid 1970s, as shown in this photograph taken at Philadelphia’s Holmesburg Prison.

Much ink has been spilled over the Institute of Medicine's (IOM) recent recommendation to loosen federal restrictions on using prisoners as human subjects in medical research. Supporters point to the pharmaceutical and biomedical industry's growing need for participants in clinical trials, and to changing values among ethicists regarding autonomy and informed consent. Opponents highlight the legacy of past abuses and the likelihood that they will be repeated.

The Department of Health and Human Services commissioned the Institute of Medicine to "review the ethics regarding research involving prisoners . . . to explore whether [past] conclusions . . . remain appropriate today." Though the IOM makes several suggestions, the rubber meets the road in its recommendation to shift from the policy put in place in the 1970s, which severely limits clinical trials in prisons, to a more subjective risk/benefit analysis.

To justify this recommendation, the IOM changes the ethical framework governing prisoner participation as human subjects. The current framework, crafted to prevent repetitions of the serious abuses of past years, prioritizes justice - ensuring that prisoners are treated fairly in terms of the research's benefits and burdens - and respect for persons - ensuring that prisoners have enough personal autonomy to give voluntary consent to participation in clinical trials. The IOM committee creates an "updated" framework based on its conclusion that "ideas about justice and respect for persons have evolved over the past three decades."

The IOM report is laudable for its attempt to provide better oversight, and for reviewing whether the ethical commitments made three decades ago still serve the best interests of prisoners. Yet the committee's approach raises serious questions about the more permissive framework it recommends.

First, and most shockingly, the committee notes in its report that it "visited one prison and one prison medical facility to discuss experimentation with current prisoners and peer educators." This is both irresponsible and unacceptable. Ethics is not an empirical science, but it's difficult to understand how the committee members could come to a policy recommendation without taking a more serious first-hand look at the conditions of modern prison life.

Second, the committee bases its new ethical framework - which drives its recommendation to be more permissive about prisoner participation in clinical trials - on what it calls an evolution in the ethics literature. Put differently, the committee bases its policy conclusion largely on a literature review. The focus of the committee's ethical reasoning - that "ideas about justice and respect for persons have evolved over the past three decades" - also egregiously misses the point. Academic bioethicists and research scientists may have changed their minds, but the more relevant question is whether the conditions that gave rise to the current ethical framework - such as coercion and lack of privacy in prisons - have been substantively addressed.

This leads to the third and most significant critique of the IOM report. By isolating the ethical questions surrounding the use of prisoners as human subjects from broader ethical paradigms - most importantly, human rights - that are directly relevant to their daily lives, the report actually obscures the full impact of its own recommendation.

Arthur Caplan has been cited as saying that "bioethics was born from the ashes of the Holocaust." So too were human rights. The wide-ranging human rights violations documented in contemporary U.S. prisons by organizations such as the ACLU and Human Rights Watch suggest that inmates live in conditions not dissimilar from those of people living in dictatorships. Inadequate medical care, constant surveillance, unprovoked physical assaults, and sexual coercion are but a few of these concerns. Relations between guards and prison populations raise even larger human rights red flags.

With prisoners routinely subjected to or threatened with human rights violations, would it be possible for them to participate as human subjects in a manner that upholds Nuremberg's basic principles? Without a deeper analysis and integrated framework that brings the conditions of their lives directly into ethical deliberations, the IOM's recommendation to allow clinical trials into prisons could all too easily expose prisoners to additional health risks.

The shared heritage between bioethics and human rights needs deeper appreciation both in theory and practice. It's likely that bioethics will continue to face numerous ethical dilemmas involving prisoners. As an example, South Carolina lawmakers are considering legislation that attempts to relieve the state's kidney shortage by shaving 180 days off inmates' sentences if they agree to become donors.

Human biotechnology may also come into play. A tremendous amount of excitement has centered on the therapeutic potential of embryonic stem cell research. Given the shortage of women's eggs available to pursue cloning-based stem cell research, it's not difficult to imagine a decision to provide similar incentives to incarcerated women who might agree to provide eggs for research.

These are complicated issues, pitting hopes and claims that research will save lives against policies that protect the dignity of all people, including prisoners. If bioethical reasoning is to promote both human health and basic dignity, it must recognize its kinship with human rights. Regrettably, the reasoning underlying the IOM's recommendation to loosen rules about protecting human subjects in prisons takes a few steps back from this goal.


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