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Should prisoners participate in medical research trials?

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COUNTERPOINT: The vulnerable status of prisoners should not be compounded by systematically excluding them from the benefits of science, says Lawrence O. Gostin, professor of law and public health at Georgetown University Law Center and chairman of the Institute of Medicine committee that issued “Ethical Considerations for Research Involving Prisoners.”

Unquestionably, there’s something wrong with how research is conducted in prisons. But if we can correct the problems, then such research will yield a world of good. Sound research can profoundly improve the welfare of inmates. For example, if prisoners are enrolled in studies of such diseases as HIV/AIDS, hepatitis C and tuberculosis—which afflict prisoners in disproportionately high numbers—they could benefit from any finding or treatment discovered. Of course, research should never be conducted on captive populations simply to advance the greater good. Researchers should be required to demonstrate how prisoners themselves would benefit from a proposed experiment.

It’s true that current regulations have brought about an untenable state of affairs: No one has a complete picture of what’s being studied, by whom (whether private or federal agencies) and upon whom. Thus federal oversight needs to be strengthened in significant ways. Gaping regulatory loopholes must be closed and more safeguards established (such as ensuring the privacy of patient information). Prisoners must be uniformly protected, regardless of the source of research funding.

The recent report by the Institute of Medicine would create a national system of oversight and a public database to track studies. The institute’s report also recommended that prisoners not be allowed to participate in Phase I and II studies when safety has not been established. Furthermore, at least half of the research subjects in any clinical trial should be non-prisoners so that inmates are not singled out for research that the general public won’t volunteer for.

It’s true that a significant percentage of trial subjects aren’t protected by regulatory restrictions, but that can be remedied in two ways: Congress could mandate uniform guidelines that would govern all research that enrolls prisoners, an the definition of prisoner could be expanded to include people on probation and parole. In addition, institutional review boards should be assisted by independent prison research advocates, who would work on-site to quickly detect and report problems—and ensure that subjects have not been coerced. The issue of voluntary consent and the question of whether prisoners can truly exercise independent choice are fundamentally important. Research proposals that cannot ensure this protection should not be approved.

Finally, the argument that trial protocols cannot be followed in a prison environment subject to lockdowns and other disruptions is disingenuous. Research is never perfect, regardless of the setting. Protocols get disrupted in ordinary trials. It is both harder and easier to conduct science in prison: harder because there are lockdowns, but easier because subjects generally aren’t lost to follow-up.

For all these reasons, I’m confident that research conducted in prisons can be both scientifically and ethically sound. I don’t deny the threat of exploitation, but with rigorous legal oversight and consistently applied standards of protection, we can banish it.

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