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"No matter what safeguards are put in place, the incarcerated can never freely give voluntary, informed consent because the fear of retaliation from prison officials precludes them from saying no to experiments."

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Published On May 3, 2007

CLINICAL RESEARCH

Should prisoners participate in medical research trials?

Issues of choice, good science and the benefit of new treatments complicate the question.

POINT: If one respects the tenets of science and of human rights, the answer is clear, says Vera Hassner Sharav, founder of the Alliance for Human Research Protection (AHRP), which advocates responsible and ethical medical research practices.

In 1973 the journalist Jessica Mitford famously summarized why prisoners were the preferred medical research subjects in the United States. They were “cheaper than chimpanzees,” she wrote in The Atlantic Monthly, quoting a physician involved in prison research.

More than three decades later, inmates are not only less expensive than chimps, they have fewer government protections. Annual reports submitted to Congress document the number and disposition of every chimp (and dog and hamster) used in research trials. But no federal law requires anyone to keep track of the number of humans used—or harmed—in clinical trials. In fact, the only protection prisoners have against being subjected to experimental abuse hangs on the thread of a single federal regulation, Subpart C of the Common Rule, and that regulation governs just federally funded research.

The recent Institute of Medicine recommendations to the Department of Health and Human Services, which commissioned the study on research involving prisoners through its Office for Human Research Protections, aim to strengthen federal oversight of human research. Yet the report, “Ethical Considerations for Research Involving Prisoners,” fails to fathom a fundamental truth: No matter what safeguards are put in place, the incarcerated can never freely give voluntary, informed consent because the fear of retaliation from prison officials precludes them from saying no to experiments.

The history of U.S. prison research confirms abuse, not benefit. Prisoners were exposed to cancer-causing and radioactive chemicals at Holmesburg Prison in Pennsylvania between 1951 and 1974. Juvenile inmates at Stockton Prison in California were subjected to psychotropic drug tests in 1997 despite regulatory prohibitions. A federal investigation in 2000 documented gross violations in prison research conducted by the University of Texas at Galveston. Inmates should be off-limits except for noninvasive research aimed at improving prison conditions, such as finding ways to prevent staph infections.

The push for prison experiments is motivated by business priorities. The biotech and pharmaceutical industries are addressing the shortage of volunteers by dipping into a deep pool of captive subjects with limited rights, housed in inherently coercive environments. Prisoner research is about exploitation, profit and expediency, not about the benefit of prisoners.

What’s more, when the subjects are inmates, a study’s scientific conclusions are highly suspect. Although it’s hard to know how often lockdowns occur—according to a California study, one facility underwent 391 in a year—just a few can seriously disrupt a trial. During a lockdown, prisoners are denied access to their medicines, including lifesaving ones. So whatever results are eventually reported are little more than junk science.

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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