Report Calls for Easing Rules on Research Involving Prisoners
Federal rules should be relaxed to allow scientists to perform higher-risk medical research on prison inmates than is allowed now, a new report from the Institute of Medicine says.
But the report also recommends that the rules be broadened to add safeguards for prisoners. For example, independent monitors should work inside prisons to safeguard the well-being of research participants.
The report, released this month, offers a new stage in an old debate about to what extent it is ethically permissible to conduct research on prisoners. The report was requested by the Office for Human Research Protections, the watchdog arm of the U.S. Department of Health and Human Services that oversees human subjects, after researchers told the office that some aspects of the existing rules, in place since 1978, were confusing and needed to be updated.
That office has recorded 454 studies involving prisoners since 2001, many of which involve university researchers. One-quarter of those studies involved biomedical research and the rest were in behavioral or social-science research, including studies of prison life, the office says.
Federal rules allow prisoners to participate in biomedical research only if the experimental treatment exposes them to no more than "minimal" risks. That is because bioethicists have long recognized that prisoners are inherently more vulnerable than the average citizen to being coerced to participate in studies.
Scandals of the 70s
The government adopted the threshold of minimal risk following scandals in the 1970s about human-subjects research, including the widespread and often unethical use of prisoners as clinical-research subjects. One instance, described in the 1998 book Acres of Skin: Human Experiments at Holmesburg Prison (Routledge), involved researchers at the University of Pennsylvania who used inmates at a prison outside Philadelphia to develop the Retin-A facial cream.
Since the 1970s, researchers have described serious shortages of volunteers for drug trials, and an industry of businesses, called contract-research organizations, has sprung up to help researchers recruit human subjects and run the studies.
Among the report's recommendations that may prove most controversial is the change in the allowable level of risk to which prisoners could be exposed. In place of the minimal-risk standard, the report recommends balancing risks to prisoners against benefits. Greater risks could be allowed if justified by potentially greater benefits to prisoners, the report says.
Some advocates for prisoners have pushed for such a change. The American Civil Liberties Union has argued that the existing rules deny prisoners the exercise of their autonomy. Other advocates say prisoners should be free to benefit from experimental approaches that may prove superior to existing ones.
The report quotes Olga Grinstead, an adjunct associate professor in the Center for AIDS Prevention Studies at the University of California at San Francisco, describing the motivation of prisoners to participate in research:
"My experience has really been that prisoners want access to innovative intervention programs. They want to have access to the things that are going to help them, and that is one reason why people become involved, at least in working with us."
She added, "They are motivated to give back, and that should be taken into account, too."
Limits on Prisoners
Recognizing that prisoners are a potentially easy-to-tap source of recruits, the report recommends some additional safeguards particular to biomedical studies.
Prisoners should make up no more than 50 percent of the pool of volunteers in any one study. And they should not be allowed to participate in "early stage" clinical trials, which are meant to test the safety and efficacy of experimental drugs in small groups of research volunteers. But they could join so-called Phase 3 trials, the Food and Drug Administration's designation for trials that involved large populations of subjects to further test efficacy.
Critics of the proposed change say most or all research with prisoners is ethically wrong because of the risk that they would be coerced, even indirectly, to participate.
Some prisoners will gladly accept risks involved in biomedical research solely in the hope that it will increase their chances of being released early for good conduct, even if told that is unlikely, said Daniel S. Murphy, an assistant professor of political science and justice studies at Appalachian State University, in North Carolina.
"The prisoner does not internalize that, and says, I've got a shot," Mr. Murphy said. He has an unusual perspective on research with prisoners: He served a five-year term in federal prison during the 1990s for growing marijuana. He said he cultivated the drug only for his own medicinal use, to alleviate pain from a chronic spinal disorder. While in prison, he volunteered as a subject in a research study that examined the efficacy of an antidepressant as a painkiller. (He said it did not help him.)
The report quotes Mr. Murphy as saying: "We have 275 million people in this country. We have two million in prisons. What is the allure to this population, if it is not the fact that it is a controlled population?"
The recommendations were not made with an eye toward increasing the number of prisoners who participate in research or making it easier for them to join, according to Jonathan D. Moreno, who served on the panel that wrote the report and is a professor of biomedical ethics at the University of Virginia.
"I don't know if we really know if it would easier or harder" to involve prisoners in research if the government followed the report's advice, Mr. Moreno said.
The suggestion to ease the minimal-risk rule is "one recommendation among many." He added, "Ultimately, I think that once this gets digested, people won't think it will be easier or harder to do the research" but that "the research should be done in a different way."
Among other changes recommended in the report:
Section: Government & Politics
Volume 52, Issue 47, Page A16