The year was 1946, and under the guise of public health hundreds of Guatemalan prison inmates were deliberately infected with syphilis. Male prisoners were sometimes infected via direct injection—including right to the penis. Still other prisoners got sick after visits from prostitutes who were often also purposely infected. None of the research subjects were asked for their consent.
Some six decades later Pres. Barack Obama called Álvaro Colom, Guatemala’s president, to personally apologize for the abhorrent U.S. government–led research. But that case is just one of many egregious prisoner experiments that have occurred throughout history. Until the early 1970s most pharmaceutical research was conducted on prisoners—everything from studying chemical warfare agents to testing dandruff treatments.
In the years since, firm protections have been erected for prison populations in medical research, predicated on the idea that even when prisoners volunteer for inclusion in clinical trials, coercion might still be playing a role. As a result, the U.S. and other countries have implemented such tight controls on prison population participation that inmates are often left out of research entirely.
Such routine exclusion may harm both prisoners and the public good, argues Heather Draper, a biomedical ethicist at the University of Birmingham in England. “Exploitation need not be inevitable,” she wrote in a study published June 23 in the Journal of Medical Ethics. She calls for a reexamination of current guidance on the matter in the U.K. and other countries.
Convicts: too much of a hassle?
For this work she took a deep dive into what research is conducted on prisoners in the U.K. and how ethicists and researchers view prisoners’ role in such clinical research. Unsurprisingly, she found that when she combed a massive Web-based database listing most U.K.-related health research, there were few contenders. Her team hunted for studies between 2010 and 2012 that involved prisoners and found there were only 100 such studies, or 0.7 percent of all health research included during that time. The vast majority of the work either focused on mental health or infection. Most often, studies consisted of questionnaires or probation-related research; only a handful of studies involved clinical interventions. The U.S. likely has a similar distribution of such research, says Lawrence Gostin, chair of the U.S. Institute of Medicine (IOM) committee that published the report, Ethical Considerations for Research Involving Prisoners.
Yet, when Draper took her analysis further and surveyed 293 members of the U.K. National Health Service’s Research Ethics Committees as well as 69 medical and social science researchers, asking them to consider if prisoners should be recruited for medical studies and about obstacles to including them, she discovered that the strongest factors motivating scientists and ethicists to exclude prisoners were not about coercion or restrictive guidance discouraging prisoner involvement. Instead, the factors were usually related to perceived logistical difficulties of including them.
What’s more, about 60 percent of the researchers and ethics committee members said that “prisoners should be treated equally to other members of the population in terms of recruitment into nonprison-specific research.”
Better representation
But is the time ripe to reconsider how prison populations could or should be incorporated into studies? Consider the lack of diversity in current clinical trials in the U.S. Whereas African-Americans represent 12 percent of the U.S. population they amount to only 5 percent of clinical trial participants, according to data from the U.S. Food and Drug Administration. Hispanics, meanwhile, make up 16 percent of the population but only 1 percent of clinical trial participants. And because prison populations are disproportionately from minority groups and may have a greater burden of certain maladies, should they be included in larger studies on, say, type 2 diabetes? Right now, the well-intentioned protection for this population often results in the nearly seven million inmates in the U.S. penal system being excluded from research unless it is predominantly prison-related, confined to health problems particularly prevalent among incarcerated populations.
Although the IOM report, chaired by Gostin, recommended greater access to “beneficial” research for prisoners, those recommendations have not yet been implemented. “It’s very important to include this population. First of all they are human beings, and the fact that they have transgressed in society and may be in prison doesn’t mean they should be denied all say in how their lives unfold, including research,” Gostin says.
There are certainly logistical obstacles. Recruiting an incarcerated population may require additional approvals and transportation for researchers or prisoners, which may boost study costs. To include convicts, “there would need to be additional resources provided,” says Susan Rose, executive director of the Office for the Protection of Research Subjects at the University of Southern California. Scientists simply “couldn’t take money out of their limited budget,” she says. For her part, Rose says she has not seen a “groundswell to start including prisoners” in research efforts but she does think that there are special circumstances where such populations should be included, such as conferring a last-resort experimental treatment to an ill prisoner who has exhausted all other available treatments.
Participating in research “can be regarded as a public good,” and prisoners should be afforded the opportunity to contribute to this good if they want to, Draper wrote. Moreover, for the prisoner, “participation in clinical research may benefit participants directly by affording them access to cutting-edge interventions that are otherwise unavailable” or the “only meaningful opportunity for treatment.”
Safeguards against coercion
But the paper does not offer concrete proposals for how concerns about coercion could be overcome. “We do accept that additional safeguards may be necessary; but researchers have managed to strike a balance between inclusion and protection in the case of other potentially vulnerable participants,” Draper says. One possible protective mechanism offered by the IOM report in the U.S. was to create a national registry of prisoner research to provide greater accountability. Another was that when prisoners are included in larger phase III clinical trials, the prisoner to nonprisoner ratio should not exceed 50 percent, ensuring a fairer distribution of research burdens.
“We had such a negative reaction to the truly horrible abuses of prisoner researchers in the past that we forget and have lost the balance,” Gostin says. “In my view the balance is you enhance prisoners’ ability to participate in research but you do so with very careful ethical review.”