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By Gary Evans, Medical Writer
Human research in prison populations traditionally has raised ethical concerns that the incarcerated may be pressured to participate in a clinical trial. Thus, specific protocols and protections are federally required to protect prisoners from coercion into research participation. However, a recent study1 found a surprising counter-trend: A “significant minority” of research participants reported pressure to not participate in trials, both from fellow prisoners and correctional staff.
“I was very surprised by that,” says lead author Paul P. Christopher, MD, assistant professor of psychiatry and human behavior at Brown University in Providence, RI. “If you look at the ethics literature to date on concerns about prisoners, it has always been about whether they were going to be pressured to enroll. That’s been the historical precedent. This is the first time that I am aware of that anyone has identified dissuasion from enrolling.”
To assess how prisoners make decisions about enrolling in research, Christopher and co-investigators recruited prisoners who previously had participated in clinical trials. A total of 55 prisoners agreed to be interviewed after providing informed consent to participate in the IRB-approved study. They previously had enrolled in clinical trials that included research on addiction, HIV risk behaviors, and depression.
“No participant in our sample reported a perception of being coerced into a study,” the researchers reported. “On the contrary, most described how they were specifically, and in some cases repeatedly, informed of their freedom to decline enrollment with assurance that doing so would not adversely affect their jail or prison stay. … Nevertheless, a significant minority of participants described factors that pressured against participation. These included perceptions that participation would be publicized, that their responses to some questions would not be kept confidential, and that they might be mistreated or discriminated against by correctional staff — particularly correctional officers and, less frequently, nurses who work in correctional settings.”
Though the prisoners decided to participate in their respective trials regardless, Christopher found the results puzzling and certainly worthy of further research in a larger study.
“It took a number of different forms, most notably among the correctional staff,” he tells IRB Advisor. “Correctional officers made it clear they didn’t like the study happening. Other inmates dissuaded people from enrolling or staying in a study by mocking them. In some cases, nurses who were employed by the correctional system made it clear that they didn’t like the study, either. That’s definitely a novel finding, though it seems to be present in a minority of prisoners.”
Overall, 17 participants (30.9%) reported having been discouraged from participating in a clinical trial by a family member, friend, loved one, or another prisoner. “When the influence came from another prisoner, it tended to be a negative statement about the study or researchers,” the researchers found. “For example, that it wouldn’t be helpful, that it wasn’t worth the time required, that researchers cannot be trusted, or ascribing negative labels to participants.”
In addition, 16 participants (29.1%) reported being discouraged from enrolling because they had overheard correctional officers making negative comments about the study. Eleven of these participants came from substance abuse trials.
“Six participants (10.9%) expressed concern that certain correctional medical staff members would treat them less favorably than other inmates if they enrolled because of a perception that these staff members were biased against the research study,” Christopher and colleagues reported. “As one participant said, ‘The nurses [will] tell you straight up they don’t like [the study]. They don’t like having to deal with it. This [is] actually work for them — they don’t think they should give [the study medication] to anybody in jail at all.’”
Again, these were prisoners who were discouraged from enrolling, but ultimately participated in the study. Given these findings, a larger study should look specifically at prisoners who choose not to enroll in research, Christopher says. “Because if they chose not to enroll because of these dissuasive influences, that is a big concern,” he says. “The pendulum may be shifting away from coercion to enroll — from a time when prison researchers and authorities were working together in sponsoring research enterprises. [Now] researchers are very separate and come into the prison to conduct their research. So much so that the prison officials and correctional staff may view researchers as a kind of burden. They may be motivated to not cooperate with researchers or actually put things in place that thwart the research. That may actually keep people from enrolling in clinical research that has the opportunity to help people.”
In a sense, clinical research and incarceration are grounded in different social constructs. While clinical research seeks to identify ways to improve prisoners’ health and well-being, traditionally prison is a place of punishment and remediation.
“It is, therefore, not surprising that some correctional staff members would view research unfavorably, especially if it seems to provide special treatment to prisoner participants or creates additional administrative burdens,” the authors reported. “Nevertheless, given the degree to which prisoners identify the available correctional healthcare as inadequate and seek to access treatment through enrollment in clinical research, any form of dissuasion from prison staff or prison culture is problematic.”
Concerns about privacy, which have been identified in previous studies, also were cited as a potential barrier to enrollment. Overall, 16 participants (29%) described how their study participation while incarcerated might breach their privacy.
“Everything that happens in prison is everybody’s business, so if you’re enrolling in a study that requires you to be HIV positive, there are concerns that your HIV status will then be made public,” Christopher says. “Or if you are enrolled in a certain type of study of drug abuse [and are taking a maintenance medication for that] you’re called over the loudspeaker to come get your dose. Those kinds of things wouldn’t occur in a community setting. They seem to be unique to prisoners.”
There are measures that can be taken to protect privacy and mitigate these concerns to some degree, “but there is nothing you can do about gossip in the prison system,” he says. “It’s an institutional phenomenon.”
A positive finding is that no participant reported being directly coerced into joining or staying in the research study. In fact, 43 (78.2%) specifically indicated an absence of coercive influences. IRB Advisor asked Christopher if this finding can be read as a kind of surrogate measure of informed consent.
“It’s a positive finding that they perceive that one aspect of informed consent was present — not that they were informed, but that their consent was given voluntarily,” he says. “We didn’t assess their decisional capacity. We didn’t assess whether they had a full understanding of all the details of the study. That would require a whole other set of measures.”
Given the very nature of incarceration, prisoners who enroll in federally funded studies have protections in place that go beyond those that apply to traditional human subjects research. According to Christopher and colleagues, these include the following permitted categories for proposed prison research. The last two on this list require approval from the Department of Health and Human Services (HHS) Office for Human Research Protections. The four categories are:
“I think for IRBs the question is, what is the clinical research offering in terms of immediate benefit to the participant?” Christopher says. “If there aren’t obvious immediate benefits to the participants, are there potential benefits to prisoners as a class if the outcome of the study is implemented on a policy level? If you look at the federal guidelines as they are currently laid out, it is very clear that any minimal-risk study can proceed on sort of the institution of incarceration — studying prisoners because they are prisoners, the phenomenon of being incarcerated. The above-minimal-risk studies have to do with health conditions that seem to predominately affect prisoners, or research that is looking at policies and practices to improve the well-being of prisoners. Even if it is just slightly above minimal risk, it still has to go to the federal level to be approved to be conducted.”
In addition, the IRB reviewing a study must include a prisoner or prisoner representative in deliberations. A majority of board members cannot be affiliated with the prison in which the proposed research would be conducted. The IRB providing review and oversight also must weigh whether the study risks would be acceptable to non-prisoners, the authors emphasized.
“That is an important consideration,” he says. “If the answer to that is ‘no,’ then that is something that an IRB may want to decline to approve.”
In the study, 46 (83.6%) of the prisoners said they enrolled because they have few alternatives available to them while incarcerated, or because of dissatisfaction with the treatments offered by the prison.
“If the available care is, indeed, so poor, some prisoners may feel that in order to receive care, they have no other choice but to participate in research,” the authors noted. “While it may be tempting to equate this sort of dilemma — choosing between entering a study and forgoing adequate care — to a kind of coercion, we believe that in the context of research, it is more accurate and constructive to frame the ethical issues in terms of the potential for exploitation and the need to ensure that studies have an appropriate risk-benefit ratio.”
Christopher and colleagues chose to frame the ethical dilemma along the lines of exploitation because it more accurately captures what is happening in the interactive relationship between a researcher and a research participant, he says.
“Remember, research always proposes to exploit its subjects in some regard,” he says. “We are asking you to assume a certain level of risk to test the efficacy of an intervention. That is, by definition, exploitation. That question is whether the exploitation rises to the level of unfair in terms of its distribution of benefit and the amount of risk that it poses. That is where we shifted our discussion to really look at what are the benefits that are being purposed.”
Balancing the risks and benefits addresses the exploitation to some degree, but coercion may still be present in prisoner research, says Keramet Reiter, PhD, assistant professor of criminology, law, and society at the University of California, Irvine.
In an editorial reflecting a dissenting opinion to the Christopher study, Reiter disagreed with the authors’ conclusions about both the absence of coercion for prisoner clinical research participants and the merits of applying risk-benefit models to govern prisoner research participation.
“First, the authors conclude that the prisoners were not coerced into participating in earlier clinical research protocols, even though nearly one-quarter of participants felt ‘desperate, very scared, or extremely worried about the potential consequences of their illnesses’ if untreated,” she wrote. “They argue that, when prisoners are presented with the difficult choice between entering a study and forgoing adequate care, this is not coercion as long as no one has threatened them with being worse off if they do not consent to participate.”
This position fails to account for the severity of conditions and the lack of healthcare in U.S. prisons, she argues.
“I think they are arguing for this kind of shift in thinking — instead of thinking about coercion, think about exploitation and the great [research] benefits prisoners could have,” she tells IRB Advisor. “I am basically saying we have to step back before we can engage in that kind of balancing and ask, ‘Are people’s basic needs being met?’ If they are not, then there is a potential for coercion, no matter what they want or how much they could be helped by a trial. If they don’t have basics [necessities] and are worried about their actual ability to live, to have clothes and hygiene products, then you can’t even begin to have a conversation about coercion. You have to have a conversation about whether people’s basic needs are being met before you can have a conversation about coercion. I think that is the why the regulations exist in the first place.”
The two academics may have to agree to disagree on this one, as Christopher questions Reiter’s link between basic needs and coercion.
“If this is true that [prisoners] are not actually getting [basic needs met], which they have a constitutional right to, then as a society we are going to have to figure out if and how we are going to address that problem,” Christopher says. “That is a separate issue from research ethics. It certainly has implications for research ethics, but I don’t think it means — as Reiter points out — that clinical research should not proceed in some regard solely because prisoners perceive that the healthcare that they are getting is inadequate. She frames the issue as one of coercion if their basic needs aren’t getting met, and their only perceived option to get those needs met is to enroll in research. That [to her] constitutes coercion. She can hold that view, but I think it conflicts with what the majority of bioethicists would conceptualize coercion as being, which is that it entails some sort of threat to be made worse off if one declines [to participate in research].”
Reiter cites her own 2009 study3 and some investigative journalism reports that raise concerns that, even under the protections and parameters that are required for incarcerated populations, there are some abuses going on in prison research.
“[Christopher and colleagues] were incredibly thoughtful and ethical in their work, but when you look at the range of research that is happening in prisons, it turns out to really be hard to govern it,” she says. “I worry about the principles they suggest [being misused by] people who have less worthy motivations. That is the history of this. In spite of pretty rigid regulations, there have been cases like the one in Texas where prisoners were basically sentenced to treatment with an experimental drug treatment. They were functionally participating in a clinical trial.”4
In her aforementioned study, Reiter reviewed violation letters send out by the HHS on prison research.
“There were a surprising number happening every year, suggesting that even given the fairly rigid protections we have now, some people are conducting research that violates the ethical norms and is both exploitive and coercive,” she says.
A lot of oversight and protection is being provided by university IRBs for this kind of research, but there also are prison studies that may involve “IRB shopping” and other unscrupulous methods, Reiter says.
“I think it happens more than people think,” she says. “The other real challenge is trials that are happening outside of a university context, because private drug companies can run trials in private punishment facilities. And that is a truly scary thing. That is outside of the federal regulations we assume exist. We set up principles, but then there are all these loopholes even within the principles we have. If there is any kind of federal funding involved there would need to be IRB approval, but it could be a fairly privatized process. Sometimes private drug companies set up their own IRBs.”
The studies from which the 55 subjects were recruited all were studies that were carefully vetted by academic IRBs, by the prison system IRB, and by OHRP, Christopher says.
“I think Reiter’s probably correct in raising the concern that there are correctional systems somewhere in the United States that are probably not following those guidelines,” he says. “Perhaps there are some that are even receiving federal funds and are undergoing reviews by IRBs and academic centers, but those aren’t the ones that we studied. My experience has been that IRBs go the extra mile in protecting prisoners from both coercion and exploitation.”
Reiter sees a glass half full, cautioning against human research continuing under current prison conditions.
“I could imagine a world in which a clinical trial in prison would make a fair amount of sense, but I have a lot of concerns given the prison conditions we have today,” she says. “In an ideal scenario certainly, particularly clinical trials that are geared toward the problems prisoners are experiencing. Even then I think I have the same concerns about the sort of baseline conditions and problems in our prisons.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Dana Spector, Physician Editor Lindsay McNair, MD, MPH, MSBioethics, and Nurse Planner Kay Ball, RN, PhD, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.