Clinical research with prisoners is ethically vital and challenging. Studies investigating novel psychological, behavioral, and pharmacological interventions are imperative for the health and experiences of the people they focus on. Yet clinical research on prisoners also raises considerable ethical concerns—most notably, whether prisoners participating in research are subjected to coercion or exploitation. An article in the March-April issue of the Hastings Center Report, detailed a qualitative study of prisoners’ reasons for participating in clinical research in jails and prisons in one U.S. state. The authors sought to examine prisoners’ own considerations and motivations when deciding to participate in research, conducting interviews with adult male and female prisoners who were current or past participants in other research initiatives within the correctional system. Interviews illuminated internal and external factors that both encouraged people to participate in research and cautioned them against doing so. While U. S. regulations require that research with prisoners pose minimal risk or provide benefit to prison populations, many scholars have still questioned whether research protocols properly protect against coercion and exploitation. Principal concerns surrounding these issues are whether people are driven to participate because they believe that they will receive compensation or a medical treatment or intervention that they need and cannot receive otherwise, whether the research has sufficient benefits for the population it is studying, and whether a vulnerable population is inappropriately exposed to risks. Although the study’s findings suggest that prisoners did not perceive their experiences as coercive, the authors have concerns that people are sometimes inappropriately dissuaded from participation. I spoke with one of the paper’s authors, Charles Lidz, a professor emeritus of psychiatry at the University of Massachusetts Medical School, about the study process, his interpretation of “coercion” and informed consent, and his conclusions from and next steps for the work. This interview has been condensed and edited for clarity. RZ: What do you consider to be the most important ideas and arguments in your article? CL: It portrays the diversity of issues and concerns that prisoners have. They are not different from the rest of us. We have this model where people weigh risks and benefits against their values, and then they’ll make a decision on the basis of that. Nobody makes decisions like that. I think that’s very apparent from this study. Prisoners studied cited a number of reasons to participate. Sometimes people saw advantages that other people would see as disadvantages, or vice versa. Decisions are personal, and I thought that came across really well. Did you find that some of your participants’ experiences were all negative or all positive, or did people have mixed views of why they wanted to participate in research? It is a biased sample because we only got people who consented. We didn’t get the people who would feel like research was an awful thing or don’t want to do it for some reason. The negatives that we got were in the context of deciding that it was a good idea to participate. There were some people who were explicitly positive about it and thought it was wonderful to have the opportunity—sometimes it struck me as a little naively so. The tricky problem here comes out in Reiter’s commentary on coercion. [RZ: Keramet Reiter’s Another Voice essay in the Hastings Center Report responds to conclusions of Lidz and colleagues, arguing that given the extreme living conditions and lack of treatment alternatives in prisons, research offering treatment or meeting basic needs could present issues of coercion.] The classic definition of “coercion” (and I think the right one), is given where you are, could research being conducted threaten to make your situation worse if you don’t participate? That is clearly not what we’re dealing with here. That is the classic definition; that’s not the only consideration. The point that Reiter is making is that these people are being treated badly. Almost all the research participants I work with have lives that are pretty bad. Does that mean I shouldn’t do research with them? I think prisoners are treated very badly, and I don’t think it’s fair, but does that mean that I can’t do research with them? I don’t think so. This is not to say there aren’t types of research with prisoners that are illegitimate. Of course there are. But in Reiter’s critique, she points out that some people want to use the money [provided as compensation for research participation] for things that she feels should be a human right. But that is the situation people are in. The question is what does the research do, and how does it treat people? It’s not, is the prison system legitimate? As you just noted, the lack of treatment options, privacy issues, and many other negative factors seem like problems with jail policies and socioeconomic and sociopolitical factors. Do you imagine ways in which the research or health care communities could or should inform or address these issues? I think that that’s a separate issue for me as a researcher. I do feel that the prison system is excessively punitive and degrading. I feel this about some of our mental health institutions too. The system treats you as less than a full person. To me, that’s the core issue—everybody deserves to be treated like a human being and dealt with like a human being, as someone who thinks and feels. The question for research ethics is, has the researcher dealt with the person as a full human being? The question is not, is the whole context illegitimate? I don’t mean to say that I can’t imagine a situation in which the entire context is so awful that cooperating with it to do research is illegitimate. Could I have done research during the Nazi regime? Probably not. But on the other hand, if one was doing research that exposed what was happening at that time, that could have been a good thing. That system was fundamentally illegitimate in a way that I don’t think the prison system is fundamentally illegitimate. Some quotations from your interviews indicate that people incorrectly thought they might gain something from prison staff, doctors, researchers or others for their participation. While no one seemed to be forced (“participate or else”), are you concerned that people participate with incorrect beliefs about how a study will benefit them? They may have been informed but not truly understood. It is very hard to assess what we mean by “fully understand.” Did these prisoners fail to understand more than a subject in a standard diabetes trial in the hospital? We do find an education effect on almost any understanding measure, so probably they understood a little less, but it is hard to know. I have an unorthodox view about this. I think that informed consent is a ritual (in a sociological sense). It is something we do to demonstrate our commitment to certain values, in this case, human dignity, individualism, and so forth. The ritual is really important, but informed consent should never be the basis of thinking that subjects are adequately protected. I don’t think informed consent protects subjects. I do want researchers to do their very best to explain and make sure that people understand. But could we really say that people can’t participate in research unless they fully understand the decision? Most of my life I don’t fully understand. I had the terms of my mortgage explained to me, and I didn’t fully understand, but that didn’t stop me from signing the mortgage. Would I like them to understand more? Absolutely. Do I think that precludes them from being research participants? Not if they agreed to do this without someone lying to them or coercing them. Some of the scenarios mentioned in your article, such as research participants’ names being called out over the loudspeaker, indicate that there are some unique privacy concerns for incarcerated populations. Do these raise a significant concern for you, and if so, is there anything to be done about them? That is the way the prison operates. A few people said they got grief [when it was announced that they were participating] because they were “cooperating with the man.” Others saw this as prestigious, as an announcement that they were special. At least one person said that he felt that the people critical of his participation were jealous. So again, it’s one of these things where people’s thoughts and motives are much more complex than one would consider in abstract. What are the most important takeaways and next steps for both research with incarcerated populations and for research (like yours) that studies research on these populations? The most important takeaway is the diversity of people’s thoughts and feelings when they’re in this situation. One needs to be careful not to stereotype their decisions and thoughts. I’d really love to hear from some of the people who refused to participate in other research, but that is a tough project to get going, particularly in prisons. Of all the 800 to 900 interviews we’ve done, about 15 of those have been with people who have refused to be in other research studies. The courts, prisons, and prisoners are not always enthusiastic or receptive to research. Rachel Zacharias is a project manager and research assistant at The Hastings Center.
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.” A Novel FindingThough 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.’” Pendulum ShiftAgain, 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.” Protective MeasuresGiven 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.” Coercion vs. ExploitationIn 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.” Agree to DisagreeThe 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.” REFERENCES
A recent study found a “significant minority” of inmate research participants reported pressure to not participate in trials, both from fellow prisoners and correctional staff.
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