Abstract
This paper discusses findings of a study examining whether prisoners view their participation in clinical research studies as exploitative. Perspectives of seventy prisoners who were enrolled in one of six different clinical studies were analyzed. A minority of participants agreed with statements suggestive of potential exploitation. All but one participant believed that prisoners should have greater access to research. On balance, these data provide reassurance that prisoners in this sample do not view their involvement in clinical research as inappropriately exploitative.
Keywords: exploitation, vulnerable populations, prisoners, informed consent
Introduction
Today, U.S. prisons are overcrowded, underfunded, and house a rapidly aging population. The more than 2.2 million incarcerated* adults in the U.S.1 (BJS, 2013) share a disproportionate burden of infectious diseases, psychiatric and substance use disorders, and other major medical problems.2 Although treatment for certain conditions has improved in select correctional settings, evidence-based medical services are needed not only to improve the care offered in prison, but also to support reentry to society, since linkage to community providers is often lacking. Clinical research often gives prisoners an opportunity to receive state-of-the-art treatment or treatment options not necessarily available in correctional settings, while expanding the evidence base for disseminable interventions. However, prisoners have also historically been subject to wide range of research abuses.3
Prisoners live in conditions that restrict their social, healthcare, and economic freedoms. Thus, research studies that offer the possibility of access to otherwise unavailable resources may seem to exploit inmates' circumstances, particularly if prisoners would choose not to enroll if they were in the community or if resources were more readily available in prison. Yet if prisoners are not coerced to participate, and risks and benefits are balanced, it may seem equally unjust to exclude them from research, especially if studies offer help to individual participants or seek to improve the care of prisoners in general.
The tension between protecting prisoners from exploitation and advancing the research that may improve their care spurred a recent examination by the Institute of Medicine (IOM) of federal regulations on prisoner research.4 In its report, the IOM committee made a number of recommendations that included both incorporation of prisoner input regarding what and how research is conducted, and shifting from a categorical restriction on prisoner research to a risk-benefit analysis with greater protection as risks increase. The reports concludes, “Given the history of and continued potential for prisoner exploitation, biomedical research should be permitted only if there is a strongly favorable benefit-risk ratio for the prisoner (p. 9).”
Determining when research with prisoners is exploitative is not a straightforward task. In a transactional framework, exploitation occurs when one party (A) takes unfair advantage of another (B). Wertheimer argues that unfair advantage exists when either of two conditions is met.5 In the first condition, A can threaten to make B worse off if B does not agree to interact with A. Here, A exploits B by coercion (i.e., a threat of harm). Applying this model to prison research, an example of this first condition would be threatening to have an inmate put in segregation if he does not participate in a study. Clearly such practices are unfair and should be prevented. Under the second condition, A takes unfair advantage of B if, as a result of the transaction, A's share of the benefit is excessive compared to B's. Wertheimer contends that unlike in the first condition, this type of exploitation (where A gains more than B, but B still remains better off than before) should not always be prevented. The reason for this is that preventing a transaction between A and B simply because A stands to gain more than B may deny B whatever gains the transaction would have provided. Since B may have few or no other options at his disposal (i.e., A will not transact with B on more favorable terms), A's exploitation of B should be permissible from a regulatory perspective, even if the transaction itself remains morally problematic.6 Emanuel has also argued against preventing exploitation so long as B gives consent voluntarily, both parties stand to benefit and B is not harmed, and B receives a fair share (according to his own preferences) of the benefits.7 For Emanuel, the type and amount of benefit B receives compared to A are irrelevant; what matters is whether B receives benefit that is acceptable to him and in line with his own values. An example of exploitation under the second condition, where A benefits more than B but B still gains something, might be a trial on the safety and tolerability of an experimental drug that is unlikely to be ever made available to prisoners after the study, assuming efficacy is eventually demonstrated. Instead of benefitting from the outcome of the research, participants may gain preferential treatment through better living quarters and more attentive medical care. Arguably, the (potential) benefits to the pharmaceutical company exceed those provided to the participants. Still, under a transactional model such an arrangement may be permissible assuming all else is equal.
In the United States, federal guidelines for prisoner research impose additional constraints on how federally-funded research must be conducted beyond those that would be required under a transactional model of exploitation. These guidelines seek to safeguard against the use of inmates as means to advance scientific knowledge that is not meant to help their own interests as a class. As the National Commission Report on research involving prisoners articulates,
“…the status of being a prisoner makes possible the perpetration of certain systemic injustices. For example, the availability of a population living in conditions of social and economic deprivation makes it possible for researchers to bring to these populations types of research which persons better situated would ordinarily refuse. …And finally, it allows an inequitable distribution of burdens and benefits, in that those social classes from which prisoners often come are seldom full beneficiaries of improvements in medical care and other benefits accruing to society from the research enterprise.”8
The ethical underpinnings of these regulations come from a ‘macro’ (or systemic) view of exploitation. This broader view has roots in Kantian and Marxist theory.9 Under a macro framework, transactions that do not remedy the unjust conditions B faces are always unfair, regardless of what other benefits B obtains or the size of those benefits relative to A. From this perspective, the key shortcoming of the transaction model is that it ignores the injustices that B is subject to (the status quo), that is, the very circumstances that make B willing to accept less favorable gains in the first place.10 Here we must be careful here to define, in the context of prisoner research, what injustices inmates are subject to. Certainly we would not say that incarceration itself is unjust (although it may be for specific prisoners). Rather, what we mean is that the disparities in the scope, quality, and availability of healthcare in prison may be unjust in certain settings and for certain health conditions.
Because prisoners are not well-positioned to negotiate for better healthcare (i.e., their options are generally limited to what is available in prison or jail), they may be more inclined to enroll in a clinical study than they would be otherwise. Here, the state exercises its authority to protect prisoners from entering into studies that do not serve prisoners' own (individual or class) interests. This sort of paternalism poses its own ethical challenges because it constrains autonomy without being certain which individuals (and under what circumstances) require such protection. The practical solution is to impose a categorical restriction that sacrifices some individual autonomy in an effort to protect against what is perceived to be the greater evil, unjust exploitation. Thus, federally-funded research with prisoners must focus on problems that are particularly prominent among inmates or on phenomena that exist within or are exacerbated by the correctional system itself.11 Returning to the hypothetical pharmaceutical trial described above, under a macro view of exploitation, unless prisoners as a group stand to reasonably benefit from the outcome of the research (e.g., by ensuring there was a need for the drug to treat a condition prevalent among prisoners and making it available post-trial) then the research would not be permissible.
Although some have examined perceptions of coercion among prisoner participants,12 we know of no empirical work on prisoners' opinions about exploitation in research. In light of the IOM committee's call for prisoner input regarding research, the present study sought to address this gap. It may be that despite the level of research protection prisoners receive, they nevertheless perceive their involvement as exploitative. Although perceptions of exploitation do not necessarily indicate that exploitation exists, if a majority of prisoners perceive research they are enrolled in as exploitative, this would be a worrisome finding. On the other hand, if they view their participation in clinical studies as largely non-exploitative it would support expansion of prison-based research under appropriate circumstances. We chose not to limit our investigation to one model of exploitation over another, but rather to examine prisoner views about research from both transactional and macro level perspectives. Nor did we take a priori stances on what circumstances constitute unacceptable exploitation, but rather sought to interpret our findings under both transactional and macro frameworks. Because participants in this study were already enrolled in clinical research that conforms to U.S. regulations, the studies adhere (at least in theory) to both transactional and macro level constraints on what type of prisoner research is permissible. The purpose of this investigation, then, was to evaluate 1) whether inmate participants in clinical research experience their participation as exploitative, and 2) what opinions they have regarding access to research in general.
Method
Participants
From June 2013 to January 2014, 70 individuals were recruited from 6 different clinical research studies (hereafter, “parent studies”) being conducted in a single state Department of Correction (DOC). Of the parent studies, 3 were clinical trials for substance dependence (two for testing pharmacologic interventions for opioid dependence, 1 for testing of a community-reentry linkage intervention for alcohol dependence), 1 was a clinical trial testing a psychoeducational intervention for reducing HIV risk behaviors, 1 was a clinical trial testing group psychotherapy for major depression, and 1 was a non-trial study on the relationship between substance use and incarceration; all had enrolled participants during incarceration (either jail or prison). During the enrollment period, research staff from the parent studies informed their current study participants (English-speaking only) of the opportunity to learn about an ancillary study on prisoners' decision-making regarding enrollment in clinical research. Those who expressed interest were engaged in a separate informed consent discussion with the principal investigator (P.C.) of this study who had no role in any of the parent studies. Those who agreed to participate provided verbal and written informed consent. Typically, subjects were recruited within days to weeks of their enrollment in the parent study and prior to their release from incarceration. Citing confidentiality restrictions, the institutional review boards that approved the parent studies prohibited us from determining how many participants from the parent studies declined the offer to learn about our study. Among those who entered an informed consent discussion, however, only one chose not to participate. Prisoners were compensated twenty dollars for their participation in the ancillary study (from which the data in this paper were derived) in accordance with DOC policy. This study was approved by the institutional review board of Butler Hospital.
Measures
Study participants provided demographic information: age, gender, race/ethnicity, and highest education. Given the lack of available instruments to measure exploitation among research participants, a set of eight items was developed for the present study and designed to capture transactional and macro perspectives on potential exploitation. These included perceptions of general research exploitation in the parent study, treatment-related exploitation, and opinions about prisoner access to clinical research. Participants were asked to rate the extent of agreement with each statement on a 7-point Likert scale (1=totally disagree, 2=mostly disagree, 3=somewhat disagree, 4=neutral, 5=somewhat agree, 6=mostly agree, 7=totally agree). Statements were written at an average Flesch-Kincaid grade level of 4.9. All statements were read aloud with repetition if requested. Participants were instructed to respond to all items based on their involvement in the parent study.
Analyses
Descriptive statistics were used to summarize all study variables. Wilcoxon signed rank test and ordinal logistic regression were used to compare item responses by age, gender, race/ethnicity, and education. Significance level was set at alpha=0.05.
Results
Participant demographic characteristics are presented in Table 1. The 70 participants ranged from 18 to 56 years old (mean 35.8, SD = 9.5) and 38 (54.3%) were male. A majority of the sample was non-Latino White (n=43), 14.3% (n=10) were non-Latino Black, 14.3% (n=10) were Latino, and 10% (n=7) were from other racial groups. Four participants (5.7%) had maximum education at or below the 8th grade, 16 (22.8%) had some high school education but had not graduated or obtained a GED, 32 (45.7%) had completed high school or obtained a GED, and 18 (25.7%) had some education beyond high school.
Table 1. Demographic characteristics of prisoner participants in clinical research studies.
Variable | Total (n=70) |
Male (n=38) |
Female (n=32) |
---|---|---|---|
Mean (SD) | |||
Age | 35.8 (9.5) | 36.2 (9.6) | 35.3 (9.5) |
Number (%) | |||
Race/ethnicity | |||
White, non-Latino | 43 (61.4) | 23 (60.5) | 20 (62.5) |
Black, non-Latino | 10 (14.3) | 6 (15.8) | 4 (12.5) |
Latino | 10 (14.3) | 4 (10.5) | 6 (18.8) |
Other race | 7 (10.0) | 5 (13.2) | 2 (6.3) |
Highest Education | |||
8th grade or less | 4 (5.7) | 3 (7.9) | 1 (3.1) |
Some high school | 16 (22.9) | 7 (18.4) | 9 (28.1) |
High school graduate or GED | 32 (45.7) | 19 (50.0) | 13 (40.6) |
Some education beyond high school | 18 (25.7) | 9 (23.7) | 9 (28.1) |
Participant opinions regarding exploitation are shown in Table 2. Nineteen (24.1%) agreed with the statement that the study took advantage of the fact that the participant was in prison, and 7 (10%) felt the researchers used participants to get what they wanted. However, only 2 (2.9%) participants agreed that the study exploited them, and only 1 (1.4%) felt taken advantage of by being in the study.
Table 2.
Perceptions of exploitation among 70 prisoner subjects regarding their participation in clinical research.
Totally disagree | Mostly disagree | Somewhat disagree | Neutral | Somewhat agree | Mostly agree | Totally agree | |
---|---|---|---|---|---|---|---|
Exploitation, general | N (%) | ||||||
This study took advantage of the fact that I was in prison. | 36 (51.4) | 7 (10.0) | 5 (7.1) | 3 (4.3) | 7 (10.0) | 3 (4.3) | 9 (12.9) |
The researchers in this study used me to get what they wanted. | 51 (72.9) | 6 (8.6) | 3 (4.3) | 3 (4.3) | 5 (7.1) | 1 (1.4) | 1 (1.4) |
I felt taken advantage of by being in this study. | 62 (88.6) | 4 (5.7) | 2 (2.9) | 1 (1.4) | 1 (1.4) | - | - |
This study exploited me. | 58 (82.3) | 5 (7.1) | 2 (2.9) | 3 (4.3) | 2 (2.9) | - | - |
Treatment related | |||||||
Joining the study was the only way to get the treatment I needed. | 19 (27.5) | 4 (5.8) | 1 (1.5) | 8 (11.6) | 15 (21.7) | 9 (13.0) | 13 (18.8) |
I only joined the study because I couldn't get the treatment I needed in prison. | 20 (29.0) | 7 (10.1) | 11 (15.9) | 7 (10.1) | 9 (13.0) | 5 (7.3) | 10 (14.5) |
Desire for access | |||||||
There should be more research studies for prisoners to join if they want to. | - | - | 1 (1.4) | - | 6 (8.6) | 10 (14.9) | 53 (75.7) |
Inmates should have the chance to join more research studies. | - | - | - | 3 (4.3) | 5 (7.1) | 12 (7.1) | 50 (71.4) |
Thirty-seven (52.9%) participants agreed that joining the study was the only way to get the treatment they needed, while 24 (24.3%) agreed that they only joined the study because they couldn't get the treatment they needed in prison.
All but 1 participant (98.6%) agreed that there should be more research studies for prisoners to join if they want to. Sixty-seven (95.7%) participants agreed that inmates should have the chance to join more research studies.
Older age was significantly associated with agreement with the statements, “Joining the study was the only way to get the treatment I needed” (β=.64, 95% CI= .20, 1.09, p=.004), and “Inmates should have the chance to join more research studies” (β=.59, 95% CI=.03, 1.16, p=.041); agreement with other items did not significantly differ by age. Responses to all items did not significantly differ by participant gender, race/ethnicity, or education.
Discussion
To our knowledge, this is the first study to examine prisoner perspectives of exploitation as participants in clinical research. We found that few prisoners endorsed feeling exploited by their participation, while more felt motivated to participate as a means of gaining access to a treatment that was not readily available to them. A majority expressed a preference that prisoners should have greater access to research opportunities. Older inmates were more likely to agree they only joined to obtain what they perceive as needed treatment and that prisoners should generally have greater access to studies. Although we did not assess length of incarceration, if older inmates face longer prison sentences, they may have more experience with being in need of healthcare services while incarcerated. This would explain their more positive views toward research.
How are we to interpret the ethical implication of these findings? It seems that a transactionalist would see little cause for concern. Overall, few prisoners described their participation in the studies as exploitative. Moreover, the first two general exploitation statements (“This study took advantage of the fact that I was in prison” and “The researchers in this study used me to get what they wanted”) have an ambiguous valence; that is, they may be interpreted as factually true without being indicative of problematic exploitation. The other general exploitation items (“I felt taken advantage of by being in this study” and “This study exploited me”) connote a more negative tone but were only endorsed by one or two participants. Thus, to the extent that any of these items reveal perceptions of exploitation, they do not provide strong evidence, under a transactional framework, that such research should be prevented. A transactionalist is also likely to interpret agreement with the treatment-related items (e.g., “Joining the study was the only way to get the treatment I needed” and “I only joined the study because I couldn't get the treatment I needed in prison”) as evidence of appropriate motivation for enrollment, representative of mutually beneficial interaction. Unless the researchers had the means to provide (and scientific justification to test the outcomes of) better medical care, it seems unlikely that a transactionalist would conclude that these studies represent unacceptable exploitation. Finally, nearly all participants believed that prisoners should have greater access to research studies. Thus, the vast majority identify research, even if potentially exploitative, as permissible and, indeed, potentially desirable. Under a transactional framework then, these data support the notion that prisoners should be able to judge for themselves the circumstances under which they choose to enroll in clinical research.
Under a macro view of exploitation, however, some may be worried by the fact that so many prisoners reported that their enrollment was motivated by a desire for access to medical care. For at least some prisoners, these motives arise from constraints imposed by the correctional system. It is not clear, however, that research conducted under such circumstances inappropriately capitalizes on the predicament in which prisoners find themselves. Some have argued that if correctional institutions provided broader access to the range and quality of treatments that exist in the community, certain types of prison-based studies would not be needed and that prisoners may be less inclined to enroll in them.13 Our data certainly suggest that some inmates may not have enrolled had they means of accessing treatment other than that offered by the study. Unfortunately, there is little reason to believe that circumstances in the correctional system will change at a pace commensurate with the need to address these disparities. Providing certain forms of medical care to a large and ill prison population is expensive and unpopular to fund.14 While prisoners have a constitutional right to healthcare, courts have held that prisons need only provide minimally acceptable treatments, not the range of options available to the public.15 Here, it is worth pointing out that the responsibility for improving healthcare in prison ultimately rests with society, not with researchers. Nevertheless, the goal of prison research that focuses on interventions, services, health economics, and policy is precisely to gather data to make the case that existing prison services can and should be improved. The salient question then is whether it is unacceptably exploitative (i.e., should be prohibited) for researchers to conduct such studies if some prisoners only enroll because they want better care. Under a macro view, so long as certain requirements are met, we believe the answer to this question is no. The first requirement, as recommended by the IOM report cited above, is that studies strike an appropriate balance between risk and benefit. Second, studies should be intended and designed to identify interventions that can be disseminated to prisoners in general. Although not specifically outlined under current guidelines, a third requirement under a macro view might be that the researchers conducting the studies should have no role in depriving prisoners of such care and no direct authority and ability (which, if present, would confer responsibility) to otherwise improve the care provided to prisoners. Finally, researchers should, to the best of their ability, be sure that prisoners understand the ways in which clinical research differs from clinical care, that participation is voluntary, and that other requirements for informed consent are met. In this context, studies would be acceptable as they involve enlisting participants' help to improve the care prisoners receive.
We note several limitations in the present study. The views represented in these data come from a small group of participants who had already agreed to participate in two (the parent and present) studies and thus should not be generalized to all prisoners. Decliners or those who dropped out prior to our recruitment may be more likely to view research as exploitative. Also, the parent studies from which we recruited all met federal guidelines for prisoner research, posed no more than minimal risk to participants, and were all conducted within one state setting. It would be worth investigating prisoner views about research in other settings and toward studies that pose greater than minimal risk. Future work should address how prisoners feel about having access to hypothetical research that is not intended to help their treatment as a class (i.e., studies that will be used to advance medical knowledge not relevant to prisoners specifically but that might benefit prisoners in other ways (e.g., financial, social interaction, escape from boredom, altruism)). We did not differentiate between those enrolled in the active versus control arms of the five clinical trials; perceptions of exploitation may have been influenced by randomization to one arm over the other. Finally, the items used to evaluate exploitation were not psychometrically developed or tested; thus, participants may have interpreted statements in ways that we did not intend.
Given the myriad health problems prisoners face, there is a pressing need to understand prisoners' perspectives regarding enrollment in clinical research that is aimed at improving their care. This work provides novel data on whether prisoners view their involvement in clinical research as exploitative. Although a minority of participants agreed with statements suggestive of potential exploitation, only one participant believed that prisoners should not have greater access to research. On balance, these data provide reassurance that this group of prisoners do not view their involvement in clinical research as inappropriately exploitative.
Acknowledgments
Funding for this work was supported by awards K23DA034030 (Christopher) and K24DA022112 (Rich) from the National Institute on Drug Abuse. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Drug Abuse or the National Institutes of Health.
Footnotes
Human subjects protection statement: This study was approved the institutional review board of Butler Hospital.
Although legally distinct concepts, for the purposes of this paper the terms “incarcerated individuals,” “prisoners” and “inmates” will be used interchangeably.
Contributor Information
Paul P. Christopher, Alpert Medical School, Brown University.
Michael D. Stein, Alpert Medical School, Brown University.
Jennifer E. Johnson, Alpert Medical School, Brown University.
Josiah D. Rich, Alpert Medical School, Brown University.
Peter D. Friedmann, Alpert Medical School, Brown University.
Jennifer G. Clarke, Alpert Medical School, Brown University.
Charles W. Lidz, University of Massachusetts Medical School.
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