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Beneficial and unusual punishment: An argument in support of prisoner participation in clinical trials
Abstract
Currently, approximately 1.8 million people are incarcerated in the United States at any given time. A disproportionately large percentage of the prisoner population has serious illnesses, such as AIDS and tuberculosis. Prisoners most often, however, are barred from participation in clinical trials, even when conventional therapy has failed, and experimental treatment might provide them with their only hope of survival. Much of the reluctance to include prisoners in biomedical research is based on history. In the past, prisoners have been severely abused and even tortured in medical studies conducted in the Nazi death camps, Japanese prisoner camps, and correctional facilities in the United States. By 1969, eighty-five percent of new drugs were tested on incarcerated persons in forty-two American prisons. In the 1970s regulations regarding the use of biomedical experimentation on prisoners were issued by the federal government, designed to provide rigorous review of research protocols involving prisoners and to protect inmates from abuse in the research context. Abuse of prisoner subjects in clinical studies can lead to violations of their constitutional rights. The author argues, however, that prohibiting seriously ill prisoners from participating voluntarily in clinical research may constitute an equivalent contravention of their constitutional rights under the Eighth Amendment and the Due Process and Equal Protection clauses. The article reviews the history of prisoner participation in biomedical research, analyzes the relevant constitutional issues, and encourages the inclusion of prisoners in clinical studies involving potentially beneficial experimental treatment for life-threatening diseases.
... These limitations-including the provision that such research could pose no more than minimal risk-were driven in part by the belief that informed consent could not be provided by individuals whose autonomy was limited by their incarceration (Gostin et al. 2007). The strict DHHS guidelines, and a related landmark case against the Michigan Department of Mental Health (Kaimowitz v Michigan DMH 1973), had the effect of dramatically curtailing the amount of publicly funded clinical research conducted with incarcerated populations (Gostin et al. 2007;Hoffman 2000). For some diseases such as HIV, the new restrictions were responsible for nearly eliminating research altogether (Dubler and Sidel 1989). ...
... For some diseases such as HIV, the new restrictions were responsible for nearly eliminating research altogether (Dubler and Sidel 1989). By the late 1990s, only 15% of institutions engaging in clinical research in the United States included prisoners in any of their research protocols (Hoffman 2000). ...
... Second, prisoners and prison advocacy groups began contesting restrictions on research participation, arguing that inmates wanted "access to, not protection from" protocols offering otherwise unavailable treatments (Gostin et al. 2007). Similarly, some scholars argued that prisoners have a right to participate in potentially advantageous or even lifesaving research-an extension of their constitutional right to health care (Gostin et al. 2007;Hoffman 2000;Thomas 2010). Nevertheless, as recently as 2000, prison research at four academic centers was suspended for further institutional review board (IRB) review after an unsubstantiated complaint was raised (during a site visit) at a conference on the ethical conduct of clinical trials involving prisoners (De Groot et al. 2001). ...
In the past 30 years, the incarcerated population in the United States has more than quadrupled to 2.3 million adults. With an alarmingly high prevalence of mental illness, substance use, and other serious health conditions compounding their curtailed autonomy, prisoners constitute perhaps the nation's most disadvantaged group. Scientifically rigorous research involving prisoners holds the potential to inform and enlighten correctional policy and to improve their treatment. At the same time, prisoner research presents significant ethical challenges to investigators and institutional review boards (IRBs) alike, by subjecting participants to conditions that potentially undermine the validity of their informed consent. In 2006, the Institute of Medicine Committee on Ethical Considerations for Revisions to the Department of Health and Human Services (DHHS) Regulations for Protection of Prisoners Involved in Research recommended both further protections and a more permissive approach to research review that would allow inmates greater access to potentially beneficial research. These recommendations have sparked renewed debate about the ethical trade-offs inherent to prisoner research. In this article, the authors review the major justifications for research with prisoner subjects and the associated ethical concerns, and argue that the field of empirical ethics has much to offer to the debate. They then propose a framework for prioritizing future empirical ethics inquiry on this understudied topic.
... In building research agendas, more must be done to ensure the participation of communities affected by the resulting policies. GIVEN RECENT PROPOSALS to reexamine federal regulations pertaining to human experimentation in prisons, [1][2][3][4] it is important that more be done to ensure that the viewpoints and life experiences of prisoners, ex-offenders, and their communities be considered. There has been recent debate about what constitutes ethical research in prisons and about the possible expansion of the scope of what is allowable. ...
... 1,3,4 At least one researcher has argued that prisoners have a constitutional right to choose to participate in a study, clinical or otherwise. 2 Other work has suggested that prisoners ought to have the same access to experimental drugs as people who are not in prison and that there are ways to erect safeguards to ensure that the abuses committed in the past are not repeated. [2][3][4] We argue that until the question of adequate health care for prisoners is resolved, human experimentation should not be allowed. ...
... 2 Other work has suggested that prisoners ought to have the same access to experimental drugs as people who are not in prison and that there are ways to erect safeguards to ensure that the abuses committed in the past are not repeated. [2][3][4] We argue that until the question of adequate health care for prisoners is resolved, human experimentation should not be allowed. Why are so many people from low-income, minority communities incarcerated? ...
Prisoners, ex-offenders, and the communities they belong to constitute a distinct and highly vulnerable population, and research must be sensitive to their priorities. In light of recent suggestions that scientific experimentation involving prisoners be reconsidered, community-based participatory research can be a valuable tool for determining the immediate concerns of prisoners, such as the receipt of high-quality and dignified health care inside and outside prisons. In building research agendas, more must be done to ensure the participation of communities affected by the resulting policies.
... These tests included also dioxins (Dow Chemical Corporation, 1965-66), psychological warfare agents, injection of live cancer cells, and tests with radioactive isotopes. There is an ongoing discussion on possible relaxation of rules in favor o f participation of prisoners in biomedical research (Hoffman, 2000) 25 . On the other hand, Reiter (2009) argues that the current conditions in U.S. prisons provide no guarantees that ethical standards in research would be met, and that experience with federa l sponsored research in pre-1976 era which had no therapeutic purpose and caused permanent health damage to the research subjects should always be remembered in these debates 26 . ...
... These tests included also dioxins (Dow Chemical Corporation, 1965-66), psychological warfare agents, injection of live cancer cells, and tests with radioactive isotopes. There is an ongoing discussion on possible relaxation of rules in favor o f participation of prisoners in biomedical research (Hoffman, 2000) 25 . On the other hand, Reiter (2009) argues that the current conditions in U.S. prisons provide no guarantees that ethical standards in research would be met, and that experience with federa l sponsored research in pre-1976 era which had no therapeutic purpose and caused permanent health damage to the research subjects should always be remembered in these debates 26 . ...
... Third, in addition to health benefits of research participation, participants may benefit through the moral satisfaction of contributing to society. 23 Research contribution can be regarded as a public good. 24 As such, excluding prisoners denies them the opportunity to make the same moral contribution as free members of society, disengaging them from the wider moral community. ...
... Moreover, prisoners may particularly value this as a way 'to redeem, atone and reconcile'. 23 These benefits may result from all forms of research, and while less substantial than potential health benefits of clinical research, have less associated risks and burdens. Thus, prisoners may benefit from greater inclusion in other forms of research such as questionnaire studies. ...
The use of prisoners as research participants is controversial. Efforts to protect them in response to past exploitation and abuse have led to strict regulations and reluctance to involve them as participants. Hence, prisoners are routinely denied the opportunity to participate in research. In the absence of comprehensive information regarding prisoners' current involvement in research, we examined UK prisoners' involvement through review of research applications to the UK National Research Ethics Service. We found that prisoners have extremely limited access to research participation. This analysis was augmented by a survey of those involved in research and research governance (UK researchers and Research Ethics Committee members). Our results suggest that pragmatic concerns regarding the perceived burden of including prisoners are far more prominent in motivating their exclusion than ethical concerns or knowledge of regulations. While prisoners may remain a vulnerable research population due to constraints upon their liberty and autonomy and the coercive nature of the prison environment, routine exclusion from participation may be disadvantageous. Rigorous ethical oversight and the shift in the prevailing attitude towards the risks and benefits of participation suggest that it may be time for research to be more accessible to prisoners in line with the principle of equivalence in prison healthcare. We suggest the necessary first step in this process is a re-examination of current guidance in the UK and other countries with exclusions.
... In particular, imprisoned individuals have historically been viewed as "categorically vulnerable," due to being socially constrained by a host of structurally imposed power relations (Mitchelson, 2017). Moreover, individuals who are incarcerated are geographically residing within coercive and violent spaces, which consequently can impact their sense of self-determination and decisionmaking power within the research process (Hoffman, 2000;Michelson, 2017). ...
Black women experience myriad challenges post incarceration, from managing stigma within social relationships to navigating surveillance when interfacing with service systems. It is these challenges that also make them vulnerable participants in community‐based research. With many of potential research harms not falling under the guidance of Institutional Review Boards, it is critical to explore how communities experiencing stigma and surveillance perceive their engagement in research. As such, this study explores how 28 justice‐involved Black women experience the research process. Findings reveal that participants view the research context as spaces for reflecting on surveillance and stigma in ways that promote self‐recovery. Moreover, they perceive the interview process to allow them to envision identities as wounded healers who use their pasts as mechanisms to help others. The study's implications for anti‐oppressive inquiry underscore the need for researchers to employ ethical care and justice frameworks that center compassion, reflexivity, and equity throughout the process.
... Investigational products ranged from soap and cosmetics to dioxin, psychological warfare agents, and radioactive isotopes. As result, prisoners suffered a great deal of adverse events and serious abuse [8]. ...
Background:
Participation in first-in-human (FIH) clinical trials is a valuable contribution to science. This study aims to investigate the Saudi public's attitude toward FIH clinical trials, identify their willingness to take part in it, and their preferences for participating in these kinds of trials, given the fact that the Saudi FDA has never approved such studies in Saudi Arabia.
Methods:
This was a cross sectional study conducted in February 2018. It was based on a self-reported survey distributed by convenience among Saudi adults visiting a national festival in Riyadh and through social media. Data were analysed using descriptive and bivariate statistics, as well as linear and binary logistic regression.
Results:
Study participants who were invited and completed the survey were 657. The percentage mean score of participants' attitudes and concern was 70.1 ± 16.4 and 58.3 ± 15.3 respectively. Almost 71.5% expressed their intention to enroll in such trials. Higher attitudinal scores were reported by those who perceived healthcare services as good/excellent (adj.P < 0.001), and by those who had less concerns (adj.P = 0.005). Less educated participants were 1.75 [1.04-2.93] times more likely to enroll in future clinical trials, adj.P = 0.035. For every one unit increase in the attitudinal score, study participants were 1.03 [1.02-1.04] more likely to enroll in future trials, adj.P < 0.001. In contrary, for every one unit increase in concern scores, the odds of enrollment decreased among study participants by 0.98 [0.97-0.99], adj.P = 0.017. The factors causing people to decline participation were mainly fear of the unknown, social reasons, religious reasons, moral reasons, and the concern over human beings being treated as animals. The preferred duration for participation was 1-3 days (n = 268, 57%). Participants revealed their preferences of clinical trial studies were in favor: (a) vaccines (n = 209, 44.5%); (b) treatment drugs (n = 232, 49.4%); and (c) medical devices (n = 310, 66.0%).
Conclusion:
The Saudi public community showed a high level of enthusiasm for participation in future FIH clinical trials, yet they had some reservations. Increasing public awareness about the benefits of clinical trials and conduction process helps to alleviate the concerns of the Saudi people and to increase their likelihood of enrollment.
... Research on inmates in the 1950s and 1960s was done with little or no oversight or informed consent (Hoffman 2000 ;Kalmback and Lyons 2003 ). Abuses of excess were exposed and by 1978 the U.S. government virtually prohibited research on prisoners (Wakai et al. 2009 ). ...
The psychiatrist who passes through the sally port of a U.S. jail or prison to provide professional services enters a realm that is strikingly different from a private group practice, a clinic or a hospital. Professional ethics in a healthcare setting can be both implicit and explicit, but as a rule they are concertedly supported which creates an ethically comfortable and harmonious working atmosphere for psychiatrists. Correctional facilities in contrast serve different purposes than provision of healthcare: Security is emphasized and the leadership, management and administration of correctional facilities is driven by presumptions, customs, traditions and regulations that stress order, routine, safety and especially control.
... The matter of informed consent with prisoners does raise the question as to whether it is ever appropriate to use prisoners as research participants. Perez and Treadwell (2009) cite recent research showing that biomedical researchers in the US having difficulty recruiting volunteers for clinical trials (e.g., Hoffman, 2000) are pushing for access to prisoners as participants in clinical trials (this was common practice as late as 1969, but not currently). The authors discuss ethical issues surrounding prisoners as participants in clinical trials, and argue that "until the question of adequate health care for prisoners is resolved, human experimentation should not be allowed" (p. ...
Forensic and correctional practitioners are typically well aware of ethical problems emerging from their work with sex offenders. This chapter discusses a number of pressing ethical issues confronting researchers in the forensic and correctional domains. It draws upon two ethical concepts in the exploration of ethical problems in forensic and correctional research, namely dignity and justification. First, the chapter presents a set of ethical ideas on which we rely in the subsequent analysis of the research problems. Second, it examines the difficulties associated with the design, collection, analysis, and reporting of data in forensic and correctional research. Third, it focuses on features of offenders as research participants and researchers in their role as investigators. Finally, the chapter presents some general comments concerning ethics and research.
... Investigations into state funded trials in the US that revealed the unethical use of prisoners, racial minorities, children and the mentally challenged as trial subjects led to the establishment of the National Research Act in 1974. The Act stated the need for review boards to assess the ethical conduct of medical research (6)(7)(8). International awareness of unethical human experimentation also led to the establishment of other ethical guidelines such as the 1964 Declaration of Helsinki that ARtICLes Justice in jeopardy: a qualitative study of institutional ethics committees in New Delhi ...
Protecting the safety and welfare of clinical trial subjects is the primary responsibility of the multidisciplinary ethics committee. In India, ethics committees have come under increasing criticism for functioning as "secret societies unaccountable to the public" (1). Yet, little effort has been made to undertake qualitative research on the ethics review bodies. This article describes the essential findings of a study that aimed at providing an insight into the structure and functioning of institutional ethics committees (IECs) in selected hospitals in Delhi. Importantly, the study also attempted to investigate the challenges faced by IEC members that pose barriers to IEC performance and thus jeopardise a just and effective system of protection for the human trial subject.
... The matter of informed consent with prisoners does raise the question as to whether it is ever appropriate to use prisoners as research participants. Perez and Treadwell (2009) cite recent research showing that biomedical researchers in the US having difficulty recruiting volunteers for clinical trials (e.g., Hoffman, 2000) are pushing for access to prisoners as participants in clinical trials (this was common practice as late as 1969, but not currently). The authors discuss ethical issues surrounding prisoners as participants in clinical trials, and argue that " until the question of adequate health care for prisoners is resolved, human experimentation should not be allowed " (p. ...
... In the 1950s and 1960s state and federal prisons allowed researchers, particularly those from the pharmaceutical industry, to conduct studies including the introduction of infectious hepatitis, syphilis, or cancer to otherwise healthy individuals (Hornblum, 1997) with little or no oversight or meaningful informed consent process. In the early 1970s, the vast majority of drug toxicity trials and investigational new drug trials were conducted using inmates as research subjects (Hoffman, 2000;Kalmbach & Lyons, 2003). The Nuremberg Code, the Tuskegee Study, the Belmont Report and the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research contributed to the federal government essentially banning research with prisoners in 1978. ...
Research in correctional settings has progressed from the exploitation of a vulnerable population in the years prior to 1978 to its current overly protective and restrictive state. With the considerable growth in the numbers of inmates with medical and mental health care needs, developing effective interventions to serve this population is paramount. There now appear to be signs of interest in and support for research with inmates by correctional agencies, academia, and health care organizations. Innes (2003) has articulated the following strategies for implementing research in prison: (1) gather stakeholders; (2) include one or more experienced research collaborators; (3) consider obtaining technical assistance from a university or the National Institute of Corrections (NIC); (4) define potential opportunities/interests that support the institution's mission; (5) develop a relationship with an IRB; (6) pilot a small proposal that is of interest and potential value to the organization. The authors illustrate the implementation of a study in a correctional system that uses these strategies.
... Minimal public attention was given to prison research during most of its first century in the United States. During this time, diseases were induced for study purposes (Leopold, 1958;Reich, 1995) and up to 85% of all drug toxicity clinical trials were conducted with prisoners (Hoffman, 2000;Kalmbach & Lyons, 2003). As the public became aware of similar research with vulnerable civilian populations, the government finally responded by forming the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHSBBR) and passing the National Research Act in 1974 with additional protections added later for pregnant women, prisoners, and finally children. ...
Incarcerated populations have disparities in health risks and illness conditions meriting study, but the history of prison research is marred by unethical conduct. Ethical participation strategies are discussed in the context of studies implemented by the author in a state prison system. This study used ethnographic approaches, observed adherence to federal and institutional review board regulations and corrections department directives, and maintained continuous communication with vested interests to provide entry and long-term access for studies on female prisoners and their civilian infants. A culture clash between the punitive restrictive environment that serves the custody-control-care mission of corrections systems and the open inquiry environment needed for conduct of health research exists. Federal regulations protect prisoners as human subjects but additional vigilance and communication by researchers are required. Gaining and maintaining access to prison inmates for nursing research are leadership challenges that can be met within the caring and collaborative paradigm of nursing.
Given the considerable potential for participatory action research in correctional settings, this study gathered stakeholders’ perspectives on involving adults in custody throughout the research process. Using mixed methods, the study identified participants’ level of interest in involving prisoners in the research process to inform educational efforts to increase correctional participatory action research. Qualitative data were gathered from 94 prison administrators, Institutional Review Board throughout the Abstract section.] members, prisoner representatives, research ethicists, and correctional researchers; quantitative data were collected from 1228 correctional and noncorrectional mental health researchers, correctional and noncorrectional Institutional Review Board members, and prisoner representatives. Qualitative data revealed lack of understanding of participatory action research concepts and advantages along with disagreement about whether prisoner involvement is desirable. Quantitative data revealed that respondents were most supportive of involving incarcerated individuals in contributing ideas for future research, planning recruitment procedures, developing participant protection procedures, and disseminating information to correctional populations. Respondents least supported involving adults in custody in disseminating findings to scientific venues, designing research and protocols, interpreting data, and setting research agendas. Combined, findings indicate efforts are needed to educate stakeholders about participatory action research’s value in correctional settings. This is particularly true related to soliciting prisoner voices in proactive and meaningful ways and moving beyond simply seeking input about measures selection or recruitment advice.
A host of power relations are structurally imposed upon the imprisoned and these produce vulnerabilities that require considerable energy and attention. This paper argues, however, that ‘vulnerable populations’ is a politically reactive legal category in the context of research with prisoners. In turn, this form of categorical vulnerability is often misaligned with ‘actually existing vulnerability’ or 'relational vulnerability' in the context of prison life. Substantive ethical, methodological and practical problems result from this misalignment, as I illustrate through the case of my research with former prisoners in Athens, Georgia. I seek to prove two claims in support of my central argument. First, actually existing vulnerability is fundamentally relational and it involves the researcher, the researched, collaborators, and (often distant) people and social structures that were not necessarily directly involved in the research process. Second, vulnerability is a spatially and temporally contingent process. The essay reviews the peculiar history by which prisoners came to be categorized as a ‘vulnerable population’ in the United States, in addition to recounting my first-hand experiences during the research process.
Potentially reversible dementias comprise a heterogeneous group of physical and psychiatric conditions that may be identified in approximately 10% of patients presenting with symptoms of dementia. There is evidence that the prevalence has fallen in the last twenty years. Depressive illness, structural brain lesions and normal pressure hydrocephalus account for more than half the cases and recently identified causes include the autoimmune encephalopathies. Reversible dementias tend to be more common in younger patients (under 70 years of age). Treatment of the underlying condition should be vigorously pursued although complete reversal of cognitive impairment is rare, occurring in less than 10% of identified cases. Care protocols for the assessment of patients presenting with memory disorders should include as basic minimum a full blood count, serum electrolytes and calcium, thyroid, liver and kidney function, random glucose, vitamin B12 and folate levels, and brain neuro-imaging (either magnetic resonance or computed tomography).
The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets. Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives.
Typhoid infection causes considerable morbidity and mortality worldwide, particularly in settings where lack of clean water and inadequate sanitation facilitate disease spread through faecal-oral transmission. Improved understanding of the pathogenesis, immune control and microbiology of Salmonella Typhi infection can help accelerate the development of improved vaccines and diagnostic tests necessary for disease control. S. Typhi is a human-restricted pathogen; therefore animal models are limited in their relevance to human infection. During the latter half of the 20th century, induced human infection (“challenge”) studies with S. Typhi were used effectively to assess quantitatively the human host response to challenge and to measure directly the efficacy of typhoid vaccines in preventing clinical illness. Here, the findings of these historic challenge studies are reviewed, highlighting the pivotal role that challenge studies have had in improving our understanding of the host-pathogen interaction, and illustrating issues relevant to modern typhoid challenge model design.
Caring for persons with Alzheimer's disease presents neurologists with ethical challenges. Some of these, such as end-of-life care or research participation, are well known and have significant overlap with challenges in other areas of medicine or other neurologic diseases, such as cancer or traumatic brain injury, while others, such as the rise of biomarker-based diagnostics, are more novel and reflect the impact of developments in the science and clinical care of Alzheimer's disease. A thoughtful and systematic approach to these challenges, from the preclinical to the late symptomatic stage of this disease, is required and will help clinicians be better advocates and stewards of their patients. This chapter addresses a number of the most pressing ethical problems facing patients, caregivers, and clinicians during this disease, including early and presymptomatic testing, assessment of decision-making capacity for treatment or research participation, restriction of driving, remote monitoring, assisted suicide, and treatment of disruptive behaviors.
The ministry of health and family welfare published the national vaccination policy in April 2011. The policy document drew severe criticism from several public health experts. A review of the print and web-based literature on the national vaccine policy was done and the issues of ethics and equity involved in introducing new vaccines under the Universal Immunisation Programme (UIP) were studied. The average coverage of the UIP vaccines at the national level is below 50%. Despite this, the policy document did not state any concrete strategy for increasing the coverage. The main stumbling block for evidence-based vaccine policy in India is the lack of reliable epidemiological data, which makes it difficult for the National Technical Advisory Group on Immunisation to offer sound technical advice to the government. No attempts have been made to prioritise diseases or the selection of vaccines. The policy suggests the introduction of the following vaccines in the UIP: Haemophilus influenzae type b, pneumococcal vaccine, rotavirus vaccines and human papillomavirus (HPV). This selection is on the grounds of the vaccines' availability, not on the basis of epidemiological evidence or proven cost-effectiveness. This is a critical review of the current vaccination policy and the move to include the rotavirus and HPV vaccines in the UIP.
Publication is one of the primary rewards in the academic research community and is the first step in the dissemination of a new discovery that could lead to recognition and opportunity. Because of this, publication of research can serve as a tacit endorsement of the methodology behind the science. This becomes a problem when vulnerable populations that are incapable of giving legitimate informed consent, such as prisoners, are used in research. The problem is especially critical in transplant research, where unverified consent can enable research that exploits the vulnerabilities of prisoners, especially those awaiting execution. Because the doctrine of informed consent is central to the protection of vulnerable populations, we performed a historical analysis of the standards of informed consent in codes of international human subjects protections to form the foundation for our "limit and ban" recommendations: 1) to limit publication of transplant research involving prisoners in general, and 2) to ban publication of transplant research involving executed prisoners in particular. © 2013 American Association for the Study of Liver Diseases.
Historically, prisoners in the United States have served as an inexpensive and readily available source of human subjects for research. Coinciding with the civil rights movement, however, was an emerging conception of prisoners' rights that led to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research being charged with investigating the use of prisoners as research subjects. The recommendations that evolved and the subsequent guidelines that have been implemented by the Department of Health and Human Services significantly curtail the use of prisoners as research subjects. While these measures are designed to protect inmates from the abuses of the past, of particular concern to many health care officials is exclusion of inmates from experimental HIV/AIDS and hepatitis treatments. This paper addresses whether the vulnerability of prisoners in the United States due to their incarceration is sufficient to prohibit them from participation in clinical trials that offer the possibility of life-saving treatment. It first outlines the evolution in moral thinking that has led to laws broadly prohibiting prisoners from biomedical research studies and then analyzes cases in the law to develop ethical arguments in support of the view that prisoners should be allowed to participate in clinical trials. The conclusion is that prisoners should be allowed to participate in such trials.
Biobehavioral research, especially that which is conducted with prisoners, has become much more closely regulated in the last 30 years. State and federal law, as well as professional standards, regulate the conduct of many types of research; in the case of prisoners, this regulation is even more stringent. However, currently no mandatory, uniform, national regulatory or oversight process exists, and many privately funded research endeavors are operating in a regulatory void. In response to this, the National Bioethics Advisory Commission has argued for the creation of a single, national, independent regulatory body to oversee all human participant research, regardless of funding source. As ethicolegal research standards evolve alongside advances in science and technology, an appreciation of the history of prisoner research and an awareness of current standards is critical to conducting ethical prison research.
The abuses in experimentation that marked the 20th century has resulted in regulations. Standards for experimental treatment or for research involving human subjects has been a major development of the twentieth century, coming about in response to the horrendous experiments carried out by Nazi Germany and also in the United States and elsewhere. How these regulations have fared is discussed herein.
This article examines international and European regulations on research involving prisoners for consensus, differences, and their consequences, and offers a critical evaluation of the various approaches. Agreement exists that prisoners are at risk of coercion, which might interfere with their ability to provide voluntary informed consent to research. Controversy exists about the magnitude of this risk and the consequences that should follow from this risk. Two strategies are proposed for a method of protecting prisoners that does not lead to discrimination: first, more caution to assure non-coerced consent and second, restrictions on the type of research. Most regulations stress the importance of the principle of equivalence of healthcare in places of detention as part of an efficient protection against research risks and discrimination.
All the presented approaches have shortcomings. While ‘over-use’ of prisoners for research as compared to the general population is ethically unjustified, not granting prisoners access to studies beneficial to their own health because of over-strict regulations is equally unjustified. A middle solution should be preferred, one that grants a minimum of protection together with the lowest possible barriers. Research that does not entail a direct benefit for the individual detainee should be restricted to types of research that have a benefit for detainees as a group and that are of low risk. What will ultimately protect prisoners best, while producing the greatest benefit for them, is access to the same healthcare available to members of the community including research as a true option.
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