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Ethical and legal standards for research in prisons
Abstract
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.
... Depuis, que le code de Nuremberg est entré en vigueur, la majorité des pays se sont détournés de l'exploitation des prisonniers dans la recherche, puisque le premier amendement insistait sur le fait que le participant aux essais devait «être capable d'exercer un libre choix» (11): «The voluntary consent of the human subject is absolutely essential» (12). Le code de Nuremberg avait une formulation 'intransigeante' sur ce point précis relatif au consentement, ce qui écartait obligatoirement toutes les personnes ne pouvant répondre à ce critère; or, ces dernières étaient précisément la cible préférée des promoteurs de recherche vu leur 'vulnérabilité' (12). ...
... Depuis, que le code de Nuremberg est entré en vigueur, la majorité des pays se sont détournés de l'exploitation des prisonniers dans la recherche, puisque le premier amendement insistait sur le fait que le participant aux essais devait «être capable d'exercer un libre choix» (11): «The voluntary consent of the human subject is absolutely essential» (12). Le code de Nuremberg avait une formulation 'intransigeante' sur ce point précis relatif au consentement, ce qui écartait obligatoirement toutes les personnes ne pouvant répondre à ce critère; or, ces dernières étaient précisément la cible préférée des promoteurs de recherche vu leur 'vulnérabilité' (12). A cause de ce caractère 'intransigeant', le code de Nuremberg a eu un impact négatif sur l'activité de recherche, ce qui lui a valu plus tard l'étiquette péjorative de 'code restrictif' (12). ...
... Le code de Nuremberg avait une formulation 'intransigeante' sur ce point précis relatif au consentement, ce qui écartait obligatoirement toutes les personnes ne pouvant répondre à ce critère; or, ces dernières étaient précisément la cible préférée des promoteurs de recherche vu leur 'vulnérabilité' (12). A cause de ce caractère 'intransigeant', le code de Nuremberg a eu un impact négatif sur l'activité de recherche, ce qui lui a valu plus tard l'étiquette péjorative de 'code restrictif' (12). ...
Résumé
Les fondements éthiques relatifs aux recours aux personnes humaines dans la recherche médicale préexistaient dans les textes les plus anciens. L’évolution historique des textes et codes avait depuis toujours puisé sa légitimité et sa logique du contexte historique. Le principal but de ces textes et codes était de satisfaire un besoin de réparer les préjudices moraux ou physiques, en espérant par le biais de la loi, que ces dérives ne se reproduisent plus. Quoiqu’étant les principales victimes des expérimentations médicales, les prisonniers ont été rarement individualisés spécifiquement dans ces textes et codes. Cette note d’histoire, la troisième d’une série sur l’expérimentation médicale sur les prisonniers, vise à décrire les principaux textes fondateurs de l’éthique dans le domaine de l’expérimentation médicale, en attirant l’attention sur le contexte historique ainsi que sur les enjeux qui ont façonné ces documents.
... Les états ont le plus souvent été complices par leur laxisme. A titre d'exemple, en 1962, la FDA, cad le Food and Drug Administration, (organisme fédéral subventionnant la recherche des institutions sous la régie de l'état aux USA) avait instauré l'obligation du respect des règles d'éthiques préétablies sur le sol Américain (10). En réponse, tous les organismes de recherche ne dépendant pas financièrement de l'état (les plus grandes firmes pharmaceutiques en l'occurrence) avaient boycotté la nouvelle charte et se sont précisément détourné vers les prisonniers pour entreprendre leurs travaux (10). ...
... A titre d'exemple, en 1962, la FDA, cad le Food and Drug Administration, (organisme fédéral subventionnant la recherche des institutions sous la régie de l'état aux USA) avait instauré l'obligation du respect des règles d'éthiques préétablies sur le sol Américain (10). En réponse, tous les organismes de recherche ne dépendant pas financièrement de l'état (les plus grandes firmes pharmaceutiques en l'occurrence) avaient boycotté la nouvelle charte et se sont précisément détourné vers les prisonniers pour entreprendre leurs travaux (10). En conséquences, on avait recensé en 1969, 42 prisons qui avaient participé à des essais cliniques, ce qui représentait 85% des travaux enregistrés cette année-là (10). ...
... En réponse, tous les organismes de recherche ne dépendant pas financièrement de l'état (les plus grandes firmes pharmaceutiques en l'occurrence) avaient boycotté la nouvelle charte et se sont précisément détourné vers les prisonniers pour entreprendre leurs travaux (10). En conséquences, on avait recensé en 1969, 42 prisons qui avaient participé à des essais cliniques, ce qui représentait 85% des travaux enregistrés cette année-là (10). En 1972, l'implication des prisonniers dans les essais cliniques représentait plus de 90% (10). ...
Résumé
L’implication des médecins comme outil exécutif dans les dérives de l’expérimentation médicale en milieu carcéral continue de susciter les interrogations et l’incompréhension. Du fond des camps d’extermination sous le régime Nazi à celui des scandales itératifs d’exploitation d’après la seconde guerre mondiale, la capacité de certains médecins à outrepasser les fondements du serment d’Hippocrate de «ne pas nuire » et à s’associer à autant d’atrocités surprendra toujours. Les éléments de réponse à cette problématique semblent ambigus car il faudrait reconsidérer les dérives de l’expérimentation médicale dans leur contexte historico-politique associé. Cette note d’histoire, la deuxième d’une série sur l’expérimentation médicale dans les prisons, vise à soulever les dérives attribuées aux médecins lors de l’expérimentation médicale sur les prisonniers.
... Le prisonnier est « toute personne qui est confinée involontairement ou retenue dans une institution pénale » (1). L'exploitation des prisonniers dans le domaine de la recherche médicale est un phénomène ancien (2,3). Bien que les médecins et les chercheurs soient aujourd'hui plus 'avisés' des droits des personnes incarcérées, la réalité est que la recherche médicale avait depuis toujours su tirer 'profit' de l'environnement carcéral (3). ...
... L'exploitation des prisonniers dans le domaine de la recherche médicale est un phénomène ancien (2,3). Bien que les médecins et les chercheurs soient aujourd'hui plus 'avisés' des droits des personnes incarcérées, la réalité est que la recherche médicale avait depuis toujours su tirer 'profit' de l'environnement carcéral (3). Le recours aux prisonniers date d'avant l'ère Persique (2,3). ...
... Bien que les médecins et les chercheurs soient aujourd'hui plus 'avisés' des droits des personnes incarcérées, la réalité est que la recherche médicale avait depuis toujours su tirer 'profit' de l'environnement carcéral (3). Le recours aux prisonniers date d'avant l'ère Persique (2,3). Dans l'empire Romain, les médecins se servaient des prisonniers de guerre pour confectionner et tester de nouveaux poisons (3). ...
he exploitation of prisoners in medical research is an ancient phenomenon. However, the history of the XXth century was marked by major
events that reached the peak of horror during the second world war. Although the collective mind has remembered the outrages of the Nazi
regime, the truth is that these practices were adopted by the majority of the military powers of that time, and continued after the end of the war.
This history note is the first in a series that aims to review the circumstances and implications of these dark moments in the history of medical
research in order to pay tribute to the countless victims who paid with their lives for «scientific progress» and to understand the reasons for
current ethical considerations in biomedical experimentation on persons deprived of liberty
... Recommendations for future research must consider the unique challenges posed when seeking to conduct ethical research with incarcerated transgender populations. For example, autonomous decision-making, widely recognized as a necessary condition for informed consent, may not be achievable in a prison or jail where well-being is often contingent on conformity to behavioral standards and obedience toward authority (68). Similarly, ensuring privacy and confidentiality can be challenging in correctional settings (68,69), especially when inmate supervision is required. ...
... For example, autonomous decision-making, widely recognized as a necessary condition for informed consent, may not be achievable in a prison or jail where well-being is often contingent on conformity to behavioral standards and obedience toward authority (68). Similarly, ensuring privacy and confidentiality can be challenging in correctional settings (68,69), especially when inmate supervision is required. These barriers may be amplified for transgender people who are multiply marginalized, particularly when asked to participate in research about heavily stigmatized topics such as HIV and sexual behavior. ...
... These barriers may be amplified for transgender people who are multiply marginalized, particularly when asked to participate in research about heavily stigmatized topics such as HIV and sexual behavior. Despite the existence of several ethical and legal standards for research with incarcerated populations, (68,70,71), the ethical concerns noted in the present review have implications for research rigor, particularly the effect of social desirability bias on data validity. As noted by the Institute of Medicine (71), these concerns should not deter research with incarcerated groups, especially when research confers health-related benefits. ...
Transgender people experience a disproportionate burden of human immunodeficiency virus (HIV) and incarceration. Discrimination, victimization, poverty, and poor mental health drive vulnerability to HIV and related infections, as well as risk of arrest, detention, and incarceration. In this paper, we systematically review published data on HIV, sexually transmitted infections, viral hepatitis, and tuberculosis among incarcerated transgender people; describe potential structural determinants of HIV risk and transmission; identify gaps in the literature; and make recommendations for research and interventions to address this neglected population. We found that HIV and related infections among incarcerated transgender people have received little attention in the epidemiologic literature. The limited data available, which date from 1992, demonstrate high prevalence of HIV and sexually transmitted infections in this population internationally. Transgender people who had not had genital surgery were typically placed in jails and prisons corresponding to birth-assigned sex rather than gender identity. Once incarcerated, they routinely faced harassment, physical abuse, and sexual violence from inmates and staff and denial of access to medically necessary gender-affirming therapies. More HIV research with incarcerated transgender populations is urgently needed to inform correctional policy change that centers human rights and structural interventions, such as stigma reduction, pre-arrest diversion, and access to HIV prevention methods and gender-affirming care during incarceration.
... 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. ...
... Some researchers think that the pendulum has swung so far that prisoners are overprotected as a subject group with the unanticipated result of actually discouraging their participation in studies that have critical implications for their welfare (Moser et al., 2004). Others point out lingering limitations in human subjects protection for prisoners and for all groups for which the ability to make decisions freely might be questionable (Hoffman, Schwartz, & DeRenzo, 2000;Kalmbach & Lyons, 2003). ...
... In addition, the option to apply for a certificate of confidentiality that provides a researcher with the right to resist most legal requests for disclosure of subject information was exercised. Although the 45 CFR 46 protections have been described as "exhaustive" (Kalmbach & Lyons, 2003), a researcher must still confront additional concerns in day-to-day implementation of research. The broader ethical principles articulated in the Belmont Report (NCPHSBBR, 1979) provide the guidance needed to address ongoing issues in these complex human research situations. ...
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.
... Obtaining approval from the researchers' academic institution before submitting the proposal to the correctional facility's review board can help reassure the correctional facility that the proposal has been thoroughly examined. 13 The academic IRB will have special additional forms that the principal investigator must complete and attach to the research proposal. These forms are concerned with prisoners' status as a designated vulnerable population. ...
... The IRBs are also charged with ensuring that the magnitude of risk posed to a prisoner is at no greater level of risk than a nonprisoner would be willing to assume. 13 The correctional facility's review board will be interested in how the participants' rights will be protected as well as in making sure that the rules of the correctional facility will be respected. Of particular interest will be the process of obtaining and documenting informed consent and the possibility of posing any physical or psychosocial harm. ...
Given the increasing rate of women entering correctional facilities and the health disparities that exist between incarcerated women and women in the general population, it is troubling that so little research has been conducted with this vulnerable population. Reasons for this gap may be due to a lack of knowledge about this population, the overwhelming range of problems incarcerated women face, or assuming that the requisites for conducting research in prisons is insurmountable. The purpose of this presentation is to provide novice and experienced researchers new to prison research with practical information that may help them navigate potential institutional obstacles. Areas of information that will be addressed include: obtaining IRB approval, gaining entry, procedures, rules and regulations in prisons, recruitment and retention of participants, and data collection. This discussion is drawn from the two authors' combined 18 years of experience conducting research in two different women's correctional facilities, one in the Northeast and one in the Southwest region of the United States. Knowing what to expect ahead of time and working collaboratively with other researchers from diverse professional backgrounds will potentially increase the amount of research in this field. A concerted research effort that focuses on women in prison may lead to reformative policies and give voice to these women.
... 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. ...
... The challenges of conducting research in corrections have been well documented (Brewer-Smyth, 2008;Kalmbach & Lyons, 2003;Quina et al., 2007) and the need for developing a research infrastructure has been duly noted (Magaletta et al., 2007;Trestman, 2005). Simply documenting the concerns, however, does not bring us any closer to conducting applied research and implementing evidence-based practices to provide effective treatment to inmates. ...
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.
... Some examples of unethical research practices among prisoners include taking advantage of the unequal power distribution (e.g., prisoners' inability to refuse participation in studies), and a failure to protect prisoners' right to confidentiality and anonymity (Silva et al., 2017). To protect prisoners from exploitation, in the last few decades, there has been a closer monitoring and regulation of behavioral research in correctional settings (Kalmbach & Lyons, 2003). Although there are published ethical guidelines for conducting research and clinical work with prisoners (e.g., American Association for Correctional Psychology, 1999;Code of Federal Regulations, 2018;Indian Council of Medical Research, 2017;Office for Human Research Protection, 2003), the structural incapability of implementing these guidelines and the diversity within communities makes it difficult to implement a universal protocol across prisons (Marshall, 2007;Shaw et al., 2014). ...
Although ethical and methodological challenges of conducting research with vulnerable populations are widely acknowledged, there are fewer discussions on the unique difficulties encountered by researchers while working with prisoners sentenced to death and their families. This paper presents the reflective accounts of two researchers’ fieldwork experience, highlighting the ethical concerns and methodological challenges encountered while conducting an interdisciplinary research project on the mental health of prisoners sentenced to death and their families in India. Specifically, we discuss challenges faced during sampling of participants (prisoners and families), obtaining informed consent, confidentiality and right to anonymity, role confusion and conflict of interest, potential risks and benefits to research participants, and personal biases of researchers. We also provide suggestions for future researchers who wish to conduct research in this area and for policy makers to work toward minimizing the stigmatization and oppression faced by this community. Implications for research, clinical work, education, and training of mental health professionals are discussed.
... The involuntary and restrictive nature of incarceration makes it imperative for investigators to be attuned to possible threats to conducting research ethicallyparticularly given the severe abuse of incarcerated persons in past research. 9 Maximizing autonomy and minimizing the potential for coercion is critical; coercion is particularly important to consider when determining financial incentives and recruitment practices. Investigators should also take care that study materials are written at an appropriate reading level (typically between the fourth and sixth grade) and accurately describe what, if any, information from the study may be shared with carceral staff. ...
Although the number of people incarcerated in the United States has grown dramatically, research on how incarceration affects individuals and the communities they return to has lagged behind. This may be because of the unique challenges of doing research within carceral systems and the relatively small number of investigators who are competent to undertake these efforts.
We provide a primer for investigators with limited experience conducting research in carceral settings and highlight considerations and recommendations that may aid those conducting health research with incarcerated persons. We follow this with an illustrative case example exemplifying how the considerations apply to recent health research that our team conducted on mental illness prevalence in a large regional jail.
Understanding how to effectively conduct research with criminal justice populations and systems is the first step in beginning to understand the effects of mass incarceration as a driver of health disparities and health inequity.
... For A fuller discussion of field study methods, see Ahrens and Chapman (2006) and Baxter and Chua (1998). Kalmbach and Lyons (2003) note, behavioural science research rests fundamentally on four tenets: independent review (by disinterested parties); informed consent by participants; minimisation of harm; and privacy and confidentiality. As the authors note, these ideals require special attention when dealing with special populations who may be more vulnerable, such as prisoners. ...
Purpose - This article aims to review popular frameworks used to examine fraud and earmarks three areas where there is considerable scope for academic research to guide and inform important debates within organisations and regulatory bodies. Design/methodology/approach - The article reviews published fraud research in the fields of auditing and forensic accounting, focusing on the development of the dominant framework in accounting and fraud examination, the fraud triangle. From this review, specific avenues for future research are identified. Findings - Three under-researched issues are identified: rationalisation of fraudulent behaviours by offenders; the nature of collusion in fraud; and regulatory attempts to promote whistle-blowing. These topics highlight the perspective of those directly involved in fraud and draw together issues that have interested researchersin other disciplines for decades with matters that are atthe heart of contemporary financial management across the globe. Originality/value - In spite of the profound economic and reputational impact of fraud, the research in accounting remains fragmented and emergent. This review identifies avenues offering scope to bridge the divide between academia and practice.
... For A fuller discussion of field study methods, see Ahrens and Chapman (2006) and Baxter and Chua (1998). Kalmbach and Lyons (2003) note, behavioural science research rests fundamentally on four tenets: independent review (by disinterested parties); informed consent by participants; minimisation of harm; and privacy and confidentiality. As the authors note, these ideals require special attention when dealing with special populations who may be more vulnerable, such as prisoners. ...
Purpose: This article reviews popular frameworks used to examine fraud and earmarks three areas where there is considerable scope for academic research to guide and inform important debates within organisations and regulatory bodies. Design/methodology/approach: The article reviews published fraud research in the fields of auditing and forensic accounting, focusing on the development of the dominant framework in accounting and fraud examination, the fraud triangle. From this review, specific avenues for future research are identified. Findings: Three under-researched issues are identified: (1) rationalisation of fraudulent behaviours by offenders; (2) the nature of collusion in fraud; and (3) regulatory attempts to promote whistle-blowing. These topics highlight the perspective of those directly involved in fraud and draw together issues that have interested researchers in other disciplines for decades with matters that are at the heart of contemporary financial management across the globe.Originality/value: In spite of the profound economic and reputational impact of fraud, research in accounting remains fragmented and emergent. This review identifies avenues offering scope to bridge the divide between academia and practice.
... 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.
... This resulted in some extreme human rights abuse such as introducing diseases to otherwise healthy individuals, for example, for the purposes of experimentation by the pharmaceutical industry (Hornblum, 1997). In addition, researchers in the past have been guilty of failing to ensure the participation by prisoners in research was truly voluntary and that confidentiality was maintained (Appelbaum, 2008;Hornblum, 1997;Kalmbach & Lyons, 2003). The responsibility of the researcher is to protect subjects from any harm that may result from participation in the research (Loxley, Hawks, & Bevan, 1992). ...
his thesis explores the prison-to-community transition experience after short-term incarceration, from the perspective of men with co-occurring mental illness and substance use disorder in Queensland, Australia. A specific focus was to examine the impact of systems and structures on the individual experience of transition. Prior research has established that people with co-occurring mental illness and substance use are overrepresented in the Australian prisoner population. It is also known that transition from prison to community for the general custodial population is a time of vulnerability, with increased risk of substance use, homelessness, unemployment, reincarceration and post-release death. All of these risks are compounded for prisoners with co-occurring disorders who are also at risk of a range of poor criminal justice outcomes and losing contact with mental health services after release. Review of the literature indicates a tendency for research to focus on recidivism as an outcome and emphasise either individual risk behaviour or social and structural factors influencing prison-to-community transition. Interventions during transition for the current population have traditionally been based on the criminalisation hypothesis, with a focus on increased provision of mental health services in prison and an emphasis on continuity of care in the community. There is a growing recognition in the international literature that the issues are much broader than mental illness; however, there is a lack of clarity as to how to respond to the complex needs of this population. Research exploring the perspective of men with co-occurring severe mental illness and substance use disorder during their prison-to-community transition experience has rarely been undertaken.
The conceptual framework developed for this study shifts the emphasis away from recidivism towards recovery and wellbeing through a lens of individual action, but only in the context of the potential for systems and structures to impact on the ability of individuals to exercise agency. A qualitative method was used comprising repeat in-depth interviews with 18 men: within 1 month prior to leaving prison, within 2 weeks post-release and at 3 months post-release. Three themes characterised the transition experience of participants: “hoping against hope”; “adrift in freedom”; and “the slippery slope”. Participants reported leaving the predictable and routine life in prison where they hoped for a better life after release, to an uncertain, unstable and isolated environment in the community, eventually sliding into drug use, chaos and despair. The risk environment framework (Rhodes, 2009) and structuration theory (Giddens, 1984) were employed to understand how participants were caught in a complex dynamic between their individual risk behaviour and broader structural risk environments. This thesis proposes that a web of interrelated factors contributed to participants in the study as “ambivalent agents” who were suspended between the two worlds of prison and community, with a sense of “non-belonging” in either world. They negotiated multiple and competing identities and were ultimately set up to fail in their hope for a normal life in the community by the “structuration” of risk during transition. The findings in this study support previous research that prison mental health services alone are inadequate to meet the needs of this population. There is a need for the review of parole practices for this population, with an emphasis on prevention of incarceration related to non-offending behaviour. In addition, a focus on the provision of comprehensive interventions during prison-to-community transition, such as supported accommodation, assisted employment and other individually tailored social supports, is indicated. These interventions, in combination with a focus on flow through integrated treatment services targeting the needs of short-term prisoners with co-occurring disorders may facilitate recovery and wellbeing in this population, improve continuity of mental health care on return to the community, as well as address criminal justice outcomes. These interventions should be planned as a whole of government response, framed by a mental health recovery approach that fosters belief in the individual for recovery, as well as utilising a collaborative focus on risk in terms of both “a risk” and “at risk” identities.
... For A fuller discussion of field study methods, see Ahrens and Chapman (2006) and Baxter and Chua (1998). Kalmbach and Lyons (2003) note, behavioural science research rests fundamentally on four tenets: independent review (by disinterested parties); informed consent by participants; minimisation of harm; and privacy and confidentiality. As the authors note, these ideals require special attention when dealing with special populations who may be more vulnerable, such as prisoners. ...
Purpose
– This article aims to review popular frameworks used to examine fraud and earmarks three areas where there is considerable scope for academic research to guide and inform important debates within organisations and regulatory bodies.
Design/methodology/approach
– The article reviews published fraud research in the fields of auditing and forensic accounting, focusing on the development of the dominant framework in accounting and fraud examination, the fraud triangle. From this review, specific avenues for future research are identified.
Findings
– Three under-researched issues are identified: rationalisation of fraudulent behaviours by offenders; the nature of collusion in fraud; and regulatory attempts to promote whistle-blowing. These topics highlight the perspective of those directly involved in fraud and draw together issues that have interested researchers in other disciplines for decades with matters that are at the heart of contemporary financial management across the globe.
Originality/value
– In spite of the profound economic and reputational impact of fraud, the research in accounting remains fragmented and emergent. This review identifies avenues offering scope to bridge the divide between academia and practice.
... Protective regulations to address this vulnerability are encapsulated in Subpart C (45 CFR 46, Subpart C; Protection of Human Subjects, U.S. Department of Health and Human Services, 2009) and include several requirements, including the need for a prisoner representative on all IRB reviews of correctional research protocols and restrictions on the types of research in which prisoners may participate. These added protections, along with other factors related to the nature of correctional settings, have unintentionally created barriers to conducting research with incarcerated populations, and have resulted in limitations in the access to research and its benefits for individuals in correctional settings (Brewer-Smyth, 2008;Hammett & Dubler, 1990;Harris, 2001;IOM, 2006;Kalmbach & Lyons, 2003). ...
Being disproportionately represented by individuals living with HIV/AIDS, correctional facilities are an important venue for potentially invaluable HIV/AIDS epidemiological and intervention research. However, unique ethical, regulatory, and environmental challenges exist in these settings that have limited the amount and scope of research. We surveyed 760 HIV/AIDS researchers, and IRB chairs, members, and prisoner representatives to identify areas in which additional training might ameliorate these challenges. Most commonly identified training needs related to federal regulations, ethics (confidentiality, protection for participants/researchers, coercion, privacy, informed consent, and general ethics), and issues specific to the environment (culture of the correctional setting; general knowledge of correctional systems; and correctional environments, policies, and procedures). Bolstering availability of training on the challenges of conducting HIV/AIDS research in correctional settings is a crucial step toward increasing research that will yield significant benefits to incarcerated individuals and society as a whole.
... Strong advocacy by and for people with HIV/AIDS has redefined aspects of the interaction with researchers and the ethical bases for ensuring opportunities to benefit from available treatments (Zion 2005). Lessons may also be learned from the ethical challenges inherent in research with prisoners, where voluntary consent is constrained by total dependence on those providing care and services (Kalmbach et al. 2003). Researchers working with conflict-affected communities should study these experiences of community engagement and agency in the research process to determine what transferable or adaptable lessons may be present. ...
Issues of power and consent, confidentiality, trust, and benefit, risks to researchers, and potential harm to participants, are all contested when working with different cultures and within environments marked by violence and insecurity. Difficulty resolving these dilemmas may paralyse ethics committees, may fail to give the guidance sought by researchers, and will not help populations who are among the world's most vulnerable. Even where efforts are made to respond to ethical guidelines and to improve practice, considerable impediments are present in many developing countries, including lack of formal ethical review structures in unstable settings, lack of required skills, limited political and institutional recognition of ethical issues, competing interests, and limitations in clinical and research practice (Elsayed 200412.
Elsayed , D. 2004. The Current Situation of Health Research and Ethics in Sudan. Developing World Bioethics, 4: 154–159. View all references, Macklin 200434.
Macklin , R. 2004. Double Standards in Medical Research in Developing Countries, Cambridge: Cambridge University Press. [CrossRef]View all references). In conflict settings, these limitations are more marked, and the responsibilities of the researcher for ethical practice are greater, but the mechanisms for oversight are weaker. Moreover, the constant focus on vulnerabilities and problems, and the often almost total lack of recognition of strengths and resilience, can further disempower already exploited groups and individuals. The capacity of refugees and communities in conflict to take an active role in the research process is seldom acknowledged, and undermines the potential for more innovative research which can help generate the evidence for better policy and practice.
... Furthermore, the institutional review board approval process for research in prisons can be prohibitively arduous [30]. The patchwork nature of regulations, as well as an ethical backlash against a time when prisoners were used as populations of convenience, contributes to the current paucity of research in prisons [31]. ...
An estimated 15%–40% of incarcerated persons in the United States are infected with hepatitis C virus (HCV). Approximately
1.4 million HCV-infected persons pass through the corrections system annually, accounting for one-third of the total number
of HCV-infected persons in the United States. This high prevalence of HCV infection is due to the substantial increase in
drug-related arrests over the past 2 decades. Although the hepatitis C epidemic in the corrections system may be viewed as
a burden on correctional health systems, it is an important public health opportunity and an obligation. Research on the implementation
of cost-effective HCV screening, prevention, and treatment programs among incarcerated persons is essential. Testing, education,
and, when appropriate, treatment of prisoners should be a cornerstone of the public health response to the hepatitis C epidemic
in the United States.
It is common knowledge that the human rights of prisoners are often not respected. But can guidelines help to prevent such violations? In this chapter we explore this topic and examine how to help healthcare professionals navigate the conflicts of interest that can make it difficult to ensure that patients’ rights are respected. To do so, we explain the role of guidelines – both clinical and ethical – for non-incarcerated patients outside prisons and for those within prisons. Within such institutions, the main challenges are ensuring that patients receive healthcare that is equivalent to that available outside prison, and ensuring patient autonomy in healthcare decisions. Despite the good practices set out in many national and international guidelines, physicians (both inside and outside prisons) are often unfamiliar with this guidance. Both greater awareness of existing guidelines and development of further guidelines are required.
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.
Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users.
Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions.
The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.
Over 20 million Americans are currently or have been incarcerated. Most are from medically underserved populations; 1 in 3 African American men and 1 in 6 Latino men born in 2001 are projected to go to prison during their lifetime. The amount of funding from the National Institutes of Health (NIH) to understand and improve the health of persons involved with the criminal justice system is unknown.
To describe NIH funding for research on the health and health care needs of criminal justice-involved persons.
Review of NIH grants (2008-2012) in the RePORT (Research Portfolio Online Reporting Tools) database.
U.S. criminal justice system.
Criminal justice-involved persons participating in NIH-funded clinical research.
NIH research and training grants awarded, by number, type, research area, institute or center, and dollar amount.
Of more than 250 000 NIH-funded grants, 180 (<0.1%) focused on criminal justice health research. The 3 most common foci were substance use or HIV (64%), mental health (11%), and juvenile health (8%). The National Institute on Drug Abuse and the National Institute of Mental Health funded 78% of all grants. In 2012, the NIH invested $40.9 million in criminal justice health research, or 1.5% of the $2.7 billion health disparities budget for that year.
NIH-supported research that did not explicitly include current or former prisoners but may have relevance to criminal justice health was not included.
Federal funding for research focused on understanding and improving the health of criminal justice-involved persons is small, even compared with the NIH's overall investment in health disparities research. The NIH is well-positioned to transform the care of current and former prisoners by investing in this critical yet overlooked research area.
National Institute on Aging, National Institutes of Health; Tideswell at UCSF.
Housing a large number of individuals living with or at risk for HIV/AIDS, correctional settings have considerable potential for epidemiological, prevention, and treatment research. However, federal regulations and institutional challenges have limited the extent and types of such research with prisoners. This study examines the degree to which HIV/AIDS correctional researchers report greater challenges than do their noncorrectional counterparts. Results indicate that correctional researchers reported significantly more frequent challenges than those in noncorrectional settings, even after controlling for experience, with the dominant difference related to challenges due to the research setting. These findings add empirical data and support previous research in the field; however, additional research should include correctional staff and incarcerated individuals, and explore whether these differences extend to other research topics.
© The Author(s) 2015.
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 March 2007, a national work group met to review the state of mental health research in correctional settings. Participants identified gaps in current knowledge and topics most in need of further research. The discussion of important subjects for further investigation focused on five broad, and often overlapping, content areas: epidemiology, research methodology, functional behaviors, efficacy of interventions, and safety. Barriers to conducting correctional research that the group identified included funding difficulties, resistance from stakeholders, restricted access to subjects, limited information technology, ethical concerns, and institutional review board (IRB) requirements. Potential strategies for overcoming these barriers, such as setting appropriate priorities, easing the burden of research protocols, identifying key collaborators, and facilitating the IRB-approval process, were also discussed.
Through the mid-1970s, most new drug clinical trials were conducted in America's jails and prisons. Due to the extensive human rights violations acknowledged at that time, laws were enacted that essentially brought corrections-based research to a halt. The Code of Federal Regulations, 45 CFR 46 subpart C, specifies the limitations upon research with correctional populations that are currently in place. These guidelines both informed the ethical conduct of research and arguably created a significant problem in today's correctional environment - prisoners are under-studied. We know far less about the health and health care needs of people under conditions of incarceration than those in the community. Linked with the extraordinary explosion over the last 20years in the population of America's jails and prisons and with a disproportionate number of mentally ill inmates, inadequate knowledge currently exists to guide clinical decision-making. Over the last decade, a gradually growing body of work, ethically developed and clinically focused, has been evolving. This article presents the challenges of conducting correctional research in health and healthcare delivery. Legal, ethical, and pragmatic barriers are reviewed. Further, practical solutions that allow meaningful research to be conducted are presented. Such research can create a foundation for developing both public policy and clinical practice.
Background: We explored ethical challenges in conducting psychiatric or mental health research with incarcerated people. Methods: Semistructured interviews were conducted with 87 people who were researchers; institutional review board (IRB) chairs, members, and prisoner representatives; research ethicists; and prison administrators with experience in and knowledge about the conduct of research in correctional settings. NVivo 9.0 was used to conduct grounded theory analysis of responses to the question: “What would you say are the top three ethical challenges to conducting psychiatric or mental health research with incarcerated people?” Results: Key informants identified autonomy and consent, balancing the potential for direct benefit with the risk for harm, and access to and standards of psychiatric care in correctional facilities as the three most important ethical challenges. The characteristics of incarcerated individuals, the nature of correctional systems, and federal regulations for oversight of prisoner research provided the contextual framework for these challenges. Conclusions: Findings from this study provide insights into ethical challenges affecting the conduct of psychiatric and mental health research with incarcerated individuals. Given the potential benefit to incarcerated people from access to participation in research, these ethical challenges should be addressed.
To explore ethical challenges in the conduct and oversight of HIV/AIDS research in correctional settings, 92 researchers; IRB chairs, members, and prisoner representatives; research ethicists; and prison administrators were asked the question, "If you had to pick the single most important ethical challenge to HIV/AIDS research with incarcerated people, what would it be?" Data were analyzed with NVivo 8.0 software and revealed that key concerns were confidentiality and privacy; autonomy and informed consent; and justice and access. Characteristics of people who are incarcerated, the nature of correctional institutions, and state and federal regulatory issues contributed to these challenges. These findings provide insights into ethical challenges that affect the conduct of HIV/AIDS research in correctional settings.
While most people make staying out of jail and prison a priority, a growing number of researchers are eager to get into correctional
facilities in order to study the criminal justice system, the causes and consequences of incarceration, and the role of corrections
in our society. For health researchers and their collaborators, the audience for this chapter, correctional facilities offer
several unique advantages: a population at high risk of many health problems including infectious and chronic diseases, substance
abuse, and mental health problems; social and physical environments that can enhance or impede well-being; a setting that
is a focal point for the class, racial/ethnic, and gender differences that divide the United States; a site where health and
mental health services and prevention programs are offered and can be evaluated; a controlled environment for administration
of treatments such as directly observed therapy for tuberculosis; and a stopping point in the cycle of incarceration and reentry
that so profoundly affects community well-being.
Despite the healthcare needs of an increasing number of incarcerated women in the United States, few researchers access this underserved population. The authors provide practical information to help novice researchers navigate potential institutional challenges including obtaining institutional review board approval, gaining entry, complying with rules and regulations, recruiting and retaining participants, and collecting data.
The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki.
Although numbers of prison inmates are increasing rapidly, limited research addresses health-related conditions prevalent in prisons. Compelling reasons exist for prison research to address high rates of psychiatric, neurological, and other health-related conditions that may precipitate or result from incarceration, high-risk behaviors, infectious disease transmission, traumatic brain injuries, and other issues related to incarceration. Prison research is critical because inmates are frequently re-incarcerated and released, posing potential risks to themselves and the community. The purpose of this article is to provide a pragmatic overview of ethical, regulatory, and investigator considerations to facilitate critically needed research with vulnerable prison populations.
In When Medicine Went Mad, one of the nation's leading bioethicists-and an extraordinary panel of experts and concentration camp survivors-examine problems first raised by Nazi medical experimentation that remain difficult and relevant even today. The importance of these issues to contemporary bioethical disputes-particularly in the thorny areas of medical genetics, human experimentation, and euthanasia-are explored in detail and with sensitivity.
Courage is required of an individual who has been touched by the Holocaust, as was Arthur L. Caplan, PhD, to write about it. (His father, Sidney, was among the American troops that liberated Dachau.) Dr Caplan, the prominent director of the Center for Biomedical Ethics at the University of Minnesota, organized a conference in May 1989, which examined the bioethical implications of the Holocaust. The articles published in his book represent the product of that meeting.Countless books have been written about the Holocaust by individuals as divergent as revisionist historians who wish to deny its existence and victims who bear the scars of this monstrous experience. This book is divided in a very readable fashion into five main segments: "Testimonies," "Medicine, Bioethics, and Nazism," "The Use of Information From Nazi 'Experiments,'" "Medical Killing and Euthanasia: Then and Now," and "The Abuse of Medicine and the Legacy of the Holocaust."
Presents the American Psychological Association's Ethics Code. The document consists of an introduction, a preamble, 6 general principles, and specific standards and rules for conduct by psychologists. Topics covered by the standards include (1) General Standards, (2) Evaluation, Assessment or Intervention, (3) Advertising and Other Public Statements, (4) Therapy, (5) Privacy and Confidentiality, (6) Teaching, Training Supervision, Research, and Publishing, (7) Forensic Activities, and (8) Resolving Ethical Issues. (0 ref) (PsycINFO Database Record (c) 2012 APA, all rights reserved)
The purpose of this book is to describe and explain methodology and research design in clinical psychology. The book elaborates the methods of conducting research and the broad range of practices, procedures, and designs for developing a sound knowledge base. It also focuses on the underpinnings, rationale, and purposes of these practices. (PsycINFO Database Record (c) 2012 APA, all rights reserved)
Report and Recommendations of the National Bioethics Advisory Commission regarding the federal oversight system of human research participants. The National Bioethics Advisory Commission examined the current state of human research subject oversight by the federal government. The Commission concluded that the federal oversight system should protect the rights and welfare of human subjects participating in research whether it is publicly or privately sponsored.
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.
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