Biomedical research involving prisoners : Ethical values and legal regulation. Commentary (original) (raw)
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Bioethics, 2000
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.
Experimentation on Prisoners: Persistent Dilemmas in Rights and Regulations
Cal. L. Rev., 2009
In 2006, the Institute of Medicine (IOM) released Ethical Considerations for Research Involving Prisoners. This federal report recommends long-overdue changes to the federal regulations that limit human subjects research on prisoners. First, the Report recommends more systematic and rigorous review of all experimentation involving prisoners and other persons supervised under any form of state or federal custody. Second, the Report recommends implementing a flexible, risk-benefit analysis to evaluate proposed experiments on prisoners, in place of current federal regulations, which categorically exclude prisoners from many forms of experimentation. This Comment represents the first careful legal analysis of the 2006 IOM Report’s recommendations regarding prisoner experimentation. Investigative research reveals that medical experimentation currently takes place in prisons across the United States, in spite of federal regulations implemented in the 1970s in order to curtail such experimentation. Furthermore, an analysis of modern standards regulating experimentation on prisoners, from across the world and throughout U.S. courts, suggests that current protections for U.S. prisoner subjects of experimentation are inadequate. This Comment argues that the calls for greater oversight of prisoner experimentation in the 2006 IOM Report represent a necessary and welcome reform. However, the suggested risk-benefit framework for evaluating future experimental protocols fails to account for current prison conditions and does not provide adequate protections to prisoners. Therefore, the federal government should not implement this risk-benefit framework.
Knowledge of Federal Regulations for Mental Health Research Involving Prisoners
AJOB Empirical Bioethics, 2014
Background-Given their vulnerability to coercion and exploitation, prisoners who participate in research are protected by Office for Human Research Protections (OHRP) regulations designed to ensure their safety and wellbeing. Knowledge of these regulations is essential for researchers who conduct and institutional review boards (IRBs) that oversee mental health research in correctional settings. Methods-We explored depth of knowledge of OHRP regulations by surveying a nationwide sample of: (1) mental health researchers who have conducted research in correctional settings; (2) mental health researchers who have conducted research in non-correctional settings; (3) IRB members who have overseen mental health research in correctional settings; (4) IRB members who have overseen mental health research in in non-correctional settings; and (5) IRB prisoner representatives. Participants responded to a 10-item knowledge questionnaire based on OHRP regulations. Results-1,256 participants provided usable data (44.9% response rate). Results revealed limited knowledge of OHRP regulations, with a mean across groups of 44.
Ethical issues in prison research: A risk/benefit analysis
Behavioral Sciences & the Law, 1987
Ethical issues in research are especially important when working with confined populations such as prisoners. One method that has been proposed to assist the decision-muking process is the use of a risklbeneft model. The informed estimation of the probable risks and potential benefts of any given research project should be used to determine the ethical justifibility of conducting the research. The present article enumerates the variables relevant to a risklbenefit analysis when conducting research in a prison setting. Also, the risks of undue influence and the limits of conjidentiality will be discussed. Finally, the appropriate use of informed consent will be discussed as a safeguard against these risks. James C. Overholser, Ph.D., is a Postdoctoral Fellow in Psychology at Brown University. The auihor would like io thank the co-ediior and an anonymous reviewer for ihe many helpful comments provided on an earlier version of ihis paper. Also, Linda Walion and Bridget Buckless should be commended for their persistence in acquiring the liieraiure cited in ihis ariicle.
PRISON RESEARCH: A BIOETHICS OR AN ETHICS ISSUE?
Acta Bioethica; 27 (1): 79-86, 2021
The hypothesis of reducing aggressiveness through transcranial direct current stimulation was recently tested on a cohort of inmates in Spain. The experiment, including 1.5 mA electric shocks, was an external research initiative that received the initial acquiescence of the carceral system. An alarm was raised at the time the research was published, encouraging the directorate of prisons to stop the ongoing replication of the experiment. Nevertheless, no (bio)ethics committee, in the universities or among bioethics experts, has questioned the research. In this think piece, we aim to again discuss some ethical approaches to these clinical interventions on crime. After its positivistic period, the field of criminology has been questioning the simple psychobiological approach to crime because of the reductionistic view of this phenomenon and its harmful consequences. Thus, we address academic experimentation under prison governance and the "re" roles of prisons. We argue that the minor disadvantages of such research, if performed with consent, could be positive if the research can minimize the harmfulness of prison itself; thus, penitentiary treatment and science should go together. Prison administrations, in addition to their duty to protect the individuals under their control from ethically biased research, must promote reintegration. We conclude that human rights are over criminal policy and science and that ethics are over narrower bioethics. Keywords: prison research, bioethics, ethics, prison governance, transcranial stimulation Investigación en prisión: ¿una cuestión de bioética o de ética? Resumen: La hipótesis de la reducción de la agresividad por medio de estimulaciones transcraneales ha sido recientemente testada sobre encarcelados en España. El experimento, que incluyó descargas eléctricas de 1.5mA, fue una iniciativa de investigadores externos que encontró la aquiescencia inicial del sistema carcelario. La alarma surgió en el momento en que se publicó la investigación, alentando a la dirección de las prisiones a detener la replicación del experimento. Sin embargo, hasta entonces, ningún comité encontró ningún inconveniente, ni en las universidades ni entre expertos en bioética. En este artículo de reflexión pretendemos argumentar algunos enfoques éticos de estas intervenciones clínicas sobre la delincuencia. De nuevo, ya que la criminología, después de su periodo positivista, ha venido cuestionado el mero enfoque psicobiológico de la delincuencia. Así, abordamos el experimento académico dentro de la gobernanza penitenciaria y los roles “re” de las prisiones. Argumentamos que no es tanto que no se pueda investigar con internos, sino que posibles inconvenientes de tales investigaciones puedan servir, bajo consentimiento, para minimizar los inconvenientes de la misma pena de prisión. La administración, además del deber de proteger a sus individuos de investigaciones éticamente sesgadas ha de fomentar la reintegración. Concluimos que los derechos humanos han de estar por encima de la política criminal y de la ciencia, y la ética por encima de una más limitada bioética. Palabras clave: investigación en prisiones, bioética, ética, gobernanza penitenciaria, estimulaciones transcraneales Investigação em contexto prisional: Um questão de bioética ou de ética? Resumo: A hipótese de diminuir a agressividade através da estimulação elétrica transcraniana foi recentemente testada num grupo de reclusos em Espanha. A experiência, que incluiu choques elétricos de 1,5mA, partiu de uma iniciativa de investigadores externos que encontraram a aquiescência no sistema prisional. O alarme surgiu no momento em que a investigação foi publicada, o que levou a direção administrativa das prisões a interromper a replicação do estudo. No entanto, até ao momento, nenhuma comissão de (bio)ética encontrou qualquer inconveniente, nem nas universidades, nem entre os especialistas em bioética. Com este artigo, pretendemos discutir algumas abordagens éticas dessas intervenções clínicas no crime. A criminologia tem vindo a questionar, após o seu período de investigação positivista, a abordagem psicobiológica do crime, devido à visão redutora desse fenómeno e das suas consequências nefastas. Assim, neste artigo, abordamos a experiência académica dentro da governança prisional e os fins da prisão. Concluímos que as pequenas desvantagens da investigação seriam positivas se pudessem, sob consentimento, minimizar os malefícios da própria prisão, o que significa que o tratamento penitenciário e a ciência deveriam andar ‘de mãos dadas’. A administração das prisões, para além do dever de proteger os indivíduos de estudos que acarretem problemas éticos, deve promover a reintegração. Concluímos, assim, que os direitos humanos estão acima da política e da ciência criminais, e a ética acima da bioética mais restrita. Palavras-chave: investigação prisional, bioética, ética, governança prisional, estimulação transcraniana
2017
Ethical considerations from prisoners in medical research: informed consent, free choice and risk/benefit analysis. Abstract Medical research with prisoners, classified by the Common Rule guidelines, as a vulnerable population, is an increasingly discussed topic within the field of bioethics due to the number of ethical challenges it poses despite the efforts conducted by governments from the 20th century to regulate and ensure that participants rights are respected. Among these challenges, the more pressing ones are informed consent in the context of questionable freedom of choice and confronted by a situation of uneven bargaining power between inmates as subjects and researchers. Due to the numerous scandals that have arisen due to unethical experimentation, new guidelines for research with prisoners are now enforced in a way that many experts consider crippling for the inmates. This paper will try to present an overview of the position of prisoners in medical research, the regulatory efforts made in recent history and will discuss the permissibility of research with inmates.