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      La investigación biomédica y conductual en prisiones. Claves para un cambio de marco normativo Translated title: La recerca biomèdica i conductual en presons. Claus per a un canvi de marc normatiu Translated title: Biomedical and behavioral research in prisons. Criteria for a legal reform in Spain

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          Abstract

          Resumen La investigación biomédica y conductual si bien se erige en una actividad fundamental de cara al desarrollo científico en áreas básicas para el bienestar de la humanidad, constituye una temática que plantea cuestiones éticas de calado, en particular, cuando la misma se lleva a cabo en poblaciones vulnerables. El presente trabajo se configura como un estudio de naturaleza bioética y jurídica acerca de la investigación biomédica y conductual en el entorno penitenciario que, partiendo de la normativa actualmente vigente en España, se adentra en las concepciones sostenidas en las últimas décadas a nivel comparado en materia de investigación en el medio carcelario, con el fin de establecer una serie de pautas que coadyuven a sentar criterios sólidos en dicha esfera.

          Translated abstract

          Resum La recerca biomèdica i conductual si bé s'erigeix en una activitat fonamental de cara al desenvolupament científic en àrees bàsiques per al benestar de la humanitat, constitueix una temàtica que planteja qüestions ètiques de calat, en particular, quan la mateixa es duu a terme en poblacions vulnerables. El present treball es configura com un estudi de naturalesa bioètica i jurídica sobre la recerca biomèdica i conductual en l'entorn penitenciari que, partint de la normativa actualment vigent a Espanya, s'endinsa en les concepcions sostingudes en les últimes dècades a nivell comparat en matèria de recerca en el mitjà carcerari, amb la finalitat d'establir una sèrie de pautes que coadjuvin a asseure criteris sòlids en aquesta esfera.

          Translated abstract

          Abstract Biomedical and behavioral research, despite being a fundamental activity so as to increase scientific knowledge in basic areas for the well-being of humanity, is a topic that raises ethical issues of importance, particularly, when the aforementioned experimentation is carried out in vulnerable populations. The present paper constitutes a study of bioethical and legal nature about biomedical and behavioral research on prisoners. To this end, regulations currently in force in Spain on this topic are analyzed. Additionally, the author reviews the different conceptions held in recent decades at international level related to research in the prison environment, in order to establish useful guidelines in this field.

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          Most cited references34

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          Coercion and informed consent in research involving prisoners.

          Prison-based research has been limited due to concern that prisoners may represent a vulnerable population secondary to possible coercion and limited capacity for voluntary informed consent. This study was designed to assess decisional capacity and susceptibility to coercion in prison research subjects. Subjects were 30 mentally ill prisoners and 30 healthy controls. The groups were compared on ability to provide informed consent to a hypothetical drug trial, susceptibility to possible coercion, neuropsychological functioning, and psychiatric symptoms. Results indicated that all controls and all but one of the prisoners demonstrated adequate capacity to consent to the hypothetical drug trial. However, when decisional capacity was measured quantitatively, prisoners performed significantly worse regarding two aspects of this ability. Regarding possible coercion, prisoners' main reasons for participating in research included avoiding boredom, meeting someone new, appearing cooperative in hopes of being treated better, and helping society. Neuropsychological functioning was strongly positively correlated with decisional capacity and negatively correlated with susceptibility to possible coercion, whereas psychiatric symptoms were only weakly correlated with these variables. In conclusion, a very high percentage of particularly vulnerable, mentally ill prisoners demonstrated adequate capacity to consent to research. Lower scores on a quantitative measure of decisional capacity suggest that extra care should be taken during the consent process when working with these subjects. The reasons prisoners gave for participating in our research indicated that the prison setting may have influenced their decision to participate, but that they were not actually coerced into doing so. Despite serious past incidents, ethicists will need to consider the possibility that prisoners have become an overprotected population.
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            Ethics in research involving prisoners

            Jörg Pont (2008)
            Research involving prisoners repeatedly went astray during the last century, culminating in the cruel medical experiments inside the Nazi concentration camps that gave rise to the Nuremberg Code. However, prisoners continued to become victims of scientific exploitation by the rapidly evolving biomedical research industry. The common roots of these abuses were the flawed philosophy that the needs of the society outweigh the needs of the individual and the researchers' view that prisoners are cheap, easy to motivate and stable research subjects. Prisoners are vulnerable to exploitation and abuse by research because their freedom for consent can easily be undermined, and because of learning disabilities, illiteracy and language barriers prevailing within prisoner populations. Therefore, penal laws of some countries supported by a number of internationally agreed documents prohibit research involving prisoners completely. However, prisoners must also be regarded as vulnerable to the specific health problems in prisons, e.g. transmissible diseases, mental disorders and suicide - problems that need to be addressed by research involving prisoners. Additionally, the participation of prisoner patients in research they directly can benefit from should be provided. Hence, it must be a common objective to find the right balance between protection from exploitation and access to research beneficial to prisoners.
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              Nuremberg and the Issue of Wartime Experiments on US Prisoners

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                Author and article information

                Journal
                bioetica
                Revista de Bioética y Derecho
                Rev. Bioética y Derecho
                Observatori de Bioètica i Dret - Cátedra UNESCO de Bioética (Barcelona, Barcelona, Spain )
                1886-5887
                2021
                : 52
                : 5-27
                Affiliations
                [1] Aragón orgnameUniversidad de Zaragoza orgdiv1Departamento de Derecho Penal, Filosofía del Derecho e historia del Derecho Spain
                Article
                S1886-58872021000200002 S1886-5887(21)00005200002
                10.1344/rbd2021.52.31089
                2ffbc268-ddfd-4795-b676-194eac4e829e

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

                History
                : 19 March 2020
                : 30 July 2020
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 35, Pages: 23
                Product

                SciELO Spain

                Categories
                Perspectivas Bioéticas

                biomedical and behavioral research,prison research,experimentació amb persones privades de llibertat,població vulnerable,assajos clínics,recerca biomèdica i conductual,recerca en presons,experimentación con personas privadas de libertad,población vulnerable,ensayos clínicos,investigación biomédica y conductual,investigación en prisiones,experimentation with persons deprived of liberty,vulnerable population,clinical trials

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