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首页> 外文期刊>Bioethics >RESEARCH ON PRISONERS – A COMPARISON BETWEEN THE IOM COMMITTEE RECOMMENDATIONS (2006) AND EUROPEAN REGULATIONS
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RESEARCH ON PRISONERS – A COMPARISON BETWEEN THE IOM COMMITTEE RECOMMENDATIONS (2006) AND EUROPEAN REGULATIONS

机译：囚犯研究–国际移民组织委员会建议（2006年）与欧洲法规之间的比较

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ABSTRACTThe 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.
机译：摘要医学研究院（IOM）关于修订涉及研究的囚犯的DHHS法规的道德考量委员会于2006年发布了其报告。该委员会负责制定与囚犯进行研究的道德框架，并确定保障措施和条件确保对囚犯进行研究符合道德要求是必要的。 IOM报告中包含的建议在一些方面与当前的欧洲法规有所不同，其中一些限制性更强，有些限制性更小。例如，国际移民组织的报告建议将应参与生物医学研究的囚犯百分比限制为50％，这一限制在欧洲尚不存在。但是，该报告并没有特别建议不要对单个囚犯没有直接好处的研究：欧洲法规在这方面比国际移民组织委员会的建议更具限制性。最低风险的定义以及最低风险要求和辅助原则的拟议作用（只能在监狱中有效进行的研究）各不相同。国际移民组织的报告提出了一些深思熟虑的建议，这将有益于各地实施，例如关于囚犯的研究记录。欧洲法规为一些棘手的问题提供了务实的解决方案。总而言之，IOM委员会的报告代表了令人钦佩的努力，旨在解决美国联邦法规中有关囚犯研究的当前矛盾和缺陷（45 CFR 46 Subpart C）。尽管如此，在按照建议采取行动之前，美国监管机构可能会考虑重新考虑国际准则，例如国际医学科学组织理事会（CIOMS）和赫尔辛基宣言所发布的准则。

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