Legal aspects of ethics committees in biomedical research

被引:0
|
作者
Lippert, HD [1 ]
机构
[1] Univ Ulm Klinikum, Dept Legal Med, D-89081 Ulm, Germany
关键词
ethics committees; hospital ethics committees; biomedical research; clinical trial; drug; medical device; Helsinki Declaration; legal basis; Central ethics committee;
D O I
暂无
中图分类号
B82 [伦理学(道德学)];
学科分类号
摘要
In the late fifties, Institutional Review Boards (IRBs) were established in the United States (US), which was followed by ethics committees (ECs) also in Germany in the early seventies, especially in the field of clinical research at the universities. Later on, similar ECs of the German Medical Associations (Chambers of Physicians) were founded, The task of these bodies was to provide an ethical review of the (bio)medical research performed at their institutions tin US), or to review the research projects submitted by the Medical Associations' (Physicians' Chambers') members tin Germany). ECs' should review research projects concerning the scientific merits and ethical acceptability. The review should be multidisciplinary. The paper focuses on the legal basis for establishing ECs for the biomedical research in Germany.
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页码:63 / 70
页数:8
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