加拿大研究伦理委员会的起源与发展,1960-1978

Fedir V. Razumenko
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引用次数: 0

摘要

第二次世界大战后,许多医学研究者继续他们雄心勃勃的实验干预作为合理化的,而不是正当的,试验。在加拿大,直到20世纪60年代,几乎没有任何法律上的禁止或规定的文书来规范临床实验。只有在制定临床研究方案并执行相关程序的过程中,才能正确地确立什么是伦理的。本文考察了在加拿大形成人类主体研究及其监管的历史轨迹。我认为,人类实验的公开披露、临床研究引起的法庭诉讼、生物医学研究法规的国际标准化以及临床试验的激增,导致了人类研究伦理的演变和规范准则的制定。在这一过程中,加拿大的医师研究人员采用了英国和美国关于进行道德上可接受的临床研究的指导方针,并根据当地情况对其进行了修改。第一个研究伦理委员会出现在加拿大大学附属教学医院,那里的调查实践揭示并澄清了人类研究伦理的变化意义。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Genesis and Development of Research Ethics Committees in Canada, 1960–1978
Following World War ii, many medical investigators continued their ambitious experimental interventions as rationalized, rather than justified, trials. In Canada, there were hardly any legally proscriptive or prescriptive instruments to regulate clinical experimentation until the 1960s. What was ethical could rightly be established only in the course of devising clinical research protocols and undertaking the procedures thereof. This paper examines an historical trajectory shaping human-subject research and its regulation in Canada. I argue that public disclosures of human experimentation, court litigation resulting from clinical research, international standardization of regulations on biomedical investigation, and the proliferation of clinical trials induced the evolution of human research ethics and the elaboration of guidelines to regulate it. In this process, Canadian physician-investigators adopted British and American guidelines on the conduct of ethically acceptable clinical research and modified them according to local circumstances. The first research ethics committees emerged at the Canadian university-affiliated teaching hospitals, where the investigative practices revealed and clarified the changing meanings of human research ethics.
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