A plea for pragmatism in clinical research ethics

A plea for pragmatism in clinical research ethics
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DOI:
10.1080/15265160802166025
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发表时间:
2008-01-01
影响因子:
13.4
通讯作者:
Miller, Franklin G.
Miller, Franklin G.
中科院分区:
人文科学1区
文献类型:
--
作者:
Brendel, David H.;Miller, Franklin G.

文献摘要

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实用主义是临床研究伦理学的一种独特方法,可以指导生物伦理学家和机构审查委员会(IRB)成员努力平衡促进医学研究和保护参与其中的人类受试者的相互竞争的价值观。在定义了我们对临床研究伦理学中实用主义的理解之后,我们展示了一种务实的方法如何不仅为IRB的日常运作提供指导,而且还为政策标准的评估提供指导,例如在临床研究试验中为健康儿童提供可接受的风险。我们还展示了如何务实的考虑可能会影响有关使用欺骗在临床研究的辩论。最后,我们将展示如何采取务实的方法,将促进人类研究和保护人类受试者视为同等重要的价值观,有助于打破临床研究中科学与伦理之间的错误二分法。
Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.