The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight
The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight
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DOI：
10.1002/hast.133
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发表时间：
2013-01-01
影响因子：
3.3
通讯作者：
Beauchamp, Tom L.
中科院分区：
文献类型：
--
作者：
Kass, Nancy E.;Faden, Ruth R.;Beauchamp, Tom L.
卫生保健环境中质量改进研究和比较有效性研究的兴起构成了医学研究所所谓的学习型卫生保健系统的目标的进步，在这个目标中，我们通过将知识开发和应用建立在卫生保健提供过程的每个阶段，使研究更接近临床实践。随着临床研究和临床实践越来越接近一个刻意整合的系统，两者之间的区别越来越模糊，尽管美国法规和研究伦理文献中的明显区别仍然存在。在20世纪70年代和之后的20年里，这种区分很有帮助：对于某些形式的研究，它阐明了哪些活动需要伦理监督。然而，与卫生保健密切结合的研究——特别是卫生服务研究——当时并不多见。这种情况已不复存在，监管和研究伦理需要改变，以适应新的格局。在本文中，我们认为概念、道德和经验问题围绕着我们可以而且应该在临床研究和临床实践之间划清界限的公认观点。我们从美国国家委员会报告和美国联邦法规中研究-实践区分的历史开始，然后对政策文件和学术文献中使用的研究的五种特征进行批判性评估，以试图在研究和实践之间做出明确的区分。我们挑战这些特征作为区分研究与实践的一种方式的清晰度和可持续性。我们认为，对研究与实践区分的公认观点导致某些情况下对患者权益的过度保护，而另一些情况下对患者权益的保护不足。我们认为，需要建立一个新的伦理基础，以促进可能造福患者的护理和研究，并提供监督，而不是基于研究和实践之间的区别，而是与这两个领域的风险和负担相称。
The rise of quality improvement research and comparative effectiveness research in health care settings constitutes progress toward the goal of what the Institute of Medicine has called a learning healthcare system, in which we are drawing research closer to clinical practice by building knowledge development and application into each stage of the healthcare delivery process. As clinical research and clinical practice move closer to a deliberately integrated system, the distinction between the two is increasingly blurred, although the sharp distinction in U.S. regulations and research ethics literature remains in place. In the 1970s and for two decades thereafter, this distinction was helpful: for some forms of research, it sheds light on which activities require ethical oversight. Research that is closely integrated with health carenotably, health delivery researchwas then uncommon, however. That is no longer the case, and regulations and research ethics need to change to accommodate the new landscape. In this paper, we argue that conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice. We start with the history of the research-practice distinction in the reports of a U.S. national commission and in U.S. federal regulations, and then offer a critical assessment of five characterizations of research that have been used in policy documents and the scholarly literature to try to make a sharp distinction between research and practice. We challenge the clarity and the tenability of these characterizations as a way of distinguishing research from practice. We argue that the received view of the research-practice distinction leads to overprotection of the rights and interests of patients in some cases and to underprotection in others. We contend that a new ethical foundation needs to be developed that facilitates both care and research likely to benefit patients, and that provides oversight that, rather than being based on a distinction between research and practice, is commensurate with risk and burden in both realms.