Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel.
Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel.
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DOI：
10.1177/1740774515594362
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发表时间：
2015-12
期刊：
影响因子：
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通讯作者：
Forrest A
中科院分区：
文献类型：
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作者：
Lorell BH;Mikita JS;Anderson A;Hallinan ZP;Forrest A
知情同意是临床试验中保护受试者的基石。然而，越来越多的证据表明，美国需要改革知情同意程序。临床试验转型倡议对25名有经验的知情同意程序观察员进行了访谈，以确定限制因素和可行的改革建议。目前的做法往往未能履行在知情同意过程中告知潜在研究参与者的道德义务，这一点得到了广泛共识。最常见的一项建议是改革知情同意文件，这将影响联邦监管的临床研究的所有参与者。访谈还确定了机构审查委员会对临床研究审查进行改革的必要性，包括过渡到多地点试验的单一机构审查委员会。受访者提出的协商一致建议为知情同意程序的有意义的改变提供了一个框架。虽然一些拟议的变化对于快速实施是可行的，但其他一些变化，如知情同意文件的实质性改革，可能需要改变联邦法规。
Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed. The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionable recommendations for change. There was broad consensus that current practices often fail to meet the ethical obligation to inform potential research participants during the informed consent process. The most frequent single recommendation, which would affect all participants in federally regulated clinical research, was reform of the informed consent document. The interviews also identified the need for reform of clinical research review by institutional review boards, including transitioning to a single institutional review board for multi-site trials. The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations.