在知情同意文件上获得正确的签名

Clinical researcher (Alexandria, Va.) Pub Date : 2016-10-01 DOI:10.14524/CR-16-0018

Lindsay McNair, Patience Stevens, Glenn Veit

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引用次数: 0

摘要

在临床研究中，当研究人群包括有能力的成年人时，获得知情同意是简单的，但当某些参与者需要合法授权的代表(LARs)或公正的证人时，就变得复杂了。本文讨论了LARs和证人应该参与同意过程的情况，为什么这些问题被如此密切地审查的监管基础，以及研究文件如何促进协议审查。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Getting the Right Signatures on Informed Consent Documents

Obtaining informed consent in clinical research is straightforward when the study population includes capable adults, but becomes complex when certain participants require either legally authorized representatives (LARs) or impartial witnesses. This article discusses situations in which LARs and witnesses should participate in the consent process, the regulatory basis of why these issues are scrutinized so closely, and how the study documents can facilitate protocol review.

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Clinical researcher (Alexandria, Va.)

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