Lad Pramod M, Dahl Rebecca
Human Subjects Protection Program, Children's Hospital Los Angeles, 4650 Sunset Boulevard, Mailstop #23, Los Angeles, CA, 90027, USA,
Sci Eng Ethics. 2014 Jun;20(2):469-79. doi: 10.1007/s11948-013-9461-4. Epub 2013 Aug 24.
Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.
对知情同意过程的审核是临床研究质量保证计划的关键要素。文献中尚未描述对此类审核的系统方法。在本文中，我们描述了审核的两个组成部分。第一个是对知情同意文件的审核，以核实是否符合联邦法规。第二个组成部分是对知情同意会议的审核，重点是实时审查知情同意关键要素的适当传达。质量衡量标准可能包括编制知情同意历史记录日志、伴随知情同意的注释、使用知情同意反馈工具以及使用机构调查来评估对知情同意过程的理解。
