Randomization to standard and concise informed consent forms: Development of evidence-based consent practices
Randomization to standard and concise informed consent forms: Development of evidence-based consent practices
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DOI：
10.1016/j.cct.2012.04.005
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发表时间：
2012-09-01
影响因子：
2.2
通讯作者：
Grady, Christine
中科院分区：
文献类型：
--
作者：
Enama, Mary E.;Hu, Zonghui;Grady, Christine
背景：同意参与研究是进行伦理临床试验的重要组成部分。目前的同意做法很大程度上是政策驱动的。本研究旨在评估受试者对研究信息的理解和对同意书的满意度，这些受试者随机分为简明知情同意书或标准知情同意书，作为制定循证同意书实践的一种方法。 方法：在 NIH 临床中心参加两项 I 期研究性流感疫苗方案（VRC 306 和 VRC 307）的参与者 (N = 111) 被随机分配到两份 IRB 批准的同意书之一；标准形式或简明形式。简洁同意的字数平均减少 63%。同意过程的所有其他方面都是相同的。两项研究均在入组时和最后一次访视时完成有关研究和同意程序的调查问卷。 结果：使用简明同意书的受试者和使用标准长度同意书的受试者在理解程度方面得分相同（7 比 7，p = 0.79 和 20 比 21，p = 0.13），然而，趋势是简明同意书组报告感觉更了解情况。两组都认为同意书的长度和细节是适当的。 结论：将研究对象随机分配到不同长度的 IRB 批准的同意书作为制定基于证据的同意书实践的一种方法，导致研究理解或对同意书的满意度没有差异。简明的同意书可以在由训练有素的工作人员进行的同意过程中道德地使用，并在整个研究过程中提供讨论和教育的机会。由爱思唯尔公司出版
Background: Consent to participate in research is an important component of the conduct of ethical clinical trials. Current consent practices are largely policy-driven. This study was conducted to assess comprehension of study information and satisfaction with the consent form between subjects randomized to concise or to standard informed consent forms as one approach to developing evidence-based consent practices.Methods: Participants (N = 111) who enrolled into two Phase I investigational influenza vaccine protocols (VRC 306 and VRC 307) at the NIH Clinical Center were randomized to one of two IRB-approved consents; either a standard or concise form. Concise consents had an average of 63% fewer words. All other aspects of the consent process were the same. Questionnaires about the study and the consent process were completed at enrollment and at the last visit in both studies.Results: Subjects using concise consent forms scored as well as those using standard length consents in measures of comprehension (7 versus 7, p = 0.79 and 20 versus 21, p = 0.13), however, the trend was for the concise consent group to report feeling better informed. Both groups thought the length and detail of the consent form were appropriate.Conclusions: Randomization of study subjects to different length IRB-approved consent forms as one method for developing evidence-based consent practices, resulted in no differences in study comprehension or satisfaction with the consent form. A concise consent form may be used ethically in the context of a consent process conducted by well-trained staff with opportunities for discussion and education throughout the study. Published by Elsevier Inc.