Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, GA.
Department of Hematology and Oncology, Emory University School of Medicine, Atlanta, GA.
Ann Emerg Med. 2015 Feb;65(2):162-71.e3. doi: 10.1016/j.annemergmed.2014.06.023. Epub 2014 Jul 29.
Federal regulations permitting an exception from informed consent for research in emergency settings require community consultation before study approval. Rates of acceptance of exception from informed consent in community consultation are often reported, but predictors of acceptance are not well understood, and investigators and institutional review boards struggle to interpret and use acceptance data.
We systematically reviewed empirical literature on community consultation for exception from informed consent trials in the PubMed, EMBASE, and Web of Science databases. We included peer-reviewed articles reporting acceptance data from community consultation for US exception from informed consent trials. Questions were categorized by enrollment focus (eg, personal enrollment versus more general exception from informed consent acceptance), and observed acceptance was compared across studies. We also compared potential predictors of acceptance, including demographic factors, consultation method, and target community.
Nine studies (total n=9,036 participants) were included in the final analysis. Personal acceptance of enrollment in the proposed exception from informed consent study ranged from 45% to 93% and clustered in the range of 64% to 80%. Acceptance of the exception from informed consent mechanism in general (without reference to personal inclusion) was lower (35% to 84%) than personal acceptance. The effect of demographic characteristics on acceptance was inconsistent, and meeting-based consultation methods were associated with greater acceptance than survey-based methods. Finally, acceptance rates varied substantially according to the phrasing of the question.
Personal acceptance clustered between 64% and 80%. This range may be informative for institutional review boards and investigators evaluating community consultation results. However, numerous factors affect acceptance, and there is a need for considerable caution against overreliance on acceptance data.
允许在紧急情况下的研究中免除知情同意的联邦法规要求在研究批准前进行社区咨询。社区咨询中免除知情同意例外的接受率通常会被报道，但接受率的预测因素尚不清楚，调查人员和机构审查委员会也在努力解释和使用接受数据。
我们系统地检索了 PubMed、EMBASE 和 Web of Science 数据库中关于例外情况下社区咨询的实证文献。我们纳入了报道美国例外情况下知情同意试验社区咨询接受数据的同行评审文章。问题按招募重点进行分类（例如，个人招募与更广泛的豁免知情同意接受），并比较了研究之间的观察接受率。我们还比较了潜在的接受预测因素，包括人口统计学因素、咨询方法和目标社区。
最终分析纳入了 9 项研究（共 9036 名参与者）。拟议的豁免知情同意研究中个人参与的接受率从 45%到 93%不等，集中在 64%到 80%之间。一般情况下（不涉及个人纳入）对豁免同意机制的接受率较低（35%到 84%）低于个人接受率。人口统计学特征对接受率的影响不一致，基于会议的咨询方法与基于调查的方法相比，与更高的接受率相关。最后，接受率根据问题的措辞有很大差异。
个人接受率集中在 64%到 80%之间。这一范围可能为机构审查委员会和评估社区咨询结果的调查人员提供信息。然而，许多因素会影响接受率，因此需要非常谨慎，避免过度依赖接受数据。
