Center for Policy and Research in Emergency Medicine, Oregon Health and Science University, Portland, OR 97239, USA.
Resuscitation. 2013 Jun;84(6):825-30. doi: 10.1016/j.resuscitation.2013.01.030. Epub 2013 Feb 8.
We sought to characterize persons who requested to opt out of an exception from informed consent (EFIC) cardiac arrest trial and their reasons for opting out.
At one site of a multi-site, out-of-hospital, cardiac arrest EFIC trial (September 2007 - June 2009), persons who did not want to participate in the study could request an opt-out "NO STUDY" bracelet to prevent trial enrollment. We surveyed all persons who requested a bracelet by phone interview, web or mail. Opt-out bracelets were advertised in all public communication about the study, including community consultation and public disclosure efforts. Survey questions included demographics, Likert scale items about attitudes toward the trial and research in general, plus open-ended questions. We used descriptive statistics for standardized questions and qualitative analysis to identify common themes from open-ended questions.
Sixty bracelets were requested by 50 individuals. Surveys were completed by 46 persons (92% response rate). Seventy percent of respondents agreed emergency research is important, but 87% objected to any research without consent. In the qualitative analysis, 5 overlapping themes emerged: questioning the ethics of EFIC research; concerns about how the study would impact end-of-life preferences; subjective emotions including sarcasm, anger, and allusions to past unethical research; negative reference to unrelated public health controversies; and objections to the study protocol based on misinformation.
A primary reason for opting out from this EFIC trial was opposition to all research without informed consent, despite stated support for emergency research. Understanding the demographics and beliefs of persons opting out may aid researchers planning EFIC studies and help provide clarity in future EFIC-related community education efforts.
我们试图描述那些要求退出知情同意例外（EFIC）心脏骤停试验的人及其退出的原因。
在一项多中心、院外心脏骤停 EFIC 试验的一个地点（2007 年 9 月至 2009 年 6 月），那些不想参与研究的人可以要求佩戴“不参与研究”的手镯以防止试验入组。我们通过电话访谈、网络或邮件对所有要求佩戴手镯的人进行了调查。退出手镯在研究的所有公共宣传中都有广告，包括社区咨询和公开披露工作。调查问题包括人口统计学、对试验和一般研究的态度的李克特量表项目，以及开放式问题。我们使用标准化问题的描述性统计和定性分析来识别开放式问题的常见主题。
50 名个人中有 60 人要求佩戴手镯。有 46 人（92%的回复率）完成了调查。70%的受访者同意紧急研究很重要，但 87%的人反对任何未经同意的研究。在定性分析中，出现了 5 个重叠的主题：质疑 EFIC 研究的伦理；对研究如何影响临终偏好的担忧；包括讽刺、愤怒和对过去不道德研究的暗示在内的主观情绪；对与无关的公共卫生争议的负面提及；以及基于错误信息对研究方案的反对。
退出这项 EFIC 试验的主要原因是反对任何未经知情同意的研究，尽管他们表示支持紧急研究。了解退出者的人口统计学和信仰可能有助于研究人员计划 EFIC 研究，并有助于在未来的 EFIC 相关社区教育工作中提供清晰度。
