Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA
J Investig Med. 2020 Dec;68(8):1341-1348. doi: 10.1136/jim-2020-001481. Epub 2020 Oct 1.
The prevalence of randomized controlled trials (RCTs) performed without fully informed prospective consent from subjects is unknown. We performed this study to estimate the prevalence of high-impact RCTs performed without informed consent from all subjects and examine whether such trials are becoming more prevalent. We performed a systematic review of English-language RCTs published from 2014 through 2018 identified in Scopus and sorted to identify the top 100 most highly cited RCTs each year. Text search of title and abstract included terms randomized controlled or clinical trial and spelling variants thereof, and excluded metaanalyses and systematic reviews. We independently identified the most highly cited RCTs based on predefined criteria and negotiated to agreement, then independently performed keyword searches, read, abstracted and coded information regarding informed consent from each paper and again negotiated to agreement. No quality indicators were assessed. We planned descriptive qualitative analysis and appropriate quantitative analysis to examine the prevalence and characteristics of trials enrolling subjects with other than fully informed prospective consent. We find that 44 (8.8%, binomial exact 95% CI 6.5% to 11.6%) of 500 high-impact RCTs did not secure informed consent from at least some subjects. The prevalence of such trials did not change over the 5 years (OR=1.09, z=0.78, p=0.44). A majority (66%) of the trials involved emergency situations, and 40 of 44 (90.9%) of the trials involved emergency interventions, pragmatic designs, were cluster randomized, or a combination of these factors. A qualitative analysis explores the methods of and justifications for waiving informed consent in our sample of RCTs.
尚未完全知情的前瞻性同意的随机对照试验（RCT）的流行情况尚不清楚。我们进行了这项研究，以估计未获得所有受试者知情同意而进行的高影响力 RCT 的流行程度，并研究这种 RCT 是否变得更为普遍。我们对 Scopus 中 2014 年至 2018 年发表的英语 RCT 进行了系统回顾，并进行了排序，以确定每年引用最多的前 100 项 RCT。标题和摘要的文本搜索包括随机对照或临床试验的术语及其拼写变体，并排除荟萃分析和系统评价。我们根据预设标准独立确定了引用最多的 RCT，并进行了协商以达成一致，然后独立进行了关键词搜索，阅读、摘要和编码了每份论文中关于知情同意的信息，并再次进行了协商以达成一致。未评估质量指标。我们计划进行描述性定性分析和适当的定量分析，以研究纳入受试者的 RCT 的流行情况和特征，这些受试者没有获得完全知情的前瞻性同意。我们发现，在 500 项高影响力 RCT 中，有 44 项（8.8%，二项式精确 95%CI 6.5%至 11.6%）未获得至少部分受试者的知情同意。在这 5 年中，此类试验的流行率没有变化（OR=1.09，z=0.78，p=0.44）。大多数（66%）试验涉及紧急情况，44 项 RCT 中的 40 项（90.9%）涉及紧急干预、实用设计、是集群随机化，或这些因素的组合。定性分析探讨了我们 RCT 样本中放弃知情同意的方法和理由。
