Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Department of Medical Ethics & Health Policy, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Acad Emerg Med. 2023 Feb;30(2):133-138. doi: 10.1111/acem.14645. Epub 2023 Jan 19.
The exception from informed consent (EFIC) rule was adopted in 1996, permitting waiver of informed consent for certain emergency research, including trials funded by the U.S. government. The rule requires prospective consent from patients or their legally authorized representative(s) (LAR) if practicable. For those enrolled without consent, the patient or their LAR must be given an opportunity to opt out from continued participation at the earliest opportunity. We sought to census the trials conducted under the EFIC rule to facilitate research to better understand how the rule is being used.
We conducted a multipronged search to identify all trials conducted under the EFIC rule, drawing on reviews, database searches, examination of the FDA's docket, posting an inquiry on the institutional review board forum, and email requests to lead authors of all published EFIC trials and related review articles. We describe the trials, when they were started and completed, and whether they were terminated early.
We identified a total of 110 trials as of the end of April 2022: 78 complete, 13 recruiting, seven registered on clinicaltrials.gov but not yet recruiting, five trials that were abandoned before enrolling any subjects, and seven trials in early planning. Nine of the 78 completed trials were pilot or feasibility trials. Of 69 completed full trials, 30 (43.5%) were terminated early. The most common reason for early termination was futility (15 trials, 25.0%) followed by poor recruitment (10 trials, 14.5%). The rate of conduct of trials has been remarkably constant since 2001, with roughly 18 trials started in each 5-year period.
We have compiled a census of trials conducted under the U.S. FDA's EFIC rule, the availability of which we hope will stimulate further in-depth data collection and analysis of this set of trials.
1996 年通过了知情同意豁免（EFIC）规则，允许对某些紧急研究豁免知情同意，包括由美国政府资助的试验。该规则要求在可行的情况下，从患者或其合法授权代表（LAR）获得前瞻性同意。对于未经同意入组的患者，必须尽早为其提供选择退出继续参与研究的机会。我们试图对根据 EFIC 规则进行的试验进行普查，以促进研究，更好地了解该规则的使用情况。
我们采用了多种方法来识别根据 EFIC 规则进行的所有试验，包括综述、数据库搜索、FDA 案卷审查、在机构审查委员会论坛上发布查询以及向所有已发表的 EFIC 试验和相关综述文章的主要作者发送电子邮件请求。我们描述了这些试验的开始和完成时间，以及是否提前终止。
截至 2022 年 4 月底，我们共确定了 110 项试验：78 项已完成，13 项正在招募，7 项已在 clinicaltrials.gov 上注册但尚未招募，5 项试验在入组任何受试者之前就已中止，7 项试验处于早期规划阶段。78 项已完成的试验中，有 9 项为试点或可行性试验。在 69 项已完成的完整试验中，有 30 项（43.5%）提前终止。提前终止的最常见原因是无效（15 项试验，25.0%），其次是招募不佳（10 项试验，14.5%）。自 2001 年以来，试验的开展率一直非常稳定，每 5 年期间大约开展 18 项试验。
我们编制了一份根据美国 FDA 的 EFIC 规则进行的试验普查，希望这将激发对这组试验进行进一步的深入数据收集和分析。
