Department of Neonatology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Trials. 2024 Apr 4;25(1):236. doi: 10.1186/s13063-024-08074-0.
The process of obtaining prior informed consent for experimental treatment does not fit well into the clinical reality of acute and intensive care. The therapeutic window of interventions is often short, which may reduce the validity of the consent and the rate of enrolled participants, to delay trial completion and reduce the external validity of the results. Deferred consent and 'opt-out' are alternative consent methods. The SafeBoosC-III trial was a randomised clinical trial investigating the benefits and harms of cerebral oximetry monitoring in extremely preterm infants during the first 3 days after birth, starting within the first 6 h after birth. Prior, deferred and opt-out consent were all allowed by protocol. This study aimed to evaluate the use of different consent methods in the SafeBoosC-III trial, Furthermore, we aimed to describe and analyse concerns or complaints that arose during the first 6 months of trial conduct.
All 70 principal investigators were invited to join this descriptive ancillary study. Each principal investigator received a questionnaire on the use of consent methods in their centre during the SafeBoosC-III trial, including the possibility to describe any concerns related to the consent methods used during the first 6 months of the trial, as raised by the parents or the clinical staff.
Data from 61 centres were available. In 43 centres, only prior informed consent was used: in seven, only deferred consent. No centres used the opt-out method only, but five centres used prior and deferred, five used prior, deferred and opt-out (all possibilities) and one used both deferred and opt-out. Six centres applied to use the opt-out method by their local research ethics committee but were denied using it. One centre applied to use deferred consent but was denied. There were only 23 registered concerns during the execution of the trial.
Consent by opt-out was allowed by the protocol in this multinational trial but only a few investigators opted for it and some research ethics boards did not accept its use. It is likely to need promotion by the clinical research community to unfold its potential.
获得实验性治疗的事先知情同意的过程与急性和重症监护的临床实际情况不太相符。干预的治疗窗口期通常很短，这可能会降低同意的有效性和入组参与者的比例，从而延迟试验完成并降低结果的外部有效性。延迟同意和“选择退出”是替代同意方法。SafeBoosC-III 试验是一项随机临床试验，研究了出生后最初 3 天内（出生后 6 小时内开始）对极早产儿进行脑氧饱和度监测的益处和危害。方案允许使用事先同意、延迟同意和选择退出同意。本研究旨在评估 SafeBoosC-III 试验中不同同意方法的使用情况，此外，我们还旨在描述和分析试验进行的前 6 个月期间出现的关注或投诉。
邀请了所有 70 位主要研究者参加本描述性辅助研究。每位主要研究者都收到了一份关于他们所在中心在 SafeBoosC-III 试验中使用同意方法的问卷，包括描述在试验的前 6 个月期间使用的同意方法引起的任何关注或投诉的可能性，这些关注或投诉是由父母或临床工作人员提出的。
有 61 个中心的数据可用。在 43 个中心，仅使用了事先知情同意：在 7 个中心，仅使用了延迟同意。没有中心仅使用选择退出方法，但有 5 个中心使用了事先和延迟同意、5 个中心使用了事先、延迟和选择退出同意（所有可能性），1 个中心同时使用了延迟和选择退出同意。有 6 个中心向当地研究伦理委员会申请使用选择退出方法，但被拒绝使用。在试验实施过程中，仅有 23 例已登记的关注。
在这项多中心试验中，方案允许使用选择退出同意，但只有少数研究者选择使用它，并且一些研究伦理委员会不接受其使用。这很可能需要临床研究界的推动，以发挥其潜力。
