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.

中文翻译：

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跨国、务实、随机临床试验 SafeBoosC-III 中使用的替代同意方法

获得实验性治疗的事先知情同意的过程不太适合急性和重症监护的临床现实。干预措施的治疗窗口往往较短，这可能会降低同意的有效性和入组参与者的比例，从而延迟试验的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，调查极早产儿出生后 3 天内（从出生后 6 小时内开始）进行脑血氧饱和度监测的益处和危害。此前，延迟同意和选择退出同意都是协议所允许的。本研究旨在评估 SafeBoosC-III 试验中不同同意方法的使用，此外，我们的目的是描述和分析试验进行前 6 个月期间出现的担忧或投诉。所有 70 名主要研究者均被邀请参加这项描述性辅助研究。每位主要研究者都会收到一份有关 SafeBoosC-III 试验期间其中心同意方法使用情况的调查问卷，包括描述由父母或家长提出的与试验前 6 个月期间使用的同意方法相关的任何担忧的可能性。临床工作人员。可获得 61 个中心的数据。 43 个中心仅使用事先知情同意：7 个中心仅使用延迟同意。没有一个中心仅使用选择退出方法，但有五个中心使用了优先和延迟方法，五个中心使用了优先、延迟和选择退出方法（所有可能性），还有一个中心同时使用了延迟和选择退出方法。六个中心向当地研究伦理委员会申请使用选择退出方法，但遭到拒绝。一个中心申请使用延期同意，但遭到拒绝。在审判执行期间，仅登记了 23 个关注点。在这项跨国试验中，协议允许选择退出同意，但只有少数研究人员选择了它，而且一些研究伦理委员会不接受它的使用。它可能需要临床研究界的推广才能发挥其潜力。