英国学术领导的临床试验中的电子同意:当前的实践,挑战和需要更多证据
E J Mitchell1, D Appelbe2, A Bravery3
1Nottingham Clinical Trials Unit, School of Medicine, Applied Health Research Building, University Park, Nottingham, NG7 2RD, UK. eleanor.mitchell@nottingham.ac.uk.
Trials
|October 11, 2023
概括
电子知情同意 (e-Consent) 在学术临床试验中越来越多地被采用. 需要进一步的研究和共同的经验来解决剩余的不确定性,并指导最佳实施.
科学领域:
- 临床试验方法论 临床试验方法论
- 数字卫生技术数字卫生技术
- 患者参与 患者参与
背景情况:
- 随着COVID-19的流行,需要远程临床试验方法的需求加速了,包括电子知情同意 (e-Consent).
- 事证据表明,在大流行期间,在学术领导的临床试验中,电子同意的普及率增加了.
- 英国学术临床试验小组之间的合作是为了分享电子同意实施经验而出现的.
研究的目的:
- 调查英国学术临床试验单位 (CTU) 关于其实施和对电子同意的看法.
- 了解系统程序员和质量保证人员使用电子同意书的经验.
- 识别电子同意采用和未来实施计划的障碍.
主要方法:
- 一项调查分发给UKCRC注册的CTU (2021年4月至6月).
- 包括不使用电子同意的CTU关于障碍和未来计划的问题.
- 为试验人员和患者和公众参与 (PPI) 代表举办了两次研讨会,讨论研究结果和分享经验.
主要成果:
- 53个中34个 (64%) 的中职工会做出了回应,显示了英国的良好地理代表性.
- 回答的CTU中有21个 (62%) 在各种试验类型 (CTIMP,ATIMP,非CTIMP) 中实施了电子同意.
- 197名参与者参加了研讨会,对电子同意进行了广泛的讨论.
结论:
- 在学术试验中,电子同意的采用正在增长,但在试验人员,患者和公众中仍然存在不确定性.
- 关键的不确定性包括缺乏最佳电子同意方法的正式实践指导和证据.
- 强烈鼓励试验者之间继续分享实施经验,以推进最佳实践.
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