Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Trials. 2024 May 8;25(1):310. doi: 10.1186/s13063-024-08149-y.
Use of electronic methods to support informed consent ('eConsent') is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK.
We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system's generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake.
We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach.
在临床研究中，使用电子方法来支持知情同意（“eConsent”）越来越受欢迎。本文报道了英国利兹临床试验研究单位（Leeds Clinical Trials Research Unit，CTRU）在一系列研究中采用电子知情同意方法的方法和后续经验，该单位是一个大型临床试验单位。
我们使用 REDCap 平台实施了远程电子知情同意流程。该流程可用于研究药物和其他干预类型或研究设计的临床试验。我们的标准电子知情同意系统专注于记录知情同意，其他同意方面（例如向潜在参与者提供信息以及招募人员与每位潜在参与者讨论研究）在系统之外进行，尽管试验团队在获得伦理批准的情况下可以使用电子方法进行这些活动。我们的整体流程包括在将机密信息输入 REDCap 之前进行口头同意步骤，以及按照监管机构的指导进行身份验证步骤。我们考虑了系统生成源文件的监管要求，如何确保遵守数据保护标准以及如何在系统内监测知情同意。我们提出了 CTRU 的四个电子知情同意案例研究：两项随机临床试验和两项其他健康研究。这些案例研究说明了实施电子知情同意的方式以及所吸取的经验教训，包括参与率的差异。
我们在 CTRU 成功实施了多项研究的远程电子知情同意流程。我们的案例研究强调了研究参与者无需亲自到研究现场即可同意的好处。这可能更符合患者的偏好和试验现场的需求，从而改善招募工作并增强对外部冲击（如大流行）的抵御能力。电子知情同意的采用率差异可能更多地受到现场因素的影响，而不是患者的偏好，而这些偏好可能与以患者为中心的研究的愿望不太一致。我们当前的流程存在一些限制，包括提供多种语言的所有与同意相关的文本，以及一次同时实施多种同意表格版本的可扩展性。我们考虑了 CTRU 流程的改进或外部发展如何影响我们的方法。
