Alzheimer Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam UMC location VUmc, Amsterdam, The Netherlands.
Amsterdam Neuroscience, Neurodegeneration, Amsterdam, The Netherlands.
PLoS One. 2023 Jul 7;18(7):e0285807. doi: 10.1371/journal.pone.0285807. eCollection 2023.
Clinical research with remote monitoring technologies (RMTs) has multiple advantages over standard paper-pencil tests, but also raises several ethical concerns. While several studies have addressed the issue of governance of big data in clinical research from the legal or ethical perspectives, the viewpoint of local research ethics committee (REC) members is underrepresented in the current literature. The aim of this study is therefore to find which specific ethical challenges are raised by RECs in the context of a large European study on remote monitoring in all syndromic stages of Alzheimer's disease, and what gaps remain.
Documents describing the REC review process at 10 sites in 9 European countries from the project Remote Assessment of Disease and Relapse-Alzheimer's Disease (RADAR-AD) were collected and translated. Main themes emerging in the documents were identified using a qualitative analysis approach.
Four main themes emerged after analysis: data management, participant's wellbeing, methodological issues, and the issue of defining the regulatory category of RMTs. Review processes differed across sites: process duration varied from 71 to 423 days, some RECs did not raise any issues, whereas others raised up to 35 concerns, and the approval of a data protection officer was needed in half of the sites.
The differences in the ethics review process of the same study protocol across different local settings suggest that a multi-site study would benefit from a harmonization in research ethics governance processes. More specifically, some best practices could be included in ethical reviews across institutional and national contexts, such as the opinion of an institutional data protection officer, patient advisory board reviews of the protocol and plans for how ethical reflection is embedded within the study.
与标准纸笔测试相比，采用远程监控技术（RMT）的临床研究具有诸多优势，但也引发了一些伦理问题。尽管有几项研究从法律或伦理角度探讨了临床研究中大数据治理的问题，但当前文献中对地方研究伦理委员会（REC）成员的观点的代表性不足。因此，本研究旨在确定 REC 在大型欧洲阿尔茨海默病所有综合征阶段远程监测研究背景下提出的具体伦理挑战，以及仍存在哪些差距。
从项目 Remote Assessment of Disease and Relapse-Alzheimer's Disease（RADAR-AD）的 9 个欧洲国家的 10 个地点收集并翻译了描述 REC 审查过程的文件。使用定性分析方法确定文件中出现的主要主题。
经过分析，出现了四个主要主题：数据管理、参与者的福利、方法问题以及定义 RMT 监管类别问题。审查过程在不同地点存在差异：过程持续时间从 71 天到 423 天不等，一些 REC 没有提出任何问题，而另一些则提出了多达 35 个问题，并且一半的地点需要数据保护官员的批准。
同一研究方案在不同地方的伦理审查过程存在差异，这表明多地点研究将受益于研究伦理治理过程的协调。更具体地说，可以在机构和国家背景下的伦理审查中纳入一些最佳实践，例如机构数据保护官员的意见、患者咨询委员会对方案的审查以及如何将伦理反思嵌入研究中的计划。
