Institute for Biomedicine, Eurac Research, Affiliated Institute of the University of Lübeck, Bolzano, Italy.
Center for Research Ethics and Bioethics, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
Eur J Hum Genet. 2022 Dec;30(12):1391-1397. doi: 10.1038/s41431-022-01160-4. Epub 2022 Sep 5.
The Cooperative Health Research in South Tyrol (CHRIS) is a longitudinal study in Northern Italy, using dynamic consent since its inception in 2011. The CHRIS study collects health data and biosamples for research, and foresees regular follow-ups over time. We describe the experience with the CHRIS study dynamic consent, providing an overview of its conceptualization and implementation, and of the participant-centered strategies used to assess and improve the process, directly linked to participation and communication. In order to comply with high ethical standards and to allow broadness in the areas of research, CHRIS dynamic consent was conceived as an interactive process: based on a strong governance and an ongoing tailored communication with participants, it aims to promote autonomy and to develop a trust-based engaged relationship with participants, also relevant for retention. Built within an online platform, the consent allows granular choices, which can be changed over time. In a process of co-production, participants views have been investigated and kept into account in policy development. Participants showed a high degree of participation, thus enabling the consolidation of the CHRIS resources. Even though a low change rate was reported in the baseline, participants valued the possibility of changing their informed consent choices. Communication (language-tailored, ongoing, multimedia) was important for participants, and for participation and retention. In our experience, dynamic consent was proven to be a flexible consent model, which allowed to meet ethical and legal standards for participation in research, and to accommodate participants' and researchers' needs.
南蒂罗尔合作健康研究（CHRIS）是意大利北部的一项纵向研究，自 2011 年成立以来一直采用动态同意。CHRIS 研究收集健康数据和生物样本用于研究，并预计随着时间的推移进行定期随访。我们描述了 CHRIS 研究动态同意的经验，提供了其概念化和实施的概述，以及用于评估和改进与参与和沟通直接相关的过程的以参与者为中心的策略。为了遵守高标准的伦理准则并允许在研究领域广泛开展，CHRIS 动态同意被视为一个互动过程：基于强大的治理和与参与者的持续定制沟通，它旨在促进自主性，并与参与者建立基于信任的参与关系，这对保留也很重要。该同意书构建在在线平台内，允许进行细粒度的选择，并可以随着时间的推移进行更改。在共同制定政策的过程中，参与者的意见得到了调查并被考虑在内。参与者表现出高度的参与度，从而巩固了 CHRIS 的资源。尽管在基线报告中报告了低变化率，但参与者重视更改其知情同意选择的可能性。沟通（语言定制、持续、多媒体）对参与者和参与度和保留度很重要。根据我们的经验，动态同意被证明是一种灵活的同意模式，它允许满足参与研究的伦理和法律标准，并满足参与者和研究人员的需求。
