van den Akker Olmo R, Stark Susanne, Strech Daniel
QUEST Center for Responsible Research, Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Charitéplatz 1, Berlin, 10117, Germany.
BMC Med. 2024 Dec 4;22(1):577. doi: 10.1186/s12916-024-03799-w.
As routinely collected patient data have become increasingly accessible over the years, more attention has been directed at the ethics of using such data for research. Patient data is often available to researchers through patient registries that typically collect data of patients with a specific condition. While ethical guidelines for using patient data are presented frequently in the literature, it is currently unknown how patient registries implement the recommendations from these guidelines in practice and how they communicate their practices. In this project, we assessed to what extent a sample of 51 patient registries provides information about a range of ethics practices.
We searched for patient registries in the resource database of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Our ethics reporting checklist was based on three sources: the Registry Evaluation and Quality Standards Tool (REQueST), the Agency for Healthcare Research and Quality (AHRQ) guide for good registry practices, and a systematic review of the principles and norms related to health data sharing by Kalkman and colleagues. The checklist includes 26 questions about five ethics components: governance, conflicts of interest, informed consent, privacy and data protection, and use-and-access.
We found substantial heterogeneity in the way patient registries provide information about ethics practices. Patient registries often mentioned their governance structure and any potential conflicts of interests but typically did not describe the responsibilities and rights allocated to their funders. Information about informed consent was often provided to patients, but the available documents often lacked relevant information like the benefits and risks of participation. Privacy and data protection and use-and-access policies were typically discussed but not very concretely.
We conclude that registries typically provide information about key ethics practices such as governance, conflicts of interest, informed consent, privacy and data protection, and use-and-access procedures, but this information is often not as detailed as recommended in existing guidelines. The ethics reporting checklist we designed could be helpful for the ethical assessments of patient registries and other types of registries in the future as well as for self-assessment of registries aiming to improve their ethics practices.
多年来，随着常规收集的患者数据越来越容易获取，人们越来越关注将此类数据用于研究的伦理问题。研究人员通常可以通过患者登记处获取患者数据，这些登记处通常收集患有特定疾病患者的数据。虽然文献中经常提出使用患者数据的伦理准则，但目前尚不清楚患者登记处在实践中如何实施这些准则的建议，以及它们如何传达其做法。在本项目中，我们评估了51个患者登记处的样本在多大程度上提供了一系列伦理实践的信息。
我们在欧洲药物流行病学和药物警戒中心网络（ENCePP）的资源数据库中搜索患者登记处。我们的伦理报告清单基于三个来源：登记处评估和质量标准工具（REQueST）、医疗保健研究与质量局（AHRQ）的良好登记处实践指南，以及Kalkman及其同事对健康数据共享相关原则和规范的系统综述。该清单包括26个关于五个伦理组成部分的问题：治理、利益冲突、知情同意、隐私和数据保护以及使用和访问。
我们发现患者登记处在提供伦理实践信息的方式上存在很大差异。患者登记处经常提及他们的治理结构和任何潜在的利益冲突，但通常没有描述分配给其资助者的责任和权利。通常会向患者提供有关知情同意的信息，但现有文件往往缺乏相关信息，如参与的益处和风险。隐私和数据保护以及使用和访问政策通常会被讨论，但不够具体。
我们得出结论，登记处通常会提供有关关键伦理实践的信息，如治理、利益冲突、知情同意、隐私和数据保护以及使用和访问程序，但这些信息往往不如现有指南中建议的那样详细。我们设计的伦理报告清单可能有助于未来对患者登记处和其他类型登记处进行伦理评估，以及有助于旨在改善其伦理实践的登记处进行自我评估。
