Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Clin Trials. 2022 Dec;19(6):681-689. doi: 10.1177/17407745221110881. Epub 2022 Sep 7.
Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trials data, and trial sponsors and journals are increasingly requiring it. However, data sharing in pragmatic clinical trials presents ethical challenges related to the use of waivers or alterations of informed consent for some pragmatic clinical trials and corresponding limitations of informed consent to guide sharing decisions; the potential for data sharing in pragmatic clinical trials to present risks not only for individual patient-subjects, but also for health systems and the clinicians within them; sharing of data from electronic health records instead of data newly collected for research purposes; and researchers' limited capacity to control sensitive data within an electronic health record and potential implications of such limits for meeting obligations inherent to Certificates of Confidentiality. These challenges raise questions about the extent to which traditional research ethics governance structures are capable of guiding decisions about pragmatic clinical trial data sharing. This article identifies and examines these ethical challenges for pragmatic clinical trial data sharing. We suggest several areas for future empirical scholarship, including the need to identify patient and public attitudes regarding pragmatic clinical trial data sharing as well as to assess the demand for pragmatic clinical trial data and the correspondingly likely benefit of such sharing. Further conceptual work is also needed to explore how requirements to respect patient-subjects about whom data are shared in the context of pragmatic clinical trials should be understood, particularly in the absence of informed consent for initial research activities, and the appropriate balance between promoting the generation of socially valuable knowledge and respecting autonomy.
已经提出了许多理由来广泛分享去识别化的、参与者层面的临床试验数据，并且试验赞助商和期刊越来越要求这样做。然而，在实用临床试验中进行数据共享提出了一些与实用临床试验中使用弃权或更改知情同意相关的伦理挑战，以及知情同意的局限性来指导共享决策；实用临床试验中数据共享可能带来的风险不仅对个体患者受试者，而且对卫生系统及其内部的临床医生都有影响；从电子健康记录中分享数据而不是为研究目的新收集的数据；以及研究人员在电子健康记录中控制敏感数据的能力有限，以及这些限制对满足保密证书所固有的义务的潜在影响。这些挑战提出了一个问题，即传统的研究伦理治理结构在多大程度上能够指导关于实用临床试验数据共享的决策。本文确定并研究了实用临床试验数据共享的这些伦理挑战。我们建议了未来实证研究的几个领域，包括需要确定患者和公众对实用临床试验数据共享的态度，以及评估对实用临床试验数据的需求以及这种共享的相应可能的好处。还需要进一步的概念性工作来探讨如何理解在实用临床试验背景下，关于数据共享的患者受试者的尊重要求，特别是在缺乏初始研究活动的知情同意的情况下，以及在促进产生具有社会价值的知识和尊重自主权之间的适当平衡。
