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 (PCTs) presents distinct ethical challenges. This project, funded by a bioethics administrative supplement from the NIH, examines ethical issues when sharing data from PCTs, including challenges in sharing data collected under a waiver or alteration of informed consent and the potential for data sharing in PCTs to present risks not only for individual patient-subjects, but also for health systems and the clinicians within them.
Data Sharing in Pragmatic Clinical Trials
- Morain SR, Bollinger J, Weinfurt K, Sugarman J. Ethics Challenges in Sharing Data from Pragmatic Clinical Trials. Clinical Trials. 2022; 19(6):681-689. doi: 1177/17407745221110881
- Morain SR, Bollinger J, Weinfurt K, Sugarman J. Stakeholder Perspectives on Data Sharing From Pragmatic Clinical Trials: Unanticipated Challenges for Meeting Emerging Requirements. Learning Health Systems. 2023. doi:1002/lrh2.10366