Data Sharing in Pragmatic Clinical Trials

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.

Berman Institute Faculty

Stephanie Morain, PhD, MPH
PhD Program Director; Associate Professor
Jeremy Sugarman, MD, MPH, MA
Deputy Director for Medicine; Harvey M. Meyerhoff Professor of Bioethics and Medicine
Juli Bollinger, MS
Research Scientist




  1. 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
  2. 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


Grand Rounds Ethics and Regulatory Series: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape