The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. The chapter, “Ethical Considerations of Data Sharing in Pragmatic Clinical Trials,” describes human subjects research regulations that may impact sharing data from embedded pragmatic clinical trials (ePCTs) and the ethical considerations for respecting the interests of patients who become ePCT participants.

When data are collected with a waiver or alteration of informed consent, as is often the case in ePCTs, a person may be unaware they are participating in research and therefore could not  have consented to have their data used in future research. This suggests need for investigators and health systems to consider additional ways to fulfill the ethical obligation of respecting patient-participants when sharing their data from PCTs.

For more on the ethical considerations of ePCTs, see the chapters on Privacy Considerations; Identifying Those Engaged in Research; Consent, Waiver of Consent, and Notification; Collateral Findings; and Data and Safety Monitoring.

For more on data sharing and ePCTs, see the chapter on Data Sharing and Embedded Research.