The scientific motivations for data sharing are clear: health information can enable scientific discovery, as well as enhance transparency and reproducibility in trial results. However, the ethical considerations of sharing data from embedded pragmatic clinical trials (ePCTs) are less well defined, especially when data are collected with a waiver or alteration of informed consent, as is often the case in ePCTs. Therefore, in this chapter, we describe the human subjects research regulations that may impact such data sharing and examine the intersection of enabling critical ePCT research, and respecting the interests of patients who become ePCT participants.