April 18, 2022
Emily Largent, PhD, JD, RN, Associate Core Leader of the IMPACT Ethics & Regulation Core co-authored an article addressing researching ethics in embedded pragmatic clinical trials. Largent and Stephanie Morain from Johns Hopkins University published the article in the April 18 online issue of The American Journal of Bioethics.
The authors present three case studies from recent pragmatic trials and identifies six differences between explanatory trials and embedded research that limit the application of existing scholarship for ascertaining investigator duties. They suggest that these limitations indicate a need to account for the implications of usual care and to move beyond a narrow focus on the investigator-subject dyad, one that better reflects the team- and institution-based nature of contemporary health systems.