Institutional Obligations for Pragmatic Clinical Trials: Developing A Normative Account and Practical Guidance

Traditional bioethics scholarship and related guidance focuses on the obligations owed by clinicians to patients and by researchers to subjects. Yet pragmatic clinical trials are fundamentally institutional endeavors. Numerous ethical challenges have emerged from recent pragmatic clinical trials that require institution-level involvement for their appropriate resolution, yet institutions lack ethical guidance to support them in this work. Prof. Morain’s project will seek to develop an empirically informed, action-guiding model of institutional obligations arising from pragmatic clinical trials.