A Framework of Institutional Obligations for Pragmatic Clinical Trials.

Abstract

Pragmatic clinical trials (PCTs) embed research into clinical care. This deliberate research-care integration means that healthcare institutions are key partners for PCTs. Prior literature has identified several ethical challenges in PCTs for which institutional involvement is a necessary condition for their resolution. However, no comprehensive account exists to describe the moral obligations of healthcare institutions for PCTs. To that end, we propose a framework of ten obligations for institutions when leading or participating in PCTs. These obligations span the lifecycle of research, beginning with decisions about whether to implement a given study within a particular institution through to decisions about (de)implementation following study completion. For each obligation, we describe both the relevant moral considerations and the corresponding practical implications. While we offer several practical suggestions that can inform current research activities, future work will be needed to further specify these obligations to provide more granular guidance for decision-making.