Think Pragmatically: Investigators’ Obligations to Patient-Subjects When Research is Embedded in Care

Afterlife: the post-research affect and effect of software

“…They would thus be in potential tension between their role to maintain software to the benefit of their 'client', and their role as a researcher to benefit society. Similar issues are found in medical research involving pragmatic clinical trials (Morain and Largent, 2022), although for software the difference may not be so pronounced since codes of ethics for software engineers typically have the public good as the first priority. Another factor arises from the duration of support: Singh et al (2019) claim that duration is the most contentious issue in PTA since it is not feasible to provide it for an unlimited time.…”

Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials

“…This study was completed under a waiver of consent, meaning that patients had no knowledge of their enrollment. 4 What obligations, if any, did the research team have upon the identification of these findings? Should they notify patients of the potential osteoporosis diagnosis and corresponding risk of future fractures (a logistical feat, given the large scale of the trial), their treating clinicians, or perhaps even both?…”

“…3 Additionally, existing guidance on incidental findings often rests on accounts that hold that the duties owed by clinicians to patients are distinct from those owed by researchers to subjects, with those of researchers more limited than those of clinicians. 4 The embedded nature of ePCTs challenges this framing, raising questions about both the scope of duty, as well as by whom (researchers or others within the health system) that duty is owned.…”

Post‐trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real‐world change

“…From this view, researchers are understood as having a more limited responsibility to trial participants than that of physicians to patients. However, the integration of research and care within a PCT may complicate assessments of the nature and scope of researchers' responsibility 22 . On the one hand, this integration may lessen the distinction between research and care so as to make the responsibilities owed to PCT patient subjects more akin to those owed to patients in clinical care.…”

“…Health systems play a distinctive role in PCTs, serving not only as research sites, but often also as research gatekeepers, shaping access to potential research subjects, and determining whether the proposed research is an appropriate use of system resources 28 . Prior scholarship has suggested the need to account for this distinctive role of health systems when identifying obligations owed to PCT patient subjects 22 . Therefore, when assessing whether or not to partner in embedded PCTs, health systems should consider not only the impact of the trial on health system operations, but also whether the health system would change practice based on trial results—and, importantly, what metrics would be relevant for that assessment.…”