The American Journal of Bioethics (AJOB) this week issued a call for peer commentaries for a forthcoming special issue on pragmatic clinical trials. Both of the target articles for the special issue are from the NIH Pragmatic Trials Collaboratory’s Ethics & Regulatory Core.

Unlike AJOB‘s typical Open Peer Commentaries, commentaries for the special issue may be written either in response to the 2 target articles or on the topic of pragmatic trials in general. Proposals of approximately 1 paragraph are due Friday, April 7, and should be submitted via the AJOB editorial website.

After evaluating the proposals, the journal’s editorial office will contact authors to inform them of whether their proposal has been selected to be submitted as a full Open Peer Commentary. Invited commentaries will be due Wednesday, April 26. Authors are limited to a single Open Peer Commentary.

Target articles:

• “Think Pragmatically: Investigators’ Obligations to Patient-Subjects When Research is Embedded in Care” by Stephanie Morain and Emily Largent: Growing interest in embedded research approaches—where research is incorporated into clinical care—has spurred numerous studies to generate knowledge relevant to the real-world needs of patients and other stakeholders. However, it also has presented ethical challenges. An emerging challenge is how to understand the nature and extent of investigators’ obligations to patient-subjects. Prior scholarship on investigator duties has generally been grounded upon the premise that research and clinical care are distinct activities, bearing distinct duties. Yet this premise—and its corresponding implications—are challenged when research and clinical care are deliberately integrated. After presenting three case studies from recent pragmatic clinical trials, we identify six differences between explanatory trials and embedded research that limit the application of existing scholarship for ascertaining investigator duties. We 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.
• “Do Clinicians Have a Duty to Participate in Pragmatic Clinical Trials?” by Andrew Garland, Stephanie Morain, and Jeremy Sugarman: Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve substantive deviation from their ordinary care practices. However, a variety of countervailing reasons may excuse clinicians from this duty in particular cases. Yet because there is a moral default in favor of participating, clinicians who wish to opt out of this research must justify their refusal. Reasons to refuse include that the trial is badly designed in some way, that the trial activities will violate the clinician’s conscience, or that the trial will impose excessive burdens on the clinician.

Open Peer Commentaries are typically between 500 and 1500 words and contain no more than 10 references. A guide to writing an Open Peer Commentary is available under the Resources section “Instructions and Forms” on the AJOB editorial website.