We read with great interest Garland, Morain and Sugarman’s manuscript on the obligations of clinicians to participate in pragmatic clinical trials (PCTs) (Garland, Morain and Sugarman 2023). We bel...

It was the spring of 2020 when the email came to our inboxes—a memo from our Institutional Review Board informing us that we were approved to begin conducting our pragmatic clinical trial with a wa...

Embedded pragmatic clinical trials (PCTs), like other types of randomized comparative-effectiveness research (CER) studies, are sometimes conducted without informed consent. Indeed, authors of both...

In this issue of the American Journal of Bioethics, manuscripts focus on the obligations of clinicians and researchers in pragmatic clinical trials (Garland, Morain, and Sugarman 2023; Morain and L...

Garland, Morain, and Sugarman (2023) can be congratulated for their comprehensive and sharp analysis of physicians’ ethical duties with respect to pragmatic clinical trials (PCTs). PCTs embed resea...

Morain and Largent’s (2023) thorough and thoughtful article concludes that the partial-entrustment model of medical researchers’ ancillary-care obligations (Richardson and Belsky 2004; Belsky and R...

In their thoughtful and well-supported target article, Andrew Garland, Stephanie Morain, Jeremy Sugarman (2023) argue that clinicians have a duty to participate in pragmatic clinical trials. This d...

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share (...) their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design. (shrink)

We whole-heartedly support Andrew Garland, Stephanie Morain, and Jeremy Sugarman’s claim that clinicians have a duty to participate in pragmatic clinical trials (Garland, Morain, and Sugarman 2023)...

Well-designed pragmatic clinical trials (PCTs) are critical for improving healthcare delivery and patient outcomes (Haff and Choudhry 2018), and the article written by Garland et al. (2023) advance...

Both Morain and Largent (2023) and Garland, Morain, and Sugarman (2023) recognize the ethical challenges inherent in clinician participation in embedded research. Focusing on the question of integr...

Garland and colleagues provide many compelling reasons for why clinicians ought to participate in pragmatic clinical trials (Garland et al. 2023), also known as effectiveness trials (Thorpe et al....

The concept of practical, or pragmatic, clinical trials was introduced in the early 2000s, in parallel with the growing availability and use of electronic health data. Researchers and policymakers...

We very much appreciate the helpful and generous commentaries in response to “Do Clinicians have a Duty to Participate in Pragmatic Clinical Trials?” (Garland, Morain, and Sugarman 2023). In that a...

The target articles in this issue advance our understanding of bioethical considerations in pragmatic trials (Garland, Morain, and Sugarman 2023; Morain and Largent 2023). Both articles appreciate...

Garland, Morain, and Sugarman's (2023) proposal is ethically attractive. But (assuming that ethics and medical law should have a close relationship with one another) it is legally seismic. It requi...