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...

More than 50 years ago, in a front-page article in the New York Times, the truth about what happened to hundreds of black men in a government-conducted research study was revealed to the American p...

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...

In this issue, Morain and Largent (2023) raise a pressing issue arising in the context of embedded research—the nature and extent of investigator duties to patient-participants when the line betwee...

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...

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...

Stephanie Morain and Emily Largent’s (2023) target article “Think Pragmatically: Investigators’ Obligations to Patient-Subjects When Research is Embedded in Care” identified a number of important c...

In their paper, “Think Pragmatically: Investigators’ Obligations to Patient-Subjects When Research is Embedded in Care,” Stephanie Morain and Emily Largent (2023) argue that investigators, and poss...

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. (shrink)

In In their article Morain and Largent suggest looking “beyond the investigator-participant dyad” to understand the ethical obligations in embedded research using Electronic Health Record (EHR) dat...

Pragmatic clinical trials (PCTs) serve an important function in the modern research landscape: studying interventions in an environment that reflects real-world conditions, rather than the relative...

In this target article by Morain and Largent (2023), the authors focus on an investigator’s duty to patient-subjects specifically regarding incidental or collateral findings within the context of e...

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...

In “Think Pragmatically: Investigators’ Obligations to Patient-Subjects When Research is Embedded in Care,” Morain and Largent 2023 persuasively argue that the prevailing ways of conceptualizing in...

Pragmatic clinical trials (PCTs) seek to show the effectiveness of treatments in routine, clinical practice (MacPherson 2004). However, a number of ethical challenges come to the fore when collater...