Ethical issues in pragmatic trials of "standard-of-care" interventions in learning health care systems

Abstract

Introduction: Learning health care systems (LHS) hold the promise of improving medical care by systematically and continuously integrating the delivery of medical services with clinical research. One important type of integration would involve embedding trials that compare interventions that are already commonly in use (as "accepted" or "standard of care") into the clinical setting-trials that could cost-effectively improve care. But the traditional requirement of informed consent for clinical trials stands in tension with the conduct of such trials.

Method: Narrative analysis.

Results: Although some have suggested that the idea of LHS makes the distinction between research and ordinary clinical care obsolete, the distinction remains ethically relevant even when it comes to randomized clinical trials (RCTs) that compare standard-of-care interventions. This paper presents an ethical framework for analyzing standard-of-care RCTs in resolving the tension between such trials and traditional requirements of research ethics.

Conclusion: It is important not to treat all standard-of-care RCTs as a monolithic category of special ethical status. Close attention to ethical issues in specific standard-of-care RCTs is crucial if the LHS movement is to avoid ethical lapses that could be counterproductive to its long term vision.

Keywords: informed consent; pragmatic; randomized clinical trial; standard‐of‐care.