Bystander Ethics and Good Samaritanism: A Paradox for Learning Health Organizations

Abstract

In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient‐care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation—a trial known as IMPACT‐AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do.

Patients’ Views About the Disclosure of Collateral Findings in Pragmatic Clinical Trials: a Focus Group Study

“…Potential PCT-CFs to prompt discussion in the focus group were identified based on an unstructured literature review, discussions with members of our project Advisory Panel (that includes members with expertise in health systems, PCTs, ethics, and law), and the experiences of members of the NIH Health Care Systems Research Collaboratory. 5,6 Ultimately, the focus group discussion was limited to a single hypothetical scenario in order to allow ample time to guide participants through it and to explain how the PCT-CF was identified.…”

“…4 For example, a PCT aimed at increasing uptake of cardiac care guidelines identified patients with diagnoses that increased their risk for a cardiac event based on insurance claims data, but for whom documentation that the diagnosis was communicated was lacking. 5 Furthermore, because PCTs straddle the research-clinical care boundary, there are conflicting opinions as to who is ultimately responsible for managing PCT-CFs. 4 Regardless of who has responsibility, when a decision has been made to disclose PCT-CFs to patients, the actual disclosure will undoubtedly involve clinicians.…”

Ostriches and Obligations: Ethical Challenges Facing Research on Usual Care

“…In recent years, a robust body of scholarship has emerged that examines ethical challenges facing the LHO model and related research designs, particularly pragmatic clinical trials and comparative effectiveness research . In “Bystander Ethics and Good Samaritanism: A Paradox for Learning Health Organizations,” in this issue of the Hastings Center Report , James Sabin and colleagues make a valuable addition to this scholarship, identifying and exploring the important question of what researchers' obligations are to patients receiving “usual care” if “that care is seen as suboptimal.”…”

Of Drowning Children and Doubtful Analogies

“…In an article in this issue of the Hastings Center Report , James Sabin and his colleagues ask how we should we think about “bystander ethics” in a learning health organization . At the outset, I must reject the label “bystander ethics.” As understood by Sabin et al, the “bystanders” here are the investigators actively designing and conducting interventional research within a learning health organization, but they are not bystanders at all.…”