Adrift in the gray zone: IRB perspectives on research in the learning health system

Sandra Soo Jin Lee, Maureen Kelley, Mildred K. Cho, Stephanie Alessi Kraft, Cyan James, Melissa Constantine, Adrienne N. Meyer, Douglas Diekema, Alexander M. Capron, Benjamin S. Wilfond, David Magnus

Research output: Contribution to journalArticlepeer-review

15 Scopus citations


Background: Human subjects protection in health care contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called “research on medical practice” (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research. Methods: We conducted six semistructured, open-ended focus-group discussions with institutional review board (IRB) members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments. Results: Our study revealed that IRB members are unclear or divided on the central questions at stake in the current policy debate over ethical oversight of ROMP: IRB members struggle to make a clear distinction between clinical research and medical practice improvement, lack consensus on when ROMP requires IRB review and oversight, and are uncertain about what constitutes incremental risk when patients are randomized to different treatments, any of which may be offered in usual care. They characterized the central challenge as a balancing act between, on the one hand, making information fully transparent to patients and providing adequate oversight, and on the other hand, avoiding a chilling effect on the research process or harming the physician–patient relationship. Conclusions: Evidence-based guidance that supports IRB members in providing adequate and effective oversight of ROMP without impeding the research process or harming the physician–patient relationship is necessary to realize the full benefits of the learning health system.

Original languageEnglish (US)
Pages (from-to)125-134
Number of pages10
JournalAJOB Empirical Bioethics
Issue number2
StatePublished - Apr 2 2016

Bibliographical note

Funding Information:
This work was supported by grants from the National Institutes of Health/National Center for the Advancement of Translational Sciences: UL1 TR000423?07S1 to the University of Washington and Seattle Children's Research Institute, and UL1 TR001085 to Stanford University

Publisher Copyright:
© 2016 Taylor & Francis Group, LLC.

Copyright 2016 Elsevier B.V., All rights reserved.


  • IRB
  • informed consent
  • qualitative research
  • randomization
  • research ethics


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