National Academy of Medicine

Revisiting the Common Rule and Continuous Improvement in Health Care: A Learning Health System Perspective

By Richard Platt, Christopher Dezii, Barbara Evans, Jonathan Finkelstein, Don Goldmann, Susan Huang, Gregg Meyer, Heather Pierce, Veronique Roger, Lucy Savitz, and Harry Selker
December 30, 2015 | Discussion Paper

Development of this paper was proposed during discussions of the NAM Clinical Effectiveness Research Innovation Collaborative, in which several of the authors are participants. Due to our affiliation, we use a learning health system perspective, especially as it relates to clinical effectiveness research and practice. This paper focuses on a subset of key principles foundational to continuous learning. We revisit the distinctions between activities that we believe should require formal oversight by an IRB and those that should not. We provide more in-depth discussion on two aspects of the learning health system: the oversight of QI activities, and the use of cluster randomization as a tool to advance learning, both for QI and other operations activities. We focus especially on establishing an IRB oversight mechanism that protects individuals while encouraging health care systems to learn as much as possible from their ongoing activities.

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Disclaimer: The views expressed in this paper are those of the authors and not necessarily of the authors’ organizations, the National Academy of Medicine (NAM), or the National Academies of Sciences, Engineering, and Medicine (the National Academies). The paper is intended to help inform and stimulate discussion. It is not a report of the NAM or the National Academies. Copyright by the National Academy of Sciences. All rights reserved.