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Learning Health Systems and the Revised Common Rule

Published online by Cambridge University Press:  01 January 2021

Joshua A. Rolnick
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Abstract

Quality improvement (QI) is an important function of learning health systems, and public policy should promote QI activities. Use of systematic methodologies in QI has prompted substantial confusion regarding when QI is human subjects research under the Common Rule, and this confusion persists with the revised Rule. Difficulty distinguishing research from QI imposes costs on the quality improvement process. I offer guidance to IRBs to mitigate these costs and suggest a new regulatory exclusion for minimal risk quality improvement activities.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 2: Human Subject Protection , Summer 2019 , pp. 238 - 246
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

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