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Learning Health Systems and the Revised Common Rule.
- Source :
-
Journal of Law, Medicine & Ethics . Summer2019, Vol. 47 Issue 2, p238-246. 9p. - Publication Year :
- 2019
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *HEALTH systems agencies
*INSTRUCTIONAL systems
*MEDICAL quality control
*HUMAN research subjects
*RULES
*ELECTRONIC health records
*AMBIGUITY
*SAFETY regulations
*LEADERSHIP
*MEDICAL care
*NATURAL language processing
*QUALITY assurance
*RISK management in business
*INSTITUTIONAL review boards
*GOVERNMENT policy
Subjects
Details
- Language :
- English
- ISSN :
- 10731105
- Volume :
- 47
- Issue :
- 2
- Database :
- Academic Search Index
- Journal :
- Journal of Law, Medicine & Ethics
- Publication Type :
- Academic Journal
- Accession number :
- 137481229
- Full Text :
- https://doi.org/10.1177/1073110519857279