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Comment & Response |

Criteria for Waiver of Informed Consent for Quality Improvement Research—Reply

Mark J. Pletcher, MD, MPH1,2,3; Bernard Lo, MD4; Deborah Grady, MD2,3,5
[+] Author Affiliations
1Department of Epidemiology and Biostatistics, University of California, San Francisco
2Department of Medicine, University of California, San Francisco
3Clinical and Translational Science Institute, University of California, San Francisco
4The Greenwall Foundation, New York, New York
5Deputy Editor, JAMA Internal Medicine
JAMA Intern Med. 2015;175(1):143. doi:10.1001/jamainternmed.2014.6997.
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In Reply We thank Baker and Persell for their thoughtful response. It is indeed useful to consider specific criteria for deciding when a waiver of consent is justified, and we generally agree with the criteria they propose. We also wish to emphasize their and our recommendation that an institutional review board be involved in decision making. The decision to waive consent in a randomized clinical trial is an important one that should be vetted carefully by a disinterested panel, even if the study can be considered a “quality improvement” project.

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January 1, 2015
David W. Baker, MD, MPH; Stephen D. Persell, MD, MPH
1Division of General Internal Medicine and Geriatrics, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois2Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
JAMA Intern Med. 2015;175(1):142-143. doi:10.1001/jamainternmed.2014.6977.
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