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.
Pletcher MJ, Lo B, Grady D. Criteria for Waiver of Informed Consent for Quality Improvement Research—Reply. JAMA Intern Med. 2015;175(1):143. doi:10.1001/jamainternmed.2014.6997