Lewy, Jacqueline R.
Patnode, Casey D.
Landrigan, Philip J.
Kolars, Joseph C. https://orcid.org/0000-0002-2603-188X
Williams, Brent C.
Article History
Received: 29 March 2022
Accepted: 10 July 2022
First Online: 19 July 2022
Declarations
:
: The IRBMED of the University of Michigan reviewed this study and determined: “as currently described, it does not require IRB approval because it does not satisfy the definition of research under 45 CFR 46.102(d), 21 CFR 56.102(c), or U-M policy as described in Human Research Protection Program Operations Manual Part 4. Research is defined as ‘...a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.’ The purpose of this Quality Assurance/Quality Improvement (QA/QI) initiative is limited to improving healthcare quality and/or delivery and/or collecting, measuring, and/or reporting patient or provider data for clinical, practical, training or administrative purposes.”
: Not applicable.
: The authors declare that they have no competing interests.