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Article History

Received: 5 August 2019

Accepted: 5 May 2020

First Online: 13 May 2020

Ethics approval and consent to participate

: Each MUSIC practice obtained an exemption or approval for collaborative quality improvement participation from a local Institutional Review Board (IRB) (see Additional file ). Those practices which were neither deemed to be not-regulated nor exempt from IRB approval were approved under expedited review as having “risk [that] is no more than minimal to the human subjects”. The practices approved through expedited review have a waiver of consent (45 CFR 46 116(d)) and waiver of HIPAA authorization. In practices in which MUSIC was deemed to be not-regulated or exempt from IRB approval, MUSIC’s work in quality improvement was determined not to fit the definition of human subjects research requiring IRB approval (per 45 CFR 46, 21 CFR 56) and thus patient informed consent is not required under those regulations. See communication from University of Michigan Institutional Review Board below:“Based on the information provided, the proposed study does not fit the definition of human subjects research requiring IRB approval (per 45 CFR 46, 21 CFR 56) because in this case, it is activities or procedures rather than human subjects that are the object of the study.”

: Not applicable.

: The authors declare that they have no competing interests.