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Authors
Sallee, Michelle https://orcid.org/0009-0009-1943-3715
Renwick, Michelle https://orcid.org/0000-0001-6473-5821
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Article History
Received: 16 July 2024
Accepted: 18 July 2024
First Online: 9 August 2024
Declarations
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: We have no known conflict of interest to disclose.
: Federal regulations require institutional review board (IRB) review and approval for human subject research. This article details a quality improvement project, which does not require IRB oversight. Quality improvement (QI) and quality assurance projects always involve human subjects but only have to be submitted for IRB for review if they meet the definition of research. Consistent with Nerenz et al. () and the VCU Office of the Vice President for Research and Innovation (n.d.), strictly QI activities do not require IRB oversight. This manuscript reflects a QI project that was mandated by the named clinic as part of its operations, to update the clinical case management program to reflect current literature, and did not involve randomization as the participants were already established in the clinical case management program.
