Willetts, Joanna
Ficociello, Linda H.
Johnson, Curtis D.
Alexander, Sandra E.
Mullon, Claudy
Hymes, Jeffrey L.
Article History
Received: 1 September 2022
Accepted: 18 December 2022
First Online: 23 January 2023
Declarations
:
: J. Willetts, L.H. Ficociello, S.E. Alexander, C. Mullon, and J.L. Hymes are employees of Fresenius Medical Care, Global Medical Office. C.D. Johnson is an employee of Spectra Laboratories. C. Mullon and C.D. Johnson own stock in Fresenius Medical Care North America. J.L. Hymes is the Global Head of Clinical Affairs.
: The purpose of this project was to a) implement a practice to improve the quality of patient care, and b) collect patient data regarding the implementation of clinical practice. Under the HHS regulations, these activities do not satisfy the definition of “research” under 45 CFR 46.102(d). For this reason, no additional study-specific informed consent or institutional review board approval was required for this quality improvement project. This project was reviewed and determined to be quality improvement using standardized criteria from the Office of Human Research Protection. This process takes into account the project’s intent, design, funding, patient risk above standard of care, and protection of health information.