Marshall, Julia E.
Mercaldo, Rachel A.
Lipner, Ettie M.
Prevots, D. Rebecca.
Funding for this research was provided by:
National Institutes of Health
Article History
Received: 22 March 2023
Accepted: 17 July 2023
First Online: 24 July 2023
Declarations
:
: All methods were carried out in accordance with relevant guidelines and regulations by the National Institutes of Health’s (NIH) Office of human subjects Research Protection (OHSRP) and the cystic Fibrosis Foundation. The Institutional Review Board (IRB) of the NIH follows all international ethics rules, regulations, and standards. This research protocol was reviewed by NIH OHSRP, which determined that analyses of CFFPR data was “not human subjects research”, under the 2018 HHS Common Rule (45 CFR 46.102(e)[CitationRef removed](ii), 45 CFR 46.116 (b)[CitationRef removed](i)), because of the use of deidentified data and, accordingly, exempt from IRB review. For inclusion in the CFFPR, written informed consent was obtained from all subjects and their legal guardian(s) by accredited CF care centers.
: Not applicable.
: The authors declare no competing interests.