Aksamit, Timothy
Wu, Jasmanda
Hassan, Mariam
Achter, Emily
Chatterjee, Anjan
Article History
Received: 18 July 2022
Accepted: 21 November 2022
First Online: 3 December 2022
Declarations
:
: This study was performed in accordance with relevant guidelines and regulations. Since the study did not involve the collection, use, or transmittal of individually identifiable data, IRB approval was not required. This study analyzed only de-identified data which are priori exempt from the Federal Policy for the Protection of Human Subjects (1991) and does not meet the identification criteria necessary to be privileged under HIPAA [CitationRef removed]. As such, IRB approval to conduct this study was not required and considered exempt according to 45CFR46.101(b)(4): Existing Data and Specimens—No Identifiers. Informed consent to participate in this retrospective study was optional but not necessary under HIPAA; the process for obtaining consent was at the discretion of the healthcare provider [CitationRef removed]. The APCD is owned by STATinMED and no further permission to access the database was required.
: Not applicable.
: TA has no competing interests to declare. JW, MH, and AC are employees and shareholders of Insmed Incorporated. EA is an employee of STATinMED, which received funding from Insmed Incorporated to conduct the study.