Londono, Maria J.
Peri, Saketh R.
Hasan, Rakib
Evans, Connor J.
Restrepo, David
De Lorenzo, Robert A.
Hood, R. Lyle
Article History
Received: 23 October 2024
Accepted: 12 June 2025
First Online: 16 July 2025
Declarations
:
: This study was conducted as part of the NSF 21–552: Innovation Corps Team Program and involved informal interviews and anonymous data collection focused on identifying end-user needs for product development. These activities were limited to general, non-sensitive feedback and did not involve identifiable or sensitive information. The study was conducted in accordance with institutional guidelines and the ethical principles outlined in the Belmont Report and the U.S. Common Rule (45 CFR 46), under which the research was deemed exempt from formal Institutional Review Board (IRB) review under section 45 CFR 46.104. Because the data collection was anonymous and focused solely on general end-user feedback without identifying information, formal informed consent procedures were not required. This determination follows institutional standards and national regulations, as outlined in the Common Rule exemptions (45 CFR 46.104), which do not mandate consent for exempt activities that involve only non-identifiable, non-sensitive data. Additionally, institutional approval for the reporting and publication of the SCRAMM device was granted, and a patent application for the device has been formally filed. All information disclosed in this manuscript complies with institutional disclosure and intellectual property policies.
: No applicable.
: MJL, SRP, RH, CJE, and DR declare that they have no competing interests. RDL and RLH disclose a conflict of interest as principals of EmergenceMed, LLC, a company involved in the development of new airway management technologies.