Pbert, Lori
Dubé, Catherine E.
Nagawa, Catherine S.
Simone, Dante P.
Wijesundara, Jessica G.
Sadasivam, Rajani S.
Funding for this research was provided by:
National Institute on Drug Abuse (R34DA050992)
Article History
Received: 11 March 2024
Accepted: 3 June 2024
First Online: 17 June 2024
Declarations
:
: All procedures, including informed assent and consent procedures, were approved by the University of Massachusetts Chan Medical School Institutional Review Board (IRB Docket# H00021082) and uploaded to clinicaltrials.gov (NCT05140915) prior to participant enrollment. Informed assent or consent (for those aged 18 years or older) was completed before enrollment and data collection.
: Parents could choose to opt their child out of the study if they wished. Potentially eligible participants reporting having vaped nicotine in the last 90 days were screened for eligibility. Informed assent procedures were completed for participants under 18 years of age who were not opted out by their parents; students 18 years and older completed informed consent. In accordance with the <i>Code of Federal Regulations</i>, § 46.117, the University of Massachusetts Chan Medical School Institutional Review Board approved both a waiver of informed consent and a waiver of parental permission for all adolescent participants under the age of 18 because they deemed that the research presented no more than minimal risk to subjects, involved no procedures for which written consent was normally required outside of the research context, the investigator provided a written statement regarding the research that embodies the elements of consent and provided participants with that written statement, the research could not have been practicably been carried out without a waiver of parental permission, and a waiver of parental permission did not adversely affect the rights and welfare of the subjects.
: The authors declare no competing interests.