Document is current

Article History

Received: 1 August 2024

Accepted: 28 August 2024

First Online: 4 September 2024

Declarations

:

: The Nationwide Children’s Hospital Institutional Review Board has given ethical approval for this study (STUDY00001919). Any modifications to the study protocol are subject to approval by the IRB of record. Relevant modifications will be reported to the trial registry and other parties as necessary. Informed consent will be obtained from all study participants according to the IRB-approved study protocol. The consent process will take place on-site at the recruitment location and will be completed prior to any data collection. At the time of enrollment, a member of the research team will review the contents of the informed consent document with the potential participant and answer any questions they may have prior to obtaining written consent via e-signature or paper consent form. Consent will be documented in REDCap and a pdf file of the signed e-consent form will be emailed to the participant. If the participant does not have an email address, a paper copy will be signed and distributed to them. Paper consent forms will be used to obtain written consent in person at the time of enrollment only as necessary (e.g., due to technology failure). Participants will be able to leave the study or stop participating in study activities at any time.

: Not applicable.

: The authors declare that they have no competing interests.

: As the primary organization conducting this study and associated data analysis, Nationwide Children’s Hospital is the sponsor of this research. They can be contacted at 700 Children’s Drive, Columbus, OH 43205, USA; phone number: 614–722-2000.