Czynski, Adam http://orcid.org/0000-0002-0062-0731
Laptook, Abbot
Das, Abhik
Smith, Brian
Simon, Alan
Greenberg, Rachel
Annett, Robert
Lee, Jeannette
Snowden, Jessica
Pedroza, Claudia
Lester, Barry
Eggleston, Barry
Bremer, Drew
McGowan, Elisabeth
Funding for this research was provided by:
National institutes for health helping to end addiction long term initiative (U24HD095254, U2COD023375, U24OD023957)
Article History
Received: 29 March 2023
Accepted: 16 May 2023
First Online: 21 July 2023
Declarations
:
: Original approval letter from cIRB is attached.Name of the ethics committee that approved the study: University of Arkansas for Medical Sciences Institutional Review Board.Committee’s reference number: FWA00001119.Protocol Number: 260053 – University of Arkansas for Medical Sciences Institutional Review Board FWA00001119. Written, informed consent, and when applicable written informed assent, will be obtained from all participants.
: Not applicable - no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are attached as supplementary materials.
: The study investigators have no financial conflicts of interest (FCOI) related to the study outlined in this protocol. We will handle any potential or perceived conflicts of interest, including FCOI, per Title 42, Code of Federal Regulations, Part 50, Subpart F (50.604 Responsibilities of Institutions regarding Investigator financial conflicts of interest). This states that institutional officials (and all subrecipients) are required to notify the grants officer of any FCOI prior to expenditure of any funds and within 60 days of any subsequently identified FCOI. The research team will simultaneously notify NICHD, ECHO office, the NRN Steering Committee, and the ISPCTN Steering Committee regarding the COI management plan, following institutional guidelines of each participating hospital.