Leen-Feldner, Ellen W. https://orcid.org/0000-0002-8524-7090
Bynion, Teah-Marie
Eglit, Graham M. L.
Bonn-Miller, Marcel O.
Gournay, L. Riley
Feldner, Matthew T.
Funding for this research was provided by:
Canopy Growth Corporation
Article History
Received: 6 June 2022
Accepted: 3 October 2022
First Online: 15 October 2022
Declarations
:
: Conflicts of interest are common in clinical science research. However, such partnerships also stand to do a lot of good in terms of forwarding the literature base and informing intervention design. The goal, therefore, is not to avoid such conflicts, but to ensure full transparency and disclosure in the conduct of all aspects of the study. The first author (Ellen Leen-Feldner) was the principal investigator on this study, which was sponsored by Canopy Growth Corporation, where Graham Eglit, Marcel Bonn-Miller, and Matthew Feldner work. Drs. Leen-Feldner and Feldner are partners. A conflict of interest management plan was approved and filed at the University of Arkansas prior to running the study. This plan included the following steps: (1) develop a detailed plan for every element of the study, including the procedures and analytic approach, and have all parties agree to it in advance. This took the form of a comprehensive study protocol from which any deviation was immediately reported to the sponsor and required a protocol deviation sign-off. Well-established procedures for ensuring scientific rigor and integrity (e.g., double-blinding) also were implemented, and the study was registered on clinicaltrials.gov prior to commencing data collection (NCT04577612). (2) Delegate operational oversight of the study (including all participant interactions) to someone other than Dr. Leen-Feldner (T.B). (3) Submit a final, locked database to an off-site statistician who was not involved in data acquisition and had no interaction with participants (G.E), and (4) clearly state conflicts of interest across all dissemination platforms.