Document is current

Article History

Received: 19 October 2022

Accepted: 25 November 2022

First Online: 17 March 2023

Declarations

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: Approvals were obtained from the IRB affiliated with each participating site and the local VA Rehabilitation and Development committees: the University of Florida Institutional Review Board and the North Florida/South Georgia Veterans Health Systems, Research & Development Committee in Gainesville, FL.; the VA Caribbean Healthcare System’s Institutional Review Board and the VA Caribbean Healthcare System’s Research & Development Committee in San Juan, PR; the Orlando VA Medical Center’s Institutional Review Board and the Orlando VA Medical Center’s Research & Development Committee in Orlando, FL.; the University of South Florida, Research Integrity & Compliance, Institutional Review Board and the James A Haley Veterans' Hospital, Research & Development Committee in Tampa, FL. The protocol is registered in clinicaltrials.gov (NCT03142841).Tracking and reporting of unanticipated or adverse events is done following IRB guidelines and both are tracked and, logged in a tracking form and reported on yearly review, unless it is an adverse event involving harm to participants which are reported within 24 h of occurrence to the IRB and research compliance officer.This study is audited. Triennial regulatory compliance audits and research safety audits are conducted independently, (one per site) once every three years by the VA medical centers’ compliance officers in Gainesville, Fl., and San Juan, PR who are independent from the funding agency. Audit procedures involve reviewing that informed consent documentation waiver criteria is documented on IRB records and verifying whether continuing review requirements are completed as required. The main study PI conducts yearly visits to all the study sites to ensure proper study procedures are properly followed.All major modifications to the research plan have been submitted for approval from the funding agency. Once approved, modifications are submitted to the IRB and the VA local R&D for approval. No changes are implemented before approvals are obtained unless there is harm to study participants.While we obtained a Waiver Documentation of Informed Consent, members of the research team trained in informed consent procedures utilize an Informed Consent Written Statement to inform interested and eligible participants about the purpose of the study, study procedures including that some sessions may be recorded, risks, volunteer nature of their participation, potential benefits, and who to contact in case of questions or concerns, etc. The written statement is also used to inform and obtain oral permission to record the interventions. A copy of the written statement is mailed to participants prior to reviewing the Informed Consent Written Statement. All informed consent procedures are conducted over the telephone by trained and experienced members of the research team from either the NF/SG VHS or the VACHS. To collect veteran healthcare utilization data, we ask caregivers to self-report.

: NA.

: The authors have no conflicts of interest to declare.