Crowell, Michael S. http://orcid.org/0000-0003-1025-0380
Brindle, Richard A.
Miller, Erin M.
Reilly, Nicholas
Ford, Kevin R.
Goss, Donald L.
Funding for this research was provided by:
Uniformed Services University of the Health Sciences (HU00011920011)
Article History
Received: 18 January 2023
Accepted: 7 July 2023
First Online: 16 October 2023
Declarations
:
: This study was approved by the Naval Medical Center Portsmouth; protocol ID number RHC-A-19–035/19KACH0004, initially approved October 2019. Modifications were approved February 2020, July 2020, September 2020, January 2021, August 2021, February 2022, July 2022, and December 2022. Recruitment began August 2020 and will be tentatively completed in May 2023. A continuing review is conducted annually, last completed in August 2022.All volunteers will read and sign an informed consent form approved by the Institutional Review Board (IRB) prior to participation. Participants will be consented by the PI or other study investigator designated by the PI on an individual basis. The investigator will provide copies of the IRB approved consent form to each participant and provide a verbal outline of the study as described in the consent form. Participants will then be encouraged to read the consent form and will be allowed up to 24 h if requested before signing to appropriately weigh the risks and benefits to them. Throughout the consent process, participants will be instructed that participation is voluntary. In the event that participants do not wish to take the whole 24 h, they may consent immediately. In this case, the investigator will allow the participant to ask any questions they may have prior to participant signature.Based on the type of data being collected in this study, the researchers do not anticipate any incidental or unexpected findings. In cases where the subject could possibly benefit medically or otherwise gain from this study, investigators will contact the subject and arrange for follow-up care. Unexpected (but not serious) adverse events occurring in participants that, in the opinion of the PI, are possibly related to participation in the protocol will be reported by the PI within 10 (ten) working days to the Institutional Official through the Human Protection Administrator (HPA) and to the IRB through the HPA and directly through EIRB.
: All authors completed the International Committee of medical Journal Editors (ICJME) Form for Disclosure of Potential Conflicts of Interest. They reported no conflicts of interest. This work was supported by a grant from the Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) program at the Uniformed Services University of the Health Sciences (USUHS). USUHS/MIRROR did/will not have a role in the study design; collection, analysis, interpretation of data, and writing of the report. USUHS/MIRROR provided technical assistance with regulatory approval and data management systems. USUHS/MIRROR will have to approve the content of the final report submission.