DeVocht, James W.
Vining, Robert
Smith, Dean L.
Long, Cynthia
Jones, Thomas
Goertz, Christine
Funding for this research was provided by:
Department of Defense Office of Congressionally Directed Medical Research Programs (W81XWH-11-2-0107)
Article History
Received: 12 April 2018
Accepted: 13 December 2018
First Online: 3 January 2019
Ethics approval and consent to participate
: Ethics approvals for the trial protocol were received from three Institutional Review Boards (IRBs): Palmer College of Chiropractic (#2012G143), the RAND Corporation (#2012–03520 AM02), and the Dwight D. Eisenhower Army Medical Center (#389611), which is the IRB of record for Blanchfield Army Community Hospital. An additional approval was given by the US Army Medical Research and Material Command, the Human Research Protection Office, and the Clinical Investigation Regulatory Office. All changes to the protocol were submitted to and approved by all three IRBs. All trial investigators have completed training in the protection of human subjects as required by the respective collaborating institutions. A Cooperative Research and Development Agreement was established between the Clinical Investigation Regulatory Office and the Samueli Institute prior to trial commencement. The Cooperative Research and Development Agreement was approved for the period of April 2014 through April 2017. All aspects of the trial were thoroughly explained to all potential participants and all participants in the trial provided written informed consent.
: Not applicable.
: The authors declare that they have no competing interests.
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