Montana VA Approved To Initiate Human Subjects Research Program

The announcement comes as the VA celebrates National VA Research Week, May 13-17. This year’s theme is “Building Community Through Research,” as the VA celebrates researchers’ contributions to both the Veteran community and the Health Science community as a whole. 

The VA defines research as a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute information to the generalizable knowledge of a scientific discipline (or other scholarly field of study). A systematic investigation is an activity that is planned in-advance and uses data collection and analysis to answer a question. The research may be funded by VA, by other sponsors, or be unfunded. 

The research must be approved by the R&D Committee before it is considered VA research and before it can be initiated.

VA researchers make up innovative teams that have historically developed effective treatments for tuberculosis, invented the CAT scan and the pacemaker, and performed the first-ever liver transplant. More recently research investigators have been critical to supporting the PACT Act, Women's Health, Telehealth, suicide prevention, the President’s Cancer Moonshot, and much more.

“This is an exciting opportunity to expand our capabilities in Montana,” said Duane Gill, Montana VA’s Interim Executive Director. “The VA has, for many years, been an innovator in research that improves the lives of our Veterans and our nation. We are very excited to be able to do our part in making a better future possible.” 

While the announcement is new, the process to begin research will take some time. No specific research project has, yet, been initiated as the R&D committee has not been formed. 

The ORD’s approval is contingent upon appointment of both an Associate Chief of Staff for Research (ACOS/R) or Coordinator for Research and Development (C for R&D) and an Administrative Officer (AO) as required by VHA Directive 1200.02(1): Research Business Operations.  

Additionally, appropriate agreements and standard operating procedures are required prior to initiation of the program:

•          Revision of standard operating policies and procedures as required by ORD for the Montana VA Health Care System Research and Development Committee (R&DC);

•          Execution of an Institutional Review Board (IRB) reliance agreement with the VA Central IRB Panel #4 with implementing standard operating policies and procedures;

•          Completion, submission, and approval of a Federal-wide Assurance (FWA) with the VA Addendum; and

•          Appointment of a Research Compliance Officer in accordance with VHA Office of Research Oversight (ORO) policies.

The ORD did not authorize any research studies involving animal or research laboratories as part of the initial launch of the MTVAHCS’ research program. 

The MTVAHCS serves over 49,000 enrolled Veterans across Montana—an area roughly 147,000 square miles in size. Veterans are cared for by a staff of 1,400 at 18 sites of care across the state.  One third of Montana VA employees are Veterans.  

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