Veterans Affairs Research:
Actions Needed to Help Better Identify Agency Inventions
GAO-18-325: Published: Apr 25, 2018. Publicly Released: May 7, 2018.
Did you know that the Department of Veterans Affairs employed researchers who helped develop the pacemaker in 1960? Since 2000, VA research has resulted in VA-owned patents. VA can grant licenses to private sector firms to make its medical technologies commercially available while VA collects the royalties.
To ensure this happens, VA requires its researchers and the universities that employ them to disclose their inventions.
We found inconsistent disclosures from researchers and low turnout in VA's training on disclosures. We also found that VA’s reporting requirements for universities were unclear—and recommended ways to address these issues.
Photo of a plaque on the VA headquarters building.
What GAO Found
The Department of Veterans Affairs (VA) has taken steps to educate agency researchers about its requirements to disclose inventions to VA, but officials reported that researchers have not consistently done so. VA policy requires researchers to disclose inventions to both VA and the university they work for even when they do not use VA resources. GAO found, through discussions with VA officials and researchers, that several factors contribute to researchers not consistently disclosing their inventions, including that VA researchers may have:
disclosed inventions to their university, assuming the university would then disclose them to VA;
not been familiar with VA's invention disclosure process, because they may not have frequently developed inventions; or
thought that invention disclosure was unnecessary when they did not use VA resources to develop their invention.
In 2017, VA staff visited universities and VA medical centers 26 times to meet with researchers about invention disclosure. Also, VA created an online training course to educate researchers on the need to disclose inventions, but the training is not mandatory, and about 4 percent of researchers took it. Without mandatory training to communicate invention disclosure requirements—consistent with federal internal control standards for internally communicating quality information—VA researchers may not be fully informed about those requirements, which can result in lost technology transfer opportunities and royalties for VA.
Path of Invention Disclosures at the Department of Veterans Affairs (VA)
VA has improved communication with universities but has not ensured that they are consistently reporting information on commercialization activities for joint inventions. VA reported that about three-quarters of VA's 79 university partners did not submit the annual reports required by VA in 2017. GAO reviewed a nongeneralizable sample of agreements VA has with universities and found that reporting requirements about timing and content of reports were unclear. Without providing a standardized method that clearly guides universities in fulfilling VA's reporting requirements, consistent with federal standards for internal control, VA cannot ensure that it has adequate information to account for its licenses and royalties.
Why GAO Did This Study
VA manages a $1.9 billion research program that has produced numerous healthcare inventions, such as the pacemaker. In 2000, VA created a program to help transfer VA inventions to the private sector so that they can be commercialized and used by veterans and the public, while VA retains ownership and collects royalties. Many of VA's 3,000 researchers also hold positions at universities, which take the lead in commercializing inventions developed by these researchers. Researchers and universities are required to disclose such inventions to VA, and universities are to report on commercialization activities according to their agreements with VA.
GAO was asked to examine VA's ability to ensure its ownership of inventions made with VA resources. This report examines, among other things, the extent to which VA has taken steps to ensure that (1) researchers disclose inventions and (2) universities report on commercialization activities for joint inventions. GAO reviewed laws; policies; a nongeneralizable sample of university agreements based on backlogs of disclosures, among other factors; and interviews with officials and researchers from VA medical centers and their affiliated universities.
What GAO Recommends
GAO recommends that VA (1) make training about invention disclosure mandatory and (2) provide universities with a standardized method for annual reporting. VA concurred with GAO’s recommendations.
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Recommendations for Executive Action
Comments: VA concurred with the recommendation and stated in July 2018 that its Office of Research and Development requested that its online training course become mandatory for VA researchers. The office is awaiting details from VA's Employee Education Service. Once the course is placed in a mandatory status, the office will ensure that all researchers will take the course by September 2019 and thereafter on an annual basis.
Recommendation: The Under Secretary of Health should make VA's online training on invention disclosure mandatory for researchers and require that it be completed annually. (Recommendation 1)
Agency Affected: Department of Veterans Affairs
Comments: VA concurred with the recommendation and stated in July 2018 that VA's Technology Transfer Program office is developing an annual report template for universities. The director of VA's Technology Transfer Program will send a letter with the annual report template requesting each university complete their annual reporting of technology transfer information to VA using the form. The status is in progress with a target complete date of December 2018.
Recommendation: The Under Secretary of Health should provide a standardized method that guides universities in fulfilling VA's reporting requirements for these annual reports, including their format and content. (Recommendation 2)
Agency Affected: Department of Veterans Affairs