In 2000, VA created the VA Technology Transfer Program to facilitate the  commercialization of VA inventions to benefit veterans and the American  public. VA employees are to disclose inventions to VA  even if they were not created with VA resources. VA Has Taken Steps to Educate Researchers and Universities about Requirements but Could Enhance Researchers’ Training

		VA Has Taken Steps to Educate Researchers but Reported that Researchers Have Not Always Disclosed Their Inventions

Although VA has taken steps to educate researchers about disclosure of  inventions, VA officials reported that the researchers have not  consistently disclosed inventions to the department because they did not  always fully understand VA’s disclosure policy. However,  according to VA officials, a university official, and two VA researchers,  there could be several reasons that contributed to researchers not  consistently disclosing their inventions to VA, including the following:
Researchers may have disclosed inventions to their university,  assuming the university would disclose them to VA on their behalf. Researchers were not familiar with VA’s invention disclosure process  because the process was not routine to them. Researchers may have believed they did not use VA resources and  did not realize they were still required to disclose to VA.
VA research administrators may not always have reminded  researchers of the need to disclose inventions, as they did not  consider this requirement a priority. In the  first 8 months of fiscal year 2017, VA staff made 26 visits to universities  and VA medical centers to meet with researchers to encourage the  disclosure of inventions. VA  provided us with a report from October 2017 indicating that out of over  3,000 eligible researchers, 130 had taken the training (about 4 percent). Without requiring  researchers to take online training on the invention disclosure process  annually, researchers may not be fully informed about the requirement to  disclose inventions, which can result in lost technology transfer  opportunities and lost royalties for VA if the inventions are not disclosed. VA Has Taken Steps to Make Universities Aware of VA Researchers and Disclosure Requirements

Based on our interviews with VA and university officials in our sample,  since fiscal year 2016, the department took steps to make universities  aware of VA researchers and their disclosure requirements in an effort to  improve university disclosures to VA. We reviewed 16 agreements  between VA and affiliated universities, including the five universities with  agreements in our sample, and all of the universities agreed to disclose  joint inventions to the department. VA Increased Communication with Universities about Reporting Commercialization Activities but Has Not Ensured that Such Activities Are Consistently Reported

VA has increased communication with universities since 2016 to help  ensure that universities report information about commercialization  activities for joint inventions, but universities’ reporting remained  inconsistent as of January 2018, according to VA. Under federal standards for internal control, management should  design control activities to achieve objectives and respond to risks. Without providing a  standardized method that clearly guides universities in fulfilling VA’s  reporting requirements for these annual reports, including their format and  content, the department will not be able to ensure detailed and  standardized annual reports that include details about licenses and  royalties. VA officials said that they were working on a template for  universities to use in reporting on commercialization activities for joint  inventions. Conclusions

VA manages a research program unique within the federal government in  that most of its researchers are dually appointed to universities, and their  inventions are jointly owned by VA and the universities, which typically  take the lead on commercialization activities. VA has also taken steps to improve communication with universities to  increase reporting of commercialization activities, but said that such  reporting by universities is inconsistent, and VA may not have adequate  information to account for all of its licenses and royalties. (Recommendation 2)

	Agency Comments

We provided a draft of this report to the Department of Veterans Affairs  for review and comment. 2).
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 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.
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.

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.