107th Congress

Report: VA Research and Non-Profit VA Research Corporations and Educational Foundations—Joint Hearing Before the House Veterans Affairs Subcommittees on Oversight and Investigations and on Health—May 16, 2002

Members Present

• VA Subcommittee on Oversight and Investigations: Representative Steve Buyer (R-IN), Chairman; Representative Julia Carson (D-IN), Ranking Minority Member; Representative John Boozman (R-AR).
• VA Subcommittee on Health: Representative Jerry Moran (R-KS), Chairman; Representative Bob Filner (D-CA), Ranking Minority Member; Representative Vic Snyder (D-AR).

Witnesses

Panel One: Michael Slachta Jr., Assistant Inspector General for Audit, U.S. Department of Veterans Affairs. He was accompanied by John Bilobran, Deputy Assistant Inspector General for Audit, and John Mather, M.D., Chief Officer, Office of Research Compliance and Assurance.

Panel Two: Robert H. Roswell, M.D., Under Secretary for Health, Veterans Health Administration, U.S. Department of Veterans Affairs. He was accompanied by Tim S. McClain, General Counsel; John R. Feussner, M.D., Chief Research and Development Officer; Mindy Aisen, M.D., Director of Rehabilitation Research and Development.

Panel Three: Antonio Laracuente, Chairman, National Association of Veterans' Research and Education Foundations and Executive Director, Atlanta Research and Education Foundation; Franklin Zieve, M.D. Ph.D., President, McGuire Research Institute, Inc.; Ken Hickman, Executive Director, Brentwood Biomedical Research Institute; and Wendy Baldwin, Ph.D., Deputy Director for Extramural Research, National Institutes of Health (NIH).

Also in attendance was Marc Smolonsky, Associate Director for Legislative Policy and Analysis, NIH.

Purpose of Hearing: Chairman Buyer announced the hearing would focus on the following four topics:

• follow up on the April, 1999 hearing on the suspension of medical research at the West Los Angeles and Sepulveda VA Medical Facilities
• review of the management and effectiveness of VA research
• the VA education foundations
• intellectual property rights of the government and investigators with respect to VA inventions and discoveries.

Summary

The first panel reported on the Office of Inspector General's work related to the VA's non profit research corporation and the establishment and progress of the Office of Research, Compliance and Assurance (ORCA). Following that report, Committee members asked panelists for their opinion of the VA's responses to a letter from Chairman Buyer, including a page by page analysis of the inadequacy of the response to individual questions.

The second panel focused on the background, operational functioning, and accomplishments of the research and educational corporations, as well as an update of VA's activities to assure that VA research is conducted in the highest regard for research participants' safety and health. The VA's intellectual property rights and benefits were also discussed. During this panel discussion, Representative Carson asked about indirect costs for hosting research projects at the VA. Dr. Roswell stated that from 1968 through 1989, the NIH provided 15 percent in indirect costs to the VA, but that there was agreement between the NIH and the VA to discontinue that arrangement in 1989. He speculated that the reason for the discontinuance was that the VA did not have the appropriate financial mechanisms in place to track the money at that time.

The third panel addressed the management challenges and the effectiveness of VA-affiliated non profits. The complex nature of NIH and VA research collaboration was also discussed. A dialogue regarding concerns about human subjects protection, especially with regard to vulnerable populations such as veterans, continued from the second panel discussion. Chairman Buyer closed the hearing by announcing that another hearing, to be held in September 2002, would examine further the issue of human subjects protections, as well as the funding relationships between the VA and NIH.

Opening Statements

Chairman Buyer outlined the four issue areas noted above that would be addressed at the hearing. He expressed his concern about specific VA medical facilities that were not in compliance with human subjects protection regulations, as well as the need to ensure that institutional review boards (IRBs) are adequately funded and sufficiently staffed to perform their responsibilities. In addition, he wanted to learn how the VA would ensure that it would get its rightful share of royalties generated by new discoveries. He also announced that another hearing would be held in September on VA medical research issues.

Chairman Moran praised the past success of VA researchers while also stating his concern over recent problems regarding the VA's informed consent practices, conflict of interest policies, internal research management practices, and IRB record keeping. Although he was concerned about these issues, he noted that these problems are duplicated in university research programs outside of the VA. He expressed interest in hearing the VA's experience to date with intellectual property law and the VA's technology transfer program.

Dr. Baldwin discussed the complex nature of the partnership that NIH has with the VA. She explained that NIH funds research directly to VA institutions, corporations, or universities (where one of the performance sites is a VA site), and that NIH awards are guided by the NIH Grants Policy Statement. She expressed her pleasure at hearing that the VA has made improvements in their auditing and oversight activities, as that will facilitate future discussions between NIH and the VA regarding administrative costs. Regarding intellectual property issues, Dr. Baldwin explained that NIH functions under the Bayh-Dole Act. She also emphasized the importance of human subjects protection to NIH, and said that NIH will spend approximately $40 million this year to support research advocate programs and IRBs. In addition to IRBs, she reminded the Committee of the role of data safety monitoring boards in protecting research subjects. She concluded by expressing a concern about multiple requirements and expectations across agencies and offices that might be duplicative or in conflict.

Questions

Representative Carson:

The VA-NIH partnership is highly valued by both agencies. As well as being mutually beneficial, is it reasonable to expect that NIH would help support the infrastructure costs of its partners? Now, let me also add, so we can make this brief for you in March of 2001, the NIH Director supported an indirect cost rate for grants to foreign institutions, but declined to provide anything to VA facilities.

Prepared by Susan Persons, OD/OLPA, May 20, 2002