11th NAVREF Annual Report 
April 2002 – March 2003 

NAVREF Mission: NAVREF’s mission is to promote high quality management and communication among the VA-affiliated nonprofit research and education corporations and to pursue issues at the government level that are of interest to its members. 

Board of Directors 

Eileen Lennon, Ph.D., Chair Executive Director, SIBCR, Seattle, WA 
Bradley Olson, Secretary/Treasurer Executive Director, DRI, Columbia, SC 
Robert Guancial Executive Director, BIMR, Buffalo, NY 
Loretta Stillings Executive Director, BRF, Little Rock, AR 
Rita I. Young, PhD, ACOS R&D Hines, IL 
William D. Montague Medical Center Director, Cleveland, OH 
Jacqueline G. Parthemore, M.D. Chief of Staff, San Diego HCS, CA 
Thomas Stripling Director Research, Education and Practice Guidelines, PVA, Washington, DC 

VA Central Office Liaisons 
Nelda P. Wray, M.D., M.B.A.                     Stephanie Pincus, M.D. 

Staff 
Barbara F. West, Executive Director           Angela Murakami, Program Manager 

In Appreciation

NAVREF’s success is highly dependent on generous contributions of time and expertise by its members. All NAVREF activities and accomplishments are made possible by the hard work of its board of directors and many others who are committed to the VA-affiliated nonprofit research and education foundations as well as the VA research and education programs. Individuals who contributed to the activities described below are too numerous to list. However, NAVREF wishes to express its gratitude to all.

Top Five Major Accomplishments April 2002 – April 2003

1. Conveyed a positive view of NPCs during three congressional oversight hearings held in May and September 2002, and April 2003. Bolstered by the “magnificent seven” NPCs that withstood extraordinary GAO and IG scrutiny of their operations, NAVREF was able to make a strong case for the value of the NPCs to VA research and education.
2. Initiated the Best Practices Program, a web-based risk assessment and management resource designed to provide NPC executive directors, boards and management staff members with tools to work toward implementing “Best Practices.”
3. Obtained VHA Technology Transfer Program staff agreement to incorporate in Cooperative Technology Administration Agreements a clause that excludes pharmaceutical studies that involve only data collection. Also, the TTP agreed to amend already approved CTAAs to this effect when requested by universities. While the impact of these decisions has not yet been felt by NPCs, NAVREF anticipates that they will facilitate future clinical research agreement negotiations.
4. Led a successful advocacy effort that:
   • Resulted in a $26.4 million increase in FY 2003 funding for the VA research program.
   • Made Congress aware of the deterioration in VA’s research buildings and for the first time, achieved an earmark for minor construction funding specifically for research facility improvements.
   • Successfully opposed legislation passed by the House that would have imposed burdensome reporting requirements on the NPCs with little improvement in oversight.
5. Conducted outreach directly with pharmaceutical companies and through the Pharmaceutical Research and Manufacturers Association (PhRMA) and the Association of Medical Surgeons of the US (AMSUS) to promote the NPCs as highly qualified administrators of research and education programs, subject to extensive oversight and regulation.

Other Accomplishments and Ongoing Initiatives

Policy Development

• Worked with the Office of General Counsel to revise NAVREF’s legislative initiatives to 1) provide VA with authority to use appropriated funds to pay for services provided by NPCs under a VA-approved contract or a unique reimbursement authority; and 2) strengthen Federal Tort Claims Act (FTCA) coverage for NPC employees.
• Participated in development of responses to IG recommendations for greater NPC oversight, including establishment of the VHA Nonprofit Program Office, and obtained ORD support for the appointment of a VA attorney to provide services and assistance to NPCs on a full time basis. NAVREF provided a detailed job description for the position as well as recommended characteristics for the appointee.
• To foster mutually beneficial relationships and compliance with all relevant guidance, coordinated an Annual Conference session on the IRS, VA, FDA, ACCME and pharmaceutical company perspectives on corporate sponsorship of scientific and educational conferences.
• Provided extensive comments on a new model for clinical research agreements that has been submitted by the OGC Corporations Panel for review by OGC Group III.
• Explored with private sector attorneys and OGC Group V issues related to the NPCs’ ability to copyright government works; conveyed results in a lively Annual Conference session.
• Responded to a draft VHA policy requiring a 10% surcharge on pharmaceutical studies for facility human protection program costs; provided VHA with a carefully researched alternative proposal designed to generate significant new revenues without jeopardizing the NPCs’ competitiveness for studies.

Member Communications and Services

• Responded to numerous email and phone questions, usually with a one-day turnaround time; used questions to prompt newsletter articles on timely topics and additional postings on the web site.
• Conducted a comprehensive survey to evaluate NAVREF programs and services; using results to consider changes, including eliminating the electronic bulletin board/listserv (pending board decision on April 28)
• After considerable research, added the Chubb “Health Care Consultant” policy to the NAVREF insurance program to avail members of professional medical liability insurance that covers the NPC as an entity against suits alleging bodily injury.
• Wrote and disseminated by email 13 newsletters; posted on web site for future reference.
• Completed Best Practices Program sections on human resource management and governance (governance section should be complete by early May), two out of four of the main components of the program.
• Regularly added new information to the NAVREF web site, including the Guidestar compensation survey, as well as continuously updated and improved existing materials.
• Conducted two Best Practices Consultations.
• Distributed to NAVREF members the Clinical Studies Costing Software (CS2) created by CARES to facilitate tracking of mandatory reimbursements to the medical care appropriation.

Advocacy

• Testified before the House Committee on Veterans Affairs on the urgent need for research facility improvements.
• Provided the House VA Committee with proposed legislation to implement the “NIH VA add on.”
• During the 107th Congress, obtained Senate approval of legislation that would provide FTCA coverage for qualified NPC employees with WOC appointments, and contract authority for transactions involving payments to NPCs using appropriated funds; building on support gained last year, initiated a similar effort in the 108th Congress.
• Vigorously opposed legislation passed by the House last year that would have imposed numerous new reporting requirements on NPCs; proposed alternative legislation for the 108th Congress that would be less burdensome but still provide improved oversight and accountability.
• Pursuant to the May and September 2002 hearings, responded in writing to numerous questions asked by the Oversight and Investigations Subcommittee of the Committee on Veterans Affairs regarding the functioning of the NPCs and NAVREF’s role in promoting high standards of operational management.
• Worked with the VSOs that author the Independent Budget (IB) to increase coordination of lobbying efforts with the Friends of VA Medical Care and Health Research (FOVA) coalition; resulted in an expanded IB section on research recommendations and greater visibility of VA research recommendations.
• As a member of the FOVA executive committee and through NAVEF members’ own efforts, advocated FY 2003 and 2004 funding increases by corresponding with members of Congress; meeting with appropriations staff, preparing statements and testimony for hearings, and generating signatures for Dear Colleague letters.
• Expanded web site specifically for members of Congress and staff to facilitate timely delivery of information about VA research in spite of post-anthrax impediments to congressional mail delivery (www.navref.org/publicpolicy).
• Issued regular electronic alerts at key times in the FY 2003 appropriations process to FOVA and NAVREF members to enlist grassroots support for advocacy efforts.

Conferences

• Managed a highly successful 2003 Annual Conference that provided two days of educational sessions specifically targeted to the needs of the NPCs as well as numerous networking opportunities.
• Careful review of evaluations and discussion during the conference prompted consideration of alternative education formats and scheduling as planning for future educational sessions begins.

Governance

• Acknowledged the significant contributions to NAVREF made by Antonio Laracuente during six years on the NAVREF board including three as chairman; appointed Rita Young, PhD, ACOS R&D Hines IL, to fill a vacant position; re-elected continuing board members William Montague, medical center director, Cleveland, OH, Jacqueline Parthemore, MD, chief of staff, San Diego, CA and Robert Guancial, vice president, Buffalo Institute for Medical Research, Buffalo NY; and welcomed newly elected board member Loretta Stillings, executive director, Biomedical Research Foundation, Little Rock, AR, as well as Nelda P. Wray, MD, chief Office of Research and Development, as the new R&D liaison to NAVREF.
• Board of directors held four full day meetings, each hosted by a NAVREF member foundation to allow interaction between the host and NAVREF boards.
• Developed positions on numerous timely issues confronting NAVREF members and directed implementation of initiatives to respond to each.
• Decided to hire a second full time staff member to develop the new Best Practices Program and to ensure business continuity should Ms. West become unable to perform her duties.
• Conducted ongoing board training by reviewing one volume of the BoardSource Governance series during each board meeting.

Administration

• Researched 403b retirement vendors and selected TIAA-CREF to replace Lincoln Life. Hired consultant to advise on financial and internal control policies and procedures which were subsequently approved by the board; established a new chart of accounts to accurately reflect true costs of programs.
• Identified a new accountant and completed a thorough review of all state and federal compliance requirements.
• Initiated credit card merchant services to facilitate conference registrations.