- Contact the Committee

James Fischl, Director

Veterans Affairs and Rehabilitation Commission

The American Legion

To a joint hearing of The

Committee on Veterans’ Affairs

Subcommittee on Oversight and Investigations

and the

Subcommittee on Health

United States House of Representatives

On

VA-Affiliated Nonprofit Research and

Education Corporations 

May 16, 2002

Mr. Chairmen and Members of the Subcommittees: 

The American Legion appreciates the opportunity to submit this statement for the record on the subject of the management and effectiveness of the relationship between Veterans Health Administration (VHA) facilities and their affiliated nonprofit research and educational foundations.  The Department of Veterans Affairs (VA) is required to report to Congress on an annual basis the activities of these corporations.   

BACKGROUND 

The Veterans’ Benefits and Services Act of 1988, PL 100-322 (now codified at 38 USC 7361-7368), authorized the establishment of a nonprofit corporation (NPC), at any VA medical center (VAMC), to provide a flexible funding mechanism for the conduct of approved research at the medical center.  NPCs are to facilitate and support the VAMC’s research program.  Any funds received for research at the VAMC, other than VA’s appropriated funds, may be transferred to a NPC.  NPCs may accept gifts and grants from individuals, public or private entities.  NPCs can also enter into contracts with individuals, public or private entities.  NPCs are authorized to hire employees.  A NPC may not spend funds for a research project unless the project is approved in accordance with procedures prescribed by the Chief Medical Director for research carried out with VA funds.  Such procedures shall include a peer review process.  

NPCs, established under this law, must comply with the nonprofit corporation laws of the State in which the VAMC is located and, to the extent not inconsistent with any Federal law, are subject to the laws of such State. For the purposes of pertinent sections of the Inspector General Act of 1978, the programs and operations of the corporation are considered to be VA programs and operations with respect to the responsibilities of the VA Inspector General.  Further, a NPC is considered an agency for the purposes of section 716 of title 31 (relating to availability of information and inspection of records by the Comptroller General).  

As of June 1, 2001, 88 VAMCs had received approval for the formation of NPCs and all had acquired nonprofit organization status under section 501(c)(3) of the Internal Revenue Code.  In 2001, 84 NPCs reported previous year revenues totaling nearly $174 million. This represents 20 percent of VA's total research funding from all sources. Individual corporation's revenues ranged from $17,000 to nearly $21 million with 36 foundations reporting income of more than $1 million. Although it was originally anticipated that NPCs would primarily accept clinical research grants from private sector organizations, administration of non-VA federal grants is increasing. Grants from other federal agencies including National Institute for Health (NIH), Department of Energy (DOE), Centers for Disease Control (CDC), Department of Defense (DoD), and National Science Foundation (NSF) amounted to 39 percent of all total NPC revenues in 2000. One NPC in Chicago claims annual revenue in excess of $3 million from a wide range of sources including Abbott Laboratories; Pfizer, Inc.; Genentech, Inc.; Merck & Co., and Smith Kline Beecham and Boehringer Mannheim Corporation. 

MANAGEMENT AND EFFECTIVENESS 

In the nearly 15 years since the authorization of the establishment of NPCs, many have grown both in size and sophistication beyond what was envisioned by the enabling legislation. We commend their success in becoming such a tremendous asset to VA and to the veteran population.  

The American Legion continues to support legislation that clarifies that VAMCs may enter into contracts or other forms of agreements with NPCs to provide services to facilitate VA research and education. The American Legion believes research and education for the betterment of veterans and their families are key elements of VA’s overall mission.  The American Legion remains a strong advocate for the VA research program and the dollars needed to support it. The American Legion supports the proposed change relating to contracts between VAMCs and NPCs. The legislation would further clarify that research corporation employees are covered under the Federal Tort Claims Act (FTCA). It is critical that these employees of VA-affiliated research corporations be protected under FTCA while carrying out their duties under a VA appointment.  If they are not, alternatives NPCs would have to consider may not be acceptable. Two of these possible alternatives would be to either use funds normally devoted to supporting research to buy an expensive blanket insurance policy or to close down the entire operation.  Neither option is acceptable to The American Legion.   

HUMAN RESEARCH SUBJECT PROTECTIONS 

As federal entities conducting medical, clinical, and prosthetic device research involving human subjects, NPCs are subject to Federal regulations governing human experimentation and informed consent.  The Department of Health and Human Services’ Office for Human Research Protections (OHRP) (previously known as the Office for Protection from Research Risks) established these Federal regulations in 38 CFR Part 16.  

The regulatory body responsible for a given clinical trial depends on the type of trial that is being conducted.  FDA regulates clinical trials involving experimental drugs and devices, while trials for other therapies, such as surgery or bone marrow transplants, are subject to HHS regulation.  However, FDA and HHS themselves do not review research proposals. Instead, federal regulations delegate authority for the review, approval, and monitoring of biomedical research studies to Institutional Review Boards (IRBs), which are committees designated by individual institutions.  Therefore, the protection of the rights and welfare of human subjects are left primarily to local peer review committees that are not themselves governmental entities. However, this satisfies peer review requirements of 38 U.S.C. 7364(b). 

Federal regulations mandate that each IRB have at least five members, with "at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are in nonscientific areas."  At least one member of each IRB must be a person "who is not otherwise affiliated with the [research] institution[,]" but all others may be staff members and individuals who are, themselves, conducting clinical trials at the research facility.  According to OHRP, 86 percent of IRB members in 1995 were affiliated with academic research institutions.  Members included people that served as full-time faculty (56 percent), clinical and research staff (18 percent), and administrators (6 percent).  Academic institutions do not compensate their IRB members for their work; therefore, these individuals must volunteer their time without receiving payment or relief from other work duties.  

IRBs must review all research activities that are covered by regulations and must approve each proposed study prior to its commencement. Regulations provide detailed criteria that are required for approval of research.  Initial IRB review can filter out clinical trials that are obviously unsound or pose excessive risks for participants, but effective periodic monitoring by IRBs during the actual course of a study is essential to the protection of human subjects.  FDA and HHS, however, provide little guidance for IRBs concerning continuing reviews. Regulations state merely that "[a]n IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research."  

The regulations further provide that the IRB may "suspend or terminate approval of” any clinical trial that does not comply with its requirements or has caused subjects to suffer “unexpected serious harm.” 

The VA Office of Research Compliance and Assurance (ORCA) is responsible for:

·        advising the Under Secretary for Health on all matters affecting the integrity of research in the protection of human subjects and animals,

·        promoting enhancements in the ethical conduct of research in conformance with regulations and policies, and

·        investigating any allegations of research improprieties and research misconduct.

ORCA identifies five functional “product lines” as its primary mission:

·        Product Line One: Comprehensive Inspection -- Annual comprehensive inspections of research integrity using a standardized Mini-Assessment Program (MAP), and periodic unannounced site visits.

·        Product Line Two: External Accreditation -- Participant/Observers on external accreditation site visits for human subjects and animal welfare, conducted tri-annually.

·        Product Line Three: Investigation --  Investigations of allegations of research improprieties:

v     Types of review:

1.      Special Inquiry Force Team (SIFT).

2.      Comprehensive Research Integrity Program (CRIP). Investigations of allegations of scientific misconduct (Level 2).

·        Product Line Four: Training, Education and Development -- Conduct training, education and development [TED approach]. Work with Veterans Integrated Services Networks (VISNs) and VA medical center “Compliance Officers”. Collaborate with other federal agencies and academic affiliates.

·        Product Line Five: Academic Affiliations – Develop and maintain specific area of emphasis and expertise.  Establish academic affiliation arrangements.  Advance “state of the art” of research assurance and compliance activities. 

ORCA has five geographic regions each overseeing a number of VISNS to which it assigns ORCA/VISN liaisons.  Each VISN has a Research Assurance and Compliance Officer (RACO) and each VAMC has a Research Compliance Officer (RCO).  

The American Legion has previously reported on the problems encountered in the protection of human research subjects at the West Los Angeles (WLA) division of the Greater Los Angeles Healthcare System (VAGLAHCS).  In 1994, the Office of Protection from Research Risks (OPRR) restricted WLA’s Multiple Project Assurance (MPA) because of reporting discrepancies and defects in informed consent procedures.  Over the next five years, an increasingly contentious relationship between OPRR and VAGLAHCS/WLA ensued eventually resulting in OPRR’s deactivation of WLA’s MPA and halted all HHS-funded research projects at that facility.  In its 1999 report, The American Legion Research Task Force made the following recommendations:

ü      Apprise Veterans Service Organizations (VSOs) of VAGLAHCS progress in implementing its recovery plan and new IRB procedures.

ü      Establish Data Safety Monitor Boards for VAGLAHCS and all VA institutions conducting research on vulnerable populations.

ü      Create a national IRB to review approved research and to assist in the process of settling disputes between and differences of opinion among multiple IRBs.

ü      Educate and train all IRB Chairs, members, VA investigators, R&D committees, and support staff.

ü      Establish a minimum and maximum work load that a single IRB can administer.

ü      Reimburse VA 15 percent for NIH and other non-VA funded federal research administered by a VA IRB and using VA assets.  Similar arrangements should be negotiated with private funders of research.

ü      Fund OPRR (now OHRP) to increased staffing.

ü      Eliminate studies having little or no benefit to the veteran population.

ü      Hire a Chief of Staff for the National Ethics Center and require an ethicist to be on both local and National IRBs.

ü      Coordinate research involving Post Traumatic Stress Disorder (PTSD) with the National Centers for PTSD. 

VA, as a sponsor of research, is limited in its ability to monitor all 88 NPCs.  The American Legion believes that a program of annual and occasional unannounced site visits is simply not enough to assure compliance with the myriad of rules and regulations.  It is further recommended that ORCA be authorized to use commercial contract research organizations to provide more frequent comprehensive site inspections.  This monitoring should be done in accordance with the International Conference on Harmonization (ICH) E6 (efficacy) Good Clinical Practices standards. Clinical Safety Data Management is also classified as an "efficacy" topic concern. 

The American Legion believes great progress has been made with the implementation of Federal-wide Assurance (FWA) procedures.  Each VA affiliated NPC that administers federal research grants involving human subjects is required to obtain OHRP approval prior to the expiration of its existing assurances, such as Multiple Project Assurances (MPAs).  VAMCs were required to complete FWA application process by September 30, 2001.  A NPC may not “share” a FWA with a VA medical center or a university.  Each NPC must have its own approval; however, underlying FWA, there must be a written document detailing each institution’s respective responsibilities in assuring oversight.  OHRP maintains that, in the event of an investigation, it will hold an institution responsible only for oversight for which it is legitimately responsible.  However, respective responsibilities must be specified in an agreement with the VAMC. FWA replaces the OHRP Multiple Project Assurance (MPA), Single Project Assurance (SPA), Cooperative Project Assurance (CPA), and the VA Multiple Project Assurance (VA MPA).  In consultation with the VA Office of General Counsel, the National Association of Veterans’ Research and Education Foundation (NAVREF) has negotiated with OHRP revisions to the standard FWA application that address the close relationship between a NPC and its affiliated VAMC.  These modifications clarify that a NPC is responsible for aspects of human studies research oversight to the extent allowed by its authorizing statute.  It also clarifies that a NPC is responsible for its own employees, not VA employees.

SUMMARY 

The American Legion is convinced that VA is the premier research organization leading the nation’s efforts to promote the health care of its veterans.  In meeting its mission, VA capitalizes on the unique opportunities provided by its integrated health care system.    VA continues to strike a balance in research resources among its basic and applied research to achieve a complementary role between the discovery of new knowledge and the application of these new discoveries to medical practice. 

VA research is divided into four organizational units:

·        Cooperative Studies Program – supports the clinical trials with its own statistical support centers and its own FDA approved pharmacy.  The research determines the efficacy and cost effectiveness of new medications and new treatment strategies.

·        Health Services Research and Development Service – supports investigator-initiated research projects, the training of clinicians in applied clinical research, centers of excellence devoted to specific aspects of health care delivery, and service directed projects addressing clinical management needs.

·        Medical Research Service – supports investigator-initiated research projects, the training of clinicians in basic and clinical research, and centers of excellence devoted to specific diseases.

·        Rehabilitation Research and Development Service – investigator-initiated research projects, the training of clinicians and engineers in rehabilitation research, centers of excellence devoted to specific disabilities and technology transfer. 

As the immediate stakeholders in VA’s medical and prosthetic research, The American Legion continues to lobby Congress annually for additional discretionary funding.  This year, National Commander “Ric” Santos urged Congress to provide VA with $420 million in FY 2003.  The American Legion believes every dollar spent in VA’s research program is a wise investment in a national resource. 

Mr. Chairman, that concludes The American Legion’s statement.