[Congressional Record (Bound Edition), Volume 149 (2003), Part 6]
[Extensions of Remarks]
[Pages 8563-8564]
[From the U.S. Government Publishing Office, www.gpo.gov]




 LEGISLATION TO ESTABLISH AN OFFICE TO OVERSEE RESEARCH AND COMPLIANCE 
               WITHIN THE VETERANS HEALTH ADMINISTRATION

                                 ______
                                 

                            HON. STEVE BUYER

                               of indiana

                    in the house of representatives

                        Thursday, April 3, 2003

  Mr. BUYER. Mr. Speaker, today, I am introducing legislation to 
establish an office to oversee research compliance and assurance within 
the Veterans Health Administration of the Department of Veterans 
Affairs. I am pleased that this legislation has bipartisan support, 
including Chris Smith, Chairman of the Committee on Veterans' Affairs; 
Representative Lane Evans, Ranking Democratic Member of the Veterans' 
Affairs Committee; Representative Terry Everett, the former chairman of 
the Veterans' Affairs Subcommittee on Oversight and Investigations; 
Representative Michael Bilirakis, Vice Chairman, Veterans' Affairs 
Committee; Representatives Michael Michaud, Julia Carson, Bob Filner, 
Michael McNulty, Bob Beauprez, Jeff Miller, John Boozman, Cliff 
Stearns, John Sweeney, Jack Quinn, Henry Brown, Ginny Brown-Waite, and 
John McHugh.
  The VA has made tremendous contributions in the field of medical 
research. I think we all recognize the many accomplishments made by the 
VA in discovering new drug therapies and developing medical devices 
that have benefited not only veterans but all Americans. For instance, 
the VA invented the implantable cardiac pacemaker, developed the 
nicotine patch, performed the first successful liver transplant, and 
assisted in the development of the first oral vaccine for smallpox.
  The intent of this legislation is to ensure that all research funds 
are directed with focus and accountability. It does not seek to impede 
the VA from continuing with the research it conducts.
  Before I summarize the bill, I want to provide some pertinent 
background information as to why this legislation is necessary. In 
April 1999, the Subcommittee on Oversight and Investigations held a 
hearing to examine violations of human research protections that 
occurred in the West Los Angeles and Supulveda Veterans Affairs medical 
facilities that resulted in the shutdown of all research activity at 
those two facilities. These violations were traced as far back as 1993 
and came to light in 1998. The subcommittee's hearing reviewed what 
happened and what was being done to correct the situation.
  At the hearing, the VA announced that it had created a new Office of 
Research Compliance and Assurance (ORCA). Then-Under Secretary for 
Health Kenneth Kizer stated at the April 1999 hearing, ``I want to 
emphasize that this new Office of Research Compliance will be an 
independent, objective, and unbiased entity in its compliance and 
oversight activities.'' Dr. Kizer also said, ``By placing the Office of 
Research Compliance outside of the Research Office, and directly 
reporting to top management within the Veterans Health Administration, 
it is my intention to minimize any real or perceived weakness of this 
type.'' In subsequent hearings, Dr. Thomas L. Garthwaite, who succeeded 
Dr. Kizer as Under Secretary for Health, and Dr. Robert H. Roswell, the 
current Under Secretary both echoed the sentiments expressed by Dr. 
Kizer in his April 1999 testimony.
  ORCA served as the primary advisory component for the Under Secretary 
for Health on all matters affecting the integrity of research in the 
protection of human subjects and welfare of laboratory animals, 
promoting enhancements in the ethical conduct of research in 
conformance with regulations and policies and

[[Page 8564]]

investigating any allegations of research improprieties and scientific 
misconduct. ORCA's major responsibilities included providing direction, 
guidance, and oversight to its field offices that perform their 
delegated roles and responsibilities, in promotion of the office's 
mission.
  ORCA conducted a follow-up review of the Greater Los Angeles Health 
Systems Research Program and recommended lifting its probationary 
status. The review also made recommendations for improvements in the 
research programs. ORCA oversaw the implementation of these 
recommendations.
  Further oversight hearings conducted by my subcommittee produced GAO 
recommendations on necessary VA actions to strengthen the protection of 
human research subjects. GAO recommended that VA identify adequate 
funding levels needed to support human subject protection activities at 
medical centers and ensure an appropriate allocation of funds to 
support the activities.
  The VA's Office of Research Development also provided preliminary 
guidance to VISN Directors on the needed Independent Review Board, IRB, 
staffing levels. The IRBs approve and monitor research protocols for 
all projects at the facility level.
  In January, 2003, it came to the committee's attention that the VA 
intended to combine the oversight responsibility for all human and 
animal research within the Office of Research Development, ORD, the 
very body it was supposed to oversee. I, along with several other 
members of the Oversight Subcommittee, including Representative Lane 
Evans, strongly objected to the proposal and requested the Department 
review its decision and brief the subcommittee before any further 
action was taken.
  The move to combine ORCA with ORD came after a report of alleged 
research misconduct involving human subjects at the VA medical center 
in Albany, NY. My colleagues and I want to insure that oversight of 
human subject research remains truly independent.
  The bill I am introducing would:
  First, create an independent office to oversee research compliance 
and assurance.
  Second, require that the new office have a director who reports 
directly to the Under Secretary for Health.
  Third, provide that the missions of the new office be to offer 
regular counsel to the Under Secretary for Health on all matters 
related to the protection of human research subjects, research 
misconduct, laboratory animal welfare and bio-safety; to promote and 
enhance the ethical conduct of research; to investigate allegations of 
research impropriety and misconduct; to suspend, restrict, or modify 
research to ensure the safety, and ethical treatment of human subjects; 
to preserve integrity and validity of research; to prevent mistreatment 
of laboratory animals used in research; and to assure compliance in the 
conduct of research.
  The bill would require that the director of the office conduct 
periodic inspections at research facilities; observe external 
accreditation site visits; investigate allegations of research 
improprieties, research misconduct, and non-compliance with research 
policies and regulations. The bill would also require the immediate 
notification of the Under Secretary for Health when endangerment of 
human research subjects is evident or suspected and requires that 
Congress be notified when impropriety of misconduct of research 
conducted by the Department has been found.
  The bill will provide that funding for the new office would come from 
the medical care account of the Veterans Health Administration rather 
than from ORD funding.
  Finally, the legislation mandates that the Comptroller General of the 
United States conduct a study of the effectiveness of the new office 
and submit a report to Congress by January 1, 2005.
  I urge my colleagues to cosponsor this important legislation to 
improve protection for our Nation's veterans who participate in VA 
medical research.

                          ____________________