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  **STATEMENT OF\                                                                      
  ROBERT H. ROSWELL,                                                                   
  M.D.\                                                                                
  UNDER SECRETARY                                                                      
  FOR HEALTH\                                                                          
  DEPARTMENT OF                                                                        
  VETERANS AFFAIRS\                                                                    
  BEFORE THE\                                                                          
  COMMITTEE ON                                                                         
  VETERANS\'                                                                           
  AFFAIRS\                                                                             
  SUBCOMMITTEE ON                                                                      
  HEALTH\                                                                              
  UNITED STATES                                                                        
  HOUSE OF                                                                             
  REPRESENTATIVES\                                                                     
  July 15, 2003**                                                                      

                                                                                       

                                                                                       
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Mr. Chairman and Members of the Committee.

            I am pleased to be here this morning to present the
Administration\'s views on H.R. 1585, a bill to establish an office to
oversee research compliance and assurance within the Veterans Health
Administration. We fully support efforts to protect human research
subjects, ensure animal welfare and research safety, oversee research
compliance, and assure full compliance with research regulations. The
Secretary recently approved the establishment of the new independent
Office of Research Oversight that is designed to achieve precisely these
ends, and we therefore do not believe this legislation is needed.
However, should the Committee decide to proceed with this bill, we
recommend that several of its provisions be revised.

            Mr. Chairman, H.R. 1585 would amend current law to establish
an independent office within VHA to oversee research compliance and
assurance. The Director of the new office would report directly to the
Under Secretary for Health. The mission of the office would be
multi-faceted. It would provide 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. It would also promote and enhance the ethical conduct of
research, investigate allegations of research impropriety and
misconduct, and suspend, restrict, or modify research.

            Under the bill, the Director of the new office would be
responsible for conducting periodic inspections and evaluations of
research integrity at VA research facilities, and observing external
accreditation site visits for human subjects and animal welfare. The
Director would also investigate allegations of research improprieties,
endangerment or mistreatment of research subjects, research misconduct,
and non-compliance with research policies and regulations. The Director
would notify the Under Secretary for Health when endangerment of human
research subjects is evident or suspected, and would notify Congress
regarding impropriety or misconduct with respect to a VA research
project. Other responsibilities would include the advancement of
research assurance and compliance activities within VA and with academic
affiliates, and the negotiation and maintenance of research assurances
with VA medical centers conducting research involving human subjects or
laboratory animals. Finally, the bill would direct the Comptroller
General of the United States to conduct a study to assess the efficacy
of the office, and to report to Congress regarding any recommendations
for legislative or administrative changes.

            One mission of the new office would be to provide 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. Mr. Chairman, we recommend revising that
provision to state that the office would provide regular counsel to the
Under Secretary on all compliance matters related to these subjects.
Within VA, the Office of Research and Development - ORD - is responsible
for education, training, and policy matters. In this capacity, the Chief
Research and Development Officer regularly advises the Under Secretary
for Health on these subjects. Our suggested revision would clarify that
the Director of this new office would deal specifically with compliance
matters related to these subjects.

            The bill also provides that the mission of the new office
would include promoting and enhancing the ethical conduct of research.
We recommend modifying that portion of the mission description to
clarify that the new office will promote and enhance the ethical conduct
of research through its oversight activities, and that the education
missions remain with ORD. With regard to this important mission area,
the Secretary has recently directed ORD to create the Program for
Research Integrity Development and Education - known as PRIDE. The PRIDE
program will provide important education, training, and policy guidance
to the field.

            The bill also provides that the mission of the new office is
to suspend, restrict, or modify research, or take other appropriate
actions. We recommend revision of that provision to clarify that this
type of action would only be carried out with the concurrence of the
Under Secretary for Health. Incidents that require the suspension or
restriction of research demand the immediate attention of the Under
Secretary for Health, whose programs would be directly affected by such
action. We also suggest removing the provision stating that the mission
of the new office includes the authority to modify research. The Office
of Research and Development has responsibility to fund and monitor all
research projects and should continue to make significant decisions
concerning research protocols and needed modifications to research
projects.

            Mr. Chairman, this portion of the mission statement goes on
to state that the office can take this action to suspend, restrict, or
modify research within the context of preserving the integrity and
validity of research. Requiring the new office to preserve the validity
of research suggests that this office may have responsibility for
overseeing the scientific validity of VA research. As mentioned above,
this important function should remain with the Director of ORD.

            The bill states that the responsibilities of the Director of
this new office would include the observation of external accreditation
site visits for human subjects and animal welfare. We recommend deleting
this provision. Mr. Chairman, the presence of VA central office
organizations in any type of external accreditation site visits does not
add value to the inspection; rather, it creates coordination problems
for the facility, and may even be construed as an attempt by central
office to influence the evaluation. Historically, ORD has sent
accreditation reports to the compliance office. I propose to communicate
accreditation information to any new compliance office by continuing to
send the office copies of all accreditation reports.

            As provided in the bill, the duties of the Director would
include notifying Congress of any finding of impropriety or misconduct
with respect to a research project conducted by the Department. I am
concerned about this provision, as it does not follow the chain of
command within the Department. We suggest deleting this provision, or
revising it to require the Secretary to notify Congress in the case of a
finding of impropriety or misconduct with respect to a VA research
project involving human subjects or animal welfare.

            Mr. Chairman, I am also concerned that this provision, as it
is currently written, may lead to the reporting of many incidents of a
minor nature that are relatively inconsequential to the protection of
human subjects or animal welfare. My experience has shown that some
reported problems, when thoroughly discussed and reviewed, are not
compliance issues. Day-to-day communication about the status of all
ongoing cases may be difficult to manage. It may cause problems, both
for Congress and the new compliance office, in assessing the
significance and importance of the alleged impropriety or misconduct,
and the appropriate actions for responding to the conduct. One option
would be to revise the provision to require reporting of serious cases
of impropriety or misconduct that lead to a site visit to assess and
resolve the incident. A second alternative would be to require the more
comprehensive reporting on a quarterly, semi-annual, or annual basis.

            As I stated earlier, nearly all of the functions that the
bill directs VA to undertake are generally being carried out in VHA,
either within the existing compliance office - the Office of Research
Oversight - or within ORD.

            Mr. Chairman this concludes my testimony. I would be pleased
to answer any questions you may have.