I 
108TH CONGRESS 
1ST SESSION H. R. 1585
To establish an office to oversee research compliance and assurance within 
the Veterans Health Administration of the Department of Veterans Affairs. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 3, 2003
Mr. BUYER (for himself, Mr. SMITH of New Jersey, Mr. EVANS, Mr. EVER-
ETT, Mr. BILIRAKIS, Mr. MICHAUD, Ms. CARSON of Indiana, Mr. FIL-
NER, Mr. BEAUPREZ, Mr. MILLER of Florida, Mr. BOOZMAN, Mr. 
STEARNS, Mr. QUINN, Mr. SWEENEY, Mr. BROWN of South Carolina, 
Ms. GINNY BROWN-WAITE of Florida, and Mr. MCHUGH) introduced the 
following bill; which was referred to the Committee on Veterans’ Affairs 
A BILL 
To establish an office to oversee research compliance and 
assurance within the Veterans Health Administration of 
the Department of Veterans Affairs.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. ESTABLISHMENT OF OFFICE OF RESEARCH 
COMPLIANCE AND ASSURANCE. 
(a) IN GENERAL.—Section 7303(e) of title 38, 
United States Code, is amended to read as follows: 
‘‘(e)(1) There is established within the Veterans 
Health Administration an office to oversee research com-
pliance and assurance, to promote responsible research 
conduct, and to ensure the ethical treatment and safety 
of research subjects (hereinafter in this subsection re-
ferred to as the ‘Office’). The Office shall be an inde-
pendent entity within the Veterans Health Administration. 
‘‘(2) There is a Director of the Office. The Director 
shall report directly to the Under Secretary for Health. 
‘‘(3) The mission of the Office is as follows: 
‘‘(A) To provide regular counsel to the Under 
Secretary for Health on all matters related to the 
protection of human research subjects, research mis-
conduct, laboratory animal welfare, and bio-safety. 
‘‘(B) To promote and enhance the ethical con-
duct of research. 
‘‘(C) To investigate allegations of research im-
propriety and misconduct. 
‘‘(D) To suspend, restrict, or modify research, 
or take such other actions as the Director deter-
mines appropriate—
‘‘(i) to ensure the safety and ethical treat-
ment of human research subjects; 
‘‘(ii) to preserve the integrity and validity 
of research; 
‘‘(iii) to prevent mistreatment of laboratory 
animals used in research; and
‘‘(iv) to assure compliance with require-
ments under law with respect to the conduct of 
research. 
‘‘(4) The Director of the Office shall carry out the 
following duties: 
‘‘(A) The conduct of periodic inspections and 
evaluations of research integrity at research facilities 
of the Department. 
‘‘(B) The observation of external accreditation 
site visits for human subjects and animal welfare. 
‘‘(C) The investigation of allegations of—
‘‘(i) research improprieties, endangerment 
or mistreatment of research subjects, 
‘‘(ii) research misconduct, and 
‘‘(iii) non-compliance with applicable re-
search policies and regulations. 
‘‘(D) The immediate notification of the Under 
Secretary for Health when endangerment of human 
research subjects is evident or suspected. 
‘‘(E) The notification of Congress in the case of 
a finding of impropriety or misconduct with respect 
to a research project conducted by the Department. 
‘‘(F) The advancement of research assurance 
and compliance activities within the Department and 
with established academic affiliation arrangements.
‘‘(G) The negotiation and maintenance of re-
search assurances with each medical center of the 
Department conducting research involving human 
subjects or laboratory animals. 
‘‘(5) Amounts for the activities of the Office, includ-
ing field offices, shall be derived from amounts appro-
priated for the Veterans Health Administration for Med-
ical Care, and shall not be derived from amounts appro-
priated for the Veterans Health Administration for Med-
ical and Prosthetic Research).’’. 
(b) REPORT.—(1) The Comptroller General of the 
United States shall conduct a study to assess the efficacy 
of the office established under section 7303(e) of title 38, 
United States Code, as added by subsection (a). 
(2) Not later than January 1, 2005, the Comptroller 
General shall submit to Congress a report on the study 
conducted paragraph (1), and shall include recommenda-
tions for any changes in legislation or administrative ac-
tion as the Comptroller General determines appropriate.
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