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paper of the United States shall be considered to be a ref-
erence to the John J. McGuirk Department of Veterans 
Affairs Outpatient Clinic.
SEC. 11. OFFICE OF RESEARCH OVERSIGHT IN VETERANS 
HEALTH ADMINISTRATION. 
(a) STATUTORY CHARTER.—(1) Chapter 73 of title 
38, United States Code, is amended by inserting after sec-
tion 7306 the following new section: 
‘‘§ 7307. Office of Research Oversight 
‘‘(a) REQUIREMENT FOR OFFICE.—(1) There is in 
the Veterans Health Administration an Office of Research 
Oversight (hereinafter in this section referred to as the 
‘Office’). The Office shall advise the Under Secretary for 
Health on matters of compliance and assurance in human 
subjects protections, animal welfare, research safety, and 
research impropriety and misconduct. The Office shall 
function independently of entities within the Veterans 
Health Administration with responsibility for the conduct 
of medical research programs. 
‘‘(2) The Office shall—
‘‘(A) monitor, review, and investigate matters of 
medical research compliance and assurance in the 
Department with respect to human subjects protec-
tions and animal welfare; and
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‘‘(B) monitor, review, and investigate matters 
relating to the protection and safety of human sub-
jects, research animals, and Department employees 
participating in medical research in Department pro-
grams.
‘‘(b) DIRECTOR.—(1) The head of the Office shall be 
a Director, who shall report directly to the Under Sec-
retary for Health (without delegation). 
‘‘(2) Any person appointed as Director shall be—
‘‘(A) an established expert in the field of med-
ical research, administration of medical research 
programs, or similar fields; and 
‘‘(B) qualified to carry out the duties of the Of-
fice based on demonstrated experience and expertise. 
‘‘(c) FUNCTIONS.—(1) The Director shall report to 
the Under Secretary for Health on matters relating to pro-
tections of human subjects and laboratory animals under 
any applicable Federal law and regulation, the safety of 
employees involved in Department medical research pro-
grams, and suspected misconduct and impropriety in such 
programs. In carrying out the preceding sentence, the Di-
rector shall consult with employees of the Veterans Health 
Administration who are responsible for management and 
conduct of Department medical research programs.
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‘‘(2) The matters to be reported by the Director to 
the Under Secretary under paragraph (1) include the fol-
lowing: 
‘‘(A) Lack of required integrity of content, va-
lidity of approach, and ethical conduct of employees 
in Department medical research programs. 
‘‘(B) Allegations of research impropriety and 
misconduct by employees engaged in medical re-
search programs of the Department. 
‘‘(3)(A) When the Director determines that such a 
recommendation is warranted, the Director may rec-
ommend to the Under Secretary that a Department re-
search activity be terminated, suspended, or restricted, in 
whole or in part. 
‘‘(B) In a case in which the Director reasonably be-
lieves that activities of a medical research project of the 
Department place human subjects’ lives or health at immi-
nent risk, the Director shall direct that activities under 
that project be immediately suspended or, as appropriate 
and specified by the Director, be limited.
‘‘(d) GENERAL FUNCTIONS.—(1) The Director shall 
conduct periodic inspections and reviews, as the Director 
determines appropriate, of medical research programs of 
the Department. Such inspections and reviews shall in-
clude review of required documented assurances.
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‘‘(2) The Director shall observe external accreditation 
activities conducted for accreditation of medical research 
programs conducted in facilities of the Department. 
‘‘(3) The Director shall investigate allegations of re-
search impropriety and misconduct in medical research 
projects of the Department. 
‘‘(4) The Director shall submit to the Under Sec-
retary for Health, the Secretary, and the Committees on 
Veterans’ Affairs of the Senate and House of Representa-
tives a report on any suspected lapse, from whatever cause 
or causes, in protecting safety of human subjects and oth-
ers, including employees, in medical research programs. 
‘‘(5) The Director shall carry out such other duties 
as the Under Secretary for Health may require. 
‘‘(e) SOURCE OF FUNDS.—Amounts for the activities 
of the Office, including its regional offices, shall be derived 
from amounts appropriated for the Veterans Health Ad-
ministration for Medical Care. 
‘‘(f) ANNUAL REPORT.—Not later than March 15 
each year, the Director of the Office shall submit to the 
Committees on Veterans’ Affairs of the Senate and House 
of Representatives a report on the activities of the Office 
during the preceding calendar year. Each such report shall 
include, with respect to that year, the following:
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‘‘(1) A summary of reviews of individual med-
ical research programs of the Department completed 
by the Office. 
‘‘(2) Directives and other communications 
issued by the Office to field activities of the Depart-
ment. 
‘‘(3) Results of any investigations undertaken 
by the Office during the reporting period consonant 
with the purposes of this section. 
‘‘(4) Other information that would be of inter-
est to those committees in oversight of the Depart-
ment medical research program. 
‘‘(g) MEDICAL RESEARCH.—For purposes of this sec-
tion, the term ‘medical research’ has the meaning given 
such term in section 7303(a)(2) of this title.’’. 
(2) The table of sections at the beginning of such 
chapter is amended by inserting after the item relating 
to section 7306 the following new item:
‘‘7307. Office of Research Oversight.’’.
(b) CONFORMING AMENDMENT.—Section 7303 of 
title 38, United States Code, is amended by striking sub-
section (e). 
(c) COMPTROLLER
GENERAL
REPORT.—(1) The 
Comptroller General shall conduct a study to assess—
(A) the effects of the establishment by law of 
the Office of Research Oversight in section 7307 of
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title 38, United States Code, as added by subsection 
(a); 
(B) the effects of the specification by law of the 
functions of that Office; and 
(C) improvements in the conduct of ethical 
medical research in the Veterans Health Administra-
tion. 
(2) Not later than January 1, 2006, the Comptroller 
General shall submit to the Committees on Veterans’ Af-
fairs of the House and Senate a report on the study con-
ducted under paragraph (1). The Comptroller General 
shall include in the report such recommendations for legis-
lation and administrative action as the Comptroller Gen-
eral considers appropriate. 
(d) REPORT
BY SECRETARY
OF VETERANS AF-
FAIRS.—Not later than 180 days after the date of the en-
actment of this Act, the Secretary of Veterans Affairs 
shall submit to the Committees on Veterans Affairs’ of 
the Senate and House of Representatives a report setting 
forth the results of the implementation of section 7307 
of title 38, United States Code, as added by subsection 
(a).
Passed the House of Representatives October 29, 
2003. 
Attest: 
JEFF TRANDAHL, 
Clerk.