[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1585 Introduced in House (IH)]
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.
Everett, Mr. Bilirakis, Mr. Michaud, Ms. Carson of Indiana, Mr. Filner,
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 Representatives 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 compliance and assurance,
to promote responsible research conduct, and to ensure the ethical
treatment and safety of research subjects (hereinafter in this
subsection referred to as the `Office'). The Office shall be an
independent 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 misconduct, laboratory animal
welfare, and bio-safety.
``(B) To promote and enhance the ethical conduct of
research.
``(C) To investigate allegations of research impropriety
and misconduct.
``(D) To suspend, restrict, or modify research, or take
such other actions as the Director determines appropriate--
``(i) to ensure the safety and ethical treatment 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 requirements 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 research
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 research
assurances with each medical center of the Department
conducting research involving human subjects or laboratory
animals.
``(5) Amounts for the activities of the Office, including field
offices, shall be derived from amounts appropriated for the Veterans
Health Administration for Medical Care, and shall not be derived from
amounts appropriated for the Veterans Health Administration for Medical
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 recommendations for any changes in legislation or
administrative action as the Comptroller General determines
appropriate.
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