[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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