To establish an office to oversee research compliance and assurance within the Veterans Health Administration of the Department of Veterans Affairs.

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

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.

END