Page:United States Statutes at Large Volume 117.djvu/2079

 117 STAT. 2060

Establishment.

VerDate 11-MAY-2000

10:15 Aug 27, 2004

PUBLIC LAW 108–170—DEC. 6, 2003

‘‘§ 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, 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 protections; and ‘‘(B) monitor, review, and investigate matters relating to the protection and safety of human subjects and Department employees participating in medical research in Department programs. ‘‘(b) DIRECTOR.—(1) The head of the Office shall be a Director, who shall report directly to the Under Secretary for Health (without delegation). ‘‘(2) Any person appointed as Director shall be— ‘‘(A) an established expert in the field of medical research, administration of medical research programs, or similar fields; and ‘‘(B) qualified to carry out the duties of the Office based on demonstrated experience and expertise. ‘‘(c) FUNCTIONS.—(1) The Director shall report to the Under Secretary for Health on matters relating to protections of human subjects in medical research projects of the Department under any applicable Federal law and regulation, the safety of employees involved in Department medical research programs, and suspected misconduct and impropriety in such programs. In carrying out the preceding sentence, the Director shall consult with employees of the Veterans Health Administration who are responsible for the management and conduct of Department medical research programs. ‘‘(2) The matters to be reported by the Director to the Under Secretary under paragraph (1) shall include allegations of research impropriety and misconduct by employees engaged in medical research programs of the Department. ‘‘(3)(A) When the Director determines that such a recommendation is warranted, the Director may recommend to the Under Secretary that a Department research activity be terminated, suspended, or restricted, in whole or in part. ‘‘(B) In a case in which the Director reasonably believes that activities of a medical research project of the Department place human subjects’ lives or health at imminent 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 include review of required documented assurances. ‘‘(2) The Director shall observe external accreditation activities conducted for accreditation of medical research programs conducted in facilities of the Department.

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