§7307 Office of Research Oversight

Summary

Establish an Office of Research Oversight inside the Veterans Health Administration to advise the Under Secretary for Health and to check that medical research is safe, follows rules, and protects people who take part. The Office must be separate from the groups that run VA research. It must watch, review, and investigate how human research subjects and VA employees are protected and kept safe. A Director will lead the Office and must report directly to the Under Secretary for Health (the reporting cannot be delegated). The Director must be an experienced expert and must consult VA research staff. The Director must tell the Under Secretary about safety issues, allegations of misconduct, and can recommend that research be stopped, limited, or suspended. If the Director reasonably believes a study puts people’s lives or health in imminent danger, the Director must immediately suspend or limit that work. The Office will do regular inspections, watch outside accreditation, investigate impropriety, and report serious safety lapses to VA leaders and the relevant Congressional committees. Money for the Office comes from amounts appropriated for the Veterans Health Administration for Medical Care. By March 15 each year the Director must send the Senate and House Veterans’ Affairs Committees an annual report covering reviews, directives, investigation results, and other oversight information. Medical research means the work described in 38 U.S.C. 7303(a)(2).