Per 38 United States Code (U.S.C.) §7307(d)(1), “[ORO] shall conduct periodic inspections and reviews, as the Director determines appropriate, of medical research programs of the Department.” In fulfillment of this statutory requirement, ORO conducts the following types of site reviews: Combined Program Reviews; Focused Reviews; For-Cause Reviews; and Technical Assistance Reviews. ORO Combined Program Reviews are broad, integrated, proactive reviews that are conducted on a cyclical basis and designed to assist VA facilities in fulfilling their research compliance responsibilities pertaining to: human research protections; research information security practices; laboratory animal welfare; research safety and laboratory security; and general research administration. ORO Focused Reviews are narrower in scope than Combined Program Reviews and focus on individual facility research program oversight areas and/or specific issues for review. ORO For-Cause Reviews are initiated in response to specific allegations of, or information about, the occurrence of potentially serious noncompliance with the laws, regulations, and policies governing VA research. ORO Technical Assistance Reviews provide VA research facilities with operational level evaluations and recommendations for fulfilling their responsibilities to conduct research in compliance with VA requirements.
ORO has made available a number of subject-specific Checklists (accessible at this link) that VA research facilities preparing for one of ORO's site reviews may use as a self-assessment instrument. Such internal use is not mandatory unless otherwise directed by ORO.
Additional information about ORO's Combined Program Reviews and Focused Reviews may be accessed by clicking on the applicable tab on the left-hand side of this webpage.