1. Office of Research Oversight 1 Core Responsibilities for Human Research Protection Research Compliance Officers Robert Brooks, MD, PhD, MBA Associate Director, Research Compliance Education and Policy, ORO 2011 VA Local Accountability for Research Meeting Washington, D.C., June 1-2, 2011

2. Office of Research Oversight 2 Role of the RCO RCO’s primary responsibility = auditing and reviewing research projects relative to VA research requirements RCO may also serve as a nonvoting consultant, as needed, to the facility’s R&D Committee, IRB, IACUC, Subcommittee on Research Safety (SRS), and other research review committees. The RCO may provide education to research program regarding VA research requirements. RCOs perform other collateral duties as assigned by their facility SOPs and the Facility Director.

3. Office of Research Oversight 3 The RCO should be familiar enough with research requirements regarding privacy and information security to identify concerns and bring them to the attention of the PO and ISO, respectively. The RCO can serve as a resource to the PO and ISO regarding compliance with all VA research requirements. RCOs audit for the presence of a HIPAA authorization or waiver in conjunction with their Informed Consent audits