Office of Research Oversight
Combined Program Reviews
ORO on-site Combined Program Reviews (CPR) provide prospective, broad, integrated reviews of facility research oversight programs in order to identify those program areas that require strengthening. An ORO CPR is not intended to provide an in-depth, comprehensive assessment for all potential research noncompliance at a facility; however, any noncompliance identified during a CPR is required to be remediated. CPRs are conducted on a rotating schedule, and each VHA facility with a research program is anticipated to receive a CPR approximately every 5 years. CPRs include a review of the facility's General Research Administration (GRA) (including the facility's Research & Development Committee (R&DC)), Human Research Protections Program (HRPP), Research Information Security Program (RISP), Animal Care and Use Program (ACUP), and Research Safety and Security Program (RSSP), as applicable.
An overview of the scope of, and process for conducting, CPRs is as follows:
CPRs are broad in scope and involve a review of the various research oversight programs (e.g., ACUP, GRA, HRPP, RISP and RSSP) at a facility. These reviews assess for: appropriate constitution of research oversight committees; adequacy of written policies and procedures for the local review, approval, conduct, and oversight of research; and whether the aforementioned policies and procedures are implemented as written. ORO utilizes a variety of methodologies to conduct this assessment, including: interviewing facility leadership, research administrative staff, research oversight committee members and staff, investigators, and/or other personnel associated with the facility’s research compliance program; reviewing facility research policies, procedures, protocols, memoranda of understanding (MOUs), inspection and audit reports, and other documentation; and conducting physical inspections of research areas. With regard to the review of individual protocols and inspection of research areas, ORO typically employs a “sampling” approach whereby it reviews select protocols and inspects a subset of the research area(s) so as to evaluate whether actual practices comport with regulations and policies governing the review, approval, and conduct of research at a facility.
CPR Procedural Overview
• ORO will contact the facility approximately 8-10 weeks prior to the CPR to discuss dates for pre-site visit interviews and the on-site portion of the review.
• ORO will create a case for tracking purposes.
• ORO will send a formal Letter of Notification (LON) approximately 6-8 weeks prior to the on-site portion of the CPR. The LON will include a list of documents the facility will need to provide to ORO, key personnel to be interviewed, meeting space and logistical requirements, and proposed agendas for videoconferencing and the on-site portion of the CPR.
• The facility will upload requested documents to ORO’s secure SharePoint site approximately 4 weeks prior to the CPR. Documents to be uploaded in advance of the on-site portion of the CPR include: policies and procedures pertaining to the facility’s R&DC, HRPP, RISP, ACUP, RSSP, Research Compliance Officer (RCO), and research pharmacy; research oversight committee rosters and meeting minutes; memoranda of understanding governing reliance on external oversight committees; external and internal research inspection reports; study protocol inventory lists and select protocols (if available electronically); assurance- and accreditation-related records; research audit and training records; hazardous agent and electronic information system inventory lists; and other documents as specified by the team conducting the site visit.
• Interviews will be conducted with key facility personnel involved with the research program. These interviews may occur via video/teleconference prior to the on-site portion of the review and/or during ORO’s on-site visit. Key personnel typically interviewed include (as applicable):
o Medical Center Director
o ACOS/R and AO/R
o R&DC Chair/Coordinator
o IRB Chair/Coordinator
o SRS, IACUC, and IBC Chairs/Coordinators
o Facility Safety Officer and Industrial Hygienist
o Facility Services/Engineer Representative
o VMU Supervisor and Chemical Hygiene Officer
o Veterinary Medical Officer
o Police Services Representative
o Occupational Health Representative
o Research Compliance Officer
o Privacy Officer, Information Security Officer, and Chief Information Officer
o Research Pharmacist
• ORO on-site activities will typically involve, if and as applicable:
o Entrance briefing with VHA facility leadership
o Walk-through of animal facilities and research laboratories with possible ad hoc interviews of Principal Investigators (PIs) and study personnel
o Walk-through of relevant areas to assess research information security with possible ad hoc interviews of PIs and study personnel
o Walk-through of the research pharmacy areas
o Interviews and follow-up interviews with facility personnel, including PIs and other study personnel
o Document review, including review of select protocols
o Exit briefing with VHA facility and Research Service leadership
• ORO will issue a written report describing any findings of noncompliance identified during the course of a CPR and required actions to remediate the noncompliance. ORO’s report may also contain observations, which do NOT constitute findings of noncompliance but may constitute vulnerabilities that facility personnel may consider addressing so as to strengthen their research oversight programs
o A draft of ORO’s written report is provided to VHA facility leadership for review and factual correction within approximately 70 days of ORO’s on-site exit briefing.
o The final version of ORO’s written report is issued within approximately 90 days of ORO’s on-site exit briefing.
o ORO’s final report is transmitted to the VHA facility Director, applicable Network Director, and VHA leadership
• If applicable, facility personnel must submit a Remedial Action Plan to ORO within 30 days after receipt of the final report. The plan must include specific remedial actions and timely completion dates for each finding of noncompliance in the report.
o Except where remediation requires substantial renovation or fiscal expenditure, hiring, legal negotiations, or other extenuating circumstances, remedial actions must be completed within 120 calendar days after any determination of noncompliance.
Where remedial actions cannot be completed in 120 calendar days, the VA facility Director must provide ORO with an acceptable written justification and an acceptable timeline for completion.
o ORO will monitor remediation efforts until satisfied.