General information

Per 38 United States Code (U.S.C.) §7307(d)(1), “[ORO] shall conduct periodic inspections and reviews … of medical research programs of the Department.” In fulfillment of this statutory requirement, ORO conducts the following types of compliance-focused site reviews: Research Oversight Program Assessments (site review format successor to Combined Program Reviews); Focused Reviews; and For-Cause Reviews. ORO Research Oversight Program Assessments are broad, periodic assessments of one or more of a VA medical facility’s research oversight programs (Human Research Protection Program (HRPP) / Animal Care and Use Program (ACUP) / Research Safety and Security Program (RSSP)) and are designated to assist VA facilities in fulfilling their research compliance responsibilities pertaining to: human research protections; laboratory animal welfare; and research safety and laboratory security. ORO Focused Reviews are narrower in scope than Research Oversight Program Assessments and assess select aspects of individual facility research program oversight areas and/or discrete issues warranting additional or specialized oversight. 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 has developed a number of self-assessment Checklists that VA research facilities may find useful when preparing for an ORO Research Oversight Program Assessment or Focused Review.

Additional information about ORO’s Research Oversight Program Assessments and Focused Reviews may be accessed by clicking on the applicable tab on the right-hand side of this webpage.

Research Oversight Program Assessments

ORO Research Oversight Program Assessments (ROPAs) are broad periodic assessments of one or more of a VA medical facility’s research oversight programs (Human Research Protection Program (HRPP) / Animal Care and Use Program (ACUP) / Research Safety and Security Program (RSSP)) for compliance with applicable laws, regulations, and policies governing the review, approval, oversight, and conduct of VA research.  ROPAs are standardized assessments that prioritize identification of research noncompliance associated with higher risk.  ROPAs typically involve a site visit and result in issuance of a formal report describing ORO’s findings of noncompliance and recommendations for programmatic improvements.

ROPA methodology

ROPAs are broad in nature and assess for:  appropriate constitution of primary/local 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 these assessments, including interviews, document review, and physical inspections. 

• Facility personnel typically interviewed during a ROPA include: facility leadership; Research Service leadership and administrative staff; primary/local research review committee members and staff; principal investigators and study staff; the Research Compliance Officer; and other personnel who support the research program.
• Documents typically reviewed during a ROPA include, but are not limited to: facility research policies and procedures; primary/local research review committee membership rosters, meeting minutes, and decisional correspondence; memoranda of understanding governing facility reliance on external research review committees and use of external space or resources for VA research; assurance and accreditation records; study protocol inventory lists; select study protocols and associated study-specific documents (e.g., informed consent documents and adverse event and noncompliance reports); training records; and inspection and audit reports.
• Research areas inspected during a ROPA vary based on the facility research oversight program(s) (HRPP / ACUP / RSSP) being assessed. As applicable, areas inspected may include:  clinical research recruitment and procedural areas; the research pharmacy; research laboratories; research animal housing areas; offices and areas where research data is stored and analyzed; and research administrative records storage locations.  NOTE:  Ad hoc interviews with study staff may occur during inspections. 

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 research areas so as to evaluate whether actual practices comport with regulations and policies governing the review, approval, and conduct of research at a facility.

ROPA procedural overview

• ORO contacts the facility approximately 2 months prior to the ROPA to provide notification that a ROPA will be conducted and discuss dates for document upload, pre-site visit remote interviews, and on-site interviews and inspections.
• ORO creates a case for tracking purposes.
• ORO sends a formal Letter of Notification to facility leadership upon agreement on dates for the ROPA. The notification addresses the documents the facility will need to provide to ORO; key personnel to be interviewed (including an informational sheet for personnel to be interviewed); and meeting space and logistical requirements.
• Facility personnel upload a list of current research protocols and a completed research program information sheet to ORO’s secure SharePoint site approximately 6 weeks prior to the ROPA.
• Facility personnel upload remaining requested documents to ORO’s secure SharePoint site approximately 4 weeks prior to the ROPA.
• ORO conducts interviews with select facility personnel via video/teleconference 1 week prior to the on-site portion of the ROPA.
• ORO conducts on-site activities, which typically involve: an entrance briefing with medical facility leadership, if requested by facility leadership; document review; additional or follow-up interviews, as needed; physical inspections; and an exit briefing with medical facility and Research Service leadership.
• Within approximately 10 weeks of the exit briefing, ORO provides a draft written report of its findings of noncompliance and required remedial actions to medical facility leadership for review and factual correction. (ORO’s report may also contain observations, which do not necessarily constitute findings of noncompliance, for consideration by facility personnel for enhancing local research oversight and sustaining research compliance.)
• Within approximately 1 week of receipt of factual corrections from facility leadership, ORO revises the draft written report, if and as appropriate, and issues its final report. ORO’s final report is transmitted to the Medical Facility Director and applicable Network Director.
• If applicable, facility personnel submit a Remedial Action Plan to ORO within 30 days after receipt of the final report.
• ORO monitors facility remediation efforts.
• ORO notifies facility leadership of closure of the case once remediation efforts are completed or ORO receives satisfactory assurance that such efforts will be completed and interim mitigation actions to manage risks posed by the noncompliance have been implemented

Focused Reviews

ORO Focused Reviews are assessments of select aspects of one of a VA medical facility’s research oversight programs (Human Research Protection Program (HRPP) / Animal Care and Use Program (ACUP) / Research Safety and Security Program (RSSP)) and/or discrete research issues warranting additional or specialized oversight.  Compared to ORO Research Oversight Program Assessments (ROPAs), ORO Focused Reviews are narrower in scope.  ORO’s decision to conduct a Focused Review, and the scope of said review, are guided by:  inherent factors of a facility’s research program (e.g., size and complexity); specific issues of concern at a facility identified by ORO through other mechanisms (Facility Director’s Certification of Research Oversight, reports of noncompliance, etc.); and known VHA-wide research compliance issues that might also be of relevance at a given facility.  Focused Reviews typically involve a site visit and result in issuance of a formal report describing ORO’s findings and recommendations for programmatic improvements.

Focused Review methodology

The methodology used for conducting a Focused Review is dependent on the nature and extent of the issues that are the focus of the review.  ORO Focused Reviews typically involve some combination of the following methodologies:  interviews, document review, and physical inspections. 

• Facility personnel interviewed during a Focused Review may include: facility leadership; Research Service leadership and administrative staff; primary/local research review committee members and staff; principal investigators and study staff; the Research Compliance Officer; and other personnel who support the research program.
• Documents reviewed during a Focused Review may include, but are not limited to: facility research policies and procedures; primary/local research review committee membership rosters, meeting minutes, and decisional correspondence; memoranda of understanding governing facility reliance on external research review committees and use of external space or resources for VA research; assurance and accreditation records; study protocol inventory lists; select study protocols and associated study-specific documents (e.g., informed consent documents and adverse event and noncompliance reports); training records; and inspection and audit reports.
• Research areas inspected during a Focused Review may include: clinical research recruitment and procedural areas; the research pharmacy; research laboratories; research animal housing areas; offices and areas where research data is stored and analyzed; and research administrative records storage locations.  NOTE:  Ad hoc interviews with study staff may occur during inspections. 

With regard to the review of individual protocols and inspection of research areas, ORO may employ a “sampling” approach whereby it reviews select protocols and inspects a subset of research areas so as to evaluate whether actual practices comport with regulations and policies governing the review, approval, and conduct of research at a facility.

Focused Review procedural overview

• ORO contacts the facility approximately 2 months prior to the Focused Review to provide notification that a Focused Review will be conducted and discuss dates for document upload, pre-site visit remote interviews, and on-site interviews and inspections.
• ORO creates a case for tracking purposes.
• ORO sends a formal Letter of Notification to facility leadership upon agreement on dates for the Focused Review. The notification addresses the documents the facility will need to initially provide to ORO; key personnel to be interviewed (including an informational sheet for personnel to be interviewed); and meeting space and logistical requirements.
• Facility personnel upload requested documents to ORO’s secure SharePoint site approximately 4-6 weeks prior to the Focused Review.
• ORO may conduct interviews remotely via video/teleconference with select facility personnel 1 week prior to the on-site portion of the Focused Review.
• ORO conducts on-site activities, which typically involve: an entrance briefing with medical facility leadership, if requested by facility leadership; document review; interviews; physical inspections; and an exit briefing with medical facility and Research Service leadership.
• Within approximately 10 weeks of the exit briefing, ORO provides a draft written report of its findings of noncompliance and required remedial actions to medical facility leadership for review and factual correction. (ORO’s report may also contain observations, which do not necessarily constitute findings of noncompliance, for consideration by facility personnel for enhancing local research oversight and sustaining research compliance.)
• Within approximately 1 week of receipt of factual corrections from facility leadership, ORO revises the draft written report, if and as appropriate, and issues its final report. ORO’s final report is transmitted to the Medical Facility Director and applicable Network Director.
• If applicable, facility personnel submit a Remedial Action Plan to ORO within 30 days after receipt of the final report.
• ORO monitors facility remediation efforts.
• ORO notifies facility leadership of closure of the case once remediation efforts are completed or ORO receives satisfactory assurance that such efforts will be completed and interim mitigation actions to manage risks posed by the noncompliance have been implemented.

Site Review and Report feedback

To continuously improve the Office of Research Oversight’s (ORO) approach to conducting site reviews, feedback is solicited from VA facility personnel following ORO Research Oversight Program Assessments (site review successor to Combined Program Reviews), Focused Reviews, and Technical Assistance visits.  To continuously improve ORO’s approach to communicating noncompliance findings and apprising facility personnel of programmatic areas that should be considered for strengthening, ORO also solicits feedback from VA facility personnel on its reports issued for Research Oversight Program Assessments and Focused Reviews.  The document below presents the survey instruments used by ORO to obtain the feedback of VA facility personnel, and sets forth procedures for:  disseminating survey invitations following ORO on-site reviews and report issuances; administration of the surveys; and post-survey data sharing, data analysis, and action planning.