Office of the Vice President forResearch and Innovation

Submit all required reports in the VIRBs

• Use the ‘Report New Information’ activity in VIRBs to open a new report
• Requirements for reporting of New Information to the VCU IRB are outlined in the HRP-103 - Investigator manual.
• The IRB refers to the HRP-024 - SOP - New Information and the HRP-321 - WORKSHEET - Review of information items for review of new information and reporting requirements.
• The HRP-318 - WORKSHEET - Additional federal agency criteria includes all reporting guidelines for specific federal entities that govern human research.
• The HRP Toolkit guidance also includes instructions for mitigation of research procedures during emergency or disaster situations.
• Refer to the VCU HRPP Kaltura channel for all VIRBs demos and training videos.

Reporting requirements for studies approved by non-VCU IRBs

Once an initial submission is approved an external, non-VCU IRB such as NCI Central, WCG IRB, Advarra or another academic IRB, the principal investigator is responsible for directly submitting all future submissions to WCG IRB, including unanticipated problems, in accordance with that IRB's policies. All unanticipated problem determinations made by an external IRB regarding a VCU research setting should subsequently be submitted in a report to the VCU IRB via the procedure described above.

The HRP-103 - Investigator manual provides guidance for reporting of new information to the IRB for single site and multi-site research.  The HRP-103p Investigator manual - Single IRB review of multi-site research (pSite) provides guidance for single IRB review of multi-site or collaborative research. For questions regarding research reviewed by external, non-VCU IRBs contact irbreliance@vcu.edu or visit the IRB reliance webpage.

Submitting a modification in VIRBs

• Modification requests are completed through the Smartform activity in VIRBs.
• Modifications can be submitted in conjunction with continuing reviews (CR) when studies require formal CR. This would be considered a ‘MOD/CR’ in the VIRBs.
• Complete a modification form in VIRBs and upload all new and revised documents. Note: The compare document feature in VIRBs applies to Microsoft word based files.  For any documents that are not saved in a Microsoft word format, such as pdf, upload tracked changes, OR a summary list of all changes that have been applied to the document, in addition to upload of final (clean) versions.  Also, be sure to disable macros when submitting any updates to word docs.
• Refer to the HRP-103 - Investigator manual for expectations related to IRB oversight and modifications.
• The HRP-103p Investigator manual - Single IRB review of multi-site research (pSite) provides guidance for sites that will serve as Single IRB of record (sIRB).  For questions regarding research reviewed by external, non-VCU IRBs contact irbreliance@vcu.edu or visit the IRB reliance webpage.
• Refer to the VCU HRPP Kaltura channel for all VIRBs demos and training videos.

All full board research must be re-reviewed by the IRB at least annually through a continuing review process. Some, but not all, expedited research also requires continuing review. Exempt research does not require continuing review.

Submitting a continuing review in VIRBs

• Continuing review requests are completed through the continuing review activity in VIRBs.
• Complete a continuing review form and upload relevant documentation such as DSMB reports.
• Refer to the HRP-103 - Investigator manual for expectations related to IRB oversight and continuing review.
• The HRP-103p Investigator manual - Single IRB review of multi-site research (pSite) provides guidance for sites that will serve as single IRB of record (sIRB). For questions regarding research reviewed by external, non-VCU IRBs contact irbreliance@vcu.edu or visit the IRB reliance webpage.
• Refer to the VCU HRPP Kaltura channel for all VIRBs demos and training videos.

RAMS-IRB was designed to prompt an annual status update for studies that did not require formal continuing review (CR) and three year update for exempt studies.  The status updates and three year updates were part of the previous RAMS-IRB process and have been discontinued with the implementation of the VIRBs system. 

Investigators are responsible for submitting timely reporting and notifying the IRB of any updates necessary to the conduct of human subjects research activities as outlined in the HRP-103 - Investigator manual.

When a study no longer requires IRB oversight, the study may be closed with the IRB.  Research teams are expected to reach out to the HRPP staff if uncertain whether a study may be able to close with the IRB, as it varies by protocol.

The following general considerations apply when research no longer requires IRB oversight:

• The research is permanently closed to enrollment at the site(s) under the VCU IRB approval.
• All interactions/interventions with subjects, or access to a subject’s personally identifiable information, (including identifiable biological specimens) for the purpose of research data collection is complete.
• All use, study and/or analysis of identifiable private information at the research site(s) under the VCU IRB approval is complete.

  Note regarding multicenter studies: Continuing review of the research by the VCU IRB is no longer required once the above conditions are met (following a request for closure), even if (i) interactions or interventions with subjects may be occurring at study sites other than those under the VCU IRB approval; or (ii) data analysis of identifiable private information is ongoing at another central site (site other than those under the VCU IRB approval) that collects and analyzes data from all study sites. For studies closed with the VCU IRB under these conditions, investigators may still respond to queries from the statistical center at the other institution regarding previously collected data about subjects who were enrolled under the VCU IRB approval.

As a reminder, principal investigators should retain all VCU IRB correspondence, approved documents and raw data for a minimum of five years; longer retention may be necessary based on applicable regulatory requirements and/or sponsor requirements. Refer to the VCU research data ownership, retention and access policy and the VCU Record Retention Policy for specific requirements. Data security must be ensured even after study closure if identifiable information (including coded data) is retained.

Submitting a closure request in VIRBs

• Closure requests are completed through the continuing review activity in VIRBs
• Complete the continuing review and upload relevant documentation such as DSMB reports
• Refer to the HRP-103 - Investigator manual for expectations related to IRB oversight and study closure.
• Refer to the VCU HRPP Kaltura channel for all VIRBs demos and training videos.

Reliance/externally reviewed studies

Refer to the HRP-103 - Investigator manual for guidance about externally reviewed/reliance submissions. The HRP-103p Investigator manual - Single IRB review of multi-site research (pSite) includes specific considerations and requirements for research that falls under the NIH single IRB (sIRB) mandate.  Additional information can be found on the IRB reliance web page.

The purpose of the Post-Approval Monitoring and Education (PAM&E) is to assist the university and investigators in conducting human research of the highest ethical quality and compliant with federal, state, and local requirements. The PAM&E team works toward this goal by improving investigator/IRB performance through monitoring, education, and measurement of overall quality, effectiveness, and efficiency. In addition, the PAM&E team acts as a resource for the VCU/VCU Health research community by offering help through problem-solving tips, templates, focused educational services, external/internal audit preparation, and referrals.

The HRPP implemented the HRP-430 CHECKLIST – Investigator Quality Improvement under the HRPP Toolkit as part of the ongoing post-approval monitoring and quality assurance process.  The HRPP selects a random sample of studies quarterly.  Research teams will receive a direct notification from the HRPP’s PAM&E team when the HRP-430 checklist is required for a study.  The HRPP Research teams that have received a request for completion of the HRP-430 - CHECKLIST - Investigator quality improvement will need to complete the assessment by the deadline specified in the HRPP’s notice that is sent to the research team.  Questions related to PAM&E should be directed to PAM&E@vcu.edu.

More PAM&E guidance coming soon!