Study Closure

When a study meets the criteria for closure, IRB oversight is no longer needed and a study may be closed with the IRB.

VCU IRB oversight may end (following a request for closure) only when ALL of the following conditions are met:

  1. The research is permanently closed to enrollment at the site(s) under the VCU IRB approval; and
  2. 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; and
  3. All use, study, and/or analysis of identifiable private information at the research site(s) under the VCU IRB approval is complete.

    NOTE: For 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 (5) 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 RAMS-IRB

  • Login to RAMS-IRB and open the workspace for the study that is ready to close
  • Click the “New Study Closure” button
  • Complete the closure form and upload relevant documentation such as DSMB reports.

Alternatively, a study can be closed at the time of continuing review by selecting the close study option within the continuing review activity.

Please see the RAMS-IRB Submission System Guide for details on submitting a Closure request.

Maintaining Approval for Western IRB Approved Research

Once an initial submission is approved by WIRB, the Principal Investigator is responsible for directly submitting all future submissions to WIRB including study closure requests.

A copy of ALL submissions must be provided to ORSP via IRBIntake@vcu.edu, as well as to WIRB.

Be aware that WIRB updates its submission forms as much as twice yearly to improve the review of research and protection of human subjects. When preparing to submit research for review, be sure to use the most current versions of WIRB submission forms by referring directly to the WIRB forms site.