WPP #: X-4
Closure of Study from VCU IRB Oversight
06-07-04, 03-31-06; 6-21-06; 11-30-09
IRB oversight of a research protocol is required as long as the research activities conducted involve human subjects. VCU IRB-approved research studies that have been completed or terminated and meet the criteria for closure as noted below are considered to no longer involve human subjects, and therefore no longer require VCU IRB oversight. When a study meets these conditions, the principal investigator should promptly submit a study closure request to the VCU IRB. The closure request also provides the IRB with a final status report for the study.
This policy refers to research studies that were approved by the VCU IRB via expedited and full board review, as well as those that received an exempt determination. For studies reviewed by an external IRB, including Western IRB (WIRB), NCI Central IRB (CIRB), or for which IRB review was deferred to another institution’s IRB, the investigator must follow that IRB’s policy for study closure.
Criteria for Closure:
VCU IRB oversight may end (following a request for closure) only when ALL the following conditions are met:
- The research is permanently closed to enrollment at the site(s) under the VCU IRB approval, and
- All interactions/interventions with subjects, or access to subjects identifiable private information (including identifiable biological specimens) for the purpose of research data collection is complete, and
- All use, study, and/or analysis of identifiable private information at the research site(s) under the VCU IRB approval is complete.
- Note: For multi-center 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.
Lapse in Continuing Review:
Principal investigators who have any study in an Expired state due to a lapse in continuing review approval will NOT be permitted to submit a new research study for initial IRB review until the expired study has been addressed by submission of a continuing review or study closure request, as appropriate.
Procedures and Guidance
- Study Closure
- To request approval to close the study to further VCU IRB oversight, the PI must submit a closure. By submitting the study closure request, the investigator is attesting to compliance with the criteria outlined in this WPP. Once the submitted study closure request has been reviewed and the closure found to be appropriate, the study will be officially closed with the VCU IRB.
- IRB review and processing of study closure requests:
- Closure requests will be screened by ORSP administrative staff.
- Closure requests may receive administrative review by ORSP staff when the given responses do not require explanation/additional information. Otherwise, the closure request will receive an expedited IRB review. When appropriate, the closure request may be referred to the full board for a determination to either approve the closure (ending VCU IRB oversight), or disapprove the closure (requiring continued IRB oversight).
- Future use, study, or analysis of identifiable private information following study closure:
- If, after study closure, the PI finds that additional interaction/intervention with human subjects enrolled in the study is necessary for the purpose of further research data collection, or if further use, study, or analysis of the identifiable information (including coded data) is needed, the PI must immediately inform the IRB of the situation. The PI may request that the VCU IRB re-open the study by continuing review (if less than 11 months has passed). If more than 11 months has elapsed, or circumstances are substantively changed from the closed study, the IRB may require submission of a new initial review.
- Record retention following study closure:
- Research data and documents: Principal Investigators should retain all VCU IRB correspondence and 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 for specific requirements. Data security must be ensured even after study closure if identifiable information (including coded data) is retained.
- VCU IRB records: The VCU IRB will retain all pertinent documents in accordance with federal and state regulations.
- Principal Investigator Separation from VCU/VCUHS:
A principal investigator who is leaving the institution and who no longer meets the principal investigator eligibility requirements may not continue to serve as principal investigator on research conducted under the VCU IRB approval (refer to WPP# IX-1 for eligibility requirements). Note: If the investigator will continue to maintain a VCU affiliation and plans to remain as the PI for the research conducted under the VCU IRB approval, and the PI eligibility requirements are met, submit the additional documents as outlined in WPP# IX-1 (section A(2)).
- Prior to leaving the institution, the principal investigator must either:
- Obtain VCU IRB review and approval to change the PI to an individual who meets the eligibility requirements; or
- Submit a study closure request if the study will be terminated at VCU.
- The PI should allow ample time for review of the closure request (or change in PI request) prior to his/her separation date.
- The PI and his/her Division/Department Chair are responsible for ensuring these steps are in place prior to separation.
Note: Investigators who are transferring to another institution may consider reviewing the draft FDA guidance document, Considerations When Transferring Clinical Investigation Oversight to Another IRB; Guidance for IRBs, Clinical Investigators, and Sponsors Considering When Transferring Clinical Investigation Oversight to Another IRB, or the draft OHRP guidance document, Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution.
- Prior to leaving the institution, the principal investigator must either:
- Lapse in Continuing Review:
Investigators are responsible for requesting official study closure with the VCU IRB.
Note: Allowing a study to expire in lieu of submitting a study closure request does not satisfy this responsibility.
When continuing review of a research protocol does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically, and all research activities must cease (including recruitment, enrollment, data collection, interactions and interventions with current participants, and data analysis). The only exception is the continuation of current participants for their safety, which must be justified and approved by the IRB. In this case, immediate action by the PI to obtain continuing review is mandatory. Refer to WPP VIII-4 for further information regarding study expiration due to lapse in continuing review.
It is the responsibility of the PI to request study closure. It is the responsibility of the VCU IRB to review the request and approve of (discontinue IRB oversight) or disapprove of (require continuing IRB oversight) the study closure.
DHHS Regulations 45 CFR 46.109(e)
FDA Regulations 21 CFR 56.109(e)
OHRP Guidance on IRB Continuing Review of Research
Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance: Records and Reports (Section 4.9)
FDA Guidance (DRAFT) – Considerations When Transferring Clinical Investigation Oversight to Another IRB; Guidance for IRBs, Clinical Investigators, and Sponsors Considering When Transferring Clinical Investigation Oversight to Another IRB
OHRP Guidance (DRAFT) – Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution
Research Data Ownership, Retention, Access and Security
VCU Human Resources Guidelines for Separating Faculty and Staff
VCU IRB Study Closure Form
VCU IRB WPP# VIII-4; Continuing Review
VCU IRB WPP# IX-1; Principal Investigator Eligibility and Signed Statement of Responsibilities