Relevant IRB Policies/Procedures
- Closure and Re-Open (Policy 2.9)
- Research Participant Inquiries (Policy 2.10)
- Maintenance and Retention of IRB Documents (Policy 2.17)
It is the responsibility of the Principal Investigator (PI) to notify the Institutional Review Office (IRO) when a study is being closed.
Closure Criteria: How to know whether a study can be closed
An IRB file may not be closed unless all of the following criteria are met:
| Topic | Closure Criteria |
| Enrollment or accrual | Study is permanently closed to enrollment or to the accrual of new data/specimen subjects (or the study never opened to enrollment/accrual) |
| Interventions and procedures | All participants have completed all study-related interventions and procedures |
| Data collection | The collection of private identifiable information is complete |
| Data analysis | The analysis of private identifiable information is complete |
| Specimens | All biospecimens have been used, destroyed, or transferred |
The Office of General Counsel generally recommends the IRB file also be kept open until manuscripts are published because questions during the publication process could necessitate additional data or specimen analysis.
If any of the above closure criteria cannot be met, you should maintain IRB coverage of the research. Contact IRO@fredhutch.org with questions about the closing criteria.
Instructions: How to close a study or site
| Type of Study/Site | Instructions |
|---|---|
| Full or Minimal Risk Study with Continuing Review requirement | Ensure closure criteria are met (see above section). Prepare a Continuing Review Supplement and indicate closure is being requested. Submit the closure request in Hutch IRB by creating a Continuing Review submission. Answer Yes to “Are you requesting to close this study?”. A new question appears with the “Closing criteria.” You must mark each box to select all five closure criteria. Attach the Continuing Review Supplement. |
| Full or Minimal Risk Study without a Continuing Review requirement | Ensure closure criteria are met (see above section). Submit the closure request in Hutch IRB by creating a Continuing Review submission. Answer Yes to “Are you requesting to close this study?”. A new question appears with the “Closing criteria.” You must mark each box to select all five closure criteria. A Continuing Review Supplement is not required. |
| Exempt Study | Ensure closure criteria are met (see above section). Submit the closure request in Hutch IRB by creating a Continuing Review submission. Answer Yes to “Are you requesting to close this study?” A new question appears with the “Closing criteria.” You must mark each box to select all five closure criteria. A Continuing Review Supplement is not required. |
| Participating Site that is relying on the Fred Hutch IRB | To request closure, the participating site must complete and sign the Closure - Participating Site form. The Fred Hutch study team submits this form using the Comment activity on the pSite’s workspace. To do this:
Please note that a closed site will reflect the status of “Inactive” until the entire study closes. |
| Participating Site that is not relying on the Fred Hutch IRB, where Fred Hutch is the coordinating center | If Fred Hutch is the coordinating center for a multi-site trial, sites that do not rely on Fred Hutch are listed on the Multi-Center Supplement. If one of these sites closes, submit a Modification in Hutch IRB with your next Continuing Review to update the Multi-Center Supplement. |
| Fred Hutch as a site is relying on an External IRB | When a Fred Hutch PI is relying on an external IRB, the Fred Hutch PI must follow the closing procedures that are required by the external IRB. Additionally, the PI alerts the Fred Hutch IRO of the closure via Hutch IRB. To do this:
In the lefthand menu, select Add Comment and attach the closure documentation from the external IRB. Select “IRB Coordinator” as the recipient of the Comment to ensure our staff receives a notification. |
Study Closure by the IRB
Suspension or Termination by the IRB
The IRB may suspend or terminate a study based on review of unanticipated problems involving risks to subjects or others, study participant complaints/concerns requiring evaluation, or serious or continuing noncompliance with federal regulations or IRB policies. For more detailed information regarding these incidences, please see IRB Policy 2.6 Unanticipated Problems Involving Risk to Subjects or Others (0224) and IRB Policy 2.8 IRB Requirements for Reporting to Institutional and External Officials (021).
IRB Approval Lapse
If a Continuing Review has not been submitted in Hutch IRB and approved by the IRB before the study expiration date, IRB approval lapses. A lapse in approval means all research activities must stop including recruitment, enrollment, interventions and interactions, and collection and analysis of private identifiable data. The PI, Primary Contact, and PI Proxies receives an automated email from Hutch IRB as notification that the IRB approval has expired. If the PI wishes to continue to treat previously enrolled participants, the PI must contact the IRB immediately to provide rationale for the continuation of this research treatment/intervention.
The IRB must address on a case-by-case basis those rare instances where "failure to enroll" a new research patient could seriously jeopardize the safety or well-being of an individual prospective participant.
If the PI has not submitted a Continuing Review or Closure within 6 months of the expiration date, IRB staff will administratively close the study. Once a study is Closed in Hutch IRB, this action cannot be undone. The PI must submit a New Study in Hutch IRB if he/she wishes to resume research activities.
Reopening a Study
Once a study is closed in Hutch IRB, the record cannot be re-opened. If further activity needs to occur on the study, the investigator must create a new study record in Hutch IRB. You may be able to use the “Copy Submission” activity to copy the closed study into a new record. Refer to the IRB Policy 2.1 New Application (028) for the procedures for submitting a new study. A cover letter explaining the reason for study reactivation is to accompany this type of new study request.