Closing or Reopening a Study
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Relevant IRB policies/procedures: |
It is the responsibility of the Principal Investigator (PI) to notify the Institutional Review Office (IRO) when a study is being closed. Closures involving the Clinical Research Division must first be routed through the Protocol Office (206-667-4520). Contact the Protocol Office prior to submission to obtain the appropriate forms.
Closure by the PI
| Type of Study | How to close a study or terminate an agreement |
| Full or Minimal Risk Study |
To close a Full or Minimal Risk study, submit a Continuation Review Report (CRR) and indicate closure is being requested. Full or Minimal Risk studies may not be closed until all research interventions are concluded and all data analysis it complete. Note: A CRR noting study closure to accrual with continued data collection and/or intervention of previously enrolled subject is not a closed IR file. The IR file is required to receive continuation review by the IRB. |
| Exempt or Cooperative Study |
To close an exempt or cooperative review study during its approval period, complete a Research Modification Form requesting the closure. A final report is not required. |
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Terminating an IRB Authorization Agreement when FHCRC is relying on an offsite institution for IRB review, complete a Research Modification Form requesting to terminate the agreement. A final report is not required. |
| IRB Authorization Agreement when FHCRC is the IRB of Record |
The performance site's closure letter or an email from the PI/contact person stating the IAA has been terminated, including when and why it was terminated is sufficient documentation. A Research Modification Form is not required. |
| A performance site ends its engagement in research with FHCRC |
When a performance site ends its engagement in research with FHCRC and FHCRC is serving as the coordinating center, submit any documentation (email, letter, memo) stating that the performance site no longer engaged in research with FHCRC. A Research Modification Form is not needed unless other documents (e.g. protocol, consent forms) need to be updated. |
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When the relationship ends between FHCRC and the collaborating investigator, submit any documentation (email, letter, memo) to end the Individual Investigator Agreement. A Research Modification Form is not needed unless other documents (e.g. protocol, consent forms) need to be updated. |
Study Closure by the IRB
Suspension or Termination by the IRB
The IRB may close a study based on review of unanticipated problems, study participant complaints/concerns requiring evaluation or noncompliance by a PI. The PI will be notified immediately upon IRB determination of study closure by email and phone. When the IRB determines that a study should be closed, this means accrual is temporarily closed and the treatment/intervention with previously enrolled participants/patients must cease. If the PI wishes to continue to treat or intervene with previously enrolled participants/patients, he/she needs to contact the IRO immediately to provide rationale for the continuation of this treatment/intervention.
IRB Approval Lapses
If the IRB does not review and approve the IR file by the specified review date, new participant accrual must be temporarily stopped pending review and approval of the IR file by the IRB. If the PI wishes to continue to treat previously enrolled participants/patients, he/she must contact the IRO immediately to provide rationale for the continuation of this treatment/intervention.
The IRB will address on a case-by-case basis those rare instances where failure to enroll a new research patient/participant would seriously jeopardize the safety or well-being of that prospective participant.
Reopening a Study
Requests to reopen a study will undergo either full or minimal-risk review, depending on the activity. A memo explaining the reason for study reactivation should accompany the reactivation request.
Submission formats:
- If the study has been closed for more than 6 months, a new application must be submitted.
- If a protocol's reactivation is requested within 6 months (or less) of the initial closure, a CRR may be submitted to reactivate the study. Please contact one of the IRB analysts to determine the type of documentation required.
Whichever format is used, the reactivation request should include a justification for reopening the study — for example, a re-examination of the data.
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©2013 Fred Hutchinson Cancer Research Center 1100 Fairview Ave. N., P.O. Box 19024 Seattle, WA 98109 |
