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It is the responsibility of the Principal Investigator (PI) to notify the Institutional Review Office (IRO) when a study is being closed.
|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 Continuing 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 continuing review by the IRB.
|Exempt 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.|
|Fred Hutch is Relying on an External IRB||Complete an External IRB Cover Sheet - Continuing Review or Other and indicate study closure. Include closure documentation from the IRB of record.|
|A performance site ends its engagement in research with Fred Hutch||
When a performance site conducting their own IRB review ends its engagement in research with Fred Hutch and Fred Hutch is serving as the coordinating center, update the list of coordinated sites on the Multi-Center Supplement Form at the next Continuing Review Report.
A Research Modification Form is not needed unless other documents (e.g. protocol, consent forms) need to be updated.
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.
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.
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.
Whichever format is used, the reactivation request should include a justification for reopening the study — for example, a re-examination of the data.