Closing or Reopening a Study

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

Submit a Continuation Review Report (CRR) and a manuscript or abstract, if applicable.

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.

Study Closure by the IRB

Suspension or Termination by the IRB

The IRB may close a study based on review of adverse events, 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/particient 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.