In April 2006, the University of Kentucky (UK) Institutional Review Board (IRB) and the Office of Sponsored Projects Administration (OSPA) agreed to eliminate the policy, which required protocols to remain under IRB approval while a sponsored program account (ledger 4) remained active.
[D76.0000] Study Closure
Circumstances when IRB approved active protocols may be closed by the PI and/or the IRB
A study is open and the only activity remaining is analysis of data collected during the study
The study may be closed by the PI if any of the following conditions exist:
- The data is de-identified and there are no subject identifying codes or links to the de-identified data; or
- The data for studies approved after January 21, 2019, with identifiers, is encrypted; or
- For FDA-regulated studies, there are no outstanding data queries or other investigator/site responsibilities in the trial
A study has been open for a period of three or more years and there have been no subjects enrolled in the study
If, at Continuation or Annual Administrative Review, the investigator reports to the IRB that the study has been open for a period of three or more years and there have been no subjects enrolled into the study, the IRB may request study closure, unless justified (e.g., study involving a rare condition). A notification of closure is sent to the investigator.
Closing a Study Falls into Three Categories
- Final review (FR)
- Study Closure due to non-response or lapse of approval due to non-response to requests for continuation or final review (See Continuation Review SOP)
- Non-response from PI to IRB requests for revisions (a vote of 2, 3, or 4)
- Study Closure due to study never being initiated (i.e., non-enrollment, no data collection from records, and/or no specimens having been obtained)
Why close your study rather than let it expire?
- Formally closing the protocol is an investigator's responsibility. The process signals the date IRB oversight is no longer required. Allowing a protocol to expire is not an acceptable alternative to submitting a closure request.
- When submitting a closure request, E-IRB asks a series of questions to determine whether the study meets regulatory criteria for closure. FDA, pre-2019 Common Rule, and 2019 Common Rule regulations differ in this regard.
- The answers to the closure questions also tell you whether a Final Review is needed. Many studies will be able to close without completing a Final Review.
- Closing the protocol allows the audit and records retention timelines to begin. UK IRB policy requires investigators to maintain their research records (signed documents and IRB records) for six years after completion of the study.
- IRB closure records have been relied upon by investigators as a source of information for funding organizations, regulatory agencies, and reporting in ClinicalTrials.gov.
Questions?
Additional Resources
NIMH Guidance
National Institute of Mental Health (NIMH): Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers