Close Your IRB Application
The sequence of IRB activities for your study
APPLY for IRB approval
MODIFY the approved study
RENEW your IRB approval
REPORT events and new information
CLOSE your IRB application ←
What you should have already completed
- All subjects have completed all study-related interventions and procedures, including any follow-up.
- You have obtained all private identifiable data and/or specimens from all subjects.
- You have completed your analysis of all private identifiable data and specimens, as described in your IRB application.
Required skills and tools
- The same as for APPLY.
The parts of your Closure application
This application for closing your IRB application is called a Status Report or Continuing Review Report.
|Application form: Status Report required
This is a Word document that you complete and upload to Zipline. Other documents, if appropriate for your study
If you have not already provided the IRB with reports about specific events such as interim findings, audits, new funding, etc., you will be asked to upload those documents.Zipline SmartForms required
This is the web-based software that asks you some basic questions about your study and where you upload your Status Report form and any other documents.
What to do: The first step
Complete the Status Report application form. As you complete the form, your answers will determine whether the study is ready to be closed.
What to do: Other steps
- Prepare your other documents (if any) for uploading. These are described in the Status Report form.
- Create any required documents that do not already exist. For example, write a description of the subjects that withdrew.
- Label electronic and paper documents with a title, date and version number. A footer in the document is usually the best place for this information.
- Create an electronic version of any paper documents by scanning them to PDF.
- Create the Zipline part of your application. Log into Zipline and navigate to the active study you want to close. Click on Create Modification / CR (CR stands for Continuing Review). Answer the questions, and follow instructions about uploading the Status Report form and any other relevant documents you have prepared. The first four research milestones listed on the Zipline SmartForm must be accomplished for UW and all other institutions and individuals relying on the UW IRB’s review before your IRB application can be closed.
- Check your application for completeness, by using the Hide/Show Errors activity.
- Submit your application to HSD. Click on Submit and then click on OK.
What to expect after submitting
An HSD staff member will be assigned to your application, usually within one business day. You will receive an email notice if additional information is needed and also to inform you about the outcome of the review. The ongoing status of your closure request is displayed in the workflow graphic at the top of the Continuing Review (CR) workspace in Zipline.
Three common, high-impact mistakes (and how to prevent them)
- Retention of identifiers as a reason to keep the IRB application open. It is a common misunderstanding to believe that identifiers must be destroyed in order to close an IRB application. UW research must comply with Washington State records retention policies, which means that identifiable research data must be retained for (typically) 6-7 years after the completion of the study.
Prevention: IRB approval does not have to be maintained during this retention period if the study procedures and analyses described in the IRB application have been completed.
- Providing information to subjects about study results or other studies as a reason to keep the IRB application open.
Prevention: These activities can continue even after the IRB application is closed, if the activities were approved as part of the application. Note that when former subjects are provided with information about other studies, the IRB review of those other studies must include review and approval of the information and recruiting efforts.
- Keeping the UW application open just because it is part of a multi-site study that is still active under other IRBs.
Prevention: The UW IRB application can be closed if the study is permanently closed to enrollment at all sites under the UW IRB’s review, all subjects under the UW IRB’s oversight have completed all research-related interventions and interactions, and no additional identifiable private information or specimens are being obtained by the investigators under the UW IRB’s oversight. This is true even if the UW study data have not yet been analyzed by the overall study statistical center/personnel under the oversight of another IRB.