UW Research

Renew Your IRB Approval

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

  • Be sure that your study needs to re-apply for IRB Approval. If your study has no IRB expiration date: You do not need to submit or do anything. If your study meets the criteria for closing your IRB application, submit a Status Report as described below to request closure of your IRB application.

Required skills and tools

The parts of your renewal application

The application for renewing your IRB approval is called a Status Report or a 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 other documents.

What to do: The first step

Complete the Status Report form.

What to do: Other steps

  1. Prepare your other study documents (if any) for upload. These are described in the Status Report form.
    • Create any documents that do not already exist. For example, write a summary describing any subject withdrawals.
    • 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.
    • Give each electronic document a unique and descriptive name to help distinguish them in Zipline.
    • Create an electronic version of any paper documents by scanning them to PDF.
  2. Create the Zipline part of your application. Log into Zipline and navigate to the active study you wish to renew. 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.
  3. Check your application for completeness by using the Hide/Show Errors activity.
  4. 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 IRB’s review. The ongoing status of your renewal 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)

    • Missing explanations for items or events that occurred during the past year.
      Prevention: Double check the Zipline SmartForm before you submit your renewal application, to make sure that you have (1) accurately checked all applicable items; and (2) provided a summary explanation for each item you did not check.
    • Inaccurate completion of the question about research milestones. The most common mistake is that researchers believe the IRB approval must be renewed as long as any identifiable private information or specimens will be retained. However, the IRB application may be closed if the data analysis described in the IRB application has been completed and if retention of the identifiable data is consistent with information in the IRB application.
      Prevention: If you have completed the first four research milestones listed on the form, your study is eligible for closure. Consult with your Team Operations Lead if you have questions.
    • Subject numbers for multi-site studies: Not distinguishing between the number of subjects for the UW’s site versus the number of subjects across the entire multi-site study.
      Prevention: Careful completion of the questions about subject numbers.

What if your IRB approval expired?

  1. All human subjects research activities must stop. This includes recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information. Also, funding related to those activities or that was released because of a DOHR determination cannot be spent.
  2. Exceptions: If any of the following exceptions apply, immediately report this to the UW IRB including information about the continued research activities and the rationale for continuing them:
    • Continuation of activities necessary to eliminate apparent, immediate hazards to subjects.
    • The research intervention (if any) may be of direct benefit to individual subjects.
    • Withholding the research intervention (if any) may increase risks to subjects.
  3. Submit a renewal or close your application as soon as possible. If a renewal or closure is not received and IRB approval has been lapsed for 90 days HSD may administratively close the study.

In some circumstances, HSD may refuse to review additional submissions from the researcher until a status report is received, lapsed IRB approval may be considered continuing noncompliance, and the study may be “terminated” by the IRB.

See section 5.5 of SOP IRB Review for more information.

Ask for help

Contact your HSD Team or send an email to hsdinfo@uw.edu if you have questions or need help. Identify your department in your email.

More information

Zipline Online Help Library