How does the 5-year expiration date affect my exemption?

Guidance for investigators regarding the five year expiration and closure of IRB exempt protocols

Once an exemption is granted, exempt studies do not require yearly continuing reviews.  A 5-year expiration deadline is assigned to exemptions in ARROW, with the exception of 'not research' and 'not human subjects' determinations that are certified in ARROW. Once the 5 years have lapsed, the protocol will automatically be closed in ARROW. If the study team has not yet concluded the protocol, a request to Extend Exemption can be submitted prior the 5-year deadline. Reminders of an upcoming exemption will be sent at 90, 60 and 30 days prior to the set expiration date.

If the study team concludes the project prior to the 5-year expiration deadline, a Study Completion Report should be submitted to the IRB for review and acceptance.

NOTE: The University of Wisconsin Faculty Legislation recommends retention of data for 7 years after the completion of data analysis should an issue of scientific misconduct arise.

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Keywords:EX, exemption, not research, not human subjects, closure, FAQ 5 year expiration, extend   Doc ID:27054
Owner:Monica E.Group:Health Sciences IRBs
Created:2012-10-26 10:01 CDTUpdated:2018-12-12 10:24 CDT
Sites:Health Sciences IRBs
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