Note: As previously announced in July 2023, for studies that qualify under the exempt self-determination process, a confirmation of registration email will not be sent. Once the protocol is submitted in Kuali Research Protocols (KRP), the study status will remain as “submitted” or “resubmitted.
Why: The confirmation of registration email was creating a misperception that the IRB is reviewing / confirming the submissions, rather than our students and/ or faculty self-determining. Researchers would email our office to check on their protocol, asking when they would receive their email confirmation. In addition, researchers would wait for a response before initiating their research protocol. The intent of the self-determination process is to facilitate a quick mechanism such that our students and/ or faculty may begin their research timely. The current option leaving submissions as “submitted” or “resubmitted” is our best solution at present, working within the status limits in KRP.
Points to Remember:
- For the exempt self-determination process, IRB review is not required and will not be provided. The submission of the form completes the IRB review / self-determination process.
- Assuming the activity qualifies for the exempt self-determination, research activities may begin as soon as the form is submitted in KRP, even with the study status reading as “submitted” or “resubmitted.”
- Should the study sponsor require evidence of IRB review for an exempt self-determination, please provide the sponsor this letter along with a printout/PDF of the submission in KRP. The submission and the instructions contained therein specify our process, what categories qualify for exempt self-determination, and what category/ies you have selected as part of your exempt self-determination.
- Once submitted, maintain in a separate research record all supplemental documentation, as prompted in the form. This documentation may be requested by HRP for quality assurance review. (Note: HRP IS actively reviewing these for quality assurance purposes – if there is an issue, you may be contacted by HRP.)
- For the exempt self-determination process, the submission of renewals or amendments in KRP is not required. Amendments are to be tracked independently.
- If there are changes to the self-determination eligibility such that IRB review is now required, a new protocol should be submitted in KRP, with the reference # for the exempt self- determination.
- If you have submitted an email to the IRB inquiring about the status of your exempt self- determination, you may be provided a copy of this handout as a response to your inquiry.
Any questions or comments? Please feel free to reach out to HRP Staff
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