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ATSU, AZ IRB: Full Board Reviews

Arizona campus Institutional Review Board instructions, guidance, forms, consents and regulations

Application and Reporting Forms: Non-Exempt Greater Than Minimal Risk Studies

The Initial IRB Non-Exempt Application has been modified as of 03 February 2020.  Applications for IRB review must use the new form, beginning 01 March 2020.  Applications should be submitted as a single document to the IRB email address: MesaIRB@atsu.edu.

  • All IRB forms available through this page can be downloaded and completed electronically.
  • Use this form for all non-Exempt greater than minimal risk studies.
  • Non-Exempt studies do not meet the Exemption criteria, are prospective and usually require written informed consent.

For access to ATSU General Order COI/FCOI policies, go to: 

https://sites.google.com/a/atsu.edu/human-resources/policy-index or https://docs.google.com/document/d/1CM1qrWwIDSTA_KpLFMqTFs2G7sWLjjZpjnI405XGlfo/edit  

Other forms you may use during the course of your non-Exempt Greater Than Minimal Risk research, include:

  • The Continuing Review Report will be sent to the Investigator before the continuing report is due in the IRB office.
  • The Final Report form will NOT be sent to Investigators.  Investigators should submit the final report to the IRB within 30 days of completion of the study.
  • The Amendment Request form should be completed when there are amendments to the protocol, consent forms or participant communication documents, such as advertisements, flyers or brochures.  Informational letters to referral sources, such as physicians or other health professionals do not require IRB review and approval.
  • The Serious Adverse Event form should be submitted to the IRB within 10 working days of Investigator notification of participant injury or serious illness.  In the event of the death of a study participant, for any reason, the IRB should be notified within 24 hours of discovery.
  • The Unanticipated Problems form should be completed when unforeseen incidents occur that could impact participant safety or data integrity.  Issues ranging from deviations in the consent process, to protocol violations or a breach of participant confidentiality should be reported on this form.  The Unanticipated Problems Form should be submitted to the IRB within 10 working days of discovery.