What's New (Norman Campus)

Planned iRIS System Updates - Log Out of iRIS BEFORE 4:00pm on Thursday, 3/9/2023

iRIS will undergo planned system updates on Thursday, March 9 beginning at 4:00pm. The updates could take 2-4 hours to complete.

iRIS will be offline and not accessible during the update. 

To avoid losing any work, please plan to save your work and log out of iRIS before 4:00pm on 3/9. 

Users should be able to access iRIS after the planned update period ends. We apologize in advance for any inconvenience this may cause. 

The Determination Worksheet has been updated and published in iRIS.

Changes Impacting ALL Campuses:

• Project Information has been reorganized and many questions regarding the proposed activity have changed from multiple choice to open-ended text response.
  • These open-ended questions are required and may not be left unanswered.

Changes Impacting HSC IRB Only:

• HHS regulatory definitions related to research and human subjects have moved from help bubbles and are now located within form sections and questions.
• Local definitions for systematic investigation and generalizable knowledge have been added to the form.
• New explanation text boxes were added to the questions for systematic investigation and generalizable knowledge.
  • When present, these text boxes are required and may not be left unanswered.
• Identifiable and coded nature of data/biospecimens was previously addressed through multiple questions. These questions have been consolidated into one question.
• New section for QI Projects has been added to the form.  

For questions or more information, please contact your appropriate campus IRB Office: irb@ou.edu (Norman IRB) or irb@ouhsc.edu (HSC IRB)

Planned Emergency Research with Exception from Informed Consent (EFIC) at OUHSC is now live:

The process to request IRB approval to conduct planned emergency research with an exception from informed consent (EFIC) is now live. Investigators interested in submitting a planned emergency research study with EFIC are urged to read the new EFIC policy, review guidance documents, and may contact our office for a consultation about the process.

* HRPP Website:

• New EFIC webpage: Located under the HSC Campus section for Researchers & Coordinators, users have access to guidance, resources, and the new EFIC Sub-Application
• New SOP: 502-M Planned Emergency Research with Exception from Informed Consent (EFIC)
• Revised SOP: 502-G One-Time Emergency Use of an FDA Article = removed language prohibiting planned emergency research

*iRIS Changes: the following iRIS forms have been updated, which will convert users to the newest version automatically:

• HSC Application (added EFIC to Section 1200)
• Continuing Review/Final Report Form (added EFIC attestations; will only appear for EFIC studies)
• Modification/Notification Form (added EFIC and an external IRB closure checkboxes)

If you have questions or would like more information, please contact the HSC IRB Office via email to irb@ouhsc.edu.

• Relying on an External IRB Application: A new version has been published. The most significant change impacts the conflicts of interest (COI) section. The COI questions have changed and the sub-form has been removed as it is no longer required.
• Initial Submission Packet:  A new upload section for HSC was added for the Relying on an External IRB Application.
• BOTH forms above will require users to convert, which iRIS will do for you. The conversion for the Initial Submission Packet will occur for all three (3) application types: Norman Application, HSC Application, and Relying on an External IRB Application. There should be zero impacts to your Norman and HSC Applications.

If you have any questions or need assistance, please contact your campus-appropriate IRB Office:
HSC: 405-271-2045 | irb@ouhsc.edu -   NC: 405-325-8110 | irb@ou.edu

iRIS will be unavailable Monday and Tuesday (June 28th and 29th) for system updates and upgrades. The IRB/HRPP office will not be able to receive, process, or review submissions during this time.  As part of the upgrade, you will likely notice changes to the overall look of the iRIS home screen and the processes for document uploads and addressing reviewer stipulations. The changes should assist with the overall functionality of the system and make the steps in those processes easier to complete. 

The IRB/HRPP office will be available for training on the changes, and guidance will be posted to the IRB website to help navigate any differences. Please let us know if you have any questions or if you would like to set up a training session!