HOW TO SUBMIT A NEW STUDY APPLICATION TO THE IRB FOR HUMAN SUBJECTS RESEARCH THAT IS EXEMPT FROM THE FEDERAL REGULATIONS

Human research that may qualify for exemption under one of the regulatory-defined categories must be submitted to the IRB review, determination of exemption, and approval. Investigators at OU are not empowered to make the determination of whether their human subjects research is exempt from the federal regulations.

Instructions for submitting a new study application to the IRB for review are noted below.

  1. Log into iRIS (https://iris.ouhsc.edu)
  2. Click Add a New Study under the Study Assistant tab on the left.
  3. Choose the HSC Application option and click the Start Selected Application button.
  4. Respond to the questions in Sections 1.0 - 3.0. Click the Save and Continue to Next Section button to proceed throughout the form.
  5. In Section 4.0, select the Study Application / Research Application option and click save and continue.
  6. In Section 5.0, Question 5.1, click the Add New Row or Add a Row button to add all of your key study personnel to the table. Select their appropriate OU position and study-related duties/responsibilities.
    1. Complete this section, and click the save and continue button to proceed.
  7. Respond to all questions in every section, using the Save and Continue to the Next Section button proceed through the application.
  8. In Section 2700 – Level of Review, hover over the orange icon on the right side and select Exempt Categories in the pop-up to review the list of exemption categories. This will allow you to verify whether your research may qualify for one of the designated categories.
    1. If none apply, close out the window and repeat this step in the application, but select Expedited Categories this time.
    2. Once your review of the categories is completed, answer the question by either selecting the Exempt or Expedited option. Save and continue to proceed.
  9. Once you get to the Exit Application Interview section and complete the PI Certifications, click the Save and Continue to the Next Section button to move forward and complete the application portion of your submission.
  10. Once you get reach the “1.0 Study Application” screen you will click the save and continue button to proceed to "2.0 Upload Support Documents" to upload and attach any study documents you may have. (**A protocol is required at a minimum!**)
  11. Click the gray button that says: Add Multiple Documents and upload your attachments.
    1. Select Save Document(s) when you have finished. You should now see the documents listed under the gray bars in Section 1200 - Upload Support Documents.
  12. Click the Save and Continue to the Next Section button to proceed to the next section and select the Signoff and Submit button.
  13. Input your HSC username and password, select the Approve button, and the select Save Signoff.

This will route the submission to our office for processing. We will first verify that education and training requirements have been met, qualified persons are listed as PI and/or Co-PI, and a research protocol has been attached and submitted.

If acceptable, your submission will be assigned to a Board for processing by an administrator. You will be notified of the IRB’s review and outcome via an email correspondence from iRIS with either an approval letter attached, or a link to iRIS to complete stipulations to address any comments from the IRB. If you receive stipulations, resubmission will be required for additional review in orer to obtain final approval from the IRB.