OU Norman Campus Institutional Review Board (IRB)

What you can expect from this situation:

This is the Generic Research Application Process. You will also need to look at the questions #7 – 14 in this series of documents to find out what additional steps may be involved in your research application process.

What steps will you take during this process:

1. Log into iRIS:https://iris.ou.edu/
2. Go to the Study Assistant tab on the left. Select Add a New Study.
3. Submit your online application and upload supporting documents using this process.
4. Save and continue through each section of the application, answering ALL questions. Unless you are working with pre-existing materials and will not be contacting participants in any way, answer ‘Yes’ to the first question in section 320 – Participant Contact.
5. Once you’ve completed the application, you will be prompted to upload additional documents, depending on how you answered the questions in the application. For uploading Consent Forms, follow the instructions given in the table on the left when in that section. All other study documents follow a basic uploading procedure.
6. If applicable, follow the steps in Question #7 of this form for Faculty Sponsor Assurance sign-off.
7. You may now sign-off and submit your full study.
8. You will receive an email message from the iRIS system from this sender "iris@ouhsc.edu" once your study has been assigned a category and returned to you for corrections. Do not respond to this email address.
9. Log into https://iris.ou.edu and complete the Review Response Form located in your Incomplete Tasks on your home screen of iRIS.
10. Respond to the stipulations, noting whether you accept or deny the revisions. Save and continue to Section 5.0.
11. You will now revise your study documents. Click on the green bar in Section 5.0. For application changes, select the green bar in the Application Section. Now click the Create Revision button on the far right. DO NOT CLICK EDIT/VIEW! Edit/View will not save any of your changes unless you’re working on your current revision.
12. Now complete your revisions and Save and Continue from that section. Select Back when you’re finished and Save Attachments. Then select Back again. For other study documents, go to the appropriate section and select the green bar again. Click Create Revision next to that study document. Check out the document, make the required changes, save to your desktop, and check-in the document. Instructions for this process are located on that revised section page in iRIS.
13. When you save your attachments, make certain the checkboxes next to your revised document are check-marked. Select Back until you return to Section 5.0 of the Review Response form.
14. Once you are finished, Save and Continue to the next section and Sign-off and Submit.

Do you need to complete CITI Training?

Yes. All personnel who are responsible for recruiting, consenting, gathering identifiable data or having access to identifiable research records should be listed as Key Study Personnel and will need to complete the CITI training. Click here for a link to the website: https://www.citiprogram.org/

What else do you need to submit with your application?

You may be required to upload the following documents (the templates for the Protocol Description, and consent documents are found on the iRIS system and on the IRB website: http://irb.ou.edu/forms.asp

1. Protocol Description.
2. Recruitment materials.
3. Data collection instruments.
4. Site support letters.
5. Other IRB approval letters.
6. Grant application.
7. Statement of Work for funding.
8. Consent documents: Always use the most recent template version of these documents.
   1. Assent documents: For children older than 12 and less than 18 years of age, you may revise the consent template by changing the title to “Assent” form rather than “Consent” form. For children under 12, there is a separate Assent template on the website. No matter the child’s ages, be sure the language is age appropriate.
   2. Consent documents: Participants 18 years or older. Include all appropriate check-off boxes found in the template.
   3. Parental Permission form: Revise the consent form to state “your child” rather than “you”. Also, revise the title to read “Parental Permission Form” instead of “Consent”.

A list of these documents are within iRIS and you will be prompted to upload them after you complete the application.