What you can expect from this situation:
This may not be considered human subjects research. Complete the Determination of Human Research Worksheet form.
What steps will you take during this process:
- Log into iRIS:https://iris.ou.edu/
- Click on the "Add a New Study" tab on the left.
- Respond to the questions in Sections 1-4, noting that you plan to submit to the Norman Campus IRB.
- In Section 5.0, select the "Determination of Human Subjects Research Worksheet" option and save and continue.
- Select the green button that says: "Click here to start this form."
- Respond to the questions in this form, using the Save and Continue to the Next Section button to move through the questions.
- At the end of the form, select either the "Exit Form" or "Close Form" button.
- Click the "Save and Continue" to the Next Section button twice to exit the application.
- Save and continue past the Application section of the upload screen and you will be taken to the section where you may upload your study attachments.
- Click the green button that says: "Click here to attach any study document."
- Click Add Multiple Documents and upload the forms. Select Save Record(s) when you are finished.
- Make sure the check-boxes next to the documents are checked and select the "Save Attachments" button. You should now see the documents listed under the green bar in Section 1200 - Upload Support Documents.
- Save and continue and select the Signoff and Submit button. Input your 4x4 and password, select the Approve button, and select Save Signoff.
- Once the submission has been reviewed, you will receive a letter that will notify you of the IRB determination through the iRIS system (iris@ouhsc.edu), via email.
Do you need to complete CITI Training?
No. To submit a Human Research Determination form you do not have to complete CITI training. However, if it is determined that your study meets the criteria for human subjects research, you will need to complete the CITI training.
What else do you need to submit with your application?
You will not be required to upload any additional documents.