The Protocol Development form is used when you need funds distributed, but are not ready for IRB approval (study design still unclear, survey instruments need development, etc). Protocol Development approval provides you with a letter from the IRB, stating that we acknowledge the protocol development activities and confirming that you are not ready for IRB approval. Once the protocol development activities are complete and you are ready to begin collecting data, you will need to submit a Modification/Notification form to revise the Application from "Protocol Development" to "Study Application / Research Application". Please follow the instructions below to submit this form.
- Log into iRIS (https://iris.ou.edu).
- Click “Add a New Study” under the Study Assistant tab on the left. Choose the "Norman Campus Application" option.
- Respond to the questions in Sections 1-3.
- In Section 4.0, select the "Protocol Development Application" option and save and continue.
- Select the grey bar that says: "Click here to start this form."
- Respond to the questions on this form, using the “Save and Continue to the Next Section” button to save your responses.
- At the end of the form, select either the "Exit Form" or "Close Form" button. This will take you back into the original application.
- 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 a section where you may upload any study attachments you may have. If you do not have any study attachments, skip to #11 below.
- Click the gray button that says: "Add Multiple Documents” and upload the attachments. Select “Save Record(s)” when you have finished. You should now see the documents listed under the gray bars 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”.
You will receive email correspondence from iRIS with an attached letter once the submission has been approved. Please refer to the section on "How to Submit a Modification" for information on changing the type of application (from Protocol Development to full study application) and overall IRB approval for your project.