HOW TO RESPOND TO STIPULATIONS

At some point in your research, you may be sent stipulations from the IRB. When this occurs, you will be emailed an iRIS notification informing you that the study has been contingently approved and that there are stipulations that must be addressed. Please note: Contingent Approval is not the final study approval! You must respond to all stipulations and submit the response (with revised documents) back to the IRB for review and approval. After responding, the reviewer may have additional stipulations for your study, so check into iRIS regularly to stay up-to-date. The instructions noted below will help you respond to the stipulations.

1. Log into iRIS (https://iris.ou.edu) with your OU 4x4 and password.

2. Open the "Submission Response" form sitting below the Incomplete Tasks header on your iRIS Home page.

3. The first two sections include information about the form and your study, and do not need to be addressed. Click the "Save and Continue" button in the top right to skip past these sections.

4. In Section 3.0 of the form, you will see your stipulations listed. Be sure to respond to each one, noting whether or not you accept the stipulation. If you do not accept, include a detailed response for why you cannot make that revision.

5. To make the changes to the documents. Click the “Revise Existing” button next to documents linked below each stipulation. If you are asked to add a document, click the “Add Consent” or “Add Document” button under the Action column. If you are asked to remove a document, click the “Remove Document” button.

You should be taken directly to the document that requires revision. If you are revising the application, you should be taken directly to the section that requires revision. Make the required change and click the "Save and Continue" button (top right) once to save the revision. Then, click the "Back" button (top right) to return to the stipulations list. Once you are back on the stipulations list, make sure to check the “Complete Action” button under each stipulation that is completed.

  • If you are revising a previously submitted study document, click the “Check-Out” button. Wait on the check-out screen until you see a prompt to either open or download your document. Select the appropriate response (depending on your browser) to open the form. Make all requested changes and save the form to your computer. Go back into iRIS and select the “Complete checkout” button. Now, you should select the button to “check-in” the document. Follow the upload prompts and save the document. This should take you back to the stipulations list.
  • If you are adding a brand new document, you should be taken directly to the upload section. Click the “Add Document” button and upload your form. Save the document until you are taken back to the screen with the “Add Document” button. Click the Back button in the top right and you will return to the stipulations list.

If you are addressing a stipulation for a form/document that was revised in a previous stipulation, you will not see the Revise Existing button. Instead, you will need to click on the link for that new, revised document under Component Name. Look for the paper and pen icon, next to the document with the highest version number.

6. Once all revisions have been made and all stipulations have received a response, you should click the Save and Continue button past Section 5.0. Note: You do not need to provide a response to Sections 4.0 or 5.0.

7. After saving past Section 5.0, you will see a Signoff and Submit button. Select this button, choose “Approve”, input your 4x4 and password, and select "Save Signoff."

 

TIPS

  • You are allowed to disagree with a stipulation. However, you must provide an explanation for the disagreement in the text box provided below the stipulation. If the reviewer still determines that the stipulation will be required, you will be notified and given the opportunity to have the issue reviewed by the Full Board.
  • You may use the text box provided below the stipulation to provide a response to the stipulation. However, you must also include these comments/explanations in the appropriate study document(s) by clicking the "Revise Existing" button next to the linked documents below the stipulation.
  • If a stipulation references a line number, you may need to add line numbers to your document to reference the section needing revision. We recommend starting with the highest line number and working down to the lowest when making the changes.
  • If you make a change within the application that changes the branching logic within the document, you will receive a pop-up box informing you of this change. In this situation, you must save through your previously completed sections, answering any new questions as they arise. If you do not, the system will not allow you to sign off on the submission and will provide a notification that the application is incomplete. Save through the sections until you see an "Exit Form" button. Click that button to return to the Stipulation Response form.
  • After clicking the "Signoff and Submit" button, the system will take a few seconds to load the sign-off screen. Please wait for this page to load and apply the sign-off procedures noted above in number 7. If you do not complete these steps, the Stipulation Response will not be received by our office.