Answering Stipulations

Human Subjects Protection Program staff, IRB Chairs, and/or the IRB committee may request changes (also known as stipulations) or clarification on any submission prior to its approval. The changes are explained to the principal investigator and study contacts in an emailed letter as well as in iRIS. All changes and responses to stipulations must be made in iRIS via the Review Response Submission Form.

The following guidance outlines the different types of stipulations a researcher may receive and how to navigate iRIS to respond to each type. Additionally, an instructional video may be found here.

Locating the Stipulations in iRIS

When the IRB requests clarification or changes to a submission, these revisions are sent through the Review Response Submission form in iRIS. To locate this form, follow the step-by-step instructions below or you may view our video instructions found here.

• Login to iRIS.
• Scroll to the bottom of the page to the section titled “All Studies.” Click on the pencil and paper icon next to the submission you want to address.
• On the right side of the page, look for “Outstanding Submissions.” Click on the hyperlink stating, “Institutional Review Board has requested a Submission Response for…”
• You should now see the Review Response Submission form. Scroll through the form to view all stipulations.

Revising the Application

Information that has been revised in study documents must be consistent in the IRB application as well. The following instructions detail how to revise the IRB application. For instructions on how to locate your stipulations, review the instructions above.
• Locate the stipulation asking for the IRB application change.
• Under the column “Action”, click on the grey button “Revise Existing.”
• Click Confirm in the pop-up window asking, “Are you sure you want to create a revision?”
• On the left side of the screen, you can click on the specific sections you need to revise. If you want to review the entire IRB application, click on “Save and Continue to Next Section.”
• When you have completed all the requested changes, click to the last section of the IRB application and then click “Save and Continue to Next Section” and exit the form.
• You should be routed back to the Review Response Submission Form where the stipulations are listed. If you need to make additional changes to the IRB application, click on the IRB Study Application link with the pencil and paper icon next to it.

Adding a New Document

If you need to add a new document that was not previously associated with the study, review the steps below.
• Scroll to the stipulation requesting the new addition.
• On the right side, click on “Add Consent” or “Add a New Document.”
If you need to add additional documents, beyond what is linked in the stipulation or requested by the IRB, review the steps below.
• Scroll to the bottom of the Review Response Submission Form. Locate the section titled “Revised Submission Materials.”
• Click on “Add New Component.”
• Depending on the document, click on either “Informed Consent” or “Other Study Document.” Informed Consents and HIPAA documents should be placed in the Informed Consent folder. All other documents should be placed in the Other Study Document folder.
• Click on “Add Consent” or “Add Document” in top right corner of the pop-up window
• Enter the document title, version date, category, and version number. Click on the box next to the row labeled Upload your document.
• Once the document is uploaded, click on “Save Consent” in top right corner.
• After the document has been uploaded, you should see the pop-up window that lists the documents, ensure that a check mark is placed in the first column of the document(s) you wish to upload. Click “Attach” in the top right corner.

Revising an Existing Document

Use these instructions to revise documents that have previously been submitted to the IRB for review. This is not for adding new documents. To add a new document, see instructions above.
• On the Review Response Submission form, scroll to the bottom of the page to the section titled “Revised Submission Materials.”
• Click on the paper icon under the column titled “Revise/Attach” next to the document that needs to be revised.
• Click “Confirm” in the pop-up window asking, “Are you sure you want to revise this item from the submission?”
• Click “Check Out Document.” Click “Confirm” in the pop-up window stating, “Are you sure you want to check-out the document?” Your document should download in the browser window.
• If you haven’t made your changes yet, click on the downloaded document to make changes. Once these changes have been completed, save the document to your computer. In the iRIS window, update the version dates, title, and then click on “Check-In Document.”
• In the pop-up window, click on “Choose File.” Locate your document on your computer and click “Save Selected File.”
• Click “Save” in the top right corner.

Submitting Stipulations for IRB Review

The following instructions are for submitting your stipulations to the IRB for review.
• Ensure that all stipulations have been completed. This means accepting each stipulation individually by clicking on Yes next to the question “Do you accept this stipulation?” Also ensure that you have provided an explanation on how you addressed each stipulation in the text box provided. If you do not agree with the stipulation, provide your rationale in this textbox as well.
• Click “Signoff and Submit”

When submitting stipulations to the IRB and you need to make additional changes that were not requested by the IRB, you must document these changes on the Review Response Submission form.