Updated IRB Application Form

June 25, 2025

The IRB application form has been updated in iRIS. A handful of changes have been made to the form to facilitate compliance with current policies, regulations, and procedures, and to provide improved guidance to study teams.

What are the main changes?

  • New questions and guidance have been added regarding the use of artificial intelligence, machine learning, or related technologies in the study.
  • The following sites have been added to the “UCSF and Affiliated Sites” question: UCSF Health St. Francis, UCSF Health St. Mary's, UCSF Cancer Center Redwood City, and UCSF Peninsula Outpatient Center.
  • For studies involving surrogate consent, the “Surrogate Consent Requirements” application section now includes a link to the IRB’s Surrogate Consent webpage.
  • Other minor changes have been made to:
    • Clarify the meaning of a question.
    • Provide guidance to the study team.
    • Use current names of UCSF-managed databases & resources.

Which studies will be affected?

New studies created on or after today: iRIS will automatically provide you with the updated IRB application if you click “Create a New IRB Study” from today forward.

What studies will not be affected?

  • Approved studies.
  • Mid-draft studies (studies that are not yet approved, but the IRB application was created before today).

What to do if you see a ‘Convert to New Form Version’ pop-up window in iRIS:

If you modify an approved or mid-draft application, you may see a pop-up window in iRIS asking if you want to convert to the new application version. If you see this pop-up, follow these instructions:

  • Approved studies:
    • If the study does not meet the criteria described in the pop-up window, click ‘Cancel Conversion- Retain Current Version.’ 
    • If the study does meet the criteria, click ‘Convert to New Form Version.’ 
  • Mid-draft studies:
    • Click ‘Cancel Conversion- Retain Current Version.’ 

Note: If you click ‘Convert to New Form Version,’ you will be prompted to answer the newly added application questions, and there is no option to reverse this action once you have chosen it.

Questions?

If you have questions about this bulletin, please contact the IRB office by submitting an Ask Andy form.