Once you determine that your human subjects research study requires UCSF IRB review, submit a new study using iRIS, our online submission system.
As your study progresses, submit the following to the IRB as needed:
- New Study – After confirming that your research requires IRB review.
- Modifications – Any changes to your study must be approved by the IRB before implementation.
- Continuing Review – A periodic progress report required for certain studies.
- Research involving Drugs - An overview of regulatory and submission requirements for projects involving drugs.
- Research involving Devices - An overview of regulatory and submission requirements for projects involving devices.
- Emergency Use & Compassionate Use – For experimental drugs or devices used in urgent or compassionate circumstances.
- Protocol Enrollment Exception – To enroll an individual who does not meet the study’s entry criteria.
- Adverse Events, Protocol Violations, or Safety Reports – Submit if they meet IRB reporting requirements.
- Study Closeout Report – Required when the study is complete.
- Study Expiration & Extended Approval – Ensure compliance with IRB requirements.