| Memo | Guidance | Date |
|---|---|---|
| IRB Membership and Function | This memo explains how the UCSF IRB is structured and operates. It gives sponsors a quick overview of its membership, processes, and regulatory compliance. | January 2024 |
| NIH Just-in-Time (JIT) Funding Notices During the IRB System Freeze | This memo explains what to do if you receive a Notice of Award for Just in Time (JIT) funding and the NIH requests IRB approval within a date range that falls within the Submission Freeze. | June 2026 |
| Guidance on Certificate of Confidentiality | This memo provides information about CoCs, which federal agencies may issue to researchers to protect subjects' privacy, and highlights good data management practices in cases where identifiable research information is commingled with other data. Issued by Research Policy Analysis and Coordination (RPAC) unit and Ethics, Compliance and Audit Services (ECAS). | June 2022 |
| IRB Required Language on Informed Consent Forms | This letter may be shared with research sponsors to describe required, unalterable language that must be included as written on all relevant UCSF informed consent documents. | April 2026 |
| Update on Electronic Consent Signatures and Electronic Records Management Memo | This memo provides an update to the 5/28/2020 and 9/29/20 memo and also addresses which platforms are compliant with the FDA’s privacy rules at 21 CFR Part 11 for electronic signatures and for comprehensive electronic study records. Previous memos 5/28/20, 9/29/20. | April 2021 |
| IRB Reporting Requirements Memo | This memo details IRB reporting requirements for protocol deviations made in response to COVID-19 and in response to the Revised Interim UCSF Policy on Human Subjects-Related Research Visits at San Francisco Campuses during COVID-19 Outbreak | February 2021 |
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