HRPP Memos

IRB Membership and Function January 2024  
Update on Electronic Consent Signatures and Electronic Records Management Memo April 2021 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 5/28/209/29/20.
IRB Reporting Requirements Memo  February 2021 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. 
Guidance on Certificate of Confidentiality June 2022 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).
IRB Required Language on Informed Consent Forms October 2023 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.

Last updated: January 8, 2024