Guidance Updates: Reporting Adverse Events, Protocol Violations, and Investigator’s Brochures to the UCSF IRB

A summary of recent guidance updates is below. For more detailed information, please visit the following UCSF IRB website pages: adverse events and protocol violations & incidents. ADVERSE EVENTS

IRB Spotlight: Victor Reus, MD

Professor Emeritus and Parnassus IRB Chair Victor Reus, MD, has dedicated more than two decades to ensuring that UCSF meets its high standards for participant welfare, safety, and privacy. 

IRB Spotlight: Gordon Fung, MD, MPH 

Longtime IRB committee member and Mission Bay chair, Gordon Fung, MD, PhD, MPH, has taken on a role to lead a newly formed cardiology-focused panel that will support studies across a wide and growing range of cardiology sub-specialties. 

IRB Winter Schedule 2023-2024

Per the official UCOP holiday and winter 

Updates to the IRB Continuing Review Form

The Continuing Review Form in iRIS has been updated to a new version. Please see the December 7th bulletin for a summary of changes to the form. Which studies will be affected?

Updated Continuing Review Form: Monday December 18th

The Continuing Review Form in iRIS will be updated to a new version on Monday, December 18th. For guidance about continuing reviews, please visit the IRB’s Continuing Review page. What are the main changes? New:

IRB Announcements: Updated IRB Forms | iRIS Performance Tips | Notice for Studies Expiring in November-January

Updated Post-Approval Event Forms Tips for Optimal iRIS System Performance IRB Limited Meeting Schedule: Impact on Studies Expiring in November, December, January Updated Post-Approval Event Forms

Plain Language Consent Template

New! Plain Language Consent Form Template + Companion Document: Implementation Deadline for New Studies is November 15th, 2023

June 30, 2023 Deadline: “Abandoned Draft” Clean-up Project

This is a reminder to take immediate action on any new study applications that are still in Draft mode and haven’t been revised since June 30th, 2022.

Updates from the Human Research Protection Program: May 2023

  New: “Abandoned Draft” Clean-up Project