New IRB Form for Key Study Personnel Changes

This was originally published on September 5, 2017 Need to revise the Key Study Personnel sections of your IRB application? The IRB has created a new “Personnel Changes” submission form and it is now available in iRIS. When do I use the Personnel Changes form? Use this form when the ONLY changes...

UCSF IRB Facilitates Transfer of UC-wide Dataset to NIH’s National COVID Cohort Collaborative’s Centralized Data Resource

As COVID cases increase and variants spread, researchers need access to a wide variety of data to better understand the disease. To make this possible, the National Institutes of Health awarded the University of California a $500,000 grant to gather the data and make it easily accessible.

September 2021 updates

Updates from the Human Research Protection Program The following notice provides updates regarding a new resource for writing exemplary IRB applications, consenting non-English speakers, electronic research signatures, and CITI training courses. New Resource: iRIS Application Samples

Updated IRB Review Fees Effective July 1st

What is Happening? IRB review fees are being increased on July 1st, 2021. This applies to studies that are industry-sponsored and studies from UCSF-affiliated entities. Why Must Fees Be Increased at This Time?

ACTION NEEDED: Affiliates with Access Requested Through the IRB

In August 2019, the UCSF IRB started transferring responsibility for request and maintenance of affiliate access to UCSF networks and applications back to the PI’s department. This change was made to enhance campus network security, ensure that people for whom affiliate access is being requested...

April 2021 Updated Electronic Consent Guidance & Memo for Sponsors

This is a follow up to the HRPP Bulletin sent on September 29, 2020. 

Updated Guidance re: Surrogate Certification for Research

Background: What Is a Surrogate?

Updated Guidance and Letter to Investigators Regarding IRB Reporting Requirements for Protocol Deviations During the COVID-19 Public Health Emergency

The Human Research Protection Program (HRPP) has updated the May 8, 2020 memo detailing IRB reporting requirements for protocol deviations made in response to COVID-19 and for adherence to the Office of Research Guidance for Onsite Clinical Research Activities.

Information Sheet and Consent Form Addendums for COVID-19 Screening and Testing Procedures

New! Information Sheet and Consent Form Addendums for COVID-19 Screening and Testing Procedures The HRPP has created the following documents for research participants attending onsite study visits during the COVID-19 public health emergency:

Updated Electronic Consent Guidance & Memo for Sponsors

This is a follow-up to the HRPP Bulletin sent on May 28, 2020.