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

Updated March 2025: Please refer to the Electronic Consent Guidance for current information. Secure electronic signature platforms may be used for all studies, including FDA-regulated trials. Researchers are responsible for ensuring that the selected platform complies with all applicable...

Changes to Timeline for Post-Approval Reporting Requirements

Timeline and Definition Changes for Internal (on-site) adverse events Must be submitted within 5-working days of UCSF PI awareness Includes death These changes are being implemented to meet federal guidelines of reporting to the IRB.   External (off-site) adverse events and protocol...

Electronic Consent: Website Guidance & Memo for Sponsors

Electronic Consent: Website Guidance & Memo for Sponsors Updated March 2025: Please refer to the Electronic Consent Guidance for current information. Secure electronic signature platforms may be used for all studies, including FDA-regulated trials. Researchers are responsible for ensuring that...

New HRPP Director Edward Kuczynski

 

Memo to Sponsors about IRB Reporting Requirements for Protocol Deviations During the COVID-19 Public Health Emergency

To: Investigators and Staff The HRPP has created a memo that researchers can share with sponsors detailing: 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...

Transition of IRB Review for UCSF BCH Oakland Research

  Transition of IRB Review for Research Conducted at UCSF Benioff Children’s Hospital Oakland Dear Colleagues, Beginning May 1st, 2020, the UCSF HRPP will start receiving transfers of IRB approvals from UCSF Benioff Children’s Hospital Oakland (BCH Oakland) into the iRIS system. New Oakland IRB...

HRPP Response to COVID-19

  HRPP Response to COVID-19 Public Health Emergency 

COVID-19 Information for Researchers

Human Research Protection Program March 25, 2020 To: Investigators and Staff COVID-19 Information for Researchers Dear Colleagues,