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. This new letter, dated February 12,…
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 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…
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
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…
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 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…
HRPP Response to COVID-19 Public Health Emergency
Since the beginning of the COVID emergency, the Human Research Protections Program has made rapid adjustments to support the research community.