News

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

February 16, 2021
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

December 11, 2020
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

September 29, 2020
This is a follow-up to the HRPP Bulletin sent on May 28, 2020.

Changes to Timeline for Post-Approval Reporting Requirements

June 01, 2020
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

May 28, 2020
Electronic Consent: Website Guidance & Memo for Sponsors The UCSF Human Research Protection Program and Office of Research leadership have developed guidance on using DocuSign and REDCap to obtain electronic signatures for research consent and HIPAA authorization during the COVID-19 public...

Transition of IRB Review for UCSF BCH Oakland Research

April 30, 2020
  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

April 30, 2020
  HRPP Response to COVID-19 Public Health Emergency 

COVID-19 Information for Researchers

March 26, 2020
Human Research Protection Program March 25, 2020 To: Investigators and Staff COVID-19 Information for Researchers Dear Colleagues,

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