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:

IRB Limited Meeting Schedule: Impact on Studies Expiring in November, December, January

IRB Limited Meeting Schedule: Impact on Studies Expiring in November, December, January Please note that there will be slightly fewer IRB meetings in November, December, and January because of the holiday schedule. We will conduct 23 meetings throughout November-January, in contrast to the 27...

Updated Electronic Consent Guidance & Memo for Sponsors

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

Duo Two-Factor Authentication Required for MyAccess June 30th

Beginning June 30, MyAccess will require Duo. Duo provides an extra layer of protection to ensure the security of logins beyond a password. Cyber-attacks are increasing, and Duo is an important way we protect our logins from misuse.

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 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...

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

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