Updates from the Human Research Protection Program: May 2023

  New: “Abandoned Draft” Clean-up Project

Announcing PI Research Operations Bootcamp: Monday, May 8th

The Clinical Trials Operations (CTO) Training team is excited to announce a Research Operations Bootcamp for PIs, designed for Principal Investigators to provide information and resources for conducting clinical research at UCSF.  

IRB Guidance and Consent Form Language re: 2023 NIH Data Management and Sharing Plan Policy

As mentioned in previous announcements (July and December), the National Institutes of Health (NIH) now requires all researchers seeking grant funds that result in the generation of scientific data to submit a Data Management and Sharing (DMS) plan as a condition of funding. This policy applies to...

IRB Winter Schedule 2022

Per the official UCOP holiday and winter calendar, the IRB office will observe the following closure dates:

Recap of 2022 guidance

Updates from the Human Research Protection Program This notice provides end-of-year updates on new guidance and materials, reminders about submissions, and announcements on what’s coming in 2023.

Pre-visit COVID-19 testing no longer required for research participants

Posted on behalf of VCR Hal Collard and Payam Nahid, Director, Clinical Trials Operations Dear Colleagues, You may be aware from recent UCSF Health communications from Chief Clinical Officer Josh Adler, MD that as of November 21, UCSF Health no longer requires COVID-19 testing for asymptomatic...

Reminder to close inactive external IRB-reviewed studies in iRIS

Please read this message if you have studies that are reviewed by an external IRB (any IRB other than UCSF’s IRB). These studies are identifiable in iRIS by any one of the following “IRB Study Status” designations:

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 meetings we normally conduct over a 3-month period.

Reminder: New Studies Submitted on or after 10/1/2022 must use NEW IRB Application Version (v98)

Reminder: New Studies Submitted on or after 10/1/2022 must use NEW IRB Application Version (v98)

Updated IRB Application Form: New Studies Submitted on or after 10/1/2022 must use New Version

The IRB application form has been updated to facilitate compliance with current policies, regulations, and procedures, and to provide improved guidance to study teams. What are the changes? The new application version includes new questions and ‘advisements’ (these are the instructions that...