From Our Colleagues at UCI Health Compliance and Privacy: The pilot launch of the all-new Research Compliance Virtual Drop-In Hours begins tomorrow at 8am! The purpose of the virtual drop-in hours is to provide the researchcommunity with a regularly scheduled opportunity to “drop-in,” ask questions, andreceive real time healthcare compliance guidance while following COVID-19social-distancing guidelines.…

Read More

The University of California, Office of the President has advised when IRB Review, Consent, Research HIPAA and the California Bill of Rights apply to clinical activities that are treated as research. The following table illustrates this advisory and practice at UCI.   Expanded Access Humanitarian Use Right to Try IRB Review Yes Yes Yes Consent…

Read More

 The following changes will take effect on October 1, 2020:  The Office of Research (OR) will decommission the IRB Calendar Web App. Researchers seeking IRB deadlines and meeting dates can view the IRB Full Committee Calendar pdf instead (see below screenshot). Please update any bookmarks in your browser with the new link.  OR will also…

Read More

  Institutional Review Board Human Research Protections (HRP)   Translated HIPAA Research Forms Version August 31, 2020   Foreign language translatedHIPAA Research Authorization Forms are posted on the Applications and Forms webpage under the subsection, ‘Human Research Protections’ and then, ‘Foreign Language Translations.’ Reminder: Since early 2020, one form now covers UCI providers and non-UCI…

Read More

  Institutional Review Board Human Research Protections (HRP)   Program Update: Removal of Exempt 4iii Version August 28, 2020   The 2018 Common Rule went into effect on January 21, 2019, specifying revised exempt research categories under 45 CFR 46. 104.  One of the revised categories, Exempt 4iii allows for the secondary use of existing…

Read More

  Institutional Review Board Human Research Protections (HRP)   Policy Update – Results Information Reporting for Applicable Clinical Trials (ACTs) (NOT-OD-20-147) Version August 18, 2020   Update: A Federal court has held that Section 801 of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) requires submission of results information for any “applicable clinical…

Read More

View this email in your browser Join Vice Chancellor for Research Pramod Khargonekar, guest speakers and colleagues from the UCI Office of Research for this virtual celebration of surpassing the $500M research funding milestone! TOMORROW – AUGUST 13, 2020 3:00PM – 5:00PM ZOOM LINK Meeting ID: 957 7898 1022   Passcode: 529mil         ⚠ STILL ACCEPTING PHOTOS!(optional…

Read More

View this email in your browser Celebration of UCI’s $529M Research Funding Milestone! Join Vice Chancellor for Research Pramod Khargonekar, guest speakers and colleagues from the UCI Office of Research for this virtual celebration of surpassing the $500M research funding milestone! AUGUST 13, 2020 — 3:00PM – 5:00PM ZOOM LINK Meeting ID: 957 7898 1022   Passcode: 529mil    …

Read More

  Institutional Review Board Human Research Protections (HRP)   FDA Clinical Trial Guidance Updated Version July 30, 2020   The FDA has updated its Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic. This information, along with other pertinent federal guidance is available on the Office of Research – Research Continuity…

Read More