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…

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  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…

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  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…

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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…

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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    …

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  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…

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Effective July 1, 2020, the single IRB (sIRB) process will have a new fee structure thatreflects the HRP service level when submitting the study to a non-UCI IRB.  There will be two tiers.  The Self-Service model allows the research team to submit to the non-UCI IRB. In the Full-Service model, the UCI sIRB Team will…

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To help promote and facilitate human subjects research, the following changes will take effect on June 1, 2020: Researchers who use the UCI Social Ecology Human Subject Lab (SONA) may now use the Exempt Self-Determination Tool. Social – Behavioral and Educational Protocol Narratives will now prompt researchers for a Family Educational Rights and Privacy Act…

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