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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  Institutional Review Board Human Research Protections (HRP)   Non-UCI Researchers Accessing UCI Resources for Research: An Updated FormVersion April 29, 2020   Effective May 1st,HRP will release an updated form for Non-UCI students, faculty or staff conducting human research at UCI.  When this form is presented to a department or research unit (center/institute), it…

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Effective May 1, HRP is streamlining the study team information collected for IRB review so that only the Lead Researcher (LR), Co-Researchers*, and Research Personnel (as indicated on the below Research Personnel Heat Map) should be listed in the IRB Application & Protocol Narrative.  How will remaining study personnel be tracked? LR’s are responsible for tracking…

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Institutional Review Board Human Research Protections (HRP) No Subject Contact Protocol Narrative Version April 17, 2020 To facilitate IRB review and approval, effective May 1, 2020, use of a new Protocol Narrative will be required for new applications in which researchers will access identifiable private information and / or identifiable biospecimens without contacting subjects. This…

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  Institutional Review Board Human Research Protections (HRP)   When UCI Serves as the IRB of Record for Cooperative Research:  A Streamlined ProcessVersion April 13, 2020   HRP has streamlined the reliance processes for when UCI serves as the IRB of record for cooperative research[1].  These changes take effect immediately and apply to all situations…

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