Human Research Protections
Revised Continuing Review Submission Process for Single IRB
An archived version of this message may be found at news.research.uci.edu Human Research Protections Revised Continuing Review Submission Process for Single IRB Which studies are impacted? Studies that use a Single IRB (sIRB) review process. For sIRB studies, UCI is either the Reviewing IRB for external participating sites (pSites) or Relying on an external IRB.…
Read MoreSAVE THE DATE: Topic-Specific QRAM (07/15)
Dear Colleagues: Please mark your calendars for an off-cycle Quarterly Research Administration Meeting (QRAM) on Wednesday, July 15, 2026 from 2:00-3:00PM. Sponsored Projects will be hosting this topic-specific QRAM on international collaborations in federally sponsored projects. During this session, we will review proposed changes to the Uniform Guidance, specifically the updates covering foreign collaborations and…
Read MoreConsent Templates & the Witness Signature Box
An archived version of this message may be found at news.research.uci.edu Human Research Protections (HRP) Institutional Review Board Consent Templates & the Witness Signature Box Effective June 1, 2026: HRP has made minor changes to the Witness Signature Box in the following consent templates; Biomedical, Social-Behavioral and Educational, Assent and the Assent Addendum. Based on…
Read MoreZOT IRB / hSCRO System Update — Enhancements & Bug Fixes
Dear IRB Staff and Researchers, We are pleased to announce that ZOT IRB and hSCRO will be updated with the latest enhancements and bug fixes on May 11, 2026. Version Updates: ZOT IRB: 10.5.7 → 10.5.12 https://research.uci.edu/wp-content/uploads/2026-May_ZOT-IRB-Release-Notes.pdf ZOT hSCRO: 10.5.5 → 10.5.8 https://research.uci.edu/wp-content/uploads/2026-May_ZOT-hSCRO-Release-Notes.pdf Please note: The system will experience downtime starting after 7:00 PM PST…
Read MoreFood and Drug Administration (FDA) Guidance on Safety Reporting
An archived version of this message may be found at news.research.uci.edu Human Research Protections (HRP) Institutional Review Board Food and Drug Administration (FDA) Guidance on Safety Reporting In December 2025, FDA released two final guidance documents focused on safety reporting in clinical research, replacing earlier FDA guidance issued in 2009 and 2012. Investigator Responsibilities Safety…
Read MoreChanges to the Consent Process and Biomedical Consent Template
Effective March 1, 2026: HRP has made changes to the consent process and biomedical consent template. Please note the following: HRP-090 SOP – Informed Consent Process for Research has been updated to incorporate the following changes: Removal of prior requirement that only a US licensed medical doctor or a US licensed nurse practitioner may request to finalize…
Read MoreClinicalTrials.gov Registration & Report Submission
Institutional Review Board (IRB) ClinicalTrials.gov Registration & Report Submission February 6, 2026 If human subject research is subject to ClinicalTrials.gov, registration and submission of results is required. Where the protocol is investigator initiated and / or the UC Irvine Principal Investigator (PI) holds the Investigational New Drug (IND) the UC Irvine PI is responsible. A…
Read MoreResolved: ZOT IRB/hSCRO Notification Issues with Links
Visit the HRP Toolkit webpage for ZOT IRB user guides, forms, and more. Please reach out to ERA with any questions by submitting a ticket to the ERA Support Desk. The post Resolved: ZOT IRB/hSCRO Notification Issues with Links appeared first on News & Announcements.
Read MoreZot IRB/HSCRO Downtime – Saturday, January 17, 2026 11:30AM thru 9:30PM PST.
Dear Colleagues, Huron will be performing scheduled maintenance tomorrow, Saturday, January 17th from 11:30AM thru 9:30PM PST. Zot IRB/HSCRO will be down during this period. Please be sure to save your work and exit out of the system prior to the downtime. Please let the ERA Team know if you have any questions – you…
Read MoreZOT IRB/hSCRO Notifications: Issues with Links
Dear UCI Huron Community, We are experiencing an issue with the hyperlinks embedded in Zot IRB/HSCRO email notifications that is causing some users to be taken to the Dashboard instead of the study submission or workspace referenced in the email. ERA and OIT are actively working towards a resolution. There are a few workarounds to…
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