Human Research Protections
NIH Policy Update: Definition of Clinical Trial
OR Generic Template An archived version of this message may be found at news.research.uci.edu Human Research Protections NIH Policy Update: Definition of Clinical Trial The National Intitutues of Health (NIH) has recently revised requirements under the NIH Clinical Trial Definition. Basic Experimental Studies Involving Humans (BESH) will not have to follow the requirements for clinical trials,…
Read MoreUpdates in Human Research Protections (HRP) – August 2026
Updates in Human Research Protections (HRP) – August 2026 An archived version of this message may be found at news.research.uci.edu Human Research Protections Updates in Human Research Protections (HRP) August 2026 Effective Immediately: HRP has made the following changes applicable to all new ZOT IRB self-determination submissions (e.g., exempt, non-human subject). What has changed Department…
Read More08/19 QRAM Materials Available
Dear Colleagues: Thank you for joining us at last week’s Summer QRAM! The materials and video recording are posted on our QRAM page. Note that due to sensitive nature of some of our topics, the page now requires UCInetID and password. 😊 Please reach out to me directly should you have any questions. Barbara Barbara…
Read MoreExplaining updated KR Federal Disclosure & Certification
An archived version of this message may be found at news.research.uci.edu Latest News and Announcements Explaining updated KR Federal Disclosure & Certification Updated KR Federal Disclosure and Certification On June 25, 2026, the KR Federal Disclosure and Certification (KR FDC) was updated to include a new foreign agreements question to comply with a…
Read MoreLatest Updates in Human Research Protections (HRP)
An archived version of this message may be found at news.research.uci.edu Human Research Protections Latest Updates in Human Research Protections (HRP) Effective August 1, 2026: HRP has made the following changes applicable to all new submissions submitted in ZOT IRB. After August 1, 2026, if an older template is used, Principal Investigators (PI) will be…
Read MoreRevised 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An archived version of this message may be found at news.research.uci.edu Human Research Protections Revised Continuing Review Submission Process for Single IRB Which studies are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…
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