Human Research Protections
Food 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An archived version of this message may be found at news.research.uci.edu Human Research Protections (HRP) Institutional Review Board Food and Drug Administration (FDA) Guidance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 MoreLimited IRB Submissions, Data Migration and August Zoom Office Hours
Institutional Review Board (IRB) ZOT IRB Updates: Limited IRB Submissions, Important Data Migration Information and Upcoming August Zoom Office Hours August 7, 2025 ZOT IRB will launch on September 15, 2025. Limited IRB Submissions: Limited protocol submissions have begun and will run through September 14, 2025. This will allow additional time for Human…
Read MoreCORRECTION: Updated Compensation for Injury Language
Institutional Review Board Human Research Protections (HRP) Updated Consent Form Templates April 29, 2025 v2 (correction) University of California Office of the President (UCOP) has updated the human subject injury language on the consent form. Injury language is required when a participant may experience injury or illness as a direct result of participation…
Read MoreUpdated Compensation for Injury Language
Institutional Review Board Human Research Protections (HRP) Updated Consent Forms! April 29, 2025 On March 5, 2025, the University of California updated Consent language for Medical Treatment of Human Subjects for Injuries Resulting from Participation in Research. This University policy governs the provision and reimbursement of medical costs to human research participants for…
Read MoreEarly Study Terminations and Suspensions
Institutional Review Board Human Research Protections (HRP) Early Study Terminations and Suspensions April 28, 2025 Summary: This document provides guidance and resources for researchers to consider if/when faced with an early termination or suspension of an active IRB protocol. A premature suspension or termination of a study is when a study ends…
Read MoreHIPAA and Human Subject Research
Institutional Review Board Human Research Protections (HRP) HIPAA and Human Subject Research Version October 25, 2024 What is HIPAA? The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was enacted on August 21, 1996. HIP…
Read MoreIRB Fee Increase – Effective October 1, 2024
Institutional Review Board Human Research Protections (HRP) IRB Review Fee: New Rate Version October 3, 2024 IRB Review Fee: New Rate Facts About the IRB Review Fee: The IRB review fee will increase from $1850.00 to $2781.00.[1]+[2] The IRB review fee is a one-time charge for new clinical research protocols partially or fully supported by…
Read MoreClinicalTrials.gov – Registration Decision Tool
Institutional Review Board Human Research Protections (HRP) ClinicalTrials.gov Registration Decision Tool September 13, 2024 New! ClinicalTrials.gov Registration Decision Tool Click on the link below to help determine if your study requires registration on ClinicalTrial.gov What? A NEW ClinicalTrials.gov Registration Decision Tool is now available on the HRP ClinicalTrials.gov webpage. Why? The decision tool…
Read MoreNew Consent Templates
Institutional Review Board Human Research Protections (HRP) New Consent Templates Version September 5, 2024 New consent templates have been added to the HRP webpage, on the IRB Forms page. The updated templates are for immediate implementation. Researchers should revise their consent forms, as necessary, considering the current state of their research. Existing studies…
Read MoreAccess to Protected Health Info (PHI) ≠ Self Determination of Exemption
Institutional Review Board Human Research Protections (HRP) Access to Protected Health Info (PHI) ≠ Self Determination of Exemption Version August 12, 2024 Studies that qualify through the self-determination of exemption IRB application process must strictly avoid accessing PHI. This prohibition extends to observing clinical care encounters for the purposes of human subject research. Unless a…
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