Posts by OR Human Research Protections
Upcoming Transition to Huron: Limited Protocol Submissions + Data Migration
Institutional Review Board Human Research Protections (HRP) Upcoming Transition to Huron: Limited Protocol Submissions + Data Migration June 05, 2025 What is Happening Huron IRB and hSCRO will launch on September 15, 2025. In …
Read MoreMinimal Risk Human Subject Research and a Closer Look at Expedited Category 2
Institutional Review Board Human Research Protections (HRP) Minimal Risk Human Subject Research and a Closer Look at Expedited Category 2 May 15, 2025 Federal regulations define minimal risk as the probability and magnitude of harm or discomfor…
Read MoreHumanitarian Use Devices (HUD)
Institutional Review Board Human Research Protections (HRP) Humanitarian Use Devices (HUD) Version May 2025 A HUD is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manife…
Read MoreEfficiency Updates: Single IRB (sIRB)
Institutional Review Board Human Research Protections (HRP) Efficiency Updates: Single IRB (sIRB) April 2025 On Monday, April 14, 2025, the UCI HRP will simplify the current sIRB process. The UCI HRP will more closely align wit…
Read MoreQRAM (12/11) Agenda and Zoom Info
Dear Colleagues, Please join us for our Winter QRAM this Wednesday, 12/11, starting at 10AM. Below is the agenda and Zoom information. See you then! ERA Updates Huron for IRB and hSCRO C&G Accounting Updates Barbara Inde…
Read MoreName the New UCI IRB + hSCRO System: Please Complete the Poll! (LINK CORRECTED)
Institutional Review Board Human Research Protections (HRP) Name the New UCI IRB + hSCRO System: Please Complete the Poll! December 4, 2024 HRP is continuing efforts to onboard Huron IRB + hSCRO for our anticipated launch at the end of…
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 MoreNASA changes coming October 1, 2024
NASA recently issued revised policies on Current and Pending Support (CPS) and Biosketches to implement requirements contained in the National Security Presidential Memorandum 33 and the CHIPS and Science Act. The updated policies and an associated new…
Read More02/21 QRAM Materials Posted
Dear Colleagues, Thank you for attending our Winter QRAM yesterday! The meeting materials have been posted here: https://research.uci.edu/electronic-research-administration/qram/ Please also share with your areas the new instructions on h…
Read MoreHIPAA & Consent Waivers Streamlined
Institutional Review Board (IRB) Human Research Protections (HRP) HIPAA & Consent Waivers Streamlined Version February 22, 2024 The HIPAA and consent waiver sections of the IRB application have been streamlined. This change will only …
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