Human Research Protections
Translated HIPAA Research Forms
Institutional Review Board Human Research Protections (HRP) Translated HIPAA Research Forms Version August 31, 2020 Foreign language translatedHIPAA Research Authorization Forms are posted on the Applications and Forms webpage under the subsection, ‘Human Research Protections’ and then, ‘Foreign Language Translations.’ Reminder: Since early 2020, one form now covers UCI providers and non-UCI…
Read MoreProgram Update: Removal of Exempt 4iii
Institutional Review Board Human Research Protections (HRP) Program Update: Removal of Exempt 4iii Version August 28, 2020 The 2018 Common Rule went into effect on January 21, 2019, specifying revised exempt research categories under 45 CFR 46. 104. One of the revised categories, Exempt 4iii allows for the secondary use of existing…
Read MorePolicy Update – Results Information Reporting for Applicable Clinical Trials (ACTs)
Institutional Review Board Human Research Protections (HRP) Policy Update – Results Information Reporting for Applicable Clinical Trials (ACTs) (NOT-OD-20-147) Version August 18, 2020 Update: A Federal court has held that Section 801 of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) requires submission of results information for any “applicable clinical…
Read MoreCelebration of UCI’s $529M Research Funding Milestone! – TOMORROW!
View this email in your browser 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! TOMORROW – AUGUST 13, 2020 3:00PM – 5:00PM ZOOM LINK Meeting ID: 957 7898 1022 Passcode: 529mil ⚠ STILL ACCEPTING PHOTOS!(optional…
Read MoreOfficial Invitation: Celebration of UCI’s $529M Research Funding Milestone!
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 …
Read MoreFDA Clinical Trial Guidance Updated
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…
Read MoreSave the Date: August 13 @ 3PM – Celebration of $529M Research Funding Milestone!
View this email in your browser !!SAVE THE DATE!! AUGUST 13 @ 3PM 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! Please save August 13 @ 3PM on your calendar. Details to follow.
Read MoreNew IRB Fee Structure for sIRB
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…
Read MoreJune Updates in HRP
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…
Read MoreSARS-CoV-2/COVID-19 Related IRB Modifications – Points to Consider
Dear UCI Human Subject Researchers: Please remember that you do not need prospective IRB approval to eliminate apparent immediate hazards to human research subjects due to SARS-CoV-2/COVID-19. Make the change and keep a change log. At the next IRB modification request, refer to your change log and update the protocol accordingly. [1] Address the following…
Read More