Human Research Protections
New 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 MoreNon-UCI Researchers Accessing UCI Resources for Research: An Updated Form!
Institutional Review Board Human Research Protections (HRP) Non-UCI Researchers Accessing UCI Resources for Research: An Updated FormVersion April 29, 2020 Effective May 1st,HRP will release an updated form for Non-UCI students, faculty or staff conducting human research at UCI. When this form is presented to a department or research unit (center/institute), it…
Read MoreSoft Launch: Removal of (Most) Research Personnel
Effective May 1, HRP is streamlining the study team information collected for IRB review so that only the Lead Researcher (LR), Co-Researchers*, and Research Personnel (as indicated on the below Research Personnel Heat Map) should be listed in the IRB Application & Protocol Narrative. How will remaining study personnel be tracked? LR’s are responsible for tracking…
Read MoreNew Protocol Narrative for No Subject Contact
Institutional Review Board Human Research Protections (HRP) No Subject Contact Protocol Narrative Version April 17, 2020 To facilitate IRB review and approval, effective May 1, 2020, use of a new Protocol Narrative will be required for new applications in which researchers will access identifiable private information and / or identifiable biospecimens without contacting subjects. This…
Read MoreWhen UCI Serves as the IRB of Record for Cooperative Research: A Streamlined Process
Institutional Review Board Human Research Protections (HRP) When UCI Serves as the IRB of Record for Cooperative Research: A Streamlined ProcessVersion April 13, 2020 HRP has streamlined the reliance processes for when UCI serves as the IRB of record for cooperative research[1]. These changes take effect immediately and apply to all situations…
Read MoreIRB WebApps Downtime TONIGHT 4/9/20 7pm-8pm
Dear Colleagues, Tonight from 7-8pm, OIT will be deploying an important update to the IRB WebApps (IRB APP and eMOD). The below features are NEW and should be noted: X IRB APP: Add new required COVID-19 question Add new Yes/No question in Section 1 Include question and answer in IRB APP PDF For…
Read MoreUsing DocuSign and Phone Consent for UCI IRB Approved Informed Consent Processes
Dear Colleagues, the following information was recently added to the HRP section of the Office of Research – Research Continuity website. Please review and share as appropriate. Using DocuSign and Phone Consent for UCI IRB Approved Informed Consent Processes During the declared national and statewide emergency in response to the COVID-19 pandemic, the UCI…
Read MoreUpdated HRP procedures in relation to COVID-19 pandemic
Dear Colleagues, the following updated guidance has been added to the HRP section of the Office of Research Continuity website, please review and share as you see fit: What Human Research has been Halted? Non-critical research has been halted, in accordance with the Vice Chancellor for Research’s shutdown message. However, all non-critical human subject research…
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