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…

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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…

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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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UCI’s IRB and HRPP are committed to keeping the research community apprised of actions it is taking and expectations of its human subjects research community in light of the as the SARS-CoV-2/COVID-19 pandemic and the constantly evolving situation at UCI, within our region, nationally and internationally. We encourage all human subjects researchers to regularly check…

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  Institutional Review Board Human Research Protections (HRP)   Updated: HIPAA Research Authorization Form (UCOP version remains dated 2014) Version January 14, 2020   A new version of the HIPAA Research Authorization Form is now posted on the Applications and Forms webpage under the subsection, ‘Human Research Protections’ and then, ‘HIPAA Documents.’ Summary of Significant…

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  Institutional Review Board Human Research Protections (HRP)   2018 Common Rule Update: Cooperative Review in 2020: January Town Halls!   Version December 19, 2019   In January 2020, the Office of Research will hold two Town Hall Meetings to discuss the latest information about the 2018 Common Rule requirements for cooperative research.   Please…

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  Institutional Review Board Human Research Protections (HRP)   2018 Common Rule Update: Cooperative Review in 2020   Version December 13, 2019   On November 22, 2019, OHRP clarified that cooperative[1] research supported or conducted by HHS and subject to the 2018 Requirements are not required to comply with the revised Common Rule’s single IRB…

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  Institutional Review Board Human Research Protections (HRP)   Efficiency Update: Removal (Mostly) of Exempt Modifications Version October 25, 2019   Research activities in which the only involvement of human subjects will be in one or more of the categories specified under 45 CFR 46.104 (d) are exempt from the requirements of the basic Health…

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