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…

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  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…

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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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Update!  Exempt Registration Self Determination In an effort to facilitate research and focus on IRB applications that require UCI IRB review, effective July 8, 2019, Human Research Protections (HRP) staff will no longer provide a “sign off” of the Exempt Self-Determination Tool,verifying that the study meets the selected exempt category. For additional documentation to support…

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Streamlining IRB Exempt Research Review To continue to streamline the IRB review process, two new updates are now available: 1.An Optional Exempt Self-Determination Process, and 2.An updated Exempt Protocol Narrative for Exempt Research that require IRB review   Optional Exempt Self-Determination Process Researchers will be able to self-determine whether their research activity meets certain IRB…

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Streamlining IRB Exempt Research Review ·IRB Exempt Self-Determination ·Updated IRB Exempt Protocol Narrative As part of our initiative to streamline the IRB review process, two new updates will be available on April 2, 2018: 1.An Exempt Self-Determination Tool, and 2.An updated Exempt Protocol Narrative for research that requires IRB review IRB Exempt Self-Determination Lead Researchers…

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Common Rule Changes Ahead in 2018: EXEMPT RESEARCH For the first time since it was issued in 1991, the Common Rule — the set of federal regulations for ethical conduct of human-subjects research — has been updated. Most of the new requirements, many of which increase flexibility and reduce administrative burden areanticipated1to start on January…

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Dear Colleagues: In an effort to streamline and facilitate review of human subjects research conducted by undergraduate researchers, the Undergraduate Research Opportunities Program (UROP) will now review and confirm Exempt research.  This change will be effective with UROP’s 2017 Fall Call for Proposals. The Lead Researcher must be an undergraduate with a Faculty Mentor/Sponsor.  Undergraduates…

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  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…

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  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…

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