Posts by Office of Research News & Announcements

Institutional Review Board Human Research Protections (HRP) IRB Review Fee: New Rate Version October 3, 2024 IRB Review Fee: New Rate Facts About the IRB Review Fee: The IRB review fee will increase from $1850.00 to $2781.00.[1]+[2] The IRB review fee is a one-time charge for new clinical research protocols partially or fully supported by…

Institutional Review Board Human Research Protections (HRP)   ClinicalTrials.gov Registration Decision Tool September 13, 2024 New! ClinicalTrials.gov Registration Decision Tool Click on the link below to help determine if your study requires registration on ClinicalTrial.gov What? A NEW ClinicalTrials.gov Registration Decision Tool is now available on the HRP ClinicalTrials.gov webpage.   Why? The decision tool…

Institutional Review Board Human Research Protections (HRP)   New Consent Templates Version September 5, 2024 New consent templates have been added to the HRP webpage, on the IRB Forms page.  The updated templates are for immediate implementation.  Researchers should revise their consent forms, as necessary, considering the current state of their research.   Existing studies…

Institutional Review Board Human Research Protections (HRP) Access to Protected Health Info (PHI) ≠ Self Determination of Exemption Version August 12, 2024 Studies that qualify through the self-determination of exemption IRB application process must strictly avoid accessing PHI. This prohibition extends to observing clinical care encounters for the purposes of human subject research. Unless a…

Hello, As you are likely aware, we are currently experiencing a significant challenge with the KR Protocols system, particularly in the Attachments section. ERA, in collaboration with Kuali, is dedicated to resolving this issue promptly. While we await a permanent solution, we’d like to offer some temporary workarounds to facilitate your document uploading process.  Resolving…

Institutional Review Board Human Research Protections (HRP) Artificial Intelligence + Human Research (A special thank you to UC Legal) Version May 20, 2024 Artificial intelligence (AI) is an evolving, fast paced topic.  It includes chatbots, algorithms, deep learning, machine learning/ intelligence, predictive analytics, and more. The purpose of this guidance is to share current legal…

  SAVE THE DATE October 15-16, 2024  UCI | Irvine, California CLINICAL RESEARCH SUMMIT 2024 UC BRAID is pleased to announce the 2024 Clinical Research Summit, the first gathering of key stakeholders among the academic medical center campuses and sister campuses engaged in clinical research, for networking, workshops and two-way learning to problem-solve shared issues…

    Clinical Research Transition effective 5/1/24   All sponsored clinical research projects proposals and agreements will be reviewed and negotiated by Sponsored Project Administration to provide process clarity for faculty and sponsors, to streamline workflows, and to consolidate clinical research contracting expertise in a single administrative unit, starting May 1, 2024. Clinical research is…

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 how to subscribe to the CG News listserv: send a blank email to: cg-news+subscribe@uci.edu.   If there’s any topics you would like us to present,…

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 impact new studies submitted to the IRB after February 21, 2024. HIPAA waiver section was reduced from 14 questions/prompts to 3-5…