OR Human Research Protections

Institutional Review Board Human Research Protections (HRP)   HIPAA and Human Subject Research Version October 25, 2024 What is HIPAA? The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was enacted on August 21, 1996. HIPAA required the Secretary of Health and Human Services (HHS) to issue privacy regulations governing individually identifiable health information if […]

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

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

Institutional Review Board Human Research Protections (HRP) HRP Update: IRB Review Fee: New Rate Version October 9, 2023 IRB Review Fee: New Rate   A Few Facts About the IRB Review Fee:   The IRB fee will increase from $1568.00 to $1850.00.[1]    This new rate impacts protocols approved by the IRB on or after

  Your friends and colleagues in the UCI Office of Research would like to wish you a happy International Research Administrator Day.  Please click the above image for a video greeting from us to you.   Thank you for all you do!    

Good afternoon,   The presentation slides and the Zoom recording of last week’s QRAM are posted here for your reference: https://research.uci.edu/electronic-research-administration/qram/.   We will send out the next meeting information soon! As a reminder, if you are interested in a specific topic or have expertise in a topic that others might enjoy, please let us