Dear Colleagues, Please join us for our Winter QRAM this Wednesday, 12/11, starting at 10AM. Below is the agenda and Zoom information. See you then! ERA Updates Huron for IRB and hSCRO C&G Accounting Updates Barbara Inderwiesche – UC Irvine is inviting you to a scheduled Zoom meeting. Topic: Winter […]
QRAM (12/11) Agenda and Zoom Info Read More »
Institutional Review Board Human Research Protections (HRP) Name the New UCI IRB + hSCRO System: Please Complete the Poll! December 4, 2024 HRP is continuing efforts to onboard Huron IRB + hSCRO for our anticipated launch at the end of calendar year 2025. We’re now brainstorming names for the new system and would love to hear
Name the New UCI IRB + hSCRO System: Please Complete the Poll! (LINK CORRECTED) Read More »
Institutional Review Board Human Research Protections (HRP) Name the New UCI IRB + hSCRO System: Please Complete the Poll! December 4, 2024 HRP is continuing efforts to onboard Huron IRB + hSCRO for our anticipated launch at the end of calendar year 2025. We’re now brainstorming names for the new system and would love
Name the New UCI IRB + hSCRO System: Please Complete the Poll! Read More »
Institutional Review Board Human Research Protections (HRP) FDA Inspections of Clinical Investigators Policy October 29, 2024 To promote our institution’s commitment to compliance with Food and Drug Administration (FDA) requirements, UCI Health has developed a new FDA Inspections of Clinical Investigators Policy. <![if !vml]><![endif]> The policy’s primary purpose is to establish and enforce expectations for investigators
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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
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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
IRB Fee Increase – Effective October 1, 2024 Read More »
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
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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
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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
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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
Important Update: Workarounds for KR Protocols Attachments Issue Read More »
