IRB Committee Meetings & Deadlines IRB Full Committee meetings are held monthly for Biomedical and Social-Behavioral greater than minimal risk research. All full committee documentation must be provided in KRP by the specified deadlines. Minimal risk protocols and related transactions (e.g., amendments, renewals, closings) are reviewed on a rolling basis, at weekly subcommittee meetings. Greater…

China’s Personal Information Protection Law (PIPL) China’s PIPL applies to the processing of personal information of individuals living in mainland China on or after November 1, 2021.  The PIPL shares many similarities with the European Union’s General Data Protection Regulation (the “GDPR”, including its extraterritorial reach, restrictions on data transfer, compliance obligations and sanctions for noncompliance, amongst…

External Reliance Studies – How & What to Submit Reliance Agreement Tables Commercial Agreements COMMERCIAL IRB AGREEMENTHOW TO SUBMIT NEW STUDIES TO UCI IRBONLINE PORTALUCI GUIDANCESHORT FORMAMENDMENTSRENEWALSREPORTABLE EVENTS TO IRB OF RECORDAND TO UCI WCG IRBGuidance DocumentConnexusInfoDefer to UCI’s Use of Short Form (Policy 31)All changes1. Personnel changes 2. Changes affecting HIPAASubmit the Renewal Letter…

IRB Committee Calendar IRB Calendar 2021 IRB Calendar 2022

HRP Policies and Procedures Download All These Policies In a Single, Searchable File! Get the File I. IRB Authority & Institutional Commitment 01 Institutional Oversight of Assurance 02 Activities Subject to IRB Jurisdiction II. Conducting Research 03 Research Involving Performance Sites04 Offsite Research, Cooperative Research and Research at UCI-affiliated Institutions15 Research with Human Specimens and…

IRB Forms Checklists Protocol Preparation Checklist Checklist – Transition 2018 Common Rule Checklist – Continuing Review (Long CPA) Checklist – Continuing Review (Short CPA) Checklist – Emergency Use of a Test Article Checklist – Exempt Research Checklist – Informed Consent Checklist – Modification Checklist – New Expedited or Full Committee Research Checklist – NIH Genomic…

Lead Researcher Eligibility Differences Between Lead Researcher and Principal Investigator Principal Investigator eligibility for a Contract or Grant is separate from Lead Researcher eligibility for conducting research with human subjects or animals. In making this distinction, UCI recognizes both the added responsibility associated with research involving humans or animals, and the research contributions of all…

NIH sIRB Review Policy for Multi-Site Research On June 21, 2016 the National Institutes of Health (NIH) issued a policy for single Institutional Review Board (sIRB) of NIH-funded human subjects research protocols conducted at two or more U.S. sites. The goal of the policy is to enhance and streamline the IRB review process for multi-site…

National Cancer Institute Central IRB (CIRB) Independent Review Process Overview of the CIRB Initiative The Central Institutional Review Board (CIRB) Initiative is sponsored by the National Cancer Institute (NCI).  The Adult NCI CIRB reviews Cooperative Group trials from the ACOSOG, CALGB, ECOG, GOG, NCCTG, NCIC, NSABP, RTOG, and SWOG, as well as any other studies…

Existing IRB Reliance Agreements Children’s Hospital of Orange County (CHOC) and MemorialCare Health System (MHS) CHOC, MHS and UCI, established an IRB Reliance agreement that allowed for human subjects research to be reviewed by a single IRB rather than submitting for IRB approval at each institution where the research would take place. This agreement was…