UCI as Relying IRB 2
UCI as the Relying IRB (External sIRB) Relying IRB will rely on the review of the Reviewing (external) IRB. The IRB may refuse, on a case-by-case basis, to rely on the review of another IRB. External sIRB Eligibility UCI Serves as HIPAA Privacy Board External sIRB Agreements Submit an External sIRB Request Post-Cede Responsibilities External…
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UCI as the Reviewing IRB Reviewing IRB: The “IRB of record” to which authority for IRB review and oversight has been ceded by another institution for an instance of research under an institutional authorization agreement or individual investigator agreement. The Reviewing IRB is responsible for reviewing all IRB transactions for the Relying Institution. This includes,…
Read MoreHow To Register and Update Your Study
How To Register and Update Your Study The following is a quick start users guide on how to carry out some of the most common functions on ClinicalTrials.gov when registering a study. For a general overview of the registration process and requirements, see the ClinicalTrials.gov page How to Register Your Study. Want this information in…
Read MoreUCI IRB Metrics Dashboard
UCI IRB Metrics This will house the IRB Metrics Dashboard. This is updated at the end of each day, so this information reflects previous days’ studies.
Read MoreI-GREAT
I-GREAT in Human Research Protections (HRP) I-GREAT is our internal cultural agreement. HRP serves to facilitate human subject research at UCI. We don’t just want to facilitate, however, our goal is to Shine Brighter! We strive to maintain a positive work environment and thereby an equally positive IRB submission experience. If at any time HRP…
Read MoreIRB Committee Calendars
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…
Read MoreChina’s Personal Information Protection Law
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. Per Article 4 of PIPL: “Personal information” refers to various information related to an identified or identifiable natural person recorded electronically or by other means, but does not include…
Read MoreUCI as the Reviewing IRB
UCI as the Relying IRB Current UCI policy requires that all faculty, staff, and students must have UCI IRB approval before they begin research with human subjects. This requirement applies regardless of the source of funding and even when no funds are involved, regardless of the site of the study activities. UCI will consider relying…
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IRB Committee Calendar
Read MorePolicies
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…
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