UCI as the Relying IRB 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. Single IRB (sIRB) Submission Process Overview Label Label Label Label Label Label Label Step 1 Review the UCI HRP Policy #4 &…

UCI as the Relying IRB 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. Single IRB (sIRB) Submission Process Overview Label Label Label Label Label Label Label Step 1 Review the UCI HRP Policy #4 &…

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,…

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…

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…

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.  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…

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 Assurance02 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 Data;…