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 ZOT IRB by the specified deadlines. Minimal risk protocols and related transactions (e.g., Modifications, Continuing Reviews, Study Closures) are reviewed on a rolling basis, at weekly…

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…

Principal Investigator Eligibility Principal Investigator (PI) is a role in which an individual leads a research protocol that is reviewed, approved, and overseen by UCI’s Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Human Stem Cell Oversight Committee (hSCRO), or Institutional Biosafety Committee (IBC). Any UCI employee who is eligible to be a…

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…

Expanded Access to Unapproved Devices What is Expanded Access? According to Food and Drug Administration (FDA) regulations, an unapproved medical device may normally only be used on human subjects through an approved clinical study in which the subjects meet certain criteria and the device is only used in accordance with the approved protocol by a…

Drugs and  Biologics Used in Clinical Research Per FDA, Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements…

ClinicalTrials.gov Educational Opportunity ClinicalTrials.gov: Essentials for Academic Medical Centers  This virtual training from FDA and NIH specialists is designed to help academic researchers and their staff meet the federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov. The live virtual sessions will be held on: July 14 at 10:00 am  July 22 at 10:00 am  July 30 at 10:00 am Click…