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., 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;…

Lead Researcher/Principal Investigator Eligibility Lead Researcher/Principal Investigator (LR/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…

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 There are two options for treating patients with an unapproved medical device outside of a clinical trial. One option is Expanded Access. The other is Right to Try. Wrencha and Screw Driver Icon (Decorative) FDA Expanded Access eRequestA web-based tool that enables physicians to complete, sign, and submit non-emergency Expanded…

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…

What is ClinicalTrials.gov? ClinicalTrials.gov is a resource that provides access to information on clinical trials studying a wide range of diseases, conditions and interventions. Studies listed in the database are conducted in all 50 States and worldwide. Each ClinicalTrials.gov record includes summary information about studies. Want a quick start guide to CT.gov? Download a PDF…