Ethnographic Research
Ethnographic Research Most anthropology protocols involve ethnographic research (including observation, participant observation, interviews, group discussions, audio-visual records, etc.) and require IRB approval. Ethnographic research, also called fieldwork, involves observation of and interaction with the persons or groups being studied in the group’s own environment, often for long periods of time. If you aren’t sure whether…
Read MoreSubject Enrollment
Subject (Participant) Recruitment and Enrollment Subject Selection Recruitment and selection of participants must be equitable (fair or just) within the confines of the study. Researchers may not exclude participants on the basis of gender, race, national origin, religion, creed, education, or socioeconomic status. The benefits and burdens of research must be fairly distributed. Research sponsors…
Read MoreHuron IRB + Safety (hSCRO)
Huron IRB + Safety (hSCRO) The Office of Research is pleased to share that Huron will replace the current IRB and hSCRO e-submission system, Kuali Research Protocols (“KRP”). Our anticipated go-live is scheduled for Fall 2025. Why are we making this change? In September 2021, UCI HRP implemented KRP to replace a 20-year-old homegrown system.…
Read MoreUCI is the Relying IRB
UCI is 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) Review Process Overview Label Label Label Label Label Label Label Step 1 Review the UCI HRP Policy #4 &…
Read MoreArtificial Intelligence and Human Subject Research
Artificial intelligence (AI) is an evolving, fast paced topic. It includes chatbots, algorithms, deep learning, machine learning/ intelligence, predictive analytics, and more. The purpose of this guidance is to share current legal considerations, as well as best practices when conducting human subject research at UCI. Please consider the following before submitting a human subject research…
Read MoreUCI is the Reviewing IRB
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…
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