Not Human Subject Research Self-Determination
Not Human Subject Research (NHSR) Self-Determination The UCI IRB allows NHSR Self-Determination (i.e., IRB review not required) for activities that are not research, or for research that does not involve a human subjects. Registration Process When an activity is not human subject research, IRB approval is not required and will not be provided. Instead, the…
Read MoreIRB Forms
HRP Toolkit The HRP Toolkit is a central location for all critical-IRB related documentation. There are new documents corresponding to the new standard operating procedures, of note: HRP-101 Human Research Protection Plan – The plan references the scope, purpose, mission and all programmatic components of human subject research at UCI. This document, along with the Worksheets…
Read MoreEthnographic 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 MoreZOT IRB + ZOT hSCRO
To access and learn more about ZOT IRB Access ZOT IRB Visit the HRP site To access and learn more about ZOT hSCRO Access ZOT hSCRO Visit the hSCRO site Need technical help? ERA Support Desk As of September 15, 2025, ZOT IRB and ZOT hSCRO is live and has replaced Kuali Research Protocols (“KRP”).…
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…
Read MoreUCI is the Reviewing IRB
UCI is 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.
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