Exempt Self-Determination

The UCI IRB allows Exempt Self-Determination (i.e., IRB review not required) for Categories 1-4 as described below, exceptions apply. The majority of Undergraduate Research Opportunities Program (UROP) projects register a self-determination.

Registration Process

When an activity qualifies for Exempt Self-Determination, IRB approval is not required and will not be provided. Instead, the Principal Investigator (PI) must register an "Exempt Self-Determination" in ZOT IRB.

IMPORTANT! The registration process is different than the submission process for IRB review. Review the IRB Researchers Guide to learn how to "Create and Register a Self-Determination". A complete PROTOCOL NARRATIVE - Exempt Research Self-Determination must be uploaded with the registration. No other supplemental documentation is required.

Ready to Register an Exempt Self-Determination?
Go to ZOT IRB

Exempt Self-Determination Eligibility

Exempt Category 1: Research conducted in educational setting involving normal educational practice

Exempt Category 2: Educational tests, survey, interview, observations of public behavior

Exempt Category 3: Benign behavioral interventions with adult subjects

Notes: Interventions must be brief (minutes to hours in a single day). When deception is used, participants must consent to use of deception.

Exempt Category 4: Secondary uses of identifiable private information or identifiable biospecimens that are publicly available and external of the University

Exceptions (IRB Approval Required)

    1. The research is supported or regulated by the following entities: Food and Drug Administration (FDA), Department of Justice (DOJ) or Department of Energy (DOE).
    2. Disclosure of identifiable information outside the research would pose risk to participants.
    3. The use or disclosure of UC/UCI records (e.g., medical, student, employment, when the California Information Practices Act (CIPA) is applicable etc.)
    4. Creation, access to, use, or disclosure of medical records; or observations of clinical care [i.e., Protected Health Information (PHI)].
    5. A targeted recruitment of the following populations:
      • children (this includes UC students / employees under the age of 18)
      • adults (age 18 or older) with Impaired Decision-Making Capacity (who may not be legally/mentally/cognitively competent to consent)
      • prisoners (including parolees)
      • American Indian/Alaska Native tribes
      • undocumented people
    6. International Research
    7. A request for UCI to serve as IRB of Record for non-UCI individuals engaged in human subjects research. Note: To initiate a request for UCI to serve in this capacity, the LR must have a dual affiliation with the non-UCI entity and IRB review is required to formalize the reliance process.
    8. A study team member has a Disclosable Financial Interest