Exempt Self-Determination

The UCI IRB allows Exempt Self-Determination (i.e., IRB review not required) for Categories 1-4i as described below, exceptions apply. The majority of Undergraduate Research Opportunities Program (UROP) submissions are eligible for exempt self-determination. The following Exempt Self-Determination Process at UCI letter may be provided to sponsors or publishers who need verification of the UCI policy for self-determination.

UROP Research Protections Instructions

Exempt Categories Eligible for Self-Determination

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

Limitation: §46.104(d) not likely to adversely impact students’ opportunity to learn or assessment of educators

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

Limitation: §46.111(a)(7): limited IRB review required for criteria iii, where disclosure outside the research would place subject at risk

Exempt Category 3: Benign behavioral interventions with adult subjects

Limitations:

  • §46.111(a)(7): limited IRB review required for criteria C, where disclosure outside the research would place subject at risk
  • criteria ii intervention must be brief (minutes to hours in a single day)
  • criteria iii subject must authorize use of deception via consent

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

Exceptions to Exempt Self-Determination (IRB Review Required):

    1. Limited IRB review is required: Exemptions 2iii, and 3iC.
    2. Exempt Categories 5-8, Expedited, Full Board review required.
    3. The research is regulated by the Food and Drug Administration (FDA).
    4. The research is supported by the Department of Justice (DOJ).
    5. The research is supported by the Department of Energy (DOE).
    6. The research involves the following:  
      1. The use or disclosure of UC/UCI records (e.g., medical, student, employment, when the California Information Practices Act (CIPA) is applicable etc.)
      2. Creation, access to, use, or disclosure** of medical records; or observations of clinical care [i.e., Protected Health Information (PHI)]
      3. A targeted recruitment of children (this includes UC students / employees under the age of 18)
      4. A targeted recruitment of adults (age 18 or older) with Impaired Decision-Making Capacity (who may not be legally/mentally/cognitively competent to consent)
      5. A targeted recruitment of prisoners (may include parolees)
      6. A targeted recruitment of American Indian/Alaska Native tribes
      7. A targeted recruitment of undocumented people
      8. International Research
      9. 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.
      10. A study team member has a Disclosable Financial Interest

** Use is any sharing, employment, application, utilization, examination, or analysis within the entity
Disclosure is any release, transfer, provision of access to, or divulging outside of entity

How to Submit an Exempt Self-Determination

The PI must complete an "Exempt Self-Determination" in ZOT IRB to register the self-determination with the UCI IRB. This includes completing a PROTOCOL NARRATIVE - Exempt Research Self-Determination and uploading it to the registration.