Exempt Self-Determination

The UCI HRP allows Exempt Self-Determination (i.e., IRB review not required) for Categories 1-4ii, with exceptions noted below. All UCI faculty, staff, and students, may log into Kuali Research Protocols (KRP) and submit an Administrative Determination-Exempt Self-Determination.

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

Limitations:

  • not likely to adversely impact students’ opportunity to learn or assessment of educators;
  • does not involve secondary analysis of materials (i.e. school records)

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 research for which consent is not required: uses of identifiable private information or identifiable biospecimens

Exceptions to Exempt Self-Determination (IRB Review Required)

    1. Limited IRB review is required: Exemptions 2iii, and 3iC.
    2. The research is regulated by the Food and Drug Administration (FDA).
    3. The research is supported by the Department of Justice (DOJ).
    4. The research involves the following:  
      1. The use or disclosure of UCI protected health information (PHI)**
      2. A targeted recruitment of children
      3. A targeted recruitment of adults (age 18 or older) who may not be legally/mentally/cognitively competent to consent
      4. A targeted recruitment of prisoners (may include parolees)
      5. A targeted recruitment of American Indian/Alaska Native tribes
      6. A targeted recruitment of undocumented people
      7. International Research
      8. 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.
      9. 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