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