Undergraduate Researchers

University policy requires that an Institutional Review Board (IRB) must review human research projects prior to the start of the research.

Exempt Research:

All UCI faculty-mentored undergraduate research involving human subjects that meets the criteria for exempt review must complete the Exempt Self-Determination Tool. Undergraduate students conducting research through the Undergraduate Research Opportunities Program (UROP) should contact UROP for assistance with this process. There are some exceptions however, even if the research is exempt.  If one of the situations below applies, do NOT complete the Exempt Self-Determination Tool.  Instead, submit for IRB Review

Exceptions from UROP Confirmation of Exemption:

  1. The research is regulated by the Food and Drug Administration (FDA).
  2. The research is supported by the Department of Justice (DOJ).
  3. The research does not involve the following:   

a. The use or disclosure of UCI protected health information (PHI)**
b.  A targeted recruitment of children targeted recruitment of children
c.  A targeted recruitment of adults (age 18 or older) who may not be legally/mentally/cognitively competent to consent
d.  A targeted recruitment of prisoners (may include parolees)
e.  A targeted recruitment of American Indian/Alaska Native tribes
f.  A targeted recruitment of undocumented people
g.  International Research
h.  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.  
i.  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

Additional Tips for Student Researchers

If the research will be conducted off-site (e.g., non-UCI facility - elementary school, day care center, community center, etc.), researchers must obtain written permission from an authority of the site (e.g., Principal, Director, etc.) before IRB approval may be granted. See: Human Research Activities Performed at Other Institutions for additional information.

(Remember, for UROP exempt projects, research with a targeted enrollment of minors/ children is an exception.  IRB review and approval is required for research involving children.)

For non-Exempt international research, or Exempt research that requires IRB review, allow plenty of time for the IRB approval process. We suggest submitting application materials two months ahead of when research is planned to begin.  For example, if the research project will occur during the summer months, submit your IRB Application in April or May, which will allow the IRB staff sufficient time to review your IRB Application and therefore you will be able to secure your IRB approval prior to departing to the international region where your research project will occur.  More importantly, be sure to verify whether Export Control laws would be applicable to your university-related travel by contacting the Export Control Officer.

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