Share

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 submit for exempt confirmation through the Undergraduate Research Opportunities Program (UROP).

There are some exceptions however, even if your research is exempt.  If one of the situations below applies to your research, you can NOT submit for a UROP Exempt Review.  Instead, please submit for IRB Review.  A reference to the level of review is noted after each exception, for reference. This will help you to determine which Protocol Narrative to complete as part of the IRB Application.

Exceptions from UROP Confirmation of Exemption:

  1. The subjects can be identified directly or indirectly (access to key linking individual with information) when asking them to disclose sensitive information (e.g., illegal behavior, or sensitive themes such as sexual experiences, physical abuse, alcohol or drug use, undesirable work behavior, or other information that may be embarrassing or psychologically painful) that could place subjects at risk for criminal or civil liability, or might be damaging to subjects’ financial standing, employability or reputation.[Expedited Level Research]
  2. The research involves interaction with prisoners.  Individuals confined in a correctional or detention facility, including involuntary assignment to community-based alternatives to incarceration (drug treatment facilities, etc.).  [Expedited Level Research]
  3. The research involves adult participants who may not be legally/mentally/cognitively competent to consent.  [Exempt or Expedited Level Research]
  4. The research involves individuals under the age of 18[Exempt or Expedited Level Research]
  5. Deception or incomplete disclosure is involved. [Exempt or Expedited Level Research]
  6. The research involves a prospective collection of biological specimens for research purposes by noninvasive means (e.g., saliva).  [Expedited Level Research]
  7. The research involves a prospective collection of data through non-invasive procedures routinely employed in clinical practice – including the use of FDA approved / cleared medical devices (e.g., use of ultrasound, blood pressure cuff, fMRI, EKG, etc.).  [Expedited Level Research]
  8. The research involves access to or the use of protected health information (PHI)[Exempt or Expedited Level Research]

The following table helps to further illustrate the UROP exempt confirmation process. 

# Step Resource Tips Contact
1

Determine if Undergraduate Research Activity Involves Human Subjects.

If yes, is it Exempt?


Do any of the 9 exceptions listed above apply?

  • OHRP Decision Charts – use these to (also) check if your project is human subject research and then…exempt!
  • If research involves human subjects and is not exempt or is exempt but includes one of the 9 exceptions above, an IRB Application and supporting documents must be submitted to the IRB for review and confirmation.  
  • IRB approval or confirmation will be required prior to initiating research.



If an IRB submission is required, contact: Human Research Protections (HRP) Staff

2

The Undergraduate Research Activity is Exempt.  None of the 9 exceptions apply.


Initiate UROP Application!

Director Said Shokair
3 Modifications: Minor
  • Minor changes like adding or removing administrative personnel, making minor changes to your survey or interview questions does not require the submission of a modification.
Director Said Shokair
4 Modifications: Major
  • Major changes such as altering the study population, the study design or procedures requires a new submission. 
Director Said Shokair

Frequently Asked Questions



I’m a UCI student interested in conducting my own research project.  Do I need IRB approval before I can begin?

Yes. Students conducting human subjects research require IRB approval or exempt confirmation before they can initiate their project.  If the research project is exempt, and does not meet any of the exceptions, submit to UROP for confirmation.

Use the above table to make an assessment.  Does your project involve human subject research? Is it exempt? Consult with your Faculty Mentor.  If still unsure, please consult with the Human Research Protections Staff.



Can I be listed as the Lead Researcher on the IRB Application?

Yes. UCI students can be Lead Researchers on human subjects protocols with a Faculty Sponsor/Mentor. Please note: Undergraduates can be Lead Researchers on protocols that involve no more than minimal risk to subjects (i.e., Exempt or Expedited research). See: Lead Researcher Eligibility to determine who can serve as a Faculty Sponsor.



Should I submit a new IRB application, or be added to my Faculty Advisor’s protocol?

When a student’s research project consists of the collection and/or analysis of data that is part of the scope of an existing faculty member’s IRB approved research, the student can be added to the Faculty member’s protocol, rather than submitting as Lead Researcher on a new IRB Application.



Is IRB review necessary if my study involves anonymous surveys or interviews?

Yes – an exempt confirmation is needed.  If none of the exceptions apply, UROP confirmation is required for undergraduate exempt research. If an exception applies (e.g., research involves children), submit an application to the IRB for Exempt Registration.



How do I apply for IRB review?

  1. Faculty Sponsorship - Find a faculty advisor who will sponsor and guide you throughout the research process.
  2. Formulate your research question and study design. If your study involves interviews, surveys, or questionnaires identify the standardized instruments that will be used. If a new measure will be used develop your survey or questionnaire instrument or interview protocol.
  3. Define your sample population and develop recruitment procedures. See: Subject Selection, Recruitment and Compensation. For more info on the use of Social Science Human Subjects Pool (SSHSP), see: Human Subject Lab Pool
  4. Determine how you will obtain informed consent. See: Drafting the Informed Consent Form.
  5. All study team members are required to successfully complete for credit the CITI HRP tutorial and HIPAA Research tutorial as found on the Office of Research Training & Education page, if applicable, Even non-UCI investigators on UCI protocols are required to complete the tutorial(s). Applications may be withheld pending tutorial completion. You may verify that research team members have completed the required tutorial(s) by entering their name on this webpage: Tutorial Verification.
  6. Complete the IRB Application. See: Protocol Preparation Checklist. Also see: Common IRB Submission Errors.
  7. Faculty Sponsor and Department Chair’s signatures are required on IRB applications for student research. Applications will be withheld until all required signatures are provided. Please note that if your Faculty Sponsor, or any member of the study team is the Department Chair/Director, the signature of the next highest level of administrative authority is required.
  8. Submit the appropriate number of copies to the Office of Research Administration. See: How to submit Electronic IRB Applications for Review.
  9. Save a copy of your application packet for your records and back-up all files relating to your application on your computer, as you may be asked to submit revisions following the Initial Review.
  10. See: “I’ve submitted my IRB Application. Now what happens?” on IRB Frequently Asked Questions for more information about the IRB review process.



How long does it take to obtain IRB Approval/Exempt Confirmation?

The UROP exempt confirmation process is concurrent with the UROP award review process. At the IRB, Expedited and Exempt protocols are reviewed on a rolling basis. Factor in at least 4 weeks from submission to confirmation or IRB approval.



How will I be notified when my IRB application is approved?

The UROP exempt confirmation will be sent via email, following approval of an award for funding.  At the IRB, once the Expedited or Exempt protocol has been approved / confirmed, you and your Faculty Sponsor will be notified via email.  You will receive a link to the Document Depot for access to your final IRB approval/confirmation materials.



How long is my approval good for?

The UROP exempt confirmation lasts the life of the project / funding.  At the IRB, Expedited protocols are approved for 1 or 3 years from the date of approval (depending on various factors including funding). Exempt research is registered for 3 years. Continuation of an Exempt protocol beyond 3 years requires a Continuing Protocol Application.



Additional Tips for Student Researchers

If you plan to conduct research off-site (e.g., non-UCI facility - elementary school, day care center, community center, etc.), at a minimum you will need to 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 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, we recommend that you 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.

suggestions and comments