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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 registration before they can initiate their project. See Definition of Human Subjects Research for more information. Please consult with the Human Research Protection staff if you are unsure whether your project constitutes human subjects research.

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

Yes. UCI students can be Lead Researchers on human subjects protocols with Faculty Sponsorship. 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 application for Exempt Registration is required if you plan to conduct anonymous survey or interview research.

How do I apply for IRB review?

  1. Faculty Sponsorship - Find a faculty advisor who will sponsor and guide you throughout 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 and Recruitment.
  4. Determine how you will obtain informed consent. See: Informed Consent Preparation.
  5. All study team members are required to successfully complete for credit the Human Research tutorial and HIPAA tutorial, 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: Verification of Tutorial Completion.
  6. Complete the IRB Application. See: Protocol Preparation Checklist. Also see the 10 Most Common Reasons why Protocols are Deferred by the IRB.
  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 an IRB Protocol for additional guidance.
  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 this page for more information about the IRB review process.

How long does it take to obtain IRB Approval/Registration?

Exempt and Expedited protocols submitted to the social/behavioral IRB are reviewed weekly. Exempt and Expedited protocols submitted to the biomedical IRBs are reviewed on a rolling basis. The turnaround time from submission to approval generally takes 3-4 weeks for Exempt and Expedited protocols. Social/behavioral full Committee protocols are reviewed monthly; biomedical full Committee protocols are review twice per month. The turnaround time from submission to approval generally takes 4-8 weeks for full Committee protocols depending on the completeness of the submission including the required additional documents (e.g., informed consent/assent forms, recruitment materials, questionnaires) and whether other UCI Committees must first approve the research (e.g., CRFA, CTPRMC, DSRC). See: Human Subjects Application and Protocol Preparation Checklist.

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

For Exempt and Expedited protocols, you will need to contact the Research Protections staff. An official IRB approval letter and all approved documentation will be sent by mail to the Lead Researcher within a week of IRB approval. If you are listed on a full Committee protocol, Research Protections posts the IRB decisions the day after the meeting date. See: Results of Full Committee Meeting.

How long is my approval good for?

Most Expedited and full Committee protocols are approved for one year from the date of approval (the IRB may grant a shorter approval period). Continuation of an approved protocol requires submission of the Continuing Protocol Application. Exempt research is registered for three years. Continuation of an Exempt protocol beyond three years requires submission of a new IRB Application.

For more FAQ’s click here.

Additional Tips for Student Researchers

  1. 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: Offsite Research for additional information.
  2. For international research, allow plenty of time for the IRB approval process. We suggest submitting application materials two months ahead of when research is planned to begin.

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