UCLA OPRS Human Research Protection Program

CERTIFICATION OF EXEMPT

General Instructions

Certification of Exemption: Exempt categories of research are defined by the Department of Health and Human Services (DHHS) regulations for protection of human subjects in 45 CFR 46.101 (see Exemption Categories below). If an investigator believes his or her study qualifies for certification of exemption from Institutional Review Board (IRB) review, then a Certification of Exemption form must be completed and submitted to the OHRPP HRPP office for review and certification. Federal guidance and University policy do not allow investigators to make this determination on their own.

Two Forms and Exempt Categories List

There are two types of certification of exemption forms:

Certification of Exemption Form ? Categories 1, 2, 3, 5 and 6 is primarily for research that is being conducted in educational settings involving normal educational practices and research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observations of public behavior.
Certification of Exemption Form ? Category 4 is for research which involves analysis of pre-existing data or biological specimens.
Click on this Exempt Categories link for additional explanation of what may be submitted as exempt at UCLA.

Filling Out the Certification of Exemption Forms

Review the Exemption Categories list before filling out the Certification of Exempt form. This list will help you make an initial determination as to whether your proposed research falls under one or more of the exemption categories.
Be sure to use the appropriate form once you determine that your research may qualify for certification of exempt.
Save the form immediately, before filling it out. After saving it, start Word (or other word-processing program) and open the form from within that program (i.e., do not open it from your desktop).
Type your answers in the blank, un-shaded areas below questions. Do not alter the text and formatting of the form itself.
Use clear, jargon-free language, understandable to persons outside of your research field.
Complete all applicable sections of the application. The funding section must be completed. The Principal Investigator must sign the form.
Complete the on-line Human Subject Research training. All investigators and faculty sponsors must complete this training before the research can be certified exempt. The on-line certification course is available as a link from the Human Research section of the OHRPP Home Page.
If you have any questions, please contact: Wendy Brunt, Administrator; Email: wbrunt@research.ucla.edu; Call: 310- 825-4810; Fax: 310-794-9565.
Important Note to Researcher: Before implementing any changes to the certified exempt protocol, the changes require re-certification of this study. Click here for a link to the Checklist for Submitting Amendments to Exempt Protocols.