California State University, San Bernardino
Institutional Review Board for the Protection of Human Subjects of Research

rev. 08/27/01

Modified with permission of the author, Dr. James R. Brett, at CSULB's Office of University Research.

Interactive Review for Exemption Status

This program will help you decide whether to apply for permission to conduct research involving human subjects under the University's Exempt (Administrative Review) category. If your research is exempt from review by the University's Institutional Review Board for the Protection of Human Subjects (IRB), your proposal will, instead, be reviewed administratively. The ethical principles applying to proposals reviewed by the IRB also apply to Exempt category proposals. Informed consent and every other consideration respecting the rights, safety, and privacy of human subjects also apply. 

NOTE: The researcher/applicant, does not have the authority to declare research exempt. ONLY the designated IRB Chair for California State University-San Bernardino (Dr. Joseph Lovett Ph.D., Department of Health Sciences) can make that determination.  The researcher/applicant can request and check off the appropriate category for exempt status, but it is the IRB Chair who determines if your application meets the requirements of Exempt Status. Exempt does not mean that the researcher/applicant are exempt from filing an IRB application or from going through the IRB process, you are still required to fill out and submit the application. 

What is the definition of Exempt?

Answer!

"Exempt means exempt from the requirements of 45 CFR 46 that there be documentation of informed consent, annual renewals, and review by a full board. Exempt protocols still require approval of exempt status by the IRB chair, reporting of adverse events, and evidence that the researcher will take all necessary steps to assure informed consent.
 
"Research involving children, incarcerated persons, pregnant women, and persons of diminished decision-making ability are never granted exempt status."

Please answer each question about your research. You will normally be provided a choice of "yes" or "no."

This review program is a "decision tree," and it leads to the Exemption Review Form or, if there are elements of the research that place it in another category, you will be given directions to the correct form, the regular application form which is used for both "Standard" and "Expedited" reviews. Be sure to follow the program all the way to a statement that says either your project is exempt from IRB review or not. There is a map of the program available at the end.

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