Category II: Expedited Review
(Link to full text: CFR §46.110)
Expedited review involves research activities (recruitment, participant population, procedures, data storage) that pose no extra risks to participants than those they would expect from their typical daily life activities (i.e., those activities posing no greater than minimal risk). The term "expedited" does not mean fast or short review. It refers to the role the Full Board plays in the review.
For a research activity to qualify for expedited review (category II), all of the following conditions must apply:
- The frequency and magnitude of risks posed by the study and its procedures (including data storage) are expected by investigators and the IRB to reach the level of minimal risk; that is, the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (considering the participant population);
- The research must cleanly fit one of the categories for expedited review, refer to the Notice in the Federal Register;
- Sometimes research including children and other special populations cannot be classified as expedited (ask the IRB for more details about the difference between expedited and full review research); and
- The research does not involve the study of controversial or sensitive topics (as recognized by the surrounding community).
OHRP decision charts may help you decide if you should apply for exempt review. The IRB holds the final responsibility for classifying the level of review. If you would like assistance with identifying the appropriate level of review for your research, contact the IRB (email).
- Expedited Application
- Appendix A - Investigator Assurance (signature page)
- Appendix B - Co-authors and students
When you have completed the application form, attach and email to: email@example.com.
Original copies of signature-bearing documents (e.g., permission letters, Appendix A) are to be sent through U.S. Mail, intercampus mail, or by fax to the IRB. If Appendix B is applicable to your research, include Appendix B as an attachment with your emailed application.