*Notice - Please submit forms at least one month prior to the projected start of research.
1. Unsure if your project qualifies as human subjects research? Complete the Human Subjects Research Determination Form and submit it to the IRB coordinator. If you are instructed to apply for IRB exemption or approval, proceed to step 2.
2. To apply for exemption (review the categories for exemption) from IRB approval, complete a request for exemption form. If your research is not exempt, complete an IRB application and attach all supplements and required signatures and mail to Matt Zembrzuski, IRB Coordinator, 158 Sports Center Annex. Alternately, you may e-mail .pdf files with signature pages scanned to zembrzus@american.edu. Be sure to provide certification that you have completed the required training to conduct human subjects research.
3. Your application will be reviewed to determine if it is complete. Incomplete applications will be rejected and returned to the investigator. Completed applications will be evaluated to determine if they fall within one or more of the specified categories of exempt research per federal regulations, or if they should have either an expedited (review the categories for expedited review,) or full board review.
4. Exempt requests will be reviewed by the designated IRB member or the Unit IRB Liaison, and / or the IRB Coordinator. Denials will be forwarded for expedited review. Once it is determined if an application is exempt, the investigator will be informed of the decision.
5. Expedited requests will be reviewed by the IRB Chair or the designated IRB member and / or the IRB Coordinator. Approvals will be valid for up to one year. Denials for expedited review will be forwarded for full board review by the IRB. The investigator will be informed of the decision.
6. The IRB will meet twice a month and review applications. Approved applications will be valid for up to one year. The investigator will be informed of the decision.
7. Work on a project cannot extend beyond the date approved by the IRB. If it is necessary for work to extend beyond this date, a Continuation / Termination Request must be submitted.
8. Work on a project cannot be modified from the approved protocol. If any changes are to be made, a Modification Request Form must be submitted.
9. No research can be conducted until the investigator has received confirmation from the IRB Coordinator that the application is either exempt or approved, or in the case of renewals and modifications, until they are approved.
Please contact the IRB Coordinator listed above at (202)885-3447 if you have questions about the process, or to check the status of your application.
