- Unsure if your project qualifies as human subjects research? Use the IRB determination tool. If you are instructed to apply for IRB exemption or approval, proceed to step 2.
- To start an IRB application, log in to Cayuse IRB and create a New Study. From there, Add a New Submission, and select "Initial Submission." Edit the Initial Submission form and provide details for every question. On the first section of the application, you will select either a request for exemption, or apply for an expedited or full IRB review. (Review the categories for exemption). (Review categories for expedited review). IRB staff or IRB members will ultimately determine if exemption, expedited review, or full board review are required. You will be able to upload documents such as informed consent forms, recruitment materials, training certificates, and survey instruments within Cayuse IRB.
- When you are finished and ready to submit, be sure all sections in Cayuse IRB have a green check mark on the right. Any form fields with a red asterisk are required, and the check mark will not appear until the required fields are complete. After you submit, the application is routed to the Principal Investigator(PI). If you are the PI, you will need to certify the submission. If you are not the PI, the PI will receive an automated email notification to certify the application.
- 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 or full board review.
- Exempt requests will be reviewed by the designated IRB member and / or the IRB Coordinator. Denials will be forwarded to the IRB chair for expedited review. Once it is determined if an application is exempt, the investigator will be informed of the decision.
- Expedited requests will be reviewed by the IRB Chair or the designated IRB member and / or the IRB Coordinator. Denials for expedited review will be forwarded for full board review by the IRB. The investigator will be informed of the decision.
- The IRB will meet once a month to review applications. Approved applications may be valid for up one year. After one year, a renewal submission must be filed within Cayuse IRB if the work is to continue. Federally funded research must be renewed on an annual basis. The investigator will be informed of the decision.
- 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 Renewal Submission must be entered into Cayuse IRB.
- Work on a project cannot be modified from the approved protocol without approval. If any changes are to be made, a Modification Submission must be entered into Cayuse IRB.
- No research can be conducted until the investigator has received confirmation from Cayuse IRB that the application is either exempt or approved, or in the case of renewals and modifications, until they are approved.
Have additional questions about the IRB Process? Check out our IRB Process FAQ.
Please contact the IRB Coordinator at (202)885-3447 if you have questions about the process.To check the status of your application, login to your Cayuse IRB account and open your study.