IRB Application Process
Step 1: Complete Required CITI Training
Beginning January 1, 2011, ALL principal investigators (PIs) and co-PIs, must complete CITI training PRIOR to submitting the IRB application. (Log onto: https://www.citiprogram.org/ to complete the training. You will be able to create your own username and password). Failure to complete the training means the application will not be approved. ALL PIs and co-PIs need to complete the Social and Behavioral Research Investigators course regardless of the research proposal. For detailed instructions, see Registering for the CITI Course (PDF).
Step 2: Request an IRB Application
Upon successful completion of the CITI training, request an IRB Application. Please note: You must complete and submit the application sent to you by Classroom Support. Outdated applications will be returned.
Step 3: Build your Application Packet
In order to build a successful and complete IRB application packet and to get a better understanding on how the IRB process works, we ask that you complete the following steps listed below:
- Access your ClearPath account through the ecampus to complete the IRB Application Tutorial app
- Watch the graduate studies webinar: How to Successfully Complete Your IRB Application.
- View the IRB Checklist for more information about required support documentation needed to complete your IRB packet.
- Build your application packet using the forms below and using the application provided by Classroom Support.
- Submit your application materials to the IRB Sakai dropbox provided by Classroom Support.
If you are a student applicant, your application must be approved and digitally signed by your Instructor BEFORE submitting it to the IRB Sakai dropbox. Once your application has been signed, please submit all documents to your dropbox. Please monitor your mycampus email (students/faculty) or your APUS email (faculty/staff) for regular notifications concerning your IRB review. If you need help creating or accessing your IRB Sakai dropbox or have questions about your mycampus email, please contact firstname.lastname@example.org.
- Data Usage, Storage, and Destruction Agreement
- Consent Form
- Sample Permission Letter from External Organization
- Extension Request for Approved Research
- Unanticipated Problems Notification
- Protocol Amendment
Upon receipt of the application, a verification email will be sent. The IRB will review the application. Questions, concerns, or clarification may be requested. IRB applications are reviewed on a rolling basis. The IRB Committee meets twice per month, on average. Incomplete applications will be returned to applicants and the review will be deferred until the application is complete. Applicants will be notified of the committee’s decision within a month.
- If approved, no further action from the investigator prior to initiating the study is needed. However, should the research exceed the 12 month approval period, completion and submission of the renewal form is required. Likewise, any unanticipated problems involving risks to subjects must be reported to the IRB as soon as possible. A letter of approval will be sent to the applicant.
- In the event that the application is not approved pending receipt of additional information, clarifications, or modifications, the applicant may resubmit the modified application for the next IRB review cycle.
- Research that has NOT been approved by the IRB may not be initiated by the investigator. The reasons for the denial will be provided in writing. The investigator may respond in writing and this will be reviewed at the next IRB meeting.