How to Submit
Once the study protocol and all supporting documents have been developed, you will need to log into iRIS. All supporting documents must be provided at the time of initial review.
- How to start an application: In Study Assistant, select Add a new Study, then select IRB Application (Human Research)
- The online application uses smart form logic to branch out sections of the IRB Application that meet the needs of the investigator and the research protocol. Questions marked with an asterisk (*) must be answered, or an error message will be generated.
- How to attach supporting documents: Upon completing the IRB Application, select Save and Continue to Next Section until prompted to:
- Add a New Consent in the informed consent section
- Add a New Document or Add Multiple Documentsin the Study Documents section
- How to submit the IRB Application and supporting documents to the IRB: Select Sign Off and Submit. You will then need to select all study personnel that are required to sign off (e.g., Department Chair, Investigators).
- The submission will not be visible to HRPP/IRB until all sign-offs have been completed.
For assistance navigating iRIS, you may call the Support line at 979-845-4969. For assistance with the content of your IRB application, contact your HRPP Coordinator.
After all sign offs have been completed, the application will move from draft to pending and be assigned an IRB number (IRB20XX-XXXX). The submission will then be routed to an HRPP coordinator for pre-review. Submissions are assigned to an IRB Coordinator based on the PI’s department.
You may track the status of the submission in iRIS by opening the study and selecting Submission History, then select the Track Location icon (the icon consists of a document with a magnifying glass).
By selecting TAMU IRB, pertinent information will become visible, such as the name of the IRB coordinator assigned to the submission and a list of pending personnel sign offs. Additionally, the workflow of your submission will become available at the top of the Submission Tracking page.
The The system uses “states” to classify where a submission is in the process. The following table defines the possible study states for a new study submission during the course of its review.
|Pre-Submission||The application is under preparation by the PI/submission preparer. The study will remain in this state until the PI clicks Submit.|
|Pre-Review||The submission is in the queue/is being reviewed by the assigned IRB Coordinator.|
|Changes Requested||The IRB Coordinator has requested changes or clarification. The PI and Primary Contact will receive an email notification advising them of the request.|
|Post Review||The IRB letter advising the PI of the IRB member or IRB committee’s decision is being prepared.|
|Modified Required||The IRB has requested additional modifications to secure final approval. The PI and Primary contact will receive an email notification advising them of this request.|