Step 3: How to Submit an Application?

Once the study protocol and all supporting documents have been developed, you will need to log into iRIS.

How do I start an application?

In "Study Assistant", select "Add a new Study", then select "IRB Application (Human Research)."

The study application is composed of a number of sections. iRIS uses smart form logic: within some of these sections are "branching" questions which will trigger the display or repression of additional sections depending on how they are answered. Questions marked with an asterisk (*) must be answered. If they are not answered, you will receive an error message.

How do I attach my supporting documents?

Once you are done completing your study application (you may return to it later), select "Save and Continue to Next Section" until you are prompted to

  • "Add a New Consent" in the Informed Consent section.
  • "Add New Document" or "Add Multiple Documents" in the "Study Documents" section.

 

I am done filling out my application and attaching documents, how do I send it to the IRB?

Select "Sign off and Submit". Then, you will need to select all study personnel that are required to sign off. 

Each investigators, Protocol Director, Faculty Sponsor and Department Head must sign off. The submission will not be visible to HRPP/IRB until all sign-offs have been completed.

I need help navigating iRIS and filling out my application, who may I contact?

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/IRB Liaison.

How do I know my study has been submitted?

When all sign offs are completed, the application will move from "draft" to "pending" and be assigned an IRB number (IRB201X-XXXX). At that point your application is officially submitted and available to the HRPP/IRB for review.

How can I track the status of my application?

iRIS uses “statuses” to classify where a submission is in the review process. You can see a timeline showing the state of your study within the IRB review process by opening the study, under Submission Summary. More information about the review process is available in Step 4

 

iRIS  Status

Event Description

(as listed in Submission History)

 

Notes

 

 

 

Draft

Submission Form is waiting to be submitted

The application is under preparation by the Research Team.  If the PI does not submit study, the study will remain in this draft state and be editable.

Assign Personnel sign off

The submission has been routed for sign off and sign-off has been completed. All investigator, Protocol Director, Faculty Sponsor and Department Head (or the equivalent) are expected to sign off.

Each individual who has completed their respective sign-off will be identified by name.

[Name of Investigator] review and apply sign off

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pending submitted for Initial Review

TAMU IRB Assigned with the IRB number of 20xx-xxxx

The submission is officially submitted for review and the study has received its unique study number.

TAMU IRB received the submission

[HRPP coordinator name] has been assigned as the analyst

The submission has been assigned to the IRB Liaison/HRPP Coordinator for pre-review.

Assigned pre-review action of "Process Administratively"

TAMU IRB returned the submission with the outcome of Pre-review Corrections Requested

The HRPP coordinator has sent the submission back to the PI for revisions.

TAMU IRB assigned a Pre-review action of Expedite

When the submission comes back with the requested changes, it is assigned for review. Review can be Exempt ("Process Administratively" again), "Expedite" (one IRB member) or "On Agenda" (the convened Board).

TAMU IRB Committee assigned a Pre-review action of On Agenda

All reviewers completed the review of the submission.

The reviewer(s) have completed their review and the outcome of the review is forthcoming.

TAMU IRB Committee IRB returned the submission with the outcome of Pending - Corrections Requested

The HRPP coordinator compiled the reviewers’ comments and the submission is approved pending completion of the requested changes The submission has been sent back to the PI for revisions, hence restarting the process outlined above. The updated submission will go back to the original reviewer(s).

TAMU IRB Committee TAMU IRB completed the submission with the outcome of Approved at MM/DD/YEAR XX:XX:XX AM CDT

The project has been reviewed and approved as submitted. The approval letter is forthcoming

 

Active

 

The project is active for the period indicated in the approval letter or study summary.

Next Step: What happens to my application, once I submit it?