Submitting & Managing Application
Submitting Your Application
After entering your protocol information, the PI needs to sign the submission by entering their password and clicking Next.
You will then see Form Completed, and you will need to click Submit.
If you are not the PI, submitting the application will send the PI an email requesting their signature. The PI must sign and submit the form to receive IRB review.
Returning a Form for Revisions
Once a form has been sent for PI signature, the PI needs to take the following steps if they wish to edit the form before it is submitted to the IRB.
Step 1: Open the form using the link from the email alerting you that the form is ready for PI signature, or from your OA dashboard.
Step 2: Click Next until you reach the screen below. If you determine the form needs more edits, select No, return for revisions/additional information. Doing so will open an optional comment box.
Step 3: Once you are finished, click Next at the bottom of the page. Then, click Submit on the next page. The form has now been sent back to the Data Entry stage and is accessible from your OA dashboard. It has not been submitted to the IRB.
Responding to Notes
Notes are comments or changes from the IRB that require attention. If your submission requires changes after initial screening, the PI will receive an email containing a link to revise the application. In OA, the PI should take the following steps.
Step 1: Scroll to the bottom of the application and click More >> View Questions with Notes. This will open a second tab and give you a list of all IRB notes. Notes will appear in light blue boxes.
Step 2: To edit, right click the section title and select Open link in new tab to be directed to the correct part of the application.
Step 3: Update the application with the appropriate changes.
Step 4: Move to the next section. If there is an error, it will be shown at the top of the page.
Step 5: Repeat the process for all notes and resubmit to the IRB. If the IRB requires change to a section and no change is made, you will be redirected to that portion of the application and must make changes before it may be submitted again.
Note: Some changes may shorten or lengthen the application.
Modifications
Anyone with edit/mange/submit access will be able to submit modification forms in OneAegis.
Step 1: From the IRB tab in OneAegis, click on the study you wish to modify.
Step 2: Next, click on Start xForm in the top left under Actions.
Step 3: Select the form you would like to create, and fill it out.
Step 4: Once you are finished, you may submit the form for PI signature. The PI must sign all forms in order for them to be sent to the IRB.
Checking Project Status
The following are status definitions that may be listed on your xForms page. Please note that unless added as a collaborator before submission to the IRB, research personnel will not be able to see the xForm until it is approved. Once approved, an application will be listed in the Project section.
| Status | Definition |
| Data Entry | In this stage, the application is editable. IRB staff can view the application, but it is not in the processing queue. |
| Principal Investigator Review and Signature | The application is still with the PI. The IRB has not yet received it. If more edits are needed at this stage, the PI may disapprove it and send it back to the Data Entry stage. |
| SRC Review | The application is awaiting approval from the Scientific Review Committee. |
| IRB Pre-review | The IRB has received the application. |
| Under Review | No additional action is needed from the researcher at this stage. The application is most likely with an IRB committee member, and is still being reviewed. |
| Committee Review Processing | No additional action is needed from the researcher at this stage. The application is being processed by the IRB Committee. |
| Wait for Full Board Review | The application will be discussed at an IRB Committee Meeting. These take place on the first Thursday of each month. |
Locating Attachments of Approved Studies from iRIS
If you submitted a request for the IRB to manually transfer your study from the iRIS pdf to the OA platform, you will need to download your approved study documents and attach them to the form the IRB sends you.
Step 1: From the Projects view, click on the name of the study you wish to modify.
Step 2: Scroll down until you see the Events heading. Look for Historical Attachments and click the number under Attachments.
Step 3: Download an attachment by clicking on its name.
IRB Support for Transferring Approved iRIS Studies to OneAegis
To assist investigators during the transition from iRIS to OneAegis, the IRB is offering limited-time support for transferring previously approved studies.
Our team will:
- Prefill your OneAegis (OA) application using information from your approved iRIS study.
- Send the draft OA application to the PI for review and any necessary edits, and to attach supporting documents (consent forms, instruments, recruitment materials, etc.) that have transferred from iRIS to OA.
This service is designed to save time, reduce administrative burden, and ensure a smooth transition into the new system. Take advantage of this support while it’s available by clicking on the link below.
Amendments
Anyone with edit/mange/submit access will be able to create amendment forms in OneAegis.
There are two kinds of amendments in OneAegis.
1) Legacy Amendments - for minor changes to studies approved in iRIS that have not been transferred to OneAegis. Please contact IRB staff at byu.hrpp@byu.edu if you think your study may qualify.
2) Traditional Amendments - These apply in two cases:
- Studies originally submitted in OneAegis
- Studies transferred from iRIS
Legacy Amendments - If your study has the option to begin a legacy amendment, it will appear as an xForm option. Please see the Modifications section of this site guide and follow the instructions.
Traditional Amendments - If your study was originally approved in OneAegis, you may skip to the tutorial on the next page. If your study was originally approved in iRIS, it will need to be transferred to OneAegis before modifications can be made. The IRB is currently accepting transfer requests via the link on the homepage. Once the IRB staff transfers your study, you will be sent further instructions on how to proceed. Please be aware of the following:
- For EXEMPT studies, the transfer will be submitted to the IRB and reviewed in the same manner as a new exempt study. Modifications to the original protocol can be made to the transfer application. If regulations have changed since the study’s original approval, updates to the protocol may be required.
- For EXPEDITED studies, IRB staff will open a form linked to the original project’s OneAegis folder. The study must be submitted exactly as initially approved, then an amendment may be initiated. If regulations have changed since the study’s original approval, updates to the protocol may be required.
Traditional Amendment Instructions
Step 1: Open the study’s project page by searching for the study number, or selecting it from your dashboard.
Step 2: Under the Reference xForms section, click on the blue pages next to the IRB application. This will open the amendment form.
Step 3: Select all modifications you would like to make, update the protocol to reflect those changes, and submit the amendment form.
