Intro to OneAegis for Reviewers
Overview
When you log in, you will be directed to the Project Switchboard. Select IRB or Show Everything. For more login instructions, see the OneAegis Site Guide on the IRB website.
Optional: In the top right corner, click on Your Name’s Settings to turn on Dark mode. You can also click Reset or Switch Dashboard to change to Bubble View. If you switch to Bubble View, select All Projects and then IRB, because this feature will reset when you switch dashboards.
Locating Your Assigned Studies
You will receive an email for every study you are assigned to review. The study can be accessed by clicking the link in your inbox.
While it is important to check your email, you should also double-check OneAegis before each meeting to see if you have been assigned to review a study on the agenda.
When you login to OneAegis, you will be shown the Home screen. The xForms Assigned To Me tab will be highlighted in blue.
You can also locate the reviewers for each study from the Meetings tab at the top of the screen.
Click on the White Pages next to the meeting.
The reviewers will be on the far right next to each item on the agenda. The primary reviewer is bolded.
Accessing Meeting Agenda and Submissions
You can also access the meeting agenda from your dashboard in bubble view. Under Current Meetings, find the date you want to view and click Agenda (Not Finalized).
To access study forms, hover your mouse over the dropdown arrow next to each study and select which forms you would like to view.
xForm: Applications, modification forms, renewal forms, adverse event forms
Attachments: Consent forms, questionnaires, recruiting tools, etc.
Generated Docs: Approval Letter
Extra steps are required for reviewing studies that were originally submitted in iRIS. These studies have the letters IRB in front of the study number (ex. IRB2024-000-BYU).
Click on the study number. This will lead to the project page where you will access the Historical Attachments.
Scroll down to the Events heading and find Historical Attachments. Then click on the Number in the next column.
Click on the Name of the document to access the file. To access the submission and leave notes, return to the agenda and click xForms in the dropdown next to the study. Then, click the name of the form.
You may leave comments on the submission using the Add Note feature next to each section.
When you are finished leaving comments, you may close that tab. Return to the agenda using the Done button.
Repeat this review process for all items on the agenda.
Downloading the Agenda
Login to OneAegis (OA) using your BYU username and password. See these Additional Resources for more login details.
Click on the Committee Meetings tab.
There are two ways to view an agenda under the Current Meetings tab.
To download the agenda as a Word document, click on the Date to be directed to Meeting Attachments.
To view the online version of the agenda, click on Agenda (Finalized).
Completing an Expedited Review
Step 1: When you are assigned a review, you will be notified via email. The email will contain a link to the review. An example of the email notification is below.
It is recommended that you use the email link, but you can also find the reviews you’ve been assigned on your OneAegis dashboard. Scroll to the bottom of the page and select the Reviews tab. Find the review with the correct IRB number and PI. Click the review link at the top of the card to open your review.
Step 2: The link in the email or the link on your OneAegis dashboard will take you to the Submission Review Checklist (for expedited reviews only). To view the application, click IRB Application (located at the top left of your screen) next to Review Item. This will open the application in a new tab. Feel free to use multiple screens or a split screen to view the application and your reviewer checklist at the same time.
On the tab displaying the application, you can leave notes on questions you
would like to request changes on.
- Leaving notes on the application:
- Each question on the application will have an Add Note option to the right of the question text. Click Add Note to add comments about the question.
- Notes will default to Internal Only which means that the investigators will not
see these comments if/when the submission is sent back to them. Please keep
this box checked to communicate with the IRB staff, who will compile all the
notes to send back to the PI. Do not check the Require Changes box. Be sure to
click SAVE on each of your notes. - To edit a note, click the hand holding the envelope on the bottom right of the
note box. - When you have finished reviewing the application, click Save at the bottom of
the page and move to the Reviewer Checklist.
Step 4: On the tab displaying the Review Checklist, answer the review questions and determine your review outcome. The following are descriptions of each of the review outcomes.
| Reviewer Determination | Definition |
| Approval Pending | The study is generally in acceptable condition but requires minor revisions or clarifications before it can be approved. These minor changes typically involve adding or correcting non-substantive information—such as missing details, small inconsistencies, or clarifications—that do not affect the assessment of risks, benefits, or participant protections. |
| Approved Expedited | The study meets all regulatory criteria for approval under 45 CFR 46.111 and that the designated reviewer moves to approve the study as is. The study poses no more than minimal risk. |
| Exempt | The activity is human subjects research, but it meets criteria for exemption in one or more regulatory categories (1–8) and poses no more than minimal risk. |
| Not Human Subjects Research (NHSR) | A project is considered NHSR when it does not involve living individuals about whom an investigator obtains (1) data through intervention or interaction, or (2) identifiable private information or identifiable biospecimens. |
| Refer to Full Board | This determination is made when the study involves more than minimal risk, includes vulnerable populations requiring additional protections, or does not fit within any exempt or expedited review category under 45 CFR 46. A reviewer or IRB staff member may also refer a study to the full board if the risk–benefit balance is unclear, if there are ethical concerns requiring group discussion, or if disapproval might be considered (since expedited reviewers cannot disapprove research). Once referred, the study will be placed on the next available IRB agenda, distributed to members for pre-review, and discussed during a convened meeting where approval, modifications, deferral, or disapproval may be determined. |
| Not Research | The activity does not meet the federal definition of research — it is not a systematic investigation designed to develop or contribute to generalizable knowledge. |
Step 5: Once you are done with your review, click Next either at the bottom of the page
or the top right.
Step 6: On the next page, click Submit. You can then close both the tab for the review and the tab with the application if you had two windows open. After a few minutes, your number of completed reviews will update.
Second Round Reviews
After the first round of an expedited review, the IRB may compile notes and require the PI to make changes. When the PI finishes their revisions, an IRB analyst will assign the review to you for a second time.
Step 1: You will receive an email to notify you that you have been assigned to review a study. Follow the link in the email or click on the study in your OneAegis dashboard to open it. (for more detailed information click here)
This will open a review checklist containing all of your first round comments.
Step 2: Open the IRB Application in the top left corner.
Step 3: Review the revised application.
Investigator’s responses are highlighted in yellow. These are places that have been edited since you last saw the application. Reviewer comments are marked Internal, and staff comments for the PI to view are marked Not Internal. If you would like to view what was changed on the question, click View Audit to the right of the question text.
This will open a pop-up where you can see who made the change and what
the field contained before.
Step 4: Revise your checklist based on the PI’s revisions. You can delete your comments from the first round if they are no longer applicable.
Step 5: Select your review outcome from the dropdown.
Note: The comment box will be automatically populated with your responses from the first form. You will need to copy and paste any new comments into the box below before you submit.
Step 6: Once you are done with your review, click Next either at the bottom of the page
or the top right.
Step 7: On the next page, click Submit. You can then close both the tab for the review and the tab with the application if you had two windows open.