Completing a Review as an IRB Board Member
Access your Assignment
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 to use the email link, but if necessary, 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. Reviews are listed with their IRB number and the PI. Click the review link at the top of the card to open your review
Review Checklist
The link in the email or the link on your OneAegis dashboard will take you to the Submission Review Checklist. To view the application, click the link next to Review Item at the top of the page. 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.
Making Comments (Stipulations)
On the tab displaying the application, you can leave comments on questions you would like to request changes on.
a. Leaving comments 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.
b. Notes will be defaulted to Internal Only which means that the investigators will not see these comments if/when the submission is sent back to them. Use these to communicate with the IRB staff, who will compile all the comments to send back to the PI. Be sure to click SAVE on each of your comments.
c. To edit a comment, click the hand holding the envelope on the bottom right of the comment box
Review Outcome
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:
a. For Exempt Reviews
i. Exempt: The submission is ready to be approved as exempt. A question will appear asking you to select the applicable Exempt Categories for the study.
ii. Not eligible for exempt: The study does not meet exempt requirements. A text box will appear that compiles your comments on the previous questions on the reviewer checklist. You can edit this text box if needed. This feedback will be sent back to the IRB staff who will then forward it on to the study team.
iii. Not Human Subject Research: No additional information is required. Submission will be sent back to the IRB staff.
iv. Not Research: No additional information is required. Submission will be sent back to the IRB staff.
v. Require Revisions: Changes are needed before the application can be approved as exempt. A text box will appear that compiles your comments on the previous questions on the reviewer checklist. You can edit this text box if needed. This feedback will be sent back to the IRB staff who will then forward it on to the study team.
b. For Expedited Reviews
i. Approval pending: Changes are needed before the application can be approved as expedited. A text box will appear that compiles your comments on the previous questions on the reviewer checklist. You can edit this text box if needed. This feedback will be sent back to the IRB staff who will then forward it on to the study team.
ii. Approved Expedited: The submission is ready to be approved as expedited. A question will appear asking you to select the applicable Expedited Categories for the study. There will also be a question asking if continuing review is necessary.
iii. Exempt: No additional information is required. Submission will be sent back to the IRB staff.***
iv. Not Human Subjects Research: No additional information is required. Submission will be sent back to the IRB staff.
v. Not Research: No additional information is required. Submission will be sent back to the IRB staff.
vi. Refer to Full Board: No additional information is required. Submission will be sent back to the IRB staff.
Back to the Top
Reviewing PIs' Responses
If this submission has come back for your review with corrections, make sure to note any sections highlighted in yellow. These are places that have been edited since you last saw the application.
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.
Saving Your Reviews
Once you are done with your review, click Next either at the bottom of the page or the top right.
Submit the Review
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.
