Ancillary reviews allow individuals, departments, offices, and other additional reviewers to give feedback, approval, and/or provide documentation on the submission in parallel with the IRB review. During IRB review, staff of the IRB office will manually select the reviewer or reviewing organization/department each time a review is needed or required. IRB staff can add ancillary reviewers to a study, modification, or continuing review. See the Ancillary Review Guide for an Ancillary Review Overview and Ancillary Review Types.
To initiate an ancillary review, IRB staff must manually select the reviewer or reviewing organization/department from the Manage Ancillary Review activity each time a review is needed or required. IRB staff can add ancillary reviewers to a study, study modification, or continuing review as follows. Complete the Manage Ancillary Reviews activity, and:
1. Add ancillary reviewers before or after the application has been submitted for IRB review.
2. Add individuals or organizations/departments as reviewers (Organizations will be available in the system from a pre-defined list. If the organization is missing, indicate an individual named reviewer and contact the ESTR Help Desk to request adding the organization/department).
3. Indicate if the review is required or suggested. When making this selection, note that:
A required ancillary reviewer receives the submission in My Inbox, where it remains until the reviewer accepts the submission while an optional reviewer does not see the submission in My Inbox.
Both required and optional reviewers
- Receive a system notification when they have been sent a request for ancillary review. Reviewers can use the Submit Ancillary Review activity to provide feedback.
- Will only see a submission in My Inbox (as applicable) after the submission has been sent to the IRB office for review.
Once the review is assigned, the original pop up will display the added review type.
Note: To share a public message with the assigned ancillary reviewer (if the add comment activity is not preferred), the individual assigning the review can: a) add the ancillary review type, b) from the Manage Ancillary Reviews list on the pop up, click update, and then c) partially fill in the activity by marking “no” to question 4 and adding comments/documents for the ancillary reviewer to view when they are completing their review. Comments can include up to 255 characters maximum.
4. To withhold a notice from the system (to the reviewer) because documentation may already be received or is otherwise in progress, IRB staff may either:
- Assign yourself in Question 1 when adding the ancillary review. Remember to select the correct type of review and complete the steps to also “accept” the review.
- Immediately after step 3, without closing the Manage Ancillary Reviews pop up (and all in the same set of actions):
1. Click “Update” beside the newly added review type
2. On the pop up:
Question 4 Mark “Yes” (This is OK – this is standard wording, but based on the History and the attachment it is known that you are completing this on behalf of the reviewer.)
Question 5 Fill in a note, if one is available.
Question 6 Attach an electronic version of the emailed approval/confirmation documentation.
3. Click OK, the additional pop up will close.
4. See the update to the item displayed on the table in the pop up.
5. Click OK.
Important! When completing these steps, note that your entries on this activity are recorded on the History and Reviews tab and are visible to everyone who can access the submission (PI, study team, IRB staff, etc.).
Add ancillary reviewers at any time. Ancillary review can be submitted by the assigned ancillary review when a submission is in review and after the review has been completed. While Ancillary Review may be submitted by the assigned reviewer in any state, if documentation of a non-required Ancillary Review happens to be received via comment or email after a final determination is issued, on approved submissions, IRB staff may include it via the Manage Ancillary Reviews activity which is available in all states, except Pre-Submission.