The procedures below assume that the study team has completed any needed revisions and review is complete. To complete an ancillary review:
1. Log in to irb.harvard.edu
2. Navigate to the submission (see Accessing a Submission for more instructions).
3. From the submission, Click Submit Ancillary Review on the left. A pop up window will open with questions.
- If you have received a notification that Ancillary review is required, but you are unable to locate the above activity, add indication of your review via public comment via the steps described in the section: Requesting Additional Information on a Submission. IRB Staff will ensure the review is otherwise appropriately recorded on the study.
- If IRB staff are recording an ancillary determination on behalf of the reviewer, the Manage Ancillary Approvals activity will be used to update the review type.
- If IRB Staff included a note for the reviewer, it will appear in the Submit Ancillary Review pop-up for view/edit.
4. Complete the questions in the activity form:
Question 1: Select the review you are completing from the list.
Question 2: (Optional) Add comments related to the review. Note that comments made in this space do not send an email (see Requesting Changes for more instructions)
Question 3: (Optional) Attach documents related to this review. Documents can be attached by: a. clicking “Add” and browsing to the location of the document on your computer; or b. dragging one or more documents from the location on to your computer and dropping it on the Supporting Documents space provided.
Question 4: Indicate whether you have completed your review and criteria are met based on the on-screen instructions.
5. Click OK.
Upon completion of this activity, the system sends a notification of review update to the PI/Proxy, Primary Contact and the IRB Contact. Additionally, the review and comments completed here are shown on the History and Reviews tab and are visible to everyone who can access the submission.