To use this ancillary reviewer guide:
- Download a pdf copy of all sections in one document;
- Navigate to information by searching via keyword, using the search box at the upper-right of this screen (or on any page of this support site); or
- Click the guide sections linked to the right of this page.
Ancillary Review Overview
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.
When assigned by IRB staff, Ancillary reviewers will receive a notification of requested review.
Ancillary review determinations can be recorded in ESTR at any time from the Pre-Review to Post-Review states (and before the IRB determination is issued), as illustrated here.
The system does not prevent a submission from being reviewed or approved by the IRB with ancillary reviews outstanding. Decisions about how, when, and whether to interrupt the IRB review process to wait for ancillary reviews are typically based on Harvard policies, but may be made on a case by case basis by the IRB. If an Ancillary review determination is issued after IRB determination, please contact the IRB Coordinator assigned to the study (named at the center of the submission workspace).
All investigators must comply with any policy that requires an ancillary review in order to proceed with IRB review and approval (e.g. per the Harvard Research Data Security Policy, any project classified with an information security level 4 or 5 requires a signed worksheet/documentation of approval from HUIT before IRB approval may be issued).