Policy on IBC Review Designations
For the review of IBC Registrations, the following review categories will be used:
- APPROVE WITH BINDING STIPULATIONS (re-review by Committee not required)
- SUBSTANTIVE (changes require re-review by full Committee)
- REJECT (registration will not be considered further)
A description of each of the categories is provided below:
APPROVE – Full approval of the registration is granted.
APPROVE WITH BINDING STIPULATIONS – Approval is granted with specific stipulations identified by the Committee and communicated to the Principal Investigator in the approval letter. Implementation of the stipulations is the Principal Investigators’ responsibility and does not require re-review or follow up by the IBC unless stated otherwise in the Committee’s letter.
SUBSTANTIVE ISSUES – There are items that require revisions that are voted to be substantive. Re-review will require a vote by the fully convened IBC committee to determine approval status.
REJECT – The registration contains such significant deficiencies that a review cannot be completed and/or the institution is not capable of supporting the stated research at this time.