Protocol Review Outcomes
Work may commence immediately upon full approval of a protocol. Approval is valid for the study as described in the protocol form for a period of three years from the approval date. PI’s must also complete an annual renewal each year.
The Boston Public Health Commission requires notification upon IBC approval of any new BSL-3 project at least 30 days before initiating any project experimentation activity requiring the IBC’s approval.
| Review Outcome | Review Criteria | Corrective Response Required | Person(s) to Review Response |
|---|---|---|---|
| Approved | Complies with all Committee policies. No additional changes needed. | None | N/A |
| Conditionally approved | Minor changes and/or clarifications (scientific or administrative) are required | Revised protocol submission | Primary and secondary reviewers (if reviewers have asked for it); otherwise IBC office |
| Deferred | Numerous and/or major changes or clarifications are required; there is insufficient time at the IBC meeting to conduct a thorough review | Entirely re-written or none (if time is the concern) | Full Committee |
| Withhold Approval | If fails to meet one or more criteria used by the IBC for approval of research | Must re-do as new protocol submission | Full Committee |