Status Definition

Approvable with re-review by the full board

A debriefing memorandum will be sent to the principal investigator detailing changes required for approval to be obtained. For this level of review, the changes required are major and complex, requiring the expertise of the convened IRB committee to complete the re-review. The principal investigator may always choose not to supply a requested document or revision; however, this exclusion or omission must be justified in the response to the full board. Full board re-review memoranda list specific deadlines for submission as re-review must be undertaken by the same committee that performed the initial review of the protocol or action. Following the resubmission instructions within the debriefing memorandum, the principal investigator supplies revised study documents and any requested supporting materials collated and in the quantities requested to be reconsidered by the full board.

If the changes satisfactorily respond to the debriefing memorandum, approval will be granted.

If there are additional questions or requests by the committee further debriefing memoranda will be generated.