Status Definition

Tabled

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; the protocol is judged to have serious problems or to lack sufficient information for the committee to appropriately assess the risks to subjects. Memoranda for tabled studies 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. 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. 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. In some cases the principal investigator may be invited to speak at the full board meeting to respond to questions.

If the resubmitted application satisfactorily responds to the debriefing memorandum, approval will be granted.

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