Status Definition

Approvable with re-review by the sub-committee

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 slightly more complex, requiring the expertise of a sub-committee of IRB members 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 sub-committee. 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 sub-committee.

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.