Status Definition

Approvable with re-review by the chair or his designee

A debriefing memorandum will be sent to the principal investigator detailing changes required for approval to be obtained. For this level of re-review, the changes required are minor, and may consist of grammatically revised language to be incorporated into consent documents, clarification of information provided in the application, or submission of training certificates for study personnel. 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 IRB. 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 a member of the 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.