Status Definition

Tabled for Substantive Changes

The protocol is judged to have serious problems or lacking sufficient information to appropriately assess the risks to the subjects. The IRB will send a debriefing memorandum explaining the reasons for tabling with an outline of revisions necessary for reconsideration of the application.

The Principal Investigator must respond to the questions posed by the Committee in detail and resubmit a new IRB application to the full board, with all the required copies.

The same Board that tabled the application must review the revised application. In some cases, the Principal Investigator may be invited to make a personal presentation of the protocol to the Committee and/or subcommittee and respond to questions.

If there are circumstances in which the principal investigator believes the revisions are not appropriate, he/she should contact the IRB as soon as possible for appropriate resolution.