Disapprove

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Disapprove

The disapprove action allows the IRB Administrator to record a disapprove action for an IRB protocol following a full committee review.

This action only appears after the Record Committee Action has been performed on the protocol with a motion type of Disapprove. IRB can only disapprove a protocol at a convened/full board IRB meeting.

A disapproval is recorded when IRB cannot approve a protocol as designed and cannot specify the conditions under which it could grant approval (e.g., because the protocol lacks sufficient detail, or because there is an ethical issue that the IRB cannot see being resolved for the research).

The system does not allow disapprove action unless there is at least one review comment.

Table 316 Protocol Document, Protocol Actions Page, Request an Action Section, Disapprove Action – Action Attributes

Action attributes	Description
Who can perform action	IRB Administrators are allowed to perform this action
Protocol state prior to action	Prior to the action being performed, the protocol must be in the following state: The Record Committee Decision must have been performed with a motion type selection of Disapprove. The protocol status must be Submitted to IRB. The submission status must be In agenda.
Protocol state after action	After the action is performed the protocol state changes as follows The protocol status changes to Disapproved The submission status changes to Disapproved.

Figure 692 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Disapprove Action Layout

Table 317 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Disapprove Action Field Descriptions

Field	Description
Comments	To enter textual information to describe this action, click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information. Click the add note icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document. After saving, click the green arrow symbol to view full text in a separate browser window.
Action Date	Specify the date you want this action to become effective. By default, the field displays the current date. To change it, click the calendar icon to select, or type in mm/dd/yyyy format to populate the box with the desired date.
Review Comments	For more information, see “Review Comments”.