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).
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The system does not allow disapprove action unless there is at least one review comment. |
Table 366 Protocol Document, Protocol Actions Page, Request an Action Section, Disapprove Action – Action Attributes
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Action attributes |
Description |
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Who can perform action |
IRB Administrators are allowed to perform this action |
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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.
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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 1163 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Disapprove Action Layout
Table 367 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Disapprove Action Field Descriptions
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Field |
Description |
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Comments |
To enter textual information to describe this action,
click within the text box (or press the tab |
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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 |
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Review Comments |
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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.
