Review Not Required
This action allows the IRB Administrator to designate the IRB protocol to NOT require an IRB review. The nature of research is such that it does not constitute research with human subjects. Some investigators need documentation that the IRB office has evaluated and determined that a project does not need research with human subjects, and this option provides a method for such documentation. Institutions might allow the investigator to specify during protocol submission that the protocol does not require an IRB review or have the IRB Administrator change it after protocol submission.
Table 408 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Review Not Required 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 Assign to Committee and Schedule action must have been performed The submission review type must be IRB Review not required The protocol status must be in Submitted to IRB The submission status can be in any state |
|
Protocol state after action |
After the action is performed The protocol status changes to IRB Review Not Required The submission status changes to IRB Review Not Required |
Figure 1188 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Review Not Required Action Layout
Table 409 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Review Not Required – Field Description
|
Field |
Description |
|
Decision Date |
Specify
the date the decision to take this action was made. By default, the
field displays the current date. To change it, click the
calendar |
|
Comments |
To enter textual information to describe this action,
click within the text box (or press the tab |
|
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 |
|
Review Comments |
|
icon to select,
or type in mm/dd/yyyy format to populate the box with the desired
date.
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.