Record Committee Decision

This action allows IRB Administrator to record the decision of a full committee IRB review for an IRB protocol. The motion types that can be recorded are Approve, Disapprove, Specific Minor Revisions and Substantive Revisions Required. The IRB Administrator must specify the number of Yes/No vote counts. The system also allows the IRB Administrator to record the committee members who abstained or recused themselves from the voting process for the IRB protocol. Based on the motion type selected within Record Committee Decision, the system will subsequently present an action panel for Approve, Disapprove, Specific Minor Revisions or Substantive Revisions Required.

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The Record Committee Decision action cannot be performed unless attendance has been recorded within the Committee/Schedule.

 

 

Table 387 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Record Committee Decision – Action Attributes

  Action attributes

Description

Who can perform action

IRB Administrator can perform this action.

Protocol state prior to action

Prior to the action being performed, the protocol must be in the following state:

 

The protocol must have been assigned to an agenda

The protocol status can be in any state.

The submission status must be In Agenda.

Protocol state after action

After the action is performed

 

The protocol status does not change.

The submission status does not change

 

Figure 1177 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Record Committee Decision  Action Layout

 

Table 388 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Record Committee Decision Field Descriptions

Field

Description

Motion Type

Select one of the following from the list: Approve, Disapprove, Specific Minor Revisions and Substantive Revisions Required. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

tip.png  The system makes it mandatory enter at least one review comment for motion types of Disapprove, Specific Minor Revisions or Substantive Revisions Required.

No

Enter the count of IRB committee members who voted against the motion type selected.  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. 

Yes

Enter the count of IRB committee members who voted for the motion type selected.  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. 

tip.png  The system makes it mandatory to enter the number of Yes votes in order to record a committee decision.

Abstain

This field is read only. It is populated with the number of IRB committee members who abstained from voting for the motion type being recorded for the IRB protocol.

Recused

This field is read only. It is populated with the number of IRB committee members who recused themselves from voting for the motion type being recorded for the IRB protocol.

Voting Comments

To enter textual information to enter any comments associated with the voting, 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 saved, click the green arrow  symbol to view full text in a separate browser window.

Abstainers Persons

Select the IRB committee member who attended the meeting but chose to abstain from voting for the IRB protocol. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

Add

Click the add  button to add your selection as a row in the table below, which will become a numbered line item.  Once added, you can remove the selection using the  button.

Recused Persons

Select the IRB committee member who attended the meeting but chose to recuse themselves from voting for the IRB protocol. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

Add

Click the add  button to add your selection as a row in the table below, which will become a numbered line item. Once added, you can remove the selection using the  button.

Review Comments

link.png For more information, see “Review Comments”.