Who can perform action

IRB Administrators are allowed to perform this action

Protocol state prior to action

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

The Record Committee Decision must have been performed with a motion type selection of “Approve”.  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 Active - Open to Enrollment.

The submission status changes to Approved.

Approval Date

Specify the date you want the approval 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.

Expiration Date

Specify the date in which the approval will expire.  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.

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 saved, 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.

Enter Risk Level

Add

Displays sequential line item number for each table row in ascending, top-to-bottom order.  Also serves as a line selection/addition row label.

Risk Level

Select one of the following options:

•      No greater than minimal risk.

•      Greater than minimal risk but potential for direct benefit for participant

•      Moderate Risk

•      Research involving greater than minimal risk, with no potential for benefit to participant, but likely to yield generalizable knowledge about the participant’s condition

•      High Risk

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.

Date Assigned

By default, this 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.

Date Inactivated

When the status is inactive, the date it became inactive is displayed.

Status

Display-only (for example, active).  The current status of the risk level.

Comments

To enter textual information to describe the selection of the risk level, 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.

Add

Click the add  button to add your selection to as a row in the table below, which will become a numbered line item.  Click the delete button to remove a previously-added line item row from the table.

Review Comments