Consent

The Consent Module contains two submanagers: Consent Form and Patient Consent. From these two managers, users will be able to define consent forms in the system and enter consent information for an existing subject.

When the specimens associated with a patient have restrictions as defined in the consent module, users will be notified that restrictions exist. Users will then be able to choose to exclude that patient’s sample(s) from their experiment or override the restrictions.

From the Patient Consent editor, users can fill out consent questions for an existing subject in BSI. The patient consent editor allows the user to enter data through a form interface or through a table interface.  The table view will allow users to enter consent data for multiple users at once with access to the Mass Change feature. This editor is accessible through the Patient Consent manager and through the Subject editor. Users will also be able to set the form status to Active, Inactive, or Terminated from this editor.

When a consent bearing question is given a value of False/No in the Patient Consent editor, this means that a user did not consent to the use of their specimens in some way. As a result, when specimens added to requisitions have the Subject ID associated with the consent form with negative answers, a warning will be generated telling the user that the subject has not consented to the use of their specimens in some way.

Typical workflow for entering patient consent data:

Create a New Patient Consent Record → Add new patient consent data → Save

To add new patient consent data:

1. Click the New button on the right side of the Patient Consent manager.
2. The Select Consent Form dialog will open. Choose the desired Consent Form by pressing the ellipses (…) button, choosing the desired form, and pressing OK. Only active consent forms will appear on the list to choose from.
3. Press OK on the Select Consent Form dialog. The Patient Consent editor will open with the desired form. To toggle between form and table view, press the Toggle Form/Table button in the upper right hand corner of the editor. Hidden fields in the Table interface will be shown under the Additional tab in the Form interface.
4. The Patient Consent editor will be populated with the fields set up in the original Consent Form. These fields will vary depending on the Consent Form that is chosen. However, the following fields will appear in every Patient Consent editor:
   • Study ID - This field will be automatically populated based on the consent form the user chose.
   • Form Name - This field will be automatically populated based on the consent form the user chose.
   • Subject ID - Subject ID will be blank and will be a required field. Users must enter a Subject that exists in BSI to create a consent record (see the Subject Editor article for more information on how to create a new Subject).
   • Status - Allows users to mark the consent form as Active, Inactive, or Terminated (see the Change Consent Form Status article for more information about the meaning of each status).
5. Fill in the other fields in the editor. Required fields will show as red and will need to be filled in before the patient consent can be saved and become active.* To view the consent question:
   • If you are in the Table interface of the Patient Consent editor, right click on the column header menu for the desired field and choose Properties from the menu. In the Properties dialog that opens, the consent question will appear at the bottom of the listed information.
   • If you are in the Form interface of the Patient Consent editor, hover your mouse over the name of the desired field will cause a ToolTip to appear with the consent question.
6. When all of the patient consent information is filled in, save the patient consent record by choosing Save from the File menu or pressing the Save button on the toolbar. Once the save is successful, a new patient consent record will have been created for the subject.

*Note: Any field that is Boolean is a consent bearing field. Answering False/No on one of these fields will cause an error to be given in requisitions stating that the patient did not consent to the Question specified for the field.

View Patient Consent

Users are able to view an existing patient consent record. Users are not able to edit a patient consent record in View Mode.

To view an existing patient consent record:

1. Click on the desired patient consent entry from the list in the manager.
2. Press the View button on the right side of the manager.
3. The patient consent record will open in the Patient Consent editor in View Mode.

Edit Patient Consent

To edit an existing patient consent record:

1. Click on the desired patient consent entry from the list in the manager.
2. Press the Edit button on the right side of the manager.
3. The patient consent record will open in the Patient Consent editor in Edit mode. Make the desired changes to the patient consent record.
4. Press the Save button on the toolbar or choose Save from the File Menu when edits to patient consent are complete.

To edit existing patient consent data:

1. Open the Patient Consent editor with the desired form.
2. Make the desired changes to the available fields. Users will be able to edit all fields in the Patient Consent editor other than the Study ID and Form Name fields which are automatically set by BSI.
3. Once the edits have been made, press Save on the toolbar or choose Save from the File menu to save the changes to the database.

Change Patient Consent Status

A patient consent record can have one of the three statuses listed below. Depending on the status of the patient consent record, the consent constraints (if they exist) may not appear to the user in requisitions.

To change the status of a patient consent record:

1. Open the desired Patient Consent record in the Patient Consent editor.
2. Click on the Status field in the editor and press the ellipsis (...) button.
3. Choose one of the following status options from the code list:
   • Active—This is a patient consent record that is current. Users will receive a warning message in requisitions if users have not consented to an aspect of the consent form.
   • Inactive—A patient consent form with this status does not restrict users in requisitions even if one of the consent bearing questions has an answer of False/No.
   • Terminated—A patient consent form with this status will give a warning in requisitions that the consent for this subject has expired and the specimens should be destroyed.
4. When finished editing the status, press Save on the toolbar or choose Save from the File menu to make the status change permanent.

Delete Patient Consent

To delete an existing patient consent record:

1. Click on the desired patient consent record from the list in the manager.
2. Press the Delete button on the right side of the manager.
3. When the Delete button is pressed, the Delete Confirmation dialog will appear. If the user presses No on the Delete Confirmation dialog, the dialog will close and the patient consent record will not be deleted. If the user presses Yes on the Delete Confirmation dialog, the patient consent record will be deleted and the manager will automatically refresh.