You need to be well-versed with HTML to configure consent forms. The HTML files can be created by hand or using online editors like this.

In future versions, we plan to give a UI based editor within OpenSpecimen to create the consent forms.

Introduction

Consent forms are configured at a CP level in HTML and contain the following:

HTML text
Consent Statements
Custom fields

Prerequisites

'Allowed File Types' setting

The system setting “Allowed File Types” should have ‘html’ as an allowed file type.

Steps to include html in the allowed file types:

Go to Menu > Settings
Search “Allowed File Types”
Check if ‘html’ is included in the setting. If not, click on the setting
Copy all the original allowed file types from the “Existing Value”. Paste it in “New Value”, put a comma and include ‘html’ along with it. Click “Update” once done.

Consent Statements

The consent statements are defined at a global level so that they can be reused across CPs. Go to Menu->Consents to define new consent statements. Refer to Coded Consents for more details.

Consent Response Code

A unique concept code for each consent response is mandatory. These codes are used in the consent HTML document for invoking the specific consent response. For example, “Y” for “Yes” response, “W” for “Withdrawn” etc.

Make sure the concept code is unique for every response.

Steps to set the consent response concept codes

Go to Extras > Dropdown Manager > Consent Response dropdown
Click on the consent response value “Yes” and click “Edit”
Enter the concept code as “Y” and click “Update”
Similarly, edit the concept codes of all the responses. Here are the default concept codes that you can use:

Consent Response	Concept Code
Yes	Y
No	N
Not Specified	NS
Withdrawn	W
None	NN

Custom Fields

The consent form could have fields like consent witness, consent date, eSignatures, etc. These fields are to be added in a custom form attached to the “Consent Document Custom Fields” level. A single form is maintained for consent custom fields across the system to avoid duplicating fields across CPs and making it easy for reporting.

Refer to Create and Edit Formfor details on how to create a new form.

Refrain from adding duplicate fields. For example, ‘participant name’ is the same as the ‘patient name’.

Designing the Consent Form

The consent form is designed in HTML since it gives us the flexibility of easy formatting. E.g. use of bullet points, use of text formatting like bold, underline, embed videos/photos, etc.

There are three sections in the consent form:

Formatted text
Consent statements
Custom fields

Formatted HTML text

This section contains the consent text. For example:

Consent Statements

Consent statement(s) can be added anywhere in the consent form. They can be displayed as a dropdown, radio-button, or checkbox.

For example:

Custom Fields

Details such as signature, date of signature etc. that were defined in the custom form (step 2 in the “Prerequisites”) can be displayed as below in the consent form.

Set the value of date fields to default date and time

The date control fields can be set to show the current date and time by default.

Example: The ‘Consent Date’ should display the default value as current date and time.

Steps for setting the default value to date fields

Ensure that the control type in the consent custom fields form is updated to ‘Date and Time’.

In the consent HTML, the code for ‘Consent Date’ field needs to be updated as below:

<div class="clearfix">
    <div class="col-xs-8 os-no-left-padding">
      <os-date-picker name="consentDate" date="ectx.customFields.consentDate" default-current-date></os-date-picker>
    </div>
    <div class="col-xs-4 os-no-left-padding">
		  <timepicker class="os-time-no-wheels" ng-model="ectx.customFields.consentDate" show-meridian="false"></timepicker>
		</div>
    </div>

The ‘os-date-picker’ sets the value to current date and the time picker allows the display of current timestamp.

Example Consent Form

As an example, here’s the HTML for the above consent document:

Adding the Consent Form to a CP

Once the HTML is ready, you can upload it for a CP using the below steps.

Adding a consent document to the CP

From the navigation menu, go to the Collection Protocols list page > CP Overview > Consents tab
The user is redirected to the list page of the CP level consents. Click on “Add”.
Enter the name of the consent document in the “Title” field, the version in the “Revision” field and upload the HTML file in the “Document File” field. All three fields are mandatory. Click on “Add”.
It will be visible at the end of the consent statements in the list view.

Updating a Consent Form

The title, version, and the HTML content can be updated. It can be done by clicking the “Edit” icon from the consents list page.

Steps to edit eConsent document

Go to the CP Overview > Consents
Click on the “Edit” icon beside the consent document
If you want to update the title and version, just update the fields and click update. No need to re-upload the document.
In case an updated document is to be uploaded, leave the other fields unchanged. Upload the document and click “Update”.

Consent Versioning

A consent document can have multiple versions. When a new version is added, the new version is available for old and new participants. The data collected for older version remains in the database and is available for querying.

Steps to add a new version of the document

From the consents list page, click on the “+” icon across the document.
Enter the version of the consent document. Upload the document and click “Add”.

Archiving Consent Form

In case a version of a consent form is not needed anymore, it can be archived. Once archived, the form is not available anymore. However, if consent is already collected for that version, then it is available for viewing, editing, and reporting.

Download Consent

The consent form’s HTML file can be downloaded and used to edit the form or upload it to another instance or another CP. This saves the re-work of designing the document from scratch.

Sort Consents

The order of consent documents can be changed using the “Sort” option. If no order is specified, the consent documents will appear in the order that they were added.

Steps to re-order the consent documents

Go to CP Overview > Consents > Sort
Enter the sort order starting from 1. Click “Update”.
While choosing to add the consents for a participant, these documents appear in the same order as specified.

Audit Trails for consent document

You can check the audit trails for the consent document. The audit trails show who updated the consent document and when.

Click here to see the screenshot

Consents Digests

You can add multiple users to get the daily digest email about eConsents. The digest email has the information of the patient who consented on that day or who updated the consent document on that day for that patients along with the date.

Click here to see screenshots...

Digests Settings:

Digests Email Example:

Configuring eConsents in CPs

Introduction

Prerequisites

'Allowed File Types' setting

Consent Statements

Consent Response Code

Custom Fields

Designing the Consent Form

Formatted HTML text

Consent Statements

Custom Fields

Set the value of date fields to default date and time

Example Consent Form

Adding the Consent Form to a CP

Updating a Consent Form

Consent Versioning

Archiving Consent Form

Download Consent

Sort Consents

Audit Trails for consent document

Consents Digests