You need to be well-versed with HTML to configure consent forms. The HTML files can be created manually 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

eConsent Forms are configured at System level and it contains the following:

HTML text (Text formatting/Image source etc.)
Consent Statements
Custom fields (Text/Dropdowns/Signatures etc.)

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 For example, “Y” for “Yes” response, “W” for “Withdrawn,” etc.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Withdrawn	W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, e-signatures, 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
Header/Footer
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.

Examples of Consent Form

Here’s the HTML for the above consent document: The HTML document has a below example of a consent statement, custom fields, signature, and date.

Other Example

Examples to add the different types of custom fields in the consent document

The ‘Consent Date’ should display the default value as the current date and time. Ensure that the control type in the consent custom fields form is updated to ‘Date and Time’.

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

<div class="clearfix">
      <div style="width: 45%; float: left; clear: left;">
          <div class="col-xs-8 os-no-left-padding">
            <div user-input field="ectx.customFields.consentDate" type="date-time">
              <os-date-picker name="consentDate" date="ectx.customFields.consentDate" default-current-date ng-disabled="1 != 0"></os-date-picker>
            </div>
          </div>

          <div class="col-xs-4 os-no-left-padding">
            <timepicker class="os-time-no-wheels" ng-model="ectx.customFields.consentDate" show-meridian="false" readonly-input="true"></timepicker>
          </div>
        <div os-field-error field="econsentForm.consentDate"></div>
      </div>
    </div>

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

2. Add consent statement with the default value set and hidden on the overview page

<div consent-question="C0003">
        <input type="hidden" ng-model="ectx.statements.C0003" ng-init="ectx.statements.C0003 = ectx.statements.C0003 || 'Y'">
   </div>

3. Add custom field radio button "I Agree/I do not agree"

<div class="clearfix" style="padding: 8px 8px 0px;#if(true)display: none;#end">
  <div style="display: block; margin-bottom: 10px;">
    <span>
      <div user-input field="ectx.customFields.iAgree">
        <input type="radio" name="iAgree" value="Yes" ng-model="ectx.customFields.iAgree"
          ng-required="(ectx.statements.C0003=='N' || ectx.statements.C0003==null)">
          <span>
            <strong>I agree</strong> that you may contact me if there are results from the genetic research that may be relevant to my health.
          </span>
      </div>
    </span>
  </div>
  <div style="display: block;">
    <span>
      <div user-input field="ectx.customFields.iAgree">
        <input type="radio" name="iAgree" value="No" ng-model="ectx.customFields.iAgree"
          ng-required="(ectx.statements.C0003=='N' || ectx.statements.C0003==null)">
          <span>
            <strong>I do not agree</strong> that you may contact me if there are results from the genetic research that may be relevant to my health.
          </span>
      </div>
    </span>
  </div>
  <div os-field-error field="econsentForm.iAgree"></div>
</div>

4. Add custom field text-box

  <div>
      <label class="control-label">
        <span>Print Name of Biobank Participant</span>
      </label>
    </div>

    <div style="width: 70%; float: left">
      <div user-input field="ectx.customFields.participantName">
        <div>
          <textarea class="form-control" name="participantName" ng-model="ectx.customFields.participantName" rows="1" required></textarea>
        </div>
      </div>
      <div os-field-error field="econsentForm.participantName"> </div>
    </div>

5. Add signature field

 <div style="width: 70%; float: left">
      <div>
      <label class="control-label">
        <span>
          <strong>Signature of Biobank Participant</strong>
        </span>
      </label>
      </div>
      <div user-input field="ectx.customFields.signature" type="signature">
        <ec-signature name="signature" image="ectx.customFields.signature" ng-required="(ectx.customFields.signatureAuthRep==null && (ectx.statements.C0003=='N' || ectx.statements.C0003==null))">
        </ec-signature>
      </div>
      <div os-field-error field="econsentForm.signature"> </div>
    </div>

6. Add date as a custom field with default current date and non-editable

<div style="float: left; clear: left;">
    <label style="float: left; clear: left;">
        <strong>Today's Date</strong>
    </label>
</div>

  <div class="clearfix">
      <div style="width: 45%; float: left; clear: left;">
          <div class="col-xs-8 os-no-left-padding">
            <div user-input field="ectx.customFields.consentDate" type="date-time">
              <os-date-picker name="consentDate" date="ectx.customFields.consentDate" default-current-date ng-disabled="1 != 0"></os-date-picker>
            </div>
          </div>

          <div class="col-xs-4 os-no-left-padding">
            <timepicker class="os-time-no-wheels" ng-model="ectx.customFields.consentDate" show-meridian="false" readonly-input="true"></timepicker>
          </div>
        <div os-field-error field="econsentForm.consentDate"></div>
      </div>
    </div>

7. Add number custom field

<div style="margin-bottom: 20px;">
          <label style="display: block;">Height (centimetres)</label>
          <div style="width: 250px;" user-input field="ectx.customFields.height_centimetres">
            <input style="padding: 8px; border: 1px solid #ddd; border-radius: 4px; width: 100%" name="height_centimetres" ng-model="ectx.customFields.height_centimetres" required
              ng-pattern="/^[1-9][0-9]*$/">
            <div os-field-error field="econsentForm.height_centimetres"> </div>
          </div>
        </div>

8. Add OpenSpecimen PV-dropdown as a custom field site dropdown

   <div style="margin-bottom: 20px;">
          <label style="display: block;">Collection Center</label>
          <div user-input field="ectx.customFields.preferred_collection_site" type="user">
            <div style="display: inline-block; margin-right: 20px;">
              <os-sites name="preferred_collection_site" ng-model="ectx.customFields.preferred_collection_site" ></os-sites>
            </div>
            <div os-field-error field="econsentForm.preferred_collection_site"> </div>
          </div>
        </div>

9. Add custom field dropdown value with options

    <div style="margin-bottom: 20px;">
          <label style="display: block;">Visit Center</label>
          <div user-input field="ectx.customFields.visit_center">
            <div style="display: inline-block; margin-right: 20px;">
              <ec-select ng-model="ectx.customFields.visit_center" required>
                <custom-field>consent_custom_fields.visit_center</custom-field>
              </ec-select>
            </div>
            <div os-field-error field="econsentForm.visit_center"> </div>
          </div>
        </div>

10. Add print break in the consent document PDF: <ec-print-page-break></ec-print-page-break> is used to add the print break in the downloaded PDF.

In the below example, the 'We may contact you….' line will be printed on the next page.

 <ol>
	<li>
		<u>You will be asked to donate a blood sample (approximately 3 tablespoons) and urine sample.</u> If these samples are not collected today, they may be collected at a future time when you have a blood draw ordered by your doctor or a separate appointment that is convenient for you. In some cases, we may ask you for a saliva (spit) or buccal (cheek swab) sample. We may also use blood, urine, or tissue samples collected as part of your clinical care now or in the future that would otherwise be thrown away.
	</li>
	<li>
		<u>We will request information about you and your health.  We will collect your name, address and other contact information.</u> We will use your electronic health records now and, in the future, to update your health information. We will store some of your health information, including your name, contact information, and medical history, in the Columbia Biobank database.  Biobank staff will make a note that you are a participant in the biobank in your electronic health record.
	</li>
	<ec-print-page-break></ec-print-page-break>
	<li>
		<u>We may contact you in the future.</u> We may ask you to complete additional questionnaires about your health or contact you to get additional information and ask if you are interested in joining other research studies. We may also contact you for another biological sample. We may ask for additional samples in order to study changes in your sample over time, or because we used up the first sample you provided. If we ask you for another sample, you may always say no.
	</li>
	<li>
		<u>Your coded samples, health information, and the research results may be shared with the scientific research community.</u> A science and ethics committee will review each request for data access. We will not give researchers outside of Columbia University Irving Medical Center-NewYork Presbyterian your name or any other information that could directly identify you.
	</li>
</ol>

11. Show/hide field/section based on the other field selection

Syntax: Needs to add the 'ng-show' tag to implement the show/hide logic

<div ng-show="ectx.statements.C0003=='N'" >
 <p> .... </p>
 <label class="radio-inline">
  ......
 </label>
</div>

Example: When a user clicks on the “I agree to participate" option, the below section highlighted in red is enabled.

Example HTML for the above example:

12. Mark consent statement non-editable with default selected.

<div class="clearfix" consent-question="M001">
          <label class="control-label"> 
          		<input name="M001" type="checkbox" ng-true-value="'Y'" ng-false-value="'N'"  ng-disabled="1 != 0"  ng-model="ectx.statements.M001" ng-init="ectx.statements.M001 =  'Y'"> </label> 
            <span>I consented for cancer study</span>
</div>

13. Default custom value with non-editable

<input type="radio" name="health_info_described_in" value="both" ng-model="ectx.customFields.health_info_described_in" 
ng-init="ectx.customFields.health_info_described_in =  'both'" ng-disabled="1 != 0">

14. Make field mandatory based on other field value

Eg:1 - Make Guardian name custom field mandatory for Male patients.

<div>
 <textarea class="form-control" ng-model="ectx.customFields.parentGuardianName" rows="1" ng-required="cpr.participant.gender == 'Male'"> </textarea>
</div>

Eg:2 - Make Guardian name custom field mandatory when site='Stanford Hospital'

<div>
 <textarea class="form-control" ng-model="ectx.customFields.parentGuardianName" rows="1" ng-required="cpr.registrationSite == 'Stanford Hospital''"> </textarea>
</div>

Eg:3 - Make Participant Signature(signature) mandatory if Guardian signature(signatureAuthRep) is not entered

<div>
    <ec-signature name="signature" image="ectx.customFields.signature" ng-required="ectx.customFields.signatureAuthRep==null"></ec-signature>
  </div>

15. Add File Type Control

    <div style="margin-bottom: 20px;">
          <label style="display: block;">Photo Identity</label>
          <div user-input field="ectx.customFields.photo_identity" type="file">
            <div style="display: inline-block; margin-right: 20px;">
              <ec-file-uploader name="photo_identity" file="ectx.customFields.photo_identity" required></ec-file-uploader>
            </div>
            <div os-field-error field="econsentForm.photo_identity"> </div>
          </div>
        </div>

16. Conditional field mandatory (File Type Field)

Eg, The consent form has the participant’s signature, parent’s signature, and paper consent file (File type). Out of three fields, one of them needs to fill.

<div style="width: 45%; float: left;">
  <label class="control-label">
   <span>Upload Paper Consent</span></label>
   <div user-input field="ectx.customFields.signedConsentFile" type="file">
     <div>
      <ec-file-uploader file="ectx.customFields.signedConsentFile" name="signedConsentFile" ng-required="(ectx.customFields.signature==null && ectx.customFields.signatureAuthRep ==null)"></ec-file-uploader>
   </div>
   </div>
    <div os-field-error field="econsentForm.signedConsentFile"></div>
</div>

17. Change the caption for the Next and Previous button

<ec-page-nav-buttons>
  <next>Siguiente</next>
<previous>Página Anterior</previous>
<save>Guardar</save>
<cancel>Cancelar</cancel>
</ec-page-nav-buttons>

18. Configure headers and footer for the consent document print file: To configure this, you need to set the print template in OpenSpecimen settings as below. You can set the logo, stamp on headers, and footer, including page numbers.

Example: PDF

Example HTML code for the above document:

<ec-print-template>
<div>
  <ec-page-header>
    <div class="clearfix" style="border-bottom: 1px solid #ddd; position:relative;height: 70px; background: #fff; display: inline-block; width: 100%; padding: 8px 8px;">
      <div style="float: left;">
        <img style="position: absolute; z-index: 1000; height: 60px; width: 450px;" src="https://bb.cuimc.columbia.edu/os-test/logo/RS2133_RS460_Columbia_CUIMC_H_B_RGB_A.png">
      </div>
    </div>
  </ec-page-header>

  <ec-page-footer>
    <table style="border-top: 2px solid #ddd; position:relative;height: 70px; display: inline-block; width: 100%; padding: 8px 8px;">
      <tbody>
        <tr>
          <td style="text-align: left;">
            <img style="height: 70px; width: 300px;"  src="https://bb.cuimc.columbia.edu/os-test/logo/cumc_stamp_hiccc.png">
          </td>
          <td style="text-align: right; padding: 10px;">
              <div id="osPageCounter" style="position: absolute; bottom: 12px; right: 5px;"> </div>
          </td>
        </tr>
      </tbody>
    </table>
  </ec-page-footer>
</div>
</ec-print-template>

Upload Consent Document in OpenSpecimen

Users can upload consent documents in the Consents tab and can access those in the collection protocol. From v9.0, OpenSpecimen will allow using the same consent form in different CPs. The user who has. the access to the Consent can be uploaded or updated consent document in OpenSpecimen.

Upload Consent Document in OpenSpecimen

Login to the OpenSpecimen → Click on Consent Card
Click on View Documents
Click on Add and provide the Title and Revision details and upload the HTML consent form you created

Adding the Consent Document 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”.
Select the Consent Document from the list and 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 HTML content can be updated. It can be done by clicking the “Edit” icon from the consents list page.

From v9.1, OpenSpecimen will not allow updating the consent document if that is used with any patient.

Steps to edit eConsent document

Navigates to the Home page → Click on Consent Card → View Documents
Click on the “Update” icon beside the consent document(As highlighted below)
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 Revision (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

Navigate to the Home → Consents → View Documents → Click on the "+” icon
Enter the version of the consent document. Upload the document and click “Add”.

Archiving Consent Form

If a version of a consent form is not needed, it can be archived. Once archived, the consent document is not available any more for consent response collection. However, if consent is already collected for that version, then it is available for viewing, editing, and reporting.

From v9.0, OpenSpecimen allows archiving the document at the system level and CP level. If the document is archived at the system level, the user won't be able to add that in new collection protocols, but if that document is already used in other CP will work without affecting anything.

Users also allow archiving the document in the collection protocol, and users won't be able to collect any responses for new patients.

System-Level Archive Option:
1. Navigates to Home → Consent → View Documents
2. Click on the Archive option
CP Level Archive Option:
1. Go to the Collection Protocol Overview Page → Consents tab

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.

Navigate to Home → Consent Card → View Documents → Click on the Download button below

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

Navigate to Home Page → Consent Card → View Documents –> Click on the Audit Trail button

Consents Validation

One or more validation rules can be added to ensure that specimens cannot be collected before the participant has consented. These validation rules are defined at a CP level.

To define validation rules:

Go to the CP Overview > Consents > Validations

Click on “Add”.

Field	Description	Options
Statement	Coded consent statements	All the consent statements defined for the CP
Match	Condition for the consent response	is is not is one of is not one of
Response	Response of the consent statement	Any valid consent response.

The above rule is to allow collection when the response for C0001 is “Yes”. Click on “Add”.

Follow the above steps to add more than one consent.
In the validations list page, there is another match for multiple consents.

ALL: It allows the collection of visits/specimens when ALL rules are true. Works like “AND” in the query.

ANY: It allows the collection of visit/specimens when ANY one of the rules is true. Works like “OR” in the query.

ADVANCED: This is used for creating a combination of rules using ‘and’ and ‘or’.
For example,
The below will be true if either (consent 1 is yes AND consent 2 is yes) OR consent 3 is yes.

The expression in the box defines the rule which allows collection. It can be edited by clicking on “Edit”.

Consents Digests

OpenSpecimen provides two options to receive the consent digest, which described below. User will get receive the participants and consent document information who consented on that day(within 24hrs).

Site based Recipients? → No, The user has to specify a list of users and those users will get the consent digest email.

Site based Recipients? → Yes, The user has to specify a sites and user groups and those users from groups will receive the digest emails

What information is present in Digest Email?

The digest email has the information on the patient who consented on that day(24hrs) or who updated the consent document on that day for that patient along with the date. Furthermore, you can configure when to send the digest email, like Hourly, Monthly, Daily, On Demand etc.

Click here to see screenshots...

Digests Settings: Site based Recipients? → Yes

Digests Settings: Site based Recipients? → No

Digests Email Example:

Digest email configuration: The user should have the super admin privilege to change the digest job settings as below.

Navigates to Home → Jobs
Search For “Consent response” as below
Click on three dots and edit
Set up the job based on your requirements like daily, Hourly, etc

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

Examples of Consent Form

Other Example

Upload Consent Document in OpenSpecimen

Adding the Consent Document Form to a CP

Updating a Consent Form

Consent Revision (Versioning)

Archiving Consent Form

Download Consent

Sort Consents

Audit Trails for consent document

Consents Validation

Consents Digests

What information is present in Digest Email?