Introduction

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

1. HTML text (Text formatting/Image source etc.)

2. Consent Statements

3. 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.

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 For example, “Y” for “Yes” response, “W” for “Withdrawn,” etc.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.

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 Formarchivedfor details on how to create a new form.

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:

1. Formatted text

2. Header/Footer

3. Consent statements

4. 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.

Open

Other Example

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

1. 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

5. Add signature field

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

7. Add number custom field

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

9. Add custom field dropdown value with options

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.

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

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:

Open

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

13. Mark consent statement editable with default selected.

14. Default custom value with non-editable

 

15. Make field mandatory based on other field value

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

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

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

 

16. Add File Type Control

 

 

17. 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.

18. Change the caption for the Next and Previous button

 

19. 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:

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.

Adding the Consent Document Form to a CP

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

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.

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.

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.

1. System-Level Archive Option:

   1. Navigates to Home → Consent → View Documents

   2. Click on the Archive option

       

2. 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.

1. 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.

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.

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:

1. Go to the CP Overview > Consents > Validations

1. Click on “Add”.

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

1. Follow the above steps to add more than one consent.

2. 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.

Reuse Participant Consents

At many centers, participant consents are registered or collected only once as per the IRB guidelines and reused in multiple studies.

From v10.3, A new setting has been added to the CP consents tab, this allows consent responses to be shared between multiple collection protocols, streamlining the consent management process.

Points to remember :

1. No new consent tiers or documents can be added in the receiver CP.

2. Consent responses cannot be added/updated via receiver CP registrations.

3. The participants' consent responses can be seen in the read-only mode in the receiver CPs with the option to print the consent document.

4. Since the consents for participants is copied to receiver CP, openspecimen users can distribute specimens collected for the receiver CP.