Introduction
Consent documents are to be uploaded as HTML documents at CP level. These documents can contain a detailed explanation and answers of general questions, followed by at least one consent statement and the details of the consenting participant.
Create eConsent document
Prerequisites
Coded consent statement should be defined in the “Consents” of the OpenSpecimen instance. In case it isn’t, please refer to this wiki page to add the coded consents: Coded Consents
Identify the fields for which information is to be recorded along with consent responses. For instance, the e-signature, the full name as provided in identity proof, the date of signature etc. These fields are to be added in a “Consent Custom Fields” form attached at “Consent Document Custom Fields” level. Refer this wiki page to add different control types to the custom form.
Few pointers to keep in mind:
Refrain from adding repetitive controls to the form. For example, ‘participant name’ is the same as the ‘patient name’ is the same as the ‘full name of the participant’. One control can be used by changing the captions as needed in the HTML.
A single form is maintained for consent custom fields across the system. The relevant fields that are to be used in the consent document are to be defined in the consent HTML. Detailed steps are explained below, under this.
Designing the document
This can be done in 3 steps:
Descriptive text
Consent statements
Participant information and other details
Descriptive text:
The document can be a piece of descriptive information about the biobank addressing general questions like why is the consent necessary, what it means to consent, what are its present and future implications on the participants, information about the research for which these collected specimens are to be used etc. This will allow the participant to take time to understand the consent her/himself and get back with questions if any.
Here’s a demo HTML file for reference. This is an example of an assent form for a minor.
Descriptive part can be designed using any online HTML editor.
Consent Statements
Consent statement(s) are to be added after the descriptive text. You can add them in the form of dropdown, radio-button, checkbox. All these can be defined in the HTML.
Here’s how it would look in the document:
Below is the code for defining the above consent statements in the consent document:
<div style="padding: 8px 8px 8px 0px; border-top: 5px solid #ddd;">
<div class="clearfix" consent-question="C0001" style="padding: 8px 8px 8px 0px; border-bottom: 1px solid #ddd;">
<label class="control-label">
<span>Do you consent to participate in biobank activities?</span>
</label>
<div>
<label class="radio-inline">
<input type="radio" name="C0001" value="Y" ng-model="ectx.statements.C0001" required>
<span>Yes</span>
</label>
<label class="radio-inline">
<input type="radio" name="C0001" value="N" ng-model="ectx.statements.C0001" required>
<span>No</span>
</label>
</div>
<div os-field-error field="econsentForm.C0001"></div>
</div>
<div class="clearfix" consent-question="C0002" style="padding: 8px 8px 8px 0px; border-bottom: 1px solid #ddd;">
<label class="control-label">
<input name="C0002" type="checkbox" ng-model="ectx.statements.C0002" ng-true-value="'Y'" ng-false-value="'N'">
<span>I consent to store my specimens in long term storage for future research.</span>
</label>
</div>
<div class="clearfix" consent-question="C104" style="padding: 8px 8px 8px 0px; border-bottom: 1px solid #ddd;">
<label class="control-label">
<span>I consent to distribute my specimens to external institutes for future research.</span>
</label>
<div style="width: 10%">
<select name="C104" class="form-control" ng-model="ectx.statements.C104" required>
<option value="Y">Yes</option>
<option value="N">No</option>
</select>
</div>
<div os-field-error field="econsentForm.C104"></div>
</div>
Participant information and other details
Details such as signature, date of signature etc. that were defined in the custom form (step 2 in the “Prerequisites”) appear as below in the consent document.
Refer the below section of HTML for defining these custom fields in the consent document:
<div class="clearfix" style="padding: 8px 8px 8px 0px;">
<div style="width: 33%; float: left">
<label class="control-label">
<span>Consent Date</span>
</label>
<div>
<os-date-picker name="consentDate" date="ectx.customFields.consentDate"></os-date-picker>
</div>
<div os-field-error field="econsentForm.consentDate"></div>
</div>
<div style="width: 33%; float: left; padding-left: 16px;">
<label class="control-label">
<span>Consent Witness</span>
</label>
<div>
<os-users ng-model="ectx.customFields.witness" select-prop="id"></os-users>
</div>
</div>
<div style="width: 33%; float: left; padding-left: 16px;">
<label class="control-label">
<span>Signed Form</span>
</label>
<div>
<ec-file-uploader file="ectx.customFields.signedConsentFile"></ec-file-uploader>
</div>
</div>
</div>
<div>
<div>
<div class="clearfix" style="padding: 8px 8px 8px 0px;">
<div style="float: left">
<label class="control-label">
<span>Signature</span>
</label>
<div>
<ec-signature name="signature" image="ectx.customFields.signature" required></ec-signature>
</div>
<div os-field-error field="econsentForm.signature"></div>
</div>
</div>
</div>
</div>
<div class="clearfix" style="padding: 8px 8px 8px 0px;">
<div style="width: 100%; float: left">
<label class="control-label">
<span>Comments</span>
</label>
<div>
<textarea class="form-control" ng-model="ectx.customFields.comments" rows="2"></textarea>
</div>
</div>
</div>
Once this HTML is created, this is ready to be uploaded to the system.
Adding the consent document to the CP
Follow the below steps to add a consent document to the collection protocol:
From the navigation menu, go to Collection Protocols list page > CP Overview > Consents tab
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.
Update eConsent document
The title, version and the document all can be updated. It can be done by clicking the “Edit” icon from the consents list page.
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”.
Add Revision
A consent document can have different versions. The detailed information can be changed, questions can be modified in the newer version. You can add the revision of the document and upload the respective 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”
Archive Consent
In case a version of consent is not needed, it can be archived.
Download Consent
Consent HTML file can be downloaded from the CP consents tab. This can be used to update the text, statements, and details and re-upload as a new consent file. 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. T It is mandatory to put a sort order in front of each document.
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.
