Introduction
Consent documents are to be designed in HTML. They are to be uploaded at CP level
Create eConsent document
An HTML document containing at least one coded consent statement needs to be uploaded in the “Consents” tab of a collection protocol. These consents are to be set up per CP.
Prerequisite
Coded consent statement should be defined in the “Consents” of the OpenSpecimen instance.
From the navigation menu/home page, click on “Consents”
In the “Consents” tab, check whether the consent you want to use is already present
If not, click on “Create”
Input the consent code in the “Code” field and the consent statement in the “Statement” field. The statement needs to be a one-line crux of the consent. Then click on “Create”.
The consent statement will be visible in the “Consents” tab
A document describing the consent process and the detailed explanation of the consents is designed via HTML. Before that, identify the fields that the participant will be entering after he is done with reading the consent, for example, the e-signature, the full name as provided in identity proof, the date of signature etc.
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 infromation and other details
Once the description is done, consents are defined, the other participant related fields to be filled up can be added in the form. In order to add fields of different control types (like full name of the participant, e-signature of parent/guardian, date etc.), they first need to be added to a “Consent Custom Fields” form, which is attached at “Consent Document Custom Fields” level.
In order to add different control types to the custom form, refer this wiki page.
Here are a 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 “Consent Custom Fields” form is maintained across the system and the fields from this form can be used across all CPs in the system. The relevant fields that are to be used in the consent document are to be defined in the consent HTML.
Once the fields have been added to the form, they have to be defined in the HTML to add it to the consent document.
Refer the below section of HTML for defining these above 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
Here is how you can upload the above-created consent document to the collection protocol:
From the navigation menu, go to Collection Protocols list page > CP Overview > Consents tab
This would lead you to the list page of the Cp level consents. Click on “Add” from the screen
A pop-up appears for user to enter the name of the consent document in “Title” field, the version in “Revision” field and upload the HTML file in the “Document File” field. 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 for eConsent document. 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
The same 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. It is mandatory to put a sort order in front of each document.
While choosing to add the consents for a participant, these documents appear in the same order as specified.