Page Comparison

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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

We can break this into 3 steps:

1. Descriptive text

2. Consent statements

3. 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.

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Here’s a demo HTML file for reference. This is an example of an assent form for a minor.

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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:

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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 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.

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Once the fields have been added to the form, they have to be defined in the HTML to add it to the consent document.

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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>