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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.

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Prerequisites

1. Coded consent statement should be defined in the “Consents” of the OpenSpecimen instance.

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1. From the navigation menu/home page, click on “Consents”

2. In the “Consents” tab, check whether the consent you want to use is already present

3. If not, click on “Create”
   

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4. 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”.
   

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5. The consent statement will be visible in the “Consents” tab
   

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1. In case it isn’t, please refer to this wiki page to add the coded consents: Coded Consents

2. 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. In order to add different control types to the custom form, refer this wiki page.

   Few pointers to keep in mind:

   1. 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.

   2. 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.

Designing the document

This can be done in 3 steps:

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<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

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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:

1. 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.

2. 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.

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information and other details

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Refer the below section of HTML for defining these above fields in the consent document:

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