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
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.
Once the description is done, the 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