This blog is a quick tutorial for creating Consent Document for a ResearchKit based study app.
ResearchKit allows you to develop a Consent document for your study app with a few building blocks.
There are different Consent sections you can choose to have therein.
ResearchKit provides some default consent sections that you can re-use with your own content filled in.
You can also create a custom section.
Each consent section will have an image, a title, a 1-2 line summary and an elaborated version of the same.
The elaborated version (let’s call it description) is hidden under the ‘Learn More’ section of the screen for each Consent section on the mobile app.
The image and titles are pre-populated for ResearchKit’s default consent sections but you need to define everything for a Custom section.
Once you have created the Consent sections, you can choose which of them must be displayed on-screen to mobile app users thereby marking it as ‘Visual Step’
You can also choose the order in which the Consent sections must appear.
Typically, in a study app, these Consent section screens are followed by a Review screen where you would present the detailed terms of Consent (or Consent Document) to the user and ask them to Agree or Disagree to the same.
The Review screen can be created in 2 ways:
You can choose to concatenate all the Consent sections to create the Consent Document. This picks up the title and description part from each Consent section.
You can choose to create your own HTML for the same and use that instead.
The Review step is followed by asking users to provide the first name, last name and signature as part of e-consent on your app.
The content of the Review screen appended with the first name, last name, signature as captured from the user, and the date, together forms the Consent Document.
You can provide an option for people to view or email this Consent document as a PDF as well. The PDF will have the signature superimposed on it.
Note that if you have chosen to create the Consent Document using HTML, the name-signature-date part cannot be captured as part of the Consent PDF.
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