Each project requires a “Consent” survey to be configured before participants can join. When you create a project, a default consent survey will be automatically created, but will require further input.
A consent document is a multi-part document describing the terms and conditions of your project. Typical sections include:
- Data Gathering
- Data Use
- Time Commitment
- Study Survey
- Study Tasks
Unlike standard surveys, participants are prompted to complete the consent survey when joining a project, and must complete it before joining. For more information on consent, refer to ResearchKit's Informed Consent.
Creating a Consent Survey
By default, a consent survey will be added when you create a project. However, consent surveys can either be created from scratch, same as creating a standard survey, or you can download the Sample Consent from the survey store.
Adding a Consent Document
If you choose to create the consent survey from scratch, you will arrive at the following page. Start by clicking "Add Consent/Agreement" to make your survey a consent survey.
By default, Welcome, Consent, and Thank You steps will be added to your consent. You might consider adding other steps as needed. For example, you may add an instruction step or an eligibility question step with validation rules to prevent a participant from joining your project unless they state that they meet the necessary criteria. While you may have many Step Types in your consent survey, the rest of this article will focus on the Consent Step Type.
Consent Step Type Properties
Once you navigate to the Consent step, your right pane will present a consent properties to edit.
- Step Identifier: Already populated as "Consent" and is used as an internal way to reference this step. You may revise the name.
- Step Type: Leave this as Consent Step- otherwise you will not be able to add your consent content here!
- Title: This will be the title at the very top of the page. You can leave it as "Consent" or rename it after the study, e.g. "mHealth Sleep Study Consent".
- Sections: Much like your own consent document, the consent you build in MyDataHelps Designer will contain sections. You should generally add a section to the consent survey for each section that exists in your document. Add a section by clicking the "+" to the right of SECTIONS header.
- Title: Here you can give your section a title that will be displayed within the consent and as a header for the section within the right pane.
- Content: This is the section's content, pulled directly from your consent document.
The Content field for the Consent step supports HTML. Use HTML for bulleted lists and other items!
- Digital Signature: This section details options around signing of the consent. As you enable these check boxes, you can view them using the left and right arrows underneath the step viewer.
- Required typed name: If enabled, participants will be required to input their first and last name.
- Require drawn signature: If enabled, participants will be required to electronically sign the consent by drawing their signature on their device.
- Bypass drawn signature on web: If enabled, participants who are accessing the consent via web, rather than MyDataHelps, will not be required to electronically sign the consent survey.
- Requires scroll to the bottom: If enabled, participants will be required to scroll to the bottom of the consent before they can continue.
- Name Page Title: If the "Required typed name" field is enabled, you can elect to provide a custom title for the screen where they would enter their name.
- Name Page Text: If the "Required typed name" field is enabled, you can elect to provide custom text for the screen where they would enter their name.
- PDF Signature Page Title: You can elect to have a custom page title displayed on the signature page when exporting completed consent surveys.
- PDF Signature Page Content: You can elect to have custom text displayed on the signature page when exporting completed consent surveys.
- PDF Signature Title: You can elect to have a custom signature title displayed on the signature page when exporting completed consent surveys.
Adding the Consent to the Project
Finally, once you have published your consent survey, navigate to the project settings screen and select it as your consent survey. Click Save at the bottom of the settings page to save your changes.