RKStudio™
User Guide

Consent

Getting consent to gather and use data is an important part of any study. RKStudio will not allow participants to join a study until you have set up a consent survey. This survey will inform the participant about how their data will be used and optionally record their consent via a simple acknowledgement or an electronic signature.

For more information on study consent, see ResearchKit Informed Consent.

Unlike regular surveys, a consent survey is not scheduled. The user is prompted to complete the consent survey when joining a study, and must complete it before joining.

A consent survey is created like any other survey. It can contain as many steps as you want. For example, you may add an instruction step or an eligibility question step with validation rules to prevent a participant from joining your study unless they state that they meet the necessary criteria.

Once you have created your consent survey, go to the study settings screen and select it as your consent survey.

There are several survey step types designed to help you manage consent for your study: Visual Consent and Consent Review. These rely on you creating a consent document for your survey.

A consent document is a multi-part document describing the terms and conditions of your study. Typical sections include:

  • Overview
  • Data Gathering
  • Privacy
  • Data Use
  • Time Commitment
  • Study Survey
  • Study Tasks
  • Withdrawing

On the left side of the survey editor, below the list of steps, is a header for consent documents. Select the “+” button next to the header to add a new consent document.

There are global properties to a consent document that you can modify:

Property Function Examples
Title The title of the consent document. Displayed at the top of a consent review step. “Distinguished University: Consent to Participate in mHealth Study”
Signature Page Title The title to be rendered on the signature page of the generated PDF “Signatures”, “Consent”
Signature Page Content The content to be rendered below the title on the signature page of the generated PDF “I agree to participate in the mHealth Study”

A consent document is made up of various sections, accessible via the “Sections” tab when you are editing a consent document.

When adding a new section, you can modify the following properties:

Property Function Examples
Title The title of the consent section. Displayed during both visual consent and consent review. “Overview”, “Data Sharing”
Formal Title An optional formal title that is used in place of the title in the generated PDF “Overview”, “Data Use and Sharing”
Type The type of the section. Determines the icon which is rendered for the section in the visual consent step. The “Custom” type will display no icon. Data Gathering, Privacy, Custom
Summary A short summary of the section displayed only during visual consent. “This study will collect data from Apple Health”
Content The longer HTML content of the section, displayed during visual consent if the participant selects “Learn More”, and during consent review. “<p>Lorem ipsum dolor sit amet</p>”

Signatures

To record an electronic signature with a Consent Review step, you must configure a signature for your consent document. These are visible via the “Signatures” tab when editing a consent document.

Property Function Examples
Identifier The identifier of the signature. “PARTICIPANT”, “INVESTIGATOR”
Title The title of the signatory “Participant”, “Investigator”
Requires Name Whether name entry is required for the Consent Review Step Yes/No
Requires Signature Whether the participant is required to sign during the Consent Review Step Yes/No
Given Name A pre-filled given name for the signature “John”
Family Name A pre-filled family name for the signature “Doe”

The Visual Consent survey step presents these sections to the user in a nice, graphical manner in accordance with the ResearchKit visual consent model.

To use a Visual Consent step, simply add one to your consent survey and select the consent document it’s associated with.

The Consent Review step lets the user review the entire consent document on a single screen and then acknowledge it. It can also be used to capture electronic signatures.

To use a Consent Review step, simply add one to your consent survey and select the consent document it’s associated with. If you want to capture an electronic signature, select one of the consent document’s signatures. You can also configure consent review to require the user to scroll all the way to the bottom before acknowledging.