Elements of Informed Consent

The Elements of Informed Consent is a toolkit that will help researchers think through what information participants should receive as part of the consenting process in order to make an informed decision about whether or not to join a study. Developed by the Governance Team at Sage Bionetworks, the toolkit shares basic information and best practices for developing an effective consenting process. We believe that informed participants make the best participants, because they understand the study, its risks and benefits, and how their data will be treated.

What’s In the Toolkit

We hope this toolkit will help you make your consent and informing experience the best that it can be. What you’ll find:

  • What We Know: Use cases describing our approach to the informed consent process, including eConsent.
  • Real Examples: What these ideas look like when they are put into practice.
  • Consent Checklist: Reminder questions to make sure you’ve thought through your approach.
  • Additional Resources: Tools we use when we develop consent forms.

January 2020 Update: Version 3

A lot has happened since we put out version 1 of this toolkit in October 2018. In version 2 (July 2019), we added new information to reflect the January 2019 updates to the Code of Federal Regulations (the Common Rule). In version 3 we have added a few new sections:

  • Stop the Bots! How to detect bots in your online research
  • eConsent: a complement to the in person consenting experience
  • Using a question and answer format
  • Side bar: Do we still need a long form?
  • There are also a few sections in this toolkit that are not specifically about informed consent, but address closely related topics, such as using wearable devices in your study. Another consent-related section features Research Kit and Research Stack frameworks.

Note (Jan. 24, 2020): The PDF works best when downloaded via Chrome or Safari. There have been intermittent issues with hyperlinks contained within the PDF when downloaded via Firefox.

Privacy Toolkit for Mobile Health Research Studies

The Privacy Toolkit provides biomedical researchers with a catalog of design tools and patterns to use throughout the user journey of their mHealth studies and allow users to learn more about data privacy and management. The toolkit also provides accompanying use cases to help researchers decide on which patterns are most appropriate for their mHealth applications. By using privacy patterns, study participants can better understand the types of data that are being collected by the research study app and that they have the ability to change their data sharing permissions at any time. Having multiple touchpoints helps build a trusted partnership between the research team and the study participants.

Vanessa Barone and Woody MacDuffie presented on the Privacy Toolkit during the 2019 UX Scotland conference. Watch the video