Elements of Informed Consent

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.

July 2019 Update

Version 2 reflects new information related to the January 2019 updates to the Code of Federal
Regulations (the Common Rule). We’ve also added some new sections:

  • Keeping it Legal: The International Edition
  • Privacy Policies and Terms of Service: Organizing Information
  • Using wearable devices in your study
  • Translation
  • Numeracy
  • Data Sharing and Secondary use
Download Toolkit