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.
About the Governance Team: The Governance Team explores the real-world implications of open-data sharing, and developing policies and procedures for the responsible collection, use, and reuse of research assets. We have developed and tested models for patient-centered consent in app-mediated research studies, data access, data protection, and data interoperability. We are thankful to our broad network of bioethicists, patient advocates, technologists, and an independent accredited Institutional Review Board (IRB) partners who collaborate with us at each stage of our design, implementation, and assessment processes.
About Sage Bionetworks: Sage Bionetworks is a nonprofit that develops and implements collaborative practices and technology to support the integration of data science into biomedical research. Sage sits at a unique nexus of the fields of data science, open-access technology platform development, and data governance. We are located in Seattle and we are supported through a portfolio of philanthropic donations, competitive research grants, and commercial partnerships.