The Governance Team explores the real-world implications of open data sharing, 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.
Resources and policies produced by the Sage Bionetworks Governance Team, including novel approaches to informed consent, clinical protocols, and data access, are implemented by Sage’s scientists and engineers to support their work on collaborative science platforms and mobile health research efforts, and are available for open use in projects worldwide. These resources can also be accessed for your own use in the Tools, Templates, and Resources section below.
Governance at Sage Bionetworks
mHealth
The role of governance in mHealth research is to empower citizens to participate in research efforts that matter most to them, to track their personal health data, and to partner with researchers though mutual sharing of data and insights. Sage Bionetworks’ contributions include a user-friendly electronic consent framework (eConsent), open-source resources for participant-centric data collection practices, and oversight of Synapse‘s qualified researcher program.
Challenges & Research Communities
The Governance Team works hand in hand with Dream Challenge organizers and with research communities, including both scientists and participants, to create Terms of Use, oversee data access, and provide guidance on governance questions.
Synapse
The Synapse platform operates under comprehensive governance policies designed to enable cross-disciplinary research while safeguarding participant data. These policies include well-documented Terms and Conditions of Use, a standardized data use procedure, and adaptive privacy policies, as well as structured oversight from the Synapse Access and Compliance Team (ACT).
Tools, Templates, and other Resources
All downloadable resources are openly licensed and may be used in any context, by any user, for any purpose, as long as attribution is provided back to Sage Bionetworks.
Sage Bionetworks has developed a novel multi-media approach to addressing transparency and comprehension within electronic informed consent (eConsent) for app-mediated research studies. We deployed this eConsent process in minimal-risk research studies. Here we describe the rationale for the framework selected and best practice for application of the framework in other clinical studies.
Parkinson’s Disease Research Community Webinar
Learn about the governance process for the mPower Parkinson disease research study app.