Governance at Sage Bionetworks
Sage Bionetwork’s governance work seeks to explore and address the real-world impacts of widespread data reuse in cloud-based “open science”.
We develop policies and procedures for the responsible collection and use of data and other research assets. Our work covers patient-centered consent in mobile clinical studies, data access mechanisms, data protection measures, and legal-ethical aspects of data interoperability. We engage a broad network of bioethicists, patient advocates, technologists, and independent accredited Institutional Review Board (IRB) at each stage of our design and implementation processes. The governance team develops, implements, and enforces the policies and procedures for the responsible collection and use of digital research assets in a collaborative environment with critical considerations for appropriate patient-centered consents, data protection measures, and data interoperability.
The role of governance for mHealth includes empowering citizens to share and track their data, to partner on research and to fund the projects that matter most to them. The Participant-Centered Consent (PCC) toolkit (Sage Bionetworks’ eConsent), participant sharing options and implementing the qualified researcher program are examples of projects in this area.
The governance team develops and implements transparent, effective, and efficient data management and governance practices to enable cross-disciplinary research through the qualified researcher system, procedures (IRB, audit, guidance for governance decisions, internal and external training, and data access tiers. Our governance process for the Synapse collaborative data platform includes well-documented Terms and Conditions of Use, guidelines and operating procedures, privacy enhancing technologies, as well as regular auditing procedures.
Doerr, Megan and Suver, Christine and Wilbanks, John, Developing a Transparent, Participant-Navigated Electronic Informed Consent for Mobile-Mediated Research (April 22, 2016).
Abstract: 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.
Learn about the governance process for the mPower Parkinson disease research study app.