The Sage Bionetworks governance team works with legal, ethical, and regulatory experts to develop and implement the policies and procedures for appropriate data sharing on each of our collaborative platforms: Synapse and BridgeServer.
We have a unique set of data governance challenges, as our systems cover the entire life cycle of research data, from generation to analysis and reuse. This necessitates that we develop governance policies and procedures that facilitate the creation of scientific insights while prioritizing the protection and respect of individuals who provide their data.
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 the right of audit and external reviews. Synapse operates as an IRB-approved environment to store, activate, analyze, and collaborate on data. It contains “tiers” of data access based on the nature of the data and the conditions delineated on the consents for the data’s generation, ranging from very wide reuse “Open″ to “Controlled″ where requests are evaluated before access is granted.
We believe in empowering individuals to contribute their data and insights as research partners on the health problems that matter most to them. We are developing governance mechanisms for the responsible collection and use of digital research assets via web and mobile health applications, that address the concerns for privacy and data protection in a comprehensive manner and manage participant’s preferences.
We generated the Participant-Centered Consent (PCC) toolkit for electronic informed consent, or e-consent. The toolkit is designed for people who are designing clinical studies and who wish to make their informed consent user-centered, rather than document-centered. It contains the building blocks of a visual, interactive approach to informed consent. The PCC toolkit lets its users create visual summaries of consent forms, mapped to key underlying text, for use in software or print.
Last, we build tools to increase the effectiveness of our governance tools. This includes comprehension assessments (for both Synapse users and for clinical enrollment), templates for patient-reported data contribution, tools, and more.
All of our governance policies and processes are available at the links below.
The governance efforts grew out of internal demands to support our research, as well as our engagement with the broader community of researchers and bioethicists who convened at our Congresses. Read the first principles of the Commons, drafted by Bob Cook-Deegan in 2011.