Robust governance mechanisms that support the appropriate sharing of human data are essential to enable collaborative analysis within data-driven biomedical research.
The Sage Bionetworks governance team works with legal, ethical, and regulatory experts (the Sage Bionetworks Ethics Advisory Team) to develop the policies and procedures for appropriate data sharing on each of our collaborative platforms: Synapse and Bridge.
The Synapse collaborative data platform operates as an IRB-approved environment to store, activate, and collaborate on data. It contains three “tiers” of data access depending on the consents and other controls associated with the data’s generation, ranging from very wide reuse “Tier 3″ to an intermediate, validated researcher “Tier 2″ level and on to traditional secure cloud compute environment “Tier 1″ where requests are evaluated before access is granted.
In addition, Sage Bionetworks staff have designed Portable Legal Consent as an IRB-approved consent process to enable people to donate data into environments where it can be widely used and reused without additional permission. Portable Legal Consent (PLC) is a standardized informed consent system for anyone who has obtained data relevant to their health and would like to donate that data for research purposes.
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.