Big data’s power to improve health and well-being relies on building deep, broad, massive, and representative datasets. While there has been increasing attention given to the technical challenges (and methods to surmount them) of health data aggregation, concrete pathways for addressing the ethical challenges that arise have been elusive. Yet, purposeful management of potential risks arising from the creation or enrichment of health data is critical to building trust with the people who contribute data, as well as the quality of insights such research generates.

Sage Bionetworks and Aapti Institute have developed an ethical risk diagnosis tool for data aggregators and users, and have mapped a library of community-focused intervention strategies to aid in risk mitigation. This work also explores the potential implementations of meaningful participation and involvement of impacted communities in data decisions throughout the biobanking lifecycle. While these tools have most recently been adapted for mental health studies, in collaboration with the Wellcome Trust, the framework highlights ethical considerations and mitigations that are broadly applicable:

• Funders, governments, and civil society organizations/non-governmental organizations might use or build from this framework to guide the evaluation of proposals for data collection, enrichment, aggregation, and/or use.
• Research institutions and individual researchers could use this framework to extend the conceptualization, planning, and execution of their work towards more equitable and community-centred outcomes.
• Communities and people with lived experience are invited to use and adapt this framework to meet their needs as they evaluate opportunities for engaging with the research ecosystem.

In addition to the framework itself, we provide a series of supporting documents:

• A guide for individual dataset evaluation, which may be of particular use to data generators and those acquiring datasets, highlighting key due diligence requirements.
• A more in depth review and discussion of key novel and emerging ethical considerations and mitigation strategies, highlighting a subset of considerations from the framework.
• Reflections and reactions to the framework from people with lived experience, as well as subject matter experts.

Through this framework, and drawing from the expertise of Sage Bionetworks and the Aapti
Institute, we have been studying a few facets of large-scale data repositories. We are interested in:

• The role of communities in shaping data use and aggregation at scale. How can communities with lived experience participate meaningfully in data-driven research, beyond their role as research subjects?
• Mitigating systemic inequities through the participatory and ethical design of data repositories. What can be addressed at the platform and structural level to minimize harm and increase fairness in data governance?
• Building people-centric accountability structures within data governance. How can reimaginations of consent, purpose limitation, or access control support mechanisms for procedural justice?

If you are interested in these questions, or working in related spaces, please reach out to us at [email protected] – we welcome your thoughts!

Purposeful management of the risks arising from the creation, enrichment, and use of health data is critical to building trust with the people who contribute data, as well as the quality of insights such research generates. We are excited to share our ethical risk diagnosis tool for health data aggregators and users and a library of community-focused intervention strategies to aid in risk mitigation.