JMIR Publications

ABSTRACT

Background:

Personal information, including health related data, may be used in ways we did not intend when it was originally shared. Yet the social license to collect, use, and share data cannot be presumed by organizations and companies that seek it. While some technology companies have published principles on the ethical use of artificial intelligence, the foundational issue of what is and isn’t acceptable to do with data, not just the analytical tools to manage it, has not been fully considered. Nor is it clear whether input from the public or patients has been included. In 2017, the leadership at the online patient research network began to envision a new kind of community compact that laid out what the company believed, how the company should behave, and what it promised both to the individuals that engaged with them and to the community at large. While having already earned a social license from patient members as a trusted data steward with strong Privacy, Transparency, and Openness policies, the company sought to protect and strengthen that social license by creating a socially and ethically responsible contract that went beyond regulatory and legislative requirements and that considered the ethical use of multi-omics and phenotypic data in addition to patient-reported and generated data.

Objective:

A multi-stakeholder working group sought to develop easy to understand commitments that established expectations for data stewardship, governance, and accountability from those who seek to collect, use, and share personal data. The working group set out to co-create a framework that was radically patient-first in its thinking and patient-collaborative in the process of its co-development, reflecting the values, ideas, opinions, and perspectives of the co-creators, inclusive of patients and the public.

Methods:

A mixed methods approach was used that included listening sessions and a 12-question survey embedded into the conceptual frameworks of co-creation and participatory action research. The methodological approaches used by the working group were guided by the combined principles of biomedical ethics and social license and shaped through a collaborative and reflective process with similarities to reflective equilibrium, a method well known in ethics.

Results:

Commitments for the Digital Age are the output of this work. The six commitments in order of priority as determined through the co-creation process are: 1) continuous and shared learning; 2) respect and empower individual choice; 3) informed and understood consent; 4) people first governance; 5) open communication and accountable conduct; 6) inclusivity, diversity, and equity.

Conclusions:

These six commitments—and the development process itself—have broad applicability as models for other organizations who rely on digitized data sources from individuals and patients and who seek to strengthen their policies for the ethical and responsible collection, use, and reuse of that data. Clinical Trial: Not applicable