Public Health Significance. The Global Alliance for Genomics and Health: Setting the Standards for Genomics and Health-Related Data Sharing aids genomic research and human health by developing standards and policies for effective and responsible data sharing between institutions and countries around the world. In line with the policy development and technical tool-building spirit of the GA4GH, this administrative supplement will advance the novel concept of ethical provenance in human genomics. It will create a new Ethical Provenance Subgroup of the GA4GH dedicated to helping biomedical researchers consistently record, update, and activate the conditions of ethical data reuse of genomic and related health data in ways that respect the values and interests of individual data contributors and communities.

Project Narrative The Global Alliance for Genomics and Health (GA4GH) was founded on modest goals of developing technical standards and policies for sharing human genomic and health data. It has since catalyzed a social movement that recognizes data sharing as the bedrock of genomic science, as well as a conduit for narrowing research inequities. The first wave of this movement substantiated the scientific value of data sharing, while the second wave currently underway must distribute the social benefits of data sharing more equitably across global populations. We can only make progress on this mission when individual and community values are communicated and respected. However, it is increasingly difficult to establish what rules govern which singular datasets based on how the data were permissioned in the first place. Many research institutions adapt their own data access, use and transfer agreements which heighten administrative and compliance burden without measurably improving participant engagement in downstream data reuse and sharing decisions. The goals of this administrative supplement are therefore to guide data sharing policy as well as develop software solutions that enable biomedical researchers to record, compare, and update the conditions of ethical use throughout the full data lifecycle. A new Ethical Provenance Subgroup of the GA4GH will be formed to undertake this work. The EPS is comprised of a talented international team of bioethicists, lawyers, data privacy/protection experts, software engineers and genomic researchers who will collaborate on the following specific aims: (AIM 1) Explore normative values and professional norms underlying ethical provenance in human genomic and health data sharing; (AIM 2) Develop model data access and sharing agreements by extracting common clauses used across GA4GH Driver Projects; (AIM 3) Build software that integrates standardized data access agreement clauses to support machine-readable tracking of ethical provenance. We expect our innovative approaches to policy-, capacity- and tool-building related to ethical data provenance will help the GA4GH sustain its reputation as a trustworthy leader in the genomics community for responsible data reuse.