Ó³»­´«Ã½

PURPOSE: Standardizing contractual clauses that govern data access enables research institutions to responsibly steward genomic and related health data while enabling its efficient downstream re-use.METHODS: We describe a document analysis study using both qualitative and comparative law analytical approaches to identify the most common categories of clauses from 29 different data access agreements used by human biomedical research consortia globally. We furthermore characterized the legal positions and standard practices for each common element of the agreement and synthesized across them to develop model clauses. Three discussion sessions were organized virtually to refine the clauses among members of the Ethical Provenance Subgroup of the Global Alliance for Genomics and Health.RESULTS: We developed 15 unique data access clauses corresponding to the most common legal elements identified in the sampled agreements.CONCLUSIONS: Model clauses can be used to drive administrative efficiencies and institutional compliance for managing access to human genomic data for research. Additional machine-readable consents and software solutions are needed to support traceable 'ethical provenance' of human genomic data and communicate data use conditions throughout data's life-cycle.