Beyond 1 Million Genomes (B1MG) D2.2 Policy document for a genome data sharing initiative

In task 2.2, three policy recommendations were developed, based on existing literature, policy documents and guidelines. Care was taken to develop recommendations specifically for use in a large-scale pan-European research infrastructure. Three policy recommendations were developed:

1: minimal standards for inclusion of special groups of data subjects such as minors, persons not able to consent, vulnerable population groups, minorities, and deceased persons;

2: minimal standards for feedback provision to data subjects;

3: minimal standards on how to deal with incidental findings.

The fourth planned policy recommendation, minimal standards and best practice guidelines for consent forms to allow the use of genomic data in a pan-European genome initiative, was built on ethical best practice and subsequently transferred and combined for the deliverable 2.4, because the recommendations needed to be integrated in the GDPR requirements for a final recommendation on transparency and consent that meets both ethical and data protection best practice.

Below the main recommendations of the policies are described. Full recommendations, including the precise scope, background, considerations, and other relevant aspects, can be found further in this document.