B1MG D2.1 Report of ELSI Stakeholder Meetings

Abstract

The 1+ Million Genomes (1+MG) initiative aims to enable secure access to genomics and the corresponding clinical data across Europe for better research, personalised healthcare and health policy making. The Beyond 1 Million Genomes (B1MG) project was funded under the Horizon 2020 Framework Programme (duration: June 2020-May 2023) with the objective to establish the support and coordination structure for the 1+MG initiative. More recently (November 2022), the Genomic Data Infrastructure (GDI) project was funded to build upon the work carried out in 1+MG and B1MG and provide the data infrastructure that will enable secure access to genomics and corresponding clinical data across Europe. A major challenge for 1+MG, B1MG and GDI is addressing adequately the Ethical, Legal, and Social Implications (ELSI) of genomic and health research and translating them into technical specifications and implementation guidelines that capture European best practice. Stakeholders, defined as individuals, groups or organisations who may affect, be affected by or perceive themselves to be affected by a decision, activity, or outcome of a project can play a crucial role in the success of a scientific project for reasons such as helping to solve arising problems, achieving goals, increasing the availability of resources and improving the quality of products, services or outcomes. The B1MG project since its kick-off involved different groups of key stakeholders (patient organisations, HTA bodies, academics, national policy and decision makers, Research Infrastructures, clinicians and medical specialists, medicines authorities, industry, funders, EU Joint Actions) through annual B1MG Stakeholder Forum meetings, the creation of an interactive B1MG stakeholder portal, expert stakeholder consultation through regular meetings and workshops etc. The present report describes the identification and prioritisation of stakeholders from the B1MG WP2 “ELSI” perspective and summarises the different meetings and consultations that took place for the period June 2020-December 2022. The mapping exercise of WP2 resulted in an internal project inventory of more than 100 ELSI stakeholders, several of which were invited to engage with the project through the WP2 sessions in the annual B1MG Stakeholder Forum meetings, thematic workshops or their inclusion to the monthly B1MG WP2/ 1+MG WG2 meetings. In addition, several members of the B1MG WP2/1+MG WG2 have participated in meetings of other European projects and initiatives as stakeholders, advisory board members or invited speakers, ensuring knowledge transfer and alignment.

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