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The ‘1+ Million Genomes’ (1+MG) initiative, supported by the Beyond 1 Million Genomes (B1MG) project, aims to enable secure access to genomic and corresponding clinical data across Europe to research, personalised healthcare, and policy making. It is a joint initiative of 25 European Countries, the UK, and Norway. Citizen engagement and public trust have been raised as critical components in the B1MG stakeholder forum meetingsand country visits. To discuss these components, an experts workshop was facilitated by the B1MG project.

The '1+ Million Genomes' (1+MG) initiative, coordinated by the Beyond 1 Million Genomes (B1MG) project, aims to enable secure access to genomic and corresponding clinical data across Europe for research, personalised healthcare, and policy making. It is a joint initiative of 24 EU countries, the UK, and Norway. Citizen engagement and public trust have been raised as critical components in the B1MG stakeholder forum meetings and country visits. To discuss these components, an online expert workshop was facilitated on January 18, 2023. 14 Participants were invited to give a short presentation on their lessons learned regarding citizen engagement. They were selected for their expertise in bioethics, ELSI, governance, human genetics, patient representation and citizen engagement. After discussion they formulated recommendations to participating 1+MG countries. Lessons learned from various engagement activities were shared under three subthemes: “When an ELSI framework is in place, what is the (additional) role of citizen engagement in fostering data sharing and public trust?”; “How does citizen engagement relate to (interests of) other stakeholders?”; “When and how to engage and at what level?”. It was discussed that citizen engagement can have a diversity of aims that may help create preconditions for accountable research and trust. ELSI or trustworthiness frameworks don’t necessarily lead to participants having trust in an institution. The addition of citizen engagement can help build and contribute to trust. Engagement activities are situated in context with potentially conflicting interests, power differences and priorities, for instance between publicly accountable researchers and private companies. While data sharing involves international collaboration, trust is relational and context specific and dependent on many factors including the relation to the professionals or institutions asking for data sharing and trust. The tools used for citizen engagement vary for different contexts and goals. If engagement starts at the beginning of a project, there are more options to influence choices and policies. Recommendations (See D1.7) stress the need for dedicated resources; acknowledging different views and interests; the need for capacity building to enable engagement; creating meaningful participation via selected tools through early engagement with a careful choice of engagement strategy; having good and transparent governance for enabling trustworthiness to contribute to accountability; and the need to find ways to connect the relational trust established at the national level to the EU level. Health care professionals and professional organisations, particularly in the field of medical genetics, can play an important part in informing and engaging with citizens and patients and building trust. Citizen engagement needs sustained resources and attention across projects and national and EU initiatives. Trust depends on citizens and patients, so a trustworthy data sharing infrastructure needs transparent governance to consider and incorporate citizen views.

The Beyond 1 Million Genomes (B1MG) project aims to facilitate the 1+MG initiative to provide access to genomics data and associated health data across borders and drive the development of personalised health strategies within Europe. The 1+MG/B1MG Stakeholder Forum 2022 held in October 2022, assembled for the third time a broad range of stakeholder experts, active in scientific and technical communities, international initiatives, projects, national healthcare systems, as well as industry to capture their input in the design of the infrastructure, the legal guidance and the best practices to realise the 1+MG infrastructure. Being the last Stakeholder Forum (SF) organised by the B1MG project, this meeting centred on identifying how stakeholders could contribute to the scale up and sustainability of the 1+MG/B1MG efforts. The day included key updates on the progress of 1+MG/B1MG, specifically on the 1+MG Trust Framework (focussed on the ELSI and technical recommendations and guidelines for privacy-preserving access to genomics data), and including the B1MG Maturity Level Model as a tool for countries to assess progress towards implementation of genomics-based personalised health strategies into healthcare. This was then followed by a session on the next steps towards scale-up and implementation of the genomics data-sharing landscape by speakers from the recently established (1+MG-associated and EC-funded) Genomic Data Infrastructure (GDI) project, TEHDAS/EHDS and GAIA-X. Acknowledging the role of industries in the scale-up and sustainability of these efforts, the day specifically included several ways to explore the role of companies as key stakeholders in realising cross-border genomic data sharing efforts and in developing a practice of genomics-based personalised health in 1+MG associated countries. A dedicated panel discussion included representatives from 1+MG WG7 (industry engagement), an umbrella industry organisation (EFPIA), an SME (Hyve - EHDEN project), as well as Australian Genomics, an initiative outside of Europe that has considered industry as part of their genomics activities. Clear recommendations were made to build a continuous exchange with industry to build mutual trust between public and private stakeholders. Further to this there was a proposal to explore the opportunity to establish a set of projects, such as under the framework of IHI. This clear output from the SF meeting should be explored further by the 1+MG initiative. The second half of the day led into parallel workshops to consider scale up and sustainability in the context of rare diseases, cancer, common complex disease and infectious disease. The Trust Framework was regarded and the user communities addressed the question how stakeholders, including industry, could help realise these key components of the 1+MG infrastructure. It is clear that there are requirements specific to each disease community that are important to continuously review, discuss and understand in order to develop and sustain the 1+MG Trust Framework. The balance between how much research and care are entangled differs across use cases (rare diseases and cancer breakouts are already intertwined) and discussions stressed how the 1+MG infrastructure must be able to support primary and secondary use equally well. The annual Stakeholder Forum meetings run by the B1MG project have all been very successful. They have strengthened the alignment of the stakeholders with the 1+MG initiative, enabling the leads of various activities to take on board suggestions and ensuring the outcomes of the project fit with stakeholder needs, encouraging innovation and alignment across a broader landscape. To continue stakeholder engagement and ensure further impact, these events will be continued as part of the GDI project.

Gaining the trust of patients, healthcare practitioners, research participants and society at large is paramount for data sharing in genomics and health. This requires involving different stakeholders to take into consideration different national contexts, as well as cultural and societal differences to build informed policies and implement genomics practices in health and research. To this end, the B1MG WP1 efforts are geared towards increasing the engagement, awareness and alignment of the different stakeholders involved in the genomics-based research and healthcare landscape within Europe. This involves bringing together and aligning efforts between the scientific and technical communities, international initiatives, and projects as well as national healthcare and research systems. As a part of the WP1 tasks, this report describes the online Stakeholder Forum (SF) that was conducted on the 17th of November 2021 (SF 2021). The primary role of this SF was to strengthen the alignment of B1MG stakeholders with the 1+MG initiative. In particular, the central theme of the SF was the 1+MG Trust Framework. This framework brings together the specific recommendations, guidelines and best practices that can be used to realise the 1+MG vision. Its core components are related to ELSI and data governance aspects, data standards for quality and interoperability in genomics data access and to the infrastructure components for cross-border access to genomics and related health data. The SF 2021 brought together over 280 members from the various stakeholder communities registered on the B1MG Stakeholder portal in a full day virtual meeting. The morning session introduced the different elements of the 1+MG Trust Framework and set the stage for the day. The afternoon session was split across six parallel sessions, where the components of the Trust Framework were explored from the perspective of use cases. While four of these sessions included the 1+MG disease use cases - Rare disease (WG8), Cancer (WG9), Common and Complex disease (WG10) and Infectious disease (WG11), two sessions gathered recommendations for 1+MG from the perspective of Industry (WG7) and the Genome of Europe (WG12). Throughout the day, the attendees engaged in specifically evaluating the common pitfalls and gathering recommendations around ELSI, data standards, and infrastructural requirements, which they confirmed are the three priority aspects to cover in the 1+MG Trust Framework. The SF has proven to be an excellent instrument to capture the broad expert input from a large group of stakeholders to formulate recommendations to strengthen the work towards realising the 1+MG ambitions. Holding this meeting virtually gave the benefits that many stakeholders could join and participate at this early stage in the project. This report describes the various sessions and summarises the recommendations to 1+MG. The recommendations have been shared with colleagues in the 1+MG working groups on ELSI, standards and infrastructure soon after the SF and have since been taken up by these teams together with the coordination team to seed the design of the further roadmap for the 1+MG working groups.

B1MG First Stakeholder meeting - 16th October 2020 - agenda and slides

The B1MG stakeholder coordination portal aims to efficiently deliver timely analysis of challenges, opportunities and solutions resulting from external stakeholders to the operational WPs. Developed by WP1 in close relationship with the communication and coordination teams (WP6), it delivers tools and defines workflows to de-risk and improve the flow of data generation and integration towards patients. These tools will help reduce cross-border barriers, and facilitate the development of operational pipelines based on the integration of genomic and health data. The stakeholder portal allows the users to share contact information and develop a network within the B1MG project. People are organised in groups that reflect the stakeholder clusters with the possibility of users to create transversal sub-communities. The portal functionalities facilitate community participation and engagement, communication and collaboration and documents sharing and management. This allows the creation of a vibrant community, organised and focused, that can collaborate in an effective and advantageous way for improving the project outcomes.

The “1+ Million Genomes” (1+MG) initiative is a cooperation mechanism involving by now 24 countries and was launched on Digital Day 2018. Countries meet on a regular basis in order to make sure that the aim of the 1+MG Declaration - to have at least 1 million sequenced genomes accessible in the EU by 2022 - is achieved. Genomics has the potential to revolutionise healthcare in many ways. It could lead to the development of more targeted personalised medicines, therapies and interventions. It could also enable better diagnostics, boost prevention and make more efficient use of scarce resources. From cancer, to rare diseases, neuro diseases and prevention, genomics can greatly improve health conditions of EU citizens. Equally important, genomics has the potential to improve the effectiveness, accessibility, sustainability and resilience of health systems in the European Union N/A

B1MG WP1 facilitates the engagement of stakeholders in the field of genomics-based health in the B1MG project and 1+MG initiative. Priority of the overall stakeholder engagement process in B1MG is to involve key stakeholders in the essential workstreams organised as part of the B1MG Work Packages (WPs) and their corresponding 1+MG Working Groups (WGs). Stakeholders are (experts of) organisations of a variable nature and scope, and B1MG chooses to organise their involvement at multiple levels. Stakeholders are here defined as European/international, national and regional organisations and individuals active in and/or interested in the development and implementation of genomics-based health in national and regional healthcare systems. In particular, B1MG addresses stakeholders that have the expertise and capacities to play a role in the European 1+MG Initiative and are committed to realising the key goal of the 1+MG initiative: the ability to make genomics and related health data accessible across borders for trans-national use in research, diagnostics and/or innovation of healthcare. The B1MG stakeholder organisation arranges for a general Stakeholder Forum, bringing together all stakeholders engaged in, or interested in the 1+MG initiative. Stakeholder Forum meetings are held once per year, co-organised with leads/teams of all B1MG WPs/1+MG WGs to discuss the progress in the project and 1+MG initiative. The WP1 team will co-organise, facilitate and report on the outcome of these yearly meetings in yearly reports. Through a dedicated Stakeholder Portal arranged through WP1 in close collaboration with WP6 (technical implementation), B1MG arranges for a central communication channel with stakeholders on matters dealt with in the B1MG operational work packages. Experts of stakeholder organisations are invited to register to allow access to the portal, granted upon WP1 approval. All WPs of the B1MG project use the portal to inform and consult stakeholders in the design of scoping papers, recommendations, guidelines and other output. B1MG facilitates the participation of (experts of) selected stakeholders in workstreams organised in the B1MG project WPs and corresponding WGs of the 1+MG initiative. In addition, a limited selection of specific stakeholder Partner Projects is engaged. These projects have important capacity and ongoing work that fully aligns with the 1+MG/B1MG ambitions. Only projects that can actively contribute to the workstreams organised in the 1+MG initiative and are committed to help realise the 1+MG goals can become B1MG Partner Projects. Stakeholders are also involved in addressing the overarching subject of citizen trust and public engagement, crucial for the implementation of genomics-based health strategies across Europe. B1MG WP1 facilitates the B1MG process to establish recommendations to realise citizen engagement and build citizen trust across 1+MG., B1MG has received funding from the European Union's Horizon 2020 Research and Innovation programme under grant agreement No 951724

B1MG Stakeholder Coordination Group Portal goes live https://b1mg-project.eu/news-events/, B1MG has received funding from the European Union's Horizon 2020 Research and Innovation programme under grant agreement No 951724

Es besteht dringender Bedarf, die Infrastruktur für die Nachnutzung wissenschaftlicher Daten zu verbessern. Verschiedene Stakeholder aus Hochschulen, Industrieunternehmen, Forschungsförderern und wissenschaftlichen Verlagen haben sich zusammengeschlossen, um gemeinsam einen präzise gefassten Satz von messbaren Prinzipien zu formulieren und zu unterstützen. Diese Prinzipien, die wir als FAIR-Data-Prinzipien bezeichnen, sollen als Leitlinie für die Verbesserung der Nachnutzbarkeit von Datenbeständen dienen. Im Unterschied zu Peer-Initiativen, deren Fokus auf menschlichen Wissenschaftler*innen liegt, richten die FAIR-Prinzipien ein besonderes Augenmerk darauf, Maschinen das automatische Auffinden und die Verwendung von Daten zu erleichtern und somit eine Wiederverwendung durch Menschen zu unterstützen. Dieser Kommentar stellt die erste offizielle Veröffentlichung der FAIR-Prinzipen dar. Er beinhaltet die ihnen zu Grunde liegenden Überlegungen und beispielhaft einige exemplarische Implementierungen innerhalb der Community. Die vorliegende deutsche Übersetzung des Dokuments entstand im Rahmen des Verbundprojektes EcoDM mit der Förderung des Bundesministeriums für Bildung und Forschung (BMBF) unter dem Förderkennzeichen 16DWWQP.