International flagship collaboration with Canada for human data storage, integration and sharing to enable personalised medicine approaches

To build a collaboration of stakeholders in Europe and Canada in the domain of repositories storing and sharing human –omics data that will create a framework for long-term cooperation. In order to do so, this programme aims to enhance and standardise data deposition, curation and exchange procedures thus ensuring better data reuse and increased benefit to the scientific communities worldwide. The selected projects should build on the data quality metrics, standards and access policies developed by major international initiatives (e.g. IHEC, ICGC[[https://dcc.icgc.org/]], IHMC[[http://www.human-microbiome.org/]], MME[[http://www.matchmakerexchange.org]]).

Considering the existing data policies, projects should develop approaches that integrate data from disparate sources and include one or more of the following elements:

• Data models that guarantee the interoperability of human health research data from different repositories and integrate different types of –omics data and, where relevant, clinical research and lifestyle data. The data models should take into account sex/gender differences where relevant. The projects should build on existing research infrastructures such as –omics repositories, biobanks and registries.
• Reference architecture for data and process interoperability.
• Technologies and methodologies for data harvesting, data access, data transfers, and archiving complex datasets.
• Bioinformatics toolbox to support the analysis and management of data on diseases from a personalised medicine standpoint.
• International ethical and legal governance model for a research data management and storage infrastructure and an associated data management plan compliant with the required level of data security and privacy that is aligned with the recent recommendations of the OECD Council on Health Data Governance[[https://www.oecd.org/health/health-systems/Recommendation-of-OECD-Council-on-Health-Data-Governance-Booklet.pdf]].

This topic raises important issues of data sharing, privacy protection, informational right to self-determination and data security, which should be addressed from a legal, ethical as well as a social sciences perspective. It is important that proposals enable sustainable, collaborative projects and ensure cross-references with existing infrastructures (e.g. BBMRI-ERIC, ELIXIR) and other on-going initiatives (e.g. International Consortium for Personalised Medicine[[http://www.icpermed.eu/]] European Open Science Cloud[[https://ec.europa.eu/research/openscience/pdf/realising_the_european_open_science_cloud_2016.pdf]] IHEC, etc.). Synergies should be sought with other projects (e.g. calls under the Innovative Medicines Initiative (IMI)[[https://www.imi.europa.eu/content/imi-2]] and running IMI projects[[ETRIKS: https://www.etriks.org/, EMIF: http://www.emif.eu/, OPEN-PHACTS: https://www.openphacts.org/]]). The proposals should take stock of the BBMRI-ERIC Code of Conduct for using personal data in health research. A multidisciplinary approach, i.e. involving clinicians, biologists, bioinformaticians, etc., is considered a key aspect of successful proposals. Due to the specific challenge of this topic, in addition to the minimum number of participants set out in the General Annexes, proposals shall include at least one participant from Canada.

The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting different amounts. In addition to the EU/Associated Countries and Canada, the proposed project consortia may include other international partners. SME participation is encouraged.

The EU has ample experience in building and running data repositories to support biomedical research. Notable initiatives are ELIXIR[[the pan-European infrastructure for life sciences data https://www.elixir-europe.org/]] and the European Genome-phenome Archive[[https://ega-archive.org/]], storing many types of data up to the population-wide level. Similar expertise exists in Canada notably via IHEC (International Human Epigenome Consortium[[http://ihec-epigenomes.org/ and http://ihec-epigenomes.org/about/policies-and-guidelines/]]) and its Data Portal[[maintained at the Montreal Neurological Institute http://epigenomesportal.ca/ihec/]] as well as PhenomeCentral, a repository for clinicians and scientists working on human rare disorders[[http://www.phenomecentral.org]].

There is a recognised need for tools that allow researchers to manage, exchange and preserve their data efficiently. Data repositories are scattered around the world and often do not use compatible data standards. There is a pressing need for better integration of public repositories, coordinated data sharing and sustainable storage of high value data. Apart from hardware and maintenance costs, the cost of data curation, a necessary element to foster progress in biology and medicine, also needs to be considered.

• Intensified sharing, reuse, collaboration and knowledge discovery in the health field, while ensuring legal safety on the use of the data.
• Integration of various health and disease data in data-intensive fields such as personalised medicine.
• More efficient research through reduced duplication of experimentation.
• A network of research infrastructures and databases in the EU and Canada that build synergies between ongoing activities, contributing to delivering the backbone for new discoveries that address the Societal Challenges delineated in Horizon 2020[[https://ec.europa.eu/programmes/horizon2020/en/h2020-section/societal-challenges]].
• Strengthened position of the EU and Canada in science and more collaboration between academia and industry resulting in more innovation, jobs and growth.
• Contribute to the Digital Single Market through piloting IT health research solutions.
• Further the “Open science” and “Open to the world” priorities and contribute to the Health Research and Innovation Cloud, one of the thematic clouds of the European Open Science Cloud.