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EUCAN-Connect is committed to connecting existing networks via privacy-protecting data-sharing using ‘federated’ analysis infrastructure made stronger through a unique and flexible governance model by design. Within the EUCAN-Connect project, data processing can be considered as having one of three forms or purposes: (1) federated analysis, especially under DataSHIELD, (2), harmonisation of data for federated analysis, and (3) social science data collection and analysis of Ethical, Legal and Social Issues (ELSI). This report describes the integration of ELSI in the governance model and the associated data management and compliance measurements with the required level of data security and privacy integrated for good governance. In particular, this report is concerned with the governance and data management/processing of DataSHIELD.

The European biobanking landscape continues to develop and has become a key resource for biomedical research and innovation. The increasing role of biobanks to improve health and fostering innovation is accompanied by questions about the ethical, legal, and societal impacts (ELSI) of these infrastructures. Researchers and stakeholders in the field of biobanking are facing different social, ethical and legal challenges related to handling and sharing biological samples and health related data. These practices are directly impacted by new technologies and upcoming changes in European law, such as the new EU General Data Protection Regulation (GDPR), which will enhance the rights for data subjects regarding the processing of their personalised data. Improving informed consent is one of the key challenges in this regard, as samples and data may be shared widely between researchers and projects, with new possibilities for data linkage, particularly in the context of growing public-private partnerships within the health industry. This raises questions as to whether, and to what extent participants should be involved in future uses of their biomaterial in an emerging research infrastructure, where the exact purposes of samples collected prospectively are unclear at the time of donation and consent. Hence, the increasing possibilities for research, especially with data, emphasises the need to improve practices of informing and re-contacting participants, and to establish new tools for participant engagement.

Health data collected in cohort studies are valuable sources for knowledge generation and the advance of biomedical research. However, the use of these data for research projects beyond the initial purpose raises several ethical, legal, and societal questions regarding the sensitivity of genomic data sourced from vulnerable and ethnic groups, such as African genetic data and material. Federated data infrastructures have become a key approach to make population-scale genomic and biomolecular data accessible across international borders. While the FAIR principles have become a guiding technical resource for data sharing, legal and socio-ethical considerations are equally important for a fair data ecosystem for further uses of genomic data. The Horizon 2020 project CINECA aims to provide a federated cloud-based infrastructure for the discovery, access, and analysis of human genetic and phenotypic data, based on a virtual cohort of 1.4 million individuals from 10 cohorts in Europe, Canada, and Africa. Beside technical solutions, CINECA addresses and provides valuable experience and input on essential ethical, legal, and societal implications and requirements for transnational health data access, sharing and secondary processing for research purposes.

This how-to guide focuses on addressing general issues relating to governance that are commonly seen as challenge areas, notwithstanding varying regulatory requirements. Indeed, we suggest how biobanks can adequately prepare themselves with regards to develop their own governance structure and networks, including how to facilitate trust that ultimately assist daily operations and sustaining longevity of biobanks., his How-to-Guide to Governance in Biobanking is based on findings from the "Data in Question" survey, which has been supported by the H2020 project ADOPT BBMRI-ERIC (GA 676550), the COST Action IS1303 CHIP ME, the FP7 project RD-connect (GA 305444), the IMI project DO-IT (GA 116055) and Biobank Norway (GA 245464), and a qualitative follow-up study (ongoing) is supported by BBMRI-ERIC.

This deliverable outlines the sustainability plan that allows the continuation of the ELSI Services for all BMS beyond the formal termination of the project. This concerns in particular the ELSI Knowledge Base and Helpdesk. Rather than seeking sustainability via new initiatives, the continuation of services is based on the integration of the needs of the BMS community into the established BBMRI ELSI Services by focusing the existing BBMRI services, ensuring a federated structure to collaborate with national (e.g., MRC/UK) or other RI services (e.g., EATRIS pharmaceutical regulatory support) and promoting them accordingly. In following this strategy, CORBEL aims to avoid a duplication of efforts and remains just to the long-term goal to establish a single-entry portal for the benefit of the users.

This deliverable outlines the sustainability plan that allows the continuation of the ELSI Services for all BMS beyond the formal termination of the project. This concerns in particular the ELSI Knowledge Base and Helpdesk. Rather than seeking sustainability via new initiatives, the continuation of services is based on the integration of the needs of the BMS community into the established BBMRI ELSI Services by focusing the existing BBMRI services, ensuring a federated structure to collaborate with national (e.g., MRC/UK) or other RI services (e.g., EATRIS pharmaceutical regulatory support) and promoting them accordingly. In following this strategy, CORBEL aims to avoid a duplication of efforts and remains just to the long-term goal to establish a single-entry portal for the benefit of the users.

The goal of CINECA is to enable the exchange of population scale health data across international borders to allow and promote the reuse of data for health research. The rationale for sharing and reusing data in public health research is deeply rooted in the promotion of a fair distribution of research risks and benefits, and it has become an essential and powerful tool for public health research. In pursuit of this goal, this deliverable aims to give an overview of all the different ethical, legal and societal issues that the CINECA project might be confronted with: public health ethics, personal data protection, ethics of data sharing, protection of consent and vulnerability as well as compliance issues between Canada, Africa and Europe. It has been elaborated in a bottom up approach, starting from the practical legal and ethical issues encountered notably through Work Package 9 (EC Ethics Requirements). As a basis for the lawful and ethical guarantees for data sharing and reuse within CINECA, all cohorts and consortiums have provided for the copies of their own ethics approvals (Deliverable 9.4), and they are all independently responsible for ensuring researchers accessing data have their own research ethics approval. This deliverable will serve as a starting point for the future deliverable 7.2 which will be aimed at identifying and discussing the gaps in the different legislative or regulatory frameworks and corresponding literature. As a consequence, this deliverable is divided into two main parts, the first one focusing on the collective perspectives of international data sharing in public health research, the second one examining the opposite perspective of the protection of individual data subjects when their personal data is used for secondary processing.

Remaining liberties that GDPR provides to EU Member States, as well as remaining ambiguities on GDPR interpretation, continue to feed debates in the ethical and legal literature. Projects like CINECA, which is seeking to facilitate health data exchanges between cohorts in Europe, Canada and Africa, offer valuable experience and input on essential ethical and legal gaps between countries and cohorts on questions such as the ethical lawful basis for international health data sharing and secondary processing for research purposes. The focus of this deliverable will be on answering, both from a legal and an ethical point of view, two priority questions: How to choose a legal basis for CINECA’s data processing? And how should CINECA apprehend broad consent to further data processing? The goal will be to study how the CINECA project could be efficiently conducted (especially data sharing) while being legally compliant with relevant laws and regulations across all member states, and most of all, being compliant with established ethical guidelines and practices across three continents. To answer these questions we have conducted research which has consisted in reviewing GDPR provisions and their institutional sources of interpretation; the corresponding legal and ethical literature; the National laws relevant for the cohorts involved in CINECA as well as cohorts’ internal governance frameworks and privacy policies when available. We present the arguments surrounding the use of GDPR legal exemptions for data processing for scientific research purposes, why researchers are wary to use it for ethical reasons related to the absence of consent, and the practicalities of the use of broad consent for secondary data processing. We recommend using the research exemption as a lawful basis for secondary data processing; Add broad consent as an appropriate safeguard for data subjects’ rights; Restrict the use of the research exemption to research conducted in the “public interest” as defined by National laws.

The goal of CINECA is to enable the exchange of population scale health data across international borders to allow and promote the reuse of data for health research. The rationale for sharing and reusing data in public health research is deeply rooted in the promotion of a fair distribution of research risks and benefits, and it has become an essential and powerful tool for public health research. In pursuit of this goal, this deliverable aims to give an overview of all the different ethical, legal and societal issues that the CINECA project might be confronted with: public health ethics, personal data protection, ethics of data sharing, protection of consent and vulnerability as well as compliance issues between Canada, Africa and Europe. It has been elaborated in a bottom up approach, starting from the practical legal and ethical issues encountered notably through Work Package 9 (EC Ethics Requirements). As a basis for the lawful and ethical guarantees for data sharing and reuse within CINECA, all cohorts and consortiums have provided for the copies of their own ethics approvals (Deliverable 9.4), and they are all independently responsible for ensuring researchers accessing data have their own research ethics approval. This deliverable will serve as a starting point for the future deliverable 7.2 which will be aimed at identifying and discussing the gaps in the different legislative or regulatory frameworks and corresponding literature. As a consequence, this deliverable is divided into two main parts, the first one focusing on the collective perspectives of international data sharing in public health research, the second one examining the opposite perspective of the protection of individual data subjects when their personal data is used for secondary processing.