RD-Connect puts the spotlight on data sharing and patient consent
A stakeholder conference for EU project RD-Connect took place in Brussels in October 2013, and EURORDIS, as co-organiser, ensured that the patient’s perspective was well represented via the project’s Patient Advisory Council (RD-Connect PAC), made up of EURORDIS member patient association representatives. Coming at a time when data protection is being hotly debated at the European level, the two-day event put the spotlight on data sharing and consent.
The stakeholder conference sought to reach a consensus between the protection of patient privacy and confidentiality of data on the one hand, and the need for data sharing and pooling as a research priority – especially in the field of rare diseases where patient populations, resources, knowledge and expertise are scarce and scattered – on the other. Participants discussed what kind of consent model would best protect patients’ rights while encouraging research to move forward. One conclusion participants agreed to was the need for strong, adaptive governance for data-sharing initiatives in order to ensure that patient data are handled responsibly. Strong custodianship at the outset helps guarantee that patient data are appropriately and responsibly shared.
The RD-Connect PAC, operating via the project’s Work Package 6 on ethical, legal and social issues, is responsible for ensuring that the project be “patient-centric”. A capacity-building workshop preceding the conference focused on the patient perspective in data sharing and other key issues. EURORDIS Registry and Biobank Projects Manager Anna Kole presented the preliminary outcomes to the larger group. These statements will be refined throughout the project and serve as a basis of important principles to include in the ethical and regulatory framework guiding data sharing activities in RD Connect, as well as the EURenOmics, and Neuromics projects. EURORDIS will extend the consultation of patient expectations to all its members throughout the duration of the project through surveys, ad hoc consultations, and workshops during membership meetings.
RD-Connect launched in November 2012 as a six-year project funded by the EU Seventh Framework Programme under the International Rare Disease Research Consortium (IRDiRC). As an integrated platform connecting databases, registries, biobanks, and clinical bioinformatics for rare disease research, RD-Connect is developing a global infrastructure for sharing outputs of research projects, starting with the EURenOmics project focusing on the causes, diagnostics, biomarkers, and disease models for rare kidney disorders, and the Neuromics project that will use next generation whole exome sequencing to increase genetic knowledge of rare neurodegenerative and neuromuscular disorders.
RD-Connect represents an opportunity to arrive at a common position in a new era of research where expectations of all stakeholders, including patients and their representatives are not fully mature. It is hoped that the eventual data protection legislation in Europe will also meet patient expectations for obtaining the necessary balance that respects patients’ rights while allowing a robust research environment to flourish. EURORDIS organised a luncheon-debate at the European Parliament to discuss the potential impact of the legislation on rare disease research, prior to voting by the Committee for Civil Liberties, Justice and Home Affairs (LIBE) of the European Parliament that took place on 21 October. The LIBE committee overwhelmingly voted in favour of the new data protection regulation, paving the way for the rapporteur Jan Philipp Albrecht (Greens, Germany) to begin negotiations with the Council and the Commission to try to reach a common agreement on the Data Protection package before the European elections in May 2014. The amendments agreed to by the LIBE Committee need to be scrutinised ahead of the vote in plenary scheduled for December 2013 as at this writing it is still not clear what impact the new legislation will have on health and medical research.
Louise Taylor, Communications and Development Writer, EURORDIS