ELIXIR is partnering up with Germany’s TMF (Technology, Methods and Infrastructure for Networked Medical Research) to develop its Ethics policy for the protection, access and management of sensitive data in biomedical research.
ELIXIR’s Ethics policy will provide a framework of ethical and regulatory standards for the provision of sensitive personal data originating from life-science research. Based on relevant regulations and best practices, it will cover ethics committee approvals, data provision and data access, informed consent, confidentiality and data security amongst others.
As part of the collaboration, TMF will conduct a survey of how sensitive biomedical data is made available for research at ELIXIR Nodes. Using the ELIXIR-EXCELERATE Rare disease and Human data use cases, this evaluation will also cover ethical and legal aspects of representative scenarios that may arise in the context of ELIXIR, including for example cross-border data transfer, combination of data sources from different countries.
“Personal genomics and multi-omics data archives are key resources for biomedical research, personalised medicine and the study of mechanisms underlying complex diseases” says Niklas Blomberg, the ELIXIR Director. “However, their use has to follow clear ethical guidelines to maximise research benefit, while acknowledging the responsibilities owed to research participants. ELIXIR’s Ethics policy will ensure that all ELIXIR members and ELIXIR services are aware of their obligations when handling, storing or processing personally identifiable data.”
Murat Sariyar, TMF expert in IT and data protection said: “An increasing amount of health data are now stored in a variety of places including genetic databases that may be accessed relatively easily online. This increases the risk that sensitive medical data can be traced back to an individual. We need to make sure that biomedical data are only available for research projects where a suitable data protection policy is in place.”
Irene Schlünder, TMF legal expert adds: ”Data providers in Europe face a complex and fragmented regulatory landscape concerning legal and ethical aspects of biomedical data. Helping them identify relevant requirements and how they might address them is essential to sharing biological data at European and global level”.
The Policy will be reviewed by Ethics experts on the ELIXIR Scientific Advisory Board before being submitted to the ELIXIR Board for approval. It will then be regularly reviewed to address the latest technological, legal, ethical and societal developments.
TMF (Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V.) was founded in 1999 by the German Federal Ministry of Education and Research as an interdisciplinary institution to support biomedical researchers in meeting the growing legal, ethical, technical and organisational requirements their work demands. It is now one of Europe’s leading institutions in legal, ethical and technological aspects of biomedical research. The portfolio of services ranges from expert opinions, generic concepts, and IT applications to checklists, practical guides, training, and consultation services.
More information: http://www.tmf-ev.de/EnglishSite/
Premysl Velek, ELIXIR Communications and outreach officer, firstname.lastname@example.org