Seminar: Data governance and informed consent

December 11, 2017 11:00 am → December 12, 2017 4:30 pm

European Institute for Theoretical Neuroscience (EITN), Paris, France

Data on patients and research participants, stored in hospitals around the world, provide a valuable resource for research. The Human Brain Project (HBP) hopes to use these valuable health databases for its research on providing more accurate diagnoses and personalized medicine for brain diseases. The data could for example be brain images, previously received therapies, mental evaluation, genetic information, etc. However, such research raises issues of data governance, informed consent, trust and societal values.

In this seminar, leading neurologists, personal data managers, experts in bioethics and patient representatives came together to discuss the challenges setting up and participating in ‘big data’ research as suggested by the HBP. In particular the seminar focused on a discussion of the following questions:

  • Which options exists for obtaining informed consent in big data research?
  • What can we learn from biobanks and brain image databases about data governance?
  • How do we empower of data subjects in ‘big data research’?
  • Which options lies in privacy by design?
  • How can informed consent procedures be improved for unconscious people?
  • How do we balance data protection and informed consent against other societal values?
  • How can we develop standard procedures for collecting and researching on clinical data in big data projects?

The aim of the seminar was to initiate a dialogue between HBP scientists, HBP data managers and external experts and stakeholders, on how to standardize procedures for data governance and informed consent. The outcome of the seminar includes recommendations for the research community and concrete input to the HBP Standard Operating Procedures (SOPs) and data policy manuals.

Outcome of the discussions
Read a summary of the outcome in the brief: Beyond Legal Requirements of Data Driven Research

Participants at the seminar
Invited participants included researchers and ethics managers from HBP, representatives from the HBP Ethics Advisory Board (EAB), representatives from major patient organisations, researchers from biobanks and experts bioethics.

Speakers included Prof. Dr. Josep Domingo-Ferrer (Universitat Rovira, UNESCO Chair in Data Privacy), Mr. Ma’n H. Zawati (Executive Director, Centre of Genomics and Policy, McGill University); Prof. Gunter Schumann (Kings College, Principal Investigator and Coordinator of the IMAGEN project); Dr. Cindy Birck (Project officer at Alzheimer Europe, developer of the Alzheimer Europe database on clinical trials), Prof. Wim Pinxten (Researcher in medical ethics at Hasselt University), Dr. Michele Loi (University of Zürich, Institute of Biomedical Ethics and History of Medicine), Dr. Alberto Rábano (Director, CIEN Tissue Bank).

Practical information and registration
The seminar took place on December 11t, 2017 starting at 12.00 CET and December 12th, 2017 ending at 16.30 CET at the European Institute for Theoretical Neuroscience (EITN), 74 Rue du Faubourg Saint-Antoine, 75012 Paris, France.


The Danish Board of Technology Foundation, led by director Lars Klüver; HBP Ethics Management Group at De Montfort University, led by Prof. Bernd Stahl, both being part of the Subproject 12 (SP12) Ethics and Society of the HBP; European Institute for Theoretical Neuroscience (EITN).


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