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Ethics of Biomedical Big Data

Ethics of Biomedical Big Data


In biomedical research, the analysis of large datasets (Big Data) has become a major driver of innovation and success. Oxford is at the forefront of the Biomedical Big Data revolution. However, the collection, storage and analysis of biomedical Big Data potentially raises serious ethical problems, which may threaten the huge opportunities it offers. Traditional ethical issues associated with research concerning informed consent and the privacy of data subjects are undoubtedly relevant, being driven to new extremes through the capacity of Big Data analytics to identify novel relationships between data and datasets. Uncertainty over potential uses and consequences of biomedical datasets can foster doubt, hyperbole and stagnation among data subjects, researchers and regulators alike.

The risk is that of a double bottleneck: ethical mistakes or misunderstandings may lead to distorted legislation, which may cripple the usability of Biomedical Big Data in medical research, health care, and industry, as evidenced by a recent Statement issued by the Wellcome Trust on “The impact of the draft European Data Protection Regulation and proposed amendments from the rapporteur of the LIBE committee on scientific research”. As a consequence, there is a widely acknowledged need for a European framework for the ethical use of Big Data in biomedical research.

This project seeks to address this need, encouraging ethically responsible innovative uses of biomedical Big Data across the EU and beyond. The study has three main research objectives:

(1) to formulate a blueprint of the ethical aspects, requirements and desiderata underpinning the project for a European framework for the ethical use of Big Data in biomedical research;

(2) to strengthen and coordinate multidisciplinary research in Oxford in the area of ethical and relevant socio-legal aspects of Biomedical Big Data; and

(3) to consolidate world-leading expertise in the ethics of Biomedical Big Data in Oxford that will enable and support research on large health-related datasets at the Li Ka Shing Centre for Health Information and Discovery and will contribute to the goals of the Strategy for the UK Life Sciences, which aims to improve research outcomes and the attractiveness of the UK as a centre for global research excellence.

On the latter point the project is hosting an ‘Ethics of Biomedical Big Data‘ workshop in April 2015 at the Oxford Internet Institute, which will bring together the expertise of ethicists, Big Data scientists, industry and regulators in discussing issues in this area, with the aim of creating a blueprint for developing a framework for ethical use of Big Data in the future.


The project is funded through a grant from the John Fell Oxford University Press (OUP) Research Fund.

Key Information

  • John Fell OUP Research Fund
  • Project dates:
    October 2014 - October 2015

    All Publications

    Mittelstadt, B.D. and Floridi, L. (eds) (2016), The Ethics of Biomedical Big Data. Springer. ISBN: 9783319335230.



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