Beyond consent and anonymity in the big data era

Markus Labude1, Dr Vicki Xafis1, Dr Wendy Lipworth2, Dr Tamra Lysaght1, Dr Owen Schaefer1

1Centre for Biomedical Ethics, National University of Singapore, Singapore, Singapore, 2The University of Sydney, Sydney Health Ethics, Faculty of Medicine and Health, Sydney, Australia

The proposed workshop will explore the moral justifiability of waiving the requirement for informed consent for health research using existing “Big Data” resources (such as electronic health records, genomic databanks, pharmacovigilance surveillance systems and social media data). While consent waivers are often justified by the need to ensure the free flow of information and to further the ‘public good’, there is also concern that they fail to protect research participants and to respect individuals’ right to self-determination. Matters are made more complex by the impossibility—in the Big Data era—of promising that data will remain anonymous.

The workshop relates to the conference theme of Changing Paradigms with its exploration of alternatives to traditional informed consent models and it picks up the theme of Collapsing Borders with it discussion of how data from healthcare practice is used for research. The workshop will be convened under the auspices of an international Working Group of scholars from Singapore, Australia, New Zealand and the United Kingdom, which is developing a Framework for Big Data Ethics in Health and Research.


Biographies:

Vicki Xafis is a Senior Research Fellow at the Centre for Biomedical Ethics, National University of Singapore, leading the NMRC-funded SHAPES (Science, Health and Policy-relevant Ethics in Singapore) initiative. She has a background in bioethics, linguistics, education and research. Vicki has considerable professional expertise in research & clinical ethics and has recently moved to Singapore to join the SHAPES Team. In addition to interests in areas of clinical ethics, Vicki has an interest in big data ethics, privacy, consent, and research ethics.

Wendy Lipworth is an Associate Professor of Bioethics at Sydney Health Ethics at the University of Sydney. Her program of research focuses on the ethics and politics of biomedical innovation, with a particular focus on 1) research using databanks and real world evidence 2) access to “unproven” interventions and 3) commercialisation and (financial and non-financial) conflict of interest. She uses a combination of empirical and theoretical research methods understand stakeholders’ perspectives and contribute to policymaking and practice.

Owen Schaefer is a Research Assistant Professor at the Centre for Biomedical Ethics, National University of Singapore, working under the NMRC-funded SHAPES (Science, Health and Policy-relevant Ethics in Singapore) initiative. He received his DPhil in Philosophy from Oxford University, and has completed fellowships at the National Institutes of Health’s Department of Bioethics and the Oxford Centre for Neuroethics. His primary interests lie on the ethics of developing novel biomedical technologies.  He has written on big data, research ethics, the obligation to participate in research, human enhancement, gene testing and editing, assisted reproduction and in vitro meat.