Shaping the ethics and governance of UK Biobank and genetic research practices

Heather Widdows’ research on genetic ethics and governance, especially biobanking, began in 2000 it includes a monograph, a co-edited collection and Journal Special Issue, and over ten single and co-authored journal articles and book chapters.

test tubes in a lab

Objectives

Her research takes a concern about genetic ethics and property and the body generally (from 2000 onwards) to a more focused concern for the emerging phenomenon of biobanking and population genetics (from around 2005 and continuing). The research was carried out through individual research and production of papers and chapters – highlighting the inadequacy of current ethical frameworks to address the issues of the genetic era, particularly those which are emerging in biobanking – as well as in collaborative projects.

The key collaborative research emerged from two EC-funded projects.Heather was Principle Investigator of the first project, PropEur (Property Regulation in European Science, Ethics and Law), which focused on alternative models of governance, with a focus on the genome and Co-Investigator on the second project, Tiss.EU (Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union – an Evidence-Based Impact Analysis), and responsible for the theme of ‘biobanking’. Both projects involved stakeholder groups and spanned the theory, policy and practice spectrum. Participants in the project workshops included academics from many disciplines as well as policy-makers, members of NGOs and activists in order to ensure that recommendations and conclusions were as relevant and practical as possible. Appropriate ethics for biobanks, and for genetic data, is a focus throughout this body of work and in the latest publication The Connected Self.  

Research outputs

  • That current frameworks of ethics and governance are inadequate in the genetic era, so too are current ‘gold-standard’ practices of informed consent and confidentiality.
  • That while problematic in general in genetic ethics, consent and confidentiality are particularly problematic when it comes to biobanking. This is for two main reasons: first, consent is ‘one-off’, it cannot address the future-orientated and long-term nature of biobanks second, consent can never meet the criteria for ‘informed’ (as required by policy documents such as the Declaration of Helsinki) as at the time of consent it is not known what research will be undertaken using the participants samples and data.
  • That alternative frameworks such as the ‘Trust’ model (being put into practice for the first time in UK Biobank (UKB)), should be trialled, tested, and amended as possible alternatives to informed consent.
  • That to understand why it is difficult to introduce new frameworks one must understand the dominance of the ‘choice model’ (the reliance on the practice of consent) and the ‘fear of paternalism’.
  • That this research speaks to a current fault-line in contemporary public ethics, that of how to balance individual rights against public goods. For instance the security debate (civil liberties ‘v’ security) and the environmental debate (future generations and sustainability ‘v’ individual freedom). This research questions this dichotomy and suggests if one uses alternative frameworks, such as trust, then there is less conflict between individual rights and common goods.

Impact

The impact of her research is global as biobanks are being developed nationally and regionally and new and appropriate methods of ethics and governance for genetic data and biobanks are required everywhere as informed consent is ineffective for biobanking ethics and governance.

The impact of Widdows’s research is most clearly evident in her appointment and work on the Ethics and Governance Council (EGC) of UKB (2007-2013). UKB is a thirty-year epidemiological study building the world’s largest information and material resource in its area and has recruited half a million UK citizens (c.2% of the 40-69 eligible age group). UKB’s funders include the Wellcome trust, the Medical Research Council (MRC), the Department of Health (DoH), the Scottish Government, the Northwest Regional Development Agency, Welsh Assembly Government and the British Heart Foundation. UKB is the first of its size and type and its significance is attested to by the media coverage it has received. Over twenty features by the BBC and features in most broadsheets, including The Guardian, The Financial Times, Nature and New Scientist.

Widdows' research has had impact in the following ways:

  • In the critique of informed consent for biobanking and genetic research in general.
  • In policy recognition that standard ethical procedures fail in biobanking.
  • In development of new ethical models.
  • In promoting the public good as an ethical justification.
  • In making the public good and public interest key ethical criteria.

Learn more

If you are interested in the work that Professor Heather Widdows undertook in this area you can learn more by contacting her: h.widdows@bham.ac.uk

If this has sparked an interest in studying a course in the Department of Philosophy then you can find information on the Undergraduate, Postgraduate and Doctoral research opportunities on offer from the Department below.