Autumn 2005 sees the beginning of the second preparatory phase of UK Biobank, the DNA database being set up to identify genetic and environmental factors that impact on human health and disease. As the project gathers pace, there are concerns about the way its ethics will be assured.  Alastair Campbell defends the arrangements, while Sarah Wilson and John Gillott question them.

UK Biobank ethics and governance framework

An innovation in ethics governance, declares Alastair Campbell

A project as massive as UK Biobank presents unique ethical challenges.

Half a million people will be enrolled and the resource could be used for up to thirty years or more.  There are ethical issues throughout, from identification of participants and adequate consent, through security of the data, rigorous assessment of the uses of the resource and procedures for withdrawal.

Following extensive consultation, the funders have drawn up an Ethics and Governance Framework (EGF) – but this alone will not be enough.  Who ensures that the Framework meets the challenges of the project as it develops and that it is fully implemented in the details of the project?  This is where the Ethics and Governance Council comes in.

The Council is an independent body set up following public advertisement and with external assessors on the appointing committee, with members drawn from a range of professional and community perspectives.  Its task is to act as a guardian of the Framework, advise on its revision, and monitor and report publicly on UK Biobank’s conformity with it. This means that the EGF is not merely a statement of good intentions, nor is it a set of purely abstract principles.  It is a working document.

Information and feedback

Two potentially contentious ethical areas are the details to be included in information sheets, given the very broad consent required from participants, and the question of feedback of information to participants at enrolment and later in the project.

In both cases the Council is involved in giving advice and commenting on draft policy documents and protocols.  To carry out its task, it has full access to all relevant committees and documents of UK Biobank, and can request updates on the progress of the project at any time.

Trust is crucial

The central feature of the UK Biobank resource is that it is dedicated to the public good, by providing a rich data set for research into the interactions between genetic, environmental and life style factors in health and disease. Those who enrol in the project are consenting to an unspecified range of research projects, few, if any, of which will be relevant to them directly. This demands a great amount of trust in the project, a belief that their data will be used only for the stated purposes of the resource. The Framework and the Council are key to honouring that trust.

Some have suggested that the Council should have the power to veto projects if they fail to conform to the Framework - a bite as well as a bark. But UK Biobank itself holds the responsibility for ethical stewardship of the resource.   If it fails, the Council will report that publicly – and such loss of public trust will vitiate the whole enterprise. The bark will certainly suffice.

Professor Alastair V. Campbell is Chairman of the UK Biobank Ethics and Governance Council.

Reference
1. The latest briefing on Biobank is at http://www.ukbiobank.ac.uk/news/briefings.php