Issue date: Monday 22 September 2003

Joint press release issued by the Wellcome Trust, Medical Research Council and the Department of Health

Ethics and Governance Framework for UK Biobank published for comment

Project's organization and management structure announced

The funders of the UK Biobank project - the Medical Research Council, the Wellcome Trust and Department of Health - have today published for comment a rigorous Ethics and Governance Framework (EGF) that will govern the operations of this landmark project. The document is the first of its kind and sets new standards of ethics and governance in UK science.

This first public draft of the UK Biobank Ethics and Governance Framework was developed with the advice of an Interim Advisory Group (IAG). Chaired by Dr William Lowrance and comprising experts in research ethics, philosophy, law, science and social science, and consumer representation, the IAG advised the funders on the content of the document. In this it took into account views expressed in a series of consultations, which are also published on 24 September.

Upon publication of the EGF, a one-month period will follow, in which stakeholders, members of the public, and scientists involved in the project will be invited to comment. The document will then be revised and endorsed by the funders, before being adopted for the project by the Board of Directors. The Framework will evolve throughout the course of the project, adapting to scientific, ethical, legal and other developments, with advice from an Ethics and Governance Council, the Science Committee and other parties.

Professor John Newton, Chief Executive of the UK Biobank, who has recently been awarded an Honorary Chair in Public Health by the University of Manchester said: "The Framework is intended to put the interests of the participants and the public at the heart of the UK Biobank. The safeguards being proposed go well beyond what is required by law in a number of areas and they set a new standard for ethics and governance in this area - a standard that is wholly appropriate to UK Biobank's status as a flagship project for UK science.

"The project is in the interest of public health and we will be relying on the public's goodwill to make it a success. We will not begin recruiting until we have the right ethical and scientific frameworks in place."

Dr William Lowrance, Chair of the Interim Advisory Group said: "Probably no single point in the Ethics and Governance Framework hasn't been made elsewhere before. What is special about this document is the way it synthesizes all of the points into a comprehensive and logical structure and ties ethics with governance. It is a framework upon which many specifics can be developed, and is a public document. Its effectiveness will depend, of course, on how seriously it is taken in practice. The Interim Advisory Group hopes it will serve well."

The Nobel prize-winning biologist Professor Sydney Brenner said: "Following the Human Genome Project, our next task is to study human genetic variation, moving away from the individual towards the population. By studying the relationship between genes, lifestyle and environmental factors, the UK Biobank will be the future of medical research."

The EGF includes the following features:

• Participation will be entirely voluntary and all participants will have a continuing right to withdraw at any time.

• Consent will require an agreement from volunteers 'to participate in UK Biobank', based on an explanation and understanding of a number of issues, including the purpose of the project, the types of information to be collected, and the safeguards that will be in place.

• Confidentiality will be maintained by keeping all identifying information completely separate from sensitive information, such as health and lifestyle data. This information will only be linked using a code, and only re-linked using a 'key' according to strict safeguards. The number of people with access to the key will be kept to a minimum.

• All researchers, whether from the private sector, charities, or the public sector, will only gain access to the anonymized data if they meet rigorous ethical and scientific criteria, including scientific peer review, approval by an NHS Multi-centre Research Ethics Committee, and review by the UK Biobank to ensure proposed uses are consistent with the UK Biobank's purpose, the participants' consent, and the Ethics and Governance Framework.

• An Ethics and Governance Council will be appointed to serve as an independent guardian of the Ethics and Governance Framework, and to advise the UK Biobank and report publicly on the conformance of its activities with the Framework and with the interests of participants and the public.

Science Committee
The Science Committee, Chaired by Professor John Bell from the University of Oxford, has been established. It is responsible for advising the Board of Directors on the direction and scientific objectives of the UK Biobank and, more specifically, on the scientific protocol. The 17 members, listed in the notes to editors include two members of the Board of Directors, nominees of each of the Regional Collaborating Centres and each of the three funders, the CEO and other experts.

Four UK Biobank Science Committee Sub-Groups have been established to look at the following issues:

• Recruitment (Chaired by Professor Stephen Palmer, University of Wales College of Medicine);

• Questionnaire and Measurement (Chaired by Professor Valerie Beral, University of Oxford);

• Data Management (Chaired by Dr Richard Durbin, Wellcome Trust Sanger Institute);

• Sample Storage (Chaired by Professor Paul Elliott from Imperial College, University of London).

Board of Directors
A Board of Directors, Chaired by Sir Alan Langlands, Principal and Vice Chancellor of the University of Dundee, and former Chief Executive of the National Health Service for England, will act as company directors under UK company law and as Charity Trustees under UK Charity law and will exercise management oversight of the UK Biobank Ltd. The Board will be accountable to Members of the Company (the MRC and Wellcome Trust) and to the Charity Commission for England and Wales. They will have overall responsibility for the direction, management and control of UK Biobank Ltd. The full membership of the Board will be announced shortly.

For more information contact:

Shaun Griffin
Wellcome Trust Press Office
Tel: 020 7611 8612
Mobile: 07710 307059
E-mail: s.griffin@wellcome.ac.uk

Carolan Davidge
MRC Press Office
Tel: 020 7637 6011
E-mail: Carolan.Davidge@headoffice.mrc.ac.uk

Alison Pitts-Bland
Department of Health Media Centre
Tel: 020 7210 5230
E-mail: alison.pitts-bland@doh.gov.uk

Notes to Editors:

1. UK Biobank purpose and overview:
The UK Biobank aims to build a major resource to support a diverse range of research that will in turn improve the prevention, diagnosis, and treatment of illness and the promotion of health throughout society.

The project will follow the health of a large group of volunteers for many years, collecting information on environmental and lifestyle factors and linking these to medical records and biological samples. The samples will be stored so that they can be used for biochemical and genetic analysis in the future.

Data and samples will only be used for ethically and scientifically approved research consistent with the above purpose. Strong safeguards will be maintained to ensure that the confidentiality of the participants' data and samples is respected. Only anonymized data will be made available for research.

UK Biobank will seek active engagement with participants, research users and society in general throughout the lifetime of the resource.

2. The Ethics and Governance Framework and the consultations are published on the UK Biobank website: www.ukbiobank.ac.uk

3. The new headquarters for the UK Biobank coordinating centre, hosted by the University of Manchester, is based on the Manchester Science Park.

4. An initial £61 million will be provided to support the development of the project: £28 million each from the Medical Research Council (MRC) and the Wellcome Trust and £5 million from the Department of Health. In addition, the Scottish Executive have committed £0.5 million to the project.

5. Interim Advisory Group Members:
Dr William Lowrance (Chair), Professor Alastair Campbell, Professor Erica Haimes, Dr Graeme Laurie, Professor Chris Mathew, Professor Jean McHale, Mrs Helen Millar, The Baroness O'Neill of Bengarve, and Mrs Madeleine Wang. Their biographies are available at www.ukbiobank.ac.uk

6. Science Committee Members (biographies available on at www.ukbiobank.ac.uk) are:

o Professor John Bell (Chair), Regius Professor of Clinical Medicine, University of Oxford.

o Professor Valerie Beral, Professor of Epidemiology, University of Oxford and Director of the Cancer Research UK Epidemiology Unit, Oxford.

o Professor Raj Bhopal, Head of the Division of Community Health Sciences, University of Edinburgh.

o Professor Paul Burton, Professor of Genetic Epidemiology and Head of the Genetic Epidemiology Unit, University of Leicester.

o Dr Richard Durbin, Head of the Informatics Division, and Deputy Director of the Wellcome Trust Sanger Institute.

o Professor Paul Elliott, Professor of Epidemiology and Public Health Medicine and Head of the Division of Primary Care and Population Health Sciences, Imperial College.

o Professor Hilary Graham, Professor of Social Policy at Lancaster University.

o Dr Bernard Keavney, Senior Lecturer in Cardiology at the University of Newcastle.

o Professor Dame Jill Macleod Clark, Deputy Dean of the Faculty of Medicine, Health and Biological Sciences, and Head of the School of Nursing and Midwifery at the University of Southampton.

o Professor John Newton; Chief Executive Officer, UK Biobank, and Professor of Public Health at the University of Manchester.

o Professor Stephen Palmer, Mansel Talbot Professor of Epidemiology and Public Health at the University of Wales College of Medicine, and Director of the Health Protection Agency's Division of Chemical Hazards and Poisons.

o Professor Catherine Peckham, Professor of Paediatric Epidemiology, Institute of Child Health, University College London.

o Dr Jill Pell, Consultant in Public Health at Greater Glasgow NHS Board, and Honorary Reader in the Division of Cardiovascular Medicine and Sciences, University of Glasgow.

o Professor Mike Pringle (Deputy Chair), Professor of General Practice and Head of the School of Community Health Sciences in the University of Nottingham.

o Professor Alan Silman, Director of the United Kingdom's Arthritis Research Campaign Epidemiology Unit, University of Manchester, and Professor of Rheumatic Diseases Epidemiology, University of Manchester.

o Professor John Todd, Professor of Medical Genetics at the Cambridge Institute for Medical Research, and Director of the Diabetes and Inflammation Laboratory at the University of Cambridge.

o Mrs Madeleine Wang, Board member of the Northern and Yorkshire Clinical Trials Unit, and lay-member of the General Optical Council, the MRC/Wellcome Trust Joint Steering Committee on Human Developmental Biological Resources, the Northern and Yorkshire Multi-centre Research Ethics Committee and the Royal College of Anaesthetists.

7. The UK Biobank is a major UK-based resource that will be used by the world's top scientists to explore the roles of nature and nurture in health and disease. The project will involve up to 500 000 volunteers, aged 45-69, who will complete lifestyle questionnaires and provide a blood sample for DNA and other analysis. This information, together with their medical histories, will be combined to create an anonymized national database - the UK Biobank. This will serve as a resource for scientists to investigate and determine the factors that cause the common disorders of later life, such as heart disease, cancer, Parkinson's disease, and type 2 diabetes. National and international experts in the field have rigorously and independently reviewed the science of the project, which has the support of a number of leading research charities. It is being funded jointly by the biomedical research charity the Wellcome Trust, the Medical Research Council and the Department of Health.

8. The Wellcome Trust is an independent, research-funding charity, established under the will of Sir Henry Wellcome in 1936. The Trust's mission is to foster and promote research with the aim of improving human and animal health. Website: www.wellcome.ac.uk

9. The Medical Research Council (MRC) is a national organization funded by the UK tax-payer. Its business is medical research aimed at improving human health; everyone stands to benefit from the outputs. The research it supports and the scientists it trains meet the needs of the health services, the pharmaceutical and other health-related industries and the academic world. The MRC has funded work which has led to some of the most significant discoveries and achievements in medicine in the UK. About half of the MRC's expenditure of over £412 million is invested in its 50 Institutes, Units and Centres, where it employs its own research staff. The remaining half goes in the form of grant support and training awards to individuals and teams in universities and medical schools. Website at: www.mrc.ac.uk