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The Minister of State, Department of Health (Mr. John Hutton): I am grateful to my hon. Friend the Member for Norwich, North (Dr. Gibson) for giving me the opportunity to confirm the Government's commitment to the UK Biobank project and answer the important points that he has raised during this short debate. He has extensive knowledge of the issues raised by the research project, and he has demonstrated that expertise very ably and effectively tonight.
My hon. Friend has asked specific questions and thrown down the gauntlet to the Department of Health and the Government over the conduct of the project, which,
My hon. Friend has accurately explained many of the details of the project and I do not intend to go over them again. Biobank is a flagship project for the UK. As I am sure he understands, it will take time and significant investment before the potential benefits are realised, but I have absolutely no doubt that the project is in a crucial area of research that holds out the prospect of real advances in medical science. Many devastating disorders including heart disease, cancer, diabetes and Alzheimer's disease are caused by complex interactions between genes, environment and lifestyle. Information from the Biobank study could ultimately lead to improved diagnosis, treatment and prevention strategies for those disorders, thus benefiting millions of people in the UK and around the world.
The UK Biobank project is to be jointly funded by the Department of Health, the Medical Research Council and the Wellcome Trust. The initial cost of the project will be £45 million, of which more than half will be provided by the Government. Biobank is a major scientific research programme. For the reasons spelled out by my hon. Friend, it is probably one of the most exciting and potentially significant projects to be commenced in the UK for many years.
The project itself has been through a long planning process which started in 1998; the final funding decisions were taken in April this year. I accept that the process has been lengthy, but that is in large part due to the number of necessary consultations undertaken with both the scientific community who will use the resource and the general public. I understand from his arguments that my hon. Friend is generally in favour of such consultation. I hope that the process followed will help to establish a consensus on the future direction of the project. Such a consensus is important and will be of genuine benefit to the research project as a whole. None the less, concerns have rightly and properly been expressed about the project by several organisations, as well as by my hon. Friend tonight. I assure him that the Government will continue to work positively to address those concerns.
My hon. Friend raised concerns about the project design and methodology, and in particular about the selection criteria for volunteers. He asked that a clear framework for the project should be worked out in consultation with all the experts. I can tell him that that has been done. A committee of experts under the chairmanship of Professor Tom Meade produced the final project protocol, which was made widely available to the scientific community for it to comment on during its development. The protocol was then extensively and independently reviewed by a number of international expertsnot politicianssome of whom were from abroad, but all of whom had no prior involvement in the development of the protocol. That peer group judged the
My hon. Friend asked for clear leadership from the Department of Health in taking the project forward. I can certainly confirm that that will be provided. The Department of Health has been actively engaged in the creation of the UK Biobank and in shaping its programme. We will also maintain general management oversight of the project as one of its key funders.
There are at least two areas in which we have a major interest. They relate to the concerns already mentioned by my hon. Friend regarding the need to protect people who provide DNA samples and to maintain the public's confidence in the project itself. As he said, recruitment to the Biobank will be co-ordinated mainly through GP practices and, as he knows, it will be entirely voluntary. Participants will be free to withdraw from the study at any time. If a person wants to withdraw from the research programme, all their personal information and samples will be removed from the database.
I should like to make one point very clear to my hon. Friend. The Biobank will be used for research purposes only. Any data released to research workers will be properly anonymised and free of any identifiable markers. The Biobank will operate according to the relevant ethical and legal guidelines regarding the use of human tissue, biological samples and genetic information. It will also operate in accordance with the Human Rights Act 1998, the Data Protection Act 1998 and the Council of Europe's recommendations on the protection of medical data.
Those are important safeguards, but security and confidentiality of data are key issues that are rightly a matter of continuing concern. The Human Genetics Commission, the Government's independent advisory body on human genetics, has rightly taken a close interest in the project and has indicated that it will continue to do so. We welcome its continued involvement. As my hon. Friend will be aware, the commission has recently undertaken an investigation into the use of personal genetic information and how security and confidentiality of data held within databases can be properly maintained. It recommended that genetic research databases that are established for health research should not be used for any purpose other than that research, and also that that should be put beyond doubt, by legislation if necessary. The Government are considering very carefully the implications of that recommendation and will respond later this year.
Providing independent oversight of the project by a trusted third party offers a further way not only of providing protection for people taking part in the study, but of gaining the public's trust in the project. An organisation that has a clear legal identity will be needed to achieve that. The current thinking is that that should be provided through the creation of a new limited company with a power of veto over the research conducted using the Biobank resource that is enshrined in its articles of association and incorporation. I agree with my hon. Friend that the chairman of the board will need to be someone who can command the public's full trust and confidence. It is planned to appoint the chairman and all other board members in a transparent way using the full Nolan procedures and principles.
My hon. Friend asked about the role of the proposed monitoring body. It will be responsible for the development, application and monitoring of policies on access to data and samples, in accordance with the consent obtained from the participants. It will also be responsible for ensuring that the samples and data are all held securely and that all procedures to protect confidentiality are strictly adhered to. It will not provide ethical review of the initiative or its constituent projects, as that will be done through the system provided by multi-centre research ethics committees. Equally, it will not scrutinise the scientific quality of the research that is being undertaken, as that will be the remit of a separate scientific management committee. The monitoring body will exist solely to represent and protect the interests of the participants and the general public. We perceive its independence, authority and credibility as crucial to the success of the Biobank. We place the highest importance on that success.
The more general management of the project will involve creating a separate organisation responsible for establishing and using the database. Like the monitoring body, that organisation will need to have a separate legal identity and will again be incorporated as a company limited by guarantee. It will control the operation of the regionally distributed groups that will be recruited to collect the baseline dataset from participants and carry out the initial processing of blood samples.
The ability efficiently to link a participant's medical records with genetic and lifestyle data is clearly an important part of the study. That will necessitate developing both the infrastructure and the methodology needed to obtain access to NHS records. I acknowledge that that will be a significant challenge, and we do not underestimate it.
The information technology requirements for the UK Biobank will need to be fully integrated into the overall NHS information systems that are being developed. The method for doing that has not been finalised but the Biobank project offers an opportunity to pilot new methodologies whereby valuable clinical data held by the NHS in patient records can be utilised effectively to support wider, essential public health research.
My hon. Friend asked for a full public and parliamentary debate to discuss the issues raised by the UK Biobank project. As he would acknowledge, that is a matter for others to determine, but of course it is proper for Parliament to consider the issue. Ministers and officials in the Department of Health would want to play a full and positive role in such a process. However, two public consultation exercises on the project have already taken place. One was conducted in 2000 by Cragg Ross
The project's success ultimately depends on the good will of the participants. That can be achieved only if there are opportunities, such as tonight, openly to debate the project and the many issues that it raises. As I said, my Department will continue to encourage that.
The benefits of the UK Biobank need to be set out clearly and unequivocally to ensure that public acceptability and confidence in the study is maintained. We need to be especially clear that it is not a big brother exercise. Nothing could be further from the truth. The study will help facilitate the translation of the new genetic knowledge into new ways of preventing and treating common illnesses. As my hon. Friend said, the benefits to individuals and society are clear. They are potentially enormous. We therefore have a precious opportunity to advance our understanding of illness and disease, and we must take full advantage of it. We intend to do that. We shall not squander that unique opportunity.
As I said earlier, we are considering a long-term research project, and there will be no instant results. Participants will gift their samples and data for the benefit of future generations, not necessarily their own.
We know that the research supported via the Biobank project will help us better to understand the causes of many common diseases that have such a devastating effect on our society. They include cancer, heart disease and stroke. That will lead, in turn, to the development of better, more effective, treatments and, more important, to the identification of methods of prevention. There is enormous potential to improve the health and quality of life of every member of our society. That is why we must rise to the challenges and the opportunities before us.
In summary, the Government welcome the creation of the UK Biobank and are committed to its success. I believe that adequate safeguards are being built into the project to ensure the maintenance of public trust and confidence. There will be further debate and consultation on the project as it develops, and adequate independent oversight from the start. As I said, it is an important flagship project, which will establish the UK as a world leader in translating advances in genetic research into real benefits for health.