Select Committee on Science and Technology Third Report


SPENDING REVIEW 2002

47. The MRC, in line with the increases for all the Research Councils, received a substantial increase in its budget from the 2002 Spending Review (see Table 9).[82]

Table 9: Spending Review 2002 allocation for the MRC (£ million).

Resource

Capital

Baseline

SR2002 allocation

Baseline

SR2002 allocation

03-04

03-04

04-05

05-06

03-04

03-04

04­05

05-06

411.504

0.480

19.770

58.160

14.557

0.000

8.915

15.195

The increase included funds for a cross-Council programme on stem-cell research. The MRC will receive £26 million of the £40 million for the years 2004-05 and 2005-06. Some of this money (and the BBSRC's) will go to fund a UK Stem Cell Bank. This will be considered later in paragraphs 47-49.

48. The MRC also submitted a proposal, with BBSRC, EPSRC and CCLRC, for a programme on brain science. The bid, for £37 million, was only partially successful. Of the £24 million for the MRC, only £9.7 million will be forthcoming. The MRC tells us that this will "limit our scope to develop the sort of programme originally envisaged". We understand that a further bid is planned for Spending Review 2004. Dr John Taylor, Director General of the Research Councils, told us during our oral evidence session on the Science Budget allocations on 11 December 2002 that brain science was one of the "Tier 2 set of areas where we have added some money to pump prime or funds match with the councils".[83] We heard from Lord Sainsbury, Minister for Science and Innovation, that "Research Councils can add money from their own other free money to back that up".[84] From what we have learnt, free money is in short supply at the MRC.

STEM CELL BANK

49. The MRC announced on 9 September 2002 that the National Institute for Biological Standards and Control had been appointed to set up the UK Stem Cell Bank. This will enable medical researchers to work towards using stem cells to understand the processes involved in cell differentiation and development and for use as possible new treatments for common diseases. The £2.6 million contract for the bank will be awarded and managed by the MRC; the costs will be shared between the MRC, and the BBSRC, with The MRC being the majority funder. The initial funding is for three years. We asked the MRC what the financial plans were beyond this and to outline funding scenarios. Its response is disappointing. We were looking for evidence that despite the many variables, the funders were looking ahead but we have found none. The MRC tells us that Management Committee for the bank will develop charging scenarios that involve academics paying marginal costs and industry paying full economic costs. Professor Radda told us that it might "start paying for itself to some extent".[85] In its subsequent written evidence, The MRC told us that these fees will go towards the bank's running costs but we understand this income will not be significant in the short term[86].

50. A high level Steering Committee has been set up to oversee its operation, chaired by Lord Patel. This Committee will develop the code of practice for the bank and for the use of stem cell lines, and will regulate the use of embryonic stem cell lines. The bank will establish a local management committee that will report directly to the Steering Committee. There will also be User and Clinical Liaison Committees which will discuss respectively, issues relating to the use of the bank by the scientific community and issues relating to the generation of stem cell lines for banking, and eventually for clinical application. We asked the MRC how the members and observers of the Oversight Committee were appointed. The MRC said: "The chairmanship and membership/observership of the Oversight Committee were agreed by Council (itself a body of non­executive members with broad stakeholder interests) in consultation with all UK health ministers and with OST/DTI".[87] This does not tell us how these people were identified or nominated; openness and transparency are important if the venture is to gain public confidence.

51. The Stem Cell Bank is a world-leading venture which we wholeheartedly support but the management and transparency of this publicly funded body must be beyond reproach. The UK Biobank, which we discuss below has funding confirmed for the first five years of operation but the MRC has presented us with budgetary projections for the next seven years (see paragraph 53). This is welcome but the MRC should be able to do the same for the stem cell bank. The MRC should have some sort of idea as to how much it will need to spend and where it will get the money from.

  

UK BIOBANK

52. UK Biobank will be "the world's biggest study of the role of nature and nurture in health and disease"[88]. Around 500,000 participants between 45 and 69 years will contribute a blood sample, lifestyle details and their medical histories to create a national database. Researchers will use Biobank to uncover the genetic and environmental factors that lead to common conditions such as cancer, heart disease, diabetes and Alzheimer's disease which are caused by complex interactions between genes, environment and lifestyle.

Funding

53. The budget proposals on which the Council of the MRC and the Governors of the Wellcome Trust made their funding decisions in March and April 2002 are shown in Table 10. So far £45 million has been committed, with £20 million each from the Wellcome Trust and the MRC, and a further £5 million from the Department of Health. This leaves a £15 million shortfall for the first seven years of operation. Professor Radda explained to us that "We would expect that Wellcome, the Department of Health and us would continue to make commitments to it. What we would also expect, by that time to actually generate income from the Biobank, from industrial organisations who would take up some of the information".[89]   

Table 10: Projected costs for the UK Biobank (£million).

Financial Year

02-03

03-04

04-05

05-06

06-07

07-08

08-09

Total

Total cost [90]

1.7

4.4

9.2

11.1

11.9

12.8

7.8

58.9

MRC's contribution[91]

0.8

1.7

4.1

5.1

5.5

5.9

3.9

27.0


54. The MRC estimates Biobank's annual running costs beyond 2009 to be £3-4 million.[92] We appreciate the difficulties in projecting the long-term running costs of Biobank at this stage but we are reassured to see that the issue is being actively considered now.

Science

55. The Human Genetics Commission (HGC) concludes that Biobank "is an extremely important and valuable research project if the benefits of advances in genomics are to converted into a more detailed understanding of complex diseases".[93] The scientific rationale for the project is not without its critics. At an HGC meeting on 19 November Professor Alan Wright, from the MRC Human Genetics Unit in Edinburgh, voiced concerns that the methods used to identify links between single genes and disease might not work for diseases in which a large number of genes had a minor effect.[94] We are also aware of criticism that the project has been driven by epidemiologists and that there is less confidence in the clinical genetics community that the project will generate useful data. GeneWatch, a "public interest group which aims to ensure that genetic technologies are developed and used in the public interest", submitted a detailed critique of the scientific validity of the project.[95] Its principal objections are based on:

  • the inadequacy of medical records;
  • the relatively elderly cohort being used would make it difficult to study cardiovascular and metabolic diseases; and
  • it may identify spurious links between genes and disease.

Genewatch argues that a smaller, more focused study (20,000 to 100,000 people) would yield more useful information.

56. The HGC evidence highlights the importance of proteomics (the study of the proteins produced by living organisms) as a means of discovering the link between genes and environment and of providing targets for drugs and antibody therapies. The HGC understood that there were plans to take or store samples in Biobank in a way that would allow later proteomic analysis. We put this issue to The MRC and were partially reassured to learn that the blood plasma that will be stored could be used for proteomic analysis, provided it is stored under suitable conditions but it is our understanding that in some diseases the proteins of interest will only be found in the tissues and not the plasma. The MRC told us that the UK Biobank team will seek expert advice on the appropriate storage conditions to use, and "endeavour to include this in the protocol if it proves practicable and affordable".[96]

57. Professor Radda said that "Biobank came as an idea from the serious scientific community who said to us 'We now have all this wonderful information about the genome. What are you going to do about using that information to improve the health of the public? How can you convert that into real health care benefits?' and this is clearly one of the ways of doing that".[97] The Biobank is an exciting project and we commend the MRC's efforts to ensure that the UK is taking the lead in harvesting the fruits of the human genome. We are concerned, however, that funds were allocated to the project before the scientific questions over its value and methodology were fully addressed.

Peer review

58. GeneWatch argues that the peer review process has been inadequate and questions why the funders did not seek an independent body to organise its peer review.[98] In a written answer to our Chairman, Hazel Blears, Parliamentary Under Secretary of State for Public Health, insisted that "12 experts were involved [in Biobank's peer review], 10 of whom were from overseas... None of these had prior involvement in the development of the protocol nor were they involved with organisations likely to participate in the study or benefit financially.[99] We consider that it is the independence of the reviewers rather than the independence of the organising body is of principal importance. Of greater concern is how the peer-review process informed the funding decision, particularly in view of the fact that many Alpha-A-rated research proposals were rejected last year (see paragraph 25 above). It is not clear to us that Biobank was peer-reviewed and funded on the same basis as any other grant proposal. Our impression is that a scientific case for Biobank has been put together by the funders to support a politically driven project.

59. GeneWatch suggests that peer reviewers comments should be published anonymously. We appreciate that this is an unusual step and in some cases the identity of the reviewer may be apparent from the comments, but we feel that Biobank does not have widespread confidence and that this would be a positive step. We recommend that the MRC publish the comments of Biobank's peer reviewers anonymously to build confidence that the project is fully justified and supported by the scientific community.

Consent

  60. The HGC discussed the issue of consent of participants before their participation in genetic databases in great detail in its report Inside Information. The report concluded that "it should not deceive the participant about what might be done with their sample or information". There is a tension between seeking general consent which risks misleading participants and very specific consent which may prove very restrictive in the way that the information and samples may be used. The HGC argues that " it is acceptable to seek general consent in cases where there is to be irreversible or reversible anonymisation of data and samples".[100] The HGC's guidelines have support from the Consumers' Association.[101] We asked the MRC whether it was planning to adopt the guidelines. The answer was equivocal: Mrs Jane Lee, the MRC's Director of Corporate Affairs, said "Our planning has gone in parallel with that report being drafted and in many ways that is why we have not moved faster because we wanted to know the outcome of that study".[102] We believe that fully informed consent is an essential requirement for participation in Biobank. The MRC may have good grounds for not adopting the Human Genetics Commission's guidelines on consent for Biobank but it should state clearly what its position is and, if it disagrees with them, explain why.

Consultation

  61. The MRC says in its evidence "A project of the scale and nature of the UK Biobank cannot succeed without widespread support from the public and a wide range of stakeholders, including the NHS and potential users of the resource".[103]

Public

62. The MRC describes two phases of public consultation in 2000 and 2002.[104] The first consisted of a series of group discussions and one-to-one in depth interviews with more than 150 people across the UK.[105] Its aims were to:

  • explore public attitudes to the broad issue of human biological samples being collected and stored for research purposes;
  • examine public attitudes to the use of samples in conjunction with existing health data for the purposes of genetic research;
  • investigate response to the Biobank; and
  • provide initial input to the nature and structure of an ongoing public consultation process.

The results were to be used to draw up guidelines concerning the use of human DNA samples. The latter looked at the ethical and management issues surrounding Biobank. It involved three focus groups of 20 people in three UK locations. Participants were between 45 and 69 to reflect the age range of Biobank's participants.[106]

63. It is not clear to us how the results of the consultation were used to develop the Biobank project. Mrs Lee said it was about "informing the way that we are planning" but would not result in a change of tack.[107] We have concerns about the scale of the consultation. The first study concluded that "Given the publicity surrounding recent cases of research on organs removed without permission, there is some wariness towards the practice of research on samples, and signs of a loss of faith in those who carry it out - members of the medical profession". Given that there is this concern, we feel there were grounds for a more extensive consultation and an attempt to stimulate greater public awareness. The Consumers' Association is clearly unimpressed by the extent of the consultation undertaken by Biobank's funders, as it is conducting a study itself.[108] Public consultation does not come cheap and given the pressures on the MRC's finances we are hesitant about recommending further investment in this area. Nevertheless, we were pleased to learn from Professor Radda that there will be further consultation.[109] We fear that the project's long-term viability could be threatened if Biobank's funders fail to adopt a more open approach and engage not only the projects' participants and stakeholders but the wider public.

Stakeholders

64. The MRC reports that there were consultations with healthcare professionals in primary care and in industry, and that there were meetings with the HGC and a workshop on governance and ethical issues attended by representatives of the HGC, patient and pressure groups, as well as experts on biomedical law and ethics and the social aspects of genetics. We are pleased to see the HGC involved in the development of Biobank, but clearly not to the Commission's satisfaction: "HGC has been slightly frustrated by our inability to consider some specific aspects of Biobank in public HGC meetings until such time as a formal funding decision was made. Whilst we respect the difficulty that Funding bodies may have had discussing the details during these early stages, this has hampered our detailed examination of some of the issues".[110] HGC is "concerned to ensure that the Funders consult widely with other groups and companies to establish whether simple changes at the outset could dramatically improve the value of Biobank for a wide range of research." An example of this is the collection of samples for proteomic analysis. HGC reports the views of Dr Andrew Lyall of Oxford GlycoSciences, who feels that proteomics is important in establishing the link between disease and the environment and for developing therapies (see paragraph 54 above).[111] The Consumers' Association told us that for "a project that has such fundamental ethical implications, an adequate level of consultation with all key stakeholders is extremely important. It is also essential that this takes place well before the project is underway and that there is clarification of the underpinning principles and procedures at this early stage. Unfortunately, this approach has not been followed with Biobank to date".[112]

65. John Hutton, Minister of State for Health, told the House on 3 July 2002 that "I hope that the [consultation] process followed will help to establish a consensus on the future direction of the project".[113] We fear that this will not be the case. As our Chairman told the House on 3 July 2002, "we will not be able to establish trust behind closed doors. The discussions about the design of Biobank have to come out of the closet and into the open. We need an open­ended, democratic debate about how to conduct this research and about how to make it safe".[114] It is our impression that the MRC's consultation for Biobank has been a bolt-on activity to secure widespread support for the project rather than a genuine attempt to build a consensus on the project's aims and methods. In a project of such sensitivity and importance consultation must be at the heart of the process not at the periphery.

Commercial interests

66. The HGC has found from its consultation and opinion surveys that the issue of confidentiality of the information and access by commercial interests was of major concern.[115] The Consumers' Association shares these concerns, stating that public interest must take priority over commercial interests and argues that the funders should outline clearly who they see as the beneficiaries of the Biobank.[116] Professor Radda told us that he had had expressions of interest from the pharmaceutical industry but that they were holding back because "too early an involvement from them might jeopardise the programme, particularly because we are insisting that it is in the public domain and the results will be available to all".[117] The MRC appears to be taking a sensible attitude to industrial involvement in Biobank. It must be made clear that all results will be in the public domain but we recognise that if new therapies are to arise from Biobank industry's involvement is inevitable and necessary.

67. The HGC reports that the Association of British Insurers, the UK Forum for Genetics and Insurance and the British Society for Human Genetic have issued a statement to the effect that insurers will not consider results from research studies.[118] We welcome that assurance and are pleased to see the insurance industry taking a more enlightened approach to genetics since our predecessors published their report on Genetics and Insurance in 2001.[119]

Management and administration

68. Biobank will be operated and controlled by an independent not­for­profit company limited by guarantee, jointly owned by the MRC and the Wellcome Trust.[120] The project will have a scientific committee and an independent oversight (or monitoring) body. The UK Biobank resource will be centrally managed from a coordinating centre with responsibility for delivering the project. It will coordinate the activities of several Regional Centres who will be responsible for participant recruitment and initial data and sample collection. Institutions were invited to bid to host the Coordinating and Regional Centres. Site visits of short-listed applicants are underway.

69. The oversight body has a role in holding the Biobank management to account and safeguarding the interests of participants.[121] The MRC says that the members and chairman of the oversight body will be appointed according to the Nolan principles. John Hutton told the House on 3 July 2002 that "The monitoring [oversight] 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".[122] The HGC believes that the oversight body should include elected representatives. The funders have set up an interim advisory group "to develop further the ethics and governance of Biobank". The MRC says the group will "will advise the funders on the spectrum of expertise required on this group and how participants' interests can best be represented, prior to the [oversight] body being established". Our Chairman suggested to the House on 3 July 2002 the institution of participants panels at each regional centre. [123] We agree with the Human Genetics Commission that Biobank's participants should be represented on the independent oversight body or on participants' panels at each regional centre. It is vital that participants play an active role in the management of the project.

Security and confidentiality

  70. According to the Biobank, data and samples will be coded to protect the confidentiality of the individual participants.[124] It says that scientists using the data for research will not be able to identify individuals but that the data cannot be fully anonymous because the study organisers will have to be able to add information on participants' health to the individual records at a later date. The Consumers' Association raises three questions about risks of releasing identifiable data:[125]

  • Who will have control of the storage and access of files?
  • What security measures will be in place?
  • Who will hold the key to the reversing of anonymised data and will they be independent of the owners and users?

The HGC argues for "careful arrangements for vetting staff and for ensuring that maintenance of confidentiality should be a condition of employment. Any material breach of this should result in dismissal".[126] The MRC told us that "Only a very few individuals employed within the co­ordinating centre will have access to the identifying data, in order to allow follow­up information on health from NHS records to be added to the correct records. Security will be a key issue in preparing the detailed specification for the computer systems. Prior to accessing any data, users will be required to sign a licence agreement including provisions to ensure confidentiality is protected".[127] Nevertheless, the HGC rightly recognises that there is a risk that the identifiable data could be made public: "Ultimately there will remain a remote possibility that identifiable information will be released from the UK Biobank and that this must be clearly explained when seeking consent. The safeguards to ensure confidentiality will need to be clearly spelt out, along with the possible nature and type of breaches of confidentiality".[128]

71. The HGC cites the views of Dr Ross Anderson that "encryption could become a technical 'comfort blanket' that led to complacency about other aspects of data integrity". Dr Anderson told the HGC that "inference control", a technique that limits the ability to deduce the identity of an individual, could prevent information being obtained by a series of overlapping data queries.[129] The Human Genetics Commission has recommended that the Government fund research into encryption techniques to ensure data security. We support this view.

72. The HGC is concerned by comments made by the Information Commissioner about the exclusions in the Data Protection Act which may allow access to information to some parties, including the police: "We feel that this is sufficiently important to merit a statement to Parliament by the Home Secretary or other senior Minister. This should clearly state that the police would never request access to the UK Biobank, or failing, that make clear the circumstances under which police access might be sought for particularly serious crimes. This information could then be given to individuals when seeking consent". The Consumers' Association agrees, stating that "the appropriate legal safeguards should be in place before Biobank starts recruitment".[130] The Biobank website concedes that the police could have access to records, but "only in the unlikely event that the courts require information by court order". It should be unlikely, given that a national database of only 500,000 people between 45 and 69 years would be of little use to a police investigation but we recognise that the pressures faced by the police in high profile cases may lead to an attempt to use data stored in Biobank. The arguments for legislation are complex and we will not comment here except to express dismay that the HGC's views, first aired in its report Inside Information, published in May 2002, have yet to receive a response from Government.[131] Hazel Blears, Parliamentary Under Secretary of State for Public Health, said, in a written answer to the Chairman on 10 June 2002, merely that "The Government do not currently intend to introduce further safeguards for the protection of personal genetic information before members of the public are asked to donate blood samples to the UK Biobank".[132] It is important that participants in Biobank are aware of the risk that police could obtain access to their data and samples before giving consent and before their samples are taken. The funders should monitor to what extent this issue acts as a disincentive to participation.

Conclusion

73. We are not qualified to comment on the scientific merits of the UK Biobank. Nevertheless, we are concerned that the peer-review and funding process that led to its establishment was less than satisfactory. The MRC is only one of three funders and the Wellcome Trust has contributed the same amount (£20 million). The funders together must bear equal responsibility for the lack of confidence that exists in some quarters in the project and concerns about its operation.

  


82   Department of Trade and Industry, Science Budget 2003-04 to 2005-06, December 2002, page 34 Back

83   Minutes of evidence taken before the Science and Technology Committee, Session 2002-03, HC160-i, Q35 Back

84   Minutes of evidence taken before the Science and Technology Committee, Session 2002-03, HC160-i, Q34 Back

85   Q 62 Back

86   Ev 67 Back

87   Ev 68 Back

88   www.ukbiobank.ac.uk Back

89   Q 107 Back

90   Including 5% contingency Back

91   Assuming that the £5 million contribution from the Department of Health is spread evenly over 5 years. Back

92   Ev 68 Back

93   Ev 52 Back

94   Ev 53 Back

95   www.genewatch.org; Ev 27-28 Back

96   Ev 69 Back

97   Q 110 Back

98   Ev 21 Back

99   HC Deb, 10 Jun 2002, col 1091W Back

100   Ev 54 Back

101   Ev 58 Back

102   Q 131 Back

103   Ev 33 Back

104   Ev 33 Back

105   The Wellcome Trust, MRC, Public Perceptions of the Collection of Human Biological Samples, October 2000 Back

106   The Wellcome Trust, MRC, Biobank A Question of Trust: A Consultation Exploring and Addressing Questions of Public Trust, February 2002 Back

107   Q 87 Back

108   Ev 58 Back

109   Q 137 Back

110   Ev 52 Back

111   Ev 53 Back

112   Unpublished submission from Jackie Glatter, Consumers' Association Back

113   HC Deb, 3 July 2002, Col 369 Back

114   HC Deb, 3 July 2002, Col 368 Back

115   Ev 54 Back

116   Ev 59 Back

117   Q 144 Back

118   Ev 55 Back

119   Fifth Report of the Science and Technology Committee, Session 2000-01, Genetics and Insurance, HC 174 Back

120   Ev 67 Back

121   Ev 67 Back

122   HC Deb, 3 July 2002, col 371 Back

123   HC Deb, 3 July 2002, col 368 Back

124   www.ukbiobank.ac.uk Back

125   Ev 58 Back

126   Ev 54-55 Back

127   Ev 68 Back

128   Ev 55 Back

129   Ev 54 Back

130   Ev 59 Back

131   Human Genetics Commission, Inside Information ­ Balancing Interests in the Use of Personal Genetic Data, May 2002 Back

132   HC Deb, 10 Jun 2002, col 1122W Back


 
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