Select Committee on Science and Technology Written Evidence

Memorandum by the Wellcome Trust


  1.  The Wellcome Trust (the "Trust") is an independent, medical research-funding charity, established under the will of Sir Henry Wellcome and funded from a private endowment, which is managed with long-term stability and growth in mind. Its mission is to foster and promote research with the aim of improving human and animal health. The Wellcome Trust supports more than 4,000 researchers at 300 locations in 42 different countries. In addition, as well as funding major initiatives in the public understanding of science, the Wellcome Trust is the country's leading supporter of research into the history of medicine.


  2.  The Trust funds research through a variety of different mechanisms and the full range of these are outlined in the Wellcome Trust Grants Handbook (revised July 2000)[12]. Over the years, research involving humans and/or tissue samples collected from them would have been eligible for funding under the majority of the Trust's schemes as patient genetic information has always featured as a sole or key component of many projects.

  3.  In a survey[13] conducted by the Trust in 1997-98 of 1,218 researchers, there were 843 respondents of which 400 were using and had responsibility for collections of human samples. There were 384 respondents who stated that their research involved the use of biological material taken from human subjects from which DNA could be extracted and 225 were using the material for genetics research (see Appendix 1) [not printed].

  4.  The ownership and custodianship of these collections and data lie either with the individual researchers or their institution. The Wellcome Trust, acting as a funder of research, currently has no formal ownership of, or custodianship for, any human genetic collections or databases.

  5.  The proposed UK Biomedical Population Collection in collaboration with the Medical Research Council (MRC) is discussed below and the aspect of formal custodianship of the material is one of the areas still under discussion.

  6.  The Trust has always worked to ensure that research which it considers for funding complies with the best practice and guidelines of the day and that ethical approval has been obtained from the appropriate body.

  7.  The Trust has worked with other bodies to disseminate best practice and contributed to the formulation of guidelines in this area. This work has culminated in the production by the MRC of Interim Operational and Ethical Guidelines which relate to human tissue and biological samples for use in research.[14] It is now a condition of Trust funding for collections that proposals include a statement that the applicants have formulated their proposal in accordance with the draft MRC guidelines. Where large projects have been proposed, Trust staff and external experts in the field have conducted on-site visits as part of the review process which will have included aspects of the ownership, consent and bioethical issues in line with the guidelines referred to above.

  8.  In addition, Trust staff are UK delegates of the Organisation for Economic Co-operation and Development (OECD) Task Force on Biological Resource Centres.[15]

  9.  The Trust has a range of activities organised under the Medicine in Society Programme which includes the communication of science with the public and an active Biomedical Ethics Section which conducts research in its own right[16] and is responsible for:

    —  supporting research into the social, ethical and other consequences of developments in medicine and biology;

    —  building and enhancing national capacity, by providing training and other fellowships to attract academics into this area;

    —  ensuring that the research is relevant, and communicated effectively, to those making public policy.

  10.  Funding priorities in bioethics reflect the scientific interests of the Wellcome Trust, giving higher priority to investigations of the consequences of developments in neuroscience and human genetics, rather than clinical or professional practice.

What current projects involve collecting genetic information on people in the UK? What other projects are about to start? Are there collections of material (eg tissue samples) that could be used to generate databases of DNA profiles?

  11.  Since 1995, the Wellcome Trust was considering how access to family collections should be widely available for research studies. To help inform its own ethics policy and practice in relation to family collections, the Wellcome Trust carried out an investigation of the consent and ownership issues surrounding Trust-funded collections of human material for DNA analysis. A pilot study of 30 Trust-funded researchers was completed and an internal report was produced setting out the current legal and ethical issues relating to collections of human material at that time.[17]

  12.  Following this, the Trust commissioned a wider survey of researchers (Collections Census Survey—attached as Appendix 1) [not printed] throughout UK universities and the final survey included a number of researchers some of whom were non-Trust funded. A total of 1,218 researchers were contacted with a comprehensive questionnaire which asked many of the questions pertinent to this Inquiry. The results of this survey are shown in the final report which summarises:

    —  The number of collections held by each individual researcher.
    —  Storage forms.
    —  Collections size.
    —  Origin of samples.
    —  Ownership.
    —  Consent for further use.
    —  Dates of collection of the material.

  13.  At that time, 843 researchers responded to the questionnaire and follow-up telephone inquiries which showed:

    —  400 respondents who were using their own collections.
    —  651 collections in total were covered by this survey.
    —  139 researchers were using material from a collection held by other parties.
    —  384 respondents stated that their research involved the use of biological material taken from human subjects from which DNA could be extracted.
    —  225 were using the material of the collection for genetics research.

  14.  The intention was to publish the findings of this survey in a database format on the internet but the practical issues of obtaining the appropriate consent and permission from each researcher has meant that this intention has yet to be realised. This exercise highlighted the complexities of obtaining a comprehensive list of such information.

  15.  Our current records show that since 1991 the Trust has provided over £35 million, mainly in the form of fellowship, project and programme grants to over 200 different studies which have involved human subjects, a study of genetics and the use of a database (Table 1, Appendix 2). A list of project titles, grant holder and location is provided in Appendix 3 [not printed] and shows a range of different types of support both in the UK and internationally. This information will have already been published as part of the appropriate annual Wellcome Trust publication—Grants Awarded.

  16. For the purposes of this Inquiry, human genetic databases are defined as collections of genetic sequence information, or of human tissue from which such information might be derived, that are or could be linked to named individuals. The definition does not include medical histories which relate or may relate to genetically-determined syndromes.

  17. In accordance with this definition, the nature and purpose of each of the databases referred to above (paragraph 15) which are in receipt of Trust funds is not recorded on the Trust database and this information will require a manual search of the original documents which we are currently conducting. However, for information, examples of the type of research supported by the Trust are outlined below.

  18. The Avon Longitudinal Study of Parents and Children (ALSPAC). This commenced in 1990 under the scientific leadership of Professor Jean Golding of the Unit of Paediatric and Perinatal Epidemiology, University of Bristol, and Professor Marcus Pembrey, Institute of Child Health, University College London. ALSPAC is designed to investigate how environmental exposures and the genotype combine and interact to influence the health, well being and development of the child.

  19. The project includes a study of a cohort of 14,000 children born in 1991-92 and consists of biological samples as well as medical, social and environmental data. Recent advances in the work will mean an increasing number of genetic studies will be undertaken with collaborators under the guidance of the ALSPAC ethical committee.

  20. Another example of Trust-funded research is the investigation of Fragile-X syndrome by Professor Pat Jacobs, Wessex Regional Cytogenetics Unit/University of Southampton. This is a genetic disorder that has multiple gene marker associations and the project is conducting a limited population study on the frequency of these genetic markers in both boys and their mothers.

What other projects are about to start? Why are these genetic databases being assembled?

  21. The ability to identify and locate the genes involved in the development of disease together with information of the linked environmental factors will improve our ability not only to predict disease, but also to provide advice on lifestyle changes that would be of benefit to particular patients. In addition, a much more refined approach will be possible in interventions and drug therapy—the advent of pharmacogenomics will permit getting the "right medicine to the right patient" rather than the present generic approach.

Wellcome Trust Functional Genomics Development Initiative[18]

  22. Recent years have seen significant progress in genome sequencing. To help ensure that the best possible use is made of the large quantities of genome sequence information being generated, the Trust launched a new funding initiative in functional genomics in 1999. The Initiative aims to foster a cross-disciplinary, co-ordinated approach to the exploitation of sequence data for medical benefit and includes work in structural genomics.

  23. One aspect of this initiative will be the funding of large scale collections of biological material. A first call for proposals was made in December 1999 and the first awards are anticipated in October 2000. A call along similar lines was launched in June 2000. Further elements of the Initiative are under development.

Proposed UK Population Biomedical Collection[19]

  24. As a major strand of the Trust's strategy in taking forward the genetics agenda, it is considering the scientific merits and wider ethical issues of establishing a UK Population Biomedical Collection. The first discussions of this proposal emerged as a result of a workshop held in May 1999, which brought together other funders and scientists involved in existing epidemiological surveys that have been established, in many cases, decades ago. The focus of the workshop was on multi-factorial diseases of significant public health importance. The experts were asked to consider, in the light of collections already available in the UK, whether it would be valuable to set up one or more large new collections in the UK, and if so, what form it/they should take.

  25. Discussion focused on the need to link DNA sequence information emerging from the Human Genome Mapping Project to patient outcomes (through NHS research) and additional environmental information. There was general agreement at the meeting that existing cohorts which had been established for other purposes would not be suitable for a number of reasons. First using existing cohorts would not be possible as the consent given at the time of their establishment would not be appropriate for a new study of this nature.

  26. Second, technical limitations such as the size of each existing cohort study were considered to be insufficient to provide the necessary number of incidents of disease to be statistically valid and capable of being linked to environmental factors.

  27. An outcome of the workshop was the establishment of a Working Party (Appendix 4) [not printed] by the Wellcome Trust and MRC in May 1999 which produced a report and recommendations in March 2000. This report proposed the establishment of a cohort—500,000 adults aged 45-64—for the study of interaction between genetic and environmental risk factors for common multi-factorial diseases. The predicted number of outcomes within the proposed 500,000 adult (45-64 years) population cohort is shown in Table 2, Appendix 5.

  28. This proposal was approved by the Council of the MRC and has been agreed in principle by the Scientific Committee (Governors) of the Wellcome Trust in May 2000 subject to further development of the scientific case and further consideration of the ethical, legal and management issues involved.

  29. At this stage, a decision to develop a childhood cohort of up to 50,000 individuals also recommended in the Wellcome Trust/MRC Working Party report has been deferred.

How will these activities be funded?

Wellcome Trust Functional Genomics Development Initiative

  30. As part of the Wellcome Trust Functional Genomics Development Initiative the Trust will provide support for the collection and maintenance of resource material and associated data relevant to biomedical research which can include human subjects. Priority will be given to collections that are needed for studies associated with genome projects. It is anticipated that these resources will complement existing activities in an applicant's laboratory. Awards will initially be for a maximum of five years, and renewal of funding will be reviewed in year four. A condition of any award would be that the resource should be made available to other users. This scheme has a ring-fenced budget of up to £3 million per annum over three years.

Proposed UK Population Biomedical Collection

  31. As discussed above, the MRC and the Wellcome Trust are developing the proposal for a UK Population Biomedical Collection and discussing the participation of other funding agencies eg NHS in England and Wales and the Scottish Health Executive. In addition, it is our intention to involve specific disease charities, for example cancer charities, in the development of the project and this may result in the provision of additional financial support.

  32. One structural model for the collection the Wellcome Trust and MRC have discussed is to establish a non-profit charitable company limited by guarantee to manage the day-to-day operations of the activity. This will be against the background of a business plan to ensure the long-term sustainability of the resource.

  33. It is accepted by the Trust that commercial organisations will need to be involved at some stage to develop research findings into health products, but it has not yet been decided at which stage this should be and what financial arrangements would be appropriate.

What practical considerations will constrain developments?

Public understanding, acceptance and support

  34. The recruitment of a cohort of 500,000 individuals (nearly 5 per cent of the eligible population in the 45-64 age range) on an entirely voluntary basis will be dependent upon the acceptability of the goals and aims of the project to the public. Although this is a considerable challenge there is a long history of an altruistic approach to the donation of materials for medical purposes and research in the UK.

  35. The Wellcome Trust and MRC firmly believe that there needs to be both consultation and continuing dialogue with the public on the establishment and operation of the cohort. Towards this end, an initial study has been completed by the Cragg Ross Dawson Company Public Perceptions of the Collection of Human Biological Samples and the major findings of this qualitative research will be released on the respective websites and the summary report is attached (Appendix 6) [not printed].

  36. Overall, the findings of the survey reflect positively on the planned UK Collection. Its purpose, to increase understanding of and provide information to combat diseases, was considered admirable, particularly by those with experience of illness. While the full range of potential implications was not immediately apparent to most respondents, once these had been raised, discussed and addressed through factual information, positive views of the collection tended to be restored. The majority also considered that, provided essential conditions such as informed consent and anonymity were integral features of the project, they would be prepared to donate samples to the collection.

  37. The consultation has highlighted a number of issues which it is considered will need to be at the heart of the project in order to achieve and maintain public acceptance and support. These include:

    Respect: Participants should feel that they are contributing to the development of the project rather than merely being the passive subjects of a study.

    Consent: Full and informed consent will need to be obtained from the individuals recruited so they feel confident to be able to opt-in to the project from the onset.

    Feedback: Accessible, appropriate information on the progress of research should be available to participants.

    Accountability: A regulatory body will be established with key representatives on its board, including a study participant.

    Consultation: Continuous consultation with all audiences, from patients to healthcare professionals, to ensure there is understanding and support of the project.

    Ethical research: Guidelines, established by the regulatory body, will put ethical issues at the forefront of the project. In addition to setting their own standards, the Wellcome Trust and the Medical Research Council also welcome the ethical guidelines which the Human Genetics Commission intends to formulate on the collecting of genetic material and linkage to patient information.

    Public Ownership: The DNA samples will be held in public ownership for public benefit. There will not be exclusive access to information by any one organisation or commercial company.

  38. The Wellcome Trust and the MRC are continuing to develop the proposal and will ensure that full consultation is integral to its development. Other practical issues are discussed below.

Obtaining informed consent

  39. Recruitment of volunteers and the taking of biological samples for the study will be on the basis of informed consent. Widespread publicity for the project, both at the national and regional level, will make potential participants more aware. Furthermore, attendance at a clinic to provide environmental information via questionnaires and the taking of biological samples will need sufficient time for explanations to be given by specialist trained staff to ensure that consent is valid.

The role of general practitioners

  40.  Recruitment of volunteers for this cohort will, most likely, occur through GP practices that are already involved in research. The majority of the work in obtaining these samples and environmental information would be undertaken by specifically recruited research nurses.

NHS/GP Records

  41.  One significant concern about the viability of the study is that its value may be constrained by the quality of medical records at all levels within the NHS. By involving GPs, health practitioners and relevant parties within the Department of Health at an early stage in the project, it is hoped that these difficulties can be identified and mechanisms found to resolve them. This will be a key part of the development of protocols for the conduct of the study.


  42.  With regard to the ownership of biomedical samples the law is unclear and contested. The MRC guidelines recommend that ownership for large collections is held at the institutional level and the Wellcome Trust endorses this view. However, for the proposed UK Population Biomedical Collection ownership will need to be carefully considered and need not necessarily reside with an academic institution. As stated above, the intention would be for the DNA samples to be held in public ownership for public benefit and there will not be exclusive access to information by any one organisation or commercial company.

Convention on Human Rights and Data Protection Act

  43.  It is not clear what impact the Convention on Human Rights and Data Protection Act will have on data storage, patient access to information and scope of new, additional rights of individuals who are participating in population studies. Legal advice and clarification is being sought on these issues. In the meantime the Trust is aware that the MRC is due to publish guidelines, October 2000, for its researchers advising on Personal Information in Medical Research and it is likely that the Trust will endorse them.

Are there alternative ways of fulfilling the objectives?

Use of existing cohorts

  44.  With regard to the proposed new study, as discussed above, the Wellcome Trust/MRC workshop held in May 1999 looked at the possibility of using existing cohorts and this route was not considered to be feasible as outlined in paragraphs 25-30. However, linkages to existing cohort studies will be made where appropriate as this is considered to be of great value in order to enhance its medical significance. This will be subject to the consideration of the consent which was obtained at the time of the establishment of the existing cohort as to whether it allows for new studies of this kind.

  45.  For identified diseases a number of collections and smaller cohorts already exist and new major studies will continue to be established, some as part of the Wellcome Trust Functional Genomics Development Initiative. These studies generally look at a much smaller sample of patients in greater depth than in the proposed large cohort study and will continue to be of value. As mentioned above where appropriate they will be able to be linked to the UK Population Biomedical Collection.

What is the genetic information that is being collected? How is it being stored and protected?

  46.  An overview of the Collections Consensus conducted by the Trust in 1998 is attached as Appendix 1 [not printed]. Research currently in receipt of Trust funds, and listed in Appendix 2, requires a manual search of the files in order to answer this question in detail and this work is currently being undertaken.

Proposed UK Population Biomedical Collection

  47.  For this study, it is intended that the biological material to be collected—in the main, blood samples or mouth swabs—will be used to prepare a bank of DNA. Any genetic information derived from this source via genotyping (looking at single nucleotide polymorphisms or SNPs) will almost certainly be held centrally in an anonymised form on a controlled database with no remote access. Protection will be afforded via appropriate control mechanisms, which are still being discussed as part of the planning process.

How do the organisations involved see their responsibilities regarding privacy; consent; future use; public accountability and intellectual property rights?

Privacy, consent, future use and public accountability

  48.  All projects funded by the Wellcome Trust in the past were subject to local Research Ethics Committee approval and as such consent and privacy issues were part of this process. In 1998 the Trust developed specific "Guidelines for issues to be addressed when considering support for Collections of Human Samples" (Appendix 7). As mentioned previously, the Trust has worked with others to disseminate best practice and formulate guidelines in this area. This work has culminated in the production by the MRC of Interim Operational and Ethical Guidelines which relate to Human tissue and biological samples for use in research.

  49.  It is a condition of Trust funding, for collections involving human material, that all proposals include a statement that the applicants have developed their proposal in accordance with the draft MRC guidelines. Where large projects have been proposed Trust staff and external experts in the field have conducted on-site visits as part of the review process, which will have included aspects of the ownership, consent and bioethical issues in line with the guidelines referred to above.

Intellectual Property Rights

  50.  One of the conditions associated with Trust grants is the appropriate control of intellectual property rights. The Trust established Catalyst Biomedica Ltd[20] (a technology transfer company wholly owned by the Wellcome Trust) for advice on these issues and Materials Transfer Agreements are available to all grant holders on the Wellcome Trust website. The Trust has recently developed its policy on intellectual property rights prior to its release on the Internet. In developing this policy, the Trust has considered a wide range of issues, in particular the role of intellectual property rights in creating the best conditions for research and in translating that research into tangible healthcare benefits. The Trust supports the appropriate protection and use of intellectual property where this will maximise healthcare benefits and enable biomedical research to flourish.

  51.  The Trust believes that the basic DNA sequence of humans and other organisms should be placed in the public domain as soon as is practical, without any fees, patents, licences or limitations on use, giving free and equal access to all. Subject to this, the Trust is supportive of patents encompassing genes and their products when there is research data or information indicating that a particular DNA sequence has a utility such that the legal criteria for patenting can be met.

  52.  The Trust is of the view that it will be essential to involve commercial organisations at some stage in the development of any healthcare products to arise out of cohort studies. It might also be appropriate to have commercial involvement at an earlier stage. The Trust will continue to talk to all interested parties including other funders pharmaceutical companies and will engage in continued dialogue with the wider public to ensure that the degree of involvement is appropriate, understood and acceptable to all concerned.

Trust responsibility with respect to social, ethical and public policy research

  53.  As well as developing guidelines and policy, the Wellcome Trust also funds a programme of research into the social, ethical, and public policy implications of advances in genetics and in neuroscience. This relatively new area for the Trust is in response to the growing recognition, over recent years, that advances in biomedical science raise questions of ethics and of social impact which require careful examination and, in some cases, suitable regulatory supervision. The Trust issued a call for proposals, in August 1999, to academic researchers in the UK offering support for research into the social, ethical, legal and public policy implications of biological sample collections in human genetics research[21]. As part of this activity the Trust has also:

    —  funded a workshop for potential applicants in November 1999, attended by nearly 40 academics. An additional benefit of this workshop was the highlighting of policy areas which funders of biological collections may wish to consider;

    —  commissioned a background paper on Biological Sample Collections written by Dr Paul Martin, Genetics and Society Unit, University of Nottingham and Jane Kaye, University of Oxford [see p 113]. This background paper is available on the Wellcome Trust website and has been disseminated widely. It is in essence a "review" of the field and is cited widely in the research literature;

    —  prepared a short report on the workshop (also on the website referenced at footnote 19) and published a paper in the journal New Genetics and Society. (Spallone, P and Wilkie, T, "The research agenda in pharmacogenetics and biological sample collections—a view from the Wellcome Trust", New Genetics and Society, Vol 19, No 2, 2000);

    —  covered the topic as part of the Trust's summer school for postgraduate researchers, "Genetics and Society: Research Needs and Research Methods". A group of students were given the task of creating a research proposal on this subject.

  54. One project grant and four PhD studentships have been funded in this area. Three project grant proposals are expected for consideration in the next grants round. The project grants funded are:

    —  "Ethical protection in epidemiological genetic research: participants' perspectives"—University of Bristol, Dr Richard Ashcroft/Professor Alastair Campbell. This project will analyse the Avon Longitudinal Study of Parents and Children. The aim is to improve the understanding of the ethics of epidemiological research especially with regard to clinical genetics, longitudinal studies and child participants. The research will investigate what issues mothers, their partners and children find ethically important and their understanding of genetics research (Funded March 2000);

    —  "A sociological study of Iceland's DNA database project", Institute for Advanced Studies, University of Bristol, Professor Hilary Rose, (funded in 1999). Report on this work is imminent.

  55.  Studentships funded are:

    —  "Whose genes? Tracing the use and control of human genetic info through the law". Oxford studentship funded June 1999, Jane Kaye;

    —  "Exploring the meaning and ethics of tissue donation for genetic research". Nottingham studentship funded June 2000, Helen Busby;

    —  "UK and European policy in stem cell research: proposals for the ethical grounding of future regulation". Bristol studentship funded June 2000, Benjamin Capps;

    —  "Legal protection of human biotechnological inventions". Oxford studentship funded June 2000, S Thambisetty.

  56.  The Trust's "call" for social and ethics research proposals on the human sample collections, and capacity building work (workshop and summer school), has stimulated the UK research community to work on these issues. This work will help inform public policy making in due course. It is essential, though, that the system in place for making public policy decisions should be flexible enough to revise judgements in the light of new knowledge (or, indeed, of changes in social values and mores).

How do they see their activities in the area of genetic databases developing in the future? What advances in sequencing, screening and database technology are they anticipating?

  57.  The UK Biomedical Population Collection is seen as a model experimental approach to the future enhancement of links between genomic information and patient care, including the introduction of pharmacogenomic approaches to treatment and therapy. The ability to develop high throughput genotyping (which will be necessary because of the current expense of genotyping) will make this goal ultimately realisable. The outputs from the UK Biomedical Population Collection will, in some cases, be unpredictable; however, these will set the parameters for the use of genetic and environmental information in the context of individual patients in the future. We anticipate that the Single Nucleotide Polymorphism (SNPs) approach in genotyping will result in the ability to detect some of the factors involved in disease development, especially in multi-factorial diseases, before the development of the disease and take necessary measures (via drug intervention or lifestyle changes) to either prevent or lower the risk of disease. Overall, these should result in substantial benefits to the cost of therapy as well as quality of life benefits to the patient.

  58.  The UK Biomedical Population Collection could be a testing ground for future NHS database developments and will be dependent on the improved quality of patient records and the need to provide necessary linkages between GP practice-based records and hospital records. Partnership with the NHS at the commencement of the project will make this goal achievable.

What lessons should be learnt from genetic database initiatives in other countries?

  59.  The answers below refer mainly to the proposed UK Biomedical Population Collection.

  60. The background paper written by Martin and Kaye (referred to above) elaborates on the obvious example of Iceland and the deCode project. It is not clear whether policy development within a country whose total population is less than 300,000 has much relevance to a country whose population approaches 60 millions. However, one aspect of the Icelandic situation that may be of interest is that the encoding of the health records has been placed in the hands of an organisation that is independent of the Government and of the company itself. The current UK situation means that encoding of personal medical information tends to be left to researchers acting in accordance with general guidance, rather than being the executive responsibility of an independent agency. This means that information is held in private (academic) rather than public hands.

Patient recruitment

  61.  Iceland has automatic opt-in for storage and use of patient records, although informed consent is required for biological samples. This has led to some public antagonism and subsequent international response to the project especially in terms of links to commercial exploitation (see below).

  62.  USA ( This project adopts a random approach to patient recruitment with a reliance upon questionnaire-based information (unaudited) and without linkage to patient records. This seems to provide very limited ultimate value, although patients are offered the benefit of individual feedback on particular diseases. However, individual feedback, to be done properly, requires careful planning that involves counselling and an explanation of the risk factors particularly for (chronic) diseases which have no treatment.

  63.  Ensuring that the UK project has an opt-in voluntary approach will be a particular strength; however, feedback and communication will be necessary to maintain the patient volunteers' commitment and contact with the organisation in the long-term.

Legal mechanisms

  64.  Most aspects of the Icelandic database project are enshrined in detailed legislation which has been passed by the Icelandic parliament. This has provided a strong regulatory framework for genetic resources in Iceland. In the UK, regulation has been non-statutory through research ethics committees and the Human Genetics Commission.

Management of the database

  65. The Iceland project involves the use of an independent body, separate from the commercial interest, which is responsible for the coding and encryption of personal information that will link biological samples to the genealogical database and the patient records database. The UK project will ensure that this activity is regulated by a separate and independent body who will also have responsibility to audit this function. This responsibility is not clear in the Icelandic situation.

Patient records

  66. The Iceland project relies upon deCode Genetics to negotiate access to the patient records with each individual GP practice/hospital concerned. The UK project will need to work alongside the Department of Health to ensure full integration of the patient records in the project throughout the UK and ensure a uniform approach to the collection of these records.

Public understanding of science

  67. The Icelandic population is small, less than 300,000, and highly educated with literacy levels higher that most developed nations. Although opinion on the project is polarised, there has been considerable debate over the benefits to be gained from the deCode Genetics database, and the public are well informed on the issues. A general feeling, within the international community, however, is that more public consultation would have been desirable.

  68. The initial public consultation in the UK performed for the Wellcome Trust and MRC (Cragg Ross Dawson Report) reveals that the level of the public's knowledge of genetics is limited and the benefits of this type of research is not obvious to many people without careful explanation. One of the key facets to the success of the UK project will be a concerted approach to improving awareness and continuing dialogue with the general public on the issues raised. It is anticipated that this will continue for the duration of the database project.

Links to industry

  69. The Icelandic project has negotiated exclusive access arrangements for the databases and related information to deCode Genetics for a period of seven years. Although industry is expected to gain regulated access to the database in the UK (discussions are already taking place with the Association of the British Pharmaceutical Industry) it is anticipated that industry will not directly participate in the management of the project and that exclusive access will not be permitted. A management model is being developed which allows for the establishment of an independent charitable body to oversee this relationship.

Use of human biological samples in research

  70. The introduction of all-embracing legislation in Iceland has resulted in all uses of human biological samples (other than those used in diagnosis) being subject to government regulation via the Ministry of Health. The scientific community is sufficiently small in Iceland for this not to be a major imposition on scientific freedom. However, in the UK this would result in a severe administrative burden on both the research community and the government. Although self-regulation can be criticised, it has provided a workable framework for research to date.

Individual patient feedback

  71. The Iceland project has been conducted upon the basis that individual patient feedback will not be permitted, given the nature of the anonymisation process and encryption. In the Wellcome Trust/MRC public consultation, this was a key issue for many members of the general public who would view individual feedback as a positive benefit from participation in the project. This issue will need to be part of continued public consultation before a definitive policy can be introduced and form part of the project plan.

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13   Collections Census Survey, March 1998. Infratest Burke Ltd (Public Attitude Surveys Ltd) Back

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15   Culture Collections Seek Global Help. Science Vol 283, No 5406 pp 1240-1241. Back

16   The research agenda in pharmacogenetics and biological sample collections-a view from the Wellcome Trust. Patricia Spallone and Tom Wilkie. New Genetics and Society, Vol 19, No 2, 2000. Back

17   The Legal and Ethical Issues Relating to Collections of Human Material or Information used in Genetics Research, for the Wellcome Trust by Ms GAH Meijer, November 1997. Back

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