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Public Trust and Public Bodies: The Regulation of the Use of Human Tissue for Research in the United Kingdom

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Biobanks and Tissue Research

Part of the book series: The International Library of Ethics, Law and Technology ((ELTE,volume 8))

Abstract

A primary purpose of regulation is to secure public trust. In the United Kingdom in the 1990s public trust in those who procured, stored and used human tissues for research or other purposes was severely damaged following controversies about the retention and use of post mortem organs and tissue at the Bristol Royal Infirmary and the Alder Hey Royal Infirmary in Liverpool. Pathologists at both hospitals had retained large quantities of tissue and other remains of children without the knowledge and consent of their parents. Reports of unacceptable practices in Bristol and Alder Hey led to major revision of laws and regulation of the use of all human tissue in the context of research and therapy, including the donation and transplantation of human organs. A new regulatory authority, the Human Tissue Authority, was set up. Together with the previously established Human Fertilisation and Embryology Authority these two public bodies have had responsibility for key aspects of the regulation and oversight of human tissue use for research in the United Kingdom. Here we explore their role in securing public trust and confidence in current practices relating to research use of human tissue. These practices include the use of ova, embryos and aborted fetal tissue for stem cell research and most recently the approved use of “human admixed embryos”. We discuss the ethical principles underlying the current policies and legal frameworks in the UK regarding the research use of human tissue and their divergence from other European countries.

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Notes

  1. 1.

    Although the Council is interested in making comparisons between donation of HBM and volunteering for first in human trials this goes beyond the scope of our discussion here.

  2. 2.

    We refer here to the EU Tissue and Cells Directive 2004, the Blood Safety Directives 2002/98/EC and 2004/33/EC, Regulation on Advanced Therapy Medicinal Products Regulation (EC) 1394/2007, and proposals for a new EU Directive on Organ Transplantation 2008/0238 (COD).

  3. 3.

    Opinion No15 Ethical aspects of human stem cell research and use, 2000.

  4. 4.

    Opinion No12 Ethical aspects of research involving the use of human embryo in the context of the 5th Framework Programme, 1998; Opinion 22 Recommendations on the ethical review of hESC FP7 projects, 2007.

  5. 5.

    See http://ec.europa.eu/european_group_ethics/avis/index_en.htm (accessed 25 February 2011).

  6. 6.

    See http://www.hta.gov.uk/ (accessed 25 February 2011).

  7. 7.

    See HTA Code of Practice 1 Consent July 2006.

  8. 8.

    See 2008 NRES HTA Memorandum of Understanding, http://www.nres.npsa.nhs.uk/ (accessed 25 February 2011).

  9. 9.

    See http://www.nres.npsa.nhs.uk/ (accessed 25 February 2011).

  10. 10.

    There are approximately 100 NHS RECs for a fuller description see http://www.nres.npsa.nhs.uk/. Other RECs in Universities are not recognized as having powers to approve human tissue research.

  11. 11.

    Since the implementation of the Clinical Trials Regulation in 2004 the terms lay and expert are defined by NRES. See Information Paper on Membership of RECs v4.1 July 2009 at http://www.nres.npsa.nhs.uk/aboutus/about-recs/rec-membership/ (accessed 25 February 2011).

  12. 12.

    There is a further statutory consent exception for the use and storage of human tissue for research where all of the following criteria apply: tissue is from a living person; and the researcher is not in possession, and not likely to come into possession of information that identifies the person from whom it has come; and where the material is used for a specific research project approved by a recognised research ethics committee (Human Tissue Authority 2009c, para 41).

  13. 13.

    See Human Tissue Authority 2009b, para 91–123 on Disposal of tissue following pregnancy loss.

  14. 14.

    http://www.york.ac.uk/res/sci/events/FinalConfPres/Kent.pdf (accessed 25 February 2011).

  15. 15.

    http://www.progress.org.uk/ (accessed 25 February 2011).

  16. 16.

    http://www.hfea.gov.uk/ (accessed 25 February 2011).

  17. 17.

    http://www.sciencemediacentre.org/ (accessed 25 February 2011).

  18. 18.

    Minger was speaking at a meeting of the ESRC Genomics and Research Forum Event held on 12 March 2009 in London – Conscience or Consultation? The HFE Act: a retrospective.

  19. 19.

    For example Comment on Reproductive Ethics (CORE) see http://corethics.org/ (accessed 25 February 2011).

  20. 20.

    See press releases of HFEA for 7th May 2004, 25th November 2004 at http://www.hfea.gov.uk/ (accessed 25 February 2011) and cited in Pfeffer and Kent (2007).

  21. 21.

    For a simple and excellent presentation on what these new entities are and how they are produced see http://www.wellcome.ac.uk/About-us/Policy/Spotlight-issues/Human-Fertilisation-and-Embryology-Act/Humanadmixedembryos/index.htm (accessed 25 February 2011).

  22. 22.

    See Press release September 2007 http://www.nesci.ac.uk (accessed 25 February 2011).

  23. 23.

    This study was funded by the MRC at the same time and is directed by Prof Erica Haimes, see http://www.ncl.ac.uk/peals/research/project/2744 (accessed 25 February 2011).

  24. 24.

    Known as the “Hands off our ovaries” campaign. See http://handsoffourovaries.com/ (accessed 25 February 2011).

  25. 25.

    In 2001, the Human Fertilisation and Embryology (Research Purposes) Regulations were enacted. These extended the purposes for which an embryo could be created.

  26. 26.

    See Interim UK Regulatory Route Map for SC Research and Manufacture March 2009, and subsequent http://www.sc-toolkit.ac.uk/home.cfm (accessed 25 February 2011).

  27. 27.

    A discussion of the approval of stem cell therapies goes beyond the scope of this chapter but relates to the 2007 EU Regulation of Advanced Therapy Medicinal Products REGULATION (EC) No 1394/2007. In May 2010 the European Medicines Agency noted that no stem cell therapies had been approved by them.

  28. 28.

    “GTAC oversees clinical trials involving cells derived from stem cell lines. A stem cell line is a permanently established culture of unspecialised cells derived from a single parental cell, or group of parental cells, that can (1) proliferate in vitro for a prolonged period when given appropriate nutrition and space and (2) be made to differentiate in culture into more specialised types of cells when given appropriate chemical or molecular cues. This includes cell therapies derived from: genetically modified cells; embryonic stem cell lines; multipotent stem cell lines; mesenchymal stem cell lines; foetal stem cell lines; induced pluripotent stem (iPS) cell lines”. http://www.dh.gov.uk/ab/GTAC/Stemcelltherapy/index.htm (accessed 25 February 2011).

  29. 29.

    See http://www.ukbiobank.ac.uk/ (accessed 25 February 2011).

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Acknowledgments

The authors wish to thank the UK Economic and Social Research Council for the research funded by them which contributed to this chapter (Research Grant award RES-350-27-004).

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Authors and Affiliations

  1. Department of Health and Applied Social Science, Faculty of Health and Life Sciences, University of the West of England, Bristol, UK

    Julie Kent

  2. School of Social and Community Medicine, Centre for Ethics in Medicine, University of Bristol, Bristol, UK

    Ruud ter Meulen

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  1. Julie Kent
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  2. Ruud ter Meulen
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Correspondence to Julie Kent .

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Editors and Affiliations

  1. Humboldtallee 36, Göttingen, 37073, Germany

    Christian Lenk

  2. Central European University, Nádor utca 9, Budapest, 1051, Hungary

    Judit Sándor

  3. Dublin City University, Residences Campus, Glasnevin, Dublin 9, Ireland

    Bert Gordijn

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Kent, J., ter Meulen, R. (2011). Public Trust and Public Bodies: The Regulation of the Use of Human Tissue for Research in the United Kingdom. In: Lenk, C., Sándor, J., Gordijn, B. (eds) Biobanks and Tissue Research. The International Library of Ethics, Law and Technology, vol 8. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-1673-5_2

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