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

  • Julie Kent
  • Ruud ter Meulen
Chapter
Part of the The International Library of Ethics, Law and Technology book series (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.

Keywords

National Health Service Stem Cell Research Fetal Tissue Stem Cell Line Public Trust 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

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).

References

  1. Ashcroft, R., and N. Pfeffer. 2001. “Ethics Behind Closed Doors: Do Research Ethics Committees Need Secrecy?” British Medical Journal 322 (7297): 1294–96.PubMedCrossRefGoogle Scholar
  2. Beeson, D., and A. Lippman. 2006. “Egg Harvesting for Stem Cell Research: Medical Risks and Ethical Problems.” Accessed February 25, 2011. http://www.rbmonline.com edn
  3. Bristol Royal Infirmary Inquiry. 2000. Interim Report, Removal and Retention of Human Material: Annex and Annex B. London: Central Office of Information.Google Scholar
  4. Bristol Royal Infirmary Inquiry. 2001. Learning from Bristol; the Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984–1995. London: HSMO.Google Scholar
  5. Brown, N., A. Faulkner, J. Kent, and M. Michael. 2006. “Regulating Hybrids: ‘Making a Mess’ and ‘Cleaning Up’ in Tissue Engineering and Transpecies Transplantations.” Social Theory and Health 4: 1–24.CrossRefGoogle Scholar
  6. Brown, N., and M. Michael. 2004. “Risky Creatures: Institutional Species Boundary Change in Biotechnology Regulation.” Health, Risk and Society 6 (3): 207–22.CrossRefGoogle Scholar
  7. Busby, H. 2006. “Biobanks, Bioethics and Concepts of Donated Blood in the UK.” Sociology of Health & Illness 28 (6): 850–65.CrossRefGoogle Scholar
  8. Busby, H. 2010a. “The Meanings of Consent to the Donation of Cord Blood Stem Cells: Perspectives from an Interview-Based Study of a Public Cord Blood Bank in England.” Clinical Ethics 5: 22–27.PubMedCrossRefGoogle Scholar
  9. Busby, H. 2010b. “Trust, Nostalgia and Narrative Accounts of Blood Banking in England in the Twenty First Century Health.” An Interdisciplinary Journal for the Social Study of Health, Illness and Medicine 14 (4): 364–382.Google Scholar
  10. Capps, B., A. Campbell, and R. ter Meulen. 2008. Access to the UK Biobank Resources: Concepts of the Public Interest and the Public Good. UK: Biobank. Accessed February 25, 2011. http://www.egcukbiobank.org.uk/meetingsandreports/ Google Scholar
  11. Department of Health. 2001. Governance Arrangements for Research Ethics Committees. London: Department of Health.Google Scholar
  12. Department of Health. 2002. Human Bodies, Human Choices: The Law on Human Organs and Tissue in England and Wales – A Consultation Report. London: Department of Health.Google Scholar
  13. Department of Health. 2005. NHS Research Governance Framework. London: Department of Health.Google Scholar
  14. Department of Health. 2010. Liberating the NHS: Report of the Arms-Length Bodies Review. London.Google Scholar
  15. Devaney, S. 2008. “Breaches in Good Regulatory Practice – The HFEA Policy on Compensated Egg Sharing for Stem Cell Research.” Clinical Ethics 3 (1): 20–24.CrossRefGoogle Scholar
  16. Dickenson, D. 2006. “The Lady Vanishes: What’s Missing Form the Stem Cell Debate.” Bioethical Inquiry 3: 43–54.CrossRefGoogle Scholar
  17. Dickenson, D. 2007. Property in the Body: Feminist Perspectives. Cambridge: Cambridge University Press.CrossRefGoogle Scholar
  18. Dixon-Woods, M., E. Angell, R. Ashcroft, and A. Bryman. 2007. “Written Work: The Social Functions of Research Ethics Committee Letters.” Social Science and Medicine 65 (4): 792–802.PubMedCrossRefGoogle Scholar
  19. Eckstein, S. 2007. “Research Ethics Committees.” In Good Clinical, Laboratory and Manufacturing Practices Techniques for the QA Professional, edited by N. Dent and P. Carson, 99–108. Cambridge, UK: The Royal Society of Chemistry.CrossRefGoogle Scholar
  20. Farrell, A.. 2006. “Is the Gift Still Good? Examining the Politics and Regulation of Blood Safety in the European Union.” Medical Law Review 14 (2): 155–79.PubMedCrossRefGoogle Scholar
  21. Faulkner, A., J. Kent, I. Geesink, and D. Fitzpatrick. 2006. “Purity and the Dangers of Regenerative Medicine: Regulatory Innovation of Human Tissue-Engineered Technology.” Social Science & Medicine 63: 2277–88.CrossRefGoogle Scholar
  22. Hoeyer, K. 2009. “Tradable Body Parts? How Bone and Recycled Prosthetic Devices Acquire a Price Without Forming a ‘Market’.” BioSocieties 4: 239–56.CrossRefGoogle Scholar
  23. Hoeyer, K.. 2010. “An Anthropological Analysis of European Union (EU) Health Governance as Biopolitics: The Case of the EU Tissues and Cells Directive.” Social Science & Medicine 70 (12): 1867–73.CrossRefGoogle Scholar
  24. Human Fertilisation and Embryology Authority. 2006. Donating Eggs for Research: Safeguarding Donors. London: HFEA.Google Scholar
  25. Human Fertilisation and Embryology Authority. 2007a. “Hybrids and Chimeras: A Report on the Findings of a Consultation.” Accessed February 25, 2011. http://www.hfea.gov.uk/docs/Hybrids_Report.pdf
  26. Human Fertilisation and Embryology Authority. 2007b. Statement on Donating Eggs for Research. London: HFEA, February 21.Google Scholar
  27. Human Tissue Authority. 2006. Code of Practice 1: Consent. London: Human Tissue Authority.Google Scholar
  28. Human Tissue Authority. 2009a. Code of Practice 1: Consent. London: Human Tissue Authority.Google Scholar
  29. Human Tissue Authority. 2009b. Code of Practice 5: Disposal of Human Tissue. London: Human Tissue Authority.Google Scholar
  30. Human Tissue Authority. 2009c. Code of Practice 9: Research. London: Human Tissue Authority.Google Scholar
  31. Jasanoff, S. 2005. Designs on Nature: Science and Democracy in Europe and the United States. Oxford: Princeton University Press.Google Scholar
  32. Kent, J. 2008. “The Fetal Tissue Economy: From the Abortion Clinic to the Stem Cell Laboratory.” Social Science & Medicine 67: 1747.CrossRefGoogle Scholar
  33. Kent, J. 2009. “Enabling Stem Cell Science in the UK? A Short History of a Regulatory Maze, Beyond Pattison.” Stem Cell Initiative Final Conference, Wellcome Trust, London, May 2009.Google Scholar
  34. Kent, J. 2012. Regenerating Bodies: Tissue and Cell Therapies in the 21st Century. Abingdon: Routledge.Google Scholar
  35. Mclean, S., A. Campbell, H. Harper, and K. Gutridge. 2005. Scoping Study: Ethical and Practical Concerns Regarding Changes to Human Tissues Legislation. Bristol: University of Bristol; Glasgow: University of Glasgow.Google Scholar
  36. Mulkay, M. 1997. The Embryo Research Debate Science and Politics of Reproduction. Cambridge: Cambridge University Press.CrossRefGoogle Scholar
  37. Nuffield Council on Bioethics. 1995. “Human Tissue Ethical and Legal Issues.” Available at: http://www.nuffieldbioethics.org/sites/default/files/Human%20tissue (accessed 14 March 2011).
  38. Opinion Leader. 2009. Impact of Legislation and Human Tissue Authority Regulation on Research. London: Human Tissue Authority.Google Scholar
  39. O’neill, O. 2003. “Some Limits of Informed Consent.” Journal of Medical Ethics 29: 4–7.PubMedCrossRefGoogle Scholar
  40. O’reilly, M., M. Dixon-Woods, E. Angell, R. Ashcroft, and A. Bryman. 2009. “Doing Accountability: A Discourse Analysis of Research Ethics Committees’ Letters.” Sociology of Health & Illness 31 (2): 246–61.CrossRefGoogle Scholar
  41. Parry, S.. 2006. “(Re)constructing Embryos in Stem Cell Research: Exploring the Meaning of Embryos for People Involved in Fertility Treatments.” Social Science and Medicine 62 (10): 2349–59.PubMedCrossRefGoogle Scholar
  42. Pfeffer, N., and J. Kent. 2006. “Consent to the Use of Aborted Fetuses in Stem Cell Research and Therapies.” Clinical Ethics 1 (4): 216–18.CrossRefGoogle Scholar
  43. Pfeffer, N., and J. Kent. 2007. “Framing Women, Framing the Fetus: how Britain Regulates the Collection and Use of Aborted Fetuses in Stem Cell Research and Therapies.” BioSocieties 2 (4): 429–47.CrossRefGoogle Scholar
  44. Polkinghorne, J. 1989. Review of the Guidance on the Research Use of Fetuses and Fetal Material. Cm 762. London: HMSO.Google Scholar
  45. Roberts, C., and K. Throsby. 2008. “Paid to Share: IVF Patients, Eggs and Stem Cell Research.” Social Science and Medicine 66 (1): 159–69.PubMedCrossRefGoogle Scholar
  46. Royal College of Nursing. 2002. Sensitive Disposal of Fetal Remains. London: Royal College of Nursing.Google Scholar
  47. Royal College of Obstetricians and Gynaecologists. 2004. Response to MRC Draft Code of Practice for the UK Stem Cell Bank. London: RCOG.Google Scholar
  48. Royal College of Obstetricians and Gynaecologists. 2005. RCOG Ethics Committee Response to the Department of Health Review of the Human Fertilisation and Embryology Act. London: RCOG.Google Scholar
  49. Royal College of Obstetricians and Gynaecologists and Royal College of Pathologists. 2001. Fetal and Perinatal Pathology Report of a Joint Working Party. London: RCOG.Google Scholar
  50. Royal Liverpool Children’s Inquiry. 2001. Report Ordered by the House of Commons. London: The Stationary Office.Google Scholar
  51. Salter, B., and C. Salter. 2007. “Bioethics and the Global Moral Economy: The Cultural Politics of Human Embryonic Stem Cell Science.” Science, Technology & Human Values 32 (5): 554–81.CrossRefGoogle Scholar
  52. Scheper-Hughes, N. 2006. “Alistair Cooke’s Bones: A Morality tale.” Anthropology Today 22 (6): 10–15.CrossRefGoogle Scholar
  53. The Academy of Medical Sciences. 2010. Reaping the Rewards: A Vision for UK Medical Science. London: Academy of Medical Sciences. http://www.acmedsci.ac.uk
  54. Waldby, C. 2006. “Umbilical Cord Blood: from Social Gift to Venture Capital.” Biosocieties 1: 55–70.CrossRefGoogle Scholar
  55. Waldby, C., and R. Mitchell. 2006. Tissue Economies: Blood, Organs and Cell Lines in Late Capitalism. Durham: Duke University Press.Google Scholar

Copyright information

© Springer Science+Business Media B.V. 2011

Authors and Affiliations

  1. 1.Department of Health and Applied Social Science, Faculty of Health and Life SciencesUniversity of the West of EnglandBristolUK
  2. 2.School of Social and Community Medicine, Centre for Ethics in Medicine, University of BristolBristolUK

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