Skip to main content
SpringerLink
Log in

Ireland and the United Kingdom’s Approaches to Regulation of Research Involving Human Tissue

  • Chapter
  • First Online:
Biobanks and Tissue Research

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

  • 676 Accesses

Abstract

The Republic of Ireland (Ireland) and the United Kingdom (UK) share a common language, legal system, and membership of the European Union (EU) and Council of Europe (COE). However, there are also considerable cultural, social, economic, political, legal, religious, and moral differences between Ireland and the UK. These differences are reflected in Ireland and the UK’s domestic regulation of research involving human tissue. This chapter examines the extent to which international regulation affects a basic notion of political realism: that States take action based upon their national interests. Before examining Irish and UK domestic regulation, it is necessary to discuss EU and COE regulation of research involving human tissue.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Notes

  1. 1.

    For the purposes of this chapter, residual embryos created following in vitro fertilisation (IVF) will be included alongside human tissue. The issue as to whether or not they are considered human tissue is debatable.

  2. 2.

    See Donnelly (2000, 7).

  3. 3.

    See Hervey and McHale (2004, 77).

  4. 4.

    Art. 152(4)(a).

  5. 5.

    Directive 2004/23/EC (11).

  6. 6.

    Ibid.

  7. 7.

    Ibid.

  8. 8.

    Ibid., Art. 4(1).

  9. 9.

    Ibid., Art. 5.

  10. 10.

    Ibid., Art. 6.

  11. 11.

    Ibid., Art. 7.

  12. 12.

    Ibid., Art. 8.

  13. 13.

    Ibid., Art. 9.

  14. 14.

    Ibid., Art. 10.

  15. 15.

    Ibid., Art. 11.

  16. 16.

    Ibid., chap. III.

  17. 17.

    Ibid., chap. IV.

  18. 18.

    Ibid., chap. V.

  19. 19.

    Directive 2006/17/EC.

  20. 20.

    Commission Directive 2006/86/EC.

  21. 21.

    Available at: http://www.coe.int/t/dg3/healthbioethic/source/INF(2010)1%20%C3%A9tat%20sign%20ratif%20r%C3%A9serves.doc (accessed 07 March 2011).

  22. 22.

    Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Art. 15.

  23. 23.

    Convention on Human Rights and Biomedicine, Art. 16 and 17.

  24. 24.

    Ibid., Art. 18(1).

  25. 25.

    Ibid., Art. 18(2).

  26. 26.

    The Protocol does not apply to reproductive organs and tissue; embryonic or foetal organs and tissues; or to blood and blood derivatives. Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin, Art. 3.

  27. 27.

    Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin, Art. 2.

  28. 28.

    Ibid., Art. 4.

  29. 29.

    Ibid., Art. 6.

  30. 30.

    Ibid., chap. III.

  31. 31.

    Ibid., chap. IV.

  32. 32.

    Ibid., chap. VI.

  33. 33.

    For the purposes of this Protocol, the term “intervention” includes: a physical intervention, and any other intervention in so far as it involves a risk to the psychological health of the person concerned. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research, Art. 3.

  34. 34.

    This Protocol does not apply to research on embryos in vitro. It does apply to research on foetuses and embryos in vivo. Ibid., Art. 2.

  35. 35.

    Ibid., Art. 3.

  36. 36.

    Subject to the provisions of this Protocol and the other legal provisions ensuring the protection of the human being. Ibid., Art. 4.

  37. 37.

    Ibid., Art. 5.

  38. 38.

    European Communities (Quality and Safety of Human Tissue and Cells) Regulations 2006 (SI No 158 of 2006) transposes Directive 2004/23/EC and Directive 2006/17/EC; European Communities (Human Tissue and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007 (SI No 598 of 2007) transposes Directive 2006/86/EC.

  39. 39.

    See Byrne and McCutcheon (2001, 442–43) for further information on Irish statutory instruments.

  40. 40.

    See http://historical-debates.oireachtas.ie/S/0191/S.0191.200810010008.html (accessed 07 March 2011).

  41. 41.

    The Department of Health and Children (2009). Available at: http://www.dohc.ie/consultations/closed/human_tissue_bill/draft_proposals.pdf?direct=1 (accessed 07 March 2011).

  42. 42.

    See http://www.dohc.ie/consultations/closed/human_tissue_bill/covering_letter.pdf?direct=1 (accessed 07 March 2011).

  43. 43.

    Madden (2006b). Available at: http://www.dohc.ie/publications/madden.html (accessed 07 March 2011).

  44. 44.

    The Department of Health and Children (2009, 6).

  45. 45.

    Ibid., 6–7.

  46. 46.

    Ibid., 81.

  47. 47.

    Ibid., 89–97.

  48. 48.

    Ibid., 129.

  49. 49.

    Ibid.

  50. 50.

    Ibid.

  51. 51.

    Ibid., 132.

  52. 52.

    Ibid.

  53. 53.

    Ibid.

  54. 54.

    Ibid., 14.

  55. 55.

    Constitution of Ireland, Art. 40.3.3.

  56. 56.

    Madden (2006a, 33).

  57. 57.

    McDonnell and Allison (2006, 818).

  58. 58.

    Roche v.Roche & ors, Judgment of Mr. Justice Murray. (2009) IESC 82, 15 December 2009.

  59. 59.

    Constitution of Ireland, Art. 40.3.2.

  60. 60.

    Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.

  61. 61.

    The Charter of Fundamental Rights of the European Union (2000). Available at: http://www.europarl.europa.eu/charter/default_en.htm (accessed 07 March 2011).

  62. 62.

    UNGA Resolution 59/280 (2005). Available at: http://www.un.org/law/cloning/ (accessed 07 March 2011).

  63. 63.

    Roche v. Roche & ors, Judgment of Mr. Justice Hardiman (2009) IESC 82, 15 December 2009.

  64. 64.

    Roche v. Roche & ors, Judgment of Mr Justice Geoghegan (2009) IESC 82, 15 December 2009.

  65. 65.

    Roche v. Roche & ors, Judgment of Mr Justice Geoghegan (2009) IESC 82, 15 December 2009.

  66. 66.

    Roche v. Roche & ors, Judgment of Mr Justice Fennelly. (2009) IESC 82, 15 December 2009; Roche v. Roche & ors, Judgment of Mr Justice Geoghegan. (2009) IESC 82, 15 December 2009; Roche v. Roche & ors, Judgment of Mr Justice Hardiman. (2009) IESC 82, 15 December 2009.

  67. 67.

    Roche v. Roche & ors, Judgment of Mr Justice Fennelly. (2009) IESC 82, 15 December 2009.

  68. 68.

    Roche v. Roche & ors, Judgment of Mr Justice Fennelly. (2009) IESC 82, 15 December 2009.

  69. 69.

    Irish Medical Council (2009).

  70. 70.

    See McHale (2005, 169–71) and Price (2005, 798).

  71. 71.

    McHale (2005, 171–72).

  72. 72.

    Human Tissue Act 2004, Art. 1.

  73. 73.

    Ibid., Art. 13(1).

  74. 74.

    Ibid., Schedule 1, Part 1.

  75. 75.

    Ibid., Art. 1(1), (7), (8), (9) (10).

  76. 76.

    Ibid., Art. 1(1)(a).

  77. 77.

    Ibid., Art. 1(1)(b).

  78. 78.

    Ibid., Art. 1(1)(c).

  79. 79.

    “Relevant material” means material, other than gametes, which consists of or includes human cells. Human Tissue Act 2004, Art. 53(1).

  80. 80.

    Human Tissue Act 2004, Art .7(4).

  81. 81.

    Human Tissue (Scotland) Act 2006, Art. 3 and 17.

  82. 82.

    Ibid., Art. 54(1).

  83. 83.

    Ibid., Art. 3. In the Human Tissue (Scotland) Act 2006, the word “authorisation” is used instead of “consent.”

  84. 84.

    Ibid., Art. 28.

  85. 85.

    Statutory Instrument No. 1523, The Human Tissue (Quality and Safety for Human Application) Regulations 2007.

  86. 86.

    Statutory Instrument No. 1523, The Human Tissue (Quality and Safety for Human Application) Regulations 2007, Art. 1.

  87. 87.

    Statutory Instrument No. 1523, The Human Tissue (Quality and Safety for Human Application) Regulations 2007.

  88. 88.

    Human Fertilisation and Embryology Act 2008, Schedule 2(6).

  89. 89.

    Human Fertilisation and Embryology Act 2008, Schedule 2(6)(1).

  90. 90.

    In this Act, an “admixed embryo” is an embryo created by using a mixture of human and animal gametes, pronuclei or parts of each; or a human embryo that has been altered by the introduction of animal cells or DNA. Human Fertilisation and Embryology Act 2008, Art 4(6).

  91. 91.

    Human Fertilisation and Embryology Act 2008, Schedule 2(6)(3).

  92. 92.

    Ibid., Schedule 2(6)(3A)(2)(a),(b).

  93. 93.

    Ibid., Schedule 2(6)(3A)(2)(d).

  94. 94.

    Ibid., Schedule 2(6)(3A)(2)(e).

  95. 95.

    Ibid., Schedule 2(6)(3A)(2)(f).

  96. 96.

    Ibid., Schedule 2(6)(3A)(2)(g).

  97. 97.

    Ibid., Schedule 2(6)(3A)(2)(h).

  98. 98.

    See Ireland – Criminal Law (Suicide) Act 1993, Sec. 2 and UK – Suicide Act 1961, Sec. 2. Ireland – Non-Fatal Offences Against the Person Act 1997, Sec. 23 and UK – Family Law Act 1969, Sec. 8.

  99. 99.

    See Byrne and McCutcheon (2001, 52); Constitution of Ireland 1937.

  100. 100.

    The Constitution Review Group (1996, 221–22); Constitution of Ireland 1937, Art. 40.3.

  101. 101.

    For list of signatories, see http://conventions.coe.int/Treaty/Commun/ListeTableauCourt.asp?MA=3&CM=16&CL=ENG (accessed 08 March 2011).

  102. 102.

    Human Rights Act, 1998. Available at: http://www.opsi.gov.uk/acts/acts1998/ukpga_19980042_en_1#pb1-l1g1 (accessed 08 March 2011).

  103. 103.

    European Convention on Human Rights Act, 2003. Available at: http://www.irishstatutebook.ie/2003/en/act/pub/0020/index.html (accessed 08 March 2011).

  104. 104.

    See http://www.dohc.ie/publications/pdf/madden.pdf?direct=1 for the Madden Report from Ireland, and http://www.rlcinquiry.org.uk/ for the Redfern Report from the UK (accessed 08 March 2011).

  105. 105.

    Seanad Éireann. Volume 170. 4 December 2002. Adjournment Matters. Oviedo Convention.

  106. 106.

    Walters (2004, 5).

  107. 107.

    Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Art. 18(2).

  108. 108.

    Isasi and Bartha (2006, 16–17).

  109. 109.

    Ibid., 20; Caulfield (2003, 88).

  110. 110.

    Isasi and Bartha (2006, 22–23), Caulfield (2003, 89).

  111. 111.

    Dickenson (1999, 249).

  112. 112.

    Ibid., 255.

  113. 113.

    Ibid.

  114. 114.

    Ibid.

  115. 115.

    Gunning (1999, 166) and Caulfield (2003, 88).

  116. 116.

    Barrington (2002, 147).

  117. 117.

    Irish Census 2006 (2007, 102–06).

  118. 118.

    Madden (2006a, 33).

  119. 119.

    Ibid.

  120. 120.

    Ibid.

  121. 121.

    Cousins et al. (2005, 38).

  122. 122.

    Ibid.

  123. 123.

    Ibid.

  124. 124.

    Ibid.

  125. 125.

    Ibid.

  126. 126.

    See http://www.oireachtas.ie/viewdoc.asp?DocID=2365&&CatID=59&StartDate=01%2520January%25201999&OrderAscending=0 (accessed 08 March 2011).

  127. 127.

    See http://www.oireachtas.ie/viewdoc.asp?fn=/documents/bills28/bills/2008/4308/document1.htm (accessed 08 March 2011).

  128. 128.

    Irish Council for Bioethics (2005, 34).

  129. 129.

    Irish Council for Bioethics (2005, 36).

  130. 130.

    Plomer (2002, 137).

  131. 131.

    Ibid.

  132. 132.

    Ibid.

  133. 133.

    Mulkay (1997) quoted in Plomer (2002, 138).

  134. 134.

    Plomer (2002, 138).

  135. 135.

    McHale (2005, 186).

  136. 136.

    Ibid.

  137. 137.

    Price (2005, 819).

  138. 138.

    See Walin (2007, 147).

  139. 139.

    See: Braake (2004, 144), Walin (2007, 158).

References

  • Barrington, R. 2002. “Terrible Beauty or Celtic Mouse? The Research Agenda in Ireland.” New Hibernia Review 6: 138–50.

    Article  Google Scholar 

  • Braake, T. 2004. “The Dutch 2002 Embryos Act and the Convention on Human Rights and Biomedicine: Some Issues.” European Journal of Health Law 11:139–51.

    Article  Google Scholar 

  • Byrne, R., and J. P. McCutcheon 2001. The Irish Legal System. 4th edn. Dublin: Butterworths.

    Google Scholar 

  • Caulfield, T. 2003. “The Regulation of Embryonic Stem Cell Research: A Few Observations on the International Scene.” Health Law Journal (Special Issue) 87–95.

    Google Scholar 

  • Council of Europe. 2010. “Steering Committee on Bioethics.” Chart of Signatures and Ratifications. Accessed March 8, 2011. http://www.coe.int/t/dg3/healthbioethic/source/INF(2010)1%20%C3%A9tat%20sign%20ratif%20r%C3%A9serves.doc

  • Cousins, G. et al. 2005. Public Perception of Biomedical Research: A Survey of the General Population of Ireland. Ireland: Royal College of Surgeons.

    Google Scholar 

  • Dickenson, D. 1999. “Cross-Cultural Issues in European Bioethics.” Bioethics 13: 249–55.

    Article  Google Scholar 

  • Donnelly, J. 2000. Realism and International Relations. Cambridge: Cambridge University Press.

    Book  Google Scholar 

  • Gunning, J. 1999. “Article 18 of the European Biomedicine Convention: What Impact on Assisted Reproduction?” European Journal of Health Law 6: 165–71.

    Article  Google Scholar 

  • Hervey, T., and J. McHale 2004. Health Law and the European Union. Cambridge: Cambridge University Press.

    Book  Google Scholar 

  • Irish Census 2006. 2007. Volume 3 – Household Composition, Family Units and Fertility.

    Google Scholar 

  • Irish Council for Bioethics. 2005. “Bioethics Research.” Accessed March 8, 2011. http://www.bioethics.ie/uploads/docs/129171-Bioethics%20Research.pdf

  • Irish Medical Council. 2009. The Guide to Professional Conduct and Ethics for Registered Medical Practitioners. 7th edn.

    Google Scholar 

  • Isasi, R., and B. Knoppers 2006. “Mind the Gap: Policy Approaches to Embryonic Stem Cell and Cloning Research in 50 Countries.” European Journal of Health Law 13: 9–25.

    Article  Google Scholar 

  • Madden, D. 2006a. “Assisted Reproduction in the Republic of Ireland – A Legal Quagmire.” In Ethics, Law and Society, edited by J. Gunning and S. Holm , Vol. 2. Aldershot: Ashgate.

    Google Scholar 

  • Madden, D. 2006b. “Report of Dr Deirdre Madden on Post Mortem Practice and Procedures.” Accessed March 7, 2011. http://www.dohc.ie/publications/madden.html

  • McDonnell, O., and J. Allison 2006. “From Biopolitics to Bioethics: Church, State, Medicine and Assisted Reproductive Technology in Ireland.” Sociology of Health & Illness 28: 817–37.

    Article  Google Scholar 

  • McHale, J. 2005. “The Human Tissue Act 2004: Innovative Legislation – Fundamentally Flawed, or Missed Opportunity?” The Liverpool Law Review 26: 169–88.

    Article  Google Scholar 

  • Mulkay, M. 1997. The Embryo Research Debate: Science and the Politics of Reproduction. Cambridge: Cambridge University Press.

    Book  Google Scholar 

  • Plomer, A. 2002. “Beyond the HFE Act 1990: The Regulation of Stem Cell Research in the UK.” Medical Law Review 10: 132–64.

    Article  Google Scholar 

  • Price, D. 2005. “The Human Tissue Act 2004.” The Modern Law Review 68: 798–821.

    Article  Google Scholar 

  • Redfern, M. 1999. “The Royal Liverpool Children’s Inquiry.” Accessed March 8, 2011. http://www.rlcinquiry.org.uk/

  • Senead, Éireann. Volume 170. 4 December 2002. Adjournment Matters. Oviedo Convention.

    Google Scholar 

  • The Constitution Review Group. 1996. Report of the Constitution Review Group. Dublin: Stationary Office.

    Google Scholar 

  • The Department of Health and Children. 2009. “Draft Proposals for General Scheme of the Human Tissue Bill 2009.” Accessed March 8, 2011. http://www.dohc.ie/consultations/closed/human_tissue_bill/

  • Walin, L. 2007. “Ambiguity of the Embryo Protection in the Human Rights and Biomedicine Convention: Experience from the Nordic Countries.” European Journal of Health Law 14: 131–48.

    Article  Google Scholar 

  • Walters, L. 2004. “Human Embryonic Stem Cell Research: An Intercultural Perspective.” Kennedy Institute of Ethics Journal 14: 3–38.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Institute of Ethics, Dublin City University, Dublin, Ireland

    Elizabeth Yuko & Bert Gordijn

  2. School of Law and Government, Dublin City University, Dublin, Ireland

    Adam McAuley

Authors
  1. Elizabeth Yuko
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Adam McAuley
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Bert Gordijn
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Elizabeth Yuko .

Editor information

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

Rights and permissions

Reprints and permissions

Copyright information

© 2011 Springer Science+Business Media B.V.

About this chapter

Cite this chapter

Yuko, E., McAuley, A., Gordijn, B. (2011). Ireland and the United Kingdom’s Approaches to Regulation of Research Involving Human Tissue. 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_11

Download citation

  • DOI: https://doi.org/10.1007/978-94-007-1673-5_11

  • Published:

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-007-1672-8

  • Online ISBN: 978-94-007-1673-5

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation