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Law and Clinical Research — From Rights to Regulation? An English Perspective

Published online by Cambridge University Press:  01 January 2021

J.V. McHale
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Extract

The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally. Each area of research on human subjects has been the subject of a vast academic literature and extensive public policy debate, from issues of informed consent to that of regulatory structures. Professor Bernard Dickens has provided an outstanding contribution to this debate internationally through his many innovative and incisive papers in this area. This paper provides an English lawyer’s perspective upon the increasing regulation of clinical research practices and asks – does regulation equate with effective rights protection? From Nuremberg onwards, there has been concern to ensure that research practices are ethical and in accordance with legal principles. So, for example, there have been statements such as the Declaration of Helsinki, which was initially produced in 1964. In the European context in particular, notably influential statements have been the European Convention on Human Rights, which has been followed by the Council of Europe Convention on Human Rights and Biomedicine and, more recently, a Draft Additional Protocol on medical research.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 32 , Issue 4 , Winter 2004 , pp. 718 - 730
Copyright
Copyright © American Society of Law, Medicine and Ethics 2004

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References

On the legal regulation of clinical research in the U.K., see generally Grubb, A., Kennedy and Grubb Medical Law, 3d ed. (London:Butterworths, 2000); Mason, J.K., Smith, McCall R.A., and Laurie, G., Law and Medical Ethics, 6th ed., (London: Butterworths, 2002) (chapters 19 and 20); Montgomery, J. Health Care Law, 2d ed. (Oxford:OUP, 2002); Fox, M., “Clinical Research and Patient: The Legal Perspective” in Tingle, J. and Cribb, A., eds., Nursing Law and Ethics, 2d ed. (Oxford: Blackwell Scientific, 2002); McHale, J.V. “Clinical Research” in Grubb, A., ed., Principles of Medical Law, 2d ed. (Oxford:OUP, 2004); McHale, J.V. and Miola, J. “Liability for and Insurability of Biomedical Research: Health Law Aspects in England” in Dute, J., Faure, M.G. and Koziol, H. eds. Liability fir and Insurability of Biomedical Research with Human Subjects in a Comparative Perspective (Springer Wien 2004). For further detailed discussion regarding the interface with the ethical debate, see Foster, C. The Ethics of Medical Research on Humans (Cambridge: CUP 2001); Manual for Research Ethics Committees (London: Kings College, 2002).Google Scholar
See for example, “The Challenge of Equivalent Protection,” in Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, vol. II (Commissioned Papers and Staff Analyses, Bethesda, Maryland:National Bioethics Advisory Commission, 2001): at A1; Dickens, B.M. “Governance Relations in Biomedical Research,” in Law Commission of Canada, The Governance of Health Research Involving Human Subjects (Ottawa: Law Commission of Canada, 2000): at 93; “The Legal Challenge of Health Research Involving Children,” Health Law Journal 6 (1998): 131–148; Dickens, B.M. “Human Research Beyond the Medical Model: Legal and Ethical Issues,” Medicine and Law 16 (1997): 687–703; Dickens, B.M. “Introduction to the Draft Revised Guidelines” in Bankowski, Z. and Levine, R.J., eds., Ethics and Research on Human Subjects: International Guidelines (Geneva:Council for International Organizations of Medical Sciences (W.H.O.), 1993): at 11; Dickens, B.M. “Legal Issues in Embryo and Fetal Tissue Research and Therapy.” in Background and Current Practice of Fetal Tissue and Embryo Research in Canada, vol. 15 (Research Studies of the Royal Commission on New Reproductive Technologies, Ottawa, 1993): at 43.Google Scholar
Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964.Google Scholar
Council of Europe Steering Committee on Bioethics, Draft Additional Protocol to the Convention on Human Rights and Biomedicine on Biomedical Research (Strasbourg, June 23, 2003, CDBI/INF). On the background to the Convention and its scope, see Zilgalvis, P., “The European Convention on Human Rights and Biomedicine: Its Past, Present and Future,” in Garwood-Gowers, A., Tingle, J., and Lewis, T., Healthcare Law: The Impact of the Human Rights Act 1998 (London:Cavendish, 2001). Further recent guidance includes the Council for International Organisations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS: Geneva 2002).Google Scholar
Martin, J. “The Principles of the Rights of Patients in Europe: A Commentary,” European Journal of Health Law (1994): 265 and see Fallsberg, L., “Patients’ Rights in Europe: Where Do We Stand and Where Do We Go?” European Journal of Health Law 7 (2000): 1.CrossRefGoogle Scholar
Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ 2001 L 121/34).Google Scholar
See Baeyens, A., “Implementation of the Clinical Trials Directive: Pitfalls and Benefits,” European Journal of Health Law 9, no. 1 (2002): 31–47; Hervey, T. and McHale, J., Health Law and the European Union (Cambridge: CUP, 2004) (chapter 7).Google Scholar
See Hervey, T. and McHale, J. note 7 above, chapters 1 and 10.Google Scholar
Jones, J., Bad Blood: The Tuskeegee Syphilis Experiment (New York: The Free Press, 1981).Google Scholar
“News: Death of Research Volunteer at Johns Hopkins,” Bulletin of Medical Ethics (September 2001): at p3.Google Scholar
Id. at 7Google Scholar
Report of the Inquiry into the Royal Liverpool Children’s Hospital (Alder Hey 2001), available at <http://www.rclinquiry.org.uk>; Bristol Inquiry Interim Report, Removal and Retention of Human Material (2000), available at <http://www.bristol-in-quiry.org.uk>.;+Bristol+Inquiry+Interim+Report,+Removal+and+Retention+of+Human+Material+(2000),+available+at+.>Google Scholar
Griffiths, R., Report of a Research Framework in North Staffordshire NHS Trust (NHS Executive West Midlands Regional Office, 2001).Google Scholar
Guideline 3.Google Scholar
See, e.g, Megone, C. et al, “The Structure, Composition and Operation of European Research Ethics Committees,” in Mason, S. and Megone, C., eds, European Neonatal Research: Consent, Ethics Committees and Law (Aldershot:Ashgate, 2001); Nys, H., “Ethical Committees in Belgium” European Journal of Health Law 2 (1995): 175–190; Papadatos, Garanis T. and Vorgia, Dalla P, “Ethical Review Procedures for Clinical Trials in Greece,” European Journal of Health Law 7 (2000): 441–446; Glass, J., ed, Ethics Committees in Central and Eastern Europe (Limbova: Institute of Medical Ethics and Bioethics Foundation, 2001); McDonald, M. “Canadian Governance of Health Research Involving Human Subjects: Is Anybody Minding the Store?” Health Law Journal 9 (2001): 8, at 2.Google Scholar
See McHale, J.V. “Guidelines for Medical Research: Some Ethical and Legal Problems” (1993) 1 Medical Law Review 1 (1993):160–186.CrossRefGoogle Scholar
Governance Arrangements for Research Ethics Committees, London, DOH (2001). Paragraph 3.1.Google Scholar
Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ 2001 L 121/34).Google Scholar
Article 9(1)(2).Google Scholar
Note 17 above at paragraph 5.3Google Scholar
Id. at paragraph 5.10.Google Scholar
Paragraph 5.10.Google Scholar
Paragraph 5.11.Google Scholar
Paragraph 6.1.Google Scholar
Paragraph 6.2.Google Scholar
Paragraph 6.3.Google Scholar
Paragraph 6.4.Google Scholar
Which is stated to include hospital and community staff and general practice.Google Scholar
Paragraph 6.15.Google Scholar
Paragraph 6.5.Google Scholar
Paragraph 6.6.Google Scholar
Paragraph 6.7.Google Scholar
Paragraph 6.8.Google Scholar
Department of Health Research Governance Framework for Health and Social Care 2001, available at <http://www.doh.gov.uk/research>; Department of Health Governance Arrangements for Research Ethics Committees (2001) at paragraph 4.5.;+Department+of+Health+Governance+Arrangements+for+Research+Ethics+Committees+(2001)+at+paragraph+4.5.>Google Scholar
Paragraph 6.10.Google Scholar
Paragraph 3.12.8.Google Scholar
Governance Arrangements for RECs; Paragraph 7.24.Google Scholar
Id. at paragraph 7.33Google Scholar
Note also the criticism given to the availability of resources to research ethics boards in Canada in McDonald note 16 above at page 12.Google Scholar
Declaration of Helsinki.Google Scholar
See, for example, in the U.K. context in relation to embryo research the Human Fertilisation and Embryology Act 1990.Google Scholar
Article 2(j)Google Scholar
See generally the discussion in Laurie, G., Genetic Privacy (CUP, 2002); O’Neil, O. “Some Limits of Informed Consent,” Journal of Medical Ethics 29 (2003): 4–7CrossRefGoogle Scholar
Re F [1990] 2 AC 1.Google Scholar
Re Y [1996] 2 FLR 787.Google Scholar
Law Commission, Mental Incapacity LCR 235 (1995); see generally Lewis, P. “Procedures that are Against the Medical Interests of Incompetent Adults,” Oxford Journal of Legal Studies 22 (2002):575–618, at 578.Google Scholar
Paragraph 6.34.Google Scholar
Paragraph 6.33.Google Scholar
Paragraph 6.37.Google Scholar
Cm 4465.Google Scholar
Directive 2001/20/EC, article5Google Scholar
Directive 2001/20/EC, article 6 (3)(g).Google Scholar
Id. at article 5(c).Google Scholar
Id. at article 5(f).Google Scholar
Id. at article 5(g).Google Scholar
Id. at article 5(h).Google Scholar
Medicines for Human Use (Clinical Trials) Regulations 2004 SI No 1031.Google Scholar
See further the discussion in McHale (2004) note 1 above.Google Scholar
Note 57 above Regulations 14–16 and Part 3 and 5 of Schedule 1.Google Scholar
Id.Google Scholar
See discussion in McHale (2004) note 1 aboveGoogle Scholar
Clause 30 (4).Google Scholar
Clause 32(8).Google Scholar
See Richardson, R. “Fearful Symmetry: Corpses for Anatomy, Organs for Transplantation?” in Youngner, S. J., Fox, R. C., and O’Connell, L. J., eds, Organ Transplantation Meanings and Realities (Madison: University of Wisconsin Press, 1996).Google Scholar
Report of the Inquiry into the Royal Liverpool Children’s Hospital (Alder Hey, 2001), available at <http://www.rclinquiry.org.uk>; Bristol Inquiry Interim Report, Removal and Retention of Human Material (2000), available at <http://www.bristol-in-quiry.org.uk>.;+Bristol+Inquiry+Interim+Report,+Removal+and+Retention+of+Human+Material+(2000),+available+at+.>Google Scholar
See further Dickens, B., “Donation and Transplantation” in Grubb, A., ed., Principles of Medical Law, 2d. ed. (Oxford: OUP, 2004); Skegg, P.D.K. “Human Corpses, Medical Specimens and the Law of Property” Anglo-American Law Review 4 (1976) 412–425; Matthews, P. “Whose Body: People As Property,” Current Legal Problems 36 (1983): 193–239; D. Price Legal and Ethical Aspects of Organ Transplantation (Cambridge: CUP 2000) 121–159.Google Scholar
See generally on the issue of property and human material, for example, Grubb, A., “I Me Mine; Bodies, Parts and Property,” Medical Law International 6 (1998): 299–317; Dworkin, G. and Kennedy, I., “Human Tissue Rights in the Body and its Parts,” Medical Law Review 1 (1993): 291–319; Laurie, G. and Mason, J.K., “Consent or Property: Dealing with the Body and its Parts in the Shadow of Bristol and Alder Hey,” Modern Law Review 64 (2001): 710–729.CrossRefGoogle Scholar
Exelby v Handyside (1749) 2 East PC 652.; Williams v. Williams (1882) Ch.D. 659; Matthews, , supra note 62; Matthews, P., “The Man of Property,” Medical Law Review 3 (1995): 251–274.CrossRefGoogle Scholar
R. v. Welsh (1974) R.T.R. 478; R. v. Luff (1960) Times 13 December, R. v. Herbert (1960) Times 22 December; R. v. Kelly (1998) 3 All. E.R. 741.Google Scholar
Doodeward v. Spence (1908) 6 C.L.R. 406; Dobson v. North Tyneside HA (1996) 4 All. E.R. 474.Google Scholar
R. v. Kelly (1998) 3 All ER 741.Google Scholar
Emson, H.E. “It is Immoral to Require Consent for Cadaver Organ Donation,” Journal of Medical Ethics 29 (2003): 125–127.CrossRefGoogle Scholar
Savulescu, J., “Death, Us and Our Bodies: Personal Reflections,” Journal of Medical Ethics 29 (2003): 127–130Google Scholar
Brazier, M. “Retained Organs: Ethics and Humanity,” Legal Studies 22 (2002): 550.CrossRefGoogle Scholar
See, e.g., Laurie, and Mason, supra note 63.Google Scholar
Moore v Regents of the University of California, 793 P.2d 479 (Supreme Court of California 1990); see generally Dickens, B. “Living Tissue and Organ Donors and Property Law; More on Moore,” Journal of Contemporary Health Law and Policy (1992): 73–93.Google Scholar
On the controversy regarding commodification of human material see for example Wilkinson, S. Bodies for Sale: ethics and exploitation in the human body trade London:Routledge (2003) Richard Titmus The Gift Relationship: From Human Blood to Social Policy London: Allen and Unwin (1970) and. Duxbury, N. “Do Markets Degrade,” Modern Law Review 59 (1996): 331–356.Google Scholar
See, e.g., Medical Research Council Public Perceptions (London: MRC, 2001).Google Scholar
Human Bodies: Human Bodies DOH 2002; Price, D., “From Cosmos and Damien to Van Velzen: The Human Tissue Saga Continues,” Medical Law Review 11 (2003): 1–47.Google Scholar
Section 54.Google Scholar
Section 53(2).Google Scholar
Specific offences are included, such as possession of an anatomical offence away from licensed premises, s.30. Section 32, which originally prohibited trafficking in human material was redrafted to prohibit trafficking in material used for transplantation. This raises interesting issues which go beyond the scope of this article.Google Scholar
Section 3.Google Scholar
Section 4.Google Scholar
Section 6.Google Scholar
Independent Review Group, Retention of Organs at Post Mortem (Final Report) (Edinburgh: Stationary Office, 2001.Google Scholar
Id. at 16.Google Scholar
Furniss, P. and Sullivan, R. “The Human Tissue Bill: Criminal Sanctions Linked to Opaque Legislation Threaten Research,” British Medical Journal 328 (2004): 533–534.Google Scholar
Nuffield Council on Bioethics, Human Tissue: Ethical and Legal Issues (1995).Google Scholar
McHale, J., “Waste, Ownership and Bodily Products,” Health Care Analysis 8 (2000): 123–135.CrossRefGoogle Scholar
AB v Leeds Teaching Hospital NHS Trust (2004) EWHC 644.Google Scholar
Reconfiguring the Department of Health’s Arms-Length Bodies (London: Department of Health, 2004).Google Scholar
Id. at paragraph 10.Google Scholar
Directive 2004/23/EC of the European Parliament and of the Council of the 31st March 2004 setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells OJ L 102, 07/04/2004.Google Scholar
Case, P. “The Rise and Fall of Informational Autonomy in Medical Law,” Medical Law Review 11 (2003): 208–236.CrossRefGoogle Scholar