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

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).

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.

Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964.

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).

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.

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).

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).

See Hervey T. and McHale J. note 7 above, chapters 1 and 10.

Jones J. , Bad Blood: The Tuskeegee Syphilis Experiment (New York: The Free Press, 1981).

“News: Death of Research Volunteer at Johns Hopkins,” Bulletin of Medical Ethics (September 2001): At p3.

Id. at 7

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>.

Griffiths R. , Report of a Research Framework in North Staffordshire NHS Trust (NHS Executive West Midlands Regional Office, 2001).

Guideline 3.

See, e.g, Megone C. , “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.

See McHale J.V. “Guidelines for Medical Research: Some Ethical and Legal Problems” (1993) 1 Medical Law Review 1 (1993):160–186.

Governance Arrangements for Research Ethics Committees, London, DOH (2001). Paragraph 3.1.

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 L121/34).

Article 9(1)(2).

Note 17 above at paragraph 5.3

Id. at paragraph 5.10.

Paragraph 5.10.

Paragraph 5.11.

Paragraph 6.1.

Paragraph 6.2.

Paragraph 6.3.

Paragraph 6.4.

Which is stated to include hospital and community staff and general practice.

Paragraph 6.15.

Paragraph 6.5.

Paragraph 6.6.

Paragraph 6.7.

Paragraph 6.8.

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.

Paragraph 6.10.

Paragraph 3.12.8.

Governance Arrangements for RECs; Paragraph 7–24.

Id. at paragraph 7–33

Note also the criticism given to the availability of resources to research ethics boards in Canada in McDonald note 16 above at page 12.

Declaration of Helsinki.

See, for example, in the U.K. context in relation to embryo research the Human Fertilisation and Embryology Act 1990.

Article 2(j)

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): 4–7

Re F [1990] 2 AC 1.

Re Y [1996] 2 FLR 787.

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.

Paragraph 6.34.

Paragraph 6.33.

Paragraph 6.37.

Cm 4465.

Directive 2001/20/EC, article5

Directive 2001/20/EC, article 6 (3)(g).

Id. at article 5(c).

Id. at article 5(f).

Id. at article 5(g).

Id. at article 5(h).

Medicines for Human Use (Clinical Trials) Regulations 2004 SI No 1031.

See further the discussion in McHale (2004) note 1 above.

Note 57 above Regulations 14–16 and Part 3 and 5 of Schedule 1.

Id.

See discussion in McHale (2004) note 1 above

Clause 30 (4).

Clause 32(8).

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).

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>.

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.

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.

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.

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.

Doodeward v. Spence (1908) 6 C.L.R. 406; Dobson v. North Tyneside HA (1996) 4 All. E.R. 474.

R. v. Kelly (1998) 3 All ER 741.

Emson H.E. “It is Immoral to Require Consent for Cadaver Organ Donation,” Journal of Medical Ethics 29 (2003): 125–127.

Savulescu J. , “Death, Us and Our Bodies: Personal Reflections,” Journal of Medical Ethics 29 (2003): 127–130

Brazier M. “Retained Organs: Ethics and Humanity,” Legal Studies 22 (2002): 550.

See, e.g., Laurie and Mason supra note 63.

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.

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.

See, e.g., Medical Research Council Public Perceptions (London: MRC, 2001).

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.

Section 54.

Section 53(2).

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.

Section 3.

Section 4.

Section 6.

Independent Review Group, Retention of Organs at Post Mortem (Final Report) (Edinburgh: Stationary Office, 2001.

Id. at 16.

Furniss P. and Sullivan R. “The Human Tissue Bill: Criminal Sanctions Linked to Opaque Legislation Threaten Research,” British Medical Journal 328 (2004): 533–534.

Nuffield Council on Bioethics, Human Tissue: Ethical and Legal Issues (1995).

McHale J. , “Waste, Ownership and Bodily Products,” Health Care Analysis 8 (2000): 123–135.

AB v Leeds Teaching Hospital NHS Trust (2004) EWHC 644.

Reconfiguring the Department of Health's Arms-Length Bodies (London: Department of Health, 2004).

Id. at paragraph 10.

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.

Case P. “The Rise and Fall of Informational Autonomy in Medical Law,” Medical Law Review 11 (2003): 208–236.