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Innovation, informed consent, health research and the Supreme Court: Montgomery v Lanarkshire – a brave new world?

Published online by Cambridge University Press:  27 April 2017

Jean V. Mchale*
Affiliation:
Centre for Health Law, Science and Policy, Birmingham Law School, University of Birmingham, Birmingham, UK
*
*Correspondence to: Jean V. McHale, Centre for Health Law, Science and Policy, Birmingham Law School, University of Birmingham, Birmingham B15 2TT, UK. Email: [email protected]

Abstract

The Supreme Court decision in Montgomery v Lanarkshire ([2015] UKSC11) has been hailed as a landmark not least because the Court enshrines the doctrine of informed consent formally into English law for the first time in relation to medical treatment. This paper explores the decision in Montgomery. It examines what its implications may be in the future for the consent process in relation to health research and innovative treatment and whether it may prove a watershed moment leading to changing dialogues and expectations in relation to consent. First, the paper explores the concept of ‘informed consent’ in clinical research as seen through international, Council of Europe and EU instruments. Second, it considers how English law currently governs the provision of information to research participants in the context of clinical research. It questions whether such an approach will be sustainable in the future. Third, it discusses the decision of the UK Supreme Court in Montgomery v Lanarkshire and asks what might be the impact of this Supreme Court decision in the health research context. It asks whether Montgomery may result in new approaches to consent in health research and innovative treatment.

Type
Articles
Copyright
© Cambridge University Press 2017 

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References

Biggs, H. (2009), Healthcare Research Ethics and Law, Abingdon, Oxon: Routledge Cavendish.CrossRefGoogle Scholar
Brazier, M. (1987), ‘Patient autonomy and consent to treatment’, Legal Studies, 1: 169.CrossRefGoogle Scholar
Case, P. (2003), ‘Confidence matters: the rise and fall of informational autonomy in medical law’, Medical Law Review, 11: 208.CrossRefGoogle ScholarPubMed
Cassell, J. and Young, A. (2002), ‘Why we should no seek individual informed consent for participation in health service research’, Journal of Medical Ethics, 28: 313.CrossRefGoogle Scholar
Department of Health (2005), Research Governance Framework for Health and Social Care, 2nd edn, London: DoH.Google Scholar
Farrell, A. M. and Brazier, M. R. (2016), ‘Not so new directions in the law of consent? Examining Montgomery v Lanarkshire Health Board’, Journal of Medical Ethics, 42: 8588.CrossRefGoogle Scholar
Feng, T. K. (1987), ‘Failure of medical advice: trespass or negligence?Legal Studies, 1: 149.CrossRefGoogle Scholar
General Medical Council (2008), Consent Guidance: Patients and Doctors Making Decisions Together, London: GMC.Google Scholar
General Medical Council (2013), Good Medical Practice Guidance ‘Communicate Effectively’, London: GMC.Google Scholar
Heywood, R. (2015), ‘RIP Sidaway: patient oriented disclosure – a standard worth waiting for’, Medical Law Review, 23(3): 455466.CrossRefGoogle Scholar
Hobson, C. (2016), ‘No (,) more Bolam please: Montgomery v Lanarkshire Health Board ’, Modern Law Review, 79(3): 488.CrossRefGoogle Scholar
Human Tissue Authority (2014a), Code 1, Consent, London: Human Tissue Authority.Google Scholar
Human Tissue Authority (2014b), Code of Practice 9: Research, London: Human Tissue Authority. Google Scholar
Jones, M. (1999), ‘Informed consent and fairy stories’, Medical Law Review, 7: 103.CrossRefGoogle Scholar
Kaye, J. (2004), ‘Abandoning Informed Consent: The Case of Genetic Research in Population Collections’, in R. Tutton and O. Corrigan (eds), Genetic Databases: Socio-Ethical Issues in the Collection and Use of DNA, London: Routledge, 117-138.Google Scholar
Manson, N. C. and O’Neill, O. (2007), Rethinking Informed Consent in Bioethics, Cambridge: Cambridge University Press.CrossRefGoogle Scholar
McGrath, C. P. (2015), ‘“Trust me I’m a patient.” Disclosure standards and the patients right to decide’, Cambridge Law Journal, 211: 211214.CrossRefGoogle Scholar
McHale, J. V. (2004), ‘Regulating genetic databases: some legal and ethical issues’, Medical Law Review, 11: 70.CrossRefGoogle Scholar
McHale, J. V. (2010), ‘Clinical Research’, in J. V. McHale, J. Laing and A. Grubb (eds), Principles of Medical Law, 3rd edn, Oxford: Oxford University Press, 725-765.Google Scholar
McHale, J. V. (2013), ‘Reforming the regulation of health research in England and Wales: new challenges: new pitfalls’, Journal of Medical Law and Ethics, 23: 2343.Google Scholar
McHale, J. V., Habiba, M., Dixon-Woods, M., Cavers, D. and Heney, D. (2007), ‘Consent and childhood cancer tissue banking: the impact of the Human Tissue Act 2004’, Lancet Oncology, 8: 266.CrossRefGoogle Scholar
Miola, J. (2006), ‘Autonomy rued OK? Al Hamwi v. Johnston and Another ’, Medical Law Review, 14: 108.CrossRefGoogle Scholar
Miola, J. (2009), ‘On the materiality of risks, paper tigers and informed consent’, Medical Law Review, 17: 45.Google Scholar
Montgomery, J. and Montgomery, E. (2016), ‘Montgomery on informed consent: an inexpert decision?Journal of Medical Ethics, 42: 89.CrossRefGoogle ScholarPubMed
Nuffield Council on Bioethics (2015), The Collection, Linking and Use of Information in Biomedical Research and Health Care; Ethical Issues, London: Nuffield Council.Google Scholar
O’Neill, O. (2003), ‘Some limits of informed consent’, Journal of Medical Ethics, 29: 4.CrossRefGoogle ScholarPubMed
Plomer, A. (2005), The Law and Ethics of Medical Research: International Bioethics and Human Rights, London: Cavendish Publishing.Google Scholar
Price, D. (2005), ‘The Human Tissue Act 2004’, Modern Law Review, 68: 798.CrossRefGoogle Scholar
Price, D. (2009), Human Tissue in Transplantation and Research, Cambridge: Cambridge University Press.CrossRefGoogle Scholar
Reid, E. (2015), ‘ Montgomery and Lanarkshire Health Board and the rights of the reasonable patient’, Edinburgh Law Review, 19: 360.CrossRefGoogle Scholar
Royal Liverpool Children’s Inquiry (2001), Report of the Inquiry into the Royal Liverpool Children’s Hospital (Alder Hey).Google Scholar
Spatz, E. S. (2016), ‘The new era of informed consent, getting to a reasonable patient standard through shared decision-making’, Journal of the American Medical Association, 315(19): 2063.CrossRefGoogle ScholarPubMed
Taylor, M. J. (2011), ‘Health research, data protection, and the public interest in notification’, Medical Law Review, 19(2): 267.CrossRefGoogle ScholarPubMed
Taylor, M. J. and Townend, D. (2010), ‘Issues in protecting privacy in medical research using genetic information and biobanking: the privileged project’, Medical Law International, 10(4): 253.CrossRefGoogle Scholar
Taylor, M. J. and Taylor, N. (2014), ‘Health research access to personal confidential data in England and Wales: assessing any gap in public attitude between preferable and acceptable models of consent’, Life Sciences, Society and Policy, 10.CrossRefGoogle Scholar
Thornton, H. (1994), ‘Clinical trials: a brave new partnership?Journal of Medical Ethics, 20: 19.CrossRefGoogle ScholarPubMed
World Medical Association (1964), ‘Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects’, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 as amended.Google Scholar