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

  • Jean V. Mchale (a1)


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.


Corresponding author

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


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Biggs, H. (2009), Healthcare Research Ethics and Law, Abingdon, Oxon: Routledge Cavendish.
Brazier, M. (1987), ‘Patient autonomy and consent to treatment’, Legal Studies, 1: 169.
Case, P. (2003), ‘Confidence matters: the rise and fall of informational autonomy in medical law’, Medical Law Review, 11: 208.
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.
Department of Health (2005), Research Governance Framework for Health and Social Care, 2nd edn, London: DoH.
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.
Feng, T. K. (1987), ‘Failure of medical advice: trespass or negligence?Legal Studies, 1: 149.
General Medical Council (2008), Consent Guidance: Patients and Doctors Making Decisions Together, London: GMC.
General Medical Council (2013), Good Medical Practice Guidance ‘Communicate Effectively’, London: GMC.
Heywood, R. (2015), ‘RIP Sidaway: patient oriented disclosure – a standard worth waiting for’, Medical Law Review, 23(3): 455466.
Hobson, C. (2016), ‘No (,) more Bolam please: Montgomery v Lanarkshire Health Board ’, Modern Law Review, 79(3): 488.
Human Tissue Authority (2014a), Code 1, Consent, London: Human Tissue Authority.
Human Tissue Authority (2014b), Code of Practice 9: Research, London: Human Tissue Authority.
Jones, M. (1999), ‘Informed consent and fairy stories’, Medical Law Review, 7: 103.
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.
Manson, N. C. and O’Neill, O. (2007), Rethinking Informed Consent in Bioethics, Cambridge: Cambridge University Press.
McGrath, C. P. (2015), ‘“Trust me I’m a patient.” Disclosure standards and the patients right to decide’, Cambridge Law Journal, 211: 211214.
McHale, J. V. (2004), ‘Regulating genetic databases: some legal and ethical issues’, Medical Law Review, 11: 70.
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.
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.
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.
Miola, J. (2006), ‘Autonomy rued OK? Al Hamwi v. Johnston and Another ’, Medical Law Review, 14: 108.
Miola, J. (2009), ‘On the materiality of risks, paper tigers and informed consent’, Medical Law Review, 17: 45.
Montgomery, J. and Montgomery, E. (2016), ‘Montgomery on informed consent: an inexpert decision?Journal of Medical Ethics, 42: 89.
Nuffield Council on Bioethics (2015), The Collection, Linking and Use of Information in Biomedical Research and Health Care; Ethical Issues, London: Nuffield Council.
O’Neill, O. (2003), ‘Some limits of informed consent’, Journal of Medical Ethics, 29: 4.
Plomer, A. (2005), The Law and Ethics of Medical Research: International Bioethics and Human Rights, London: Cavendish Publishing.
Price, D. (2005), ‘The Human Tissue Act 2004’, Modern Law Review, 68: 798.
Price, D. (2009), Human Tissue in Transplantation and Research, Cambridge: Cambridge University Press.
Reid, E. (2015), ‘ Montgomery and Lanarkshire Health Board and the rights of the reasonable patient’, Edinburgh Law Review, 19: 360.
Royal Liverpool Children’s Inquiry (2001), Report of the Inquiry into the Royal Liverpool Children’s Hospital (Alder Hey).
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.
Taylor, M. J. (2011), ‘Health research, data protection, and the public interest in notification’, Medical Law Review, 19(2): 267.
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.
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.
Thornton, H. (1994), ‘Clinical trials: a brave new partnership?Journal of Medical Ethics, 20: 19.
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.

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

  • Jean V. Mchale (a1)


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