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

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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.

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Most cited references 20

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The New Era of Informed Consent: Getting to a Reasonable-Patient Standard Through Shared Decision Making.

Erica S. Spatz, Harlan M. Krumholz, Benjamin W Moulton (2016)

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Why we should not seek individual informed consent for participation in health services research.

J. Cassell, A. Young (2002)

Ethics committees now require that individuals give informed consent to much health services research, in the same way as for clinical research. This is misguided. Existing ethical guidelines do not help us decide how to seek consent in these cases, and have allowed managerial experimentation to remain largely unchecked. Inappropriate requirements for individual consent can institutionalise health inequalities and reduce access to services for vulnerable groups. This undermines the fundamental purpose of the National Health Service (NHS), and ignores our rights and duties as its members, explored here. Alternative forms of community consent should be actively pursued.

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Health research access to personal confidential data in England and Wales: assessing any gap in public attitude between preferable and acceptable models of consent

Mark Taylor, Natasha Taylor (2014)

England and Wales are moving toward a model of ‘opt out’ for use of personal confidential data in health research. Existing research does not make clear how acceptable this move is to the public. While people are typically supportive of health research, when asked to describe the ideal level of control there is a marked lack of consensus over the preferred model of consent (e.g. explicit consent, opt out etc.). This study sought to investigate a relatively unexplored difference between the consent model that people prefer and that which they are willing to accept. It also sought to explore any reasons for such acceptance. A mixed methods approach was used to gather data, incorporating a structured questionnaire and in-depth focus group discussions led by an external facilitator. The sampling strategy was designed to recruit people with different involvement in the NHS but typically with experience of NHS services. Three separate focus groups were carried out over three consecutive days. The central finding is that people are typically willing to accept models of consent other than that which they would prefer. Such acceptance is typically conditional upon a number of factors, including: security and confidentiality, no inappropriate commercialisation or detrimental use, transparency, independent overview, the ability to object to any processing considered to be inappropriate or particularly sensitive. This study suggests that most people would find research use without the possibility of objection to be unacceptable. However, the study also suggests that people who would prefer to be asked explicitly before data were used for purposes beyond direct care may be willing to accept an opt out model of consent if the reasons for not seeking explicit consent are accessible to them and they trust that data is only going to be used under conditions, and with safeguards, that they would consider to be acceptable even if not preferable.