title: Improving legal interpretations of informed consent in practice
Creators: name: O’Neill, Jennifer
Publisher: name: University of Glasgow
Year: 2021
Subjects: subject: Conjoint solidarity, autonomy, informed consent, relational justice, shared decision making, healthcare law, ethics.

description: The four publications included in this thesis embody a programme of research aimed at improving interpretations of informed consent to medical treatment in the United Kingdom (UK). Paper one considers the application of solidarity - often a concept associated with political debate - to bioethical issues. It examines leading conceptualisations of solidarity in healthcare and their relation to the practitioner-patient dynamic and standards of informed consent. In considering the interplay between ethical principles of solidarity and autonomy, the paper explains how current concepts of healthcare solidarity may undermine individual patient autonomy by creating imbalance in the practitioner-patient dynamic. Current constructs of solidarity are also considered to be exclusionary which, it is argued, may potentially lead to the othering of patients. The effects of patient exclusion and othering are examined in paper one and throughout the subsequent papers. In response to these issues, the novel concept of ’conjoint solidarity’ is presented in contribution to the existing scholarship. It calls upon healthcare stakeholders (incorporating healthcare practitioners and patients) to adopt a duty to assist in the identification and achievement of improved healthcare outcomes. By recognising the epistemic value of both practitioners and patients, conjoint solidarity is said to promote an inclusive form of solidarity that promotes balance in the practitioner-patient dynamic and that will support, rather than undermine, autonomy. It is anticipated that by facilitating greater patient involvement in the decision-making process, trust can be rebuilt, and healthcare outcomes improved. From this ethical grounding, informed consent is explored through the subsequent three papers which address deficiencies in current interpretations of the legal standard for informed consent and propose new ways in which shared decision-making can be enhanced to mitigate against the kind of harms which have been witnessed in recent years. Paper two explores the evolution of the legal standard of informed consent to medical treatment in the UK. It examines the development of the judicial precedence pertaining to informed consent through key cases such as Bolam v Friern Hospital Management Committee [1957], Sidaway v Board of Governors [1985], Bolitho v City and Hackney HA [1998], and Montgomery v Lanarkshire [2015]. Comparative analyses are drawn between concepts such as ‘significant’ and ‘material’ risk, and between the ‘reasonable person’ and ‘particular patient’ standards. It is argued that the legal interpretation of material risk is broad, and that patterns of judicial reasoning are suggestive of a move towards recognition of majority views on reasonableness. The paper describes how financial interests can influence healthcare practitioners to the extent that their practice may be harmful to the patient and, therefore, concludes that potent financial interests – namely those likely to have greatest impact upon patterns of practice – may be interpreted as disclosable material risks under existing common law standards. Paper three examines standards of informed consent in relation to the issues surrounding the use of pelvic (vaginal) mesh - as detailed in the 2020 Cumberlege Report - and questions whether improved interpretations of the informed consent process could mitigate against future harms. It is recognised that treatment selection - which remains a matter of professional judgement according to Bolam v Friern Hospital Management Committee [1956] - could be deemed exclusionary towards patients. Drawing on the concept of conjoint solidarity, it is suggested that patient-based evidence should be afforded greater consideration as part of evidence-based practice to promote a more inclusive healthcare system which affords greater recognition to the epistemic value of the patient to enhance overall shared decision-making. The concept of risk disclosure is also re-examined in relation to medical device implantation, and it is recommended that the long-term risks deriving from implantable devices, or indeed unknown risks associated with innovative treatment proposals, be deemed disclosable. In this way, patient autonomy can be upheld so that patients are afforded the opportunity to decide whether, or not, to incur such risk. Paper four considers how the process of shared decision-making, which precedes informed consent, can be enhanced by facilitating active discussion [4]. In returning to the concept of relational autonomy, persuasion is presented as a means of promoting greater patient-practitioner dialogue and engagement which can allow patients to question and explore the information that is presented. The example of vaccine hesitancy is used to describe the ways in which the informed consent process can be used to tackle misinformation and promote confidence in medical treatments. The standard set out in Montgomery requires that patients be informed of benefits, material risks and reasonable treatment alternatives when consenting to medical treatment. On these grounds, it is suggested that informing patients of the benefits of vaccination could be a means of addressing misinformation. Threads of conjoint solidarity also run through the argument as it is suggested that disclosure of vaccination benefits, should relate to both the individual and collective benefits in terms of individual and herd immunity. This example is particularly reflective of the bridge which exists between relational autonomy and conjoint solidarity. The thesis then explores risks and expands upon the disclosure of ‘individual risk’. It is suggested that risk of not vaccinating also be disclosed – both in terms of the risk of disease posed to individual and the most vulnerable in society. Persuasion is employed, not as a means of coercion, rather as a means of engagement to ensure patients understand the information provided which may also help to address misinformation. Similarly, the patient is afforded the opportunity to ‘persuade’ the practitioner to understand their perspective, which is a departure from traditional models of the practitioner-patient relationship. In presenting this work three key themes emerge: deficiencies in shared decision making arising from the practitioner-patient relationship, analysis of informed consent and its deficiencies, and proposals for improving interpretations of informed consent to ensure patients are engaged and informed. It is anticipated that the proposed recommendations will have utility for rebuilding patient trust and to enhance patient involvement to mitigate against recurrences of harms seen in the past.