Abstract
This thesis examines the regulatory and ethical challenges associated with surgical innovation, which in the last decade has entered public consciousness in response to innovative procedures having gone wrong. Examples of this include the metal-on-metal hip replacement, which was surgically ineffective and required revision in many patients.Using an empirical ethics methodology, the study investigates bioethical, and legal sources, alongside empirical research into the experiences of two distinctive groups – patients and professionals (including surgeons). The literature identifies several challenges associated with regulating surgical innovation, including its conceptualisation, a perceived regulatory vacuum, the provision of informed consent, and the evaluation of risk.
Utilising a hermeneutic-grounded theory methodology to produce an in-depth narrative of patient and professional experiences, and justifiable conclusions from the literature and law, I argue that in order to better regulate surgical innovation, we must first attempt to better define it within the law and in practice, and that the patient should be at the heart of these considerations. Empirical research participants informed their decision-making based upon principles of patient protection, trust, transparency, risk, and responsibility. A focus on shared decision-making processes is imperative in ensuring that patients are able to navigate the nuances of innovation, and I conclude that attempts should be made to streamline existing regulatory processes for surgical innovation, whilst continuing to allow a certain level of flexibility for the surgeon to be able to tailor treatments to individual patients. This should go hand-in-hand with clearly defined consent processes, standardised and mandatory outcome reporting, and more linear processes for educating and supporting surgeons. I make a number of recommendations to enhance the regulation of surgical innovation, disputing the common argument that innovation is not sufficiently regulated. These recommendations are grounded upon moral and ethical principles of transparency, professional responsibility, accountability, beneficence, and public good.
| Date of Award | 6 Dec 2022 |
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| Original language | English |
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| Supervisor | Giles M Birchley (Supervisor), Richard Huxtable (Supervisor) & Robert J Hinchliffe (Supervisor) |