That a person’s consent is required prior to any medical intervention, is now well established in law, ethics and medical practice, and is the most profound practical manifestation of respect for autonomy, or self-determination in medicine. For consent to be valid a number of conditions need to be satisfied; the person making the decision must have sufficient capacity (competence) to make the decision; they must have been provided with sufficient information about the proposed intervention and about relevant alternatives such that their decision is adequately informed; the decision must be appropriately and specifically authorized. While the person’s consent occupies the central legitimising feature of medical practice, little is known about how consent per se, or its elements, are conceptualised or actualised in high-risk medical settings. Aim The aim of this thesis was to develop a richer understanding of the process of consent to high-risk medical interventions. This issue was explored both theoretically (through the reflection on relevant literature) and empirically through study of the experience of consent in clinical practice. The exemplar of a high-risk medical treatment on which the empirical study was based, is allogeneic haematopoietic stem cell transplantation, referred to in this thesis as HSCT. Method This was a longitudinal qualitative study. Data was gathered from in-depth, semi-structured interviews with those people most intimately involved in the consent process (patients undergoing HSCT, their ‘significant others’, physicians performing HSCT, and other relevant healthcare professionals). Data was thematically analysed in terms of the elements of consent (which were explicitly explored during the interviews), and by reference to those additional concepts that emerged from the participants’ narratives. The accounts provided by the participants were contrasted against contemporary understandings of consent drawn from the relevant empirical and philosophical literature. Findings The results of this study reveal that each one of the elements required for valid consent are challenged in high-risk medical settings. Capacity is often compromised, decisions are enmeshed in social obligations, information disclosure is comprehensive but inevitably limited, understanding is rarely tested and never privileged, and all decisions are made in the shadow of disease and mortality. But the results also reveal that consent remains an important process – not simply because it validates decision-making and manifests respect, but because it increases trust, and builds alliances that maximise adherence, and ensure ‘presence’. Conclusion While consent in medical practice is legally established and morally justified, its realisation in practice is extraordinarily difficult. This is never more so than in high-risk medical settings. In these situations it is necessary to recognize that consent cannot be understood simply by reference to the role it plays in law – but also by acknowledgment of its moral justification, social and relational contexts, and clinical utility
