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Title: Justified emergency medicine research
Author: Sahan, Katherine Mary
ISNI:       0000 0004 7971 7118
Awarding Body: University of Oxford
Current Institution: University of Oxford
Date of Award: 2019
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My research uses the case of emergency medicine research to challenge established norms of governance and regulation which reflect an influential regulatory model of research ethics. This model has two foundational pillars: regulatory review and participant informed consent. Emergency research, where the possibility of consent is unclear, destabilises the pillar of consent and raises questions about the decision-making justification for emergency research. It asks how we may justifiably decide the research is permissible under a waiver of consent. In Chapter 1, I outline the nature of the regulatory model of research ethics. I also offer key definitions and theoretical distinctions. These include the distinction between the ethics of research decision-making and the ethics of the research itself. In Chapters 2 and 3, I characterise a landscape of issues relevant to the question of emergency research decision-making. For this I use case studies and regulatory responses arising in three research jurisdictions (the United States, the European Union and the United Kingdom). Having developed themes from case and regulatory analysis, I argue there are two main areas of decision-making to be justified: at the general level of regulatory review, and the individual level of each participant's enrolment. In Chapter 4, I justify decision-making at the level of regulatory review, uniting my arguments with existing emergency research regulations. In particular, I examine whether the current formulation of the US regulatory requirement for prior consultation with communities about the research contributes to the justification. I argue that regulatory review is justified by reason of: securing commitment to emergency research under a consent waiver as a common purpose; judging the research's risks appropriately; and considering the research's impact on social injustice through an altered form of community consultation. In Chapter 5, I turn to the justification for decision-making at the level of participant enrolment despite the emergency context and the participant's likely mental incapacity. Here I carve out a key role for the physician-researcher. I argue she is uniquely positioned to make ethical decisions about whether or not to enrol the emergency patient. Her decision-making secures a modest level of respect for the patient as a person worthy of moral consideration despite his mental incapacity. Her role is sensitive to, and avoids provoking, a deep concern in research ethics. Namely the use of patients by researchers as merely a means to the ends of the research. In Chapter 6, I describe a number of key findings arising from the justifications made, and some important policy implications. I also make recommendations for future work and scholarly thinking where regulatory models of research ethics are used.
Supervisor: Kelley, Maureen ; Sheehan, Mark Sponsor: Medical Research Council
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available