Towards an understanding of the ethics of electronic consent in clinical trials

There are good practical reasons to use electronic consent (e-consent) in randomised trials, especially when conducting large-scale clinical trials to answer population-level health research questions. However, determining ethical reasons for e-consent is not so clear and depends on a proper understanding of what e-consent means when used in clinical trials and its ethical significance. Here we focus on four features of ethical significance which give rise to a range of ethical considerations relating to e-consent and merit further focused ethics research

Justified emergency medicine research

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. </p

Justified emergency medicine research

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 participantâs 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 researchâs risks appropriately; and considering the researchâs 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 participantâs 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. </p

Access versus Choice: testing the “food desert” construct in Champaign, IL

How does one’s food environment affect food purchase decisions? Food access has received significant political and academic attention, particularly under the Obama administration. Existing literature on food access and “food deserts” mainly focuses on geographic distance or the retail of fresh fruits & vegetables versus fast food within a neighborhood to determine and identify inequitable access. In this paper I attempt to develop an endogenous measure of food access by asking how geographic placement of food retail affects food expenditure, particularly of fruits & vegetables. I use novel data on 886 households matched to food prices from a census of geocoded food retailers in Champaign County to approach this question from two perspectives. I first estimate the household’s share of grocery expenditures allocated to fresh, frozen, and canned fruits & vegetables versus other grocery items. I then use data on a person’s residence and geocoded data on food retail locations in Champaign County to test for relationships between retailer proximity, and the share of expenditure on fruits & vegetables. The next perspective uses a choice experiment to measure the tradeoff among store characteristics that determine where a consumer shops. The demand estimation reveals how much fruits & vegetables a person is actually consuming, while the choice experiment reveals whether that individual is constrained in their consumption by their existing characteristic set of stores. I find that while proximity to a grocery store is positively correlated with healthier food consumption, policy response should focus on improving store quality and product quality to induce behavioral change. I further find policy response should be cognizant of endogenous locational sorting which may require alternative means to improve health other than changing the food geography

‘A good decision is the one that feels right for me’: codesign with patients to inform theoretical underpinning of a decision aid website

Introduction: patient decision aids (PtDA) complement shared decision-making with healthcare professionals and improve decision quality. However, PtDA often lack theoretical underpinning. We are codesigning a PtDA to help people with increased genetic cancer risks manage choices. The aim of an innovative workshop described here was to engage with the people who will use the PtDA regarding the theoretical underpinning and logic model outlining our hypothesis of how the PtDA would lead to more informed decision-making. Methods: short presentations about psychological and behavioural theories by an expert were interspersed with facilitated, small-group discussions led by patients. Patients were asked what is important to them when they make health decisions, what theoretical constructs are most meaningful and how this should be applied to codesign of a PtDA. An artist created a visual summary. Notes from patient discussions and the artwork were analysed using reflexive thematic analysis. Results: the overarching theme was: It's personal. Contextual factors important for decision-making were varied and changed over time. There was no one ‘best fit’ theory to target support needs in a PtDA, suggesting an inductive, flexible framework approach to programme theory would be most effective. The PtDA logic model was revised based on patient feedback. Conclusion: meaningful codesign of PtDA including discussions about the theoretical mechanisms through which they support decision-making has the potential to lead to improved patient care through understanding the intricately personal nature of health decisions, and tailoring content and format for holistic care. Patient Contribution: Patients with lived experience were involved in codesign and coproduction of this workshop and analysis as partners and coauthors. Patient discussions were the primary data source. Facilitators provided a semi-structured guide, but they did not influence the patient discussions or provide clinical advice. The premise of this workshop was to prioritise the importance of patient lived experience: to listen, learn, then reflect together to understand and propose ideas to improve patient care through codesign of a PtDA.</p