•  57
    Affordability and Non-Perfectionism in Moral Action
    with Benedict Rumbold, Victoria Charlton, Polly Mitchell, James Wilson, Peter Littlejohns, Catherine Max, and Albert Weale
    Ethical Theory and Moral Practice 22 (4): 973-991. 2019.
    One rationale policy-makers sometimes give for declining to fund a service or intervention is on the grounds that it would be ‘unaffordable’, which is to say, that the total cost of providing the service or intervention for all eligible recipients would exceed the budget limit. But does the mere fact that a service or intervention is unaffordable present a reason not to fund it? Thus far, the philosophical literature has remained largely silent on this issue. However, in this article, we conside…Read more
  •  47
    Public Reasoning and Health-Care Priority Setting: The Case of NICE
    with Benedict Rumbold, Albert Weale, James Wilson, and Peter Littlejohns
    Kennedy Institute of Ethics Journal 27 (1): 107-134. 2017.
    Health systems that provide for universal patient access through a scheme of prepayments—whether through taxes, social insurance, or a combination of the two—need to make decisions on the scope of coverage that they secure. Such decisions are inherently controversial, implying, as they do, that some patients will receive less than comprehensive health care, or less than complete protection from the financial consequences of ill-heath, even when there is a clinically effective therapy to which th…Read more
  •  346
    Universal Health Coverage, Priority Setting and the Human Right to Health.
    with Benedict Rumbold, Octavio Ferraz, Sarah Hawkes, Rachel Baker, Carleigh Crubiner, Peter Littlejohns, Ole Frithjof Norheim, Thomas Pegram, Sridhar Venkatapuram, Alex Voorhoeve, Albert Weale, James Wilson, Alicia Ely Yamin, and Daniel Wang
    The Lancet 390 (10095): 712-14. 2017.
    As health policy-makers around the world seek to make progress towards universal health coverage, they must navigate between two important ethical imperatives: to set national spending priorities fairly and efficiently; and to safeguard the right to health. These imperatives can conflict, leading some to conclude that rights-based approaches present a disruptive influence on health policy, hindering states’ efforts to set priorities fairly and efficiently. Here, we challenge this perception. We …Read more
  •  40
    A Personalized Patient Preference Predictor for Substituted Judgments in Healthcare: Technically Feasible and Ethically Desirable
    with Brian D. Earp, Sebastian Porsdam Mann, Jemima Allen, Sabine Salloch, Vynn Suren, Karin Jongsma, Matthias Braun, Dominic Wilkinson, Walter Sinnott-Armstrong, David Wendler, and Julian Savulescu
    American Journal of Bioethics 24 (7): 13-26. 2024.
    When making substituted judgments for incapacitated patients, surrogates often struggle to guess what the patient would want if they had capacity. Surrogates may also agonize over having the (sole) responsibility of making such a determination. To address such concerns, a Patient Preference Predictor (PPP) has been proposed that would use an algorithm to infer the treatment preferences of individual patients from population-level data about the known preferences of people with similar demographi…Read more
  •  23
    What is Enough?: Sufficiency, Justice, and Health (edited book)
    Oxford University Press. 2016.
    What is a just way of spending public resources for health and health care? Several significant answers to this question are under debate. Public spending could aim to promote greater equality in health, for example, or maximize the health of the population, or provide the worst off with the best possible health. Another approach is to aim for each person to have "enough" so that her health or access to health care does not fall under a critical level. This latter approach is called sufficientar…Read more
  •  79
    Standards of practice in empirical bioethics research: towards a consensus
    with Jonathan Ives, Michael Dunn, Bert Molewijk, Jan Schildmann, Kristine Bærøe, Lucy Frith, Richard Huxtable, Elleke Landeweer, Marcel Mertz, Veerle Provoost, Sabine Salloch, Mark Sheehan, Daniel Strech, Martine de Vries, and Guy Widdershoven
    BMC Medical Ethics 19 (1): 68. 2018.
    This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the conc…Read more
  •  23
    Do patients want their families or their doctors to make treatment decisions in the event of incapacity, and why?
    with David Wendler, Robert Wesley, and Mark Pavlick
    AJOB Empirical Bioethics 7 (4): 251-259. 2016.
    Background: Current practice relies on patient-designated and next-of-kin surrogates, in consultation with clinicians, to make treatment decisions for patients who lose the ability to make their own decisions. Yet there is a paucity of data on whether this approach is consistent with patients' preferences regarding who they want to make treatment decisions for them in the event of decisional incapacity. Methods: Self-administered survey of patients at a tertiary care center. Results: Overall, 11…Read more
  •  46
    A framework for risk-benefit evaluations in biomedical research
    with David Wendler
    Kennedy Institute of Ethics Journal 21 (2): 141-179. 2011.
    One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are r…Read more
  •  39
    Ethics: Would you sell a kidney in a regulated kidney market? Results of an exploratory study
    with Lucas Bachmann, Vincent Wettstein, and Nikola Biller-Andorno
    Journal of Medical Ethics 35 (9): 558-564. 2009.
    Background: It is often claimed that a regulated kidney market would significantly reduce the kidney shortage, thus saving or improving many lives. Data are lacking, however, on how many people would consider selling a kidney in such a market. Methods: A survey instrument, developed to assess behavioural dispositions to and attitudes about a hypothetical regulated kidney market, was given to Swiss third-year medical students. Results: Respondents’ median age was 23 years. Their socioeconomic sta…Read more
  •  19
    Patients’ Priorities for Surrogate Decision-Making: Possible Influence of Misinformed Beliefs
    with E. J. Jardas, Robert Wesley, Mark Pavlick, and David Wendler
    AJOB Empirical Bioethics 13 (3): 137-151. 2022.
  •  29
    Ethics of controlled human infection studies: Past, present and future
    with Seema K. Shah
    Bioethics 34 (8): 745-748. 2020.
  •  117
    Research led by participants: a new social contract for a new kind of research
    with Effy Vayena, Roger Brownsword, Sarah Jane Edwards, Bastian Greshake, Jeffrey P. Kahn, Navjoyt Ladher, Jonathan Montgomery, Daniel O'Connor, Onora O'Neill, Martin P. Richards, Mark Sheehan, Paul Wicks, and John Tasioulas
    Journal of Medical Ethics 42 (4): 216-219. 2016.
  •  27
    Judging the social value of controlled human infection studies
    with Meta Roestenberg
    Bioethics 34 (8): 749-763. 2020.
    In controlled human infection (CHI) studies, investigators deliberately infect healthy individuals with pathogens in order to study mechanisms of disease or obtain preliminary efficacy data on investigational vaccines and medicines. CHI studies offer a fast and cost‐effective way of generating new scientific insights, prioritizing investigational products for clinical testing, and reducing the risk that large numbers of people are exposed to ineffective or harmful substances in research or in pr…Read more
  •  31
    Informed consent for controlled human infection studies in low‐ and middle‐income countries: Ethical challenges and proposed solutions
    with Vina Vaswani, Abha Saxena, Seema K. Shah, and Ricardo Palacios
    Bioethics 34 (8): 809-818. 2020.
    In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high‐income countries, CHIs have recently been expanding into low‐ and middle‐income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informed consent of participants, especially those who ma…Read more
  •  23
    Judging the Social Value of Health-Related Research: Current Debate and Open Questions
    Perspectives in Biology and Medicine 63 (2): 293-312. 2020.
    Several influential ethical guidelines and frameworks endorse the view that research with human participants is ethically acceptable only when it has “social value,” meaning that it generates knowledge which can be used to benefit society. For example, the Nuremberg Code requires that medical experiments on human beings “yield fruitful results for the good of society, unprocurable by other methods or means of study”. The Council for International Organizations of Medical Sciences guidelines hold…Read more
  •  10
    The Challenge of Selecting Participants Fairly in High-Demand Clinical Trials
    with Saskia Hendriks and Alexander A. Iyer
    American Journal of Bioethics 20 (2): 35-38. 2020.
    Volume 20, Issue 2, February 2020, Page 35-38.
  •  19
    Existing ethical frameworks for public health provide insufficient guidance on how to evaluate the risks of public health programs that compromise the best clinical interests of present patients for the benefit of others. Given the relevant similarity of such programs to clinical research, we suggest that insights from the long‐standing debate about acceptable risk in clinical research can helpfully inform and guide the evaluation of risks posed by public health programs that compromise patients…Read more
  •  21
    What is a just way of spending public resources for health and health care? Several significant answers to this question are under debate. Public spending could aim to promote greater equality in health, for example, or maximize the health of the population, or provide the worst off with the best possible health. Another approach is to aim for each person to have "enough" so that her health or access to health care does not fall under a critical level. This latter approach is called sufficientar…Read more
  •  12
    The Next Wave in Health Care Priority Setting
    Hastings Center Report 48 (4). 2018.
    A new problem in health care priority‐setting is currently emerging for wealthy countries: what should be done when a new drug is considered cost effective but implementing it would still be unaffordable? The standard approach to setting priorities in health care rests on cost effectiveness. This approach is now being tested by new drugs that are highly effective but very costly. Because they are so effective, these drugs deliver “value for money” despite their high cost. However, when the targe…Read more
  •  31
    One of the fundamental ethical concerns about biomedical research is that it frequently exposes participants to risks for the benefit of others. To protect participants’ rights and interests in this context, research regulations and guidelines set out a mix of substantive and procedural requirements for research involving humans. Risk thresholds play an important role in formulating both types of requirements. First, risk thresholds serve to set upper risk limits in certain types of research. Se…Read more
  •  27
    In his stimulating target article, 1 Philippe Calain discusses how the traditional ethical framework for clinical research was challenged during the 2013–2016 Ebola epidemic in West Africa. One of his key claims is that conventional research ethics did not have the resources to address the ‘profound tension’ 1, between individual and public interests in clinical research during this epidemic. I agree with this claim, but would like to provide a modified argument in its support. As Calain points …Read more
  •  25
    In his stimulating target article,1 Philippe Calain discusses how the traditional ethical framework for clinical research was challenged during the 2013–2016 Ebola epidemic in West Africa. One of his key claims is that conventional research ethics did not have the resources to address the ‘profound tension’1, between individual and public interests in clinical research during this epidemic. I agree with this claim, but would like to provide a modified argument in its support. As Calain points ou…Read more
  •  45
    In Defense of a Social Value Requirement for Clinical Research
    with David Wendler
    Bioethics 31 (2): 77-86. 2017.
    Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizin…Read more
  •  31
    As a matter of justice, what do we owe each other to promote and protect health in a population and to assist people when they are ill and disabled? This is the fundamental question of Norman Daniels’ new book on justice and health. Just health is in many ways a successor to Daniels’ seminal classic Just health care. As foreshadowed by a 2001 target article in the American Journal of Bioethics, Just health integrates Daniels’ account of the special moral importance of health and healthcare with …Read more
  •  18
    The Goals of Research During an Epidemic
    American Journal of Bioethics 15 (4): 47-50. 2015.
  •  45
    Can We Improve Treatment Decision-Making for Incapacitated Patients?
    with David Wendler
    Hastings Center Report 40 (5): 36-45. 2010.
    When patients cannot make their own treatment decisions, surrogates typically step in to do it for them. Surrogate decision‐making is far from ideal, of course, as the surrogate may not know what the patient prefers or what best promotes her interests. One way to improve it would be to arm surrogates with information about what patients in similar circumstances tend to prefer, allowing them to make empirically grounded predictions about what their patient would want.
  •  28
  •  576
    Can informed consent to research be adapted to risk?
    Journal of Medical Ethics 41 (7): 521-528. 2015.
    The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research parti…Read more
  •  38
    Use of a Patient Preference Predictor to Help Make Medical Decisions for Incapacitated Patients
    with D. Wendler
    Journal of Medicine and Philosophy 39 (2): 104-129. 2014.
    The standard approach to treatment decision making for incapacitated patients often fails to provide treatment consistent with the patient’s preferences and values and places significant stress on surrogate decision makers. These shortcomings provide compelling reason to search for methods to improve current practice. Shared decision making between surrogates and clinicians has important advantages, but it does not provide a way to determine patients’ treatment preferences. Hence, shared decisio…Read more