Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: providing transparency; allowing control and authorization; promoting concordance with participants' values; and protecting and promoting welfare interests. Three other functions are systemic or policy focused: promoting trust; satisfying regulatory requirements; and promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)
Increasingly, bioethicists defend informed consent as a safeguard for trust in caretakers and medical institutions. This paper discusses an ‘ideal type’ of that move. What I call the trust-promotion argument for informed consent states:1. Social trust, especially trust in caretakers and medical institutions, is necessary so that, for example, people seek medical advice, comply with it, and participate in medical research.2. Therefore, it is usually wrong to jeopardise that trust.3. Coercion, deception, manipulation and other violations of standard informed consent requirements (...) seriously jeopardise that trust.4. Thus, standard informed consent requirements are justified.This article describes the initial promise of this argument, then identifies challenges to it. As I show, the value of trust fails to account for some commonsense intuitions about informed consent. We should revise the argument, commonsense morality, or both. (shrink)
To counter the pandemic caused by severe acute respiratory syndrome coronavirus 2, some have proposed accelerating SARS-CoV-2 vaccine development through controlled human infection trials. These trials would involve the deliberate exposure of relatively few young, healthy volunteers to SARS-CoV-2. We defend this proposal against the charge that there is still too much uncertainty surrounding the risks of COVID-19 to responsibly run such a trial.
The article begins by reconstructing the just distribution of the social bases of self-respect, a principle of justice that is covert in Rawls’s writing. I argue that, for Rawls, justice mandates that each social basis for self-respect be equalized. Curiously, for Rawls, that principle ranks higher than Rawls’s two more famous principles of justice - equal liberty and the difference principle. I then recall Rawls’s well-known confusion between self-respect and another form of self-appraisal, namely, confidence in one’s determinate plans and (...) capacities. Correcting that confusion forces Rawls to accept objectionable and illiberal politics. Surprisingly, a consistent Rawls must endorse absolute economic equality, deny liberty any priority whatsoever, or sponsor still other illiberal political views - evidence of a flaw in the ethical basis of Rawls’s politics. (shrink)
The Global Burden of Disease Study is one of the largest-scale research collaborations in global health, producing critical data for researchers, policy-makers, and health workers about more than 350 diseases, injuries, and risk factors. Such an undertaking is, of course, extremely complex from an empirical perspective. But it also raises complex ethical and philosophical questions. In this volume, a group of leading philosophers, economists, epidemiologists, and policy scholars identify and discuss these philosophical questions. Better appreciating the philosophical dimensions of a (...) study like the GBD can make possible a more sophisticated interpretation of its results, and it can improve epidemiological studies in the future, so that they are better suited to produce results that help us to improve global health. (shrink)
In this article, we provide a comprehensive analysis and a normative assessment of rationing through inconvenience as a form of rationing. By “rationing through inconvenience” in the health sphere, we refer to a nonfinancial burden that is either intended to cause or has the effect of causing patients or clinicians to choose an option for health-related consumption that is preferred by the health system for its fairness, efficiency, or other distributive desiderata beyond assisting the immediate patient. We argue that under (...) certain conditions, rationing through inconvenience may turn out to serve as a legitimate and, compared to direct rationing, even a preferable tool for rationing; we propose a research agenda to identify more precisely when that might be the case and when, alternatively, rationing through inconvenience remains ethically undesirable. After defining and illustrating rationing through inconvenience, we turn to its moral advantages and disadvantages over other rationing methods. We take it as a starting assumption that rationing, understood as scarce-resource prioritization, is inevitable and, in a society that has goals beyond optimizing health care for individual patients—such as improving societal health care, education, or overall welfare—prudent and fair. (shrink)
Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research (now called T1 ). Whether or not T1 has these features, translational research beyond approval (...) ( T2 : phase IV, health services, and implementation research) is unlikely to and, when conducted on the global poor, may support development. Therefore, insofar as T1 is morally problematic, and no independent objections to T2 exist, the ethics of translational research is diverse: while some translational research is problematic, some is not. Funding and oversight should reflect this diversity, and T2 should be encouraged, particularly when conducted among the global poor. (shrink)
This article argues that, in its standard formulation, luck-egalitarianism is false. In particular, I show that disadvantages that result from perfectly free choice can constitute egalitarian injustice. I also propose a modified formulation of luck-egalitarianism that would withstand my criticism. One merit of the modification is that it helps us to reconcile widespread intuitions about distributive justice with equally widespread intuitions about punitive justice.
This report by the WHO Consultative Group on Equity and Universal Health Coverage addresses how countries can make fair progress towards the goal of universal coverage. It explains the relevant tradeoffs between different desirable ends and offers guidance on how to make these tradeoffs.
Both left libertarians, who support the redistribution of income and wealth through taxation, and right libertarians, who oppose redistributive taxation, share an important view: that, looming catastrophes aside, the state must never redistribute any part of our body or our person without our consent. Cécile Fabre rejects that view. For her, just as the undeservedly poor have a just claim to money from their fellow citizens in order to lead a minimally flourishing life, the undeservedly ‘medically poor’ have a just (...) claim to help from fellow citizens in order to lead such a life. Such obligatory help may in principle involve even the supply of body parts for transplantation. The state ought to exact such resources from the medically rich whenever doing so would secure the prospect of a minimally flourishing life to the medically poor without denying that prospect to anyone else. Fabre criticizes Ronald Dworkin's belief in ‘a prophylactic line that comes close to making the body inviolate, that is, making body parts not parts of social resources at all’. For her, ‘Duties to help. . . do not stop at material resources: they involve the body. . . in invasive ways’. (shrink)
Next SectionAccess to medicines, vaccination and care in resource-poor settings is threatened by the emigration of physicians and other health workers. In entire regions of the developing world, low physician density exacerbates child and maternal mortality and hinders treatment of HIV/AIDS. This article invites philosophers to help identify ethical and effective responses to medical brain drain. It reviews existing proposals and their limitations. It makes a case that, in resource-poor countries, ’locally relevant medical training’—teaching primarily locally endemic diseases and practice (...) in scarcity conditions, training in rural communities and admitting rural students preferentially—could help improve retention. Locally relevant training would arguably diminish medical brain drain in five ways. It would (i) make graduates less attractive for Western employers, (ii) align graduates’ expectations with actual practice, diminishing ‘burn-out’, (iii) enhance the professional prestige of local practice, (iv) hold rotations in, and recruit applicants from, rural areas, which is known to improve retention there, and (v) create local career development options that attract practitioners to stay. Such educational reform may raise worries about poor-quality care, breach of the freedom of education and occupation, breach of the freedom of movement, unequal distribution of opportunities among students, hypocrisy and resistance from influential actors. We address these worries. (shrink)
In many countries worldwide, especially in Sub-Saharan Africa, a shortage of physicians limits the provision of lifesaving interventions. One existing strategy to increase the number of physicians in areas of critical shortage is conditioning medical school scholarships on a precommitment to work in medically underserved areas later. Current practice is usually to demand only one year of service for each year of funded studies. We show the effectiveness of scholarships conditional on such precommitment for increasing physician supplies in underserved areas. (...) Then we defend these scholarships against ethical worries that they constitute slavery contracts; rely on involuntary, biased, or unauthorized early consent by a young signatory; put excessive strains on signed commitments; give rise to domination; and raise suspicion of slavery contracts. Importantly, we find that scholarships involving far longer commitment than current practice allows would also withstand these worries. Policymakers should consider introducing conditional scholarships, including long-term versions, as a means to increasing the supply of physicians to medically underserved areas. (shrink)
The goal of achieving Universal Health Coverage (UHC) can generally be realized only in stages. Moreover, resource, capacity and political constraints mean governments often face difficult trade-offs on the path to UHC. In a 2014 report, Making fair choices on the path to UHC, the WHO Consultative Group on Equity and Universal Health Coverage articulated principles for making such trade-offs in an equitable manner. We present three case studies which illustrate how these principles can guide practical decision-making. These case studies (...) show how progressive realization of the right to health can be effectively guided by priority-setting principles, including generating the greatest total health gain, priority for the worse off, and financial risk protection. They also demonstrate the value of a fair and accountable process of priority setting. (shrink)
In political philosophy and in economics, unfair inequality is usually assessed between individuals, nowadays often on luck-egalitarian grounds. You have more than I do and that's unfair. By contrast, in epidemiology and sociology, unfair inequality is traditionally assessed between groups. More is concentrated among people of your class or race than among people of mine, and that's unfair. I shall call this difference the egalitarian ‘divorce’. Epidemiologists, and their ‘divorce lawyers’ Paula Braveman, Norman Daniels, and Iris Marion Young, explain that (...) not every inequality between individuals is an inequity. Only inequality between social status groups is unfair. Only such inequality stems from problems like partiality, discrimination, oppression, inequality-related population health problems, and unfair distribution of prospects. And it alone is actionable. By contrast, inequality between individuals, e.g. in longevity, is natural, inevitable, less important, or otherwise less informative — not unjust. In ‘divorce trial’ mode, I respond to epidemiologists that group inequalities lack the intrinsic disvalue that they ascribe them. They may be instrumentally or contingently bad or wrong, not essentially so. I then shift to ‘remarriage’: although group inequalities lack intrinsic badness or wrongness, for multiple reasons they remain useful to measure. (shrink)
This response to Gail Henderson et al argues that they were right that interviewees’ appraisals of cure study participation should inform protocol review decisions, but wrong to take these appraisals at face value.
Michael Bloomberg's three terms in New York City's mayoral office are coming to a close. His model of governance for public health influenced cities and governments around the world. What should we make of that model? This essay introduces a symposium in which ethicists Sarah Conly, Roger Brownsword and Alex Rajczi discuss that legacy.
La cobertura universal de salud está en el centro de la acción actual para fortalecer los sistemas de salud y mejorar el nivel y la distribución de la salud y los servicios de salud. Este documento es el informe fi nal del Grupo Consultivo de la OMS sobre la Equidad y Cobertura Universal de Salud. Aquí se abordan los temas clave de la justicia (fairness) y la equidad que surgen en el camino hacia la cobertura universal de salud. Por lo (...) tanto, el informe es pertinente para cada agente que infl uye en ese camino y en particular para los gobiernos, ya que se encargan de supervisar y guiar el progreso hacia la cobertura universal de salud. (shrink)
We analyse three moral dilemmas involving resource allocation in care for HIV-positive patients. Ole Norheim and Kjell Arne Johansson have argued that these cases reveal a tension between egalitarian concerns and concerns for better population health. We argue, by contrast, that these cases reveal a tension between, on the one hand, a concern for equal *chances*, and, on the other hand, both a concern for better health and an egalitarian concern for equal *outcomes*. We conclude that, in these cases, there (...) is much less tension than Norheim and Johansson claim between egalitarian concerns and concerns for better population health. (shrink)
Sissela Bok's1 and Torbjörn Tännsjö's2 writings on trust and informed consent were sources of inspiration for my article.3 It is gratifying to have a chance to respond to their thoughtful comments.Bok concurs with my scepticism that the ‘trust-promotion argument for informed consent’ can successfully generate commonsense morality's full set of informed consent norms. But she finds that argument even more wanting, perhaps so wanting as to be unworthy of critical attention. What she seems to find particularly objectionable is the fact (...) that the argument treats all social trust as valuable. For Bok, misplaced trust in health practitioners who are deceitful or violate patients’ other rights lacks any value whatsoever. There isn't even a pro tanto duty in favour of promoting it.My own inclination is to say that nearly all trust has some social value, if only thanks to its tendency to promote social stability or its tendency to promote medical adherence . But often, trust also tends to generate bad outcomes, and in many cases of misplaced trust, that tendency will make its value negative on balance. Still, in my view, …. (shrink)
Most books on ethics are boring. Against Autonomy 1 is fun to read because its helpful and profound points are made without a fuss. Author Sarah Conly is right that “when individuals engage in behavior that undercuts their own chances of happiness, state interference may be justified”.In what follows I argue that Conly misinterprets that thesis in three ways. First, she says that her paternalism seeks to “help people get where they want to go... live the lives they truly want (...) to live”. That's a different idea from the one I quoted earlier. Why? Because people do not always want to live in the way that would give them the highest chance of happiness. Conly is surely right that when we “habitually choose the large fries”, that's not always because large fries is what we want truly. Such choice can also reflect ignorance and miscalculation on our parts—when we simply “choose ineffective means to our ends”. But Conly fails to recognise another potential source. Sometimes self-harming choice reflects what we truly want at the time. Many young people do not care much about health problems in their older years. They habitually choose large fries not because they …. (shrink)
Several contributions in this book tell of doctors’ increasing emigration from developing countries where they are in critical shortage, especially from the underserved rural and public sectors of countries in sub-Saharan Africa and South Asia. They point out the severe harm from that migration to some of the world’s poorest and sickest populations who have no other doctors to turn to, and gain little from their emigration. Since significant harm to the badly off is bad, decline in that migration is (...) usually a good development. But how to strive to achieve it? (shrink)
In spring, summer and autumn 2020, one abiding argument against controlled human infection studies of SARS-CoV-2 vaccines has been their impact on local communities. Leading scientists and bioethicists expressed concern about undue usage of local residents’ direly needed scarce resources at a time of great need and even about their unintended infection. They recommended either avoiding CHI trials or engaging local communities before conducting any CHIs. Similar recommendations were not made for the alternative—standard phase III field trials of these same (...) vaccines. We argue that the health effects of CHI studies on local residents not participating in the study tend to be smaller and more positive than those of field trials. That is all the more so now that tested vaccines are being rolled out. Whether or not local community engagement is necessary for urgent vaccine studies in the pandemic, the case for its engagement is stronger prior to field trials than prior to CHI studies. (shrink)
Recent observations associate naturally occurring trace levels of Lithium in ground water with significantly lower suicide rates. It has been suggested that adding trace Lithium to drinking water could be a safe and effective way to reduce suicide. This article discusses the many ethical implications of such population-wide Lithium medication. It compares this policy to more targeted solutions that introduce trace amounts of Lithium to groups at higher risk of suicide or lower risk of adverse effects. The question of mass (...) treatment with Lithium recalls other choices in public health between population-wide and more targeted interventions. The framework we propose could be relevant to some of these other dilemmas. (shrink)
Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research. Whether or not T1 has these features, translational research beyond approval is unlikely to and, (...) when conducted on the global poor, may support development. Therefore, insofar as T1 is morally problematic, and no independent objections to T2 exist, the ethics of translational research is diverse: while some translational research is problematic, some is not. Funding and oversight should reflect this diversity, and T2 should be encouraged, particularly when conducted among the global poor. (shrink)
Progress towards Universal Health Coverage (UHC) requires making difficult trade-offs. In this journal, Dr. Margaret Chan, the WHO Director-General, has endorsed the principles for making such decisions put forward by the WHO Consultative Group on Equity and UHC. These principles include maximizing population health, priority for the worse off, and shielding people from health-related financial risks. But how should one apply these principles in particular cases and how should one adjudicate between them when their demands conflict? This paper by some (...) members of the Consultative Group and a diverse group of health policy professionals addresses these questions. It considers three stylized versions of actual policy dilemmas. Each of these cases pertains to one of the three principal dimensions of progress towards UHC: which services to cover first, which populations to prioritize for coverage, and how to move from out-of-pocket expenditures to pre-payment with pooling of funds. Our cases are simplified to highlight common trade-offs. While we make specific recommendations, our primary aim is to demonstrate both the form and substance of the reasoning involved in striking a fair balance between competing interests on the road to UHC. (shrink)