Global health is at a crossroads. The 2030 Agenda for Sustainable Development has come with ambitious targets for health and health services worldwide. To reach these targets, many more billions of dollars need to be spent on health. However, development assistance for health has plateaued and domestic funding on health in most countries is growing at rates too low to close the financing gap. National and international decision-makers face tough choices about how scarce health care resources should be spent. Should (...) additional funds be spent on primary prevention of stroke, treating childhood cancer, or expanding treatment for HIV/AIDS? Should health coverage decisions take into account the effects of illness on productivity, household finances, and children's educational attainment, or just focus on health outcomes? Does age matter for priority setting or should it be ignored? Are health gains far in the future less important than gains in the present? Should higher priority be given to people who are sicker or poorer? Global Health Priority-Setting provides a framework for how to think about evidence-based priority-setting in health. Over 18 chapters, ethicists, philosophers, economists, policy-makers, and clinicians from around the world assess the state of current practice in national and global priority setting, describe new tools and methodologies to address establishing global health priorities, and tackle the most important ethical questions that decision-makers must consider in allocating health resources. (shrink)

Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher scores (...) were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali (P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries. (shrink)

Since 1964, through 7 revisions, the World Medical Association’s Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. It is consulted by ethics review committees, funders, researchers, and research participants. It has been incorporated into national legislation and is routinely invoked to ascertain the ethical appropriateness of clinical trials. There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. Nevertheless, the (...) proposed declaration contains persistent flaws... (shrink)

This book presents a collection of original essays by leading thinkers in political theory, philosophy, and bioethics on key issues concerning global justice and bioethics. It is the first collection to comprehensively address these pressing theoretical and practical questions about international distributive justice, humans rights, health care and medical research.

The curriculum design, faculty characteristics, and experience of implementing masters' level international research ethics training programs supported by the Fogarty International Center was investigated. Multiple pedagogical approaches were employed to adapt to the learning needs of the trainees. While no generally agreed set of core competencies exists for advanced research ethics training, more than 75% of the curricula examined included international issues in research ethics, responsible conduct of research, human rights, philosophical foundations of research ethics, and research regulation and ethical (...) review process. Common skills taught included critical thinking, research methodology and statistics, writing, and presentation proficiency. Curricula also addressed the cultural, social, and religious context of the trainees related to research ethics. Programs surveyed noted trainee interest in Western concepts of research ethics and the value of the transnational exchange of ideas. Similar faculty expertise profiles existed in all programs. Approximately 40% of faculty were female. Collaboration between faculty from low- and middleincome countries (LMICs) and high-income countries (HICs) occurred in most programs and at least 50% of HIC faculty had previous LMIC experience. This paper is part of a collection of papers analyzing the Fogarty International Research Ethics Education and Curriculum Development program. (shrink)

The U.S. review system for human subjects research has been widely criticized in recent years for requirements that delay research without improving human subjects protections. Any major reformulation of regulations may take some time to implement. In the meantime, current regulations often allow for streamlined ethics review without jeopardizing—and possibly improving—protections for research participants. We discuss underutilized options, including research that need not be classified as “human subjects research,” categories of studies that can be exempt from ethical review, and studies (...) that need only undergo expedited review by one IRB member. In addition, we consider ways to simplify review of multi-center research using one institution’s IRB. We speculate on multiple reasons for the underuse of these mechanisms, and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process. (shrink)

NIH's fogarty international Center has provided grants for the development of training programs in international research ethics for low- and middle-income (LMIC) professionals since 2000. Drawing on 12 years of research ethics training experience, a group of Fogarty grantees, trainees, and other ethics experts sought to map the current capacity and need for research ethics in LMICs, analyze the lessons learned about teaching bioethics, and chart a way forward for research ethics training in a rapidly changing health research landscape. This (...) collection of papers is the result. (shrink)

This introduction begins with two simple case studies that reveal a background of socio-economic complexities that hinder development. The availability of healthcare and the issue of cross-border justice are the key points to be addressed in this study. The chapters consider philosophy, economics, and bioethics in order to provide a global perspective. Two theories come into play in this book—the ideal and non-ideal—which offer insight on why and how things are done.

This paper assesses the state of research ethics in low- and middle-income countries and the achievements of the Fogarty International Center's bioethics training program since 2000. The vision of FIC for the next decade of research ethics education is encapsulated in four proposed goals: (1) Ensure sufficient expertise in ethics review by having someone with long-term training on every high-workload REC; (2) Develop LMIC capacity to conduct original research on critical ethical issues by supporting doctoral and postdoctoral training and career (...) paths for research ethicists; (3) Make research training and review at LMIC institutions sustainable by identifying additional funding mechanisms and models; (4) Make institutional research systems more ethical and efficient through context-specific training integrated into all levels of scientific training. (shrink)

In this paper I examine the ethics of benefit-sharing agreements between victims and beneficiaries of injustice in the context of trans-national bodily giving, selling, and sharing. Some obligations are the same no matter who the parties to a transaction are. Prohibitions on threats, fraud and harm apply universally and their application to transactions in unjust contexts is not disputed. I identify three sources of obligations that are affected by unjust background conditions. First, power disparities may illegitimately influence transactions in unintentional (...) ways. Second, better-off individuals have duties to ameliorate injustices. These are not specifically duties to those with whom they interact, though often it is easier and more effective to help those with whom one already interacts. Third, the power differentials created by injustice make exploitative transactions more likely. I summarize a transactional account of exploitation and argue that avoiding exploitation is usually easiest to achieve by ensuring that the more powerful party does not obtain an unfair share of the benefits from the transaction. The beneficiaries of a transaction do not have to be only those individuals directly involved in it. Indeed, in many cases it is thought that exploitation may be avoided by providing benefits to third parties. Working out when this is the case requires working out when a contribution or burden on another’s behalf can count towards the avoidance of exploitation. I argue that it counts as such in two main cases: when the people in question are already involved in relationships of reciprocation, and when the individual making the contribution identifies with the interests of the other people. (shrink)

Canada’s Tri-Council Policy Statement: Ethical conduct for research involving humans, first published in 1998, has recently been updated.1 The US Department of Health and Human Services has just issued an Advance Notice of Proposed Rulemaking that would substantially change the 20-year-old Common Rule governing most federally funded research involving human participants.2 A comparison of the two countries’ systems for protecting human research participants is therefore timely. This analysis situates the Canadian system in an international context, with particular attention to its (...) similarities and differences to the US system and their shared challenges going forward with their changes. (shrink)

This collection presents six case studies on the ethics of mental health research, written by scientific researchers and ethicists from around the world. We publish them here as a resource for teachers of research ethics and as a contribution to several ongoing ethical debates. Each consists of a description of a research study that was proposed or carried out and an in-depth analysis of the ethics of the study.

Despite the frequency of stillbirths, the subsequent implications are overlooked and underappreciated. We present findings from comprehensive, systematic literature reviews, and new analyses of published and unpublished data, to establish the effect of stillbirth on parents, families, health-care providers, and societies worldwide. Data for direct costs of this event are sparse but suggest that a stillbirth needs more resources than a livebirth, both in the perinatal period and in additional surveillance during subsequent pregnancies. Indirect and intangible costs of stillbirth are (...) extensive and are usually met by families alone. This issue is particularly onerous for those with few resources. Negative effects, particularly on parental mental health, might be moderated by empathic attitudes of care providers and tailored interventions. The value of the baby, as well as the associated costs for parents, families, care providers, communities, and society, should be considered to prevent stillbirths and reduce associated morbidity. (shrink)

Waiting time is widely used in health and social policy to make resource allocation decisions, yet no general account of the moral significance of waiting time exists. We provide such an account. We argue that waiting time is not intrinsically morally significant, and that the first person in a queue for a resource does not ipso facto have a right to receive that resource first. However, waiting time can and sometimes should play a role in justifying allocation decisions. First, there (...) is a duty of fairness prohibiting line-cutting where a sufficiently just queue exists. Second, waiting time has several morally attractive features that can justify its incorporation into allocation schemes. Where candidates are in relevantly similar circumstances, allocating by waiting time is relatively efficient, maximizes distribution equality relative to other Pareto efficient distributions, and treats candidates fairly. The claim that allocation using waiting time is fair is controversial. Some have claimed that formal lotteries are a fairer way to select among equal beneficiaries. We argue that lotteries are no fairer than allocation based on waiting time when it is equiprobable how a prospective queue will be ordered. In practice, lotteries share many of the disadvantages of queues; which is fairer will depend on contingent features of the allocation scenario. The upshot is that first-come, first-served is in fact a just way to allocate resources in many of the cases where it seems pre-theoretically compelling, and waiting time has unique normative properties which frequently justify its incorporation into resource allocation schemes. (shrink)

Clinicians and health researchers frequently encounter opportunities to rescue people. Rescue cases can generate a moral duty to aid those in peril. As such, bioethicists have leveraged a duty to rescue for a variety of purposes. Yet, despite its broad application, the duty to rescue is under-analyzed. In this paper, we assess the state of theorizing about the duty to rescue. There are large gaps in bioethicists’ understanding of the force, scope, and justification of the two most cited duties to (...) rescue—the individual duty of easy rescue and the institutional rule of rescue. We argue that the duty of easy rescue faces unresolved challenges regarding its force and scope, and the rule of rescue is indefensible. If the duty to rescue is to help solve ethical problems, these theoretical gaps must be addressed. We identify two further conceptions of the duty to rescue that have received less attention—an institutional duty of easy rescue and the professional duty to rescue. Both provide guidance in addressing force and scope concerns and, thereby, traction in answering the outstanding problems with the duty to rescue. We conclude by proposing and propose research priorities for developing accounts of duties to rescue in bioethics. (shrink)

One widely used method for allocating health care resources involves the use of cost-effectiveness analysis (CEA) to rank treatments in terms of quality-adjusted life-years (QALYs) gained. CEA has been criticized for discriminating against people with disabilities by valuing their lives less than those of non-disabled people. Avoiding discrimination seems to lead to the ’QALY trap’: we cannot value saving lives equally and still value raising quality of life. This paper reviews existing responses to the QALY trap and argues that all (...) are problematic. Instead, we argue that adopting a moderate form of prioritarianism avoids the QALY trap and disability discrimination. (shrink)

In this article we argue that the social value of health research should be conceptualized as a function of both the expected benefits of the research and the priority that the beneficiaries deserve. People deserve greater priority the worse off they are. This conception of social value can be applied for at least two important purposes: in health research priority setting when research funders, policy-makers, or researchers decide between alternative research projects; and in evaluating the ethics of proposed research proposals (...) when research ethics committees assess whether the social value of the research is sufficient to justify the risks and burdens to research participants and others. In assessing how far a proposed research project will advance the interests of people who are more disadvantaged, research priority setters and RECs should examine the diseases that the research targets and the type of research. Just as certain diseases impose a greater burden on people who are more disadvantaged, so certain types of intervention and forms of research are more likely to benefit people who are more disadvantaged. We outline which populations are likely to be representative of the global worst off and identify what types of health research, and which disease categories, are priorities for these populations. (shrink)

This volume offers a carefully argued, compelling theory of bioethics while eliciting practical implications for a wide array of issues including medical assistance-in-dying, the right to health care, abortion, animal research, and the definition of death. The authors' dual-value theory features mid-level principles, a distinctive model of moral status, a subjective account of well-being, and a cosmopolitan view of global justice. In addition to ethical theory, the book investigates the nature of harm and autonomous action, personal identity theory, and the (...) 'non-identity problem' associated with many procreative decisions. Readers new to particular topics will benefit from helpful introductions, specialists will appreciate in-depth theoretical explorations and a novel take on various practical issues, and all readers will benefit from the book's original synoptic vision of bioethics. This title is also available as Open Access on Cambridge Core. (shrink)

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid (...) consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (shrink)

The available resources for global health assistance are far outstripped by need. In the face of such scarcity, many people endorse a principle according to which highest priority should be given to the worst off. However, in order for this prioritarian principle to be useful for allocation decisions, policy-makers need to know what it means to be badly off. In this article, we outline a conception of disadvantage suitable for identifying the worst off for the purpose of making health resource (...) allocation decisions. According to our total advantage view: the worst off are those who have the greatest total lifetime disadvantage; advantage foregone due to premature death should be treated in the same way as other ways of being disadvantaged at a time; how badly off someone is depends on the actual outcomes that will befall her without intervention, not her prospects at a time; and all significant forms of disadvantage count for determining who is worst off, not just disadvantage relating to health. We conclude by noting two important implications of the total advantage view: first, that those who die young are among the globally worst off, and second, that the epidemiological shift in the global burden of disease from communicable to non-communicable diseases should not lead to a corresponding shift in global health spending priorities. (shrink)

Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of first-come, (...) first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; and (vi) the need to avoid quality-of-life judgments. In the second part, we lay out some positions on which reasonable people can and do differ. These include (i) conflicts between maximizing benefits and priority to the worst off; (ii) role-based priority; and (iii) whether patients’ existing lifesaving resources should be subject to redistribution. (shrink)

The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent-undermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. By contrast, (...) coercion as subjection indicates a way in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment. (shrink)

Angela Ballantyne (2010) argues that international research is exploitative when the transactions between researchers and participants who lack basic goods do not provide participants with the maxi...

Misconceived Consent: Miguel has stage IV lung cancer. He has nearly exhausted his treatment options when his oncologist, Dr. Llewellyn, tells him about an experimental vaccine trial that may boost his immune response to kill cancer cells. Dr. Llewellyn provides Miguel with a consent form that explains why the study is being conducted, what procedures he will undergo, what the various risks and benefits are, alternative sources of treatment, and so forth. She even sits down with him, carefully talks through (...) the most important points, and gives him time to ask questions. Though it is a Phase 1 study and the chance that he will benefit is very low, Miguel happily agrees to take part. A week later, after the first experimental injection, she asks him if he is worried about the risks. “Risks?” he asks. “I’m sure this is safe—you’re a doctor, after all!”. (shrink)

Torture is unethical and usually counterproductive. It is prohibited by international and national laws. Yet it persists: according to Amnesty International, torture is widespread in more than a third of countries. Physicians and other medical professionals are frequently asked to assist with torture. -/- Medical complicity in torture, like other forms of involvement, is prohibited both by international law and by codes of professional ethics. However, when the victims of torture are also patients in need of treatment, doctors can find (...) themselves torn. To accede to the requests of the torturers may entail assisting or condoning terrible acts. But to refuse care to someone in medical need may seem like abandoning a patient and thereby fail to exhibit the beneficence expected of physicians. -/- In this paper, we argue that this dilemma is real and that sometimes the right thing for a doctor to do, overall, is to be complicit in torture. Though complicity in a wrongful act is itself prima facie wrongful, this judgment may be outweighed by other factors. We propose three criteria for analyzing how those factors apply to particular cases of medical complicity in torture. (shrink)

In this book, Joseph Millum explains how parental rights and responsibilities are acquired, what they consist in, and how parents should go about making decisions on behalf of their children. In doing so, he provides a set of frameworks to help solve pressing ethical dilemmas relating to parents and children.

It is common to cite the child’s “right to an open future” in discussions of how parents and the state may and should treat children. However, the right to an open future can only be useful in these discussions if we have some method for deriving the content of the right. In the paper in which he introduces the right to an open future Joel Feinberg seems to provide such a method: he derives the right from the content of adult (...) autonomy rights. In this paper I argue that his argument fails. If it is to give us guidance about the content of the child’s right to an open future, then the right should be interpreted as a right to a maximally open future. But this strong interpretation is unjustified: the arguments that can be found in Feinberg in favor of the right are invalid, and, in any case, this interpretation has implausible implications. A moderate interpretation of the right to an open future, according to which children have a right to acquire some reasonable range of skills and options, is more plausible. However, if a moderate interpretation is correct, there is not only no argument in Feinberg to support it, there is also no method for deriving the content of the right. Without such a method we have to bring in other moral considerations in order to work out the limits on parental discretion and what children are owed. The right to an open future then does no normative work. (shrink)

In this paper we analyze the non-coercive ways in which researchers can use knowledge about the decision-making tendencies of potential participants in order to motivate them to consent to research enrollment. We identify which modes of influence preserve respect for participants’ autonomy and which disrespect autonomy, and apply the umbrella term of manipulation to the latter. We then apply our analysis to a series of cases adapted from the experiences of clinical researchers in order to develop a framework for thinking (...) through the ethics of manipulating people into research participation. All manipulation disrespects autonomy and is therefore pro tanto wrong. However, only deceptive manipulation invalidates the consent that results from it. Use of the other forms of manipulation can be permissible, but only if the outcome of using manipulation is sufficiently good and if the research cannot be carried out using ethically preferable means to obtain consent. (shrink)

When allocating scarce healthcare resources, the expected benefits of alternative allocations matter. But, there are different kinds of benefits. Some are direct benefits to the recipient of the resource such as the health improvements of receiving treatment. Others are indirect benefits to third parties such as the economic gains from having a healthier workforce. This article considers whether only the direct benefits of alternative healthcare resource allocations are relevant to allocation decisions, or whether indirect benefits are relevant too. First, we (...) distinguish different conceptions of direct and indirect benefits and argue that only a recipient conception could be morally relevant. We analyze four arguments for thinking that indirect benefits should not count and argue that none is successful in showing that the indirectness of a benefit is a good reason not to count it. We conclude that direct and indirect benefits should be evaluated in the same way. (shrink)

The vast majority of health research resources are used to study conditions that affect a small, advantaged portion of the global population. This distribution has been widely criticized as inequitable and threatens to exacerbate health disparities. However, there has been little systematic work on what individual health research funders ought to do in response. In this article, we analyze the general and special duties of research funders to the different populations that might benefit from health research. We assess how these (...) duties apply to governmental, multilateral, nonprofit, and for-profit organizations. We thereby derive a framework for how different types of funders should take the beneficiaries of research into account when they allocate scarce research resources. (shrink)

Some placebo-controlled trials can continue ethically after a candidate vaccine is found to be safe and efficacious.

This chapter explores the foundation and content of the duty to respect persons. The authors argue that it is best understood as a duty to recognize people’s rights. Respect for persons therefore has specific implications for how competent and non-competent persons ought to be treated in research. For competent persons it underlies the obligation to obtain consent to many research procedures. The chapter gives an analysis of the requirements for obtaining valid consent. It then considers respect for persons as it (...) relates to four common topics: the therapeutic misconception, research with children and adolescents, the use of deception in research, and research on competent adults without their consent. (shrink)

Background: In prevalence studies of sexually transmitted infections (STIs), investigators often provide syndromic management for symptomatic participants, but may not provide specific treatment for asymptomatic individuals with positive laboratory test results due to the delays between sample collection and availability of results as well as logistical constraints in recontacting study participants. Methods: To characterize the extent of this issue, 80 prevalence studies from the World Health Organization’s Report on global sexually transmitted infection surveillance, 2018, were reviewed. Studies were classified as (...) to whether clinically relevant positive results were returned or if this was not specified. Results: More than half (56%) of the cited studies did not specify if participants were notified of clinically relevant positive STI test results. The percentages were similar for low- and middle-income country populations (57%) and high-income country populations (53%). Conclusions: The absence of documentation of the provision of test results raises the possibility that in some instances, results may not have been communicated, with potential negative effects for participants, their sexual partners, and newborns. From an ethical perspective, clinically relevant results should be returned to study participants and treating clinicians in a timely fashion to ensure appropriate management of identified infections. Study authors should document if they returned test results to study participants and report on numbers lost to follow-up. (shrink)

Tom Dougherty argues that culpably deceiving another person into sex is seriously wrong no matter what the content about which she is deceived. We argue that his explanation of why deception invalidates consent has extremely implausible implications. Though we reject Dougherty’s explanation, we defend his verdict about deception and consent to sex. We argue that he goes awry by conflating the disclosure requirement for consent and the understanding requirement. When these are distinguished, we can identify how deceptive disclosure invalidates consent. (...) This alternative explanation also allows for a response to Neil Manson’s recent criticisms of Dougherty’s argument. (shrink)

ABSTRACT Many recent articles argue that participants who seroconvert during HIV prevention trials deserve treatment when they develop AIDS, and there is a general consensus that the participants in HIV/aids treatment trials should have continuing post‐trial access. As a result, the primary concern of many ethicists and activists has shifted from justifying an obligation to treat trial participants, to working out mechanisms through which treatment could be provided. In this paper I argue that this shift frequently conceals an important assumption: (...) that if there is an obligation to supply treatment, then any party who could provide it may be prevailed upon to discharge the obligation. This assumption is false. The reasons why trial participants should get ART affect who has the duty to provide it. We should not burden governments with the obligations of sponsors, nor researchers with the obligations of the international community. And we should not deprive a group of treatment because their need is less salient than that of research participants. Insisting otherwise may lead to people being wrongfully deprived of access to antiretrovirals. (shrink)

Coercion by the recipient of consent renders that consent invalid. But what about when the coercive force comes from a third party, not from the person to whom consent would be proffered? In this paper I analyze how threats from a third party affect consent. I argue that, as with other cases of coercion, we should distinguish threats that render consent invalid from threats whose force is too weak to invalidate consent and threats that are legitimate. Illegitimate controlling third party (...) threats render consent invalid just as they do in two party cases. However, knowing that the consent is invalid is not sufficient to tell the recipient of consent what she may or should do. I argue that when presented with a token of consent from someone whom she thinks is experiencing an illegitimate controlling threat, the recipient may act on that token if and only if doing so represents a reasonable joint decision for her and the victim of coercion. The appropriate action for someone faced with third party coercion therefore depends on the other options open to her and those open to the victim of coercion. (shrink)

Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; and (...) third, participants’ understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

According to standard comparativist views, death is bad insofar as it deprives someone of goods she would otherwise have had. In The Ethics of Killing, Jeff McMahan argues against such views and in favor of a gradualist account according to which how bad it is to die is a function of both the future goods of which the decedent is deprived and her cognitive development when she dies. Comparativists and gradualists therefore disagree about how bad it is to die at (...) different ages. In this paper I examine two prominent criticisms of gradualism and show that both misconstrue McMahan. I develop a related criticism that seems to show that a gradualist cannot coherently relate morbidity and mortality. This criticism also fails, but has an instructive implication for how policy-makers setting priorities for health care investments should regard choices between life-saving interventions and interventions against non-fatal diseases in the very young. (shrink)

Research projects sponsored by rich countries or companies and carried out in developing countries are often described as exploitative. One important debate about the prevention of exploitation in research centres on whether and how clinical research in developing countries should be responsive to local health problems. This paper analyses the responsiveness debate and draws out more general lessons for how policy makers can prevent exploitation in various research contexts. There are two independent ways to do this in the face of (...) entrenched power differences: to impose restrictions on the content of benefit-sharing arrangements, and to institute independent effective oversight. Which method should be chosen is highly dependent on context. (shrink)

Advances in immunotherapy pave the way for vaccines that target not only infections, but also unhealthy behaviors such as smoking. A nicotine vaccine that eliminates the pleasure associated with smoking could potentially be used to prevent children from adopting this addictive and dangerous behavior. This paper offers an ethical analysis of such vaccines. We argue that it would be permissible for parents to give their child a nicotine vaccine if the following conditions are met: (1) the vaccine is expected to (...) result in a net benefit to each individual vaccinated, (2) the expected harms from the side effects of the vaccine are lower than the non-voluntary harms of smoking, and (3) there are no less manipulative methods available that are as effective at preventing smoking initiation. Finally, we show how the framework developed here could be used to analyze the ethics of other chemical interventions designed to modify children’s behavior. (shrink)

In Natural Goodness Philippa Foot gives an analysis of the concepts we use to describe the characteristics of living things. She suggests that we describe them in functional terms, and this allows us to judge organisms as good or defective depending on how well they perform their distinctive functions. Foot claims that we can judge intentional human actions in the same way: the virtues contribute in obvious ways to good human functioning, and this provides us with grounds for making moral (...) judgements. This paper criticises Foot’s argument by challenging her notion of function. I argue that the type of judgement she makes about living things requires an evolutionary biological account of function. However, such an account would render her meta-ethical claims implausible, since it is unlikely that human beings are adapted to be maximally virtuous. I conclude that Foot is wrong about the logical structure of our judgements of human action. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)