Joseph Millum

The Belmont Report was written by a US Commission charged by the US Congress to advise on research supported by the US government. Its focus was understandably domestic. In the 40 years since its publication, clinical research has become increasingly international. Many clinical trials have sites in multiple countries, and many of the host countries are relatively impoverished. Such research raises some distinctive ethical issues. This paper outlines some of the key ethical challenges that have been raised by clinical research conducted in low- and middle-income countries (LMICs) and sponsored by high-income country (HIC) institutions. It then considers whether the Belmont Report has the resources to address these problems and argues that it does not. The article closes by noting some parallels between this international research and domestic US research, which suggest that the US might benefit from the discussions abroad.

A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of research to improve emergency care in low-income and middle-income countries (LMICs) and the widely acknowledged ethical challenges, very little has been written on the ethics of emergency care research in LMICs. This paper examines the ethical and regulatory challenges to conducting emergency care research with human participants in LMICs. We outline key challenges, present potential solutions or frameworks for addressing these challenges, and identify gaps. Despite the ethical and regulatory challenges, conducting high-quality, ethical emergency care research in LMICs is possible and it is essential for global health.

Hundreds of millions of rare biospecimens are stored in laboratories and biobanks around the world. Often, the researchers who possess these specimens do not plan to use them, while other researchers limit the scope of their work because they cannot acquire biospecimens that meet their needs. This situation raises an important and underexplored question: how should scientists allocate biospecimens that they do not intend to use? We argue that allocators should aim to maximise the social value of the research enterprise when allocating scarce biospecimens. We provide an ethical framework for assessing the social value of proposed research projects and describe how the framework could be implemented.

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.

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.

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.

Donors to global health programs and policymakers within national health systems have to make difficult decisions about how to allocate scarce health care resources. Principled ways to make these decisions all make some use of summary measures of health, which provide a common measure of the value (or disvalue) of morbidity and mortality. They thereby allow comparisons between health interventions with different effects on the patterns of death and ill health within a population. The construction of a summary measure of health requires that a number be assigned to the harm of death. But the harm of death is currently a matter of debate: different philosophical theories assign very different values to the harm of death at different ages. This chapter considers how we should assign numbers to the harm of deaths at different ages in the face of uncertainty and disagreement.

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.

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.

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!”

During the recent Ebola epidemic, some commentators and stakeholders argued that it would be unethical to carry out a study that withheld a potential treatment from affected individuals with such a serious, untreatable disease. As a result, the initial trials of experimental treatments did not have control arms, despite important scientific reasons for their inclusion. In this paper, we consider whether the duty to rescue entails that it would be unethical to withhold an experimental treatment from patient-participants with serious diseases for which there are no effective treatments, even when doing so is scientifically necessary to test the effectiveness of the treatment. We argue that the duty to rescue will rarely apply. The context of medical research also throws new light on the content of the duty to rescue, since the interests of future patients—who stand to benefit from the fruits of medical research—are relevant to whether the duty applies.

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.

In When Clinical Trials Compete: Prioritizing Study Recruitment, Gelinas et al tackle an important issue—study non-completion—and draw conclusions with which we largely agree. Most importantly, we accept that setting priorities among competing research studies is necessary and should be informed by ethical analysis. We disagree with the conclusion of Gelinas et al that this priority setting should take place at the level of the individual research institution. At a minimum, they should consider other actors who might be better suited for this role instead of—or alongside—the institutions that host research. Our view is motivated by three main considerations. First, research institutions have significant latitude to promote their own interests, and there is reason to suspect that their interests do not closely align with the interests of the public. Thus, asking research institutions to set research priorities may result in the selection of studies with suboptimal social value. Second, a large proportion of clinical trials recruits participants at multiple institutions.1 If each institution sets its own priorities, we can expect discrepancies between the priorities set by partner institutions. These discrepancies may delay and discourage collaborative research projects. Finally, we suspect that a great deal of recruitment competition occurs between, rather than within, research institutions. Setting priorities only at …

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.

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.

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.

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.

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

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

The Global Forum on Bioethics in Research (GFBR) served as a global platform for debate on ethical issues in international health research between 1999 and 2008, bringing together research ethics experts, researchers, policy makers and community members from developing and developed countries. In total, nine GFBR meetings were held on six continents. Work is currently underway to revive the GFBR. This paper describes the purpose and history of the GFBR and presents key elements for its reinstatement, future functioning and sustainability. Potential participants and sponsors are encouraged to contribute actively to the future of this unique international research ethics event.

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.