Joseph Millum

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.

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.

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.

Most bioethicists who address questions to which global justice matters have not considered the significance of the disputes over the correct theory of global justice. Consequently, the significance of the differences between theories of global justice for bioethics has been obscured. In this paper, I consider when and how these differences are important. I argue that certain bioethical problems can be resolved without addressing disagreements about global justice. People with very different views about global justice can converge on the existence of a duty to aid the very badly off — those in absolute poverty — wherever they may be. However, despite agreement on extreme cases, there should be disagreement over the extent of international obligations to those who are only relatively poor. Consequently, different theories of justice will diverge in their implications for a number of important problems in contemporary bioethics. I close by sketching in more detail two contemporary bioethical issues —concerning pharmaceutical patents and the health worker brain drain —and show how responses to them might be developed by cosmopolitan and statist liberals.

The International Bill of Rights enshrines a right to health, which includes a right to access essential medicines. This right frequently appears to conflict with the intellectual property regime that governs pharmaceutical patents. However, there is also a human right that protects creative works, including scientific productions. Does this right support intellectual property protections, even when they may negatively affect health? This article examines the recent attempt by the Committee on Economic, Social and Cultural Rights to resolve this issue and argues that it fails. This is problematic because it means defenders of the present patent regime can continue using human rights documents to support their position. I offer a new framework for resolving the problem by examining the values that underlie human rights.

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.

In this paper I develop a theory of the acquisition of parental rights. According to this investment theory, parental rights are generated by the performance of parental work. Thus, those who successfully parent a child have the right to continue to do so, and to exclude others from so doing. The account derives from a more general principle of desert that applies outside the domain of parenthood. It also has some interesting implications for the attribution of moral parenthood. In particular, it implies that genetic relationships per se are irrelevant to parental rights and that it is possible to have more than two moral parents

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.

Research studies increasingly use genomic sequencing to draw inferences based on comparisons between the genetic data of a set of purportedly related individuals. As use of this method progresses, it will become much more common to discover that the assumed biological relationships between the individuals are mistaken. Consequently, researchers will have to grapple with decisions about whether to return incidental findings of misattributed parentage on a much larger scale than ever before. In this paper we provide an extended argument for the view that the default position for researchers ought to be the non-disclosure of misattributed parentage.

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.

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.

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...

Estimates of the burden of disease assess the mortality and morbidity that affect a population by producing summary measures of health such as quality-adjusted life years and disability-adjusted life years. These measures typically do not include stillbirths among the negative health outcomes they count. Priority-setting decisions that rely on these measures are therefore likely to place little value on preventing the more than three million stillbirths that occur annually worldwide. In contrast, neonatal deaths, which occur in comparable numbers, have a substantial impact on burden of disease estimates and are commonly seen as a pressing health concern. In this article we argue in favor of incorporating unintended fetal deaths that occur late in pregnancy into estimates of the burden of disease. Our argument is based on the similarity between late-term fetuses and newborn infants and the assumption that protecting newborns is important. We respond to four objections to counting stillbirths: that fetuses are not yet part of the population and so their deaths should not be included in measures of population health; that valuing the prevention of stillbirths will undermine women's reproductive rights; that including stillbirths implies that miscarriages should also be included; and that birth itself is in fact ethically significant. We conclude that our proposal is ethically preferable to current practice and, if adopted, is likely to lead to improved decisions about health spending

In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection.

The search for valuable new products from among the world’s stock of natural biological resources is mostly carried out by people from wealthy countries, and mostly takes place in developing countries that lack the research capacity to profit from it. Surely, the indigenous people should receive some compensation from it. But we must build a robust defense for this intuition, rooted in the Western moral traditions that are widely accepted in wealthy countries, if we are to put it into practice and enforce it.

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.

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.

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.

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