Joseph Millum

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.

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...

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.

Public funders of health research have been widely criticized on the grounds that their allocations of funding for disease-specific research do not reflect the relative burdens imposed by different diseases. For example, the US National Institutes of Health spends a much greater fraction of its budget on HIV/AIDS research and a much smaller fraction on migraine research than their relative contribution to the US burden of disease would suggest. Implicit in this criticism is a normative claim: Insofar as the scientific opportunities are equal, each patient merits research into their condition proportional to the burden of disease for which that condition is responsible. This claim—the proportional view—is widely accepted but has never been fully specified or defended. In this paper, I explain what is required to specify the view, attempt to do so in the most charitable way, and then critically evaluate its normative underpinnings. I conclude that a severity-weighted proportional view is defensible. I close by drawing out five key lessons of my analysis for health research priority-setting.

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.

Suppose you come to my house and I invite you in. ‘I’m just heading out’, I say, ‘but make yourself at home’. I have consented to you remaining in my house, but what else? In your home, you put your feet up on the coffee table, so may you now do that in mine? If I complain that you’ve left crumbs from eating biscuits in my bed, can you defend yourself on the grounds that I told you to make yourself at home? These questions concern the scope of my consent. How we should ascertain the scope of someone's consent is the topic of Tom Dougherty's book.The book is divided into three main parts, each corresponding to a view about what fixes the scope of consent: the mental account, the successful communication account, and the evidential account, which Dougherty favours.Versions of the mental account have in common that they think consent can be granted without any behavioural signal. Provided that the person granting consent has the appropriate mental state, they can grant permission to the recipient of consent, even if they do nothing to communicate the consent. Proponents of these views, Dougherty argues, should adopt a principle according to which the scope of consent is fixed by what the consent-giver intends to permit. However, Dougherty rejects the mental account on the grounds that consent requires some sort of publicity so that we can hold each other accountable: ‘what you do in the privacy of your own mind is not enough to waive your rights in the public sphere’ (p. 60).

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.

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.

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 …

Several influential organisations have attempted to quantify the costs and benefits of expanding access to interventions—like contraceptives—that are expected to decrease the number of pregnancies. Such health economic evaluations can be invaluable to those making decisions about how to allocate scarce resources for health. Yet how the benefits should be measured depends on controversial value judgments. One such value judgment is found in recent analyses from the Disease Control Priority Network (DCPN) and the Study Group for the Global Investment Framework for Women’s and Children’s Health. Noting the decrease in the number of pregnancies expected to result from providing access to family planning, DCPN and the Study Group claim that a substantial benefit of such interventions is averting the stillbirths and child deaths that would have resulted from those pregnancies. We argue that health economic analyses should not count such averted deaths as benefits in the same way as saved lives. First, by counting averted stillbirths and child deaths as a benefit but not counting as a cost the lives of babies who survive, DCPN and the Study Group implicitly commit themselves to antinatalism. Second, this method for calculating the benefits of family planning interventions implies that infertility treatments are harmful. Determining how potential people should be treated in health economic analyses will require grappling with population ethics.

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.