Return of Positive Test Results to Participants in Sexually Transmitted Infection Prevalence Studies: Research Ethics and Responsibilities.

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 because of 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.

How not to count the health benefits of family planning.

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.

Allocation of scarce biospecimens for use in research.

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.

Informed Consent: What Must Be Disclosed and What Must Be Understood?

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.

International Clinical Research and Justice in the Belmont Report.

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.

Ethical challenges in global health-related stigma research.

BACKGROUND: It is critically important to conduct research on stigmatized conditions, to include marginalized groups that experience stigma, and to develop interventions to reduce stigma. However, such research is ethically challenging. Though superficial reference is frequently made to these widely acknowledged challenges, few publications have focused on ethical issues in research on stigmatized groups or conditions. In fact, a brief literature review found only two such publications. MAIN TEXT: At a recent Science of Stigma Reduction workshop comprising 60 stigma researchers from the USA and low and middle-income countries, the need for more robust and critical discussion of the ethics of the research was highlighted. In this paper we describe, illustrate through cases, and critically examine key ethical challenges that are more likely to arise because a research study focuses on health-related stigma or involves stigmatized groups or conditions. We examine the ethics of this research from two perspectives. First, through the lens of overprotection, where we discuss how the perception of stigma can impede ethical research, disrespect research participants, and narrow the research questions. Second, through the lens of research risks, where we consider how research with stigmatized populations can unintentionally result in harms. Research-related harms to participants include potential breaches of confidentiality and the exacerbation of stigma. Potential harms also extend to third parties, including families and populations who may be affected by the dissemination of research results. CONCLUSIONS: Research with stigmatized populations and on stigmatized conditions should not be impeded by unnecessary or inappropriate protective measures. Nevertheless, it may entail different and greater risks than other health research. Investigators and research ethics committees must be particularly attentive to these risks and how to manage them.

How Payment for Research Participation Can Be Coercive.

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.

Health Research Priority Setting: The Duties of Individual Funders.

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.

Stillbirths: economic and psychosocial consequences.

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.

Informed consent to HIV cure research.

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.

The Social Value of Health Research and the Worst Off.

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: (1) in health research priority setting when research funders, policy-makers, or researchers decide between alternative research projects; and (2) in evaluating the ethics of proposed research proposals when research ethics committees (RECs) 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 (at least) 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.

Rescuing the duty to rescue.

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 underanalysed. In this paper, we assess the state of theorising 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 research priorities for developing accounts of duties to rescue in bioethics.

Are Indirect Benefits Relevant to Health Care Allocation Decisions?

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.

Valuing Stillbirths.

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 (QALYs) and disability-adjusted life years (DALYs). These measures typically do not include stillbirths (fetal deaths occurring during the later stages of pregnancy or during labor) 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: (1) that fetuses are not yet part of the population and so their deaths should not be included in measures of population health; (2) that valuing the prevention of stillbirths will undermine women's reproductive rights; (3) that including stillbirths implies that miscarriages (fetal deaths early in pregnancy) should also be included; and (4) 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.

When Should Genome Researchers Disclose Misattributed Parentage?

Researchers need a decision-making framework about disclosing a finding of misattributed parentage that accounts for nonclinical factors like the effects of personal identity and familial relationships.