We extend recent conversation about the ethics of human challenge trials to tuberculosis (TB). TB challenge studies could accelerate vaccine development, but ethical concerns regarding risks to trial participants and third parties have been a limiting factor. We analyse the expected social value and risks of different challenge models, concluding that if a TB challenge trial has between a 10% and a 50% chance of leading to the authorisation and near-universal delivery of a more effective vaccine 3–5 years earlier, then (...) the trial would save between 26 400 and 1 100 000 lives over the next 10 years. We also identify five important ethical considerations that differentiate TB from recent human challenge trials: an exceptionally high disease burden with no highly effective vaccine; heightened third party risk following the trial, and, partly for that reason, uniquely stringent biosafety requirements for the trial; risks associated with best available TB treatments; and difficulties with TB disease detection. We argue that there is good reason to consider conducting challenge trials with attenuated strains like Bacillus Calmette-Guérin or attenuatedMycobacterium tuberculosis. (shrink)

New techniques for the genetic modification of organisms are creating new strategies for addressing persistent public health challenges. For example, the company Oxitec has conducted field trials internationally—and has attempted to conduct field trials in the United States—of a genetically modified mosquito that can be used to control dengue, Zika, and some other mosquito-borne diseases. In 2016, a report commissioned by the National Academies of Sciences, Engineering, and Medicine discussed the potential benefits and risks of another strategy, using gene drives. (...) Driving a desired genotype through a population of wild animals or insects could lead to irreversible genetic modification of an entire species. The NASEM report recommends community, stakeholder, and public engagement about potential uses of the technology, and it argues that the engagement should occur as research advances, well before gene drives are deployed. Yet what “engagement” means in practice is unclear. This article seeks clarity on this problem by offering a justification for community engagement and drawing out implications of this argument for the implementation and desired outcomes of community engagement. Community engagement is essential when it comes to research that would release genetically modified insects or animals into the environment. By contrast, obtaining informed consent from people who live near such a proposed field trial is neither necessary nor sufficient. Drawing on the epistemic and moral arguments for deliberative democracy, I propose two discrete mechanisms of community engagement: community advisory boards and deliberative forums, neither of which has been systematically incorporated into research governance. The proposed mechanisms would engender respect for persons who live near field trials, even when the results of deliberation override some individuals’ preferences. Community engagement foregrounds the community in our thinking about humans’ relationship to nature, and it implies that deciding to release genetically modified insects or animals into the wild ought to be a collective decision, not one made by product developers, policy-makers, private companies, research funders, or scientists alone. (shrink)

Zika virus was recognised in 2016 as an important vector-borne cause of congenital malformations and Guillain-Barré syndrome, during a major epidemic in Latin America, centred in Northeastern Brazil. The WHO and Pan American Health Organisation, with partner agencies, initiated a coordinated global response including public health intervention and urgent scientific research, as well as ethical analysis as a vital element of policy design. In this paper, we summarise the major ethical issues raised during the Zika epidemic, highlighting the PAHO ethics (...) guidance and the role of ethics in emergency responses, before turning to ethical issues that are yet to be resolved. Zika raises traditional bioethical issues related to reproduction, prenatal diagnosis of serious malformations and unjust disparities in health outcomes. But the epidemic has also highlighted important issues of growing interest in public health ethics, such as the international spread of infectious disease; the central importance of reproductive healthcare in preventing maternal and neonatal morbidity and mortality; diagnostic and reporting biases; vector control and the links between vectors, climate change, and disparities in the global burden of disease. Finally, there are controversies regarding Zika vaccine research and eventual deployment. Zika virus was a neglected disease for over 50 years before the outbreak in Brazil. As it continues to spread, public health agencies should promote gender equity and disease control efforts in Latin America, while preparing for the possibility of a global epidemic. (shrink)

Many instances of scientific research impose risks, not just on participants and scientists but also on third parties. This class of social risks unifies a range of problems previously treated as distinct phenomena, including so-called bystander risks, biosafety concerns arising from gain-of-function research, the misuse of the results of dual-use research, and the harm caused by inductive risks. The standard approach to these problems has been to extend two familiar principles from human subjects research regulations—a favorable risk-benefit ratio and informed (...) consent. We argue, however, that these moral principles will be difficult to satisfy in the context of widely distributed social risks about which affected parties may reasonably disagree. We propose that framing these risks as political rather than moral problems may offer another way. By borrowing lessons from political philosophy, we propose a framework that unifies our discussion of social risks and the possible solutions to them. (shrink)

The release of over 6,000 genetically modified mosquitoes (GMM) into uninhabited Malaysian forests in 2010 was a frantic step on the part of the Malaysian government to combat the spread of dengue fever. The field trial was designed to control and reduce the dengue vector by producing offspring that die in the early developmental stage, thus decreasing the local Aedes aegypti population below the dengue transmission threshold. However, the GMM trials were discontinued in Malaysia despite being technologically feasible. The lack (...) of systematic studies in terms of cost-benefit analysis, questionable research efficacy and safety-related concerns might have contributed to the termination of the field trial. Hence, this research aims to evaluate the feasibility of GMM release in Malaysia by using a holistic approach based on an Islamic ethical-legal assessment under the maslahah-mafsadah (benefit-risk) concept. Three main strategies based on the maslahah-mafsadah concept approach have been applied: 1) an evidence-based approach, 2) an impact-based approach and, 3) a priority approach. The analysis concluded that GMM could be categorised as zanniyyah (probable). GMM is a promising alternative for dengue control, but many issues must be addressed before its widespread adoption. (shrink)

This review provides an overview of the ethics of extinctions with a focus on the Western analytical environmental ethics literature. It thereby gives special attention to the possible philosophical grounds for Michael Soulé’s assertion that the untimely ‘extinction of populations and species is bad’. Illustrating such debates in environmental ethics, the guiding question for this review concerns why – or when – anthropogenic extinctions are bad or wrong, which also includes the question of when that might not be the case (...) (i.e. which extinctions are even desirable). After providing an explanation of the disciplinary perspective taken (section “Introduction”), the concept of extinction and its history within that literature are introduced (section “Understanding extinction”). Then, in section “Why (or when) might anthropogenic extinctions be morally problematic?”, different reasons for why anthropogenic extinctions might be morally problematic are presented based on the loss of species’ value, harm to nonhuman individuals, the loss of valuable biological variety and duties to future generations. This section concludes by also considering cases where anthropogenic extinctions might be justified. Section “How to respond to extinctions?” then addresses a selection of topics concerning risks and de-extinction technologies. Finally, the section on “Extinction studies” introduces other viewpoints on the ethics of extinction from the extinction studies literature, followed by the “Conclusion”. (shrink)