As the usual regulatory framework did not fit well during the last Ebola outbreak, innovative thinking still needed. In the absence of an outbreak, randomised controlled trials of clinical efficacy in humans cannot be done, while during an outbreak such trials will continue to face significant practical, philosophical, and ethical challenges. This article argues that researchers should also test the safety and effectiveness of novel vaccines in wild apes by employing a pluralistic approach to evidence. There are three reasons to (...) test vaccines in wild populations of apes: i) protect apes; ii) reduce Ebola transmission from wild animals to humans; and iii) accelerate vaccine development and licensing for humans. Data obtained from studies of vaccines among wild apes and chimpanzees may even be considered sufficient for licensing new vaccines for humans. This strategy will serve to benefit both wild apes and humans. (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)

Biomedical research funding bodies across Europe and North America increasingly encourage—and, in some cases, require—investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what ‘good’ or ‘successful’ public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for (...) the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement. (shrink)

Non-human animal models of human diseases advance our knowledge of the genetic underpinnings of disease and lead to the development of novel therapies for humans. While mice are the most common model organisms, their usefulness is limited. Larger animals may provide more accurate and valuable disease models, but it has, until recently, been challenging to create large animal disease models. Genome editors, such as Clustered Randomised Interspersed Palindromic Repeat, meet some of these challenges and bring routine genome engineering of larger (...) animals and non-human primates well within reach. There is growing interest in creating NHP models of brain disorders such as autism, depression and Alzheimer’s, which are very difficult to model or study in other organisms, including humans. New treatments are desperately needed for this set of disorders. This paper is novel in asking: Insofar as NHPs are being considered for use as model organisms for brain disorders, can this be done ethically? The paper concludes that it cannot. Notwithstanding ongoing debate about NHPs’ moral status, animal welfare concerns, the availability of alternative methods of studying brain disorders and unmet expectations of benefit justify a stop on the creation of NHP model organisms to study brain disorders. The lure of using new genetic technologies combined with the promise of novel therapeutics presents a formidable challenge to those who call for slow, careful, and only necessary research involving NHPs. But researchers should not create macaques with social deficits or capuchin monkeys with memory deficits just because they can. (shrink)

In “Obligations of the Gift,” Lee argues that ethical thinking regarding return of genetic research results has been too narrowly focused on individual consent and participants’ “right to kn...

:In a recent paper in Cambridge Quarterly of Healthcare Ethics on the necessary conditions for morally responsible animal research David DeGrazia and Jeff Sebo claim that the key requirements for morally responsible animal research are an assertion of sufficient net benefit, a worthwhile-life condition, and a no-unnecessary-harm condition. With regards to the assertion of sufficient net benefit, the authors claim that morally responsible research offers unique benefits to humans that outweigh the costs and harms to humans and animals. In this (...) commentary we will raise epistemic, practical, and ethical challenges to DeGrazia and Sebo’s emphasis on benefits in the prospective assessment of research studies involving animals. We do not disagree with DeGrazia and Sebo that, at the theoretical level, the benefits of research justify our using animals. Our contribution intends to clarify, at the practical level, how we should understand benefits in the prospective assessment and moral justification of animal research. We argue that ASNB should be understood as an assessment of Expectation of Knowledge Production in the prospective assessment and justification of animal research. EKP breaks down into two further claims: that morally responsible research generates knowledge worth having and that morally responsible research is designed and executed to produce generalizable knowledge. We understand the condition called knowledge worth having as scientists’ testing a hypothesis that, whether verified or falsified, advances an important interest, and production of generalizable knowledge in terms of scientific integrity. Generalizable knowledge refers to experimental results that generalize to a larger population beyond the animals studied. Generalizable scientific knowledge is reliable, replicable, and accurately descriptive. In sum, morally responsible research will be designed and carefully executed to successfully test a hypothesis that, whether verified or falsified, advances important interests. Our formulation of EKP, crucially, does not require further showing that an experiment involving animals will produce societal benefits. (shrink)

This August, I participated in the conference “Genome Editing: Biomedical and Ethical Perspectives,” hosted by the Center for the Study of Bioethics at the University of Belgrade and cosponsored by the Division of Medical Ethics of NYU Langone Health and The Hastings Center. The prime minister of Serbia, Ana Brnabić, spoke of the significance of bringing together an international community of bioethicists, acknowledging that ethical, social, and legal issues surrounding gene editing technologies transcend national boundaries. Europe's Oviedo Convention prohibits human (...) germline gene editing, and UNESCO's Universal Declaration on the Human Genome and Human Rights says that germline editing “could be contrary to human dignity,” an assault on humanity itself. Whether one agrees or not, engaging with the idea forces us to think about what it means to be part of the global human community and about the moral significance of the human genome to creating that community. The conference highlighted for me how challenging having international, much less global, conversations about bioethics can be. (shrink)