The Human Genome Organisation (HUGO) and a vision for Ecogenomics: the Ecological Genome Project.

BACKGROUND: The following outlines ethical reasons for widening the Human Genome Organisation's (HUGO) mandate to include ecological genomics. MAIN: The environment influences an organism's genome through ambient factors in the biosphere (e.g. climate and UV radiation), as well as the agents it comes into contact with, i.e. the epigenetic and mutagenic effects of inanimate chemicals and pollution, and pathogenic organisms. Emerging scientific consensus is that social determinants of health, environmental conditions and genetic factors work together to influence the risk of many complex illnesses. That paradigm can also explain the environmental and ecological determinants of health as factors that underlie the (un)healthy ecosystems on which communities rely. We suggest that The Ecological Genome Project is an aspirational opportunity to explore connections between the human genome and nature. We propose consolidating a view of Ecogenomics to provide a blueprint to respond to the environmental challenges that societies face. This can only be achieved by interdisciplinary engagement between genomics and the broad field of ecology and related practice of conservation. In this respect, the One Health approach is a model for environmental orientated work. The idea of Ecogenomics-a term that has been used to relate to a scientific field of ecological genomics-becomes the conceptual study of genomes within the social and natural environment. CONCLUSION: The HUGO Committee on Ethics, Law and Society (CELS) recommends that an interdisciplinary One Health approach should be adopted in genomic sciences to promote ethical environmentalism. This perspective has been reviewed and endorsed by the HUGO CELS and the HUGO Executive Board.

What Do Chimeras Think About?

Non-human animal chimeras, containing human neurological cells, have been created in the laboratory. Despite a great deal of debate, the status of such beings has not been resolved. Under normal definitions, such a being could either be unconventionally human or abnormally animal. Practical investigations in animal sentience, artificial intelligence, and now chimera research, suggest that such beings may be assumed to have no legal rights, so philosophy could provide a different answer. In this vein, therefore, we can ask: What would a chimera, if it could think, think about? Thinking is used to capture the phenomena of a novel, chimeric being perceiving its terrible predicament as no more than a laboratory experiment. The creation of a thinking chimera therefore forces us to reconsider our assumptions about what makes human beings (potentially) unique (and other sentient animals different), because, as such, a chimera's existence bridges our social and legal expectations about definitions of human and animal. Society has often evolved new social norms based on different kinds of (ir)rational contrivances; the imperative of non-contradiction, which is defended here, therefore requires a specific philosophical response to the rights of a thinking chimeric being.

One Health Requires a Theory of Agency.

One health suggests that human and animal health are comparable, but in practice, the concept aligns with the principles of public health ethics. One health ethics, as such, appears to eschew connotations of equality for the natural world. A theory of agency revises that anthropocentric assumption. This article begins with a critique of environmental dualism: the idea that human culture and nature are separate social realms, thus justifying public health as a (unifying) purpose. In response, this article argues that, first, a neuroethics of one health might equally regard humans and (some) animals, which have comparable mental states, as rational agents. Second, rational agency should ground our moral connections to nature in terms of the egalitarian interests we have (as coinhabitants) in the health of the planet. While this article makes a moderate case for interspecific rights (as the first argument asserts), neuroscience is unlikely for now to change how most public institutions regard nonhuman animals in practice. However, the second argument asserts that rational agency is also grounds for philosophical environmentalism. One health ethics, therefore, is a theory of equality and connects culture to nature, and, as such, is a separate, but coextensive approach to that of public health.

One health ethics.

One health has brought to the fore connections-between human culture and nature-that underlie healthy (and unhealthy) ecological niches. Like other emerging environmental concepts-eco-health, one medicine and planetary health-one health merges scientific evidence with reasons for sustaining a healthy environment. This narrative is not new, but the importance of a cogent way of thinking about nature in ways that allow us to ameliorate harms brought about by human activities has become a theme of the Anthropocene. Many societies face seemingly insurmountable crises, brought about by a collective failure to foster ethical forms of environmental health. The following essay is an egalitarian reimagining of one health ethics. Undertaking this task is of considerable philosophical importance, because solving the problem of denotation-asking what is one health?-could change our rational view of nature for the betterment of humankind and our Earthly companions.

The Human Genome Organisation (HUGO) and the 2020 COVID-19 pandemic.

This letter is the Human Genome Organisation's summary reaction to the 2020 COVID-19 pandemic. It identifies key areas for genomics research, and areas in which genomic scientists can contribute to a global response to the pandemic. The letter has been reviewed and endorsed by the HUGO Committee on Ethics, Law and Society (CELS) and the HUGO Council.

Where Does Open Science Lead Us During a Pandemic? A Public Good Argument to Prioritize Rights in the Open Commons.

During the 2020 COVID-19 pandemic, open science has become central to experimental, public health, and clinical responses across the globe. Open science (OS) is described as an open commons, in which a right to science renders all possible scientific data for everyone to access and use. In this common space, capitalist platforms now provide many essential services and are taking the lead in public health activities. These neoliberal businesses, however, have a problematic role in the capture of public goods. This paper argues that the open commons is a community of rights, consisting of people and institutions whose interests mutually support the public good. If OS is a cornerstone of public health, then reaffirming the public good is its overriding purpose, and unethical platforms ought to be excluded from the commons and its benefits.

Chimeras and the Problem of Other Minds.

The writer responds to the article "Human-Animal Chimeras: The Moral Insignificance of Uniquely Human Capacities," by Julian J. Koplin, in the September-October 2019 issue of the Hastings Center Report.

One health ethics: a response to pragmatism.

Johnson and Degeling have recently enquired whether one health (OH) requires a comprehensive normative framework, concluding that such a framework, while not necessary, may be helpful. In this commentary, we provide a context for this debate, and describe how pragmatism has been predominant in the OH literature. We nevertheless argue that articulating a comprehensive normative theory to ground OH practice might clear existing vagueness and provide stronger guidance in relevant health dilemmas. A comprehensive theory will also be needed eventually to ground notions such as universal good. We, thus, call for the systematic articulation of a comprehensive, metaethical theory, concomitantly with already ongoing normative work.

Conflicts of interest in e-cigarette research: A public good and public interest perspective.

The tobacco industry's involvement in the electronic cigarette research that informs public health policy is controversial. On the one hand, some are concerned that their involvement presents conflicts of interest that bias research outputs and invalidate the policies that use them. On the other hand, some have argued that the tobacco industry may support valid research and contribute to the goals of public health, for instance, if the interests of the e-cigarette industry could be part of a tobacco smoking cessation policy. We approach this debate from the ethical perspective of the public interest and the public good, considering how legitimate researchers can square their expert opinion with validating tobacco industry-funded research, given the perfidy of the tobacco industry and paucity of robust, conclusive evidence on the public health impacts of liberalizing e-cigarette use.

Statement on bioinformatics and capturing the benefits of genome sequencing for society.

The HUGO Committee on Ethics, Law and Society (CELS) undertook a Working Group exploration of the key ethical issues arising from genome sequencing in 2013. The Imagined Futures paper the group subsequently published proposed points to consider when applying genomic bioinformatics to data repositories used in genomic medicine and research ( http://www.hugo-international.org/Resources/Documents/CELS_Article-ImaginedFutures_2014.pdf ). Given the ever-increasing power to sequence the human genome rapidly and inexpensively-as well as trends toward "Big Data" and "Open Science"-we take this opportunity to update and refine the key findings of that paper.

Do Chimeras Have Minds?

Suppose that a colleague proposed a fantastic experiment: to introduce human stem cells into a neonatal mouse so that its entire brain developed into "human-like" neuronal structures. The colleague claimed it would still be a mouse, and that its chimeric brain would be nothing like a "human" one. It would not, as a result, have a moral status beyond its nonhuman animal origins. Thus, the "human neuron mouse" would allow scientists to tinker with human-like neurology in ways that would be precluded if it were a human being, and that would promise to lead to substantial understanding of the destructive and incurable brain diseases that befall humanity. The colleague does admit, however, that for reasons of comparative fidelity, experiments in human patients would be scientifically preferable, although in this case, neither ethically justified nor legally permitted. For that reason, it might be desirable to create a human brain in a nonhuman primate, where it would be more likely that significant human-like neuronal development would occur, but still could not become a person. This article explores the significance of a "human neuron chimpanzee," and suggests that contradictions in the design of the experiment make it unethical to proceed in either murine or primate models.

Falling giants and the rise of gene editing: ethics, private interests and the public good.

This paper considers the tensions created in genomic research by public and private for-profit ideals. Our intent is to strengthen the public good at a time when doing science is strongly motivated by market possibilities and opportunities. Focusing on the emergence of gene editing, and in particular CRISPR, we consider how commercialisation encourages hype and hope-a sense that only promise and idealism can achieve progress. At this rate, genomic research reinforces structures that promote, above all else, private interests, but that may attenuate conditions for the public good of science. In the first part, we situate genomics using the aphorism that 'on the shoulders of giants we see farther'; these giants are infrastructures and research cultures rather than individual 'heroes' of science. In this respect, private initiatives are not the only pivot for successful discovery, and indeed, fascination in those could impinge upon the fundamental role of public-supported discovery. To redress these circumstances, we define the extent to which progress presupposes research strategies that are for the public good. In the second part, we use a 'falling giant' narrative to illustrate the risks of over-indulging for-profit initiatives. We therefore offer a counterpoint to commercialised science, using three identifiable 'giants'-scientists, publics and cultures-to illustrate how the public good contributes to genomic discovery.

Expect the unexpected: screening for secondary findings in clinical genomics research.

Background: Due to decreasing cost, and increasing speed and precision, genomic sequencing in research is resulting in the generation of vast amounts of genetic data. The question of how to manage that information has been an area of significant debate. In particular, there has been much discussion around the issue of 'secondary findings' (SF)-findings unrelated to the research that have diagnostic significance. Sources of data: The following includes ethical commentaries, guidelines and policies in respect to large-scale clinical genomics studies. Areas of agreement: Research participant autonomy and their informed consent are paramount-policies around SF must be made clear and participants must have the choice as to which results they wish to receive, if any. Areas of controversy: While many agree that clinically 'actionable' findings should be returned, some question whether they should be actively sought within a research protocol. Growing points: SF present challenges to a growing field; diverse policies around their management have the potential to hinder collaboration and future research. Areas timely for developing research: The impact of returning SF and accurate estimates of their clinical utility are needed to inform future protocol design.

Ethical issues of CRISPR technology and gene editing through the lens of solidarity.

Background: The avalanche of commentaries on CRISPR-Cas9 technology, a bacterial immune system modified to recognize any short DNA sequence, cut it out, and insert a new one, has rekindled hopes for gene therapy and other applications and raised criticisms of engineering genes in future generations. Sources of data: This discussion draws on articles that emphasize ethics, identified partly through PubMed and Google, 2014-2016. Areas of agreement: CRISPR-Cas9 has taken the pace and prospects for genetic discovery and applications to a high level, stoking anticipation for somatic gene engineering to help patients. We support a moratorium on germ line manipulation. Areas of controversy: We place increased emphasis on the principle of solidarity and the public good. The genetic bases of some diseases are not thoroughly addressable with CRISPR-Cas9. We see no new ethical issues, compared with gene therapy and genetic engineering in general, apart from the explosive rate of findings. Other controversies include eugenics, patentability and unrealistic expectations of professionals and the public. Growing points: Biggest issues are the void of research on human germ cell biology, the appropriate routes for oversight and transparency, and the scientific and ethical areas of reproductive medicine. Areas timely for developing research: The principle of genomic solidarity and priority on public good should be a lens for bringing clarity to CRISPR debates. The valid claim of genetic exceptionalism supports restraint on experimentation in human germ cells, given the trans-generational dangers and the knowledge gap in germ cell biology.

Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations.

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies.

Justice Is the Missing Link in One Health: Results of a Mixed Methods Study in an Urban City State.

BACKGROUND: One Health (OH) is an interdisciplinary collaborative approach to human and animal health that aims to break down conventional research and policy 'silos'. OH has been used to develop strategies for zoonotic Emerging Infectious Diseases (EID). However, the ethical case for OH as an alternative to more traditional public health approaches is largely absent from the discourse. To study the ethics of OH, we examined perceptions of the human health and ecological priorities for the management of zoonotic EID in the Southeast Asia country of Singapore. METHODS: We conducted a mixed methods study using a modified Delphi technique with a panel of 32 opinion leaders and 11 semi-structured interviews with a sub-set of those experts in Singapore. Panellists rated concepts of OH and priorities for zoonotic EID preparedness planning using a series of scenarios developed through the study. Interview data were examined qualitatively using thematic analysis. FINDINGS: We found that panellists agreed that OH is a cross-disciplinary collaboration among the veterinary, medical, and ecological sciences, as well as relevant government agencies encompassing animal, human, and environmental health. Although human health was often framed as the most important priority in zoonotic EID planning, our qualitative analysis suggested that consideration of non-human animal health and welfare was also important for an effective and ethical response. The panellists also suggested that effective pandemic planning demands regional leadership and investment from wealthier countries to better enable international cooperation. CONCLUSION: We argue that EID planning under an OH approach would benefit greatly from an ethical ecological framework that accounts for justice in human, animal, and environmental health.

Can a good tree bring forth evil fruit? The funding of medical research by industry.

BACKGROUND: Systematic reviews analysing the influence of funding on the conduct of research have shown how Conflicts of Interest (COIs) create bias in the production and dissemination of data. SOURCES OF DATA: The following is a critical analysis of current opinions in respect to COIs created by industry funding of medical research in academic institutions. AREAS OF AGREEMENT: Effective mechanisms are necessary to manage COIs in medical research, and to prohibit COIs that clearly affect validity of research conduct and outcomes. AREAS OF CONTROVERSY: While most hold that industry investment in university research is not a barrier to good science, there are questions about how securing funding opportunities might be prioritized over the risks of potential COIs. It is argued that COIs are inherent risks to research integrity, requiring the strengthening of current governance frameworks. GROWING POINTS: The focus on COIs, created by the ostensibly categorical actions of industry, challenges the evolving research priorities within academic institutions. AREAS TIMELY FOR DEVELOPING RESEARCH: Less well-defined COIs are equally culpable to financial ones, in terms of the systemic damage they do to science. So, are they appropriately managed as risks within university research settings?

Therapeutic Misconception in Psychiatry Research: A Systematic Review.

Therapeutic misconception (TM) denotes the phenomenon in which research subjects conflate research purpose, protocols and procedures with clinical treatment. We examined the prevalence, contributory factors, clinical associations, impact, and collated solutions on TM within psychiatric research, and made suggestions going ahead. Literature search for relevant empirical research papers was conducted until February 2015. Eighty-eight reports were extracted, of which 31 were selected, summarised into different headings for discussion of implications and collated solutions of TM. We found variable and high rates of TM (ranging from 12.5% to 86%) in some psychiatry research populations. Contributory factors to TM included perceived medical roles of researchers, media, research setting and subject factors. Greater TM in affective, neurodevelopmental and psychotic spectrum conditions were associated with demographic variables (such as lower education, increased age), clinical factors (such as poor insight, cognitive deficits, increased symptoms, poorer self-rated quality of health), and social functioning (such as decreased independence). Inattention to TM may lead to frustration, negative impression and abandonment of participation in psychiatry research. Strategies such as the employment of a neutral educator during the informed consent process and education modules may be effective in addressing TM. Further research is warranted to examine the different TM facets, specific clinical correlates and more effective management strategies.