Michael J. Selgelid

Ethical and philosophical consideration of the dual-use dilemma in the biological sciences.

The dual-use dilemma arises in the context of research in the biological and other sciences as a consequence of the fact that one and the same piece of scientific research sometimes has the potential to be used for bad as well as good purposes. It is an ethical dilemma since it is about promoting good in the context of the potential for also causing harm, e.g., the promotion of health in the context of providing the wherewithal for the killing of innocents. It is an ethical dilemma for the researcher because of the potential actions of others, e.g., malevolent non-researchers who might steal dangerous biological agents, or make use of the original researcher’s work. And it is a dilemma for governments concerned with the security of their citizens, as well as their health. In this article we construct a taxonomy of types of “experiments of concern” in the biological sciences, and thereby map the terrain of ethical risk. We then provide a series of analyses of the ethical problems and considerations at issue in the dual-use dilemma, including the impermissibility of certain kinds of research and possible restrictions on dissemination of research results given the risks to health and security. Finally, we explore the main available institutional responses to some of the specific ethical problems posed by the dual-use dilemma in the biological sciences.

A TALE OF TWO STUDIES: Ethics, Bioterrorism, and the Censorship of Science

Some scientific research should not be published. The risks to national security and public health override the social benefits of disseminating scientific results openly. Unfortunately, scientists themselves are not in a position to know which studies to withhold from public view, as the National Research Council has proposed. Yet neither can government alone be trusted to balance the competing interests at stake.

Managing the Unimaginable. Regulatory Responses to the Challenges posed by Synthetic Biology and Synthetic Genomics

The past few years have seen a growing academic and commercial interest in synthetic genomics and synthetic biology. We refer collectively to these technologies as synthetic life sciences. They involve several distinct engineering strategies drawn from the convergence of molecular genetics, chemistry, nanotechnology and electronic engineering. Synthetic genomics can be defined as the creation of either new or already existing individual genes, chromosomes and even whole genomes through the assembly of DNA molecules. Synthetic biology encompasses the design and construction of new biological parts, devices and systems—as well as the re‐design of existing, natural biological systems—for practical purposes (EC, 2005). It often uses the technologies and tools of synthetic genomics, but this is not a prerequisite. > …progress in science and technology often outpaces the relevant ethical, legal and moral discourse, and regulation… The considerable interest in the synthetic life sciences from scientists and the public alike is due to the enormous potential of these technologies for the development of pharmaceuticals, renewable fuel production, the detoxification of chemicals, the repair of defective genes in biomedicine, and environmental control. As beneficiaries of considerable support from both the public and private sectors, these technologies are advancing rapidly. However, progress in science and technology often outpaces the relevant ethical, legal and moral discourse and regulation, which can create suspicion and cause backlashes from the public. To avoid this situation in the synthetic life sciences, it is imperative that the ethical and regulatory issues surrounding synthetic genomics and synthetic biology are identified, analysed and addressed sooner rather than later. The potential of synthetic genomics was shown as early as 2002, when researchers at the State University of New York at Stony Brook (NY, USA) published the synthesis of the poliovirus in Science (Cello et al , 2002). In 2005, US scientists recreated the 1918 ‘Spanish Flu’ …

The mousepox experience

Much of the debate about science policy in recent years has focused on ‘the dual‐use dilemma’, which arises when well‐intentioned scientific research has the potential to be misused by state and non‐state actors for nefarious purposes. In the context of the life sciences, for example, the same discoveries that lead to advancements in medicine could also be used to facilitate the development of biological weapons. Although all life science techniques and discoveries might be inherently dual‐use (Atlas, 2009), current debates are concerned primarily with cases where the consequences of malevolent use would be especially severe (Selgelid, 2009). The dual‐use dilemma is not new. When physicists observed atomic fission and the nuclear chain reaction early in the twentieth century, they realized that these discoveries might have beneficial applications in medicine and energy production; but they also realized that they could lead to the production of new, horribly efficient weapons. The manufacture and use of the first atomic bombs—and the nuclear arms race that followed—demonstrated that their fears were justified. According to the American biologist Matthew Meselson, this is not specific to nuclear physics: “Every major technology—metallurgy, explosives, internal combustion, aviation, electronics, nuclear energy—has been intensively exploited, not only for peaceful purposes but also for hostile ones” (Meselson, 2000). Similarly, recent advances in biology and genetics in particular raise the possibility of a new generation of biological weapons. > …recent advances in biology and genetics in particular raise the possibility of a new generation of biological weapons One of the most cited examples of dual‐use research is that of Australian researchers who inadvertently developed a lethal mouse virus. In this now‐famous study, the researchers used standard genetic engineering techniques to insert the gene for interleukin‐4 (IL‐4) into the mousepox virus. They hoped that the altered virus would induce infertility in mice—which are …

Placebo use in vaccine trials: Recommendations of a WHO expert panel

Highlights • Placebo controls may be acceptable even when an efficacious vaccine exists, in the following four possible situations:• When developing a locally affordable vaccine.• When evaluating the local safety and efficacy of an existing vaccine.• When testing a new vaccine when an existing vaccine is not considered appropriate locally.• When determining the local burden of disease.

Gain-of-Function Research: Ethical Analysis.

Abstract Gain-of-function (GOF) research involves experimentation that aims or is expected to (and/or, perhaps, actually does) increase the transmissibility and/or virulence of pathogens. Such research, when conducted by responsible scientists, usually aims to improve understanding of disease causing agents, their interaction with human hosts, and/or their potential to cause pandemics. The ultimate objective of such research is to better inform public health and preparedness efforts and/or development of medical countermeasures. Despite these important potential benefits, GOF research (GOFR) can pose risks regarding biosecurity and biosafety. In 2014 the administration of US President Barack Obama called for a “pause” on funding (and relevant research with existing US Government funding) of GOF experiments involving influenza, SARS, and MERS viruses in particular. With announcement of this pause, the US Government launched a “deliberative process” regarding risks and benefits of GOFR to inform future funding decisions—and the US National Science Advisory Board for Biosecurity (NSABB) was tasked with making recommendations to the US Government on this matter. As part of this deliberative process the National Institutes of Health commissioned this Ethical Analysis White Paper, requesting that it provide (1) review and summary of ethical literature on GOFR, (2) identification and analysis of existing ethical and decision-making frameworks relevant to (i) the evaluation of risks and benefits of GOFR, (ii) decision-making about the conduct of GOF studies, and (iii) the development of US policy regarding GOFR (especially with respect to funding of GOFR), and (3) development of an ethical and decision-making framework that may be considered by NSABB when analyzing information provided by GOFR risk-benefit assessment, and when crafting its final recommendations (especially regarding policy decisions about funding of GOFR in particular). The ethical and decision-making framework ultimately developed is based on the idea that there are numerous ethically relevant dimensions upon which any given case of GOFR can fare better or worse (as opposed to there being necessary conditions that are either satisfied or not satisfied, where all must be satisfied in order for a given case of GOFR to be considered ethically acceptable): research imperative, proportionality, minimization of risks, manageability of risks, justice, good governance (i.e., democracy), evidence, and international outlook and engagement. Rather than drawing a sharp bright line between GOFR studies that are ethically acceptable and those that are ethically unacceptable, this framework is designed to indicate where any given study would fall on an ethical spectrum—where imaginable cases of GOFR might range from those that are most ethically acceptable (perhaps even ethically praiseworthy or ethically obligatory), at one end of the spectrum, to those that are most ethically problematic or unacceptable (and thus should not be funded, or conducted), at the other. The aim should be that any GOFR pursued (and/or funded) should be as far as possible towards the former end of the spectrum.

Biosecurity and Open-Source Biology: The Promise and Peril of Distributed Synthetic Biological Technologies

Abstract In this article, we raise ethical concerns about the potential misuse of open-source biology (OSB): biological research and development that progresses through an organisational model of radical openness, deskilling, and innovation. We compare this organisational structure to that of the open-source software model, and detail salient ethical implications of this model. We demonstrate that OSB, in virtue of its commitment to openness, may be resistant to governance attempts.

Moderate eugenics and human enhancement

Though the reputation of eugenics has been tarnished by history, eugenics per se is not necessarily a bad thing. Many advocate a liberal new eugenics—where individuals are free to choose whether or not to employ genetic technologies for reproductive purposes. Though genetic interventions aimed at the prevention of severe genetic disorders may be morally and socially acceptable, reproductive liberty in the context of enhancement may conflict with equality. Enhancement could also have adverse effects on utility. The enhancement debate requires a shift in focus. What the equality and/or utility costs of enhancement will be is an empirical question. Rather than philosophical speculation, more social science research is needed to address it. Philosophers, meanwhile, should address head-on the question of how to strike a balance between liberty, equality, and utility in cases of conflict (in the context of genetics).

Professionalization as a governance strategy for synthetic biology

This article considers professionalization as a governance strategy for synthetic biology, reporting on social science interviews done with scientists, science journal editors, members of science advisory boards and authors of nongovernmental policy reports on synthetic biology. After summarizing their observations about the potential advantages and disadvantages of the professionalization of synthetic biology, we analyze professionalization as a strategy that overcomes dichotomies found in the current debates about synthetic biology governance, specifically “top down” versus “bottom up” governance and scientific fact versus public values. Professionalization combines community and state, fact and value. Like all governance options, professionalization has limitations, particularly regarding war and peace. It is best conceptualized as potentially part of a wider range of governance mechanisms working in concert: a “web of prevention”.

Reflections on the Synthetic Production of Poliovirus

In 2002, three microbiologists announced the artificial synthesis of poliovirus, provoking international outrage and concern that other deadly viruses could also be created. Years later, they look back on their work and discuss ethics, security, and the future of synthetic biology.