Gain-of-function research involves experimentation that aims or is expected to 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 can pose risks regarding biosecurity and biosafety. In 2014 the (...) administration of US President Barack Obama called for a “pause” on 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 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 review and summary of ethical literature on GOFR, identification and analysis of existing ethical and decision-making frameworks relevant to the evaluation of risks and benefits of GOFR, decision-making about the conduct of GOF studies, and the development of US policy regarding GOFR, and 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. 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 : research imperative, proportionality, minimization of risks, manageability of risks, justice, good governance, 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, at one end of the spectrum, to those that are most ethically problematic or unacceptable, at the other. The aim should be that any GOFR pursued should be as far as possible towards the former end of the spectrum. (shrink)

Dual Use Research of Concern constitutes a major challenge for research practice and oversight on the local, national and international level. The situation in Germany is shaped by two partly competing suggestions of how to regulate security-related research: The German Ethics Council, as an independent political advisory body, recommended a series of measures, including national legislation on DURC. Competing with that, the German National Academy of Sciences and the German Research Foundation, as two major professional bodies, presented a strategy which (...) draws on the self-control of science and, inter alia, suggests expanding the scope of research ethics committees to an evaluation of DURC. This situation is taken as an occasion to further discuss the scope and limits of professional self-control with respect to security-related research. The role of RECs as professional bodies of science is particularly analyzed, referring to the theoretical backgrounds of professionalism. Two key sociological features of professionalism – ethical orientation and professional self-control – are discussed with respect to the practice of biomedical science. Both attributes are then analyzed with respect to the assessment of DURC by RECs. In conclusion, it is stated that issues of biosecurity transcend the boundaries of the scientific community and that a more comprehensive strategy should be implemented encompassing both professional self-control and legal oversight. (shrink)

Scientists and policy‐makers have long understood that the products of research can often be used for good or evil. Nuclear fission research can be used to generate electricity or create a powerful bomb. Studies on the genetics of human populations can be used to understand relationships between different groups or to perpetuate racist ideologies. While the notion that scientific research often has beneficial and harmful uses has been discussed before, the threat of bioterrorism—a concern that has only grown since 2001—has (...) led to increased awareness about the need to prevent the misuse of biomedical research, particularly when it involves dangerous pathogens or toxins. In 2012, the concern was ratcheted up another notch by two papers reporting the results of research on genetically engineered strains of the H5N1 avian influenza virus. Although the H5N1 papers have potential scientific and social value, some scientists and policy‐makers opposed their publication because they feared that terrorists (or others with nefarious motives) could use the research to create a bioweapon that could trigger a global pandemic. The H5N1 papers raise difficult questions concerning the ethics of knowledge. Should scientific research with dangerous applications be published? Should some types of research be kept secret or not be conducted at all? What type of government oversight of dangerous research is appropriate? In this essay, I will develop a framework for thinking about the ethics of knowledge and apply it to the H5N1 controversy, focusing on issues related to publication. I will argue that redacted publication would have been a reasonable response to the dilemmas posed by the H5N1 papers if not for practical and legal problems with this option. Given these problems, full publication seems appropriate. (shrink)

Most recent studies of dual use research have focused on the life sciences, although some researchers have suggested that dual use research occurs across many disciplines. This research is an initial investigation into the prevalence of dual use research in other scientific disciplines by surveying senior editors of scientific journals, drawn from Journal Citation Reports. The survey was emailed to 7,500 journal editors with a response rate of 10.1 %. Approximately 4.8 % of life science editors reported they had to (...) consider whether to publish dual use research and 38.9 % said they decided to not publish the research in question. In disciplines other than the life sciences, 7.2 % of editors from other science disciplines reported that they had to consider whether to publish dual use research, and 48.4 % declined to publish it. The survey investigated relationships between dual use and the journal’s source of funding and place of publication, but no relationships were found. Further research is needed to better understand the occurrence of dual use research in other science disciplines. (shrink)

Advances in the life sciences are occurring with extreme rapidity and accumulating a great deal of knowledge about life’s vital processes. While this knowledge is essential for fighting disease in a more effective way, it can also be misused either intentionally or inadvertently to develop novel and more effective biological weapons. For nearly a decade civil-academic society as well as States Parties to the Biological and Toxin Weapons Convention have recognised the importance of dual-use biosecurity education for life scientists as (...) a means to foster a culture of responsibility and prevent the potential misuse of advances in the life sciences for non-peaceful purposes. Nevertheless, the implementation of dual-use biosecurity education for life scientists has made little progress in institutions of higher learning. Professional societies and academic organizations have worked from the bottom-up in developing online dual-use biosecurity education modules that can be used for instruction. However, top-down help is needed from goverments if further progress is to be made in implementing biosecurity education for life scientists. (shrink)

In 2011, for the first time ever, two scientific journals were asked not to publish research papers in full detail. The research in question was on the H5N1 influenza virus (bird flu), and the concern was that the expected public health benefits of disseminating the findings did not outweigh the potential harm should the knowledge be misused for malicious purposes. This constraint raises important ethical concerns as it collides with scientific freedom and openness. In this article, we argue that constraining (...) the dissemination of dual-use knowledge can in certain cases be justified because, for example: scientists have a responsibility for potentially harmful consequences of their research; the public need not always know of all scientific discoveries; uncertainty about the risks of harm may warrant precaution; and expected benefits do not always outweigh potential harm. However, the constraints in question are not absolute but can be both temporary and partial. We propose three core aspects for an ethics of dual-use dissemination: dual-use awareness, precaution, and acknowledgment of conflicting values. Additionally, to help scientists understand when constraints on dissemination may be justified we suggest three corresponding conditions that prompt scientists to recognize dual-use material or research, consider the potential impact of dual-use knowledge dissemination, and acknowledge and respond to external dissemination concerns. (shrink)

The emergence of synthetic biology holds the potential of a major breakthrough in the life sciences by transforming biology into a predictive science. The dual-use characteristics of similar breakthroughs during the twentieth century have led to the application of benignly intended research in e.g. virology, bacteriology and aerobiology in offensive biological weapons programmes. Against this background the article raises the question whether the precautionary governance of synthetic biology can aid in preventing this techno-science witnessing the same fate? In order to (...) address this question, this paper proceeds in four steps: it firstly introduces the emerging techno-science of synthetic biology and presents some of its potential beneficial applications. It secondly analyses contributions to the bioethical discourse on synthetic biology as well as precautionary reasoning and its application to life science research in general and synthetic biology more specifically. The paper then identifies manifestations of a moderate precautionary principle in the emerging synthetic biology dual-use governance discourse. Using a dual-use governance matrix as heuristic device to analyse some of the proposed measures, it concludes that the identified measures can best be described as “patchwork precaution” and that a more systematic approach to construct a web of dual-use precaution for synthetic biology is needed in order to guard more effectively against the field’s future misuse for harmful applications. (shrink)

A wide variety of bioethical themes have recently been debated and researched in Sweden, including genetic screening, HPV vaccination strategies, end-of-life care, injustices and priority setting in healthcare, dual-use research, and the never-ending story of scientific fraud. Also, there are some new events related to Swedish biobanking that might be of general interest. Here we will concentrate on four themes: end-of-life care, dual-use research, scientific fraud, and biobanking.

The rapid advance of life science within the context of increased international concern over the potential misuse of findings has resulted in the lack of agreement on the issues of responsibility, control and collaboration. This progress of knowledge outpaces the efforts of creating moral and legal guidelines for the detection and minimization of the risks in the research process. There is a need to identify and address normative aspects of dual-use research. This paper focuses on the issues of safety and (...) global collaboration in life science research by highlighting the importance of openness, enabling policies and cooperative governance. These safeguards are believed to reduce the risks related to the misuse of science while enabling the important research to move forward. The paper addresses the need for a better definition of dual use concept and, based on the historical precedents, explores the moral concerns and governmental strategies of dual-use research. The three necessary moves in addressing the issue of security in life sciences are suggested: the move from constraining to enabling types of policies, the move from secrecy to openness, and the move from segregation to integration of the public voice. (shrink)

Technological measures meant to change sexual orientation are, we have argued elsewhere, deeply alarming, even and indeed especially if they are safe and effective. Here we point out that this in part because they produce a distinctive kind of ‘clinical collective action problem’, a sort of dilemma for individual clinicians and researchers: a treatment which evidently relieves the suffering of particular patients, but in the process contributes to a practice that substantially worsens the conditions that produce this suffering in the (...) first place. We argue that the role obligations of clinicians to relieve the suffering of their patients put them in a poor position to solve this problem, though they can take measures to avoid complicity in the harms that would result from widespread use of individually safe and effective reorientation biotechnology. But in the end the medical community as a whole still seems obligated to provide these measures, if they become technologically feasible. Medical researchers are in a better position to prevent the harms that would result if reorientation techniques were safe, effective and widely available. We argue that the harms attendant on the development of safe and effective re-orientation techniques give researchers reason to avoid ‘applied‘ research aimed at developing these techniques, and to be careful in the conduct of basic orientation research which might be applied in this way. (shrink)

Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...) associated with experimental design, including controlled variation and randomization, this chapter will provide a summary of key ethical issues that tend to arise in experimental contexts. In addition, by exploring assumptions about the nature of causation and by analyzing features of causal relationships, systems, and inferences in social contexts, this chapter will summarize the ways in which experimental design can undermine the integrity of not only social and behavioral research but policies implemented on the basis of such research. (shrink)