Humanity entered the twenty-first century with revolutionary achievements in biomedical research. At the same time multiple “dual-use” results have been published. The battle against infectious diseases is meeting new challenges, with newly emerging and re-emerging infections. Both natural disaster epidemics, such as SARS, avian influenza, haemorrhagic fevers, XDR and MDR tuberculosis and many others, and the possibility of intentional mis-use, such as letters containing anthrax spores in USA, 2001, have raised awareness of the real threats. Many great (...) men, including Goethe, Spinoza, J.B. Shaw, Fr. Engels, J.F. Kennedy and others, have recognized that liberty is also a responsibility. That is why the liberty to decide now represents an acknowledged necessity: biomedical research should be supported, conducted and published with appropriate measures to prevent potential “dual use”. Biomedical scientists should work according to the ethical principles of their Code of Conduct, an analogue of Hippocrates Oath of doctors; and they should inform government, society and their juniors about the problem. National science consulting boards of experts should be created to prepare guidelines and control the problem at state level. An international board should develop minimum standards to be applicable by each country. Bio-preparedness is considered another key-measure. (shrink)

Biological research with legitimate scientific purpose that may be misused to pose a biological threat to public health and/or national security is termed dual use. In Poland there are adequate conditions for conducting experiments that could be qualified as dual use research, and therefore, a risk of attack on Poland or other countries exists. Optimal solutions for limiting such threats are required, and the national system of biosecurity should enable early, reliable, and complete identification of this (...) type of research. Scientists should have a fundamental role in this process, their duty being to immediately, upon identification, report research with dual use potential. An important entity in the identification system of dual use research should also be the Central Register of Biological and Biomedical Research, which gathers information about all biological and biomedical research being conducted in a given country. Publishers, editors, and review committees of journals and other scientific publications should be involved in evaluating results of clinical trials. The National Council of Biosecurity should be the governmental institution responsible for developing a system of dual use research threat prevention. Its role would be to develop codes of conduct, form counsel of expertise, and monitor the problem at national level, while the Dual Use Research Committee would be responsible for individual cases. In Poland, current actions aiming to provide biological safety were based on developing and passing an act about genetically modified organisms (GMO’s) and creating a GMO Committee. Considering experiences of other nations, one should view these actions as fragmentary, and thus insufficient protection against dual use research threats. (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)

Continuing rapid developments in the life sciences offer the promise of providing tools to meet global challenges in health, agriculture, the environment, and economic development; some of the benefits are already being realized. However, such advances also bring with them new social, ethical, legal, and security challenges. Governance questions form an increasingly important part of the discussions about these advances--whether the particular issue under debate is the development of ethical principles for human genome editing, how to establish regulatory systems for (...) the safe conduct of field trials of gene drive-modified organisms, or many others. However there are continuing concerns that the knowledge, tools, and techniques resulting from life sciences research could also enable the development of bioweapons or facilitate bioterrorism. Between June 10 and 13, 2018, more than 70 participants from 30 different countries and 5 international organizations took part in an international workshop, The Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight, in Zagreb, Croatia. Hosted by the Croatian Academy of Sciences and Arts, the workshop was a collaboration among the InterAcademy Partnership, the Croatian Academy, the Croatian Society for Biosafety and Biosecurity, and the U.S. National Academies of Sciences, Engineering, and Medicine. This publication summarizes the presentations and discussions from the workshop."--Publisher's description. (shrink)

The paper ‘Biodefence and the production of knowledge’ by Buchanan and Kelley1 is an extremely valuable addition to the scientific and bioterrorism defence literature. It points out the myriad of ways that the structure of current debates about the dual use problem neglects important values, and discussions of how these values should be considered in policy making. In this commentary, I will focus on only one of these areas: what the authors characterise as ‘dual use opportunity’. My goal (...) is not to challenge the authors’ main points , but to draw out the complicated set of value conflicts that this single area of bioterror defence policy has neglected.Buchanan and Kelley characterise the concept of ‘dual use opportunity’ as the idea that ‘research undertaken for biodefence may contribute, or might be made to contribute, to the alleviation of the burden of disease among the world's worst-off people.’ I have argued for a similar idea of dual use opportunity in a different context by suggesting that we should prioritise global public health infrastructure over narrowly defined research on specific agents and/or projects that seek to prevent altogether biological attacks—a goal that, I have argued, is futile given the almost limitless number of forms of, and mutations to, disease bacteria and viruses that might be employed by biological terrorists.2–5 Effective control of an epidemic requires a fundamental infrastructure of surveillance and reporting. Because the …. (shrink)

Biomedical research, on the one hand, contributes to important goals from generation of knowledge about the human body to the development and testing of therapeutics of all kinds. On the other hand, it can produce serious and sometimes unforeseeable consequences. In the ethical analysis of these two aspects of biomedical research, two important argumentative strategies play a major role. First, slippery slope arguments are used to warn of potential risks and to highlight knowledge-based limitations. Second, a (...) dual-use problem describes the challenge that already established techniques can be used for both morally wrong and morally right purposes. These two argumentative strategies appear to share several similarities, which will be investigated in this article. For this purpose, the article will first provide clear working definitions for both types of argument. This lays the foundation for the further ethical analysis. In a second step, and in order to investigate the similarities and differences of the argumentative strategies with an example from current ethical debates, CRISPR-Cas9, a currently very promising tool of genome editing, will be examined. The extent to which the possible applications of this genome editing tool can be addressed by slippery slope arguments or the dual use problem will be investigated. For this purpose, selected studies involving the use of CRISPR-Cas9 will be examined. Based on this two-step, analytic and example-based comparison of slippery-slope argumentation and dual-use considerations, the article will detail the ethically relevant difference between the two argumentative strategies and at the same time contribute to the ongoing ethical debate about CRISPR-Cas9. (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)

In recent years, the publication of the studies on the transmissibility in mammals of the H5N1 influenza virus and synthetic genomes has triggered heated and concerned debate within the community of scientists on biological dual-use research; these papers have raised the awareness that, in some cases, fundamental research could be directed to harmful experiments, with the purpose of developing a weapon that could be used by a bioterrorist. Here is presented an overview regarding the dual-use concept (...) and its related international agreements which underlines the work of the Australia Group Export Control Regime. It is hoped that the principles and activities of the AG, that focuses on export control of chemical and biological dual-use materials, will spread and become well known to academic researchers in different countries, as they exchange biological materials and scientific papers. To this extent, and with the aim of drawing the attention of the scientific community that works with yeast to the so called Dual-Use Research of Concern, this article reports case studies on biological dual-use research and discusses a synthetic biology applied to the yeast Saccharomyces cerevisiae, namely the construction of the first eukaryotic synthetic chromosome of yeast and the use of yeast cells as a factory to produce opiates. Since this organism is considered harmless and is not included in any list of biological agents, yeast researchers should take simple actions in the future to avoid the sharing of strains and advanced technology with suspicious individuals. (shrink)

Israel has a long history of concern with chemical and biological threats, since several hostile states in the Middle East are likely to possess such weapons. The Twin-Tower terrorist attacks and Anthrax envelope scares of 2001 were a watershed for public perceptions of the threat of unconventional terror in general and of biological terror in particular. New advances in biotechnology will only increase the ability of terrorists to exploit the burgeoning availability of related information to develop ever-more destructive bioweapons. Many (...) areas of modern biological research are unavoidably dual-use by nature. They thus have a great potential for both help and harm; and facilitating the former while preventing the latter remains a serious challenge to researchers and governments alike. This article addresses how Israel might best (1) prevent hostile elements from obtaining, from Israel’s biological research system, materials, information and technologies that might facilitate their carrying out a biological attack, while (2) continuing to promote academic openness, excellence and other hallmarks of that system. This important and sensitive issue was assessed by a special national committee, and their recommendations are presented and discussed. One particularly innovative element is the restructuring and use of Israel’s extensive biosafety system to also address biosecurity goals, with minimal disruption or delay. (shrink)

This paper provides an overview of the various dual-use concepts applied in national and international non-proliferation and anti-terrorism legislation, such as the Biological and Toxin Weapons Convention, the Chemical Weapons Convention and United Nations Security Council Resolution 1540, and national export control legislation and in relevant codes of conduct. While there is a vast literature covering dual-use concepts in particular with regard to life sciences, this is the first paper that incorporates into such discussion the United Nations Security (...) Council Resolution 1540. In addition, recent developments such as the extension of dual-use export control legislation in the area of human rights protection are also identified and reviewed. The discussion of dual-use concepts is hereby undertaken in the context of human- and/or national-security-based approaches to security. This paper discusses four main concepts of dual use as applied today in international and national law: civilian versus military, peaceful versus non-peaceful, legitimate versus illegitimate and benevolent versus malevolent. In addition, the usage of the term to describe positive technology spin-offs between civilian and military applications is also briefly addressed. Attention is also given to the roles civil society and research ethics may play in the governance of dual-use sciences and technologies. (shrink)

Most life science research entails dual-use complexity and may be misused for harmful purposes, e.g. biological weapons. The Precautionary Principle applies to special problems characterized by complexity in the relationship between human activities and their consequences. This article examines whether the principle, so far mainly used in environmental and public health issues, is applicable and suitable to the field of dual-use life science research. Four central elements of the principle are examined: threat, uncertainty, prescription and action. (...) Although charges against the principle exist – for example that it stifles scientific development, lacks practical applicability and is poorly defined and vague – the analysis concludes that a Precautionary Principle is applicable to the field. Certain factors such as credibility of the threat, availability of information, clear prescriptive demands on responsibility and directives on how to act, determine the suitability and success of a Precautionary Principle. Moreover, policy-makers and researchers share a responsibility for providing and seeking information about potential sources of harm. A central conclusion is that the principle is meaningful and useful if applied as a context-dependent moral principle and allowed flexibility in its practical use. The principle may then inspire awareness-raising and the establishment of practical routines which appropriately reflect the fact that life science research may be misused for harmful purposes. (shrink)

This paper considers multiple meanings of the expression ‘dual use’ and examines lessons to be learned from the life sciences when considering ethical and policy issues associated with the dual-use nature of nanotechnology (and converging technologies). After examining recent controversial dual-use experiments in the life sciences, it considers the potential roles and limitations of science codes of conduct for addressing concerns associated with dual-use science and technology. It concludes that, rather than being essentially associated with voluntary (...) self-governance of the scientific community, codes of conduct should arguably be part of a broader regulatory oversight system. (shrink)

Scientific research that could cause grave harm, either through accident or intentional malevolence, is known as dual-use research. Recent high-profile cases of dual-use research in the life sciences have led to debate about the extent to which restrictions on the conduct and dissemination of such research may impede scientific progress. We adapt formal models of scientific networks to systematically explore the effects that different regulatory schemes may have on a community’s ability to learn about (...) the world. Our results suggest that, contrary to common wisdom, some restrictions on the conduct and dissemination of dual-use research do not inhibit scientific progress and may actually aid communities in learning. (shrink)

This book deals with the problem of dual-use science research and technology. It first explains the concept of dual use and then offers analyses of collective knowledge and collective ignorance. It goes on to present a theory of collective responsibility, followed by four chapters focusing on a particular scientific field or industry of dual use concern: the chemical industry, the nuclear industry, cyber-technology and the biological sciences. The problem of dual-use science research and technology (...) arises because such research and technology has the potential to be used for great evil as well as for great good. On the one hand, knowledge is a necessary condition, and perhaps a constitutive feature, of technologies that contribute greatly to individual and collective well-being. Consider, for example, nuclear technology that enables the generation of low cost electricity in populations without obvious alternative energy sources. So technological knowledge is a good thing and ignorance of it a bad thing. On the other hand, these same technologies can be extremely harmful to individuals and collectives, as with the atomic bombs dropped on Hiroshima and Nagasaki. So, at least with respect to some technologies evidently knowledge is a bad thing and ignorance a good thing. Accordingly, the question arises as to whether we ought to limit scientific research and/or the development of technology and, if so, which research or technology, in what manner and to what extent. This book examines the answer to that question. (shrink)

Debates about dual-use research often turn on the potential for scientific research to be used to benefit or harm humanity. This dual-use potential is conventionally understood as the product of the magnitude of the harms and benefits of dual-use research, multiplied by their likelihood. This account, however, neglects important social aspects of the use of science and technology. In this paper, I supplement existing conceptions of dual-use potential to account for the social context (...) of dual-use research. This account incorporates relational and positional concerns that feature in the success or failure of dual-use. I then defend this account against foreseeable objections. (shrink)

Digitization of a health record changes its accessibility. An electronic health record (EHR) can be accessed by multiple authorized users. Health information from EHRs contributes to learning healthcare systems’ development. The objective of this systematic review is to answer a question: What are ethical issues concerning research using EHRs in the literature? We searched Medline Ovid, Embase and Scopus for publications concerning ethical issues of research use of EHRs. We employed the constant comparative method to retrieve common ethical (...) themes. We descriptively summarized empirical studies. The study reveals the breadth, depth, and complexity of ethical problems associated with research use of EHRs. The central ethical question that emerges from the review is how to manage access to EHRs. Managing accessibility consists of interconnected and overlapping issues: streamlining research access to EHRs, minimizing risk, engaging and educating patients, as well as ensuring trustworthy governance of EHR data. Most of the ethical problems concerning EHR-based research arise from rapid cultural change. The framing of concepts of privacy, as well as individual and public dimensions of beneficence, are changing. We are currently living in the middle of this transition period. Human emotions and mental habits, as well as laws, are lagging behind technological developments. In the medical tradition, individual patient’s health has always been in the center. Transformation of healthcare care, its digitalization, seems to have some impacts on our perspective of health care ethics, research ethics and public health ethics. (shrink)

ABSTRACTMost life science research entails dual‐use complexity and may be misused for harmful purposes, e.g. biological weapons. The Precautionary Principle applies to special problems characterized by complexity in the relationship between human activities and their consequences. This article examines whether the principle, so far mainly used in environmental and public health issues, is applicable and suitable to the field of dual‐use life science research. Four central elements of the principle are examined: threat, uncertainty, prescription and action. (...) Although charges against the principle exist – for example that it stifles scientific development, lacks practical applicability and is poorly defined and vague – the analysis concludes that a Precautionary Principle is applicable to the field. Certain factors such as credibility of the threat, availability of information, clear prescriptive demands on responsibility and directives on how to act, determine the suitability and success of a Precautionary Principle. Moreover, policy‐makers and researchers share a responsibility for providing and seeking information about potential sources of harm. A central conclusion is that the principle is meaningful and useful if applied as a context‐dependent moral principle and allowed flexibility in its practical use. The principle may then inspire awareness‐raising and the establishment of practical routines which appropriately reflect the fact that life science research may be misused for harmful purposes. (shrink)

BackgroundThe use of great apes (GA) in invasive biomedical research is one of the most debated topics in animal ethics. GA are, thus far, the only animal group that has frequently been banned from invasive research; yet some believe that these bans could inaugurate a broader trend towards greater restrictions on the use of primates and other animals in research. Despite ongoing academic and policy debate on this issue, there is no comprehensive overview of the reasons (...) advanced for or against restricting invasive research with GA. To address this gap, we conducted a systematic review of the reasons reported in the academic literature on this topic.MethodsSeven databases were searched for articles published in English. Two authors screened the titles, abstracts, and full texts of all articles. Two journals specialized in animal ethics, and the reference lists of included articles were subsequently also reviewed.ResultsWe included 60 articles, most of which were published between 2006 and 2016. Twenty-five articles argued for a total ban of GA research, 21 articles defended partial restrictions, and 14 articles argued against restrictions. Overall, we identified 110 reason types, 74 for, and 36 against, restricting GA research. Reasons were grouped into nine domains: moral standing, science, welfare, public and expert attitudes, retirement and conservation, respect and rights, financial costs, law and legal status, and longer-term consequences.ConclusionOur review generated five main findings. First, there is a trend in the academic debate in favor of restricting GA research that parallels worldwide policy changes in the same direction. Second, in several domains (e.g., moral standing, and respect and rights), the reasons were rather one-sided in favor of restrictions. Third, some prominent domains (e.g., science and welfare) featured considerable engagement between opposing positions. Fourth, there is low diversity and independence among authors, including frequent potential conflicts of interests in articles defending a strong position (i.e., favoring a total ban or arguing against restrictions). Fifth, scholarly discussion was not the norm, as reflected in a high proportion of non-peer-reviewed articles and authors affiliated to non-academic institutions. (shrink)

In considering how to weigh the risks and benefits of synthetic biology, Kaebnick, Gusmano, and Murray pose the question of whether there is scientific re­search that should not be funded or performed, or if there are potentially dangerous results that should not be wide­ly disseminated. Such questions, they propose, require a new set of rules and norms for knowledge generation—an “ethics of knowledge.” They identify two examples of research that might fall into a nonpermissible category, including “research that (...) is aimed at producing and dis­seminating knowledge of... how to produce more dan­gerous forms of H5N1 and smallpox.” There are already rules and norms to guide the funding and generation of scientific knowledge, however, including research on in­fluenza and smallpox. Even if more rules and guidance were added to the practice of science, potentially prob­lematic, “dual‐use” research would still occur, and as a practical matter, it is unlikely that results from those stud­ies can be contained, particularly if the research is of wide interest. (shrink)

In debates over the regulation of communication related to dual-use research, the risks that such communication creates must be weighed against against the value of scientific autonomy. The censorship of such communication seems justifiable in certain cases, given the potentially catastrophic applications of some dual-use research. This conclusion however, gives rise to another kind of danger: that regulators will use overly simplistic cost-benefit analysis to rationalize excessive regulation of scientific research. In response to this, we (...) show how institutional design principles and normative frameworks from free speech theory can be used to help extend the argument for regulating dangerous dual-use research beyond overly simplistic cost-benefit reasoning, but without reverting to an implausibly absolutist view of scientific autonomy. (shrink)

Central to the argument of ‘Biodefense and the Production of Knowledge: Rethinking the Problem’ are claims that the vast majority of ethical debate about biodefense research to date has focused on the dual use problem, and the focus of ethical discussion of dual-use research has been on the need to strike ‘a proper balance of only two dominant values: biosecurity and “open science”’ —the idea being that ‘under current conditions other values can and ought to be (...) ignored because the stakes are so high’.1With regard to , Buchanan and Kelley's main point is that policy making regarding biodefense and dual use should be seen as an ‘optimisation problem’—the aim should be to achieve the greater good of society, where all relevant values are taken into account, rather than limiting attention to just two values—security and open science—in particular. While, as other commentators have argued, it is questionable whether these authors have provided an accurate account of ethical discussion of biodefense and dual use to date, in this brief commentary my purpose is to argue that the values of security and open science should themselves be seen as proxies for other values and that solution to …. (shrink)

In the past decade, the perception of a bioterrorist threat has increased and created a demand on life scientists to consider the potential security implications of dual use research. This article examines a selection of proposed moral obligations for life scientists that have emerged to meet these concerns and the extent to which they can be considered reasonable. It also describes the underlying reasons for the concerns, how they are managed, and their implications for scientific values. Five criteria (...) for what constitutes preventable harm are suggested and a number of proposed obligations for life scientists are considered against these criteria, namely, the obligations to prevent bioterrorism; to engage in response activities; to consider negative implications of research; not to publish or share sensitive information; to oversee and limit access to dangerous material; and to report activities of concern. Although bioterrorism might be perceived as an imminent threat, the analysis illustrates that this is beyond the responsibility of life scientists either to prevent or to respond to. Among the more reasonable obligations are duties to consider potential negative implications of one's research, protect access to sensitive material, technology and knowledge, and report activities of concern. Responsibility, therefore, includes obligations concerned with preventing foreseeable and highly probable harm. A central conclusion is that several of the proposed obligations are reasonable, although not unconditionally. (shrink)

BackgroundExisting research on perceptions of plagiarism and cultural influences mainly focuses on comparisons between the Western World and the Eastern World. However, possible differences within the Western World have hardly been assessed, especially among biomedical academics. The authors compared perceptions of plagiarism among European biomedical researchers who participated in an online survey.MethodsThe present work is based on the data collected in a previous online survey done in 2018 among biomedical researchers working in leading European and Chinese (...) universities. Respondents based in Europe were grouped into three geographical regions and their responses were analyzed using logistic regression analysis with adjustments for demographic factors.ResultsData were available from 810 respondents. In addition to their generally similar responses, different perceptions of plagiarism were observed among respondents in the three European regions. In summary, among the three European regions, Nordic respondents identified the most types of practices as plagiarism. Compared to the southern respondents, Nordic and northwestern respondents were more likely to consider less evident practices as plagiarism, such as Rephrasing another person’s work without crediting the source [aORN|S 1.99, aORS|NW 0.50 ] and With permission from the original author, using another’s text without crediting the source [aORN|S 3.16, aORS|NW 0.26 ]. In contrast, the southern respondents were the most inclined to recognize recycling of one’s previously rejected research proposal as plagiarism.ConclusionsIn spite of a generally similar response pattern, the present study indicates different perceptions of plagiarism among European biomedical researchers. These intra-European differences should be considered when addressing plagiarism. (shrink)

The term dual use technologies refers to research and technology with the potential both to yield valuable scientific knowledge and to be used for nefarious purposes with serious consequences for public health or the environment. There are two main approaches to assessing dual use technologies: pragmatic and metaphysical. A pragmatic approach relies on ethical principles and norms to generate specific guidance and policy for dual use technologies. A metaphysical approach exhorts us to the deeper study of (...) human nature, our intentions, goals, values ideals and social relations when considering dual use technology. Use of science and technology (S and T) is determined by two components of human nature: human intentions and choices. We have drawn a distinction between specific measures, goals and intentions with respect to technologies in order to show that moral judgment about technologies must precede their use. Understanding of our intentionality and values, and our moral ideals, as a measurable, tangible part of the real world is important for the prevention of any possible harm from S and T. In the context of dual use technologies, we stress the importance of three main understandings of human nature: vulnerability, responsibility and narrative identity. These can become a strong ontological “antidote” to technology’s poisoning of modern man. Each new technology can be measured and compared with man’s values, traditions and societal norms. This can be done bearing in mind the concept that human nature is not dualistic, but pluralistic. A system of ethical principles that includes the principles of good intentions, the correspondence of goals and means, the balancing of risks and benefits, simplicity, and contextuality, will help ensure that technologies are more humanistic and friendly to human beings. (shrink)

AI researchers have developed sophisticated language models capable of generating paragraphs of 'synthetic text' on topics specified by the user. While AI text generation has legitimate benefits, it could also be misused, potentially to grave effect. For example, AI text generators could be used to automate the production of convincing fake news, or to inundate social media platforms with machine-generated disinformation. This paper argues that AI text generators should be conceptualised as a dual-use technology, outlines some relevant lessons from (...) earlier debates on dual-use life sciences research, and calls for closer collaboration between ethicists and the machine learning community to address AI language models’ dual-use implications. (shrink)

The concept of dual-use encapsulates the potential for well-intentioned, beneficial scientific research to also be misused by a third party for malicious ends. The concept of dual-use challenges scientists to look beyond the immediate outcomes of their research and to develop an awareness of possible future (mis)uses of scientific research. Since 2001 much attention has been paid to the possible need to regulate the dual-use potential of the life sciences. Regulation initiatives fall under two (...) broad categories—those that develop the ethical education of scientists and foster an awareness and responsibility of dual-use issues, and those which assess the regulation of information being generated by current research. Both types of initiatives are premised on a cautious, risk-adverse philosophy which advocates careful examination of all future endpoints of research endeavors. This caution advocated within initiatives such as pre-publication review of journal articles contrasts to the obligation to share underpinning data sharing discussions. As the dual-use debate has yet to make a significant impact on data sharing discussions (and vice versa) it is possible that these two areas of knowledge control may present areas of ethical conflict for scientists, and thus need to be more closely examined. This paper examines the tension between the obligation to share exemplified by data sharing principles and the concerns raised by the risk-cautious culture of the dual-use debates. The paper concludes by reflecting on the issues of responsibility as raised by dual-use as relating to data sharing, such as the chain of custody for shared data. (shrink)

The growing threat of the misuse of science and technology for terrorist or criminal purposes has led scientists, institutions, professional organizations, funding agencies, journals, and governments to consider how best to control research that can be readily used to cause significant harm to public health, the economy, the environment, or national security, also known as dual use research. This commentary argues that scientists can regulate dual use research, provided that they are committed to developing effective (...) dual use policies and a culture of shared responsibility. (shrink)

Like nuclear energy, most technologies could have dual use—for health and well being and disaster and terror. Some research publications have brought to the forefront the tragic consequences of the latter potential through their possible use. Monitoring life science research and development (R&D) to prevent possible misuse is a challenging task globally, more so in developing economies like India, which are emerging as major biotech hubs. As a signatory to the Biological and Toxin Weapons Convention, India has (...) put in motion a process of evolving a series of measures to manage dual-use technology. The Indian Council of Medical Research (ICMR) has taken a lead in drafting model codes of conduct, ethics and practice for use by other S&T agencies to tailor them as per their requirements. Taking cue from the discussions held by the editors of the various medical and science journals in the developed world, the Indian Journal of Medical Research, the official publication of the ICMR, is working on policy and uniform practice of publication of dual-use research results. The Government of India too has promulgated legal provisions to minimize the risks of misuse of technology, like the Weapons of Mass Destruction Act. Clearly, no single agency would be able to manage the dual-use of technology effectively. Multiple agencies have to come together to work in tandem for effective implementation of various measure and also like Janus, ensure that they are neither too restrictive nor intrusive to discourage the development of science. (shrink)

Artificial Intelligence (AI) seems to be impacting all industry sectors, while becoming a motor for innovation. The diffusion of AI from the civilian sector to the defense sector, and AI’s dual-use potential has drawn attention from security and ethics scholars. With the publication of the ethical guideline Trustworthy AI by the European Union (EU), normative questions on the application of AI have been further evaluated. In order to draw conclusions on Trustworthy AI as a point of reference for responsible (...) research and development (R&D), we approach the diffusion of AI across both civilian and military spheres in the EU. We capture the extent of technological diffusion and derive European and German patent citation networks. Both networks indicate a low degree of diffusion of AI between civilian and defense sectors. A qualitative investigation of project descriptions of a research institute’s work in both civilian and military fields shows that military AI applications stress accuracy or robustness, while civilian AI reflects a focus on human-centric values. Our work represents a first approach by linking processes of technology diffusion with normative evaluations of R&D. (shrink)

Finding an effective microbicide that could substantially lower women’s risk of acquiring HIV infection is an ethical imperative. Women and girls continue to be disproportionally affected by HIV in sub-Saharan Africa. Ethics guidelines for conducting preventive HIV microbicide trials call for steps that intertwine biomedical research and public health. Ethical considerations include adequate studies of the safety of microbicides, the use of placebo controls in future trials once a microbicide is shown to be effective, whether leftover microbicide from (...) a trial that demonstrated efficacy should be made available to the public or used in the control group of a future trial, what preventive measures and treatment should be provided for trial participants during and after the research, and what constitute ‘fair benefits’ to the community or country when a trial is completed. The Global Campaign for Microbicides conducted a study of the benefits being provided to participants in microbicide trials and others, and found substantial evidence that researchers and sponsors are meeting the obligations stated in ethical guidelines. A cautionary tale of an HIV prevention trial that was prematurely halted demonstrates the need for engagement with the community where trials are carried out. (shrink)

This article addresses three questions concerning the legal regulation of the use of race as a category in biomedical research: how does the law currently encourage the use of race in biomedical research?; how might the existing legal framework constrain its use?; and what should be the law's approach to race-based biomedical research? It proposes a social justice approach that aims to promote racial equality by discouraging the use of “race” as a biological category (...) while encouraging its use as a socio-political category to understand and investigate ways to eliminate disparities in health status, access to health care, and medical treatment. (shrink)

Next SectionBiodefence, broadly understood as efforts to prevent or mitigate the damage of a bioterrorist attack, raises a number of ethical issues, from the allocation of scarce biomedical research and public health funds, to the use of coercion in quarantine and other containment measures in the event of an outbreak. In response to the US bioterrorist attacks following September 11, significant US policy decisions were made to spur scientific enquiry in the name of biodefence. These decisions led to (...) a number of critical institutional changes within the US federal government agencies governing scientific research. Subsequent science policy discussions have focused largely on ‘the dual use problem’: how to preserve the openness of scientific research while preventing research undertaken for the prevention or mitigation of biological threats from third parties. We join others in shifting the ethical debate over biodefence away from a simple framing of the problem as one of dual use, by demonstrating how a dual use framing distorts the debate about bioterrorism and truncates discussion of the moral issues. We offer an alternative framing rooted in social epistemology and institutional design theory, arguing that the ethical and policy debates regarding ‘dual use’ biomedical research ought to be reframed as a larger optimisation problem across a plurality of values including, among others: (1) the production of scientific knowledge; (2) the protection of human and animal subjects; (3) the promotion and protection of public health (national and global); (4) freedom of scientific enquiry; and (5) the constraint of government power. (shrink)

This paper discusses the hazards of regulating controversial biomedical research in light of the emergence of powerful, multi-national biotechnology corporations. Prohibitions on the use of government funds can simply force controversial research into the private sphere, and unilateral or multilateral research bans can simply encourage multi-national companies to conduct research in countries that lack restrictive laws. Thus, a net effect of government regulation is that research migrates from the public to the private sphere. Because (...) private research receives less oversight and external scrutiny than public research, it can threaten the welfare and rights of human subjects, scientific progress and openness, and the quality of the approval process for new biomedical technologies. In order to avoid the harmful effects of government regulation of biotechnology, society should promote meaningful discussion and dialogue among scientists, industry leaders, and the public before resorting to regulatory solutions. Legislative or executive initiatives should be applied with great discretion and care, and should be crafted in such a way that they protect public health and safety, promote scientific progress, and avoid the hazards of privatized research and polarized debates. (shrink)

Discourse about the use of animals in biomedical research usually focuses on two issues: its empirical and moral use. The empirical issue asks whether the use of nonhumans in experiments is required in order to get data. The moral issue asks whether the use of nonhumans can be defended as matter of ethical theory. Although the use of animals in research may involve a plausible necessity claim, no moral justification exists for using nonhumans in situations in which (...) we would not use humans. (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)

Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs in developing (...) countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)

In 1979 the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research in the US delivered a set of guidelines for the ethical conduct of research on human research subjects.1 In developing these guidelines, subsequently known as The Belmont Report, the Commission was “...directed to consider: the boundaries between biomedical and behavioural research and the accepted and routine practice of medicine”; and outline a set of ethical principles which would specifically (...) govern research activities. The Report notes that maintaining this distinction is important to ensure that all research activities are subjected to ethical review and, while it acknowledges that distinguishing research and clinical care is less easy in some cases, it suggests that this is a relatively simple and straightforward task. Forty years later, biomedical activities appear more complex: clinical activities are hybridised, trial design is no longer solely aimed at improving the evidence base, but at fostering closer integration with clinical activities and learning health systems reuse individuals’ health data to generate real-time improvements in patient care.2 In short, the conceptual boundaries between research and clinical care do not appear to be as distinct as the Belmont Report implies. Two papers in this issue and Ballantyne and Schaefer ) address some of the ethical challenges generated by merging of research and clinical care. The UK’s 100 000 Genomes Project is an example of a biomedical development in which research and clinical care are no longer understood as distinct activities. Patients in the 100kGP are offered clinical genomic sequencing on the understanding that their health data will be used for research purposes. Dheensa et al note that the 100kGP was designed with the dual purpose of providing patients with …. (shrink)

Discourse about the use of animals in biomedical research usually focuses on two issues. The first, which I will refer to as the “necessity issue,” is empirical and asks whether the use of nonhumans in experiments is required in order to gather statistically valid information that will contribute in a significant way to improving human health. The second, which I will refer to as the “justification issue,” is moral and asks whether the use of nonhumans in biomedical (...) research, if necessary as an empirical matter, can be defended as a matter of ethical theory.If it is not necessary as an empirical matter to use animals in research, then there is no need to inquire about moral justification. Therefore, I examine the necessity issue first. The argument that it is necessary to use nonhumans in biomedical research, though flawed, is at least plausible, unlike our necessity arguments for other animal uses. I then discuss the justification issue and conclude that we cannot morally justify using nonhuman animals in research. (shrink)

Due to the terrorist attacks of 9/11 and the anthrax letters of a few weeks later, the concept of dual use has spread widely in the life sciences during the past decade. This article is aimed at a clarification of the dual use concept and its scope of application for the life sciences. Such a clarification would greatly facilitate the work of policymakers seeking to ensure security while avoiding undesirable interventions of government in the conduct of science. The (...) article starts with an overview of the main developments in life sciences in relation to dual use. This is illustrated by discussions on synthetic biology and dual use. The findings lead to a reconsideration of the dual use concept. An area in need of further attention is to what extent threats and intentions should have impact on the definition of dual use. Possible threats are analyzed against the background of the phenomenon of securitization of health care and life sciences: considering these sectors of society in security terms. Some caveats that should be taken into account in a dual use policy are described. An acceptable, adequate and applicable definition of the dual use concept could help researchers, universities, companies and policy makers. Such a definition should build upon, but go beyond, the view developed in the influential Fink-report, which concentrates on the so-called ‘experiments of concern’, e.g. experiments that enhance the virulence of pathogens (National Research Council of the National Academies 2004) It will be argued that—in addition to these more technical aspects—a definition of dual use should include the aspect of threats and intentions. (shrink)

Experiments on animals have always been considered as necessary for scientific research, both fundamental and applied. In addition to scientific suitability criteria, this practice also must be justified from a moral point of view. This concern arises from the demand of our civilization that a certain moral value be recognized to animals. In this paper it is discussed in detail that how animals should be handled while doing research and what are animal rights and their uses in (...) class='Hi'>biomedical research.Bangladesh Journal of Bioethics 2015 Vol.6 (1):11-14. (shrink)

The increasing possibilities for using tissue for research and development in genetics and biotechnology have made stored human biological materials more important than ever. Using stored human biological materials raises many legal and ethical questions. On an international level however, the use of these materials has not been regulated in a detailed manner so far. The Council of Europe recently declassified the text of the proposal for an instrument on the use of archived human biological materials in biomedical (...) research for public consultation. The purpose of this paper is to comment on this document regarding its primary goal, which is to protect the rights and fundamental freedoms of the individual whose biological materials could be included in a research project. The guidelines offer good basic protection for sources of identifiable human biological materials but, surprisingly, offer no protection to sources of anonymous or anonymised materials. (shrink)

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)

Research in infection biology aims to understand the complex nature of host–pathogen interactions. While this knowledge facilitates strategies for preventing and treating diseases, it can also be intentionally misused to cause harm. Such dual-use risk is potentially high for highly pathogenic microbes such as Risk Group-3 (RG3) bacteria and RG4 viruses, which could be used in bioterrorism attacks. However, other pathogens such as influenza virus (IV) and enterohemorrhagic Escherichia coli (EHEC), usually classified as RG2 pathogens, also demonstrate high (...) dual-use risk. As the currently approved therapeutics against these pathogens are not satisfactorily effective, previous outbreaks of these pathogens caused enormous public fear, media attention and economic burden. In this interdisciplinary review, we summarize the current perspectives of dual-use research on IV and EHEC, and further highlight the dual-use risk associated with evolutionary experiments with these infectious pathogens. We support the need to carry out experiments pertaining to pathogen evolution, including to gain predictive insights on their evolutionary trajectories, which cannot be otherwise achieved with stand-alone theoretical models and epidemiological data. However, we also advocate for increased awareness and assessment strategies to better quantify the risks-versus-benefits associated with such evolutionary experiments. In addition to building public trust in dual-use research, we propose that these approaches can be extended to other pathogens currently classified as low risk, but bearing high dual-use potential, given the particular pressing nature of their rapid evolutionary potential. (shrink)