The dual use of research ethics committees: why professional self-governance falls short in preserving biosecurity.

BACKGROUND: Dual Use Research of Concern (DURC) 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 (RECs) to an evaluation of DURC. MAIN BODY: 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. CONCLUSION: 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.

From Healthcare to Warfare and Reverse: How Should We Regulate Dual-Use Neurotechnology?

Recent advances in military-funded neurotechnology and novel opportunities for misusing neurodevices show that the problem of dual use is inherent to neuroscience. This paper discusses how the neuroscience community should respond to these dilemmas and delineates a neuroscience-specific biosecurity framework. This neurosecurity framework involves calibrated regulation, (neuro)ethical guidelines, and awareness-raising activities within the scientific community.

Biological Dual-Use Research and Synthetic Biology of Yeast.

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 (AG) 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 (i.e. plasmids, strains, antibodies, nucleic acids) 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.

If you build it, they will come: unintended future uses of organised health data collections.

BACKGROUND: Health research increasingly relies on organized collections of health data and biological samples. There are many types of sample and data collections that are used for health research, though these are collected for many purposes, not all of which are health-related. These collections exist under different jurisdictional and regulatory arrangements and include: 1) Population biobanks, cohort studies, and genome databases 2) Clinical and public health data 3) Direct-to-consumer genetic testing 4) Social media 5) Fitness trackers, health apps, and biometric data sensors Ethical, legal, and social challenges of such collections are well recognized, but there has been limited attention to the broader societal implications of the existence of these collections. DISCUSSION: Although health research conducted using these collections is broadly recognized as beneficent, secondary uses of these data and samples may be controversial. We examine both documented and hypothetical scenarios of secondary uses of health data and samples. In particular, we focus on the use of health data for purposes of: Forensic investigations Civil lawsuits Identification of victims of mass casualty events Denial of entry for border security and immigration Making health resource rationing decisions Facilitating human rights abuses in autocratic regimes CONCLUSIONS: Current safeguards relating to the use of health data and samples include research ethics oversight and privacy laws. These safeguards have a strong focus on informed consent and anonymization, which are aimed at the protection of the individual research subject. They are not intended to address broader societal implications of health data and sample collections. As such, existing arrangements are insufficient to protect against subversion of health databases for non-sanctioned secondary uses, or to provide guidance for reasonable but controversial secondary uses. We are concerned that existing debate in the scholarly literature and beyond has not sufficiently recognized the secondary data uses we outline in this paper. Our main purpose, therefore, is to raise awareness of the potential for unforeseen and unintended consequences, in particular negative consequences, of the increased availability and development of health data collections for research, by providing a comprehensive review of documented and hypothetical non-health research uses of such data.

Between Scylla and Charybdis: reconciling competing data management demands in the life sciences.

BACKGROUND: The widespread sharing of biologicaConcluding Comments: Teaching Responsible Datal and biomedical data is recognised as a key element in facilitating translation of scientific discoveries into novel clinical applications and services. At the same time, twenty-first century states are increasingly concerned that this data could also be used for purposes of bioterrorism. There is thus a tension between the desire to promote the sharing of data, as encapsulated by the Open Data movement, and the desire to prevent this data from 'falling into the wrong hands' as represented by 'dual use' policies. Both frameworks posit a moral duty for life sciences researchers with respect to how they should make their data available. However, Open data and dual use concerns are rarely discussed in concert and their implementation can present scientists with potentially conflicting ethical requirements. DISCUSSION: Both dual use and Open data policies frame scientific data and data dissemination in particular, though different, ways. As such they contain implicit models for how data is translated. Both approaches are limited by a focus on abstract conceptions of data and data sharing. This works to impede consensus-building between the two ethical frameworks. As an alternative, this paper proposes that an ethics of responsible management of scientific data should be based on a more nuanced understanding of the everyday data practices of life scientists. Responsibility for these 'micromovements' of data must consider the needs and duties of scientists as individuals and as collectively-organised groups. Researchers in the life sciences are faced with conflicting ethical responsibilities to share data as widely as possible, but prevent it being used for bioterrorist purposes. In order to reconcile the responsibilities posed by the Open Data and dual use frameworks, approaches should focus more on the everyday practices of laboratory scientists and less on abstract conceptions of data.

Biopreparedness in the Age of Genetically Engineered Pathogens and Open Access Science: An Urgent Need for a Paradigm Shift.

Our systems, thinking, training, legislation, and policies are lagging far behind momentous changes in science, and leaving us vulnerable in biosecurity. Synthetic viruses and genetic engineering of pathogens are a reality, with a rapid acceleration of dual-use science. The public availability of methods for dual-use genetic engineering, coupled with the insider threat, poses an unprecedented risk for biosecurity. Case studies including the 1984 Rajneesh salmonella bioterrorism attack and the controversy over engineered transmissible H5N1 influenza are analyzed. Simple probability analysis shows that the risks of dual-use research are likely to outweigh potential benefits, yet this type of analysis has not been done to date. Many bioterrorism agents may also occur naturally. Distinguishing natural from unnatural epidemics is far more difficult than other types of terrorism. Public health systems do not have mechanisms for routinely considering bioterrorism, and an organizational culture that is reluctant to consider it. A collaborative model for flagging aberrant outbreak patterns and referral from the health to security sectors is proposed. Vulnerabilities in current approaches to biosecurity need to be reviewed and strengthened collaboratively by all stakeholders. New systems, legislation, collaborative operational models, and ways of thinking are required to effectively address the threat to global biosecurity.

Domesticating the Drone: The Demilitarisation of Unmanned Aircraft for Civil Markets.

Remotely piloted aviation systems (RPAS) or 'drones' are well known for their military applications, but could also be used for a range of non-military applications for state, industrial, commercial and recreational purposes. The technology is advanced and regulatory changes are underway which will allow their use in domestic airspace. As well as the functional and economic benefits of a strong civil RPAS sector, the potential benefits for the military RPAS sector are also widely recognised. Several actors have nurtured this dual-use aspect of civil RPAS development. However, concerns have been raised about the public rejecting the technology because of their association with military applications and potentially controversial applications, for example in policing and border control. In contrast with the enthusiasm for dual-use exhibited throughout the EC consultation process, the strategy for avoiding public rejection devised in its roadmap would downplay the connection between military and non-military RPAS and focus upon less controversial applications such as search and rescue. We reflect upon this contrast in the context of the European agenda of responsible research and innovation. In doing so, we do not rely upon critique of drones per se, in their neither their civil nor military guise, but explore the extent to which current strategies for managing their public acceptability are compatible with a responsible and socially beneficial development of RPAS for civil purposes.

Dual use research: investigation across multiple science disciplines.

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.

The concept of governance in dual-use research.

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.