Dual Use Research Of Concern Research Articles

Dual use in the 21st century: emerging risks and global governance.

Dual use research of concern (DURC) is defined by the World Health Organization as "life sciences research that is intended for benefit, but which might easily be misapplied to do harm." Ethical and policy discussions on DURC span the past three decades. Today, however, new and emerging technologies and associated sociocultural transformations within the scientific community are reshaping the current risk scenario. This paper identifies three major trends that are likely to characterise dual use dilemmas in the near future: the diversification of dual use domains, the digitalisation of potential threats and the proliferation of actors. This analysis illustrates an increasingly heterogeneous and fragmented risk scenario, which can hardly be effectively governed top-down from a centralised authority. We propose that in order to meet the critical challenges of dual use in the 21st century, a global and distributed governance is needed. In contrast to globally binding sets of legal mechanisms administered by a central and hierarchical authority supported by leading powers, we suggest a global and decentralised governance architecture encompassing multilevel, multipolar and bottom-up strategies that can stretch across a spectrum of stakeholders and scientific domains in an agile, proactive and adaptive manner. Finally, we discuss how Switzerland can take a leading role in the promotion and development of this global governance architecture.

‘Dual Use Research of Concern’ and ‘Select Agents’

AbstractCreating a suspect community is a time-consuming task and requires persistence. Once achieved, it is difficult to undo. In security terms, inspiring fear of dual use is one of many successful methods used to create suspicion. The concept of dual use research of concern (DURC) is the idea that scientific knowledge can be created by the worthy, stolen by the malevolent and used to make war on the innocent. On campus, ideas about Islam are currently often viewed as if Islam epitomisesDURC. By this means, a Derridean binary opposition springs up between Islam and the rest, whereby that-which-is-Islam is demeaned and the ‘rest’ is privileged. This emanates from political intervention on campus and creates a risk-averse ‘othering’ approach to students’ interaction with Islam and Muslims and the Western world. In order to demonstrate how this political intervention influences the university curriculum and university life on campus, the termdual usewill function here as a heuristic: the ‘metaphor’ ofDURCshows how certain government ideologies are being used on campus to ‘weaponise’ ideas about Islam as if they are malevolent. Using a complementary and mutually enhancing combination of philosophy, empirical research and policy analysis, three positive solutions are proposed that show how important it is that academics be aware of national policy: first, in order to make people cognisant of the urgent need to offer alternatives to the British counter terrorism programme ‘Prevent’ and the work of the Charity Commission with student societies; second, to support the work of academic subject associations; and third, to create a useful debate about free speech.

A New Approach to Evaluating the Risk-Benefit Equation for Dual-Use and Gain-of-Function Research of Concern.

In the twenty-first century, biology faces a problem that has previously vexed other disciplines such as physics, namely the prospect that its knowledge domain could be used to generate biological agents with altered properties that enhanced their weapon potential. Biological weapons bring the additional dimension that these could be self-replicating, easy to manufacture and synthesized with commonly available expertise. This resulted in increasing concern about the type of research done and communicated, despite the fact that such research often has direct societal benefits, bringing the dual-use dilemma to biology. The conundrum of dual use research of concern was crystallized by the so-called “gain-of-function” type of experiments in which avian influenza viruses were endowed with new properties in the laboratory such as increased virulence and the capacity for mammalian transmission. After more than a decade of intensive discussion and controversy involving biological experiments with dual-use potential, there is no consensus on the issue except for the need to carry out such experiments in the safest conditions possible. In this essay, we review the topic with the hindsight of several years and suggest that instead of prescribing prohibitions and experimental limitations the focus should be on the importance of scientific questions at hand. We posit that the importance of a scientific question for medical and scientific progress provides a benchmark to determine the acceptable level of risk in biological experimentation.

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.

Life scientists’ views and perspectives on the regulation of dual-use research of concern

In the early 2000s, several publications initiated a debate about the potential misuse of academic life science research. The debate was refueled in 2012, when two studies describing the engineering of human transmissive H5N1 bird flu virus were published. To facilitate the debate on dual-use research of concern (DURC) and regulatory measures, we interviewed life science researchers working in Switzerland about their views on DURC. The results indicate that all scientists interviewed were aware of the debate, however, few had reflected about dual-use aspects with regard to their own work. Although all respondents believed in freedom of research, a majority was supportive of some form of regulation of DURC. This article discusses the major implications of the study, especially regarding the implementation of regulatory measures. In addition, preliminary recommendations are given for raising awareness on DURC in the life sciences among researchers.

How to Balance the Risk and Benefit of Dual Use Research of Concern

Dual use research on H5N1 Influenza is a big debate topic as technologies in research improve. Once DURC research is published, these studies could be misused by bioterrorist and considered a potential risk for public health with individual ill intent. There are many risks and benefits of performing and publishing of H5N1 studies in the United States. Some restriction in DURC are needed to take place to make sure the benefits outweigh the risks, so research could be performed to ensure the global health.

Biosafety Oversight and Compliance: What do you Mean, I have to Fill Out Another Form?!

This unit is an overview of biosafety compliance and oversight in the United States. Specific attention is given to the oversight of the Institutional Biosafety Committee (IBC) and how the purview of the IBC may overlap with other local committees, such as the Institutional Animal Care and Use Committee (IACUC) for animal research and the Institutional Review Board (IRB) for research on human subjects. Requirements for the Federal Select Agent Program and Dual Use Research of Concern (DURC) are also briefly reviewed for those working with materials and experiments covered under these regulations. This unit serves as a guide for new and established investigators who are navigating the regulatory world and how regulatory oversight applies to their research.

A New Synthesis for Dual Use Research of Concern

Michael Imperiale and Arturo Casadevall propose a path forward for life sciences research whose results could be misused to cause harm.

DUAL USE RESEARCH OF CONCERN: DERIVATIVES OF 3-QUINUCLIDINYL BENZILATE (BZ)

Summary Dual Use Research of Concern (DURC) deals with the unintended consequences of and development and is particularly acute in the area of drug development. The United States National Science Advisory Board for Biosecurity (NSABB) has defined DURC as research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health, agriculture, plants, animals, the environment, or materiel” (1). One particular receptor antagonist and glycolate anticholinergic compound (BZ, QNB or 3 -quinuclidinyl benzilate) was stockpiled by the United States as a non-lethal chemical weapon that incapacitates and severely degrades the capability of exposed individuals (2). Given time and medical treatment, combatants and non-combatants exposed to such incapacitating agents could recover without any long-term effects. The purpose of this review is to identify potential new and more potent incapacitating agents based on the structures of BZ or atropine using peer reviewed publications of new pharmaceutical agents. A number of peer reviewed studies have reported on compounds with effects observed at lower concentrations than or comparable to BZ suggesting that these compounds could also be developed as potential chemical incapacitating chemical warfare agents and represent good examples of the principal of Dual Use Research of Concern.

Re-thinking the ethics of dual-use research of concern on transmissible pathogens

Rapid acceleration in the science of genetic engineering of infectious diseases has outpaced legal and ethical frameworks for dealing with such research. Dual-use research of concern (DURC), which can be used for good or for harm, raises new questions about potential harm to human beings which have not traditionally been considered by medical research ethics committees, and may require us to revise and standardize ethical guidelines worldwide for the conduct of such research. The weighing of harm versus benefit of research as traditionally considered on an individual level needs to be considered on a population level for infectious diseases DURC, and on a global level due to the potential for transmissible infections to cause a pandemic, thus affecting people in places far from where the research was conducted. The harm of such research could result from either laboratory accidents or bioterrorism. As an example, engineered organisms such as influenza could result in an unnatural pandemic, affecting and harming people who were never informed of the research nor consented to it. The debate to date has been held among medical researchers and has been focused on the rights of researchers and scientific freedom. The community is also a stakeholder with rights, and DURC done in one country could cause harm to people in other countries who were never included in the debate. The first requirement is to inform and engage the public as a stakeholder in such research, and to make deliberations about DURC public and transparent. Secondly, governance structures and guidelines are not uniform internationally, and only some institutions and countries have specific DURC policies, none of which are enforceable. Consistent international guidelines and uniform, enforceable global governance models need to be developed for medical research ethics committees around potential population harm and benefit of DURC. Finally, researchers should be required to quantify potential population risks and benefits of DURC before it is approved. Models for quantifying risk–benefit equations could be drawn from health economics, with the onus on researchers to demonstrate that potential benefit outweighs potential harm. These would be positive steps towards protecting the interests and rights of all potentially affected populations in the case of transmissible infectious disease DURC. Past quantum changes in medical research governance such as mandatory registration of clinical trials show that major changes in research culture can be achieved. Current systems leave community stakeholders vulnerable to potential harms of infectious diseases DURC, and need to be addressed in a consistent and comprehensive manner internationally to ensure ethical obligations are met.

Institutional Review of Dual Use Research of Concern to Support a Culture of Responsibility

The National Biodefense Analysis and Countermeasures Center (NBACC) plays a central role in the US Biodefense community, and its unique mission has driven NBACC to make dual use research of concern (DURC) review a focus since inception. Review of research results prior to external release began in 2007 and an institution-level review of all projects that considers DURC was implemented beginning in 2011. The DURC review process at NBACC has evolved through four approaches—each with advantages and disadvantages—that are all consistent with the recently issued U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. The current NBACC review process emphasizes Principal Investigator (PI) ownership and accountability, builds transparency in DURC review, and is specifically tailored to NBACC in order to reinforce an institutional culture of responsibility. This paper summarizes NBACC’s evolutionary process for effective DURC review.

Trends in U.S. Policy on Dual Use Research of Concern.

Trends in U.S. Policy on Dual Use Research of Concern.

Dual-use research debates and public health: better integration would do no harm.

The rapid pace of discovery in the life-sciences can have profound implicationsfor public health, and the focus of muchdeliberation in recent years has been onhow best to ensure that they are positiveand not negative. A key focus of debatehas been on dual-use research of con-cern (DURC), which has been defined aslife-science research that“could be directlymisapplied to pose a significant threatwith broad potential consequences to pub-lic health and safety, agricultural crops,and other plants, animals, the environ-ment, materiel, or national security (1).”Debates such as the one that surroundedgain-of-function (GOF) research on avianinfluenza have led to many existentialquestions about contemporary life-scienceresearch, including whether or not suchresearch should even be conducted in thefirst place, what viable alternative exper-imental approaches exist, if or how thefindings should be made public,and how –or whether – such research can be gov-erned (2–6).Responding to these questions at apolicy level necessarily involve a broadersphere of actors than life scientists alone asthey have potential ramifications in differ-ent sectors and for society-at-large. Often,it is the security and research commu-nities that have been at the frontline ofsuch debates and driving policy. The pub-lic health community tends to enter thefray at later stages, such as after the com-pletion of “concerning” research, at whichpoint it is asked to either facilitate discus-sion or comment on the potential publichealth risks and benefits of research (7, 8).By that stage, public health organizationsrisk being viewed of as a partisan supporterof dual-use research (9).In this paper, we demonstrate how thepublic health sector could more substan-tially contribute to the debate, guide pol-icy decisions, and promote actions alongall phases of the research life-cycle. Beforedoing so, we articulate the key aspects ofthe dual-use debate as they are relevant topublic health.

H5N1: A Cautionary Tale

OPINION article Front. Public Health, 12 August 2014Sec. Infectious Agents and Disease Volume 2 - 2014 | https://doi.org/10.3389/fpubh.2014.00117

Biosecurity Policy in the US: A Critical Assessment.

This commentary will critically evaluate the US Government Policy for Oversight of Life Sciences Dual Use Research of Concern with a special focus on the process of assessing the risks and benefits of studies that are deemed to be dual use research of concern (DURC). Assessing the risks and benefits of DURC studies is probably the most complicated part in implementing the policy. Curiously, little attention has been paid to this complex process. This paper details how this process is conducted and points out a major challenge it faces. We will suggest that this challenge is difficult to resolve thereby requiring further policy development.

Taking stock of security concerns related to synthetic biology in an age of responsible innovation.

In early May, the German Ethics Council produced an in-depth report on the oversight of dual-use research of concern (DURC) (1). The report follows in the wake of recent international emergency reviews of avian influenza research and builds on discussions, which have been taking place internationally for over a decade (2). In addition to calling for greater awareness raising and education in the scientific community, the report also calls for the establishment of a new legal framework to address DURC within Germany. This framework would provide a legal definition of DURC and would require researchers to report to a newly established central DURC committee before embarking on certain lines of research. Such a legal framework would also generate new responsibilities for those outside the research team who impact upon the research process; from funding right through to publication. For example, this would include new legal responsibilities for Laboratory Biosecurity Officers. Such an approach would be in stark contrast to the patch-work of largely voluntary measures, which are in place in the rest of the world. The German Ethics Council has also taken the view that Germany should encourage the adoption of similar review models at EU level and internationally.

Selected Abstracts From the 2013 International Neuroethics Society Annual Meeting

Selected Abstracts From the 2013 International Neuroethics Society Annual Meeting

On the Need for a National Board To Assess Dual Use Research of Concern

After dispersal of anthrax spores through the U.S. mail in 2001, there was heightened awareness of the potential of biological knowledge to be used for nefarious purposes. Consequently, there was greater scrutiny of published articles for information that, although not intended for this purpose,

Do Latin American Scientific Journals Follow Dual-Use Review Policies?

During the past decade, a number of journals have implemented dual-use policies in order to analyze whether the papers submitted for publication could raise concern because of the potential for misuse of their content. In this context, an analysis was performed on Latin American scientific journals to examine whether they apply formal written dual-use review policies and whether they inform their authors and reviewers about potentially sensitive issues in this area, as other international journals do. Peer-reviewed life sciences journals indexed in Latindex from Brazil, Mexico, Argentina, and Chile were analyzed. The Guide for Authors and the Instructions to Referees of 216 journals included in the Latindex catalogue (which means that they meet the best quality standards of the Latindex system) were screened for biosecurity-related information using the keywords biosecurity, biological weapons, and dual-use research of concern. Results showed that the screened publications had a total lack of dual-use review policies, even though some of them pointed out ethical behaviors to be followed related to authorship, plagiarism, simultaneous submission, research results misappropriation, ethical principles for medical research involving human subjects, guiding principles for the care and use of animals in research, research standard violations, and reviewer bias, among others.

Redaction of Sensitive Data in the Publication of Dual Use Research of Concern

ABSTRACTThe publication of scientific information that derives from dual use research of concern (DURC) poses major problems for journals because it brings into conflict the benefits of free access to data and the need to prevent misuse of that information by others. Recently, a group of authors and a major scientific journal addressed the issue of publishing information on a newly discovered, highly lethal toxin that can be delivered to large populations and for which there are no available countermeasures. The journal addressed this conflict by permitting the redaction of information that is normally considered essential for publication. This action establishes a precedent for redaction of sensitive data that also provides an example of responsible scientific publishing. However, this precedent leaves many questions unanswered and suggests a need for a discussion by all stakeholders of scientific information so as to derive normative standards for the publication of DURC.