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

The dual use of research ethics committees: why professional self-governance falls short in... 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. Keywords: Dual use research of concern, Biosecurity, Research ethics committees, Professionalism, Germany Background  the reconstruction of the Spanish flu virus, which Dealing with Dual Use Research of Concern (DURC) had killed between 20 and 50 million people in constitutes a major challenge for research practice and 1918/19 [3, 4]; and oversight on the local, national and international level.  the enhancement of the transmissibility of the avian Cases of ethically questionable research in biology and influenza A/H5N1 virus on mammals [5, 6]. biosciences have attracted considerable even before the term DURC came into use. They included: Decision-making regarding the legitimacy and value of such research, which obviously entails the risk of being The insertion of the mouse IL-4 gene into the misused in bioterrorism or biowarfare, is required by mousepox virus, which led to the production of a various actors [7]. Individual scientists decide which superstrain of mousepox affecting mice that had types of research they undertake and which results they been resistant before [1]; submit for publication. Scientific institutions, such as the de novo artificial synthesis of a live polio virus universities, regulate potentially dangerous research ac- which paralyzed and killed mice [2]; tivities of their members. Professional societies have an influence on the development and implementation of ethical codes of conduct and play an important role in Correspondence: Sabine.Salloch@Uni-Greifswald.de the education of their members. Publishers have the final Institute of Ethics and History of Medicine, University Medicine Greifswald, decisive power on whether scientific results are Ellernholzstr. 1-2, 17487 Greifswald, Germany © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Salloch BMC Medical Ethics (2018) 19:53 Page 2 of 8 promulgated to the scientific community and the wider research which increases the transmissibility and/or the public. National governments make decisions on re- virulence of pathogens [16]. In contrast to DURC, a search funding and legal controls regarding potentially term which is typically used for issues of biosecurity as dangerous materials and technologies. International the deliberate misuse of science for malevolent purposes bodies, such as the WHO, finally, can build global (see, for example, NSABB definition above), GOFR is policies with respect to the threat of bioterrorism and discussed with respect to both: biosecurity and biosafety biowarfare. The responsibility for dealing with [16, 17]. The scientific and public debates on GOFR security-related research is, thus, spread between a var- were particularly triggered after the US Government had iety of individual and collective actors who can exert initiated a pause of funding research on dangerous path- their influence on the conduct and promulgation of po- ogens (such as influenza, SARS, and MERS viruses) in tentially dangerous scientific enterprises. 2014. This governmental decision was mainly driven by The complex discussions about the regulation of bio- a series of biosafety mishaps in the sense of human ex- medical research which bears the potential of being mis- posure to pathogens or inadvertent contamination of used for terrorism or warfare are closely related to the viral samples. Whereas issues of biosafety are linked question regarding which items can be sensibly thought with a number of highly relevant ethical questions [17, of as having a ‘dual use’ character. Finding appropriate 18] this article’s focus will be on the biosecurity debate, regulative measures to prevent the misuse of science, so on the deliberate misuse of scientific data, products therefore, depends greatly on what is the subject of such or technologies, which is typically discussed in the regulations. Different items are listed in this context, context of DURC. such as ‘material, technology or knowledge’ [8]or ‘re- The question of how to prevent the misuse of science search, technologies and artefacts.’ [9]. Other authors is often framed with respect to the two alternatives of also frame the misuse of biological and biomedical data governmental oversight by the state or state-like organi- as a DURC problem [10]. Whereas ‘immaterial’ subjects, zations versus scientific self-control [19]. State oversight such as knowledge, can often be transmitted easily and mechanisms can include legal regulations, such as the informally, more developed structures are necessary to US Patriot Act and the Bioterrorism Act, which control remove technologies and artefacts from their original re- the access, transfer and storage of potentially dangerous search context and use them for terrorist or military biological, chemical or radiological materials [20]. On purposes. Any regulation of DURC must, therefore, as- the international level, multilateral treaties, such as the sess the various levels of threat which, inter alia, depend Geneva Convention or the Biological Weapons Conven- on the necessary expertise and equipment [11]. The US tion (BWC), ban the development, production and National Science Advisory Board for Biosecurity stockpiling of biological weapons and promote their de- (NSABB) and the U.S. Government define DURC as: struction from a global perspective [21]. However con- crete suggestions for the national level are missing in life sciences research that, based on current this multilateral treaty. An obvious drawback of govern- understanding, can be reasonably anticipated to mental regulation lies in the fact that it might pose a sig- provide knowledge, information, products, or nificant threat to academic freedom [22]. The value of technologies that could be directly misapplied to pose academic freedom can be principally depicted as both, a significant threat with broad potential consequences an intrinsic as well as an instrumental good. Evans, how- to public health and safety, agricultural crops and ever, has convincingly shown that referring to scientific other plants, animals, the environment, materiel, or freedom as a good for its own sake can fail with respect national security [12]. to DURC when it has to be critically weighed against the public good of preventing mass casualties [23]. Instru- This rather broad definition has been internationally mental appeals to scientific freedom are limited as well, adopted [13, 14], forms a main point of reference in the for example because scientific principles such as the German discussions and will be followed hereafter. confirmation of results can often be achieved without Whereas the definition refers to any form of “life sci- full transparency about potentially dangerous aspects of ences research” the article’s main focus will be on bio- the research [23]. medical research and not, for example, on agriculture or Scientific self-control, on the other hand, comprises veterinary medicine. such different measure as the review of research by com- In more recent publications, the debate on potentially mittees, education and training, and the development harmful biomedical research is often framed with respect and promulgation of professional ethics codes and insti- to so-called “Gain-of-function Research” (GOFR). The tutional policies addressing DURC-related issues [24]. term GOFR refers to the creation of biological agents Whereas professional self-control can prove beneficial with altered properties [15]or – more concretely – to regarding freedom of inquiry, an overemphasis of the Salloch BMC Medical Ethics (2018) 19:53 Page 3 of 8 internal regulation within the scientific community is contributions [27–29]. The basic conflict between free- laden with problems, such as a bias towards avoiding re- dom of science and avoiding harm is spelt out more search restrictions. concretely regarding duties such as stopping research, This paper illuminates the tension between the two informing public authorities or not publishing results, options of scientific self-control versus governmental which must be discussed in detail with respect to the in- oversight by using the example of the debates in dividual researcher’s obligations [30]. Germany. Similar to other biomedical developments, ex- Whereas the ‘ethical dilemma framing’ of DURC might tensive discussions on how to regulate DURC started be useful in specific contexts, such as education and only rather recently in Germany. The situation is shaped awareness-raising, it has considerable shortcomings [31]. by two partly competing suggestions: The German Firstly, the ‘ethical dilemma framing’ does not mirror Ethics Council, an independent political advisory body the way in which the dual use issue is experienced and to the Bundestag and Federal Government, suggested a responded to by the scientific community. If scientists series of measures, including a national legislation on and institutions do not experience a ‘dilemma’, they are DURC [14]. Competing with that, the National Academy likely to remain ignorant regarding potential issues of of Sciences and the German Research Foundation, two concern. As any attempts to DURC regulation and gov- major professional bodies, made a suggestion which ernance finally aim for the prevention of potentially fatal draws on the self-control of science and, inter alia, sug- events, the ‘dilemma framing’ does not serve as a useful gests expanding the scope of existing research ethics strategy when it fails to motivate the relevant stake- committees (RECs) to an evaluation of DURC [25]. This holders. Secondly, speaking of a ‘dilemma’ may require ambiguous situation is taken as an occasion to further broader political negotiations of the structures and prac- analyze the scope and limits of professional self-control tices of biotechnology. If dual-use issues are primarily in dealing with potentially dangerous research. An ex- discussed case by case as a series of dilemmas, this emplary focus addresses the role of RECs in assessing might hinder the politics of governing DURC in the DURC. The critical evaluation of the subjects will be long-term, which should instead function anticipatorily conducted from the perspective of professionalism, and at a higher political level. Describing DURC as an which, as a sociological concept, is applied to RECs as ethical dilemma, therefore, does not always contribute to bodies of professional self-governance which deal with the building of adequate policies which are successful ethical issues. and accepted by the relevant stakeholders. Finally, from a more theoretical perspective, the problem of DURC Main text deviates from traditional notions of a ‘dilemma’: Prob- DURC as an ethical issue lems of DURC regulation usually do not appear in the RECs have a particular focus on the ethical legitimacy of sense that we have to decide about either being fully per- biomedical research projects. It is, therefore, in a first missive with respect to research practice and publication step, necessary to clarify how far dealing with DURC or being advocates of a complete prohibition of such re- constitutes an ethical problem when assessing whether search. Instead, complex evaluations are necessary which RECs can contribute to the prevention of science mis- have to carefully consider each individual case of re- use. Threats which emanate from the misuse of science search conduct, also with respect to its legal, ethical and and scientific results are obviously related to a range of social implications. fields that affect researchers and their institutions, the The demand to discuss the ethical issues of DURC publishing system, professional and political bodies, and from a more comprehensive perspective also arises re- society. Clearly pointing out the ethical concerns which garding the role of the precautionary principle (PP), are in play is not easy regarding such a complex and which is often taken as a normative point of reference. multilayered phenomenon as DURC. The PP as a conceptual tool is usually applied to guide A widespread way of framing the ethical debate on decision-making in risk management. A canonical for- DURC consists of a confrontation between the two main mulation of this principle is, however, missing. A com- values of the freedom of research versus the duty to mon feature of all attempts to explicate the PP lies in avoid causing harm [26]. The advancement of science, the fact that they advance precaution in some way. How- mirrored in the individual researcher’s right to freely ever, the formulas differ in their concrete content and pursue projects which are beneficial to society, is, thus, relationship to cost-benefit analysis as another tool for contrasted with society’s interest in being saved from se- the assessment of risk [32]. The PP can be usefully ap- vere threats, such as bioweapons or a toxic contamin- plied regarding DURC, especially concerning aspects of ation of food chains. This tension arising between raising awareness and the establishment of routines freedom and security is sometimes characterized as the which ensure that research is not misused for harmful ‘dual-use dilemma’ in public reports and scientific purposes [8]. Furthermore, it has been argued that the Salloch BMC Medical Ethics (2018) 19:53 Page 4 of 8 PP is particularly suited for the assessment of situations thus, characterized, inter alia, by their commitment to which are characterized by a high degree of uncertainty self-imposed ethical rules and independency from stately [32]. In contrast to risk, uncertain situations are those in institutions with respect to certain aspects of which the probability of possible outcomes cannot be self-jurisdiction. Regarding the first point, there are nu- quantified on the basis of reliable evidence [33]. As most merous codices dealing with the professional and ethical practical situations contain aspects of risk as well as of duties of researchers which have been issued, promul- uncertainty, a combination of the PP with a cost-benefit gated and promoted internationally by professional bod- analysis is a promising approach, also regarding research ies [41–43]. Even the call for a ‘Hippocratic Oath for which carries the potential of being misused. Applying Scientists’ has been raised and discussed vividly [44–46]. the PP in an isolated and inflexible way, by contrast, Codes of professional conduct have been suggested as runs the danger of promoting conservative or restrictive one measure to minimize biosecurity risks in the context options to the disadvantage of a nuanced evaluation of of DURC in the recent debates on security-related re- all available evidence on chances and challenges. search [12, 14]. They are regarded particularly as an ap- In summary, the discussions on DURC as an ethical propriate means to achieve the necessary balance issue mirror considerations which are typical of the as- between freedom of research and the need to protect sessment of complex situations affecting certain social high-value goods, such as national security. groups as well as the entire society. Dealing with the Professional self-control – as a second key feature of ethical aspects of DURC requires caution and thought- professionalism – forms part of the professional author- fulness and has to consider the genuine interests of sci- ity, which again, emanates from the exclusive body of ence and security issues appropriately without framing knowledge that members of the profession have at their both points as an irresolvable dilemma. command [40]. Professionals use their knowledge and competencies to serve their clients’ needs and maintain Science as a profession: ethical orientation and professional societal trust. Professional authority is the basis upon self-control which society confers certain rights to the profession for The notion of professionalism serves as a key concept to self-control. Depending on the branch and national con- understand and interpret structures and developments text, these rights extend, for example, to regulations of of modern societies. Physicians and the medical system the education curriculum, admission into the profession, usually serve as paradigm cases for professionalism in structure of the advanced training for specialization or the sociological literature [34, 35]. In contrast to a mere duties towards clients and colleagues. The professional occupation or job, professions are characterized by cer- authority is, however, not limitless: It is restricted to tain features, structures or functions in society which are those spheres in which the professionals have been edu- analyzed extensively by the sociology of the professions cated, therefore, to their distinct field of expertise. The as a scientific subdiscipline. Professions can be traced scope and limits of self-control are under continual dis- back historically to the guilds, which were the major cussion, for example, regarding the professional organi- organizations for skilled work in the Middle Ages. The zations’ right to advance ethically controversial positions guilds served for a public good (the permanent and reli- [47, 48]. With respect to the current debates on DURC, able provision of products and services) and, simultan- professional organizations in different countries have eously, maintained comfortable working conditions and stressed that they regard self-governance of science as a high income for their members [36]. Professional orga- the most effective means of managing the risks of mis- nizations, replacing the guilds in modern times, are still use [13, 49]. It is also stressed from other sides that powerful at regulating highly important social goods, for regulative measures towards DURC should, in the first example, medical services and research. Compared to instance, be taken by the scientific community before a clinical medicine, there is a scarcity of literature expli- state intervention becomes necessary [19]. In the re- citly addressing biomedical science as a profession [37]. mainder of this article RECs as bodies of professional However, the sociology of scientific knowledge, as a re- self-control will be examined regarding their potential to lated field, highlights the character of science as a social assess DURC-suspected research. activity and describes the construction of biomedical knowledge through functional and critical analyses of RECs and the regulation of DURC in Germany the related occupations [38, 39]. Professional self-control with respect to DURC can be Several features are listed typically as distinguishing realized by establishing committees particularly dedi- professions from other kinds of occupations [40]. cated to this task in research institutions or by expand- Among the most prominent of these characteristics are ing the spectrum of the RECs or Institutional Review the presence of professional codes of ethics and the ex- Boards already existing with respect to biosecurity is- clusive right to professional self-control. Professions are, sues. The last option, however, raises questions Salloch BMC Medical Ethics (2018) 19:53 Page 5 of 8 particularly concerning scope, competencies and respon- This background information is necessary to under- sibilities of the respective boards. The RECs are dedi- stand the impact of the current suggestion of the cated to ethical standards and, simultaneously, form German Research Foundation and the National Acad- bodies of professional self-control. In this degree, they emy of Sciences on the regulation of DURC. These two realize the two key components of professionalism dis- major professional bodies published their Recommenda- cussed before. It seems, thus, worthwhile discussing tions for Handling Security-Relevant Research [49]in whether the professional community of science in the 2014 and, simultaneously, installed a Joint Committee form of RECs establishes the appropriate setting to de- on the same subject which is supposed to support re- cide about security-related research. As national con- search institutions in the sustainable implementation of texts differ considerably regarding the functions and the recommendations. The committee is composed of legal status of RECs, in this article, the German situation senior researchers from biomedical sciences, social is taken as an example for discussing the chances and science, law and theology. In their 2014 recommenda- limits of professional self-control concerning DURC. tions, the two organizations claim jointly that research The RECs, as interdisciplinary committees, assess institutions should define ethics rules for handling ethical, legal and medical aspects of research involving hu- security-relevant research and that there should be a man subjects, biomaterial or data. In fulfilling this task, specialized REC to advise on issues arising from the im- the committees evaluate such different aspects as scientific plementation of such rules [49]. It is suggested in a sub- originality and relevance, ethical duties towards study par- sequent document (‘Progress Report’) from October ticipants, and specific legal issues, for example, regarding 2016 that extending the responsibilities of ethics study registration or monitoring. In this way, RECs protect committees already existing would be one option for the research participants as well as the investigators, and assessing DURC [25]. By now (March 2018) both contribute to the high quality of research as an important options – building new and specialized committees or societal goal. The RECs in Germany fulfil their function using the already established committees – have been real- regarding the physicians’ Professional Code, the German ized by German research institutions. Furthermore, there Drug Law and the Medicinal Products Act. According to are research institutions which are still in their planning paragraph 15 of the Professional Code, German physicians phase and others which do not plan to initiate an internal have to seek the advice of an REC when undertaking hu- DURC assessment. There is only anecdotal evidence re- man medical research: garding the concrete handling of DURC-suspected research within the committees. The German National Academy of Physicians who participate in a research project which Sciences and the German Research Foundation function as invades the mental or physical integrity of a human very active promotors of the field who initiate networking being, or uses human body material or data which can and provide further support. be traced to a particular individual, must ensure that This suggestion of an internal regulation of DURC advice on questions of professional ethics and professional within scientific institutions competes partly with an conduct associated with the project is obtained from opinion paper of the German Ethics Council published an Ethics Committee […] before conducting the in May 2014 [14]. The German Ethics Council provides research [50]. a thorough analysis of empirical, ethical and legal issues related to DURC. It suggests a bundle of measures to What is provided by the REC in this professional law prevent the misuse of dangerous knowledge, products or context is, however, advice. By contrast, German RECs technologies. The level of awareness is supposed to be have an authorization function regarding studies which raised by introducing the respective topics in academic are subject to drug or medicinal products law. These education, training and public discourse. Furthermore, a studies must only be undertaken – next to other condi- national biosecurity code of conduct shall be developed tions – when there is a positive vote from the respect- including, for example, regulations on the funding, plan- ive REC. German RECs are generally situated at the ning and execution of biosecurity-relevant research. medical faculties or the respective State Chamber of Finally – and divergent from the two main professional Physicians. They are composed of at least six members bodies characterized above – the German Ethics Council and their substitutes. It is usually required that one pleads for legally binding regulations on DURC, which member is qualified judge, one member has profes- include a legal definition and the obligatory consultation sional expertise in medical ethics and that three mem- of a DURC commission which operates on a national bers have a background in clinical medicine. Expertise level. Several members of the German Ethics Council in experimental design and statistics is also obligatory even suggested the implementation of a Federal author- as well as a balanced composition of the commission ity to approve suspected DURC on an obligatory basis regarding gender [51]. [14]. Thus, the German Ethics Council, as a political Salloch BMC Medical Ethics (2018) 19:53 Page 6 of 8 advisory body, supports measures of self-regulation and supposed to deal with major security threats. Measures to awareness-raising within the scientific community, but, at prevent the abuse of research are not exclusively directed the same time, does not exclude legal measures operating towards members of the professional community (which in parallel. In the remainder of the paper, whether such a could, however, happen in case of criminal colleagues), ‘double-tracked’ solution emerges as necessary or whether but towards outsiders who use research information, tech- professional self-regulation alone bears enough potential nologies or products for their illegal and highly dangerous to prevent the misuse of science will be discussed. purposes. The boundaries of professional ethics are, there- fore, markedly transgressed if RECs are used to assess and The ‘dual use’ of RECs – a critical evaluation from the regulate biosecurity-related issues. perspective of professionalism A second key component of professionalism, as The eligibility of RECs for assessing potentially dangerous depicted above, lies in the professionals’ right to inde- research can be discussed from a number of perspectives. pendently regulate issues which form part of their field The legal situation, for example, is far from clear regarding of expertise. The assessment of suspect DURC research, the juridical basis for assessing security-related research or however, can only partly be seen as falling under this the liability of committee members and the institutional scope. The RECs are composed of experienced re- providers. In addition to this, an unfavorable ‘mission searchers, including bioscientists, lawyers and ethicists. creep’ of RECs can be suspected if their spectrum of tasks They, thus, possess a range of competences which are is widened to DURC-related issues [52]. Albeit these and helpful to understand and estimate, for example, bio- other points deserve further attention, there is, so far, a logical backgrounds, chances and challenges, and the re- scarcity of literature on the suitability of RECs to assess search practice of certain experiments. Furthermore, suspect DURC research or to include a public they can assess the compliance with legal regulations security-related viewpoint in their ‘portfolio’ [26, 53]. and can deal with other ‘traditional’ tasks of research David Resnik comes to the conclusion that RECs should ethics, such as the protection of subjects and risk-benefit not be burdened with the responsibility of conducting analyses. What is missing, however, are specific compe- dual use reviews [53]. Instead, he suggests separate dual tencies needed to deal with terroristic threats or biowar- use or institutional biosafety committees. From Resnik’s fare. Scientists may not always be able to classify point of view, the major task of RECs is the protection of research appropriately as being a threat to security. human subjects, and too much extraneous responsibility There has not been any established connection to na- should be avoided. He argues that ‘Broader social or polit- tional security agencies and the respective political bod- ical issues should be resolved through legislation or ad- ies so far, and it remains doubtful whether top secret ministrative policy-making, not through IRB review [53].’ information regarding national interests or terrorist In addition to these important arguments, the perspec- threats can be easily shared with RECs at scientific insti- tive from professionalism taken in this article sheds a new tutions. Finally, a conflict of interest may arise between light on the role of RECs in assessing security-related re- the scientists’ interest in promoting research and their search. As argued before, RECs embody two major traits responsibility to prevent harmful misuse of science [19, associated with professionalism: They represent the ethical 26]. Researchers have a genuine professional interest in orientation within professional conduct and, simultan- advancing knowledge and, in addition, form part of a eously, form important bodies regarding professional system which puts them under considerable pressure re- self-control. Both aspects, which are used fruitfully in the garding, for example, presenting new results and pub- assessment of ‘usual’ biomedical research, can, however, lishing. Tensions may arise between the legitimate be challenged with respect to DURC. The ethical orienta- impetus of knowledge acquisition and the orientation to- tion of a profession is directed towards its clients as well wards public welfare as another key trait of professional- as towards the entire society. Orientation towards public ism. Deciding whether a suspect DURC study should be welfare thus forms a key trait of professionalism. Profes- carried out transcends the boundaries of the scientific sional organizations maintain certain privileges against ex- community in many respects and, in the worst case, can ternal forces, while simultaneously ensuring a high quality have catastrophic consequences for major parts of the of services. Regulations, such as those included in profes- population. It is, therefore, particularly important to sional codes of ethics, are addressed predominantly to weigh the expected gain of knowledge carefully and im- members of the profession and sanction deviant behavior partially against the possible consequences, even if they within the community. This function of professional eth- appear unlikely. ics, however, contrasts with certain aspects of the regula- The internal regulation of DURC within scientific in- tion of DURC, which could now be required from RECs stitutions, as it is currently suggested by the German as professional bodies: The aim of providing good services Research Foundation and the National Academy of to clients and society is considerably expanded if RECs are Sciences, clearly carries certain advantages related to the Salloch BMC Medical Ethics (2018) 19:53 Page 7 of 8 preservation of academic freedom and progress in sci- self-control reveals that assessment through RECs as ence. Both are important values which, in liberal states, professional bodies might not be appropriately suited to must only be restricted for important reasons. The evaluate and, finally, prevent the abuse of scientific threats, however, emanating from experiments, such as knowledge, products or technologies for terroristic or the reconstruction of a lethal virus, or from technologies warfare activities. Instead both, ethical orientation as which render vaccinations ineffective, could lead to cata- well as professional self-control, should be promoted strophic events. The level of risk in each case of DURC through measures aiming at awareness-raising, educa- depends on a variety of different factors which must be tion, and the development of a culture of responsibility evaluated carefully. Among these factors are not only and research integrity. the potential for being used as a weapon and the expert- The recent discussions on DURC in Germany are only ise and equipment needed for misuse [11], but also the in their infancy. Context-related and balanced strategies political situation and the likelihood of terrorist attacks. must be developed taking into account the international A comprehensive assessment encompassing scientific context. The final success of these attempts will depend and social and political factors cannot be performed by ultimately on the willingness to open communication RECs alone, but requires an extensive strategy including and cooperation on the side of the scientists as well as measures of professional self-control as well as aspects politicians and representatives of the public. It is to be of state and international oversight. hoped that serious and constructive processes will be The major role of scientific self-control then could lie initiated and continued and that effective solutions will in measures which promote awareness-raising, educa- be installed before the first severe incident happens tion, and a culture of responsibility and research integ- which could have disastrous consequences for human rity. More concretely, research institutions could initiate health and the environment. undergraduate and graduate curricula on biosecurity, the Abbreviations respective training for staff members and further the ex- BWC: Biological Weapons Convention; DURC: Dual Use Research of Concern; change between scientific and public discourse. Mea- GOFR: Gain-of-function Research; NSABB: National Science Advisory Board for Biosecurity; REC: Research ethics committees sures like these have been suggested by the German Ethics Council [14] and, in fact, they might be most Author’s contributions powerful in preventing the deliberate misuse of research SS is the sole author of this article. The author read and approved the final results, technologies or products for harmful purposes. manuscript. Activities like these can be considered as concrete Ethics approval and consent to participate implementations of ethical orientation which forms a Not applicable. key trait of professionalism. In addition, professional self-control could extend to interdisciplinary committees Competing interests The author declares that she has no competing interests. which offer collegial advice to those researchers who, by themselves, see a “dual use” potential in their research. These intra-professional ways of dealing with biosecurity Publisher’sNote Springer Nature remains neutral with regard to jurisdictional claims in published risks, however, should not be seen as substitutes for legal maps and institutional affiliations. regulation in high risk fields of research. The argument from scientific freedom, in many cases, has a limited Received: 16 January 2018 Accepted: 23 May 2018 power in light of the pragmatic circumstances of scien- tific work and its dissemination [23]. It can thus not be References brought forward in general to limit DURC governance 1. Jackson RJ, et al. Expression of mouse Interleukin-4 by a recombinant to scientific self-control which is, for the reasons dem- Ectromelia virus suppresses Cytolytic lymphocyte responses and overcomes genetic resistance to Mousepox. J Virol. 2001;75(3):1205–10. onstrated above, as a context not sufficient for dealing 2. Cello J, et al. 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The dual use of research ethics committees: why professional self-governance falls short in preserving biosecurity

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Philosophy; Ethics; Philosophy of Medicine; Theory of Medicine/Bioethics
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Abstract

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. Keywords: Dual use research of concern, Biosecurity, Research ethics committees, Professionalism, Germany Background  the reconstruction of the Spanish flu virus, which Dealing with Dual Use Research of Concern (DURC) had killed between 20 and 50 million people in constitutes a major challenge for research practice and 1918/19 [3, 4]; and oversight on the local, national and international level.  the enhancement of the transmissibility of the avian Cases of ethically questionable research in biology and influenza A/H5N1 virus on mammals [5, 6]. biosciences have attracted considerable even before the term DURC came into use. They included: Decision-making regarding the legitimacy and value of such research, which obviously entails the risk of being The insertion of the mouse IL-4 gene into the misused in bioterrorism or biowarfare, is required by mousepox virus, which led to the production of a various actors [7]. Individual scientists decide which superstrain of mousepox affecting mice that had types of research they undertake and which results they been resistant before [1]; submit for publication. Scientific institutions, such as the de novo artificial synthesis of a live polio virus universities, regulate potentially dangerous research ac- which paralyzed and killed mice [2]; tivities of their members. Professional societies have an influence on the development and implementation of ethical codes of conduct and play an important role in Correspondence: Sabine.Salloch@Uni-Greifswald.de the education of their members. Publishers have the final Institute of Ethics and History of Medicine, University Medicine Greifswald, decisive power on whether scientific results are Ellernholzstr. 1-2, 17487 Greifswald, Germany © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Salloch BMC Medical Ethics (2018) 19:53 Page 2 of 8 promulgated to the scientific community and the wider research which increases the transmissibility and/or the public. National governments make decisions on re- virulence of pathogens [16]. In contrast to DURC, a search funding and legal controls regarding potentially term which is typically used for issues of biosecurity as dangerous materials and technologies. International the deliberate misuse of science for malevolent purposes bodies, such as the WHO, finally, can build global (see, for example, NSABB definition above), GOFR is policies with respect to the threat of bioterrorism and discussed with respect to both: biosecurity and biosafety biowarfare. The responsibility for dealing with [16, 17]. The scientific and public debates on GOFR security-related research is, thus, spread between a var- were particularly triggered after the US Government had iety of individual and collective actors who can exert initiated a pause of funding research on dangerous path- their influence on the conduct and promulgation of po- ogens (such as influenza, SARS, and MERS viruses) in tentially dangerous scientific enterprises. 2014. This governmental decision was mainly driven by The complex discussions about the regulation of bio- a series of biosafety mishaps in the sense of human ex- medical research which bears the potential of being mis- posure to pathogens or inadvertent contamination of used for terrorism or warfare are closely related to the viral samples. Whereas issues of biosafety are linked question regarding which items can be sensibly thought with a number of highly relevant ethical questions [17, of as having a ‘dual use’ character. Finding appropriate 18] this article’s focus will be on the biosecurity debate, regulative measures to prevent the misuse of science, so on the deliberate misuse of scientific data, products therefore, depends greatly on what is the subject of such or technologies, which is typically discussed in the regulations. Different items are listed in this context, context of DURC. such as ‘material, technology or knowledge’ [8]or ‘re- The question of how to prevent the misuse of science search, technologies and artefacts.’ [9]. Other authors is often framed with respect to the two alternatives of also frame the misuse of biological and biomedical data governmental oversight by the state or state-like organi- as a DURC problem [10]. Whereas ‘immaterial’ subjects, zations versus scientific self-control [19]. State oversight such as knowledge, can often be transmitted easily and mechanisms can include legal regulations, such as the informally, more developed structures are necessary to US Patriot Act and the Bioterrorism Act, which control remove technologies and artefacts from their original re- the access, transfer and storage of potentially dangerous search context and use them for terrorist or military biological, chemical or radiological materials [20]. On purposes. Any regulation of DURC must, therefore, as- the international level, multilateral treaties, such as the sess the various levels of threat which, inter alia, depend Geneva Convention or the Biological Weapons Conven- on the necessary expertise and equipment [11]. The US tion (BWC), ban the development, production and National Science Advisory Board for Biosecurity stockpiling of biological weapons and promote their de- (NSABB) and the U.S. Government define DURC as: struction from a global perspective [21]. However con- crete suggestions for the national level are missing in life sciences research that, based on current this multilateral treaty. An obvious drawback of govern- understanding, can be reasonably anticipated to mental regulation lies in the fact that it might pose a sig- provide knowledge, information, products, or nificant threat to academic freedom [22]. The value of technologies that could be directly misapplied to pose academic freedom can be principally depicted as both, a significant threat with broad potential consequences an intrinsic as well as an instrumental good. Evans, how- to public health and safety, agricultural crops and ever, has convincingly shown that referring to scientific other plants, animals, the environment, materiel, or freedom as a good for its own sake can fail with respect national security [12]. to DURC when it has to be critically weighed against the public good of preventing mass casualties [23]. Instru- This rather broad definition has been internationally mental appeals to scientific freedom are limited as well, adopted [13, 14], forms a main point of reference in the for example because scientific principles such as the German discussions and will be followed hereafter. confirmation of results can often be achieved without Whereas the definition refers to any form of “life sci- full transparency about potentially dangerous aspects of ences research” the article’s main focus will be on bio- the research [23]. medical research and not, for example, on agriculture or Scientific self-control, on the other hand, comprises veterinary medicine. such different measure as the review of research by com- In more recent publications, the debate on potentially mittees, education and training, and the development harmful biomedical research is often framed with respect and promulgation of professional ethics codes and insti- to so-called “Gain-of-function Research” (GOFR). The tutional policies addressing DURC-related issues [24]. term GOFR refers to the creation of biological agents Whereas professional self-control can prove beneficial with altered properties [15]or – more concretely – to regarding freedom of inquiry, an overemphasis of the Salloch BMC Medical Ethics (2018) 19:53 Page 3 of 8 internal regulation within the scientific community is contributions [27–29]. The basic conflict between free- laden with problems, such as a bias towards avoiding re- dom of science and avoiding harm is spelt out more search restrictions. concretely regarding duties such as stopping research, This paper illuminates the tension between the two informing public authorities or not publishing results, options of scientific self-control versus governmental which must be discussed in detail with respect to the in- oversight by using the example of the debates in dividual researcher’s obligations [30]. Germany. Similar to other biomedical developments, ex- Whereas the ‘ethical dilemma framing’ of DURC might tensive discussions on how to regulate DURC started be useful in specific contexts, such as education and only rather recently in Germany. The situation is shaped awareness-raising, it has considerable shortcomings [31]. by two partly competing suggestions: The German Firstly, the ‘ethical dilemma framing’ does not mirror Ethics Council, an independent political advisory body the way in which the dual use issue is experienced and to the Bundestag and Federal Government, suggested a responded to by the scientific community. If scientists series of measures, including a national legislation on and institutions do not experience a ‘dilemma’, they are DURC [14]. Competing with that, the National Academy likely to remain ignorant regarding potential issues of of Sciences and the German Research Foundation, two concern. As any attempts to DURC regulation and gov- major professional bodies, made a suggestion which ernance finally aim for the prevention of potentially fatal draws on the self-control of science and, inter alia, sug- events, the ‘dilemma framing’ does not serve as a useful gests expanding the scope of existing research ethics strategy when it fails to motivate the relevant stake- committees (RECs) to an evaluation of DURC [25]. This holders. Secondly, speaking of a ‘dilemma’ may require ambiguous situation is taken as an occasion to further broader political negotiations of the structures and prac- analyze the scope and limits of professional self-control tices of biotechnology. If dual-use issues are primarily in dealing with potentially dangerous research. An ex- discussed case by case as a series of dilemmas, this emplary focus addresses the role of RECs in assessing might hinder the politics of governing DURC in the DURC. The critical evaluation of the subjects will be long-term, which should instead function anticipatorily conducted from the perspective of professionalism, and at a higher political level. Describing DURC as an which, as a sociological concept, is applied to RECs as ethical dilemma, therefore, does not always contribute to bodies of professional self-governance which deal with the building of adequate policies which are successful ethical issues. and accepted by the relevant stakeholders. Finally, from a more theoretical perspective, the problem of DURC Main text deviates from traditional notions of a ‘dilemma’: Prob- DURC as an ethical issue lems of DURC regulation usually do not appear in the RECs have a particular focus on the ethical legitimacy of sense that we have to decide about either being fully per- biomedical research projects. It is, therefore, in a first missive with respect to research practice and publication step, necessary to clarify how far dealing with DURC or being advocates of a complete prohibition of such re- constitutes an ethical problem when assessing whether search. Instead, complex evaluations are necessary which RECs can contribute to the prevention of science mis- have to carefully consider each individual case of re- use. Threats which emanate from the misuse of science search conduct, also with respect to its legal, ethical and and scientific results are obviously related to a range of social implications. fields that affect researchers and their institutions, the The demand to discuss the ethical issues of DURC publishing system, professional and political bodies, and from a more comprehensive perspective also arises re- society. Clearly pointing out the ethical concerns which garding the role of the precautionary principle (PP), are in play is not easy regarding such a complex and which is often taken as a normative point of reference. multilayered phenomenon as DURC. The PP as a conceptual tool is usually applied to guide A widespread way of framing the ethical debate on decision-making in risk management. A canonical for- DURC consists of a confrontation between the two main mulation of this principle is, however, missing. A com- values of the freedom of research versus the duty to mon feature of all attempts to explicate the PP lies in avoid causing harm [26]. The advancement of science, the fact that they advance precaution in some way. How- mirrored in the individual researcher’s right to freely ever, the formulas differ in their concrete content and pursue projects which are beneficial to society, is, thus, relationship to cost-benefit analysis as another tool for contrasted with society’s interest in being saved from se- the assessment of risk [32]. The PP can be usefully ap- vere threats, such as bioweapons or a toxic contamin- plied regarding DURC, especially concerning aspects of ation of food chains. This tension arising between raising awareness and the establishment of routines freedom and security is sometimes characterized as the which ensure that research is not misused for harmful ‘dual-use dilemma’ in public reports and scientific purposes [8]. Furthermore, it has been argued that the Salloch BMC Medical Ethics (2018) 19:53 Page 4 of 8 PP is particularly suited for the assessment of situations thus, characterized, inter alia, by their commitment to which are characterized by a high degree of uncertainty self-imposed ethical rules and independency from stately [32]. In contrast to risk, uncertain situations are those in institutions with respect to certain aspects of which the probability of possible outcomes cannot be self-jurisdiction. Regarding the first point, there are nu- quantified on the basis of reliable evidence [33]. As most merous codices dealing with the professional and ethical practical situations contain aspects of risk as well as of duties of researchers which have been issued, promul- uncertainty, a combination of the PP with a cost-benefit gated and promoted internationally by professional bod- analysis is a promising approach, also regarding research ies [41–43]. Even the call for a ‘Hippocratic Oath for which carries the potential of being misused. Applying Scientists’ has been raised and discussed vividly [44–46]. the PP in an isolated and inflexible way, by contrast, Codes of professional conduct have been suggested as runs the danger of promoting conservative or restrictive one measure to minimize biosecurity risks in the context options to the disadvantage of a nuanced evaluation of of DURC in the recent debates on security-related re- all available evidence on chances and challenges. search [12, 14]. They are regarded particularly as an ap- In summary, the discussions on DURC as an ethical propriate means to achieve the necessary balance issue mirror considerations which are typical of the as- between freedom of research and the need to protect sessment of complex situations affecting certain social high-value goods, such as national security. groups as well as the entire society. Dealing with the Professional self-control – as a second key feature of ethical aspects of DURC requires caution and thought- professionalism – forms part of the professional author- fulness and has to consider the genuine interests of sci- ity, which again, emanates from the exclusive body of ence and security issues appropriately without framing knowledge that members of the profession have at their both points as an irresolvable dilemma. command [40]. Professionals use their knowledge and competencies to serve their clients’ needs and maintain Science as a profession: ethical orientation and professional societal trust. Professional authority is the basis upon self-control which society confers certain rights to the profession for The notion of professionalism serves as a key concept to self-control. Depending on the branch and national con- understand and interpret structures and developments text, these rights extend, for example, to regulations of of modern societies. Physicians and the medical system the education curriculum, admission into the profession, usually serve as paradigm cases for professionalism in structure of the advanced training for specialization or the sociological literature [34, 35]. In contrast to a mere duties towards clients and colleagues. The professional occupation or job, professions are characterized by cer- authority is, however, not limitless: It is restricted to tain features, structures or functions in society which are those spheres in which the professionals have been edu- analyzed extensively by the sociology of the professions cated, therefore, to their distinct field of expertise. The as a scientific subdiscipline. Professions can be traced scope and limits of self-control are under continual dis- back historically to the guilds, which were the major cussion, for example, regarding the professional organi- organizations for skilled work in the Middle Ages. The zations’ right to advance ethically controversial positions guilds served for a public good (the permanent and reli- [47, 48]. With respect to the current debates on DURC, able provision of products and services) and, simultan- professional organizations in different countries have eously, maintained comfortable working conditions and stressed that they regard self-governance of science as a high income for their members [36]. Professional orga- the most effective means of managing the risks of mis- nizations, replacing the guilds in modern times, are still use [13, 49]. It is also stressed from other sides that powerful at regulating highly important social goods, for regulative measures towards DURC should, in the first example, medical services and research. Compared to instance, be taken by the scientific community before a clinical medicine, there is a scarcity of literature expli- state intervention becomes necessary [19]. In the re- citly addressing biomedical science as a profession [37]. mainder of this article RECs as bodies of professional However, the sociology of scientific knowledge, as a re- self-control will be examined regarding their potential to lated field, highlights the character of science as a social assess DURC-suspected research. activity and describes the construction of biomedical knowledge through functional and critical analyses of RECs and the regulation of DURC in Germany the related occupations [38, 39]. Professional self-control with respect to DURC can be Several features are listed typically as distinguishing realized by establishing committees particularly dedi- professions from other kinds of occupations [40]. cated to this task in research institutions or by expand- Among the most prominent of these characteristics are ing the spectrum of the RECs or Institutional Review the presence of professional codes of ethics and the ex- Boards already existing with respect to biosecurity is- clusive right to professional self-control. Professions are, sues. The last option, however, raises questions Salloch BMC Medical Ethics (2018) 19:53 Page 5 of 8 particularly concerning scope, competencies and respon- This background information is necessary to under- sibilities of the respective boards. The RECs are dedi- stand the impact of the current suggestion of the cated to ethical standards and, simultaneously, form German Research Foundation and the National Acad- bodies of professional self-control. In this degree, they emy of Sciences on the regulation of DURC. These two realize the two key components of professionalism dis- major professional bodies published their Recommenda- cussed before. It seems, thus, worthwhile discussing tions for Handling Security-Relevant Research [49]in whether the professional community of science in the 2014 and, simultaneously, installed a Joint Committee form of RECs establishes the appropriate setting to de- on the same subject which is supposed to support re- cide about security-related research. As national con- search institutions in the sustainable implementation of texts differ considerably regarding the functions and the recommendations. The committee is composed of legal status of RECs, in this article, the German situation senior researchers from biomedical sciences, social is taken as an example for discussing the chances and science, law and theology. In their 2014 recommenda- limits of professional self-control concerning DURC. tions, the two organizations claim jointly that research The RECs, as interdisciplinary committees, assess institutions should define ethics rules for handling ethical, legal and medical aspects of research involving hu- security-relevant research and that there should be a man subjects, biomaterial or data. In fulfilling this task, specialized REC to advise on issues arising from the im- the committees evaluate such different aspects as scientific plementation of such rules [49]. It is suggested in a sub- originality and relevance, ethical duties towards study par- sequent document (‘Progress Report’) from October ticipants, and specific legal issues, for example, regarding 2016 that extending the responsibilities of ethics study registration or monitoring. In this way, RECs protect committees already existing would be one option for the research participants as well as the investigators, and assessing DURC [25]. By now (March 2018) both contribute to the high quality of research as an important options – building new and specialized committees or societal goal. The RECs in Germany fulfil their function using the already established committees – have been real- regarding the physicians’ Professional Code, the German ized by German research institutions. Furthermore, there Drug Law and the Medicinal Products Act. According to are research institutions which are still in their planning paragraph 15 of the Professional Code, German physicians phase and others which do not plan to initiate an internal have to seek the advice of an REC when undertaking hu- DURC assessment. There is only anecdotal evidence re- man medical research: garding the concrete handling of DURC-suspected research within the committees. The German National Academy of Physicians who participate in a research project which Sciences and the German Research Foundation function as invades the mental or physical integrity of a human very active promotors of the field who initiate networking being, or uses human body material or data which can and provide further support. be traced to a particular individual, must ensure that This suggestion of an internal regulation of DURC advice on questions of professional ethics and professional within scientific institutions competes partly with an conduct associated with the project is obtained from opinion paper of the German Ethics Council published an Ethics Committee […] before conducting the in May 2014 [14]. The German Ethics Council provides research [50]. a thorough analysis of empirical, ethical and legal issues related to DURC. It suggests a bundle of measures to What is provided by the REC in this professional law prevent the misuse of dangerous knowledge, products or context is, however, advice. By contrast, German RECs technologies. The level of awareness is supposed to be have an authorization function regarding studies which raised by introducing the respective topics in academic are subject to drug or medicinal products law. These education, training and public discourse. Furthermore, a studies must only be undertaken – next to other condi- national biosecurity code of conduct shall be developed tions – when there is a positive vote from the respect- including, for example, regulations on the funding, plan- ive REC. German RECs are generally situated at the ning and execution of biosecurity-relevant research. medical faculties or the respective State Chamber of Finally – and divergent from the two main professional Physicians. They are composed of at least six members bodies characterized above – the German Ethics Council and their substitutes. It is usually required that one pleads for legally binding regulations on DURC, which member is qualified judge, one member has profes- include a legal definition and the obligatory consultation sional expertise in medical ethics and that three mem- of a DURC commission which operates on a national bers have a background in clinical medicine. Expertise level. Several members of the German Ethics Council in experimental design and statistics is also obligatory even suggested the implementation of a Federal author- as well as a balanced composition of the commission ity to approve suspected DURC on an obligatory basis regarding gender [51]. [14]. Thus, the German Ethics Council, as a political Salloch BMC Medical Ethics (2018) 19:53 Page 6 of 8 advisory body, supports measures of self-regulation and supposed to deal with major security threats. Measures to awareness-raising within the scientific community, but, at prevent the abuse of research are not exclusively directed the same time, does not exclude legal measures operating towards members of the professional community (which in parallel. In the remainder of the paper, whether such a could, however, happen in case of criminal colleagues), ‘double-tracked’ solution emerges as necessary or whether but towards outsiders who use research information, tech- professional self-regulation alone bears enough potential nologies or products for their illegal and highly dangerous to prevent the misuse of science will be discussed. purposes. The boundaries of professional ethics are, there- fore, markedly transgressed if RECs are used to assess and The ‘dual use’ of RECs – a critical evaluation from the regulate biosecurity-related issues. perspective of professionalism A second key component of professionalism, as The eligibility of RECs for assessing potentially dangerous depicted above, lies in the professionals’ right to inde- research can be discussed from a number of perspectives. pendently regulate issues which form part of their field The legal situation, for example, is far from clear regarding of expertise. The assessment of suspect DURC research, the juridical basis for assessing security-related research or however, can only partly be seen as falling under this the liability of committee members and the institutional scope. The RECs are composed of experienced re- providers. In addition to this, an unfavorable ‘mission searchers, including bioscientists, lawyers and ethicists. creep’ of RECs can be suspected if their spectrum of tasks They, thus, possess a range of competences which are is widened to DURC-related issues [52]. Albeit these and helpful to understand and estimate, for example, bio- other points deserve further attention, there is, so far, a logical backgrounds, chances and challenges, and the re- scarcity of literature on the suitability of RECs to assess search practice of certain experiments. Furthermore, suspect DURC research or to include a public they can assess the compliance with legal regulations security-related viewpoint in their ‘portfolio’ [26, 53]. and can deal with other ‘traditional’ tasks of research David Resnik comes to the conclusion that RECs should ethics, such as the protection of subjects and risk-benefit not be burdened with the responsibility of conducting analyses. What is missing, however, are specific compe- dual use reviews [53]. Instead, he suggests separate dual tencies needed to deal with terroristic threats or biowar- use or institutional biosafety committees. From Resnik’s fare. Scientists may not always be able to classify point of view, the major task of RECs is the protection of research appropriately as being a threat to security. human subjects, and too much extraneous responsibility There has not been any established connection to na- should be avoided. He argues that ‘Broader social or polit- tional security agencies and the respective political bod- ical issues should be resolved through legislation or ad- ies so far, and it remains doubtful whether top secret ministrative policy-making, not through IRB review [53].’ information regarding national interests or terrorist In addition to these important arguments, the perspec- threats can be easily shared with RECs at scientific insti- tive from professionalism taken in this article sheds a new tutions. Finally, a conflict of interest may arise between light on the role of RECs in assessing security-related re- the scientists’ interest in promoting research and their search. As argued before, RECs embody two major traits responsibility to prevent harmful misuse of science [19, associated with professionalism: They represent the ethical 26]. Researchers have a genuine professional interest in orientation within professional conduct and, simultan- advancing knowledge and, in addition, form part of a eously, form important bodies regarding professional system which puts them under considerable pressure re- self-control. Both aspects, which are used fruitfully in the garding, for example, presenting new results and pub- assessment of ‘usual’ biomedical research, can, however, lishing. Tensions may arise between the legitimate be challenged with respect to DURC. The ethical orienta- impetus of knowledge acquisition and the orientation to- tion of a profession is directed towards its clients as well wards public welfare as another key trait of professional- as towards the entire society. Orientation towards public ism. Deciding whether a suspect DURC study should be welfare thus forms a key trait of professionalism. Profes- carried out transcends the boundaries of the scientific sional organizations maintain certain privileges against ex- community in many respects and, in the worst case, can ternal forces, while simultaneously ensuring a high quality have catastrophic consequences for major parts of the of services. Regulations, such as those included in profes- population. It is, therefore, particularly important to sional codes of ethics, are addressed predominantly to weigh the expected gain of knowledge carefully and im- members of the profession and sanction deviant behavior partially against the possible consequences, even if they within the community. This function of professional eth- appear unlikely. ics, however, contrasts with certain aspects of the regula- The internal regulation of DURC within scientific in- tion of DURC, which could now be required from RECs stitutions, as it is currently suggested by the German as professional bodies: The aim of providing good services Research Foundation and the National Academy of to clients and society is considerably expanded if RECs are Sciences, clearly carries certain advantages related to the Salloch BMC Medical Ethics (2018) 19:53 Page 7 of 8 preservation of academic freedom and progress in sci- self-control reveals that assessment through RECs as ence. Both are important values which, in liberal states, professional bodies might not be appropriately suited to must only be restricted for important reasons. The evaluate and, finally, prevent the abuse of scientific threats, however, emanating from experiments, such as knowledge, products or technologies for terroristic or the reconstruction of a lethal virus, or from technologies warfare activities. Instead both, ethical orientation as which render vaccinations ineffective, could lead to cata- well as professional self-control, should be promoted strophic events. The level of risk in each case of DURC through measures aiming at awareness-raising, educa- depends on a variety of different factors which must be tion, and the development of a culture of responsibility evaluated carefully. Among these factors are not only and research integrity. the potential for being used as a weapon and the expert- The recent discussions on DURC in Germany are only ise and equipment needed for misuse [11], but also the in their infancy. Context-related and balanced strategies political situation and the likelihood of terrorist attacks. must be developed taking into account the international A comprehensive assessment encompassing scientific context. The final success of these attempts will depend and social and political factors cannot be performed by ultimately on the willingness to open communication RECs alone, but requires an extensive strategy including and cooperation on the side of the scientists as well as measures of professional self-control as well as aspects politicians and representatives of the public. It is to be of state and international oversight. hoped that serious and constructive processes will be The major role of scientific self-control then could lie initiated and continued and that effective solutions will in measures which promote awareness-raising, educa- be installed before the first severe incident happens tion, and a culture of responsibility and research integ- which could have disastrous consequences for human rity. More concretely, research institutions could initiate health and the environment. undergraduate and graduate curricula on biosecurity, the Abbreviations respective training for staff members and further the ex- BWC: Biological Weapons Convention; DURC: Dual Use Research of Concern; change between scientific and public discourse. Mea- GOFR: Gain-of-function Research; NSABB: National Science Advisory Board for Biosecurity; REC: Research ethics committees sures like these have been suggested by the German Ethics Council [14] and, in fact, they might be most Author’s contributions powerful in preventing the deliberate misuse of research SS is the sole author of this article. The author read and approved the final results, technologies or products for harmful purposes. manuscript. Activities like these can be considered as concrete Ethics approval and consent to participate implementations of ethical orientation which forms a Not applicable. key trait of professionalism. In addition, professional self-control could extend to interdisciplinary committees Competing interests The author declares that she has no competing interests. which offer collegial advice to those researchers who, by themselves, see a “dual use” potential in their research. 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BMC Medical EthicsSpringer Journals

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