Prudently conduct the engineering and synthesis of the SARS-CoV-2 virus
Identifieur interne : 000825 ( Pmc/Corpus ); précédent : 000824; suivant : 000826Prudently conduct the engineering and synthesis of the SARS-CoV-2 virus
Auteurs : Peng Gao ; Shiwen Ma ; Daru Lu ; Carl Mitcham ; Yijia Jing ; Guoyu WangSource :
- Synthetic and Systems Biotechnology [ 2405-805X ] ; 2020.
Abstract
In response to the outbreak of COVID-19 that has been sweeping the world, scientists reconstructed the SARS-CoV-2 rapidly using a synthetic genomics platform, in order to accelerate therapeutics and vaccine development. However, given the dual-use nature of this technology, there exists a high biosecurity risk. This paper points out the potential risks of the engineering SARS-CoV-2 virus and puts forward 6 questions to this work. The authors emphasize that the two basic values of safety/security and intellectual freedom of research must be considered evenly. From the perspective of responsible development of biotechnology, this paper calls for a careful assessment to the risks of the technology, replacing risky technologies with safe ones. The risks of publication also need to be strictly assessed. The authors believe, in addition to enhancing the “self-government” and self-discipline of scientists and scientific communities, government supervision must be reinforced, laws and regulations should be improved, and global regulation framework ought to be constructed.
Url:
DOI: 10.1016/j.synbio.2020.03.002
PubMed: NONE
PubMed Central: 7178320
Links to Exploration step
PMC:7178320Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Prudently conduct the engineering and synthesis of the SARS-CoV-2 virus</title><author><name sortKey="Gao, Peng" sort="Gao, Peng" uniqKey="Gao P" first="Peng" last="Gao">Peng Gao</name><affiliation><nlm:aff id="aff1">The Human Phenome Institute, Fudan University, Shanghai, 200433, China</nlm:aff></affiliation><affiliation><nlm:aff id="aff2">Law School, Anhui University of Finance and Economics, Bengbu, Anhui, 233030, China</nlm:aff></affiliation></author><author><name sortKey="Ma, Shiwen" sort="Ma, Shiwen" uniqKey="Ma S" first="Shiwen" last="Ma">Shiwen Ma</name><affiliation><nlm:aff id="aff3">Department of Philosophy, Dalian University of Technology, Dalian, Liaoning, 116024, China</nlm:aff></affiliation></author><author><name sortKey="Lu, Daru" sort="Lu, Daru" uniqKey="Lu D" first="Daru" last="Lu">Daru Lu</name><affiliation><nlm:aff id="aff4">State Key Laboratory of Genetic Engineering and MOE Engineering Research Center of Gene Technology, School of Life Sciences, Fudan University, Shanghai, 200433, China</nlm:aff></affiliation><affiliation><nlm:aff id="aff5">Key Laboratory of Birth Defects and Reproductive Health of National Health Commission, Chongqing Population and Family Planning, Science and Technology Research Institute, Chongqing, 400020, China</nlm:aff></affiliation></author><author><name sortKey="Mitcham, Carl" sort="Mitcham, Carl" uniqKey="Mitcham C" first="Carl" last="Mitcham">Carl Mitcham</name><affiliation><nlm:aff id="aff6">Renmin University of China, Beijing, 100872, China</nlm:aff></affiliation><affiliation><nlm:aff id="aff7">Colorado School of Mines, Golden, Colorado, 80401, USA</nlm:aff></affiliation></author><author><name sortKey="Jing, Yijia" sort="Jing, Yijia" uniqKey="Jing Y" first="Yijia" last="Jing">Yijia Jing</name><affiliation><nlm:aff id="aff8">Institute for Global Public Policy & School of International Relations and Public Affairs, Fudan University, Shanghai, 200433, China</nlm:aff></affiliation></author><author><name sortKey="Wang, Guoyu" sort="Wang, Guoyu" uniqKey="Wang G" first="Guoyu" last="Wang">Guoyu Wang</name><affiliation><nlm:aff id="aff9">School of Philosophy, Fudan University, Shanghai, 200433, China</nlm:aff></affiliation><affiliation><nlm:aff id="aff10">Center for Biomedical Ethics, Fudan University, Shanghai, 200433, China</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmc">7178320</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7178320</idno><idno type="RBID">PMC:7178320</idno><idno type="doi">10.1016/j.synbio.2020.03.002</idno><idno type="pmid">NONE</idno><date when="2020">2020</date><idno type="wicri:Area/Pmc/Corpus">000825</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000825</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Prudently conduct the engineering and synthesis of the SARS-CoV-2 virus</title><author><name sortKey="Gao, Peng" sort="Gao, Peng" uniqKey="Gao P" first="Peng" last="Gao">Peng Gao</name><affiliation><nlm:aff id="aff1">The Human Phenome Institute, Fudan University, Shanghai, 200433, China</nlm:aff></affiliation><affiliation><nlm:aff id="aff2">Law School, Anhui University of Finance and Economics, Bengbu, Anhui, 233030, China</nlm:aff></affiliation></author><author><name sortKey="Ma, Shiwen" sort="Ma, Shiwen" uniqKey="Ma S" first="Shiwen" last="Ma">Shiwen Ma</name><affiliation><nlm:aff id="aff3">Department of Philosophy, Dalian University of Technology, Dalian, Liaoning, 116024, China</nlm:aff></affiliation></author><author><name sortKey="Lu, Daru" sort="Lu, Daru" uniqKey="Lu D" first="Daru" last="Lu">Daru Lu</name><affiliation><nlm:aff id="aff4">State Key Laboratory of Genetic Engineering and MOE Engineering Research Center of Gene Technology, School of Life Sciences, Fudan University, Shanghai, 200433, China</nlm:aff></affiliation><affiliation><nlm:aff id="aff5">Key Laboratory of Birth Defects and Reproductive Health of National Health Commission, Chongqing Population and Family Planning, Science and Technology Research Institute, Chongqing, 400020, China</nlm:aff></affiliation></author><author><name sortKey="Mitcham, Carl" sort="Mitcham, Carl" uniqKey="Mitcham C" first="Carl" last="Mitcham">Carl Mitcham</name><affiliation><nlm:aff id="aff6">Renmin University of China, Beijing, 100872, China</nlm:aff></affiliation><affiliation><nlm:aff id="aff7">Colorado School of Mines, Golden, Colorado, 80401, USA</nlm:aff></affiliation></author><author><name sortKey="Jing, Yijia" sort="Jing, Yijia" uniqKey="Jing Y" first="Yijia" last="Jing">Yijia Jing</name><affiliation><nlm:aff id="aff8">Institute for Global Public Policy & School of International Relations and Public Affairs, Fudan University, Shanghai, 200433, China</nlm:aff></affiliation></author><author><name sortKey="Wang, Guoyu" sort="Wang, Guoyu" uniqKey="Wang G" first="Guoyu" last="Wang">Guoyu Wang</name><affiliation><nlm:aff id="aff9">School of Philosophy, Fudan University, Shanghai, 200433, China</nlm:aff></affiliation><affiliation><nlm:aff id="aff10">Center for Biomedical Ethics, Fudan University, Shanghai, 200433, China</nlm:aff></affiliation></author></analytic><series><title level="j">Synthetic and Systems Biotechnology</title><idno type="eISSN">2405-805X</idno><imprint><date when="2020">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>In response to the outbreak of COVID-19 that has been sweeping the world, scientists reconstructed the SARS-CoV-2 rapidly using a synthetic genomics platform, in order to accelerate therapeutics and vaccine development. However, given the dual-use nature of this technology, there exists a high biosecurity risk. This paper points out the potential risks of the engineering SARS-CoV-2 virus and puts forward 6 questions to this work. The authors emphasize that the two basic values of safety/security and intellectual freedom of research must be considered evenly. From the perspective of responsible development of biotechnology, this paper calls for a careful assessment to the risks of the technology, replacing risky technologies with safe ones. The risks of publication also need to be strictly assessed. The authors believe, in addition to enhancing the “self-government” and self-discipline of scientists and scientific communities, government supervision must be reinforced, laws and regulations should be improved, and global regulation framework ought to be constructed.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Thao, T T N" uniqKey="Thao T">T.T.N. Thao</name></author><author><name sortKey="Labroussaa, F" uniqKey="Labroussaa F">F. Labroussaa</name></author><author><name sortKey="Ebert, N" uniqKey="Ebert N">N. Ebert</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Baillie, L" uniqKey="Baillie L">L. Baillie</name></author><author><name sortKey="Dyson, H" uniqKey="Dyson H">H. Dyson</name></author><author><name sortKey="Simpson, A" uniqKey="Simpson A">A. Simpson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Miller, S" uniqKey="Miller S">S. Miller</name></author><author><name sortKey="Selgelid, M J" uniqKey="Selgelid M">M.J. Selgelid</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Fuller, L L" uniqKey="Fuller L">L.L. Fuller</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Enserink, M" uniqKey="Enserink M">M. Enserink</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="White House" uniqKey="White House">White House</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Regalado, A" uniqKey="Regalado A">A. Regalado</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Engineering And Physical Sciences Research Council" uniqKey="Engineering And Physical Sciences Research Council">Engineering and Physical Sciences Research Council</name></author></analytic></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Synth Syst Biotechnol</journal-id><journal-id journal-id-type="iso-abbrev">Synth Syst Biotechnol</journal-id><journal-title-group><journal-title>Synthetic and Systems Biotechnology</journal-title></journal-title-group><issn pub-type="epub">2405-805X</issn><publisher><publisher-name>KeAi Publishing</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmc">7178320</article-id><article-id pub-id-type="publisher-id">S2405-805X(20)30019-3</article-id><article-id pub-id-type="doi">10.1016/j.synbio.2020.03.002</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Prudently conduct the engineering and synthesis of the SARS-CoV-2 virus</article-title></title-group><contrib-group><contrib contrib-type="author" id="au1"><name><surname>Gao</surname><given-names>Peng</given-names></name><xref rid="aff1" ref-type="aff">a</xref><xref rid="aff2" ref-type="aff">b</xref><xref rid="fn1" ref-type="fn">1</xref></contrib><contrib contrib-type="author" id="au2"><name><surname>Ma</surname><given-names>Shiwen</given-names></name><xref rid="aff3" ref-type="aff">c</xref><xref rid="fn1" ref-type="fn">1</xref></contrib><contrib contrib-type="author" id="au3"><name><surname>Lu</surname><given-names>Daru</given-names></name><xref rid="aff4" ref-type="aff">d</xref><xref rid="aff5" ref-type="aff">e</xref></contrib><contrib contrib-type="author" id="au4"><name><surname>Mitcham</surname><given-names>Carl</given-names></name><xref rid="aff6" ref-type="aff">f</xref><xref rid="aff7" ref-type="aff">g</xref></contrib><contrib contrib-type="author" id="au5"><name><surname>Jing</surname><given-names>Yijia</given-names></name><xref rid="aff8" ref-type="aff">h</xref></contrib><contrib contrib-type="author" id="au6"><name><surname>Wang</surname><given-names>Guoyu</given-names></name><email>wguoyu@fudan.edu.cn</email><xref rid="aff9" ref-type="aff">i</xref><xref rid="aff10" ref-type="aff">j</xref><xref rid="cor1" ref-type="corresp">∗</xref></contrib><aff id="aff1"><label>a</label>The Human Phenome Institute, Fudan University, Shanghai, 200433, China</aff><aff id="aff2"><label>b</label>Law School, Anhui University of Finance and Economics, Bengbu, Anhui, 233030, China</aff><aff id="aff3"><label>c</label>Department of Philosophy, Dalian University of Technology, Dalian, Liaoning, 116024, China</aff><aff id="aff4"><label>d</label>State Key Laboratory of Genetic Engineering and MOE Engineering Research Center of Gene Technology, School of Life Sciences, Fudan University, Shanghai, 200433, China</aff><aff id="aff5"><label>e</label>Key Laboratory of Birth Defects and Reproductive Health of National Health Commission, Chongqing Population and Family Planning, Science and Technology Research Institute, Chongqing, 400020, China</aff><aff id="aff6"><label>f</label>Renmin University of China, Beijing, 100872, China</aff><aff id="aff7"><label>g</label>Colorado School of Mines, Golden, Colorado, 80401, USA</aff><aff id="aff8"><label>h</label>Institute for Global Public Policy & School of International Relations and Public Affairs, Fudan University, Shanghai, 200433, China</aff><aff id="aff9"><label>i</label>School of Philosophy, Fudan University, Shanghai, 200433, China</aff><aff id="aff10"><label>j</label>Center for Biomedical Ethics, Fudan University, Shanghai, 200433, China</aff></contrib-group><author-notes><corresp id="cor1"><label>∗</label>Corresponding author. <email>wguoyu@fudan.edu.cn</email></corresp><fn id="fn1"><label>1</label><p id="ntpara0045">The authors contributed to this work equally.</p></fn></author-notes><pub-date pub-type="pmc-release"><day>02</day><month>4</month><year>2020</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on .</pmc-comment>
<pub-date pub-type="collection"><month>6</month><year>2020</year></pub-date><pub-date pub-type="epub"><day>02</day><month>4</month><year>2020</year></pub-date><volume>5</volume><issue>2</issue><fpage>59</fpage><lpage>61</lpage><history><date date-type="received"><day>15</day><month>3</month><year>2020</year></date><date date-type="accepted"><day>16</day><month>3</month><year>2020</year></date></history><permissions><copyright-statement>© 2020 Production and hosting by Elsevier B.V. on behalf of KeAi Communications Co., Ltd.</copyright-statement><copyright-year>2020</copyright-year><copyright-holder></copyright-holder><license license-type="CC BY-NC-ND" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0/"><license-p>This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).</license-p></license></permissions><abstract id="abs0010"><p>In response to the outbreak of COVID-19 that has been sweeping the world, scientists reconstructed the SARS-CoV-2 rapidly using a synthetic genomics platform, in order to accelerate therapeutics and vaccine development. However, given the dual-use nature of this technology, there exists a high biosecurity risk. This paper points out the potential risks of the engineering SARS-CoV-2 virus and puts forward 6 questions to this work. The authors emphasize that the two basic values of safety/security and intellectual freedom of research must be considered evenly. From the perspective of responsible development of biotechnology, this paper calls for a careful assessment to the risks of the technology, replacing risky technologies with safe ones. The risks of publication also need to be strictly assessed. The authors believe, in addition to enhancing the “self-government” and self-discipline of scientists and scientific communities, government supervision must be reinforced, laws and regulations should be improved, and global regulation framework ought to be constructed.</p></abstract><kwd-group id="kwrds0010"><title>Keywords</title><kwd>Engineering SARS-CoV-2 virus</kwd><kwd>Dual-use</kwd><kwd>Risk</kwd><kwd>Biosafety/Biosecurity</kwd><kwd>Regulation</kwd></kwd-group></article-meta></front><body><p id="p0010">On Feb. 21, 2020, a research group of the University of Bern published a non peer-reviewed paper titled “Rapid reconstruction of SARS-CoV-2 using a synthetic genomics platform” [<xref rid="bib1" ref-type="bibr">1</xref>] on the pre-print platform BioRxiv. In response to the outbreak of (Coronavirus Disease 2019, COVID-19) that has been sweeping the world, the authors claimed to be able to engineer and resurrect chemically-synthesized clones of the (Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV-2) with a yeast-based synthetic genomics platform. This paper presents the genetic reconstruction of diverse RNA viruses, including the novel coronavirus. The authors believe that by using this platform, generation of SARS-CoV-2 from chemically synthesized DNA could bypass the limited availability of virus isolates to allow genetic modifications and functional characterization of individual genes, as well as to generate serological diagnostics, to develop and assess antivirals and vaccines, and to establish appropriate <italic>in vivo</italic> models. During this critical period of global combat with this epidemic disease, the present research could contribute to the development of antiviral therapeutics and that of a vaccine.</p><p id="p0015">The authors of the aforementioned paper claimed to have taken into consideration the “dual-use” problem. The so-called “dual-use” problem in biology denotes that “the techniques needed to engineer a bioweapon are the same as those needed to pursue legitimate research” [<xref rid="bib2" ref-type="bibr">2</xref>]. For example, the pathogen synthesis technique can be used to rescue patients, as well as to possibly manufacture bioweapons. Even if the motivation for developing this type of technology is noble, any deviation, misuse, or abuse during the research may result in calamitous consequences; for instance, an accidental leak from the laboratory, or the purposeful misuse by others.</p><p id="p0020">The chemically synthesized SARS-CoV-2 virus is a part of this type of technology. Its benefits mainly include the acceleration of therapeutics and vaccine development, and the protection of human life and health from the virus. However, there are risks including the following: (1) Owing to the fact that SARS-CoV-2 is a virus with high transmissibility and susceptibility, there exists a biosecurity risk wherein bioterrorists could exploit this characteristic, with potentially hazardous consequences. (2) By publishing the technology roadmap, it is possible for both scientists and terrorists to apply the same technique to synthesize more complex viruses [<xref rid="bib3" ref-type="bibr">3</xref>]<sup>27</sup>, or to develop a “super virus” with extremely high infectivity, virulence, or vaccine-resistance. Currently, the internet has also made it easier to order the related biological materials that could potentially be used to synthesize bioweapons. (3) Accidental leakage of synthesized virus particles from the laboratory increases biosafety risks, threatening the safety of humans as well as that of the ecological environment.</p><p id="p0025">In view of these risks, the international scientific community had previously reached an agreement on the development of dual-use techniques. First, based on the “Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction” (better known as “The Biological Weapons Convention” (BWC) effective since March 1975) and the existing international laws and regulations,<xref rid="fn2" ref-type="fn">2</xref> the research and development of dual-use biotechnology must guarantee safety and security, and never, in any circumstance, be used to harm the safety of individuals and the society at large. The convention and the relevant laws and regulations draw a red line for dual-use biotechnology research, to ensure “morality of duty”<xref rid="fn3" ref-type="fn">3</xref> [<xref rid="bib4" ref-type="bibr">4</xref>], and also to serve as the bottom line for the development of biological science. Second, dual-use biotechnology must promote scientific independent innovation while ensuring the protection of social safety. The two basic values of safety/security and intellectual freedom of research must be considered evenly. Therefore, countries all over the world are promoting biotechnological innovation while placing equal stress on the importance of biosafety and biosecurity legislation. To reduce the predictable risks caused by the dual-use of biotechnology as much as possible, it is necessary to take the following into consideration before developing any high-risk technology: (1) Whether it is essential to undertake the research and to undertake it now? Whether there exist other alternative technologies, as in, whether it is necessary and urgent? (2) Whether and how to undertake the implementation of mandatory safety/security measures? (3) Whether and how to compulsorily certify the technology? (4) Whether and how to educate and train researchers? (5) Whether and how to assure the reliability of the researchers? (6) Whether and how to oversee the publication and propagation of the research results? How to answer the above questions on the basis of balancing the value of safety/security and intellectual freedom depends on who lawfully exercise the authority to regulate biosafety/biosecurity, and on which standards and norms are practiced in the regulatory processes.</p><p id="p0030">According to previous research, from the perspective of the rights distribution on biosafety/biosecurity regulation, there are five theoretical and practical decision-making models, ranging from an individual researcher to a complete government agency [<xref rid="bib3" ref-type="bibr">3</xref>]<sup>63−64</sup>:<fig id="undfig1"><alt-text id="alttext0010">Image 1</alt-text><graphic xlink:href="fx1"></graphic></fig></p><p id="p0035">There would exist some problems when the distribution of regulatory authorities is located too far on the left or right side of the above axis. Individual scientists and research institutions (located on the left) may emphasize too much technological development in their tradeoff of the values, and they may also lack the professional abilities to assess the economic, political, and ethical issues arising from the development of a specific biotechnological innovation. On the right side of the axis, government agencies often lack professional judgment on rapidly changing biotechnology. They may overemphasize the value of social safety/security and strictly adhereto formal norms. This is not beneficial for flexible case-by-case decision-making. However, in the case of the independent regulatory agencies consisting of scientists, ethicists, jurists, and government regulators, due to the diversity of their membership, they are able to undertake a comprehensive review of the process of knowledge acquisition from the perspectives of science, economics, politics, and law, and balance the values of social safety/security and technological development.</p><p id="p0040">With respect to the norms of biosafety/biosecurity regulation, owing to the rapid progress of biological research, it is difficult for regulators and researchers to design or construct clear and specific systems for the measurement or ranking of the various values of science, economics, politics, and ethics involved in research. Therefore, even if a particular research action complies with the law, it does not mean that it is ethically responsible. To achieve responsible research<xref rid="fn4" ref-type="fn">4</xref>, it is necessary to supplement the deficiencies of the “hard law” with the more flexible, voluntary, and ethical “soft law,” so as to promote the voluntary participation of diverse groups and the action of the safety committee within the research institution, and to encourage the relevant personnel to comply with the “morality of aspiration” or the “challenge of excellence”<xref rid="fn5" ref-type="fn">5</xref> [<xref rid="bib4" ref-type="bibr">4</xref>].</p><p id="p0045">As observed in the ethical statement from the research group of the University of Bern, there was an assessment of the benefits and risks involved in the synthesis of SARS-CoV-2 virus [<xref rid="bib1" ref-type="bibr">1</xref>]<sup>15−16</sup>. Regarding dual-use biological research, Switzerland utilizes the regulatory mode where an independent biosafety committee and government agencies share the determination right: the Swiss Federal Office of Public Health (FOPH)<xref rid="fn6" ref-type="fn">6</xref>and the relevant ethics committee (the Swiss Expert Committee for Biosafety<xref rid="fn7" ref-type="fn">7</xref>,in this case), and other regulators (the Federal Office for Environment and the Federal Food Safety and Veterinary Office, in this case) communicate and negotiate, and finally the FOPH gives permission according to the review of the aforesaid institutions. However, it is unclear whether the balance between social safety/security and biotechnological innovation has been sufficiently evaluated and whether the representative public participation has been absorbed before acquiring administrative permission, due to the brief ethical statement.</p><p id="p0050">In fact, there has always existed a controversy pertaining to the gain-of-function research on engineering viruses in the scientific community. In 2011, Ron Fouchier of Erasmus Medical Center, the Netherlands, and Yoshihiro Kawaoka at the University of Wisconsin, Madison, USA, separately performed the genetic alteration of the H5N1 virus, which was found to be easily transmissible between ferrets through the air. Fouchier claimed that it was “probably one of the most dangerous viruses you can make” [<xref rid="bib5" ref-type="bibr">5</xref>]. Regarding this, scientists and critics believed that this highly transmissible virus could cause a huge risk to human beings if it was accidently leaked or was misused by bioterrorists [<xref rid="bib5" ref-type="bibr">5</xref>]. In 2014, the U.S. Government instituted a pause on funding for any new studies that included certain gain-of-function experiments involving influenza, Severe Acute Respiratory Syndrome (SARS), and Middle East Respiratory Syndrome (MERS) viruses, and encouraged those currently conducting this type of work to voluntarily pause their research while the risks and benefits were being reassessed by the National Science Advisory Board for Biosecurity (NSABB) and the National Research Council (NRC) [<xref rid="bib6" ref-type="bibr">6</xref>].</p><p id="p0055">From the perspective of responsible development of biotechnology, regarding the risk assessment of a highly dangerous virus like SARS-CoV-2, it is necessary to clarify the items of risk assessment. For instance, whether the yeast-based synthetic genome method in the paper is irreplaceable in the development of therapeutics or a vaccine? If there are alternative safe methods to develop a vaccine and select therapeutics with recombinant DNA technology, such as recombinant viral protein, production of a pseudovirus, or transfection with mRNA fragments of viral structure proteins, why should such a huge risk be undertaken? Especially, the risk of this virus reconstruction technique (Transformation-Associated Recombination, TAR) exists in the production of not only the novel coronavirus, but also other dangerous RNA viruses, such as other coronaviruses and the Zika Virus (ZIKV). Faced with the situation where other laboratories or universities (such as the University of North Carolina) are also trying to create a copy of the virus from scratch [<xref rid="bib7" ref-type="bibr">7</xref>], how can we ensure that this technology is not misused or abused in the future? For such technologies, which can be easily applied or converted to risks, the risk of publication needs to be strictly assessed, for example, whether to publish, to which group of people, and under what circumstances could the research be published? In addition, how should we compare and quantify which groups will benefit and which groups will undertake the risk, and what is the criterion of determination? Whether scientists have enough expertise and intelligence to fully assess the dual-use risks of a synthesized virus (including the assessment of the motivation, condition, and capability of bioterrorists to acquire SARS-CoV-2 or to design and synthesize it) [<xref rid="bib3" ref-type="bibr">3</xref>]<sup>54</sup>? Once the risks become a reality, who or which organization should take responsibility for them? Whether it is sufficient to deal with and resolve the risk only depending on the “responsibility after the event”? Furthermore, the ratio of benefits to risks is not only a scientific issue, but also involves differences in risk perception and value judgment of different subjects; the views about the risks involved often differ between the experts and the public. Then, which subject's sense of risk should be taken into consideration in the prior ethical review and for the determination of the value balance between social safety/security and biotechnological innovation?</p><p id="p0060">According to one theoretical framework proposed by the Engineering and Physical Sciences Research Council of the UK (EPSRC) on the basis of Responsible (Research and) Innovation (RI/RRI) <xref rid="bib8" ref-type="bibr">[8]</xref>, responsibility should include: Anticipate, Reflect, Engage and Act (AREA). Such an AREA framework depends on research transparency and public participation in any research of pathogen synthesis technology. Scientists and regulators should cooperate with the public and other stakeholders to encourage dialogue with the public to address key issues, such as public acceptability. Although scientific research requires a spirit of freedom and autonomy, for such dual-use biotechnology with a high-risk potential, no single scientist and scientific community can undertake the responsibility, once the risks materialize into real dangers. For that reason, in addition to enhancing the “self-government” and self-discipline of scientists and scientific communities, government supervision must be reinforced, laws and regulations should be improved, and global regulation framework ought to be constructed. Therefore, we appeal to scientists to be highly prudent and responsible while undertaking the research and development involving pathogen synthesis technologies. We share the same earth, interests, risks, and destiny and therefore, we are supposed to assume equal responsibility to protect our world. The whole world should join hands to overcome the challenge posed by this novel virus. Only through joint participation and effective regulation can we guide dual-use technologies like engineering SARS-CoV-2 to benefit human society.</p></body><back><ref-list id="cebib0010"><title>References</title><ref id="bib1"><label>1</label><element-citation publication-type="journal" id="sref1"><person-group person-group-type="author"><name><surname>Thao</surname><given-names>T.T.N.</given-names></name><name><surname>Labroussaa</surname><given-names>F.</given-names></name><name><surname>Ebert</surname><given-names>N.</given-names></name></person-group><article-title>Rapid reconstruction of SARS-CoV-2 using a synthetic genomics platform</article-title><source>bioRxiv</source><year>2020</year></element-citation></ref><ref id="bib2"><label>2</label><element-citation publication-type="book" id="sref2"><person-group person-group-type="author"><name><surname>Baillie</surname><given-names>L.</given-names></name><name><surname>Dyson</surname><given-names>H.</given-names></name><name><surname>Simpson</surname><given-names>A.</given-names></name></person-group><chapter-title>Dual use of biotechnology</chapter-title><person-group person-group-type="editor"><name><surname>Chadwick</surname><given-names>R.</given-names></name><name><surname>Callahan</surname><given-names>D.</given-names></name><name><surname>Singer</surname><given-names>P.</given-names></name></person-group><source>Encyclopedia of applied ethics</source><year>2012</year><publisher-name>Academic Press</publisher-name><publisher-loc>London</publisher-loc><fpage>876</fpage></element-citation></ref><ref id="bib3"><label>3</label><element-citation publication-type="book" id="sref3"><person-group person-group-type="author"><name><surname>Miller</surname><given-names>S.</given-names></name><name><surname>Selgelid</surname><given-names>M.J.</given-names></name></person-group><series>Ethical and philosophical consideration of the dual-use dilemma in the biological sciences</series><volume>2008</volume><year>2008</year><publisher-name>Springer Science + Business Media B.V.</publisher-name></element-citation></ref><ref id="bib4"><label>4</label><element-citation publication-type="book" id="sref4"><person-group person-group-type="author"><name><surname>Fuller</surname><given-names>L.L.</given-names></name></person-group><chapter-title>The morality of law (revised edition)</chapter-title><year>1969</year><publisher-name>Yale University Press</publisher-name><publisher-loc>New Haven</publisher-loc><fpage>5</fpage><lpage>9</lpage></element-citation></ref><ref id="bib5"><label>5</label><element-citation publication-type="journal" id="sref5"><person-group person-group-type="author"><name><surname>Enserink</surname><given-names>M.</given-names></name></person-group><article-title>Scientists brace for media storm around controversial flu studies</article-title><source>Sci. Insid.</source><year>Nov. 23, 2011</year></element-citation></ref><ref id="bib6"><label>6</label><element-citation publication-type="book" id="sref6"><person-group person-group-type="author"><name><surname>White House</surname></name></person-group><chapter-title>Doing diligence to assess the risks and benefits of life sciences gain-of-function research</chapter-title><year>Oct. 17, 2014</year><publisher-name>White House</publisher-name><publisher-loc>Washington, DC</publisher-loc></element-citation></ref><ref id="bib7"><label>7</label><element-citation publication-type="journal" id="sref7"><person-group person-group-type="author"><name><surname>Regalado</surname><given-names>A.</given-names></name></person-group><article-title>Biologists rush to re-create the China coronavirus from its DNA code</article-title><source>MIT Technol. Rev.</source><year>Feb. 15, 2020</year></element-citation></ref><ref id="bib8"><label>8</label><element-citation publication-type="other" id="sref8"><person-group person-group-type="author"><name><surname>Engineering and Physical Sciences Research Council</surname></name></person-group><article-title>Anticipate, reflect, engage and act (AREA)</article-title><ext-link ext-link-type="uri" xlink:href="https://epsrc.ukri.org/research/framework/area/" id="intref0020">https://epsrc.ukri.org/research/framework/area/</ext-link></element-citation></ref></ref-list><ack id="ack0010"><title>Acknowledgements</title><p>This work was supported by research grants from the <funding-source id="gs4">National Key R&D Program of China</funding-source> "Research on the ethical policy and regulatory framework of precision medicine" (No. 2017YFC0910100), the Major Program of the <funding-source id="gs5">National Social Science Fund of China</funding-source> "Research on high-tech ethical issues (No. 12&ZD117) and the Emergency management project of the <funding-source id="gs3">National Natural Science Foundation of China</funding-source> "Study on ethics and integrity governance of scientific research " (No. 71843009).</p></ack><fn-group><fn id="d31e13"><p id="ntpara0010">Peer review under responsibility of KeAi Communications Co., Ltd.</p></fn><fn id="fn2"><label>2</label><p id="ntpara0015">For example, “Regulation of Research into Biological Disease Agents Act” of Israel, “Public Health Security and bioterrorism preparedness response act” of the U.S., “Safety management measures for biotechnology research and development” of China, etc.</p></fn><fn id="fn3"><label>3</label><p id="ntpara0020">The so-called “morality of duty” lays down the basic rules without which an ordered society is impossible or without which an orderly society fails to achieve certain essential goals. Such moral norms can be regarded as a synonym of state law. The violation of such rules will lead to the punishment of the state's coercive power.</p></fn><fn id="fn4"><label>4</label><p id="ntpara0025">Responsible research includes, but is not limited to, research with irreplaceable necessity, research behaviors with sufficient goodness, and research value with an optimal balance between risks and benefits.</p></fn><fn id="fn5"><label>5</label><p id="ntpara0030">The so-called morality of aspiration is the morality of the Good Life, of excellence in the fullest realization of human powers. The violation of such a moral norm does not lead to the punishment by the state, but to the public evaluation of their own quality of life. In such a case, people would be condemned for shortcomings, instead of wrong doing.</p></fn><fn id="fn6"><label>6</label><p id="ntpara0035">More information can be seen in: <ext-link ext-link-type="uri" xlink:href="https://www.bag.admin.ch/bag/en/home.html" id="intref0010">https://www.bag.admin.ch/bag/en/home.html</ext-link>.</p></fn><fn id="fn7"><label>7</label><p id="ntpara0040">More information can be seen in: <ext-link ext-link-type="uri" xlink:href="https://www.efbs.admin.ch/en/homepage/" id="intref0015">https://www.efbs.admin.ch/en/homepage/</ext-link>.</p></fn></fn-group></back></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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