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Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Appendix E

Examples of Activities Across the Governance Landscape

This appendix provides examples of relevant governance activities assembled as background to inform the workshop discussions and is augmented by input from participants. The material provides a snapshot as of October 2018; it does not provide a comprehensive accounting of actors and activities. Special thanks to Tracy Kambara for assembling these materials and observations during her Christine Mirzayan Science & Technology Policy Graduate Fellowship at the U.S. National Academies of Sciences, Engineering, and Medicine (the National Academies) in spring 2018. We also wish to acknowledge contributions made by participants at a preliminary discussion held on May 18, 2018, at the U.S. National Academies, particularly to supplement information on the landscape of U.S. governance activities addressing dual use life sciences research.

Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Argentina Education and outreach Government National Project on Education on the Responsible and Safe Use of Chemical Science and Technologies
Argentina Education and outreach Universidad Nacional de Rosario The responsible use of chemistry
Australia Education and outreach University of New South Wales Australia (via FutureLearn) Biosecurity and Bioterrorism: Public Health Dimensions–MOOC
Australia National policy Government Weapons of Mass Destruction (Prevention of Proliferation) Act 1995
Australia National policy Government National Health Security Act (2007) and National Health Security Regulations (2008) (both revised 2013); Security Sensitive Biological Agent Standards
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
A four-pronged approach for education about chemical dual use issues through a partnership between the Ministry of Education and the Ministry of Foreign Affairs: (1) network of universities, (2) train-the-trainer program, (3) virtual classroom online learning platform, and (4) outreach.

http://cancilleria.gov.ar/en/en-proyecto-nacional-de-educacion

A description of the initiative in English may be found in a report by the Advisory Board on Education and Outreach of the Organization for the Prohibition of Chemical Weapons

(https://www.opcw.org/fileadmin/OPCW/ABEO/abeo-5-01_e.pdf, pp. 26–27).
Implements topics related to bioethics, professional responsibility, and issues of the CWC in the curricula for the degree in chemistry through curricular activities, elective courses, and complementary activities.

http://www.fbioyf.unr.edu.ar/alumnos/quim/licquimica_descarga.htm
Free 4-week online course that covers epidemiology/infectious disease, biosecurity, bioterrorism, and policy/regulatory/ethical concerns related to biosecurity and bioterrorism. Taught by David Heslop, M.D.; David Muscatello; and Raina MacIntyre.

https://www.futurelearn.com/courses/biosecurity-terrorism
Export control regulations.

https://www.legislation.gov.au/Series/C2004A04891

See description of outreach program in Chapter 2.
Created in response to a 2006 review of the Council of Australian Governments. Establishes the Security Sensitive Biological Agents (SSBA) regulatory scheme. Lists SSBAs into two tiers based on security risk and requires registration for facilities handling these agents. Authorizes the Office of Gene Technology Regulator to inspect all facilities on a regular basis (every 18–24 months depending on SSBA tier). Also includes routine monitoring via spot checks and “desktop” inspections (paper-based compliance checks). The government has also put together “Fact Sheets” to aid in awareness of the SSBA scheme. Fact Sheet 14 is about dual use.

http://www.health.gov.au/ssba
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Bulgaria National policy Government Relevant national legislation
Canada National policy Government Human Pathogens and Toxins Act (2009)
Canada National policy Government Human Pathogens and Toxins Regulation (2015)
Canada National policy Government Tri-Agency Framework: Responsible Conduct of Research (2011) and Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (2010)
China/Pakistan Code Government Proposal for the development of a model code of conduct for biological scientists under the Biological Weapons Convention
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
Relevant national legislation: Bulgarian Criminal Code, Chapter 11, section I, “Crimes Committed in Generally Dangerous Manner or by the use of Generally Dangerous Means,” articles 337 and 339 (last amended SG No. 19/2014); Bulgarian Defence-Related Products and Dual-Use Items and Technologies Export Control Act (last amended SG No. 9/2014); Decree of the Bulgarian Council of Ministers No. 158 of July 24, 2012, on the adoption of a list of Defence-Related Products and a list of Dual-Use Items and Technologies subject to control at import; Order No. 4 from 14.10.2002 of the Ministry of Labor and Social Policy and the Ministry of Health on the protection of workers from risks related to exposure to biological agents at work (SG No. 105/08.11.2002); Instruction No. 5 from 19.11.2003 of the Ministry of Health on the work with causative agents of bacterial, fungal, and viral infections with a high medical and epidemic risk (SG No. 105/14.03.2004); and Genetically Modified Organisms Act.
Expanded government oversight of research on genetically altered human pathogens, gain-of-function research, and dual use.
Implements provisions in 2009 Act and has a biosecurity focus. Requires a license for laboratories working on human pathogens and toxins, security clearance for personnel, inspections, designation of biological safety officer at each institution, and the development of a “Plan for Administrative Oversight” at each institution.

http://laws-lois.justice.gc.ca/eng/AnnualStatutes/2009_24/
Mandates an internal ethics review process at each private research institution; only applies to publicly funded research taking place at a private institution.
First introduced in 2015, a draft code of conduct developed by the Center for Biosafety Research and Strategy at Tianjin University was submitted to the Eighth Review Conference in 2016. Work on the code continues, with an international workshop at Tianjin in June 2018, and discussions during the BWC Meetings of Experts in July 2018.

See, for example, http://undocs.org/en/BWC/MSP/2018/MX.2/WP.9 and https://www.unog.ch/80256EDD006B8954/(httpAssets)/A023173F53FE3DADC12582E80044947A/$file/TJU-Weiwen-2018-08-10-Request-3.pdf.
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Croatia National policy Government Relevant national legislation and policy
Croatia Funder guidelines Government Croatian Sciences Foundation
Croatia Professional association Nongovernment Croatian Society for Biosafety and Biosecurity
Cuba Code Government Code of professional ethics for science workers in Cuba (2016, see also Annex II: Principles and ethics associated with biosecurity)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
Law on GMOs established in 2018, Law on Homeland Security System in 2017, and National Security Strategy in 2017.
Requires applicants to provide information concerning ethics and dual use issues when submitting project proposals.
For further information, see Appendix D.

http://www.hdbib.hr/index_en.html
Introduced at the 2016 BWC, the code lays out ethical principles and rules (both aspirational and advisory). Annex II focuses on biosecurity issues and includes dual use: scientists must “always bear in mind the potential repercussions - possibly damaging - of their research and recognize that a clear individual conscience does not justify ignoring the possible misuse of their scientific endeavors.”

https://documents-dds-ny.un.org/doc/UNDOC/GEN/G16/221/05/pdf/G1622105.pdf
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Denmark National policy Government Act on securing biological substances, delivery systems, and related materials. Act no. 474 of June 2008. Executive Order on securing specific biological substances, delivery systems, and related materials. EO no. 981 of 15 October 2009 with Updated Annex 1 to EO 2017 (under Related Materials section j)
Denmark Code Government  
Egypt National policy Government  
France National policy Government Code de la recherché (Research Code)
France National policy Government Code de la santé publique (Public Health Code)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
Administered by the Centre for Biosecurity and Biopreparedness (CBB). CBB has a variety of means to secure dual use technology. Public and private laboratories that intend to work with controlled materials must fill an application for a license to do so. In the application, they must also assess if they have any dual use technology. CBB will check up on this during inspections. Inspections can also be carried out in institutions and companies without a license from CBB, but with research activities that suggest dual use technology potential. If inspections indicate that the companies conduct research that is deemed to have a misuse potential, the organization/company must apply for a license from CBB. Spot checks and screening of publications are also conducted on a regular basis.
If dual use technology is detected the company is categorized according to the risk potential and must either obtain a license to continue its research activities and/or receive mandatory guidance and advice from CBB. Violations could result in fines or imprisonment. CBB also has a large number of outreach and educational activities where dual use technology is addressed specifically. Teaching and awareness-raising activities are arranged for biosecurity officers, university life sciences students (all levels), and researchers. For more information regarding regulation of immaterial technology with dual use potential in Denmark visit https://www.biosecurity.dk/689.
CBB adheres to a Code of Biosecurity Ethics: https://www.biosecurity.dk/504.
Within the last 10 years, Egypt has restructured many of its government agencies to manage increased science and technology (S&T) capabilities: (1) created the Ministry of Higher Education and Scientific Research (HCST) to design research policies; (2) restructured the Academy of Scientific Research and Technology (ASRT) as an advisory board for assessment and evaluation of research and policy only, no longer a funding body; (3) created the Science and Technology Development Fund (STDF) as a new funding agency; and (4) created the Egyptian Network of Research Ethics Committees (ENREC), focusing on the protection of research subjects.
Authorizes the High Council for the Evaluation of Research and Higher Education (an independent administrative body) to evaluate research and research institutions.

https://www.legifrance.gouv.fr/affichCode.do?cidTexte=LEGITEXT000006071190
Imposes regulations on genetic and biomedical research for the protection of human subjects.

https://www.legifrance.gouv.fr/affichCode.do?cidTexte=LEGITEXT000006072665
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
France National policy Government Code de l’environnement (Environment Code)
France National advisory board Government La Conseil National Consultatif Pour La Biosecurite (CNCB)
Germany National policy/position paper Government Committee on Biological Agents (ABAS)/The Federal Institute for Occupational Safety and Health (BAuA); “Biosecurity from an occupational safety and health perspective” (Decision 36/2011 of the ABAS)
Germany Code Max Planck Society Guidelines and rules on a responsible approach to freedom of research and research risks (Max Planck Society, 2010)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
Regulations on GMOs.

https://www.legifrance.gouv.fr/affichCode.do?cidTexte=LEGITEXT000006074220
National Advisory Council for Biosecurity whose mission is to inform the public authorities, the scientific community, and the public on security issues, profits, and the risks posed by the progress of research in the life sciences. It is empowered to make a range of recommendations for the funding, conduct, and dissemination of dual use research, as well as to forecast trends. The Council has six members, half from government and half nominated by the French Academy of Sciences.

http://www.sgdsn.gouv.fr/missions/lutter-contre-la-proliferation/le-conseil-national-consultatif-pour-la-biosecurite-cncb
The ABAS is the advisory body of the BAuA on the Biological Agents Ordinance. Its members are public and private employers, trade unions/employees, state authorities, statutory accident insurance institutions, and universities and science institutions.

The position paper states that biosecurity measures can be considered as an extension of a biosafety programme in the framework of a general security management concept, which may be necessary only in the context of targeted activities in the framework of protection levels 3 and 4 and when working with toxins.

Biosecurity questions are regulated according to their exactly defined objectives in the legal areas of occupational safety and health and infection protection as well as in the legal areas of genetic engineering legislation, and in the framework of the elimination of epizootic diseases and plant protection among others.

Generally, ABAS refers to a vast majority of laboratory biosecurity issues in Germany being covered by a historically evolved legal network. Occupational health/biosafety surveilled in a dual approach by both supervisory authorities and carriers of legal accident insurances or trade unions. Furthermore, guidelines have a nationwide legal binding character.

https://www.baua.de/DE/Aufgaben/Geschaeftsfuehrung-von-Ausschuessen/ABAS/pdf/Biosecurity-EN.pdf?__blob=publicationFile&v=2
Establishes the process for inclusion of risk mitigation plans for research applications submitted to Max Planck for funding. Specifies that all other Codes of Conduct in Germany apply to Max Planck researchers as long as their provisions do not conflict.

https://www.mpg.de/197392/researchFreedomRisks.pdf
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Germany Code Leibinz Association Code of Conduct for Biosecurity for Facilities dealing with Biological Resources (Leibinz Association, 2012)
Germany Code BIO Deutschland Position Paper by BIO Deutschland on the Topic of Biosecurity: The Dual-Use Dilemma (2008)
Germany Code The Society for Virology DURC Commission
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
The Leibinz Association is a group of 91 research institutes. The code essentially adopts the Code of Conduct on Biosecurity for Biological Resource Centres (2012, European Consortium of Microbial Resources Centres). Focus is on minimizing biorisk and misuse of biological resources.

http://www.embarc.eu/deliverables/EMbaRC_D.NA1.3.2_D2.34_BiosecCoCfinal%20for%20ExecCommAug2012.pdf
BIO Deutschland = Biotechnology Industry Organisation. Adopted the DFG Code of Conduct for its 330 member companies.

Starts on page 38 of https://www.jura.uni-freiburg.de/de/institute/ioeffr2/weiterfuehrendelinksdokumenteordner/dokumenteordner/2013-4.-quartal/codes-of-conduct-on-biosecurity.pdf.
Provides opinions and recommendations. Homepage is being updated at time of publication.

https://www.g-f-v.org/kommission_durc and https://www.gfv-sub.webspace.rocks/DURC/durc_main.html
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Germany Code Robert Koch Institute (and others) Code of conduct for risk assessment and risk mitigation: “Dual use potential of life sciences research” (2013)
Germany Policy research University of Hamburg/The Carl Friedrich von Weizsäcker-Centre for Science and Peace Research (ZNF) Interdisciplinary Research Group on the Analysis of Biological Risks (INFABRI), one project on “Governance of Dual Use Research of Concern”
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
The Robert Koch Institute (RKI) is the government’s central scientific institution in the field of biomedicine and the national public health institute commissioned to protect and improve the health of the population. It is a federal institute within the portfolio of the Federal Ministry of Health.

The code of conduct, which is obligatory for employees of RKI, is a risk assessment and risk management tool. It provides the criteria for assessing the dual use potential of research projects and their results. Along with the code of conduct, awareness raising via training and seminars is planned for the future.

Other local codes of conduct:

Technische Universität Darmstadt: https://www.intern.tu-darmstadt.de/gremien/ethikkommisson/zivilklausel/zivilklausel.de.jsp

Uni Marburg: https://www.uni-marburg.de/de/universitaet/administration/amtlichemitteilungen/jahrgang2015/02_2015.pdf (German)

Fraunhofer Gesellschaft: Europe’s largest application-oriented research organization puts emphasis on information, consulting, and sensitization and has established an export control system for all actions and activities, which centrally controls the topic of dual use under the inclusion of Fraunhofer Institutes and facilities.

https://www.fraunhofer.de/de/ueber-fraunhofer/corporate-responsibility/forschung-und-entwicklung/ethik-und-wissenschaftsverantwortung.html

All of the above listed in the table “Contact persons and committees in Germany responsible for ethics concerning security-relevant research” (see entry for Leopoldina and DFG below).
Publicly funded research group to assess the comparative risks of different biological threat scenarios and available response options. This includes one project on the governance of Dual Use Research of Concern.

https://www.znf.uni-hamburg.de/forschung/infabri.html
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Germany Code German Research Foundation (DFG) Code of Conduct: Working with Highly Pathogenic Microorganisms and Toxins (DFG, 2013)
Germany Policy German Ethics Council Biosecurity—Freedom and Responsibility of Research (2014, German Ethics Council report)
Germany Code Leopoldina and DFG Scientific Freedom and Scientific Responsibility: Recommendations for Handling Security Relevant Research (DFG and Leopoldina joint committee, 2014)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
DFG = the self-governing organization for science and research in Germany, which receives the large majority of its funds from the federal government and the federal states being represented in all grants committees.

Establishes a procedure for reviewing research proposals with dual use: principal investigators (PIs) must address the presence of dual use in their research, then reviewers will assess and make recommendations before funding is approved.

http://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/2013/130313_verhaltenscodex_dual_use_en.pdf
Report was commissioned by the government in response to the gain-of-function controversy. Recommends legislation to regulate dual use research: (1) creation of dual use commission that approves dual use funding; (2) creation of legally binding regulations on dual use; and (3) development of a national biosecurity code of conduct for the scientific community. Also lists existing regulations not explicitly about dual use but relevant to biosecurity. A Joint Committee of Leopoldina and DFG (German Research Foundation) on the handling of security-relevant research was created in response, as an alternative to legislation.

http://www.ethikrat.org/files/opinion-biosecurity.pdf
Leopoldina = The “Deutsche Akademie der Naturforscher Leopoldina” (German National Academy of Sciences), which scientifically reviews and addresses key issues of prospective significance to society. Its findings are conveyed to policy makers and the public alike and are nationally and internationally advocated.

As part of the gain-of-function debate, DFG and the Leopoldina appointed a joint interdisciplinary and cross-institutional working group in Summer 2013 that was tasked with analyzing and discussing the complex relationship between freedom of research and research risks.

Its report describes balance between academic freedom and social responsibility and legal and ethical constrains on research. The report also lists recommendations for both individual scientists and research institutions on minimizing risk associated with dual use research.

https://www.leopoldina.org/uploads/tx_leopublication/2014_06_DFG-Leopoldina_Scientific_Freedom_Responsibility_EN.pdf
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Germany N/A Leopoldina and DFG Joint Committee of Leopoldina and DFG (German Research Foundation) on the handling of security-relevant research

and

Contact persons and committees in Germany responsible for ethics concerning security-relevant research
Germany Code Leopoldina and DFG Model Statutes for Committees for Ethics in Security-Relevant Research (Joint Committee of Leopoldina and DFG, 2016)
Indonesia Code Indonesian Academy of Sciences Code of Conduct on Biosecurity
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
A private–public partnership committee that aims to implement recommendations from the publication listed above. This committee oversees the creation and guidance of Committees for Ethics in Security-Relevant Research (KEFs) at research institutions.

https://www.leopoldina.org/en/about-us/cooperations/joint-committee-dual-use

For committees and contact persons, see https://www.leopoldina.org/en/about-us/cooperations/joint-committee-dual-use/list-of-committees.
Provides guidance for setting up and operating Committees for Ethics in Security-Relevant Research and for ensuring uniformity across different institutions. First progress report of the committee was published in October 2016.

https://www.leopoldina.org/fileadmin/redaktion/Ueber_uns/Kooperationen/2016_Model_Statutes_Committee_on_Ethics_in_Security-Relevant_Research.pdf
A code of conduct created by the Indonesian Academy of Sciences, with support from the Royal Netherlands Academy of Arts and Sciences. Introduced in 2016 at the Academy’s 25th anniversary and disseminated within the Indonesian research community.

http://perpustakaan.depkes.go.id:8180/bitstream//123456789/4502/1/Pedoman%20Perilaku%20untuk%20Keamanan%20Hayati%20=%20Code%20of%20Conduct%20on%20Biosecurity%202014.pdf
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Israel National policy Government Regulation of Research into Biological Disease Agents Act (2008)
Israel National advisory board Government Council for the Regulation of Research in Biological Pathogens
Japan Code Science Council of Japan (government) Code of Conduct for Scientists (Science Council of Japan, revised in 2013 to include dual use)
Japan National policy Government Infectious Diseases Control Law (revised 2007)
Japan National policy Government Domestic Animal Infectious Disease Control Law (amended 2011)
Jordan National policy Government Jordan Biorisk Management Guidelines (Ministry of Health, 2016)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
Created in response to a report by the Steering Committee on Issues in Biotechnological Research in an Age of Terrorism (COBRAT, 2008). Authorizes the Ministry of Health (MOH) to oversee research institutions that possess or conduct research on select agents; requires MOH authorization to work on select agents (licensing); requires institutional biosafety and biosecurity committees comprised of scientists, security experts, and safety personnel to supervise research; and establishes a council for biological disease agent research to advise MOH.

https://www.health.gov.il/English/MinistryUnits/PH/Scientist/Pages/default.aspx
Fifteen-member council with a mix of technical experts from government ministries and academics from the fields of microbiology, infectious diseases, or biotechnology, and advises the Ministry of Health on the implementation of the 2008 regulations.

https://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx
Ethics regarding dual use: “Recognizing the potential malicious use of their research products for destructive purposes against their will, scientists shall choose appropriate and socially acceptable media and manners for disclosing their research process and products.” Dual use reviews are not currently included in funding decisions for health science grants by the Ministry of Health, Labour, and Welfare.

http://www.scj.go.jp/ja/scj/kihan/kihan.pamflet_en.pdf
Classifies pathogens into four groups based on risk levels, and imposes regulations surrounding possession, importation, and transport for each.
Authorizes Ministry of Agriculture, Forestry and Fisheries to issue permits for use or possession of livestock pathogens and requires outbreak prevention plans and inventory keeping.
Focuses on biosafety and risk management, not dual use or biosecurity. National Biorisk Management Policy is to be created in line with these guidelines.

http://emphnet.net/wp-content/uploads/2016/08/Jordan-Biorisk-ManagementGuideline.pdf
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Malaysia Code Government Code of Conduct (STRIDE/Ministry of Defense, draft, 2015)
Malaysia Education and outreach Academy of Sciences Malaysia Educational Module on Responsible Conduct of Research (RCR)—online Module
Malaysia National policy Government Malaysia Laboratory Biosafety and Biosecurity Policy and Guideline (2015, Ministry of Health)
Malaysia National policy Government National Biosafety Act (2007)
Netherlands Code Royal Netherlands Academy of Arts and Sciences KNAW Code of Conduct for Biosecurity (2008, Royal Netherlands Academy of Arts and Sciences KNAW)
Netherlands National policy Government Ministry of Economic Affairs, Manual on Strategic Goods (2011)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
Developed by STRIDE, in collaboration with the Ministry of Health. Draft incorporates feedback and guidance of academic and industry scientists, including Academy of Sciences Malaysia, that was collected from workshops held throughout Malaysia in 2015.

https://issuu.com/asmpub/docs/code_of_conduct_for_biosecurity_wor
The first publication in Malaysia outlining RCR practices, including a chapter on dual use issues, and based on active learning approaches.

https://issuu.com/asmpub/docs/rcr_module_readonly
Primarily a biosafety policy.

http://mkak.moh.gov.my/download/Biosafety_Policy_and_Guideline_2015.pdf
Establishes a National Biosafety Board to oversee biosafety and GMO research.

http://www.utar.edu.my/osh/file/Biosafety%20Act%202007%20-%20Act%20678.pdf
Developed at the request of the Dutch government after 2005 BWC discussions. Section 4.3 on Dual Use similar to U.S. NSABB definition of dual use. Reviewed in the wake of the gain-of-function controversy.

https://knaw.nl/en/news/publications/a-code-of-conduct-for-biosecurity
Export control regulations. Lists dual use goods, although most are not related to life sciences. Includes microorganisms and toxins (does not specify).

www.hetlnvloket.nl/txmpub/files/?p_file_id=2201306
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Netherlands National policy Government Ministerial Regulation on GMOs; Environmental Management Act; Establishment and Permits Decree
Netherlands   Biosecurity Office Workshops, online modules, and resource collection
Singapore National policy Government Biological Agents and Toxins Act (2006)
Singapore National policy (effectively) Bioethics Advisory Committee Research Involving Human Subjects: Guidelines for IRBs (2004, Bioethics Advisory Committee report)
South Africa National policy Government Non-Proliferation of Weapons of Mass Destruction Act (1993)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Summary
Regulations specifically for GMO research; must have a permit for “activities involving GMOs.”
The Biosecurity Office undertakes a variety of education and outreach activities, including workshops bringing together various stakeholders (universities, medical centers, industry, veterinarians, plant scientists, etc.). “Toolkits,” surveys that identify biosecurity strengths and weaknesses within an organization, are available on the website (https://www.bureaubiosecurity.nl/Toolkit). The Office also created a 5-minute movie on the “8 pillars of biosecurity”

(https://www.bureaubiosecurity.nl/en/Information/Biosecurity_movie). https://www.unog.ch/80256EDD006B8954/(httpAssets)/F4010F726D2F812CC1257EAB0056AD76/$file/Ppt.+2+Raising+biosecurity+awareness+among+professionals.pdf
Establishes a biosafety regulatory framework and regulates possession/use/transport of biological agents and toxins. Requires inventory control, permits, and Ministry of Health to certify research facilities on a regular basis.

https://sso.agc.gov.sg/Act/BATA2005
Established a comprehensive ethical review focused on Institutional Review Boards (IRBs). Although not in itself a legal document, the Ministry of Health requires medical practitioners to comply with the guidelines, and the Agency of Science Technology and Research (A*STAR), the main biomedical research funding agency, requires compliance for funding.

http://www.bioethics-singapore.org/index/publications/reports/172-research-involving-human-subjects-guidelines-for-irbs.html
Facilities working with select agents or equipment are required to register with the South African Council for the Non-Proliferation of WMDs (“Non-Proliferation Council”). The BW Working Committee is a subgroup of this Council, which advises on chemical and biological weapons and controls.
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
South Africa National policy Government Health Act (2003): various regulations updating the act (2012)
South Africa National policy Government Animal Diseases Act (1984)
South Africa National policy Government Hazardous Substances Act (1973)
South Africa Policy research Academy of Science of South Africa The State of Biosafety and Biosecurity in South Africa
South Africa Policy research Academy of Science of South Africa The State of Laboratory Biosafety and Biosecurity in the Southern African Development Community (SADC) Region
Switzerland Norms/principles Swiss Academies of Arts and Sciences Misuse Potential and Biosecurity in Life Sciences Research: A Discussion Basis for Scientists on How to Address the Dual Use Dilemma of Biological Research
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Summary
Regulations for biological materials, possession/handling of pathogens, biosafety, and biomedical research.
Research guidelines and import/export permits.
Classifies substances and regulates use, sale, and production of certain pathogens.
The 2015 consensus report includes descriptions of national legislation related to biosecurity and biosafety, including those submitted to show compliance with UNSCR 1540.

https://www.assaf.org.za/files/2017%20reports/The%20State%20of%20Biosafety%20%20Biosecurity%20Report%20FINAL.pdf
Proceedings of a March 2018 regional conference, building on the consensus study cited above.

The proceedings may be found at http://hdl.handle.net/20.500.11911/101; photographs and presentations at https://drive.google.com/open?id=1daX0Jju3N4lJWm_IubeLPW9ia9kZLnmq.
Discussion document-based outcomes of three workshops with life scientists to establish principles that should be considered when doing science. Includes sections on awareness and assessing misuse potential.

http://swiss-academies.ch/en/dms/publikationen/12/report1203e_Biosecurity_Web.pdf
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Ukraine Education and outreach Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine Project 633: Education and Awareness-Raising in Ukraine—workshops
United Kingdom National policy Government Anti-Terrorism, Crime and Security Act (2001/2007)
United Kingdom National policy Government Biological Security Strategy (2018)
United Kingdom Funder guidelines Public/private Wellcome Trust/BBRC/MRC
United Kingdom Education and outreach Bradford Disarmament Research Centre (BDRC) Dual Use Education Materials
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Summary
Seminars and conferences about education related to biosafety and biosecurity. Established website to allow the community to stay connected (http://bsseducation.com.ua); translated and disseminated Bradford materials to Ukrainian university professors; developed Biosafety, Biosecurity, and Bioethics module based on United Kingdom’s National Series.

http://www.bsseducation.com.ua/sites/default/files/Report%203%20Int_Met-Kyiv.pdf
Focuses on biosecurity: controlled access to pathogens and toxins; security clearance for personnel; and includes plant pathogens.

https://www.legislation.gov.uk/ukpga/2001/24/contents
Describes the UK government’s response to biological risks under four pillars (Understand, Prevent, Detect, and Respond) and two cross-cutting themes (A Strong Science Base and The Role of Industry and Academia in Biological Security). It lays out a plan for a “cross-Government director-level governance board” to oversee implementation of the strategy.

https://www.gov.uk/government/publications/biological-security-strategy
Common statement on how the major public and private funders of life sciences research will manage potential dual use risks of research they support.

https://wellcome.ac.uk/funding/managing-grant/managing-risks-research-misuse
Education Module Resource (EMR): An online collection of lectures with notes, references, and videos. Covers BWC history and background, dual use issues, and governance issues. Available in English and Japanese.

National Series (NS): A resource collection; teaching guidelines and materials for facilitators, whether or not they are biosecurity subject-matter experts, which can be easily adapted for different countries.

Train-the-trainer programme (TTT): Online training; an online, 12-week course that was UK Master’s accredited. Involves dual use scenarios and a sustainability component by asking students how they will incorporate EMRs into their curricula.

https://www.brad.ac.uk/bioethics
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
United Kingdom Education and outreach Bradford Disarmament Research Centre (BDRC) Biosecurity textbook and handbook of team-based learning (TBL) exercises
United Kingdom Education and outreach Bradford Disarmament Research Centre (BDRC) Neuroscience
United States Code American Society for Microbiology (ASM) Code of Ethics (2005)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Summary
Preventing Biological Threats: What You Can Do is intended to raise awareness and knowledge of biological security of everyone active in the life sciences, ranging from those engaged in research to those engaged in management and policy making, both nationally and internationally. Biological Security Education Handbook: The Power of Team-Based Learning has a number of exercises that relate to dual use issues and/or the responsibilities of scientists.

https://www.brad.ac.uk/social-sciences/peace-studies/research/publications-and-projects/guide-to-biological-security-issues (includes textbook, handbook, and information about the project)

https://www.unog.ch/80256EE600585943/(httpPages)/0A20E57D9F8424B8C12581D8007EC32E?OpenDocument (includes translations in French and Russian for the textbook and French, Russian, and Arabic translations for the TBL handbook)
The Bradford Centre has also undertaken a variety of work related to dual use issues associated with neuroscience, including an earlier series of online materials similar to the EMR for the then UK Neuroscience Dual-Use Education Network, and more recent work with the Human Brain Project (HBP) under EC Horizon 2020. The latter includes a lecture on neuroscience and dual use as part of an HBP online course (https://www.youtube.com/watch?v=Dc7Uwpdfwt8&list=PLvAS8zldX4Cg0nsIQ6gT39Ncl7Pnm8-XH&index=7) and a workshop in 2018 in Sweden that featured a TBL Exercise on “Social, ethical and legal responsibilities of life sciences” that drew on the edited volume described above; the video of the exercise is available at https://education.humanbrainproject.eu/web/1st-hbp-curriculum-ethics/workshop-media.

More general information about the online courses of the HBP Education Programme may be found at https://education.humanbrainproject.eu/web/hbp-curriculum-online-course/research-ethics-societal-impact and about its work on Ethics and Society at https://www.humanbrainproject.eu/en/social-ethical-reflective.
Lists aspirational guiding principles as well as “rules of conduct,” which are more specific. Guiding principle 6 states “ASM members are obligated to discourage any use of microbiology contrary to the welfare of humankind, including the use of microbes as biological weapons. Bioterrorism violates the fundamental principles upon which the Society was founded and is abhorrent to the ASM and its members. ASM members will call to the attention of the public or the appropriate authorities misuses of microbiology or of information derived from microbiology.”

https://www.asm.org/index.php/governance/code-of-ethics
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
United States Education and outreach U.S. National Academies of Sciences, Engineering, and Medicine (the National Academies) International Initiatives on Responsible Science
United States Education and outreach American Association for the Advancement of Science (AAAS) International Engagement: Secure Science, Technology, and Research - BMENA Case Studies
United States Education and outreach Federation of American Scientists Case Studies in Dual Use Biological Research and Case Studies in Agricultural Biosecurity
United States Education and outreach Sandia National Laboratories Global Biorisk Management Curriculum—resource collection
United States Education and outreach Nuclear Threat Initiative (NTI) NTI Education Tutorials—online modules
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Summary
Train-the-trainer model of week-long (and shorter) workshops using active learning techniques to discuss responsible research practices (including dual use topics). Past workshops have been in the Middle East and North Africa and South/Southeast Asia. Many workshop participants become facilitators for future workshops.

http://nas-sites.org/responsiblescience
AAAS designed a set of 10 practical training exercises for life scientists throughout the broader Middle East and North Africa (BMENA) region. The exercises are based on high quality, published life sciences research from the BMENA region and can be included in training courses, educational curricula, and awareness-raising programs.

https://www.aaas.org/resources/international-engagement-secure-science-technology-and-research-bmena-case-studies
The dual use case studies are intended to help define the issues associated with dual use research and security in the research laboratory. They include interviews with researchers whose legitimate scientific work could potentially be used for questionable or harmful endeavors, as well as a historical perspective on their research, bioterrorism, and research regulations. The materials include primary scientific research papers and discussion questions that are meant to raise awareness about the importance of responsible biological research. The agricultural biosecurity modules are intended to raise awareness about agricultural biosecurity issues in the United States and is targeted toward the educated public. These modules address two different aspects of agricultural biosecurity, the nexus of agricultural production and international security. They include interviews with experts, historical perspectives on agroterrorism, and regulations.

https://fas.org/biosecurity/education/dualuse/index.html; https://fas.org/biosecurity/education/dualuse-agriculture
Some of the basic documents are publicly available and some are proprietary.

http://ibctr.sandia.gov/human_capacity_development/hcd-gbrmc.html
Online tutorials developed in partnership with the James Martin Center for Nonproliferation Studies aimed at students, professionals, and the media. Topics include biological weapons, chemical weapons, and nuclear weapons. Tutorials are divided into modules with infographics, interactive maps, slides, and quizzes.

http://tutorials.nti.org/table-of-contents
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
United States Education and outreach Johns Hopkins University (via Coursera) Engineering Life: Synbio, Bioethics & Public Policy—MOOC
United States Education and outreach Georgia Institute of Technology Sam Nunn Security Program (SNSP)
United States National policy Department of Health and Human Services Science, Safety, and Security website
United States National policy Government National Biodefense Strategy (2018)
United States National policy Government Federal Select Agent Program (administered by CDC and USDA)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Summary
Six-week online course (not free) that covers GOF debate, synthetic biology, human health, and governance issues.

https://www.coursera.org/learn/synbioethics
Year-long program on intersection of science, technology, and security, with emphasis on emerging technologies and governance. Includes week-long immersion in Washington, DC, each spring.

https://cistp.gatech.edu/programs/sam-nunn-security-program
Consolidates links and descriptions of major dual use policies.

https://www.phe.gov/s3/dualuse/Pages/default.aspx
Describes the U.S. government’s actions to address biological risks and respond to biothreats. An associated National Security Presidential Memorandum establishes a Biodefense Steering Committee chaired by the Secretary of the Department of Health and Human Services to coordinate implementation of the strategy.

https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Biodefense-Strategy.pdf
The original Select Agent Program was created in 1996 under the Antiterrorism and Effective Death Penalty Act (P.L. 104-132) and then expanded by the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (PATRIOT Act) (P.L. 107-56) and the Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188) of 2002. The program regulates the possession, use, and transfer of biological select agents and toxins (a list of human, plant, and animal pathogens and toxins that have the potential to pose significant threats); certain types of experiments require review and approval before they are carried out.

https://www.selectagents.gov
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
United States National policy Government U.S. Government Policy for Oversight of Life Sciences Dual Use Research of Concern (March 2012)
United States National policy Government U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (September 2014; effective September 2015)
United States National advisory board Government National Science Advisory Board for Biosecurity (various reports and recommendations)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Summary
Federal agencies that conduct or fund potential Dual Use Research of Concern (DURC) must review research portfolios to screen for DURC, assess its risks and benefits, develop a risk mitigation plan in consultation with the research institution, and review annual progress reports for changes that may affect the risk assessment. If risk cannot be mitigated, federal agencies can ask researchers to voluntarily redact findings, classify the research, or terminate funding.

https://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf
“The policy addresses institutional oversight of DURC, which includes policies, practices, and procedures to ensure DURC is identified and risk mitigation measures are implemented, where applicable. Institutional oversight of DURC is the critical component of a comprehensive oversight system because institutions are most familiar with the life sciences research conducted in their facilities and are in the best position to promote and strengthen the responsible conduct and communication.”

https://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf

DURC Companion Guide: https://www.phe.gov/s3/dualuse/Documents/durc-companion-guide.pdf

A set of case studies, Implementation of the U.S. Government Policy for Institutional Oversight of Life Sciences DURC: Case Studies, “demonstrate the type of analysis that should be brought to bear during institutional reviews of DURC and highlight important administrative steps in the DURC review process.” They could also be used more broadly as an education tool about dual use issues.

https://www.phe.gov/s3/dualuse/Documents/12-case-studies-durc.pdf
The NSABB is a federal advisory committee that addresses issues related to biosecurity and dual use research at the request of the U.S. government. The NSABB has up to 25 voting members with a broad range of expertise, as well as non-voting ex-officio members from 15 federal departments and agencies. The NSABB has produced reports and recommendations on a range of dual use and biosecurity issues, including proposed governance measures.

https://osp.od.nih.gov/biotechnology/national-science-advisory-board-for-biosecurity-nsabb
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
United States National policy Government HHS Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (2010)
United States National policy Government Gain-of-function policies
United States National policy Government Department of Homeland Security (DHS)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Summary
The primary goal of the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA is to minimize the risk that unauthorized individuals or individuals with malicious intent will obtain “toxins and agents of concern” through the use of nucleic acid synthesis technologies, and to simultaneously minimize any negative impacts on the conduct of research and business operations.

https://www.phe.gov/Preparedness/legal/guidance/syndna/Pages/default.aspx
White House funding pause and deliberative process (October 2014): https://www.phe.gov/s3/dualuse/Documents/gain-of-function.pdf.

NSABB final recommendations and related documents (May 2015 to May 2016): https://osp.od.nih.gov/biotechnology/national-science-advisory-board-for-biosecurity-nsabb.

Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (January 2017): https://www.phe.gov/s3/dualuse/Pages/GainOfFunction.aspx.

Department of Health and Human Services Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (December 2017); replaces 2013 guidance: https://www.phe.gov/s3/dualuse/Documents/p3co.pdf.

NIH announcement of lifting of funding pause (December 2017): https://www.nih.gov/about-nih/who-we-are/nih-director/statements/nih-lifts-funding-pause-gain-function-research.
DHS Directive 041-01; issued May 25, 2007. Compliance with, and Implementation of, Arms Control Agreements;

Also

Testimony describing DHS review of intramural research funded by or performed by DHS for DURC concerns or other BW/security concerns prior to publication or disclosure.

https://www.dhs.gov/news/2012/04/26/written-testimony-science-and-technology-directorate-senate-committee-homeland
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
United States National policy Government NBACC
United States Self-governance Journal publishers Journal Editors and Authors Group “Statement on Scientific Publication and Security”
United States Journal policies Journal publisher American Society for Microbiology journals
United States Education and outreach Government Federal Experts Security Advisory Panel (FESAP)
United States Outreach Engineering Biology Research Consortium (EBRC) Working group on security in engineering biology
Regional Laboratory management European Committee for Standardization (CEN) Laboratory Biorisk Management, CEN Workshop Agreement (CWA) 15793 (2011)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Summary
Landon et al. 2015. Institutional Review of Dual Use Research of Concern to Support a Culture of Responsibility. Journal of Bioterrorism and Biodefense 2015, 6:1.

http://dx.doi.org/10.4172/2157-2526.1000130
Statement by prominent, primarily U.S. journal editors recognizing both value of scientific publication and potential risks of misuse. Urges journals to develop review processes and states that “on occasion an editor may conclude that the potential harm of publication outweighs the potential societal benefits. Under such circumstances, the paper should be modified, or not be published. Scientific information is also communicated by other means: seminars, meetings, electronic posting, etc. Journals and scientific societies can play an important role in encouraging investigators to communicate results of research in ways that maximize public benefits and minimize risks of misuse.” Appeared simultaneously in Science, Nature, and Proceedings of the National Academy of Sciences.

http://www.sciencemag.org/site/feature/data/security/statement.pdf
The ASM policies are described in Casedevall et al. 2015. Dual-Use Research of Concern (DURC) Review at American Society for Microbiology Journals. mBio 6(4):e01236-15.

http://mbio.asm.org/content/6/4/e01236-15.full%22
FESAP Culture of Biosafety, Biosecurity, and Responsible Conduct (educational materials at https://ebsaweb.eu/awareness-biosafety-and-biosecurity; additional info at http://www.sciencediplomacy.org/files/perkins_et_al_biosafety_september_2017.pdf).
EBRC is a nonprofit membership organization focused on building partnerships between academia, industry, and government in precompetitive research in engineering biology. In addition to their focus on advancing research, they maintain a working group on security in engineering biology, including working toward advancing an improved culture of security within the research base.

www.ebrc.org
The agreement provides a management system to complement existing biosafety standards, such as those provided by the World Health Organization. Since CWAs have a set lifespan, there is a process under way to turn this into an ISO standard, which would apply internationally.

http://www.uab.cat/doc/CWA15793_2011
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
Regional Funder guidelines European Commission Ethics self-assessment
Regional Education and outreach European Union (EU)—Nonproliferation Consortium Online modules
Regional Code Europe—DIYbio community DIYbio Code of Ethics from European Congress (draft, 2011)
Regional Code Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Italy, Mexico, and Spain Code of Conduct for Scientists (2014)
Regional Code ALLEA—All European Academies The European Code of Conduct for Research Integrity, Revised 2017
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Summary
In its oversight of research under the Horizon 2020 program, the European Commission maintains a distinction between traditional dual use research and what it terms research that “involves materials, methods or technologies or generates knowledge that could be misused for unethical purposes” (emphasis added). “Although such research is usually carried out with benign intentions, it has the potential to harm humans, animals or the environment,” which corresponds to the concept developed in the Fink report. A researcher applying for funding addresses questions of whether his or her research has the potential for misuse as part of the mandatory ethics self-assessment that is part of the proposal process.

https://erc.europa.eu/sites/default/files/document/file/EthicsSelfAssessmentStepByStep.pdf
The EU Non-proliferation Consortium is a network of independent nonproliferation think tanks. In 2017, the consortium released a collection of 15 learning modules available online for free, including slides, videos, and quizzes. Module 3 is about biological weapons and covers research areas with misuse potential, background info on BWC, and bioweapons.

https://nonproliferation-elearning.eu
“In May 2011, individuals and delegates from regional groups of DIY biologists from across Europe came together at the London School of Economics BIOS Centre with the goal of generating an aspirational code of ethics for the emerging do-it-yourself biology movement. The congress was composed of participants from five countries, including Denmark, England, France, Germany, and Ireland.”

https://diybio.org/codes/draft-diybio-code-of-ethics-from-european-congress
Submitted as a draft document to the 2014 BWC that was meant to be a code “of general application” for life scientists. Discusses professional integrity (more aspirational), responsibility (includes improper use of information), and responsibility of scientific institutions.

https://www.unog.ch/80256EDD006B8954/(httpAssets)/A0E89AEE9BA5731AC1257DA4003BB8A1/$file/BWC_MSP_2014_WP.6.pdf
In addition to traditional elements of research integrity, the code stipulates that “Researchers recognise and manage potential harms and risks relating to their research.”

https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/h2020-ethics_code-of-conduct_en.pdf
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
×
Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
International Journal policies Council of Science Editors (CSE) White Paper on Promoting Integrity in Scientific Journal Publications
International Certification International Federation of Biosafety Associations (IFBA) Professional Certification Program for Biorisk Management and Biosafety Professionals
International Industry Initiative International Gene Synthesis Consortium Harmonized Screening Protocol (International Gene Synthesis Consortium, 2009, updated 2017)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
The Council of Science Editors (CSE) is an international membership organization whose aim is to be “an authoritative resource on current and emerging issues in the communication of scientific information.” Since 2006 CSE has published a White Paper on Promoting Integrity in Scientific Journal Publications, which is periodically revised and, beginning in 2018, will be added to and updated on a rolling basis to keep pace with new information and best practices.

https://www.councilscienceeditors.org/resource-library/editorial-policies/white-paper-on-publication-ethics
“The IFBA has launched a new certification program for biorisk management and biosafety professionals worldwide. An IFBA certificant is an individual who has met the eligibility requirements and achieves acceptable performance levels on examinations. The IFBA certifies individuals at the ‘Level 1—Professional Certification’ and ‘Level 2—Specialist Professional Certification’ in a number of specializations and technical disciplines related to the field of biosafety, biosecurity and biorisk management. Certifications are valid for a period of 5 years and require ongoing maintenance demonstrating active upgrading of skills and participation in the profession.”

http://www.internationalbiosafety.org/index.php/professional-certification/ifba-professional-certifications/about-the-program
Voluntary screening of gene synthesis orders by member companies.

https://genesynthesisconsortium.org/wp-content/uploads/IGSCHarmonizedProtocol11-21-17.pdf
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
International Clearinghouse UN Interregional Crime and Justice Research Institute (UNICRI) International Network on Biotechnology (INB)
International Education and outreach EU CBRN Centres of Excellence Project 18: International Network of universities and institutes for raising awareness on dual use concerns in biotechnology
International Norms/principles International Science Council (ISC) Freedom, Responsibility and Universality of Science (2014)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
The INB is a global network of academic and research institutions, nongovernmental and international organizations, and other stakeholders committed to advancing responsible and secure conduct in the life sciences. Network partners may be found in Asia, Europe, the MENA, and North and South America. In its clearinghouse role, the INB is developing a digital platform to view, download, upload, and share customizable and user-friendly teaching/training materials, which include technology briefs, case study videos, scenario-based exercises, and immersive learning (virtual reality laboratory tours). The INB also provides a sustainable platform for network partners to (co-)develop and share educational resources tailored to local needs.

https://www.unog.ch/80256EDD006B8954/(httpAssets)/DB56FEFFA3325E82C12582E4006A837A/$file/INB_Presentation_BWC+MXaug2018_9+Aug+2018.pdf
Two-year project (2013–2015): “To raise awareness of dual-use (peaceful use and misuse) concerns in bio-technology for academics, scientists, researchers, technicians and students, as well as to foster the sharing and transfer of best practices in biosafety and biosecurity.” Information about the implementation of the project is available on the website of the implementer, the Landau Network Centro Volta (see previous entry in this table). A similar project was carried out for chemistry (#42).

http://www.cbrn-coe.eu/Projects/TabId/130/ArtMID/543/ArticleID/46/Project-18-International-Network-of-universities-and-institutes-for-raising-awareness-on-dual-use-concerns-in-bio-technology.aspx
Published by the Committee on Freedom and Responsibility in the Conduct of Science (CFRS), this lists both the responsibilities and freedoms of scientists. “Given this potential for multiple-use, the demands on scientists to pay careful attention to their individual and communal responsibilities are higher than in many other areas of work. Scientists have an obligation to critically reflect upon how their expertise is used, particularly when asked to support decision-making and policy processes.”

https://council.science/publications/freedom-responsibility-and-universality-of-science-2014

NOTE: In 2018, the International Council for Science (ICSU) merged with the International Social Science Council and became the International Science Council (ISC). The work of the CFRS continues in the new organization.
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
International Norms/principles InterAcademy Partnership (IAP) Statement on Biosecurity (2005)
International Norms/principles InterAcademy Partnership (IAP) Statement on Synthetic Biology (2014)
International Norms/principles InterAcademy Partnership (IAP) Responsible Conduct in the Global Research Enterprise (2012); Doing Global Science (2016)
International Norms/principles Organisation for the Prohibition of Chemical Weapons (OPCW) The Hague Ethical Guidelines (2015)
International Code International Union of Biochemistry and Molecular Biology (IUBMB) Code of Ethics (2005)
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
Describes five guiding principles for elements to be considered by organizations or other science bodies in drafting codes of conduct: awareness, safety and security, education and information, accountability, and oversight. Researchers should “always bear in mind the potential consequences—possibly harmful—of their research and recognize that individual good conscience does not justify ignoring the possible misuse of their scientific endeavor.”

http://www.interacademies.org/13912/IAP-Statement-on-Biosecurity
IAP Statement on Realising Global Potential in Synthetic Biology: Scientific Opportunities and Good Governance. “Maintaining biosecurity brings challenges beyond those of biosafety: for biosecurity the core defence rests on the responsibility of the scientific community.”

http://www.interacademies.org/10878/Scientific_Opportunities_and_Good_Governance.aspx
Policy report and accompanying educational handbook prepared by an international committee provides globally applicable principles for responsible conduct of research, including biosecurity as part of “preventing the misuse of research and technology.”

http://www.interacademies.org/19787/Responsible-Conduct-in-the-Global-Research-Enterprise
Intended for guidance in creating ethical codes to support the Chemical Weapons Convention. Promotes sustainability, awareness and engagement, safety and security, oversight, education, ethics, accountability, and exchange of information. “Teachers, chemistry practitioners, and policymakers should be aware of the multiple uses of chemicals, specifically their use as chemical weapons or their precursors. They should promote the peaceful applications of chemicals and work to prevent any misuse of chemicals, scientific knowledge, tools and technologies....” The OPCW website also has a database of existing chemistry codes of conduct.

http://www.interacademies.org/33345/Doing-Global-Science-A-Guide-to-Responsible-Conduct-in-the-Global-Research-Enterprise
Created after the 2005 BWC discussions. Lists members’ obligation to the public, to other investigators, and to trainees. Similar to Code of Ethics by the American Society for Biochemistry and Molecular Biology (1998), but also includes “They will not engage knowingly in research that is intended for the production of agents of biological warfare or bioterrorism, nor promote such agents.”

https://iubmb.org/about-iubmb/mission-code-of-ethics
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
International Code International Union of Microbiological Societies (IUMS) Code of Ethics (2008)
International Code International Association of Synthetic Biology Code of Conduct for Best Practices in Gene Synthesis (International Association of Synthetic Biology, 2009)
International Code UNESCO Recommendation on Science and Scientific Researchers (revised 2017)
International Code iGEM (Synthetic Biology) iGEM Safety Policy
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
Code resulted from discussions at the BWC in 2005. “IUMS is opposed to the misuse of microbiological knowledge, research and resources. In particular, IUMS also strives to promote ethical conduct of research and training in the areas of biosecurity and biosafety so as to prevent use of microorganisms as biological weapons and therefore to protect the public’s health and to promote world peace.” Also encourages member societies to adopt codes.

https://www.iums.org/index.php/code-of-ethics
Voluntary screening of gene synthesis orders by member companies.

http://op.bna.com.s3.amazonaws.com/hl.nsf/r%3FOpen%3Djaqo-7xqpnr
Lists responsibilities and freedoms of individual researchers, institutions, and funding agencies. Researchers have a responsibility “to express themselves freely and openly on the ethical, human, scientific, social or ecological value of certain projects, and in those instances where the development of science and technology undermine human welfare, dignity and human rights or is ‘dual use’, they have the right to withdraw from those projects if their conscience so dictates and the right and responsibility to express themselves freely on and to report these concerns.” Report on member states’ progress in implementing the recommendations to occur every 4 years, starting in 2019. Annex contains a list of other conventions, recommendations, and initiatives (helpful resource for self-governance).

http://portal.unesco.org/en/ev.php-URL_ID=49455&URL_DO=DO_TOPIC&URL_SECTION=201.html
iGEM prohibits gene drives and has restrictions on antimicrobial resistance work, animal work, use of certain organisms, and a review process for genetic modifications. Compliance is necessary for entry into the competition. As an extra step, they have FBI presence at competitions to instill in students the potential connection between science and biosecurity issues (more education and outreach). See also “2017 iGEM safety and security insights” document.

http://2017.igem.org/Safety/Policies
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Country or Community Type of Governance Activity Organization Name of Policy/Regulation/Code/Activity or Organizer, etc.
International Funder guidelines Gene Drive Funders and Supporters Consortium Principles for Gene Drive Research
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Summary
Published as Emerson et al., Science 358(6367):1135–1136; includes five guiding principles for sponsors and supporters of gene drive research and identifies signatories in the acknowledgement section. Does not address dual use but contains a potential model for such efforts.

http://science.sciencemag.org/content/358/6367/1135
Suggested Citation:"Appendix E: Examples of Activities Across the Governance Landscape." National Academies of Sciences, Engineering, and Medicine. 2018. Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25154.
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Next: Appendix F: Examples of Regional and International Forums, Organizations, or Bodies »
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Continuing advances in science and technology offer the promise of providing tools to meet global challenges in health, agriculture, the environment, and economic development; some of the benefits are already being realized. However, such advances have the potential to challenge the oversight systems for responsible conduct of life sciences research with dual use potential – research that may have beneficial applications but that also could be misused to cause harm.

Between June 10 and 13, 2018, more than 70 participants from 30 different countries and 5 international organizations took part in an international workshop, The Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight, to promote global dialogue and increased common understandings of the essential elements of governance for such research. Hosted by the Croatian Academy of Sciences and Arts in Zagreb, Croatia, the workshop was a collaboration among the InterAcademy Partnership, the Croatian Academy, the Croatian Society for Biosafety and Biosecurity, and the U.S. National Academies of Sciences, Engineering, and Medicine. This publication summarizes the presentations and discussions from the workshop.

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