Governance of Dual Use Research in the Life Sciences Advancing Global Consensus on Research Oversight: Proceedings of a Workshop (2018) / Chapter Skim
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Appendix E: Examples of Activities Across the Governance Landscape
Appendix E: Examples of Activities Across the Governance Landscape
Pages 131-184
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National Academies, particularly to supplement information on the landscape of U.S. governance activities addressing dual use life sciences research.
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; Security Sensitive Biological Agent Standards
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Created in response to a 2006 review of the Council of Australian Governments. Establishes the Security Sensitive Biological Agents (SSBA)
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Canada National policy Government Human Pathogens and Toxins Regulation (2015) Canada National policy Government Tri-Agency Framework: Responsible Conduct of Research (2011)
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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.
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136 GOVERNANCE OF DUAL USE RESEARCH IN THE LIFE SCIENCES Name of Policy/ Type of Regulation/ Country or Governance Code/Activity or Community Activity Organization Organizer, etc. Croatia National policy Government Relevant national legislation and policy Croatia Funder guidelines Government Croatian Sciences Foundation Croatia Professional Nongovernment Croatian Society association 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)
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. 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.
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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)
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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)
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France National advisory Government La Conseil board National Consultatif Pour La Biosecurite (CNCB) Germany National policy/ Government Committee on position paper Biological Agents (ABAS)
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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.
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Germany Code BIO Deutschland Position Paper by BIO Deutschland on the Topic of Biosecurity: The Dual-Use Dilemma (2008) Germany Code The Society for DURC Virology Commission
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. Focus is on minimizing biorisk and misuse of biological resources.
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assessment and risk mitigation: "Dual use potential of life sciences research" (2013) Germany Policy research University of Interdisciplinary Hamburg/The Research Group Carl Friedrich von on the Analysis Weizsäcker-Centre of Biological for Science and Risks (INFABRI)
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. Publicly funded research group to assess the comparative risks of different biological threat scenarios and available response options.
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Working with Highly Pathogenic Microorganisms and Toxins (DFG, 2013) Germany Policy German Ethics Biosecurity -- Council Freedom and Responsibility of Research (2014, German Ethics Council report)
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Also lists existing regulations not explicitly about dual use but relevant to biosecurity. A Joint Committee of Leopoldina and DFG (German Research Foundation)
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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 Model Statutes DFG for Committees for Ethics in Security-Relevant Research (Joint Committee of Leopoldina and DFG, 2016) Indonesia Code Indonesian Code of Conduct Academy of on Biosecurity Sciences
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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.
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Israel National advisory Government Council for board the Regulation of Research in Biological Pathogens Japan Code Science Council of Code of Conduct Japan for Scientists (government) (Science Council of Japan, revised in 2013 to include dual use)
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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.
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Malaysia Education and Academy of Educational outreach Sciences Malaysia 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)
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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.
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South Africa National policy Government Non-Proliferation of Weapons of Mass Destruction Act (1993)
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http://www.bioethics-singapore.org/index/publications/reports/172-researchinvolving-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")
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South Africa National policy Government Hazardous Substances Act (1973) South Africa Policy research Academy of The State of Science of South Biosafety and Africa Biosecurity in South Africa South Africa Policy research Academy of The State of Science of South Laboratory Africa Biosafety and Biosecurity in the Southern African Development Community (SADC)
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Includes sections on awareness and assessing misuse potential. http://swiss-academies.ch/en/dms/publikationen/12/report1203e_Biosecurity_Web.
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United Kingdom National policy Government Biological Security Strategy (2018) United Kingdom Funder guidelines Public/private Wellcome Trust/ BBRC/MRC United Kingdom Education and Bradford Dual Use outreach Disarmament Education Research Centre Materials (BDRC)
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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)
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team-based learning (TBL) exercises United Kingdom Education and Bradford Neuroscience outreach Disarmament Research Centre (BDRC)
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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.
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Technology, and Research BMENA Case Studies United States Education and Federation Case Studies outreach of American in Dual Use Scientists Biological Research and Case Studies in Agricultural Biosecurity United States Education and Sandia National Global Biorisk outreach Laboratories Management Curriculum -- resource collection United States Education and Nuclear Threat NTI Education outreach Initiative (NTI) Tutorials -- online modules
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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.
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& Public Policy -- MOOC United States Education and Georgia Institute Sam Nunn outreach of Technology Security Program (SNSP) United States National policy Department Science, Safety, of Health and and Security Human Services website United States National policy Government National Biodefense Strategy (2018)
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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)
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Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (September 2014; effective September 2015) United States National advisory Government National Science board Advisory Board for Biosecurity (various reports and recommendations)
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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/durccompanion-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.
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United States National policy Government Gain-of-function policies United States National policy Government Department of Homeland Security (DHS)
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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.
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United States Outreach Engineering Working group Biology Research on security in Consortium engineering (EBRC) biology Regional Laboratory European Laboratory management Committee for Biorisk Standardization Management, (CEN)
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. EBRC is a nonprofit membership organization focused on building partnerships between academia, industry, and government in precompetitive research in engineering biology.
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Salvador, Guatemala, Italy, Mexico, and Spain Regional Code ALLEA -- All The European European Code of Conduct Academies for Research Integrity, Revised 2017
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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.
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on Promoting Integrity in Scientific Journal Publications International Certification International Professional Federation Certification of Biosafety Program Associations for Biorisk (IFBA) Management and Biosafety Professionals International Industry Initiative International Harmonized Gene Synthesis Screening Consortium Protocol (International Gene Synthesis Consortium, 2009, updated 2017)
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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/ifbaprofessional-certifications/about-the-program Voluntary screening of gene synthesis orders by member companies.
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(INB) International Education and EU CBRN Centres Project 18: outreach of Excellence International Network of universities and institutes for raising awareness on dual use concerns in biotechnology International Norms/principles International Freedom, Science Council Responsibility and (ISC)
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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-ofscience-2014 NOTE: In 2018, the International Council for Science (ICSU) merged with the International Social Science Council and became the International Science Council (ISC)
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International Code International Code of Ethics Union of (2005) Biochemistry and Molecular Biology (IUBMB)
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"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-ResearchEnterprise 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.
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Microbiological Societies (IUMS) International Code International Code of Conduct Association of for Best Practices Synthetic Biology in Gene Synthesis (International Association of Synthetic Biology, 2009)
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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.
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182 GOVERNANCE OF DUAL USE RESEARCH IN THE LIFE SCIENCES Name of Policy/ Type of Regulation/ Country or Governance Code/Activity or Community Activity Organization Organizer, etc. International Funder guidelines Gene Drive Principles for Funders and Gene Drive Supporters Research Consortium
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APPENDIX E 183 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.
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