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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2 Governance in Theory and Practice
2 Governance in Theory and Practice
Pages 7-36
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From page 7... ...
Beginning at the international level, Charo emphasized that no single international institution has the mandate and capacity to provide oversight of dual use biotechnologies. She noted that a number of institutions provide or could provide a forum for discussions of dual use issues to develop common understandings and approaches to action.
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From page 8... ...
A second approach is to focus on different regulatory issues, and Charo illustrated this by drawing on a framework developed for agricultural applications that included intellectual property rights, public information, retail and trade, food and health safety, consumer choice, and public research investment (Haga and Willard, 2006: 967)
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From page 9... ...
In addition, other measures such as self-governance activities undertaken by the scientific community on a voluntary basis, are also important to responsible conduct of research, as had been the case in her experience with the governance of embryonic stem cell research.2 And she commented that there are also a number of other instruments that do not receive much attention in discussions of dual use issues, including intellectual property rights, restrictions by private funders, material transfer restrictions, oversight committees, and advisory bodies and stakeholder/advocacy groups. She provided a number of specific examples of the different parts of the ecosystem, which are described in greater detail in Chapter 3.
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In the U.S. context, the initial planning stage for publicly funded research would involve oversight bodies for biotechnology research, including reviews by an Institutional Biosafety Committee (IBC)
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to identify potential DURC, which is then subject to an institutional review process. The objective is to identify the anticipated benefits, in conjunction with the risks, and if necessary develop a "risk mitigation plan." Funding decisions are a second important phase, and one that is subject to different national approaches.
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She provided an example of how this had been employed in the area of stem cells, wherein intellectual property owners were in a position to put conditions into every license stipulating that the intellectual property could (or could not) be used for cloning.
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The participant suggested that government funding for academic research ensured that there is a degree of control, but not in the case in the private sector. Other participants countered this suggestion, arguing that many companies in the private sector had undertaken voluntary measures in support of dual use governance.
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He opened the plenary by describing some of his own experiences with biosafety and security governance activities undertaken in the context of South and sub-Saharan Africa as an example of the roles that academies of science can play. He described an assessment of existing legislation and regulations undertaken by the South African Academy of Sciences at the request of the South African government to identify strengths and weaknesses of such measures; provide a critical overview of measures in laboratories in southern Africa; conduct an assessment of dual use concerns; and evaluate existing measures and capacity to prevent natural, accidental, and deliberate events.
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Additionally, the research raised concerns 6 More information about iGEM may be found at International Genetically Engineered Machine Competition. Available at http://igem.org/Main_Page (accessed September 4, 2018)
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. Millett next provided examples of dual use research projects that could fall under each of the seven experiments of concern originally identified in the work of the Fink committee (NRC, 2004: 5–6)
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Governance of Dual Use Research in the Life Sciences in Australia The first panel speaker was Julia Bowett of Australia's Department of Defence Export Control Branch who drew from her expertise as both a technical adviser on export controls in the life sciences area and a co-chair in the Australia Group. Bowett introduced the Australia Group as an informal arrangement among 42 countries plus the European Union as an institution that meets annually to discuss trade restrictions on certain sensitive technologies of concern in order to counter the proliferation of chemical and biological weapons.8 She then outlined Australia's approach to export controls, and the lead role of the Department of Defence in controlling traditional dual use items, that is, those with military utility as well as uses in legitimate research, commercial, or industrial uses.
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Consultations with the working group extended for approximately 2 years over the various iterations of the Guide. Bowett commented that the Guide included all of the controls that might apply to life scientists and the exemptions the Australian government makes available to them.
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Additionally, the team at the Australian Defence Export Controls Branch provided a free export control helpline and frequently presented at conferences and expos. Governance of Dual Use Research in the Life Sciences Joseph Kanabrocki of The University of Chicago, the second panelist, introduced himself as a faculty member who also oversaw the research safety office.
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Based on the outcome of the first review, the DURC Task Force provides binding recommendations and supervision related to the conduct of the DURC. The University has developed a Framework for Review of Risk Mitigation Plans with four steps, following the guidance provided by the U.S.
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Moreover, the current regulatory framework is list based, which makes little sense to him as some of the experiments do not fit easily within the categories. He also acknowledged that there is limited screening of molecular engineering and synthetic biology research and the current mechanisms for dual use research screening rely on a risk mitigation platform originally established for the oversight of work with recombinant DNA.
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org/responsiblescience/iircs/institutes/institute-in-se-asia (accessed September 20, 2018)
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Neuroenhancement, Responsible Research, and Innovation The final panel speaker was Agnes Allansdottir of the Toscana Life Sciences Foundation, who spoke about a project that illustrated governance of research with dual use potential beyond pathogens. Neuroenhancement, Responsible Research, and Innovation (NERRI)
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The NERRI project, along with other projects publicly funded by the European Commission, aimed to explore the way inclusiveness could potentially be reached in different cultures and countries and across segments of society. "Responsiveness" refers to how activities structured along the first three dimensions will lead to actual policy outcomes, that is, how the knowledge and experiences captured in the course of public engagement activities can be made relevant to policy makers and affect policy-making processes.
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Italian National Bioethics Committee Opinions 2013–2014. Roma: Presidenza del Consiglio dei Ministri, Dipartimento per l'informazione e l'Editoria.
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Bowett provided a detailed response, indicating that they did not require scientists to obtain an export license to present at a conference, and that they had set the control threshold very high so the content of a PowerPoint presentation overseas would not be detailed enough to cross the threshold. Bowett reiterated the difficulties posed by export controls on intangible technology, highlighting the importance of outreach to deal with this and explaining how they engaged with universities and the circumstances in which researchers would need to come and speak with her organization.
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From page 27... ...
Huising began with the example of how to get people to wear laboratory coats to illustrate some of the challenges of governance in real workplace settings, before relating this to the more sophisticated topic of dual use. She outlined issues with compliance in academic laboratories, noting that most researchers' experience with compliance requests is as an intrusion on -- and impediment to -- their work (Gray and Silbey, 2014; Smith-Doerr and Vardi, 2015)
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From page 28... ...
Compared with corporate or diagnostic laboratories, academic laboratories also have less stability and cyclical resource flows, along with rules and procedures that are often quite localized and tacitly passed on through training. Moreover, in academic laboratories organizational-level rules were secondary, an important contrast with the corporate approach in which rules and procedures were developed at the organizational level in written form.
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The example of laboratory coats mentioned above illustrates how these complementary approaches could be applied. She noted that researchers not wearing laboratory coats in laboratories was a common infraction and something scientists openly admitted, in part, she suggested, because wearing them was perceived as a signal that the wearer was an amateur.
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She also suggested that a key element of cultural change was determined by human resource practices and leadership. Returning to the laboratory coat example, she commented that wearing laboratory coats was not common in promotional material for grant winners and questioned what message this sent to students.
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, a human activity that is difficult to quantify; • Risk management -- how one addresses risks (and the missed ben efits of not fully taking advantage of someone's science) ; and • Risk communication -- how one addresses others' concerns and manages the risks in a way that is perceived as appropriate.
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From page 32... ...
improve the science base, to identify and verify environmental etiologies of disease and develop and validate research methods; (2) involve the affected populations, that is, engage with citizens from the affected populations in communities of concern, who should be actively recruited to participate in the design and execution of research; and (3)
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From page 33... ...
In terms of establishing working relations, Fischhoff presented examples of how this had been achieved in other domains, including intelligence analysis and cybersecurity, emphasizing the importance of creating a common language and drawing on an organizational model from behavioral science for these forms of collaboration (NASEM, 2017d; 13 Materials, including videos and links to related activities for the three colloquia in 2012, 2013, and 2017 may be found at National Academy of Sciences, "Arthur M Sackler Colloquia: The Science of Science Communication." Available at http://www.nasonline.org/programs/ sackler-colloquia/completed_colloquia/science-communication.html; "Arthur M
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From page 34... ...
Fischhoff concluded by discussing the FDA's strategic plan for risk communication and template for making risk-benefit decisions (FDA, 2013) , noting the template had been developed through collaborative effort in a manner that drew from the behavioral sciences and employed design principles such as stakeholder engagement.
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From page 35... ...
GOVERNANCE IN THEORY AND PRACTICE 35 ence of top-down risk management following a workplace accident that totally changed the operation of the organization, triggering the release of resources and leadership from the highest levels that brought everyone into line. In another case, the participant outlined how he helped to address community concerns through the establishment of a citizens group with a rotating chair that allowed the community to become more closely involved in the conversation.
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