yes / The outbreak of Ebola in West Africa in 2014 has underlined the risks posed by outbreaks of highly virulent and deadly diseases, whether caused naturally, accidentally or deliberately. It also emphasised the responsibility of all those engaged in the life sciences, whether in government, industry or academia, to ensure that research is done safely and securely. This book, Preventing Biological Threats, 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. The advances in biotechnology over the past decades and in the future have brought and will bring significant benefits to humankind, animals and plants -- however, these advances also bring risks that we need to be aware of and ensure that they cause no harm. The continuing debate about the potential danger of carrying out ‘Gain-of-Function’ experiments with highly pathogenic viruses such as avian influenza has brought the problem of biological security to the attention of many within but also beyond the life science community. It also has left some of them wondering what biological security is and how it can be incorporated into the life sciences. What steps should be taken to ensure that these and other dual use research activities are not misused? It is being increasingly recognised that biosecurity and biosafety are not only relevant to activities within a laboratory, but also extend to the effects that these activities can have outside the laboratory if they result in accidental outbreaks of diseases in humans, animals or plants. The international basis for the prevention of the hostile misuse of life sciences is the Biological and Toxin Weapons Convention which this year, on 26 March 2015, has been in force for forty years. The Convention was the first treaty to prohibit the development and possession of an entire category of weapons. At this moment 173 States Parties have ratified the Convention (and the Convention has a further 9 Signatories). At the Seventh Review Conference of the Biological and Toxin Weapons Convention in 2011, of which I was President, the States Parties agreed on the need for all those engaged in the life sciences to be involved as key stakeholders in the protection of their work from hostile misuse, and therefore on the importance of broad biosecurity education. This book with its 21 chapters addresses the need for biosecurity education, in six sections on the history of threats and responses; scientists, organisations and biosecurity; biosecurity and law enforcement; states and biosecurity; and biosecurity and active learning. It is a significant and welcome step forward both in its integrated content and the active learning focus in the associated Team Based Learning exercises. I am convinced that this approach will help all those engaged in the life sciences - in government, industry or academia – to become more aware of biosecurity and of their responsibilities for it. It is therefore a great pleasure to commend the authors and editors for their work and the Governments of Canada, Jordan and the United Kingdom for their funding and involvement in the production of this book under the Global Partnership. Ambassador Paul van den IJssel

No / The COVID-19 virus pandemic has again demonstrated the devastating impact that a microbial pathogen can have on our health, society and economic systems. It necessitates a fundamental rethink of how the security of our societies can be better sustained. This rethinking will require many aspects of our security systems to be re-examined, but we concentrate here on the consequences of the rapid advances being made in the life and associated sciences. In this chapter, we will describe and analyse one of the most likely means by which the BTWC could be strengthened at the 9th Review Conference, namely: agreement of an International Aspirational Code of Conduct supported by mandatory biological security education for life and associated scientists. We conclude that a vigorous effort by civil society will be needed to assist the achievement of an agreement on this issue at the 9th Review Conference.

Submitted by Fabricia Pimenta (fabricia.pimenta@icict.fiocruz.br) on 2016-05-05T15:46:14Z No. of bitstreams: 1 dissertação Adriano Campos.pdf: 1587224 bytes, checksum: 004e65061e94398f2a80656458e824a3 (MD5) / Approved for entry into archive by Vanessa Suane (vanessa.suane@icict.fiocruz.br) on 2016-05-06T14:10:42Z (GMT) No. of bitstreams: 1 dissertação Adriano Campos.pdf: 1587224 bytes, checksum: 004e65061e94398f2a80656458e824a3 (MD5) / Made available in DSpace on 2016-05-06T14:10:42Z (GMT). No. of bitstreams: 1 dissertação Adriano Campos.pdf: 1587224 bytes, checksum: 004e65061e94398f2a80656458e824a3 (MD5) Previous issue date: 2015 / Fiocruz. Centro de Desenvolvimento Tecnológico em Saúde / O tema biossegurança é de grande relevância para o desenvolvimento do país nas áreas da saúde, ciência e biotecnologia. A regulamentação deste tema no Brasil é caracterizado por documentos pulverizados, editados por diferentes órgãos governamentais, que não interagem efetivamente, gerando incertezas para a comunidade cientifica e a sociedade. Há a necessidade do desenvolvimento, análise, consolidação e harmonização dos documentos nacionais de referência de biossegurança visando tornar mais clara e eficaz a compreensão e aplicação dos requisitos. O presente trabalho visa realizar uma análise crítica dos documentos nacionais de referência vigentes e elaborar uma proposta de um modelo consolidado e harmonizado de um Manual de Biossegurança para a área da saúde, com a finalidade de subsidiar a definição de critérios de forma mais clara. Para este fim, foram identificados e analisados os documentos nacionais que tratam do tema biossegurança, a saber: Diretrizes Gerais para o Trabalho em Contenção com Agentes Biológicos (Ministério da Saúde, 2010); Resolução Normativa nº 02, de 27 de novembro de 2006 (Ministério da Ciência, Tecnologia e Inovação); Norma Regulamentadora - NR.32 - Segurança e Saúde no Trabalho em Serviços de Saúde (Ministério do Trabalho e Emprego, 2011) e Diretrizes para Projetos Físicos de Laboratórios de Saúde Pública (FUNASA, 2007). Em seguida, definiu-se três macrotemas para a análise comparativa: Utilidades, Infraestrutura e Equipamentos. Cada macrotema foi abordado em função de temas mais específicos e palavras-chave que refletissem os principais critérios utilizados para assegurar as condições de biossegurança de uma instalação laboratorial de saúde, os quais foram utilizados para a busca do tema em cada documento de referência. Cada requisito foi analisado e consolidado, criando-se uma redação única, que harmoniza todos os documentos nacionais de referência. Foram geradas tabelas consolidando, para cada macrotema, em cada nível de segurança biológico (NB-1, NB-2 e NB-3), os temas e requisitos observados nos documentos nacionais de referência. A partir de cada tabela foi possível identificar os aspectos comuns e omissos nestes documentos e estabelecer um texto propositivo consolidado para cada tema, harmonizando-os. Como produto, foi elaborado um documento harmonizado como proposta de um Manual de Biossegurança para a área da saúde a ser considerado pela Fiocruz e Inmetro. Este documento consolidou e/ou harmonizou os documentos nacionais de referência de biossegurança brasileiros editados por diferentes órgãos governamentais, de modo a subsidiar a discussão e definição de requisitos para a estruturação de um Programa de Avaliação da Conformidade Laboratorial em Segurança Biológica. A análise dos resultados obtidos permitiu concluir que os documentos nacionais de referência não se apresentam completos para todos os requisitos de biossegurança e, em alguns casos, há requisitos fundamentais não contemplados. O Manual de Biossegurança para a área da saúde proposto supera tal limitação por conter todos esses requisitos. Adicionalmente, o documento proposto agrega requisitos ainda não contemplados, visando aproxima-lo das normas técnicas internacionais atuais. / The issue of biosafety is of great importance for the country's development in health, Science and biotechnology. The regulation of biosafety in Brazil is characterized by several standards issued by different government agencies, that do not interact effectively, creating uncertainties for the scientific community and society. There is the need for development, analysis, consolidation and harmonization of Brazilian biosafety laws/rules issued by diferente government agencies, in order to make the comprehension and application of these laws more effective and widespread. This study carried out a critical analysis of the existing legislation in biosafety and produced a draft for a consolidated and harmonized model of a technical Biosafety Guidelines for laboratories acting in the area of health in order to support the definition of criteria and the most appropriate approach for structuring a future Program in Assessment of Laboratory Conformity in Biosafety. To accomplish this, the national documents dealing with the issue of biosafety were identified and critically analyzed. The documents included: Diretrizes Gerais para o Trabalho em Contenção com Agentes Biológicos (Ministério da Saúde, 2010); Resolução normativa nº 02, de 27 de novembro de 2006 (Ministério da Ciência, Tecnologia e Inovação); Norma Regulamentadora - NR.32 - Segurança e Saúde no Trabalho em Serviços de Saúde (Ministério do Trabalho e Emprego, 2011) and Diretrizes para Projetos Físicos de Laboratórios de Saúde Pública (FUNASA – 2007). The content of the documents was divided into three main issues for comparative analysis: Utilities, Infrastructure and Equipment. Each issue was further subdivided into more specific topics and ascribed keywords, that reflect the main criteria used to ensure biosafety conditions of a laboratory acting in the area of health, which were used for to search for the topics within each reference document. Each requirement was analyzed and consolidated, creating a single text, which harmonizes all the existing laws and regulations, formulated into a single reference document. As a result, consolidated tables were developed for each main issue at each biosafety level, with the issues and requirements observed in the legislation. From each table it was possible to critically identify common issues and omissions in legislation and establish a consolidated text for the purpose of harmonizing them against current legislation. The product of this process, was a harmonized document in the form of a Biosafety Guidelines to be considered by Fiocruz and Inmetro. This document consolidated and/or harmonized the existing Brazilian biosafety laws/rules, issued by different government agencies in order to offer a platform for the discussion and definition of requirements for structuring a Program in Assessment of Laboratory Conformity in Biosafety. Based on the analysis of the results, it was concluded that the multiple national standards are incomplete in relation to all biosafety requirements and, in some cases, there are fundamental requirements that are not covered. The proposed Biosafety Guidelines overcomes those limitations and also standardizes the requirements for biosafety in healthcare laboratories. In addition, the proposed Guidelines consider and add requirements not contemplated in the national legislation in order to bring it into line with current international standards.

Yes / The devastating effects of the COVID-19 pandemic have acutely shown the need for maintaining robust international and national systems for biological security and ensuring that life sciences are used only for peaceful purposes. Life science stakeholders can play an important role in safeguarding scientific and technological advances in biology and related fields against accidental or deliberate misuse, not least because they are on the frontlines of driving innovation. In this paper, we argue that enhancing awareness and understanding of the risk of deliberate disease is essential for effective biological security. We first discuss the issue of ‘dual use’ in science and technology as it relates to disarmament and non-proliferation of weapons of mass destruction. Second, we review how scientist engagement with dual-use risks has been addressed in the context of the Biological and Toxin Weapons Convention (BTWC). Third, we report on the development of an innovative awareness-raising tool, a cartoon series, that can be used for engaging life science stakeholders with BTWC issues. Finally, we outline a set of practical considerations for promoting sustainable life science engagement with the BTWC. / The graphic design of the Cartoon Series and the publication of this manuscript have been funded by a grant provided by the UK Research and Innovation Strategic Priorities Fund and HEIF Rescaling Fund through London Metropolitan University, UK.

yes / Introduction Combining Contents with Strategy: A Case for Team-Based Learning. The term "biosecurity‟ has been used in many different contexts for many different purposes. The present Handbook uses the concept of "biosecurity‟ (or biological security) to mean successful minimising of the risks that the biological sciences will be deliberately or accidentally misused in a way which causes harm for humans, animals, plants or the environment, including through awareness and understanding of the risks. Biosecurity thus involves a complex and rapidly evolving set of issues that concern a broad range of stakeholders: policy makers, legislators, industry, academia, the security community, science educators, life science students and practitioners, and the general public.1 Addressing those issues requires continuous cooperation among all concerned parties, that is, biosecurity awareness is a responsibility incumbent upon all. The need for fostering awareness of biological security among those engaged in the life sciences has been widely acknowledged in various fora and, as a result, over the past few years a number of important initiatives have been carried out, designed to further education about the broader social, ethical, security and legal implications of cutting-edge biotechnology.2 The chief objective of the present Handbook is to complement those efforts by combining teaching material in biological security with an active learning training approach – Team-Based Learning (TBL) – to empower educators, students and practitioners as they begin to engage with biological security. The Handbook seeks to supplement the Guide "Preventing Biological Threats: What You Can Do‟ by providing its users with tips and insights into how to implement its content in different educational settings. Part 5 of the Guide introduces the reader to the value of active learning in the context of biosecurity education and training. Chapter 20 in particular details the implementation of the TBL format at an interactive biosecurity seminar and the results achieved by the seminar participants. Consequently, the Handbook aims to: i. Highlight the strengths of the TBL format in teaching biological security. ii. Provide practical guidance on how to organise, run, and facilitate TBL biosecurity seminars. iii. Offer sample sets of exercises based on the individual chapters of the Guide. iv. Explain how each set of exercises can be used for achieving specific learning objectives. Each chapter of the Handbook introduces the reader to a key concept discussed in the respective chapter of the Guide and elaborates on the specific learning objectives, which the TBL exercises are aimed at. Each set comprises Individual and Team Readiness Assurance Test questions, and Application Exercises in the form of multiple-choice problem-solving tasks and practical scenarios (see below). A growing body of evidence suggests that the use of active learning approaches to teaching and training can significantly enhance the effectiveness of education programmes.3 Part of the reason behind this trend is the fact that active learning strategies aid the learner in „unlocking‟ their existing knowledge and linking new subject matter to their established conceptual framework.4 In other words, through case studies, scenarios, problem-solving games, role plays, and simulations – to name few examples of active learning methods – learners are prompted to think critically, reflect and develop understanding of unfamiliar concepts. Active learning approaches allow fostering a learner-centred environment where the learner rather than the instructor is at the centre of the activities taking place in the classroom.5 The Handbook focuses on a specific format of active learning instruction – Team Based Learning (TBL). This is a special form of collaborative learning which uses a specific sequence of individual work, group work, and immediate feedback to create a motivational framework, whereby the focus is shifted from conveying concepts by the instructor to the application of concepts by student teams.6 TBL is an easy-to-replicate, user-friendly approach, that can be applied in many different educational settings at various stages of instruction, and for different purposes. It enables the instructor to cover new material in a way that engages learners as active participants, allowing them to take ownership of their own learning, and develop reflection and self-evaluation skills.