Chapter 1

Introduction

THE LIFE SCIENCES AND THE RESPONSIBLE CONDUCT OF RESEARCH

To many in the life sciences community, the 21st century will be the “Century of Biology,” just as the 20th was the “Century of Physics” (National Research Council [NRC], 2009a). A wave of discoveries, supported by new enabling technologies and drawing on many fields beyond biology, is yielding great social and economic benefits and holds out the promise of even more widely available gains in the future. Inspired by this vision, national governments as well as regional and international organizations are creating strategies and making investments to apply continuing developments in the life sciences to help solve challenges related to food, energy, economic development, the environment, animal and plant health, and human well-being (see, for example, African Union, 2006; OECD, 2009; Bibliotheca Alexandrina, 2012; White House, 2012).

These accomplishments and ambitions are accompanied, however, by concerns about the implications of such dramatic advances. Concerns include unease about how increased understanding of basic life processes, and the resulting potential to manipulate and control them, may result in unintended impacts on the environment or human well-being as well as the risk of deliberate misuse of knowledge, tools, and techniques from the life sciences to cause harm (NRC, 2002, 2004, 2005; IOM, 2010).

Among a myriad of issues related to the responsible conduct of science, these security issues and the scientific community’s response to them can be considered part of the broader relationship between science and society. Beyond its fundamental quest for greater knowledge and understanding, science is conducted in a social context. Science depends on public support, including but not limited to the substantial funding that enables research to take place.

The ability of science to deliver on its promise of practical and timely solutions to the world's problems does not depend solely on research accomplishments but also on the receptivity of society to the implications of scientific discoveries. That receptivity depends on the public’s attitude about what science is finding and on how it perceives the behavior of scientists themselves. (Agre and Leshner, Science, 2010:921)

This relationship has important implications for all members of the scientific community.

Even scientists conducting the most fundamental research need to be aware that their work can ultimately have a great impact on society. Construction of the atomic bomb and the development of recombinant DNA— events that grew out of basic research on the nucleus of the atom and investigations of certain bacterial enzymes, respectively—are two examples of how seemingly arcane areas of science can have tremendous societal consequences. The occurrence and consequences of discoveries in basic research are virtually impossible to foresee. Nevertheless, the scientific community must



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Chapter 1 Introduction THE LIFE SCIENCES AND THE to them can be considered part of the broader RESPONSIBLE CONDUCT OF RESEARCH relationship between science and society. Beyond its fundamental quest for greater To many in the life sciences community, the 21st knowledge and understanding, science is century will be the “Century of Biology,” just as conducted in a social context. Science depends the 20th was the “Century of Physics” (National on public support, including but not limited to Research Council [NRC], 2009a). A wave of the substantial funding that enables research to discoveries, supported by new enabling take place. technologies and drawing on many fields beyond biology, is yielding great social and The ability of science to deliver on its promise economic benefits and holds out the promise of of practical and timely solutions to the world's even more widely available gains in the future. problems does not depend solely on research Inspired by this vision, national governments as accomplishments but also on the receptivity of well as regional and international organizations society to the implications of scientific are creating strategies and making investments discoveries. That receptivity depends on the public’s attitude about what science is finding to apply continuing developments in the life and on how it perceives the behavior of sciences to help solve challenges related to food, scientists themselves. (Agre and Leshner, energy, economic development, the Science, 2010:921) environment, animal and plant health, and human well-being (see, for example, African This relationship has important implications Union, 2006; OECD, 2009; Bibliotheca for all members of the scientific community. Alexandrina, 2012; White House, 2012). These accomplishments and ambitions are Even scientists conducting the most accompanied, however, by concerns about the fundamental research need to be aware that implications of such dramatic advances. their work can ultimately have a great impact Concerns include unease about how increased on society. Construction of the atomic bomb understanding of basic life processes, and the and the development of recombinant DNA— resulting potential to manipulate and control events that grew out of basic research on the them, may result in unintended impacts on the nucleus of the atom and investigations of environment or human well-being as well as the certain bacterial enzymes, respectively—are risk of deliberate misuse of knowledge, tools, two examples of how seemingly arcane areas and techniques from the life sciences to cause of science can have tremendous societal harm (NRC, 2002, 2004, 2005; IOM, 2010). consequences. The occurrence and Among a myriad of issues related to the consequences of discoveries in basic research responsible conduct of science, these security are virtually impossible to foresee. issues and the scientific community’s response Nevertheless, the scientific community must 9

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10 Developing Capacities for Teaching Responsible Science in the MENA Region recognize the potential for such discoveries Conference on Science, a collaboration of the and be prepared to address the questions that International Council for Science (ICSU) and they raise. If scientists do find that their the United Nations Educational, Scientific, and discoveries have implications for some Cultural Organization (UNESCO), which important aspect of public affairs, they have a proclaims that responsibility to call attention to the public issues involved. . . . science and technology The practice of scientific research and the use have become such integral parts of society that of knowledge from that research should always scientists can no longer isolate themselves aim at the welfare of humankind, including the from societal concerns. (NRC, 1995:20-21) reduction of poverty, be respectful of the dignity and rights of human beings, and of the The relationship between science and society global environment, and take fully into also means that changing social attitudes can account our responsibility towards present and affect the conduct of science. The conduct of future generations,… research in the life sciences has been particularly affected by the continuing evolution of social and further that attitudes and research practices for both human and animal subjects. In response to appalling All scientists should commit themselves to abuses, standards were created to govern the high ethical standards, and a code of ethics treatment of human subjects in experiments based on relevant norms enshrined in (Beecher, 1966; The Nuremberg Code, 1949; international human rights instruments WMA, 2008; IOM, 2001). The care and use of should be established for scientific professions. laboratory animals is another area where The social responsibility of scientists requires standards continue to evolve (NRC, 2011a; IOM, that they maintain high standards of scientific 2011). As the products of science and technology integrity and quality control, share their enter the marketplace, both standards and the knowledge, communicate with the public and ethics of practice become critical for educate the younger generation. Political authorities should respect such action by environmental safety as well as public health. scientists. Science curricula should include The scientific community, through its science ethics, as well as training in the history professional bodies and other groups, plays a and philosophy of science and its cultural leading role in fostering and maintaining the impact. (UNESCO, 1999)2 norms and standards for what constitutes responsible conduct of science. As discussed The Singapore Statement, produced by the below, these also provide the basis for training Second World Conference on Research Integrity and education about the expectations—and in in 2010, includes the principle that “Researchers some cases, requirements—for professional and and research institutions should recognize that responsible behavior. As science has become an they have an ethical obligation to weigh societal increasingly global enterprise, a growing number benefits against risks inherent in their work” (2nd of statements and declarations from international scientific organizations have                                                              2 underscored the ethical imperatives for all those Key documents from the World Conference on Science involved in scientific research. An early example are available at www.unesco.org/science/wcs/, including the text of the Declaration on Science and the Use of Scientific is the Declaration on Science and the Use of Knowledge in six languages, www.unesco.org/science/ Scientific Knowledge from the 1999 World wcs/eng/declaration_e.htm.

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Introduction 11 WCRI, 2010). Similarly, in 2011 the World community and in the broader society, that Science Forum adopted a recommendation on explore the implications of research and “responsible and ethical conduct of research and impose constraints on research if those innovation.” constraints are justified. (IAC and IAP,   2012:15) In this era of global science, the scientific establishment needs to implement continuous These high-level declarations help set the self-reflection to appropriately evaluate its tone for discussions and can lead to a change in responsibilities, duties and rules of conduct in attitudes about the importance of responsible research and innovation. A universal code of conduct. In 2006, for example, ICSU replaced its conduct addressing the rights, freedoms and Standing Committee on Freedom in the responsibilities of scientific researchers, and Conduct of Science with a new standing the universal rules of scientific research should Committee on Freedom and Responsibility in be shared by the world’s scientific community. the Conduct of Science (emphasis added). While Furthermore, these rules and policies should maintaining its traditional strong advocacy for be respected by the states and adopted by their the principles of the universality of science, such national legislations. as the rights of scientists to travel, associate, and Scientists should strengthen their communicate freely, the new committee “differs individual and institutional responsibilities to significantly from its predecessors in that it has avoid possible harm to society due to been explicitly charged with also considering the ignorance or misjudgment of the consequences of new discoveries and responsibilities of scientists” (ICSU, 2008:2).3 In applications of scientific knowledge. 2011 the ICSU General Assembly adopted an It is the responsibility of those who amendment to the language of its statute on the promote science and scientists to maintain the Universality of Science to recognize formally the primacy of moral and social concerns over importance of responsibility as well as freedom. short-term economic interest in the selection and implementation of industrialised research Such practice, in all its aspects, requires projects. (World Science Forum, 2011) freedom of movement, association, expression and communication for scientists, as well as In 2012, an international committee equitable access to data, information, and convened by the InterAcademy Council (IAC) other resources for research. It requires and IAP—the Global Network of Science responsibility at all levels to carry out and Academies (formerly the InterAcademy Panel communicate scientific work with integrity, respect, fairness, trustworthiness, and on International Issues) produced its report on transparency, recognising its benefits and Responsible Conduct in the Global Research possible harms.4 Enterprise, which among its findings noted that Researchers have learned that they cannot dissociate themselves from the uses of the new knowledge they generate. They need to take                                                              3 into consideration the reasonably foreseeable The ICSU statement on the universality of science may be found at www.icsu.org/5_abouticsu/INTRO_ consequences of their own activities. They also UnivSci_1.html. have an obligation to participate in the social 4 See www.icsu.org/about-icsu/structure/committees/ mechanisms, both within the research freedom-responsibility/statute-5.  

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12 Developing Capacities for Teaching Responsible Science in the MENA Region THE “CULTURE OF RESPONSIBILITY” IN cover research “with both recombinant and/or THE LIFE SCIENCES synthetic nucleic acids” (NIH 2012:1). The activities of scientists and organizations A strong tradition of self-governance to involved in synthetic biology and the response in maintain responsible conduct in scientific late 2011 by flu researchers to the controversy research, often referred to as a “culture of over publication of experiments resulting in responsibility” (NRC, 2009b), provides the increased transmissibility of influenza among foundation for scientists to respond to societal mammals provide recent examples of voluntary concerns. The iconic example of self-governance actions.6 An example of efforts by a government is the response of the life sciences community in to address potential societal concerns as an the early 1970s to new gene splicing techniques integral part of a research program is the Human that would enable them to create recombinant Genome Project’s formal Ethical, Legal, and DNA (rDNA) from different organisms. Many Social Implications (ELSI) Program (1990– of the initial discussions, such as those at a 2003).7 Gordon Research Conference in 1973, As discussed in greater detail in Chapter 2, concerned potential hazards to laboratory life scientists address ethical and safety issues in workers or the consequences of an accidental their work through three overlapping fields that release of rDNA into the environment. This was provide norms and practices to guide research: followed by letters in Science and Nature from biosafety, bioethics, and responsible conduct of prominent scientists who called for a temporary research. Biosafety practices, which are codified moratorium on rDNA experiments to enable an in national and international guidelines, have assessment of the potential risks. Scientists, as developed over the last several decades to well as some journalists and legal experts, came safeguard the health of laboratory workers and together in 1975 in the famous Asilomar avoid accidental or inadvertent releases of Conference.5 The conference concluded that, dangerous biological agents and toxins that with appropriate safeguards (i.e., physical and could harm people or the environment.8 The biological containment procedures), most rDNA World Health Organization (WHO) first research could continue. The National Institutes published its Laboratory Biosafety Manual of Health (NIH), which had begun its own (LBM) in 1983; the third edition came out in reviews of rDNA research in the early 1970s, 2004 (WHO, 2004). In the United States, the released Guidelines for Research Involving rDNA first edition of the Biosafety in Microbiological Molecules in 1976. The guidelines provided                                                              procedures and methods for conducting 6 A group of avian influenza researchers declared a year- research sponsored by NIH, including a long moratorium on further research while international discussions of security and safety issues took place and a mechanism for reviewing proposed experiments number of countries added new measures to address the at the institutional level and for adjudicating any concerns. A special section in Science in May 2012 provides cases that could not be resolved there. To extend articles from a number of perspectives (Science, 2012); the biosafety procedures to developments in the end of the moratorium was announced in January 2013 (Fouchier et al., 2013). field of synthetic biology, as of March 2013 the 7 For further information, see www.ornl.gov/sci/ Guidelines were expanded for the first time to techresources/Human_Genome/project/hgp.shtml. NIH and                                                              the Department of Energy devoted 3-5 percent of their 5 The Asilomar Conference focused only on the health, annual project budgets to studying ELSI issues. 8 safety, and environmental risks of accidentally creating new For laboratory technicians biosafety training is the organisms with dangerous properties. primary channel for education about responsible conduct.

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Introduction 13 and Biomedical Laboratories (BMBL) appeared standards that suggested appropriate subjects for in 1984; the Centers for Disease Control and instruction but did not mandate a curriculum or Prevention (CDC) and the NIH produced the 5th require specific topics. That changed in 2000, edition in 2007 (CDC and NIH, 2007). It is when the Department of Health and Human important to note that the current editions of Service’s Office of Research Integrity (ORI) both documents have chapters addressing the issued a policy that required all researchers and potential risks of deliberate misuse. In Europe, research trainees funded by the Public Health the 2008 International Laboratory Biorisk Service to undergo training in nine core areas of Management Standard from the European RCR (ORI, 2000). ORI’s policy itself was short Committee for Standardization (CEN) provided lived, but formal programs in RCR instruction a voluntary management system to support the continued to grow. Most recently, in November implementation of specific biosafety practices as 2009, NIH issued guidelines on topics from well as ways to reduce the risks of misuse (CEN, which RCR courses could be built. Eight of the 2008). subjects are drawn from ORI’s original core Bioethics is a diverse field and encompasses a topics, such as the components of research wide range of ethical issues in different national misconduct (plagiarism, data falsification, and and disciplinary contexts, including basic data fabrication) and criteria for authorship, but research, medical interventions and specifically the new ninth area is “the scientist as a clinical settings, and protections for human responsible member of society, contemporary subjects in research. Bioethics also engages many ethical issues in biomedical research, and the disciplines beyond science and medicine, such as environmental and societal impacts of politics, law, philosophy, and theology, so that scientific research” (NIH, 2009). there is great diversity in bioethics education Significantly expanding the potential reach programs (see, for example, AAAS, 2008; Revill of RCR education beyond NIH and biomedical and Mancini, 2008; Revill, 2009; and Revill et al., research, in 2009 the National Science 2009). Foundation (NSF) mandated that all trainees The third field is known by various names, supported by, or working on, NSF-funded including “research integrity,” “scientific research projects must receive RCR instruction. integrity,” and “research ethics.” In the United NSF is the major funder of basic research in the States the term “responsible conduct of broader life sciences, including fundamental research” (RCR) emerged in the late 1980s in sciences in agriculture, and also supports fields response to rising concerns about research such as physical sciences, engineering, and misconduct. An influential report from the computer sciences that play growing roles in the Institute of Medicine (IOM, 1989) increasingly integrated world of life sciences recommended systematic education to promote research (NRC, 2010). Given that NIH and NSF responsible research practices. In 1989 the NIH fund international scientists and collaborations, issued requirements that all those holding their expanded requirements have a global certain categories of training grants provide impact. These initiatives by U.S. funders their trainees with instruction in scientific complement a growing international effort to integrity.9 Over time, the mandate evolved into a raise awareness of responsible science and variably defined set of policies and professional promote RCR education, for example through                                                              the series of World Conferences on Research 9 The requirement was expanded to cover all training grant Integrity and the concomitant statements on recipients in 1992 and expanded further in 2009.  

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14 Developing Capacities for Teaching Responsible Science in the MENA Region various aspects of research integrity issued by might be misused to cause deliberate harm. them.10 The first World Conference was held in These concerns come in the wider context of a Portugal in 2007, the second in Singapore in dramatically changed international security 2010, and the third in Canada in 2013. environment, where threats from nonstate Where and what students learn about any of actors—including a potential willingness to use the norms and practices depends on their field of weapons of mass destruction (WMD)—are study, institution, and stage of education. They considered as grave as those nation-states could may receive formal instruction ranging from pose (United Nations, 2004). In the United single lectures or online modules to full courses; States, for example, the attacks on September 11, and informal mechanisms such as mentoring by 2001, and the anthrax mailings a month later senior researchers play an essential role. As heightened these concerns dramatically and respected members of the community, mentors focused attention on harmful uses of biological serve as important messengers for the norms of agents and toxins on a large scale.11 At the same the profession. time, the publication of a number of scientific The scope and quality of available education articles early in the 2000s sparked debates about varies widely, but many students still receive whether the published methods and results of little or no exposure to education about certain types of experiments could provide a responsible conduct of research. The proposals “blueprint” or “roadmap” for those who sought and initiatives to extend the reach and improve to cause harm.12 the quality of education for life scientists about It is noteworthy, however, that the research responsible conduct of research, such as those that raised the most concern about potential described above, coincide with and provide a misuse in many cases also promised important context for a growing interest in education as a potential benefits. Then and now, judgments fundamental component of efforts to address about relative risks and rewards were seldom concerns about deliberate misuse. The next simple or definitive (NRC, 2004; Science, 2012). section discusses this development further. The difficulties and uncertainties associated with assessing whether and how the results of life sciences research intended for legitimate and EDUCATION AS THE FOUNDATION FOR                                                              11 RESPONSIBLE CONDUCT OF RESEARCH In October 2001, letters containing anthrax were sent to offices of several media organizations in the United States as well as to members of Congress. Five people eventually The Life Sciences and the died, including postal workers who were exposed to “Web of Prevention” anthrax spores that escaped the letters. An FBI investigation concluded that the letters had been sent by a scientist at the U.S. Army Research Institute for Infectious One of the concerns that has arisen in response Diseases (NRC, 2009b). to the rapid advances in the life sciences is the 12 Some of the key articles are discussed in Biotechnology potential risk that the knowledge, tools, and Research in an Age of Terrorism (NRC, 2004:25-29). Epstein techniques resulting from these discoveries (2001) reviews the issues and policy options under discussion at the time; Zilinskas and Tucker (2002) reflect                                                              the concerns in the security policy community. These 10 The 2010 Singapore Statement on Research Integrity is discussions have not abated. For example, many similar available at www.singaporestatement.org/statement.html, concerns were raised more recently about publications and the 2013 Montreal Statement on Research Integrity in related to the sequencing of the influenza virus from the Cross-Boundary Research Collaborations at 1918 pandemic (van Aken, 2006; CDC, 2006) and synthetic www.wcri2013.org/Montreal_Statement_e.shtml. mutations in the H5N1 virus (Science, 2012).

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Introduction 15 beneficial purposes could be misused is as well as the positive contributions they can sometimes referred to as the “dual use dilemma” make to crafting and implementing strategies (NRC, 2004:1).13 That term and a number of and policies to support continued scientific others associated with potential misuse remain progress while preventing harm (Royal Society, the subject of considerable confusion and 2004; NRC, 2004, 2006a, 2011c; IAP, 2005; debate. Box 1-1 provides definitions and brief WHO, 2007; IAC and IAP, 2012). The preferred discussions of some of the key terms as they are path to awareness and engagement is generally used in this report. through widespread education about potential It is important to underscore that the current risks and how responses fit within the broader concerns extend beyond the infectious disease perspective of responsible conduct of science agents that were the focus of past state-level and scientific research. For example, the second biological weapons programs (Wheelis et al., phase of the IAC-IAP project that produced 2006). Two examples are advances in Responsible Conduct in the Global Research neuroscience (Royal Society, 2012) and the Enterprise (IAP-IAC, 2012) will create promise of constructing living organisms de educational materials, based in part on the novo through synthetic biology (Tucker and model of the widely adopted handbook, On Zilinskas, 2006; Garfinkel et al., 2007; Mukunda Being a Scientist,16 from the National Research et al., 2009).14 Council (NRC) of the U.S. National Investigators in many areas of the life Academies.17 The IAC-IAP resources are sciences could be affected even if their particular intended to be used by national and regional research poses no apparent risks. Policy actions scientific organizations to promote discussion taken in response to perceptions about a about what responsible conduct means in particular field or research focus could have practice. direct but also larger indirect consequences for The project described in this report is part of the research enterprise.15 A shift in public the work of a number of national and perceptions to see more risks than rewards from international scientific organizations to put such expanding knowledge and capabilities will have recommendations about engaging scientists into repercussions for all life scientists. A number of practice. As Chapter 3 discusses, it is also clear studies have recommended that life scientists from the emerging research literature on human need to become more aware of and engaged in discussions about potential misuse of their work,                                                              13 Efforts to foster attention to dual use issues extend beyond the life sciences and research ethics to include other fields of science, engineering, and health; NRC (2007a) provides an example from the United States. 14 The implications of these and other developments are                                                              16 discussed in a report prepared by several national and The third edition (NRC, 2009c) is available at international scientific organizations (NRC, 2011b). www.nap.edu/catalog.php?record_id=12192; the second 15 In the United States, for example, the Select Agent edition (1995) at www.nap.edu/ Program administers an extensive set of regulations catalog.php?record_id=4917. 17 governing approximately 80 biological agents and toxins The National Academies is the collective name for four that affect humans, plants, and animals. For an account of private, nonprofit U.S. institutions: the National Academy the development and implementation of the program see of Sciences, the National Academy of Engineering, the NRC (2009b); current information is available at Institute of Medicine, and the National Research Council. www.selectagents.gov/. Further information is available at www.nas.edu.  

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16 Developing Capacities for Teaching Responsible Science in the MENA Region BOX 1-1 Definitions of Key Terms Dual Use Traditionally, “dual use” refers to items that have both commercial and military applications. Obvious examples are helicopters and computers, particularly high-performance ones. It may also have positive connotations for the “spin-off” of military research and development to benefit the civilian economy. Research and equipment that supports dual use products may also fall into the dual use category; very broadly, basic research might not usually be considered dual use, whereas applied research would. Concerns arising in the mid- to late 1990s and early 2000s that the results of research in the life sciences might be misused to cause deliberate harm led to a different use of the term “dual use”: research intended for beneficial purposes that could be misused for malevolent purposes (see, for example, NRC, 2004). In an attempt to define what should be the appropriate focus of efforts to prevent misuse, the U.S. National Science Advisory Board for Biosecurity proposed a specialized category called “dual use of concern” (DURC), which it defined in 2007 as “research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment, or materiel” (NSABB, 2007). More recently, the World Health Organization adopted the term dual use research of concern for an international workshop on oversight of research in the wake of the H5N1 controversy (see WHO, 2013). Its definition of DURC is “life sciences research intended for benefit, but with results which might easily be misapplied to produce harm” (WHO, 2013:1). learning and cognition that learners are able to Toxin Weapons Convention (BWC).19 The BWC understand issues more deeply, acquire was the first international treaty to ban an entire knowledge more easily, and retain it for longer class of weapons.20 BWC States Parties are periods of time when they actively engage with                                                              them rather than confronting them more 19 The formal title of the Geneva Protocol, which prohibits passively (e.g., by listening to lectures). first use of chemical and biological weapons, is the The challenge of engaging scientists in “Protocol for the Prohibition of the Use in War of helping to mitigate the potential misuse of life Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods of Warfare.” The BWC’s formal sciences is part of what some in the international title is the “Convention on the Prohibition of the law and security community have proposed as a Development, Production and Stockpiling of “web of prevention” (Rappert and MacLeish, Bacteriological (Biological) and Toxin Weapons and on 2007).18 A central element of this web is the Their Destruction.” These two agreements address threats international norm against the use of disease as a from nation-states; the 2004 UN Security Council Resolution 1540 extends the prohibitions to cover nonstate weapon, embodied in two agreements: the 1925 actors. Geneva Protocol and the 1972 Biological and 20 The 1997 Chemical Weapons Convention (CWC) is the                                                              second WMD prohibition treaty. The increasing 18 The term was coined by the International Committee of convergence of chemistry and biology in research and the Red Cross in 2002 as part of its “Biotechnology, applications is also fostering greater connections between Weapons, and Humanity” campaign. the BWC and the CWC.

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Introduction 17 Biosafety and Biosecuritya Two widely available definitions of these terms are: Biosafety: “Laboratory biosafety describes the containment principles, technologies and practices that are implemented to prevent the unintentional exposure to pathogens and toxins, or their accidental release” (World Health Organization [WHO], 2006:iii). Biosecurity: “the protection, control and accountability for valuable biological materials [including information] … within laboratories in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release” (WHO, 2006:iii). Confusion about the terms raises two different types of issues. The most basic is that in quite a few languages the term “biosecurity” does not exist or is identical with “biosafety.” French, Spanish, and other Romance languages, as well as German, Russian, and Chinese illustrate this practical problem. The more serious problem for biosecurity is that the term is already in widespread use for a number of other international issues. For example, to many “biosecurity” refers to the obligations undertaken by states adhering to the Convention on Biodiversity and particularly the Cartagena Protocol on Biosafety, which is intended to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology.b “Biosecurity” has also been narrowly applied to efforts to increase the security of dangerous pathogens, either in the laboratory or in dedicated collections; guidelines from both the World Health Organization (WHO, 2004) and the Organization for Economic Cooperation and Development (OECD, 2007) use this more restricted meaning of the term. In an agricultural context, the term refers to efforts to exclude the introduction of plant or animal pathogens. a  This section is taken from NRC, 2011c:20-21. b  Further information on the convention is available at www.cbd.int/convention/ and on the Protocol at www.cbd.int/biosafety/. obligated to “take any necessary measures” attention or initiatives on the part of appropriate to their legal processes to carry out international bodies such as the World Health the treaty’s goals. In addition, countries and Organization (WHO, 2005, 2007, 2013) and the some regional organizations are increasingly Organization for Economic Cooperation and promulgating laws, regulations, and guidelines Development (OECD, 2004) and from the to address potential misuse directly or to activities associated with the operation and contribute indirectly through the governance of implementation of the BWC cited above.21 research and commercial activities. The concept of a web also assigns an essential role to measures of self-governance, including                                                              guidelines, “soft law,” codes of conduct, and 21 The papers and presentations during the 2008 meetings other voluntary practices that could have both of experts and states parties and the 7th BWC Review nongovernment and possibly government Conference in December 2011 provide a number of examples. They also underscored the need for the States components. Institutions such as universities, Parties to the Convention to take a more active role in nongovernmental organizations, and scientific supporting the bottom-up initiatives. For further organizations are providing essential “bottom- information, see the “Meetings and Documents” section on up” initiatives (NRC, 2009d; Rappert, 2010). the BWC website These complement the prospects for “top-down” (www.unog.ch/80256EE600585943/(httpPages)/92CFF2CB7 3D4806DC12572BC00319612?OpenDocument.  

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18 Developing Capacities for Teaching Responsible Science in the MENA Region Origins of the Project organizations; the Polish Academy of Sciences served as the host in collaboration with an ad Since the early 2000s, national and international hoc committee with substantial international scientific organizations have been engaged in a membership under the auspices of the National series of activities to address the risks of Academies. potential misuse of the results of life sciences The meeting, which combined plenary research to cause deliberate harm in the context sessions to introduce topics and breakout of responsible conduct of science. One major sessions to permit discussions in depth, brought line of work has been informing policymakers together more than sixty experts from just under about the implications of trends in the life thirty countries and several international sciences for the implementation of national and organizations. The participants included active international efforts to prevent misuse, both in researchers from a range of fields in the life terms of potential risks and the contributions sciences, specialists in bioethics and biosecurity, that science and technology can make to and, as one of the workshop’s special features, reducing them (Royal Society, 2006; NRC, experts in the science of learning. This mix of 2011b). Another has been identifying how best backgrounds and expertise underscored the two to encourage greater engagement by scientists themes at the heart of the workshop’s design: and scientific organizations through education and raising awareness (NRC, 2009d; 2011c).22  To engage the life sciences community, the The latter activities set the stage for a major new particular security issues related to research initiative by the National Academies and its with dual use potential would best be international partners to develop and implement approached in the context of responsible a strategic approach to their education activities. conduct of research, the wider array of issues In 2008 the U.S. Department of State asked that the community addresses to fulfill its the IAP to convene a workshop to: responsibilities to society.  Education about dual use issues would  survey strategies and resources available benefit from the insights of the “science of internationally for education on dual use learning,” the growing body of research issues and identify gaps, about how individuals learn at various stages  consider ideas for filling the gaps, including of their lives and careers and the most development of new educational materials effective methods for teaching them, which and implementation of effective teaching provides the foundation for efforts in many methods, and parts of the world to improve the teaching of  discuss approaches for including education science and technology at all levels of on dual use issues in the training of life instruction. (NRC, 2011c:3) scientists. (NRC, 2011c:2) The workshop also discussed the similar The workshop (hereafter the Warsaw challenges faced by any effort to introduce new workshop) was organized as a collaboration of material, such as the competition for space in an IAP with several other international scientific already crowded curriculum, or an academic                                                              reward structure that did not put high value on 22 Both of these reports, undertaken with a number of innovation or excellence in teaching. One clear international partners, include accounts of work by message was “the importance of identifying and national and international scientific organizations.

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Introduction 19 supporting ‘champions’ to the success of The discussion also included some models initiatives” (NRC, 2011c:87). In addition, for more general faculty development that could participants consistently cited the limited be adapted, in particular the National Academies number of faculty and instructors able to teach Summer Institutes for Undergraduate Biology about dual use issues. This led to an extensive Education (NASI) that became the basis for the discussion of the importance of networks to project described in this report.24 support and sustain efforts to introduce new The NRC committee took responsibility for topics and new approaches. A number of producing the report, which contained a number examples related to dual use that also drew on of conclusions and recommendations. Selected the research about effective teaching—such as conclusions relevant to this project and the full online faculty development courses from the list of recommendations may be found in University of Bradford in the United Kingdom Appendix A, but one specific recommendation and the WHO train-the-trainer courses on is particularly relevant. biosafety and biosecurity redesigned to escape an older “death by PowerPoint” approach— Build networks of faculty and instructors offered potential models for new efforts.23 through train-the-trainer programs, undertaking this effort if possible in For all the approaches participants stressed the cooperation with scientific unions and importance of including plans for post- professional societies and associations. (NRC training support, both for developing and 2011c:9-10) implementing new methods and materials and for sharing lessons learned and best practices. It is worth noting that some models… CREATING NETWORKS OF FACULTY: deliberately include small teams rather than THE MIDDLE EAST–NORTH AFRICA single individuals from a given institution in PROJECT order to enhance the chances of sustaining what is learned and a commitment to In 2010, the Biosecurity Engagement Program implementation is part of the selection (BEP) of the U.S. Department of State, which process. The champions…may also help to provided the funding for the Warsaw workshop, create and sustain a more hospitable climate agreed to support a two-year project to for new content and methods. In addition to implement some of the workshop’s key supporting work at home institutions, some recommendations. The broad goal of the project models for building networks of faculty and was to “develop a framework for an instructors also bring graduates together after their training for special follow-up activities to international series of faculty development reinforce what was learned, while others rely institutes in key regions around the world with on the normal cycle of meetings that take place the goal of promoting and enhancing education in a discipline or professional field to provide about issues related to research in the life convening opportunities (NRC, 2011c:89). sciences with dual use potential in the context of responsible conduct of science.” The full                                                              23 Two examples of other dual use–related projects that                                                              24 have taken place since the Warsaw workshop that include The general characteristics of faculty development active learning are EUBARnet (2012) and Novossiolova et programs, one variant of train-the-trainer models, are al. (2013). discussed in Chapter 3.  

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20 Developing Capacities for Teaching Responsible Science in the MENA Region Statement of Task (SOT) for the project is institutes might be adapted and organized in shown in Box 1-2. other contexts. The project was overseen by an ad hoc NRC The BEP program operates in many parts of committee with members from the United the world, but it emphasizes certain regions and States, Europe, and Egypt (see Appendix E). The priority countries with them. After consultation committee interpreted the “framework” in the with the sponsor, the Middle East–North Africa SOT as concerned with the design of the (MENA) region was chosen to test a prototype institutes and not the development of underlying that could then be applied in other countries or concepts. The project in fact builds on the regions. In addition to the lessons from the concepts related to responsible science and dual Warsaw workshop about the most effective ways use issues developed in the course of almost a to introduce issues of potential misuse, the decade of work by the National Academies and committee hoped combining the best pedagogy other organizations already discussed in this with responsible conduct of science would be an chapter, as well as on other concepts related to appealing capacity-building opportunity for active learning described in Chapter 3 that faculty in countries interested in using life reflects a comparably long National Academies sciences research for economic growth and engagement. improved wellbeing. This report is intended to be useful to a The project was carried out in stages as a number of audiences: partnership with the Bibliotheca Alexandrina in Alexandria, Egypt, and The World Academy of  Scientists in the Middle East–North Africa Sciences (TWAS), in Trieste, Italy (see Appendix (MENA) region and elsewhere who may not B). The two institutions’ standing and extensive have considered the issues addressed in the networks in the region were essential to the Institute and want information about the effective implementation of the project. concepts associated with responsible science Unfortunately, continuing political uncertainties and ideas about how to introduce the in the MENA region in the wake of the Arab material into their classrooms and Spring necessitated a number of delays and institutions. changes, prolonging the project by about a year.  Program managers and funders who might The first phase centered on a planning meeting support projects related to dual use issues, held at TWAS in late spring 2011 to design a responsible conduct, or capacity building in general framework for educational institutes for the life sciences and be interested in new faculty based on the NASI model; a description approaches. of NASI is provided in Chapter 3.25 In the  Experts in responsible conduct who might project’s second phase, discussed in detail in not be familiar with active learning Chapter 4, the first Institute was held in Aqaba, techniques. Jordan, in September 2012 for 28 participants  Experts in active learning who might not from Algeria, Egypt, Jordan, Libya, and Yemen. have considered how the approaches could An online survey shortly after the Institute be applied to new areas. gathered the participants’ initial impressions. In the third and final phase, project participants It has a strong emphasis on practical applied for small grants to implement some of implementation and tries to provide sufficient                                                              25 detail to give readers a sense of how similar In the context of this report, the terms “workshop” and “institute” are interchangeable.

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Introduction 21 the content/methods combinations they and continued scientific progress. designed at the Institute in Jordan in their home Chapter 2 elaborates on the development institutions.26 In April 2013 a small reunion for and current status of the basic concepts and the leaders of the teams that received grants in approaches to education and training in the Amman, Jordan, enabled the participants to responsible conduct of science. Chapter 3 discuss their experiences up to that point and provides an overview of the science of learning, also share their insights about the Institute. research that reveals how people learn and how Their suggestions and lessons provided to use the insights on human learning and important input into the formulation of the cognition to improve teaching practices. As committee’s findings and conclusions for this noted above, commitment to supporting the best report. possible pedagogy is a key feature of the MENA project. These two chapters are intended to offer quick primers for readers with expertise in one STRUCTURE OF THE REPORT but not necessarily both of the subjects. Chapter 4 describes the planning meeting and the first This chapter has provided an introduction to Institute, held in Jordan in September 2012, how concerns about potential misuse of while Chapter 5 discusses the activities advances in the life sciences can be addressed in undertaken by participants after the Institute to the context of responsible conduct of science implement what they learned. Chapter 6 offers a and the essential role that education plays in preliminary evaluation of the Institute, along fostering the engagement of the scientific with the committee’s findings, conclusions, and community in responses that seek both security ideas for the future.                                                              26 The project was able to support five grants and BEP provided funds to support another three.  

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22 Developing Capacities for Teaching Responsible Science in the MENA Region Box 1-2 Statement of Task An ad hoc committee appointed by the National Research Council will develop a framework for an international series of faculty development institutes in key regions around the world with the goal of promoting and enhancing education about issues related to research in the life sciences with dual use potential in the context of responsible conduct of science. The institutes will bring together higher education faculty in the life sciences as well as experts in related areas to gain greater understanding and experience with methods for effective teaching and learning, develop curricular materials to facilitate education about dual use issues that they will use in their classes, and become prepared to be leaders in their communities on these topics. The project will be conducted in three phases:  Phase I: Planning. The committee will organize and hold a planning meeting, which will bring together life science educators from the Middle East–North Africa region with leaders in dual use issues and science education. The planning meeting will help to answer substantive and logistical questions that will guide the organization of Phase II, including issues such as scheduling, language, target audience, and evaluation, outreach and dissemination strategies. A consensus letter report will be prepared to guide the organization of Phase II and to serve as a model for organizing similar institutes in the MENA or other regions. In its report, the committee may offer guidance on the distribution of resources to support implementation and follow-up activities.  Phase II: First Faculty Development Institute. The committee will organize a first institute that will feature several invited presentations in addition to workgroups and hands-on exercises. The committee will identify the topics, select and invite speakers and other participants, and work with regional hosts in organizing the session.  Phase III: Implementation and Additional Activities. The committee will work with participants from the first institute to help them implement what they have learned at their home institutions. Small amounts of funding to support implementation, such as the development of new materials, brown bag seminars, or other activities will be made available to at least some of the participating faculty. A follow-up meeting for institute alumni will take be held approximately 6-9 months after the institute, which a small group of staff and committee members will attend. The committee will also oversee the preparation of a final consensus report that would provide an account of the first institute, the activities initiated by the participants at their home institutions, the discussions at the follow-up meeting of the alumni, and an evaluation of the outcomes. It will also offer further conclusions about successful practices for preparing faculty to teach about research with dual use potential.