Overview

INTRODUCTION

Prior to 2001, the life sciences were largely spared from government concerns about the potential for misuse of scientific knowledge. Only a few in the scientific community had raised concerns about the potential contributions of life sciences research to biological weapons programs and bioterrorism before the anthrax attacks of 2001.1 There were no regulatory

1

In his presentation to the May 2000 annual meeting of the National Academy of Sciences, Matthew Meselson, a leading figure in the life sciences and biological arms control communities, highlighted the potential for harm that could be done through biotechnology: “Every major technology—metallurgy, explosives, internal combustion, aviation, electronics, nuclear energy—has been intensively exploited, not only for peaceful purposes but also for hostile ones. Must this also happen with biotechnology, certain to be a dominant technology of the coming century? During the century just begun, as our ability to modify fundamental life processes continues its rapid advance, we will be able not only to devise additional ways to destroy life but will also be able to manipulate it—including the processes of cognition, development, reproduction, and inheritance. A world in which these capabilities are widely employed for hostile purposes would be a world in which the very nature of conflict has radically changed. Therein could lay unprecedented opportunities for violence, coercion, repression, or subjugation” (Meselson 2000). Meselson and others were worried about biological weapons programs, such as those of the former Soviet Union, and what those programs could do with advanced molecular biology to make biological weapons. He and others (e.g., Block 1999; Roberts 2000; Tucker 2000; Leitenberg 2005) were concerned with the intentional use of biotechnology for weapons development and how to evaluate the threat of bioterrorism. However, these studies were not yet focused on the potential subversion of legitimate research in the life sciences for malevolent purposes of bioterrorism. Concerns about bioterrorism risks grew substantially after the first World Trade Center attack, the Oklahoma City



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Overview INTRODuCTION Prior to 2001, the life sciences were largely spared from government concerns about the potential for misuse of scientific knowledge. Only a few in the scientific community had raised concerns about the potential contributions of life sciences research to biological weapons programs and bioterrorism before the anthrax attacks of 2001.1 There were no regulatory 1 In his presentation to the May 2000 annual meeting of the National Academy of Sci - ences, Matthew Meselson, a leading figure in the life sciences and biological arms control communities, highlighted the potential for harm that could be done through biotechnology: “Every major technology—metallurgy, explosives, internal combustion, aviation, electronics, nuclear energy—has been intensively exploited, not only for peaceful purposes but also for hostile ones. Must this also happen with biotechnology, certain to be a dominant technology of the coming century? During the century just begun, as our ability to modify fundamental life processes continues its rapid advance, we will be able not only to devise additional ways to destroy life but will also be able to manipulate it—including the processes of cognition, development, reproduction, and inheritance. A world in which these capabilities are widely employed for hostile purposes would be a world in which the very nature of conflict has radically changed. Therein could lay unprecedented opportunities for violence, coercion, re- pression, or subjugation” (Meselson 2000). Meselson and others were worried about biologi - cal weapons programs, such as those of the former Soviet Union, and what those programs could do with advanced molecular biology to make biological weapons. He and others (e.g., Block 1999; Roberts 2000; Tucker 2000; Leitenberg 2005) were concerned with the intentional use of biotechnology for weapons development and how to evaluate the threat of bioterror- ism. However, these studies were not yet focused on the potential subversion of legitimate research in the life sciences for malevolent purposes of bioterrorism. Concerns about bioter- rorism risks grew substantially after the first World Trade Center attack, the Oklahoma City 

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 DUAL USE RESEARCH IN THE LIFE SCIENCES or legislative actions taken by the U.S. government aimed at constraining research and communication in the life sciences outside of some govern- ment laboratories where classified biological research was performed.2 But as fear gripped the nation in the aftermath of the tragic events of Sep - tember 11 and the anthrax attacks that followed a month later, questions began to be raised about whether publicly available scientific information could be used for malevolent purposes and what actions the government should take to constrain “dangerous” information. The security com- munity and policy makers in the United States began to discuss whether some life science research should be categorized as “sensitive but unclas - sified (SBU) information,” asking whether such information needed to be constrained to protect against future bioterrorist attacks.3 Additional dis- cussions focused on risks from international collaborations and whether research by foreign graduate students at U.S. academic institutions should be restricted. Given the high level of anxiety about the anthrax attacks, accentuated by allegations in the news media about who conducted those attacks and uncertainties as to where the anthrax bacteria originated, questions arose bombing, and the Aum Shinrikyo sarin chemical attack and revelations about the latter’s efforts to develop bioweapons (Wright 2007). But much of the discussion focused on the likelihood of terrorist groups’ pursuing biological capabilities and their abilities to overcome technical barriers to acquisition and use (for a review of these discussions and debates, see Frerichs et al. [2004]). It was not until after the publication of a paper by Australian research - ers showing that the insertion of an interleukin gene, IL-4, into the mousepox virus could render the virus vaccine-resistant (Jackson et al. 2001) that concern about the potential con - tribution of publications in the open literature to enabling bioterrorism became a significant focus of concern. Advances in biotechnology have been increasingly seen as a dangerous and powerful new way to produce biological weapons. 2 Regulations were put in place to control the transfer of select microbial pathogens and toxins in 1996, but knowledge generated by fundamental biological research was not viewed with concern. 3 SBU is one of dozens of categories the federal government uses to control access to information; like many others, it has never been defined in statute. SBU has been used to denote unclassified national security information that might nonetheless be useful to an ad - versary. Efforts to define what constitutes SBU information provoke recurrent controversies (National Research Council [NRC] 2007a). A review of SBU and other such categories by the Congressional Research Service provides a detailed history (Knezo 2004). On May 7, 2008, the White House announced a new policy to create a single category, “Controlled Unclassi - fied Information,” that is to apply across the executive branch (White House 2008). Many of the details of how the new policy will be implemented have not been decided or released.

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 OVERVIEW about the safety of freely disseminating knowledge in the life sciences. 4 Policy makers and members of the security and scientific communities soon began to focus on the dual use dilemma in the life sciences 5—recog- nizing that the very research needed for bettering human health, advanc - ing the economy, and other societal benefits could be misused to do harm. Slowing research in the life sciences, however, would harm the nation, global health, and the advancement of science, and so whatever policies might be developed to enhance security needed to be crafted very care - fully. Given this tension, it is not surprising that 7 years later the debates continue over what to do about the dual use dilemma for research and communication in the life sciences.6 Clearly, during the past 50 years, rapidly expanding knowledge in the life sciences has brought great benefits to society. Smallpox has been eradicated; new vaccines are available to prevent childhood diseases such as measles, mumps, and rubella; there is a vaccine to protect against cervical cancer; numerous therapeutic drugs are available to treat infec- tious diseases, heart disease, cancer, etc.; and life expectancy has been increasing. Moreover, with regard to national security, research activities in the life sciences are vital for providing essential protection against infectious diseases and bioterrorism through understanding pathogenesis and host–agent (pathogen or toxin) interactions, and the development of vaccines, therapeutics, and diagnostics. In many areas, advances in the life sciences, enabled by government investments such as those by the National Institutes of Health (NIH) have led to economic development in the United States, which contributes to national security and national prosperity. As a result of its preeminent research enterprise, the United States has achieved a global leadership position in biotechnology. The continu - 4 In August 2008, after the current survey was conducted, the U.S. attorney in the case announced that the Federal Bureau of Investigation (FBI) had concluded that Bruce Ivins, a senior researcher at the U.S. Army Medical Research Institute of Infectious Diseases, was the “only person responsible for these attacks” (Johnson et al. 2008). (Ivins had committed suicide in late July [Shane and Lichtblau 2008]). The FBI has released some of the evidence they used to implicate Ivins as the suspect (Willman and Savage 2008). 5 The term “dual use” in this context refers to legitimate research knowledge and materials that could be misused for malicious purposes; it does not refer to activities banned by the Biological and Toxin Weapons Convention (BWC) that can be cloaked by a guise of legiti - macy. Thus, the dilemma is that the research is legitimate and should be conducted, even if it has the potential for misuse, as opposed to illegitimate research intended to do harm, which should not be allowed. For a discussion of the multiple uses of the term “dual use,” see Atlas and Dando (2006). 6 For ongoing discussion about the dual use dilemma, see the minutes of meetings of the National Science Advisory Board for Biosecurity (NSABB) available at http://oba.od.nih. gov/biosecurity/.

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 DUAL USE RESEARCH IN THE LIFE SCIENCES ing globalization of biotechnology has meant, however, that the United States does not have a monopoly on advanced research and technologies in the life sciences (NRC 2006a). Any development of systematic policies and practices to protect against the misuse of knowledge generated by researchers in the life sciences ultimately will have to extend globally. 7 Unilateral U.S. policies could even cause harm if they disrupted interna - tional collaborations essential to the advancement of the biomedical and other life sciences research. A number of recent NRC reports have argued that maintaining U.S. national security depends on continued promotion of the open exchange of research (NRC 2007a,b, 2009). Overall, finding the right mix of policies to advance research and share knowledge in the life sciences and also to address the potential for misuse of the knowledge generated by such research present a daunting challenge for the scientific community and policy makers.8 The life sciences are not the only area of science to have experi - enced concerns about misuse of the knowledge generated from research. In the 1980s, there was great concern about the potential for informa - tion in the open scientific literature being expropriated by enemies of the United States for arms development. Much of this concern centered on the physical sciences, with nuclear weapons development the initial focus. A National Academy of Sciences report, Scientific Communication and National Security, issued in 1982 and commonly known as the Corson report after its chair Dale Corson, ignored the life sciences when it con - sidered the national security risks associated with research in the United States (NAS/NAE/IOM 1982). The report underscored the importance of maintaining the openness of fundamental research regardless of the field of science, and called upon the U.S. government to keep secret only very narrowly defined scientific knowledge. It pointed to the need to use classification as the means of protecting information that could readily be misused, thereby rejecting the idea of government control of unclassified scientific data. However, the issue of restricting unclassified information continued to arise. In 1984, the American Association for the Advancement of Science (AAAS) passed a resolution opposing “continuing governmental efforts to 7A report from the National Research Council, Biotechnology Research in an Age of Terror- ism (NRC 2004a), recommended that the United States undertake measures to address the potential risks from dual use research. The report pointed out that this was a first step and also called for international action to prevent the misuse of science that would be adapted to address local needs and conditions as well as global concerns. 8 See Making the Nation Safer: The Role of Science and Technology in Countering Terrorism (NAS/NAE/IOM 2002) for a discussion of research areas needed to enhance security against bioterrorism and Globalization, Biosecurity, and the Future of the Life Sciences (NRC 2006a) for a discussion of concerns about the need for enhancing biosecurity in a globalized world.

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 OVERVIEW restrict the communication or publication of unclassified research” (Bor- ras 1984). This statement reaffirmed a AAAS resolution passed in 1982, which voiced opposition to “governmental restrictions on the dissemina - tion, exchange, or availability of unclassified knowledge” (Borras 1982). According to the AAAS Committee on Scientific Freedom and Responsi - bility, the second resolution was prompted by what the AAAS considered excessive executive branch efforts to prevent the export of U.S. technology to Soviet bloc countries. These efforts included requesting prepublica - tion review of unclassified technical papers, inhibiting communication of unclassified scientific research in university classrooms and research labo- ratories, limiting foreign students’ access to university research projects and results, censoring technical papers at professional society meetings, and restricting otherwise unclassified meetings to U.S. citizens. In response to the Corson report and continuing concerns about the openness of science, President Reagan issued National Security Decision Directive (NSDD) 189 in 1985, which stated that to the maximum extent possible, fundamental research results should remain unrestricted, and that the appropriate mechanism for controlling information produced by federally funded research is the classification process.9 Nevertheless, by the 1990s the issue again arose—this time for the field of cryptography. Recognizing the threat to national security that could arise from advances in cryptography, cryptographers agreed to submit articles on a voluntary basis for government review simultaneously with submission to journals and to consider requests to restrict publication of details that could harm national security (Dam and Lin 1996:417; Diffie 1996:2). 9 NSDD-189 states: “’Fundamental research’ means basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons. . . . It is the policy of this Admin - istration that, to the maximum extent possible, the products of fundamental research remain unrestricted. It is also the policy of this Administration that, where the national security re - quires control, the mechanism for control of information generated during federally funded fundamental research in science, technology and engineering at colleges, universities and laboratories is classification. Each federal government agency is responsible for: a) determin- ing whether classification is appropriate prior to the award of a research grant, contract, or cooperative agreement and, if so, controlling the research results through standard classi - fication procedures; b) periodically reviewing all research grants, contracts, or cooperative agreements for potential classification. No restrictions may be placed upon the conduct or reporting of federally funded fundamental research that has not received national security classification, except as provided in applicable U.S. Statutes” (White House 1985).

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 DUAL USE RESEARCH IN THE LIFE SCIENCES EFFORTS TO ENHANCE BIOSECuRITy Following the U.S. anthrax attacks in 2001, discussions within the government and the life sciences community began to consider whether there was SBU information in the life sciences that posed a national security risk and if so what should be done to mitigate the potential for misuse. Then National Security Advisor Condoleezza Rice reaffirmed the government policy embodied in NSDD-189 in November 2001.10 The Office of Science and Technology Policy and the Office of Management and Budget consulted with the scientific and academic communities in several meetings conducted in 2002 about potential policies to define and constrain unclassified information in the life sciences that could be used for bioterrorism (Check 2002a, b). Some openly asked whether there were areas of research in the life sciences that should be prohibited and/or specific scientific information that should not be communicated; for example, the bioethicist Arthur Caplan is quoted as having said: “We have to get away from the ethos that knowledge is good, knowledge should be publicly available, that information will liberate us. Informa - tion will kill us in the techno-terrorist age, and I think it’s nuts to put that stuff on websites” (Lichtblau 2001). Such comments raised the inevitable debate as to whether scientific knowledge is value free and thus without bounds, or whether there is “dangerous research” that should not be done and “dangerous scientific information” that should not be freely commu - nicated.11 Indeed, the question arose as to whether the life sciences, with their fundamental presumption of openness, needed to be redefined and restructured because of potentially “forbidden knowledge” (Kempner 2005). 10 The letter to former Secretary of Defense Harold Brown stated: “The key to maintaining U.S. technological preeminence is to encourage open and collaborative basic research. The linkage between the free exchange of ideas and scientific innovation, prosperity, and U.S. national security is undeniable. This linkage is especially true as our armed forces depend less and less on internal research and development for the innovations they need to maintain the military superiority of the United States. In the context of broad-based review of our technology transfer controls that will begin this year, this Administration will review and update as appropriate the export control policies that affect basic research in the United States. In the interim, the policy on the transfer of scientific, technical, and engineering information set forth in NSDD-l89 shall remain in effect, and we will ensure that this policy is followed” (Rice 2001). 11 For further discussions see Salyers (2002), Vastag (2002), Zilinskas and Tucker (2002), and Petro (2007).

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 OVERVIEW Journal Editors and Authors group During the year following the anthrax attacks of 2001, the question of openness of scientific communication in the life sciences became a conten- tious topic. Some members of the scientific community viewed the pos - sibility that information might be withheld for national security purposes as self-censorship. Others considered such actions as responsible citizen - ship. The controversy escalated, perhaps because of the lack of guidance as to what should constitute “forbidden knowledge” and how potentially dangerous information should be constrained (Kempner 2005; Campbell 2006; Wimmer 2006; Selgelid 2007). In 2002 the American Society for Microbiology (ASM) requested that the National Academies consider whether national security concerns should result in a fundamental change in the communication of science, namely, whether critical details that could permit the misuse of knowl - edge in the life sciences should be withheld from open publications. The National Academies and the Center for Strategic and International Stud- ies (CSIS) convened a 1-day workshop in January 2003 to discuss issues regarding scientific publication and security.12 The challenge presented at the workshop was how to minimize the risk of bioterrorism without jeop- ardizing the ability to repeat experiments and validate scientific claims, which was too important to scientific advancement to fundamentally change the way scientific research is communicated (Atlas 2003). The following day, a group of scientists, journal editors, and secu- rity experts met and drafted a “Statement on Scientific Publication and Security,” the crux of which was that many of the leading journals in the life sciences would accept responsibility for screening manuscripts to reduce the risk of misuse of scientific information (see Box 1-1). The statement was simultaneously published in Science, Nature, the Proceed- ings of the National Academy of Sciences (PNAS), and by the ASM (Fox 2003; Journal Editors and Authors Group 2003a,b,c). The overarching principle accepted by the Journal Editors and Authors Group stated that: “there is information that, although we cannot now capture it with lists or definitions, presents enough risk of use by terrorists that it should not be published” (Journal Editors and Authors Group 2003c). The group indicated that if “the potential harm of publication outweighs the poten - tial societal benefits,” a manuscript may be rejected (Journal Editors and Authors Group 2003a,b,c). Of note, the statement by the Journal Editors and Authors Group says that publications are not the only place where science is communicated and that all scientists are responsible for moni - 12 See http://www7.nationalacademies.org/DSC/Scientific_Openness_Homepage.html.

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 DUAL USE RESEARCH IN THE LIFE SCIENCES BOX 1-1 Statement of Principles by Journal Editors and Authors Group First: The scientific information published in peer-reviewed research journals car- ries special status, and confers unique responsibilities on editors and authors. We must protect the integrity of the scientific process by publishing manuscripts of high quality, in sufficient detail to permit reproducibility. Without independent verification—a requirement for scientific progress—we can neither advance bio- medical research nor provide the knowledge base for building strong biodefense systems. Second: We recognize that the prospect of bioterrorism has raised legitimate concerns about the potential abuse of published information, but also recognize that research in the very same fields will be critical to society in meeting the chal- lenges of defense. We are committed to dealing responsibly and effectively with safety and security issues that may be raised by papers submitted for publication, and to increasing our capacity to identify such issues as they arise. Third: Scientists and their journals should consider the appropriate level and de- sign of processes to accomplish effective review of papers that raise such security issues. Journals in disciplines that have attracted numbers of such papers have already devised procedures that might be employed as models in considering process design. Some of us represent some of those journals; others among us are committed to the timely implementation of such processes, about which we will notify our readers and authors. Fourth: We recognize that on occasions an editor may conclude that the potential harm of publication outweighs the potential societal benefits. Under such circum- stances, the paper should be modified, or not be published. Scientific information is also communicated by other means: seminars, meetings, electronic posting, etc. Journals and scientific societies can play an important role in encouraging investigators to communicate results of research in ways that maximize public benefits and minimize risks of misuse. SOURCE: Journal Editors and Authors Group (2003a,b,c) and Fox (2003). toring their communication to maximize the benefits and minimize the risks of their research. Several journals adopted formal policies to consider dual use and the potential for misuse of the information in the manuscript during the review. Today, the Nature Publishing Group, PNAS, the ASM journals, and Science have policies in place on biosecurity. Though these policies are not uniform, they signify the concern regarding science and security among high-impact journals. At a session on ethics in publishing held at the 2008 AAAS meeting, Donald Kennedy suggested that security issues

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 OVERVIEW were likely to intrude upon the peer-review process in a way that leaves editors with little control (Timmer 2008). In practice, the authors of several contentious manuscripts reportedly considered the dual use and societal implications of their research before submitting their manuscripts for publication; several also have said that their research had been modified because of dual use concerns. Prior to the statements by the Journal Editors and Authors Group, Ron Jackson and his colleagues brought the potential dual use issues of their work on IL-4 insertion into mousepox virus to the attention of the Australian gov - ernment officials before going ahead with the publication (Cohen 2002; Federation of American Scientists 2008a). Following publication and the ensuing controversy, the research was terminated because of concerns about its dual use potential (Federation of American Scientists 2008a). Eckard Wimmer has said that the original version of the manuscript on the synthesis of poliovirus (Cello et al. 2002) included a section on social and security implications of the experiment, but that the space limitations in the journal forced the removal of that section prior to publication (Fed - eration of American Scientists 2008b; private communication from Eckard Wimmer to Kathleen Vogel). Prior to publication of his work on the syn- thesis of a bacteriophage (Smith et al. 2003), Craig Venter had discussions with government officials about the dual use implications of the research (Venter 2007). The authors were fully aware of the controversy that had occurred following publication of the Wimmer poliovirus synthesis paper and Venter has said he was prepared to modify the manuscript. A formal governmental review, however, did not find any reason to make modifica- tions because of dual use concerns. More recently, the synthesis of the 1918 influenza virus (Taubenberger et al. 2005; Tumpey et al. 2005) also received prepublication review for dual use concerns by government officials and by the NSABB (CDC 2005). The NSABB endorsed publication of the paper and did not request that any information be withheld. The board did request that a statement be added to the manuscripts stating that the work was important for pub - lic health and was conducted safely, and suggested that Science should include an editorial to support the case for the importance of the research (Kennedy 2005; Sharp 2005). The authors argued that there can be no absolute guarantee that the research information in the publication will not be misused: “We are aware that all technological advances could be misused. . . . But what we are trying to understand is what happened in nature and how to prevent another pandemic. In this case, nature is the bioterrorist” (Nature 2005). Finally, the publication of botulinum toxin as a threat to the milk supply (Wein and Liu 2005) was reviewed for dual use concerns prior to publication:

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0 DUAL USE RESEARCH IN THE LIFE SCIENCES The PNAS review considered both the above criteria and a more general sense that our publication of an article must not constitute a “roadmap for terrorists” by providing anyone who intends to do harm with key information that is otherwise difficult to obtain. . . . NAS and PNAS representatives met with government representatives to discuss their specific concerns about the Wein and Liu article on June 7. Following this meeting, the Council of the National Academy of Sciences decided to publish the article as originally accepted (after a standard round of final copyediting), accompanied by this editorial to make clear our reasons for doing so (Alberts 2005). Only in a few of these cases was there any discussion of modifications to the manuscripts to remove information of dual use concern. Deci- sions to provide accompanying editorials to explain and endorse the scientific importance of the research reflected the perceived need to make the strongest case possible for the value of such potentially controversial research.13 The Fink Committee Beyond the ad hoc actions by the Journal Editors and Authors Group and individual journals, a continuing need remained for broader consen - sus building within the life sciences community regarding issues of dual use research and the potential misuse of the life sciences for bioterrorism. In June 2001, the National Academies began planning a project that led to the formation of the Committee on Improving Research Standards and Practices to Prevent Destructive Application of Advanced Biotechnology. The committee, which began work in spring 2002, was charged with examining how to address the potential risks posed by dual use research in the United States. The committee addressed the critical question of how to define what is dangerous and how to design a system that could minimize that danger while allowing legitimate biomedical research to proceed. Released in October 2003, the committee’s report, Biotechnology Research in an Age of Terrorism (also known as the Fink report after the chair of the committee, Gerald Fink of Massachusetts Institute of Technol - ogy [MIT]), was published as a book a few months later (NRC 2004a). Box 1-2 contains a summary of the report’s major recommendations. 13 The only statistic available regarding changes in research communication in response to dual use research of concern is that, of the 16,000-plus manuscripts reviewed by the 11 jour- nals of ASM since it began screening manuscripts for dual use research, only 4 manuscripts have actually been modified in any way (these were published with minor modifications) and only 2 others were not published because the authors were unwilling to provide full methodological details, which the ASM regards as essential (Kaplan 2008).

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 OVERVIEW Using several published studies as examples of “contentious research” (Epstein 2001), the committee described the dual use dilemma, which it defined as occurring because the “same technologies can be used legitimately for human betterment and misused for bioterrorism” (NRC BOX 1-2 Key Recommendations: Biotechnology Research in an Age of Terrorism Recommendation: Educating the Scientific Community We recommend that national and international professional societies and related organizations and institutions create programs to educate scientists about the nature of the dual use dilemma in biotechnology and their responsibilities to miti- gate its risks. Recommendation: Review at the Publication Stage We recommend relying on self-governance by scientists and scientific journals to review publications for their potential national security risks. Recommendation: Harmonized International Oversight We recommend that the international policymaking and scientific communities create an International Forum on Biosecurity to develop and promote harmonized national, regional, and international measures that will provide a counterpart to the system we recommend for the United States. Recommendation: Review of Plans for Experiments We recommend that the Department of Health and Human Services (DHHS) augment the already established system for review of experiments involving re- combinant DNA conducted by the National Institutes of Health to create a review system for seven classes of experiments (the Experiments of Concern) involving microbial agents that raise concerns about their potential for misuse. Recommendation: Creation of a National Science Advisory Board for Bio- defense We recommend that the Department of Health and Human Services create a National Science Advisory Board for Biodefense (NSABB) to provide advice, guid- ance, and leadership for the system of review and oversight we are proposing. Recommendation: Additional Elements for Protection Against Misuse We recommend that the federal government rely on the implementation of cur- rent legislation and regulation, with periodic review by the NSABB, to provide protection of biological materials and supervision of personnel working with these materials. Recommendation: A Role for the Life Sciences in Efforts to Prevent Bioter- rorism and Biowarfare We recommend that the national security and law enforcement communities de- velop new channels of sustained communication with the life sciences community about how to mitigate the risks of bioterrorism. SOURCE: National Research Council (2004a).

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 DUAL USE RESEARCH IN THE LIFE SCIENCES ons. The first legislation that included provisions dealing directly with possession of biological agents that were highly dangerous was the Anti - terrorism and Effective Death Penalty Act of 1996 (P.L. 104-132, April 24, 1996), which was enacted after a U.S. scientist attempted to obtain plague- causing bacteria for potentially nefarious purposes (Gronvall 2008). The act established the “select agent” program to control the transfer of certain biological agents that were considered especially dangerous.32 The pro- gram was created to prevent bioterrorism and protect public safety while not unduly hindering research using select agents. After the anthrax attacks of 2001, the United States sought to estab- lish a rigorous formal oversight system to decide who could possess microorganisms and toxins that could be used as weapons. Appropriately defined, such a system would ensure that pathogens and toxins would be available to legitimate researchers and denied to those who should not possess dangerous agents. The aim of material control efforts for the life sciences soon focused on ways to ensure that any individual given access to select agents was trustworthy and that these agents would be secure within each facility that housed dangerous pathogens and toxins. 33 The USA PATRIOT Act of 2001 (P.L. 107–56, October 26, 2001) estab- lished restrictions on the possession of select agents by aliens from coun- tries designated as supporting terrorism and for other individuals who were deemed unsafe for specific objective reasons, such as those ineligible to purchase handguns. The act also made it an offense for a person to knowingly possess any biological agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justi- fied by prophylactic, protective, bona fide research or other peaceful pur- pose. The provisions of the Patriot Act were subsequently augmented by the Public Health Security and Bioterrorism Preparedness and Response Act, known as the Bioterrorism Preparedness Act of 2002 (P.L. 107–188, 32 Since its inception the select agent program has been modified to include oversight of possession as well as transfer of certain agents; the list of agents that might be used as bio - logical weapons to attack humans has also increased, and potential agricultural biothreat agents have been added. More information on the program can be found at http://www. cdc.gov/od/sap/. 33 In 2008, after the FBI identified a researcher at the USAMRIID as the perpetrator of the 2001 anthrax attacks, the issue of whom to trust and how to ensure the reliability of those with access to dangerous pathogens again gained special attention. The NSABB was charged with developing a system for determining the reliability of researchers with access to potentially dangerous pathogens and toxins. The U.S. Congress, following a report by the Commission on the Prevention of WMD Proliferation and Terrorism (2008), also began to consider taking action to enhance the protection of biological agents against acquisition by terrorists; see, for example, the hearings of the U.S. Senate Homeland and Government Affairs Committee at http://hsgac.senate.gov/public/index.cfm?Fuseaction=Hearings. Detail&HearingID=d0d0b4c1-d1d1-4b7a-9c16-fd9af22d97e0.

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 OVERVIEW June 12, 2002). This act added requirements for regulations governing possession of select agents, including approval for laboratory personnel by the attorney general following a background check by the FBI. 34 While some scientists have expressed concern about the impact of the select agent regulations on the advancement of science, others have worried that additional oversight is needed. On January 9, 2009, President George W. Bush issued an executive order, Strengthening Laboratory Biosecurity in the United States, that established a process for new government oversight to further “the policy of the United States that facilities that possess bio - logical select agents and toxins have appropriate security and personnel assurance practices to protect against theft, misuse, or diversion to unlaw- ful activity of such agents and toxins” (White House 2009). In addition to the United States, Great Britain and some other nations have also taken the approach of legally restricting who can have access to the microorganisms and toxins thought to have the highest risk of use for bioterrorism and have established regulations for the possession of these agents. In the United Kingdom, the Anti–Terrorism, Crime and Security Act of 2001 strengthened controls on access to pathogens and toxins used in research laboratories. All UK facilities handling pathogens and toxins in hazard group 2, 3, or 4 must be registered, and strict control of hazard group 3 and 4 organisms is in place.35 In Germany, the Act on the Reform of the Communicable Diseases Law (Communicable Diseases Law Reform Act) contains provisions that limit the distribution of pathogens to authorized individuals. Although the purpose of this act is to prevent the spread of communicable diseases in human beings by early detection of infections, the provisions that restrict the distribution of human pathogens are intended to contribute to the deterrence of bioterrorism.36 Policies implemented in the United States after September 11 have significantly increased the level of scrutiny and the time involved in the 34 Clinical laboratories were granted a special exemption to permit them to legally isolate and identify (and thereby possess) select agents cultured from patients as part of the medical diagnostic process, even if they were not registered to possess select agents. This is critical for medical diagnoses where there is no way to predict what disease a patient might have, thereby precluding the ability to register for specific select agents. The clinical laboratories, however, are required to destroy any select agents or transfer them to a registered laboratory that is permitted to possess that select agent within a few days, and they must also notify public health authorities whenever a select agent has been isolated and identified. 35 The approved list of biological agents established by an Advisory Committee on Danger- ous Pathogens is available at http://www.hse.gov.uk/pubns/misc208.pdf. The categories are similar to the biosafety levels for laboratories in the United States, but the lists of agents within the categories are different. 36Available at http://www.unog.ch/80256EDD006B8954/(httpAssets)/E0C6A0305240 C953C12574AA0044D41B/$file/BWC_MSP_2008_MX-Statement-Germany-080818-PM.pd f.

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 DUAL USE RESEARCH IN THE LIFE SCIENCES process of obtaining a visa for a short or extended stay and increased the tracking of students and scholars once they arrive on U.S. shores. 37 Although there are differing views within the scientific community regarding the consequences of the select agent regulations, several in the scientific community consider that increased restrictions on foreign students and scholars through measures such as more stringent visas pose a far greater threat to the conduct of life sciences research.38 As the presidents of the National Academies have stated: “Our visa processing system not only must provide genuine security against those who might do us harm, but also keep our borders open to the stream of scientific and technical talent that fuels our progress . . . the U.S. scientific, engineering, and health communities cannot hope to maintain their present position of international leadership if they become isolated from the rest of the world” (Alberts et al. 2002).39 As noted earlier, in addition to limiting visas, the restrictions in place under the Patriot and Bioterrorism Pre- paredness acts prohibit any national of a country currently designated by the Department of State as a state sponsor of terrorism from having access to select agents. Oversight of Research A more contentious issue than control of pathogens and toxins is whether there should be oversight of life science research and communi - cation, and if so, what kind. The BWC does not include measures to limit research, although its intersessional processes and confidence-building measures do collect information about national activities and address how continuing advances in research affect the implementation and operation of the treaty. This brief review highlights some of the major proposals from government and private sources but does not attempt to do justice to the range and variety of ideas for addressing dual use research. The Controlling Dangerous Pathogens Project of the Center for Inter- national and Security Studies at Maryland has developed a proposal for 37 The National Academies created a special International Visitors Office to provide a re - source on visa policy and to collect data on cases involving delays or difficulties experienced by students or visiting scientists. For further information see http://www7.nationalacad- emies.org/visas/. 38 In addition to visa issues, the issue of the impact of export controls on scientific research through restrictions on the transfer of dual use equipment and materials has drawn sub - stantial attention from the scientific community. These problems are dealt with in another NRC report, Beyond Fortress America: National Security Controls on Science and Technology in A Globalized World (NRC 2009). 39 See NRC (2006b) for a discussion of this issue focused on international graduate students.

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 OVERVIEW the oversight of research in the life sciences that involves enhancing the responsibilities of institutional biosafety committees (IBCs) to include review of biosecurity implications of research activities (Steinbruner et al. 2007). This review would be complemented by regional IBCs and interna- tional IBCs. The project has also developed an electronic questionnaire for these entities to help them evaluate research activities for their dual use potential. A consequence of the proposal would be that the performance and communication of specific life sciences research falling within a nar- row set of parameters could be prevented at a series of review stages, including potential review by a new international organization. Van Aken (2006) has also called for internationally harmonized and legally binding rules for conducting dual use research, in order to prevent the misuse of biological knowledge. Under the scientific self-governance approach, the Center for Biosecu- rity of the University of Pittsburgh Medical Center supports responsible stewardship and self-governance by life scientists without mandated governmental restrictions (Kwik et al. 2003). The basic tenets of this perspective are that scientists should be involved in determining which experiments are dangerous and made aware of the potential misuse of biotechnology; security measures should be thoughtfully developed and integrated into the existing research culture; biosecurity awareness and measures should begin with scientists rather than be prescribed by governments; periodic evaluation and improvement of biosecurity mea- sures should occur; and through collaborations, the norms and ethical standards to prevent misuse of biotechnology should be established and propagated globally. The Fink committee also supported a self-governance approach for protecting scientific knowledge from misuse. However, as already men- tioned, it supported an advisory role for the federal government in pro- viding guidelines along the model of RAC administered by the NIH. Although formal federal regulations or guidelines have yet to be devised, the IBCs of three of the six member institutions in the Southeast Regional Center of Excellence for Emerging Infections and Biodefense (SERCEB) have assumed responsibility for dual use review (Davidson et al. 2007). Providing federal government guidelines and then relying upon self- governance by research institutions is the key to the proposed NSABB oversight system. As mentioned earlier, in June 2007 the NSABB released its Proposed Framework for the Oersight of Dual Use Life Sciences Research, which it hopes will lead to common oversight standards across all federal agencies funding such research (NSABB 2007). Under the proposed sys - tem, each principal investigator would make an initial assessment of the potential for misuse, and IBCs would expand the scope of their current reviews to include a biosecurity evaluation. The proposed framework

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 DUAL USE RESEARCH IN THE LIFE SCIENCES is currently undergoing an interagency review.40 Some have expressed concerns that this may result in mandated actions, including: training for all life scientists receiving federal funds, signing of codes of conduct (equivalent to taking an oath), and reporting of suspicions about others’ research activities. In particular, concern has been expressed about what actions will be required once awareness of dual use issues increases (Steb- bins 2008). One area of life sciences research that has attracted particular atten- tion regarding potential oversight is synthetic biology. This growing field combines elements of biological science, chemistry, and engineering into a highly interdisciplinary area of research. Synthetic biology has the poten - tial for construction of bioengineered microorganisms that can mass- produce drugs to treat disease, detect and break down toxic chemicals to reverse polluted sediments and water, and generate new energy forms to help solve the energy crisis. There also is substantial concern, however, regarding the potential for the creation of dual use products, either inten- tionally or unintentionally, that could function as biological weapons in the hands of terrorists. The NSABB has proposed greater oversight of syn- thetic biology (NSABB 2006). In addition, several groups have proposed governance strategies for preventing misuse of synthetic biology that combine government oversight and self-governance. In the United States this includes a collaboration among the Venter Institute, CSIS, and a sci- entist at MIT (Garfinkel et al. 2007a,b), as well as a group in the Goldman School of Public Policy at the University of California, Berkeley (Maurer et al. 2006). Internationally, the International Consortium for Polynucleotide Synthesis (Bügl et al. 2006) and the Industry Association for Synthetic Biology (Bernauer et al. 2008) have also made proposals. LIFE SCIENTISTS’ ATTITuDES AND AWARENESS OF DuAL uSE ISSuES Since responsible conduct is considered key to the success of self- governance measures to protect against the misuse of the life sciences, there is concern that life scientists are insufficiently aware of and engaged in discussions about biosecurity and dual use issues. Most life scientists have little experience with the issues of biological weapons. Without conscious personal effort or systematic education, very few life scientists working today in the United States or overseas would have reason to know of past offensive weapons programs. Between the end of the U.S. 40 Thestatus of the NSABB oversight document in the U.S. federal agency review process was discussed at the December 10, 2008, NSABB meeting. The archived Webcast can be viewed at http://oba.od.nih.gov/biosecurity/nsabb_past_meetings.html#dec2008.

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 OVERVIEW biological weapons program in 1969 and the anthrax mailings in October 2001, few biologists had connections to the national security branches of government.41 This has left the life sciences community poorly prepared to interact with the security community and divided about whether dual use issues are really of serious concern. Many studies and conferences on biosecurity thus end with recommendations for greater awareness raising and education in the life sciences community.42 The report of the Commis- sion on the Prevention of WMD Proliferation and Terrorism, released in 2008, gave the scientific community this ominous warning: The choice is stark. The life sciences community can wait until a cata - strophic biological attack occurs before it steps up to its security respon - sibilities. Or it can act proactively in its own enlightened self interest, aware that the reaction of the political system to a major bioterrorist event would likely be extreme and even draconian, resulting in signifi- cant harm to the scientific enterprise (Commission on the Prevention of WMD Proliferation and Terrorism 2008:26). Many of the major U.S. scientific organizations and professional soci - eties, however, including the National Academies, delayed undertaking significant education and awareness-raising initiatives until the U.S. gov - ernment clearly defined its policies. In the interim, a number of universi - ties and organizations, such as the NIH-supported Regional Centers for Excellence, the Federation of American Scientists (FAS), and AAAS have undertaken educational activities.43 41 In this regard, the life sciences community differs markedly from the physics and engi - neering communities, which have been continuously aware of security concerns associated with government-sponsored weapons research programs since at least World War II. The closest analogy in the life sciences is development and advancement of recombinant DNA technology. Other examples of social considerations to the life sciences include human sub - jects research (e.g., the Tuskegee syphilis experiments) and the welfare of research animals. Although the United States had a biological weapons program between 1943 and 1969, it has not used biological weapons in times of war. At the time of the Asilomar conference (1975) and the development of the BWC (1972), there was extensive discussion about the harmful uses of recombinant DNA, but the concerns of biotechnology and offensive biologi- cal weapons programs did not propagate that interest or awareness of science policy to the broader life sciences community. 42 See, for example, NRC (2004a,b, 2006a), and the discussions at the 2008 BWC meet - ings of experts and states parties (http://www.unog.ch/80256EE600585943/(httpPages)/ 92CFF2CB73D4806DC12572BC00319612?OpenDocument). 43 FAS Case Studies in Dual use Biological Research illustrate the dual use potential of actual life science research via interviews with the lead researchers. The case studies provide a historical background on bioterrorism, bioweapons, and the current laws, regulations, and treaties that apply to biodefense research. They include interviews with researchers as well as the primary scientific research papers and discussion questions meant to raise awareness about the importance of responsible biological research. The case studies are available at

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 DUAL USE RESEARCH IN THE LIFE SCIENCES In September 2005, the National Academies and AAAS cohosted a workshop, “Education and Raising Awareness: Challenges for Respon- sible Stewardship of Dual Use Research in the Life Sciences,” that brought together over 50 participants to share information and explore ways to engage and educate the life science research community most effectively.44 The workshop addressed (1) opportunities for outreach presented by the BWC, NSABB, and others interested in biosecurity education; (2) challenges and opportunities in framing the discourse on biosecurity as well as differences in those factors created by multiple stakeholders and audiences; (3) case studies of outreach; and (4) the roles of codes of ethics, conduct, and practices in raising awareness.45 Although the workshop did not produce formal recommendations, one theme that emerged from the discussions was the need to move beyond anecdotal evidence to empirical information about perceptions and attitudes among life scientists that could provide a basis for creating programs and assessing their impact. Remarkably few data are available today. There have been numerous surveys of scientists on other topics related to professional responsibility, such as ethics, responsible conduct, and financial conflicts of interest.46 Several small-scale studies using inter- views or surveys with practicing scientists in the United States and the http://www.fas.org/programs/ssp/bio/educationportal.html. The SERCEB Policy, Ethics and Law Core has developed an online module to assist those involved with the biologi - cal sciences to better understand the dual use dilemma of some life science research. This module is intended for graduate students and postdoctoral fellows, faculty members, and laboratory technicians involved in biological research in microbiology, molecular genetics, immunology, pathology, and other fields related to emerging infectious diseases and bio - defense. The module consists of an approximately 20-minute online presentation followed by a brief assessment. The recently updated module is available at http://www.serceb. org/modules/serceb_cores/index.php?id=3. It has been used by over 600 people. AAAS held a workshop in November 2008 to document and discuss existing education programs on dual use research and to highlight challenges and provide recommendations for develop - ment and implementation of other educational programs on dual use research. A summary of the workshop is available at http://cstsp.aaas.org/files/AAAS_workshop_report_educa- tion_of_dual_use_life_science_research.pdf. 44 The participants included staff from several U.S. government agencies, representatives of nongovernmental organizations such as the ASM, the FAS, and the Royal Society, as well as university professors from the United States and Britain. 45 For details, see http://www7.nationalacademies.org/dsc/Biosecurity_Workshop.html. 46 See, for example, Blumenthal et al. (1996a,b, 1997, 2006); Eastwood et al. (1996); Wenger et al. (1997, 1999); Korenman et al. 1998; Rabino (1998, 2003a,b); Berk et al. (2000); McCrary et al. (2000); MORI (2000); Price et al. (2001); Campbell et al. (2002); Martinson et al. (2005, 2006); Union of Concerned Scientists (2005a,b, 2006, 2008); De Vries et al. (2006); Hansen et al. (2006); Royal Society/Research Councils UK/The Wellcome Trust 2006; and Vogeli et al. (2006).

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 OVERVIEW United Kingdom, including those in biodefense research in the U.S. case, offer perspectives on dual use research.47 Seminars and discussions conducted by Brian Rappert and Malcolm Dando provide insights about the views of some 2,500 scientists in 13 countries. A series of about 100 information exchange seminars have served as focus groups to gauge awareness of dual use issues, ascertain attitudes about potential oversight mechanisms, and raise awareness of the potential misuse of the life sciences for bioweapons development. As a result, Rappert and Dando have compiled substantial qualitative infor- mation. They report that their 26 seminars in the United Kingdom “found little evidence that [scientists] regarded bioterrorism or bioweapons as a substantial threat; considered that developments in the life sciences research contributed to biothreats; were aware of the current debates and concerns about dual use research; or were familiar with the BTWC”; similar results were found in the 28 seminars they conducted in Finland, South Africa, and the Netherlands, although not completely in the United States (Rappert 2008).48 With regard to measures to address the potential risk of dual use research, Rappert and Dando reported that they encountered overwhelm- ing skepticism about the value of publication restraint, but there was a sense that some contentious experiments perhaps should not have been openly reported. For instance, they found support for doing the IL-4 mousepox research and communicating the results; to whom the results were communicated was a topic of contention, however. They also stated that only a small percentage of scientists indicated knowledge of the IL-4 study. Although some saw value in community involvement in dem- onstrating responsibility, there was general skepticism of the oversight approach proposed by the Fink committee. Doubts were also expressed about the feasibility of pre-project review and oversight systems for dual use research (Rappert 2007). All of these studies provide useful information and insights. How - ever, there is no example of a large-scale, representative survey of prac - ticing life scientists regarding their views on biosecurity and how they would allocate responsibility for biosecurity activities such as education, training, and oversight among individuals and institutions. The need for a baseline survey to address these questions at this time was underscored 47 See, for example, Corneliussen (2005), McLeish and Nightingale (2005), Fischer (2006), Lentzos (2006), Sutton (2007, 2009), and U.S. Government (2008). 48 “A significant difference between the U.S. seminars and those elsewhere was the greater knowledge about biosecurity discussions in general, potential misuse policy initiatives, and related BW issues. This is perhaps not surprising because of the heightened attention to po - tential misuse issues in the US and because nearly all the organizations visited had a direct stake in that they were receiving biodefence research funding” (Rappert et al. 2006).

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0 DUAL USE RESEARCH IN THE LIFE SCIENCES by the release in 2007 of the NSABB’s draft oversight framework for all federally funded life sciences research and its plans for education and outreach activities (NSABB 2007). THE AAAS-NRC PROJECT Building on the results of their 2005 planning meeting, the AAAS Center for Science, Technology, and Security Policy (CSTSP)49 and two program units within the National Research Council50 developed a plan to survey a sample of the AAAS membership in the life sciences about their knowledge of dual use issues and attitudes toward their responsibilities to help mitigate the risks of misuse. In addition to providing essential baseline data, it was hoped that the results of the survey would generate more attention to the continuing challenges of dual use issues and addi- tional debate among life scientists about their personal and professional responsibilities. Concerns about potential misuse of dual use research relate to questions of whether advanced research could facilitate biologi - cal weapons development by states and nonstate actors. The introductory material in this chapter has covered both issues. The survey, however, focused on bioterrorism by nonstate actors because that is the concern that has driven so many of the policy discussions of dual use research in the United States since September 11. The survey project occurred in three phases: Phase 1: • Define the issues to be addressed and identify the critical populations to be surveyed by a questionnaire that will assess the attitudes and val - ues of a statistically valid sample of life scientists relevant to the design of biosecurity education programs; and 49 CSTSP is a nonpartisan, nonadvocacy organization supported by the John D. and Cath - erine T. MacArthur Foundation’s Science, Technology and Security Initiative. CSTSP serves as a two-way portal between scientists studying matters related to national and interna - tional security and the Washington policy community, especially the Congress, the execu - tive branch agencies, and Washington-based nongovernmental organizations. The center’s goal is to bring to the Washington policy community objective, high-quality, scientific and technical information related to security issues. For additional information see http://cstsp. aaas.org. 50 NRC is part of the National Academies, which also include the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. Created in 1916, NRC has become the principal operating agency of both the National Academy of Sci - ences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The program units involved in this project were the Board on Life Sciences and the Program on Development, Security, and Cooperation.

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 OVERVIEW • Devise a preliminary questionnaire to be used in the survey. Phase 2: • Work with a professional firm to conduct focus groups to explore the attitudes and values of selected groups of scientists and also provide a pretest of the questionnaire; • Implement the survey in partnership with AAAS; and • Review the results of the survey and prepare a report of the initial findings. Phase 3: • Based on the analysis of the findings of the survey, recommend ap - proaches for engaging members of the life sciences community on bios - ecurity issues. NRC appointed a committee to provide oversight for the Academies’ participation in the project. The biographies of the committee members can be found in Appendix A. Kavita Marfatia Berger, Project Director at the AAAS CSTSP, served as a consultant to the committee and actively participated in the development and implementation of the survey and preparation of the final report. Because funding came in increments to support particular phases of the project, however, the committee was not formally appointed until after the focus groups were completed and decisions had been made about the survey instrument, the survey design and whom to survey without input from the committee. The committee oversaw the analysis of the survey results and the preparation of the final report. To ensure the privacy of the AAAS members who were sampled, while also permitting follow-ups to encourage a higher response rate, the AAAS Office of Member Services administered the questionnaire. The NRC assumed responsibility for the review of the final report. This was a genuine partnership between the two organizations. This chapter has provided an introduction to the issues surrounding dual use research and the rationale for undertaking the survey. The next chapter describes the survey methodology and provides details about the sample and the demographic characteristics of the respondents. Chapter 3 describes the results of the survey and Chapter 4 provides the committee’s conclusions and recommendations.

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