Since 2001, there has been a flurry of activity in the United States and international community regarding oversight of dual use life sciences research. Dual use research is defined as beneficial research that may be directly misapplied for malicious purposes. The National Science Advisory Board for Biosecurity was established in 2004 to develop recommendations to the federal government for oversight and education of dual use research in the United States. The 2008 Biological Weapons Convention Meetings of Experts and State Parties addressed oversight, awareness and education of dual use research and codes of conduct to prevent misuse of advancing biotechnologies.
The United Kingdom has recently started asking researchers seeking grants if they have considered the dual use implications of their research. The InterAcademy Panel issued a statement providing principles for codes of conduct. Researchers at the Australian National University have advocated mandatory education and training for scientists about the dual use dilemma. The Israeli government recently passed a law regarding dual use life sciences research.
Most recently, the report of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, entitled World at Risk, calls for mandatory education of life scientists about dual use research and biosafety.
Workforce Development: Preparing the Next Generation against Infectious Disease Threats (2009)
The importance of a robust public health infrastructure is the cornerstone for preparing for and responding to infectious disease threats regardless of their origin (natural or man-made). During the past 10 years, several infectious disease outbreaks have shaped current policy developments surrounding public health preparedness. While all but one disease outbreak- the 2001 anthrax attacks in the United States – emerged naturally or accidentally in the human population, their impact on domestic and international public health has been profound.
Within the U.S., there has been increased funding to boost scientific, public health, and first response capabilities against a disease outbreak from chemical, biological, radiological, and nuclear agents. High-risk municipalities have been given financial support to improve their public health and traditional first response systems as well as disease surveillance capabilities. States have been given vehicles to stockpile vaccines and drugs against threat agents, and state agencies play important roles in confirming and mitigating infectious disease outbreaks. Policy discussions have gone beyond traditional first responders and public health professionals to scientists, veterinarians, and community leaders.
Biological Safety Training as a Component of Personnel Reliability (2009)
The revelation in 2007 of an initially unreported incident from 2006 at Texas A&M University, in which a laboratory researcher was accidentally infected with Brucella, a pathogen that infects both humans and animals, and which was formerly weaponized by the Soviet Union, spurred a series of inquiries by Congress and the Executive Branch. Their focus was on the safety regulations and physical security of high-containment laboratories working on select agents (pathogens and toxins itemized by the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) that pose significant risks to human, animal, and/or plant health organizations (42 CFR 73)). By February 2009, 336 entities were registered with the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) to work with select agents, and 14,612 laboratory researchers and support staff were registered to work with these agents. Along with the expansion of biodefense research on select agents and high-containment laboratories to accommodate that research came increased concern about pathogen security and laboratory safety. To address this concern, HHS established the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight to consider oversight of research conducted in high-containment laboratories, including but not limited to certification and training of scientists and appropriate non-scientists on biosafety.
Building the Biodefense Policy Workforce (2009)
Following 9/11 and the anthrax letters in 2001, the field of biodefense significantly expanded to address global health, public health preparedness and response, medical countermeasure development, and civilian biological research, some of which includes select agents. The increasing investment in biodefense and concern about a bioterrorism attack within the United States and abroad suggests that the landscape for biodefense policy issues and workforce needs continue to evolve. During the past year alone, concerns about oversight of high-containment laboratories; vetting of personnel (personnel reliability); the efficacy of security measures in place for the select agent program; medical countermeasure research, development and distribution; bioterrorism and pandemic influenza preparedness; misuse of beneficial biological research and technologies; and microbial forensics have generated several policy evaluations and prompted the development of policy recommendations and legislation. Both governmental and non-governmental experts were, and continue to be, influential during this policy process. Although there exist several biodefense education and training programs as well as fellowships, there is still a critical need to educate the next generation of policy experts and scientists about these issues and encourage their involvement in the development of biodefense policies.
Professional and Graduate-Level Programs on Dual Use Research and Biosecurity for Scientists Working in the Biological Sciences (2008)
Two units of AAAS—the Center for Science, Technology and Security Policy and the Program on Scientific Freedom, Responsibility and Law—have conducted a study of existing education programs for scientists that address dual use research and/or biosecurity. The goals of this study were:
- to document and describe existing educational programs and materials on biosecurity and dual use research for scientists (information provided by course instructors);
- to provide recommendations for developing an educational program on dual use research; and
- to highlight major challenges in developing and implementing educational initiatives on biosecurity-related issues.
With the help of the Association of American Universities and university professors and administrators, we identified fourteen programs that specifically dealt with educating graduate or professional students in the biomedical sciences on dual use research issues. We convened a group of experts in responsible conduct of research, bioethics, the life sciences, and biosecurity on November 21, 2008 at AAAS to review these educational programs and provide recommendations on how best to design and implement similar programs. The existing programs discussed at this workshop educate graduate students working in the biological sciences about dual use research within the context of responsible conduct of research.
In this workshop report, “scientists” refer to undergraduate and graduate students, laboratory technicians, post-doctoral fellows, and principal investigators in the life sciences, chemistry, physics, engineering, medicine, veterinary medicine, nursing, and public health who conduct biological research. This workshop is one of four workshops on biosecurity education; the other three workshops will address biosafety, bioterrorism preparedness and biodefense policy.
At the AAAS workshop, participants discussed the benefits and challenges of educating graduate and professional students on dual use research via a range of educational methods and contexts. There was clear consensus at the workshop that students learn best by active learning methods Ã‚â€“ including real-life simulations, case studies using real examples, small group discussions, and mentorship; that all scientists have a responsibility to consider the societal consequences of their research; and that funding is needed to develop and implement programs to educate scientists about the dual use dilemma.
Several tools (internet-based case studies or modules), methods for teaching (case studies, simulations, and small group discussions) and educational contexts (biosafety programs, mentorship, and responsible conduct of research) currently exist for educating students about dual use research. Topics to cover in education programs range from a focus on the dual use dilemma to a broad array of information regarding biological weapons, biosecurity, bioethics, and dual use issues. Participants did not agree on a preferred method for teaching, but instead supported the idea that these programs should be flexible and allow institutions to tailor their program to best suit their researchers.
Workshop participants highlighted several major gaps and challenges:
- Lack of funding and time for development and implementation of education programs;
- Low levels of interest and knowledge of the dual use dilemma by senior scientists (the educators) and institutional leaders;
- Defining appropriate metrics for the impact of education programs on behavior;
- Shortage of case studies tailored to specific disciplines, such as bioengineering and nanotechnology, and to audiences including non-scientists, such as administrators and the public;
- Lack of educational tools to help scientists develop the skills needed to assess the risks and benefits of their research;
- Absence of data about how much and by whom dual use research is being conducted, and the nature of any ongoing contentious research; and
- Need to identify the target audiences and best approaches to educate them
These gaps in knowledge and challenges should be considered when undertaking the development of educational programs about biosecurity and the dual use dilemma for scientists.
Specific Recommendations can be viewed in the workshop report.