NSABB: Function, Structure, Administration
The NSABB is currently tasked with:
- Recommending strategies and guidance for enhancing the culture of responsibility among individuals with access to biological select agents and toxins;
- Providing recommendations on outreach, education and training in dual use research issues for scientists, laboratory workers, students and trainees in relevant disciplines;
- Advising on polices governing publication, public communication, and dissemination of dual use research methodologies and results;
- Recommending strategies for fostering international engagement on dual use life science research issues;
- Advising on strategies for fostering the development, utilization and promotion of codes of conduct to interdisciplinary life scientists and relevant professional groups;
- Advising on policies regarding the conduct, communication, and oversight of dual use research and research results as requested;
- Advising on the Federal Select Agent Program, as requested; and
- Addressing any other issues as directed by the Secretary of HHS
The Board includes nonvoting ex officio members from relevant Federal departments and agencies that have an interest in life sciences research. These include:
- Executive Office of the President
- Department of Health and Human Services
- Department of Energy
- Department of Homeland Security
- Department of Veterans Affairs
- Department of Defense
- Department of the Interior
- Environmental Protection Agency
- Department of Agriculture
- National Science Foundation
- Department of Justice
- Department of State
- Department of Commerce
- National Aeronautics and Space Administration
- Intelligence Community
- Others as appropriate
The NSABB has submitted a series of reports advising the United States Government (USG) on dual use research:
- Criteria for identifying dual use research and guidance for the responsible oversight, conduct and communication of dual use research (i.e. Oversight Framework)
- Biosecurity concerns related to the synthesis of select agents
- A strategic plan for outreach and education on dual use research issues
- Strategies for enhancing personnel reliability among individuals with access to select agents
- Biosecurity concerns related to synthetic biology
In addition the NSABB has hosted a series of international meetings on dual use research, with the aim of raising awareness of the dual use research issues, and to facilitate international engagement and information sharing on strategies for managing risk(s) posed by dual use life science research.
Dual Use Research and Biosecurity Policy
At this time, the mandated roles and responsibilities of IBCs have not changed to include review of dual use research of concern. IBCs should continue to carry out the duties outlined in the NIH Guidelines for Research Involving Recombinant DNA Molecules and any others as determined by their institutions.
The IBC community will be notified directly of any future changes in Federal policies, guideline and/or requirements. Also, any relevant developments will be posted on the IBC section of this website.. This will also include opportunities for public input on proposed Federal policies, guidelines, and/or requirements.
When the USG receives recommendations from the NSABB, it convenes relevant Federal agencies to analyze the findings and recommendations and to identify options for considering the recommendations. The internal deliberative process may utilize existing forums such as an Interagency Policy Committee of the National Security Council or a committee/subcommittee of the National Science and Technology Council within the Office of Science and Technology Policy. Once options for addressing the recommendations are identified, policy actions are decided upon and the relevant Federal agencies are tasked with implementing those policy actions. Examples of policy actions in response to NSABB recommendations include the development of screening guidance for providers of synthetic double-stranded DNA; clarification of language in the Select Agent Rules regarding their applicability to synthetic genomics; a legal interpretation of the applicability of 18 USC 175c to research involving orthopoxviruses; revision of the NIH Guidelines for Research Involving Recombinant DNA Molecules to more explicitly address synthetic nucleic acids; and convening a panel of the National Academies to address scientific milestones needed before a predictive oversight system could be contemplated for select agents and toxins.
The Administration recognizes the immensely beneficial nature of life sciences research, and its critical role in enabling the development of new therapeutics, vaccines, and technologies that promote public health and well-being. A robust life sciences research enterprise is also important for agricultural and energy production, environmental protection, and a thriving economy.
At the same time, the Administration is mindful that scientific information or technologies can be misused to harm people, animals, or plants, or otherwise threaten national security. To address this challenge, President Obama's National Strategy for Countering Biological Threats emphasizes the need to (1) improve global access to the life sciences to combat infectious disease regardless of its cause; (2) establish and reinforce norms against the misuse of the life sciences; and (3) institute a suite of coordinated activities that collectively will help influence, identify, inhibit, and/or interdict those who seek to misuse the life sciences.
With regard to dual use life sciences research, the Strategy highlights the importance of efforts that reduce the potential for the exploitation of legitimate life sciences research by (1) managing the risk of misuse of dual use information of concern, (2) optimizing security of known virulent high-risk pathogens and toxins, and (3) addressing potential risks presented by emerging technologies. The Strategy also states that "life scientists are best positioned to develop, document, and reinforce norms regarding the beneficial intent of their contribution to the global community as well as those activities that are fundamentally intolerable." To this end, the NSABB views efforts to reinforce norms of safe and responsible conduct by supporting the culture of responsibility in the life sciences as essential and fundamental elements of a balanced approach to risk management in the life sciences.
Select Agent research is a very specific subset of life sciences research; it involves only those microorganisms and toxins specifically identified in DHHS and USDA regulations as having the potential to pose a severe threat to human, animal, or plant health, or to animal and plant products (for further information see 42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121).
Dual use research is a concept that relates to a broad category of life sciences research. Certain research projects that do or do not involve Select Agents may be considered dual use research depending on the nature of the particular experiments and the potential for misuse of the results and/or technology. Within this smaller category there will be some projects that may be considered dual use research of concern. This latter category is the focus of the NSABB's recommendations to the Federal government.
The oversight system for dual use research is likely to be complementary to that of Select Agents in that it will be based on principles and practices for reducing the likelihood that biological organisms, knowledge, and technologies are intentionally misused to pose a risk to public health and national security.
Dual Use Research and Dual Use Research of Concern
Life sciences research is vital to improving public health, agriculture, and the environment, and to strengthening our national security and economy. Yet the very research designed to find ways to better the health, welfare and safety of mankind can also yield information or technologies that could potentially be misused for harmful purposes. For instance, information from certain life sciences research can be misapplied to create dangerous pathogens for employment as weapons, bypass or diminish the effectiveness of medical countermeasures, or threaten in other ways the health and safety of humans, animals, plants, and the environment. Research yielding new technologies or information with the potential for both benevolent and malevolent applications is referred to as "dual use research."
Some degree of dual use potential may be inherent in a significant portion of life sciences research. However, the small subset of life sciences research with the highest potential for yielding knowledge, products, or technology that could be misapplied to threaten public health or national security is referred to as "dual use research of concern."
The National Science Advisory Board for Biosecurity (NSABB) has defined dual use research of concern as research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment or materiel.