RS–IAP-ICSU, September 2006 NSABB National Science Advisory Board on Biosecurity Dual Use Research: Scope, Criteria and Communication

The “Dual Use” Issue Good science can be put to bad uses

Anthrax Letter Attacks October 2001

Photo credit: Dr. John Ezzell

October 2001 Inhalational Anthrax Florida Victim October 2001 Inhalational Anthrax Florida Victim

The Ames Strain

NRC Report on Dual Use Research Report of the National Research Council of the National Academies: “Biotechnology Research in an Age of Terrorism: Confronting the Dual Use Dilemma” (October 2003) “The Fink Report”

Fink Report – “Experiments of Concern” Demonstrate how to render a vaccine ineffective. Confer resistance to antibiotics or antivirals. Enhance a pathogen's virulence or render a non-pathogen virulent. Increase a pathogen's transmissibility. Alter a pathogen's host range. Enable evasion of diagnostic tests. Enable weaponization of pathogens and toxins.

Life Sciences: Need for Biosecurity  “Dual use” potential of certain life sciences research requires consideration of biosecurity measures  Goal (and challenge) is to enhance biosecurity protections for life sciences research while ensuring that any impact to the free flow of scientific inquiry is minimized.  The Fink Commission recommends the establishment of NSABB.

National Science Advisory Board for Biosecurity (NSABB)  Advisory to the Secretary of Health and Human Services, Director of National Institutes of Health, and heads of all US federal departments and agencies that conduct or support life science research  Will recommend specific strategies for efficient and effective oversight of US federally conducted or supported dual use biological research

NSABB Charges Recommend :  Criteria for identifying dual use research of concern  National guidelines for oversight of dual use research at both local and federal levels, including  Local review and approval processes e.g., Institutional Biosafety Committees (IBCs)  Criteria/processes for referral of issues to NSABB  Strategies for oversight of new classes of experiments and technologies

NSABB Charges Advise on :  Program for biosecurity education and training for all scientists and laboratory workers at federally funded institutions  A code of conduct for scientists and laboratory workers in life sciences research  National guidelines on communication and dissemination of dual use research methodology and research results  Strategies for promoting international dialogue on dual use research issue

NSABB Structure and Operations  25 voting members appointed by Secretary of Health and Human Services, after consultation with other Federal Agencies  Meetings open to public, unless otherwise determined by the Secretary, HHS  Managed by National Institutes of Health, Department of Health and Human Services

NSABB Expertise  Molecular/genomics  Microbiology  Clin. ID/diagnostics  Lab biosafety/security  PH/epidemiology  Health physics  Pharm. production  Veterinary medicine  Plant health  Food production  Bioethics  National security  Intelligence  Biodefense  IBCs  Export controls  Law, law enforcement  Scientific publishing  Perspectives from academia, industry, public, RAC

NSABB ex officios  Exec. Office of the President  Department of Health and Human Services  Department of Energy  Department of Homeland Security  Department of Veteran’s Affairs  Department of Defense  Environmental Protection Agency  United States Department of Agriculture  Department of Interior  National Sciences Foundation  Department of Justice  Department of State  Department of Commerce  National Aeronautics and Space Administration  Intelligence community

NSABB’s Approach to Fulfilling its Mission  NSABB Working Groups:  Criteria for identifying dual use research  Code of conduct for life scientists  Responsible communication of dual use life sciences research  Strategies to foster international dialogue  Biosecurity concerns associated with synthetic genomics  Framework for oversight of dual use research

Life Sciences Research Dual Use Research of Concern Guidelines for Oversight of Dual Use Research Review Process Responsible Communication of Dual Use Research Training and Education Criteria Code of Conduct for Life Science Researchers Risk Management Risk Assessment

Identifying Dual Use Research CriteriaCriteria

 Criteria are needed to identify research which should be considered “of concern” because of the likelihood that it could produce knowledge, products or technologies that could be misapplied to pose a threat to national security  The criteria will require periodic review and modification in response to scientific advances  “We’ll know it when we see it.” ????

Key Concept: National Security  Term not understood same way by all  Solution: Identify and use the relevant component elements of national security  Public health  Agriculture  Plants  Animals  Non-biological resources (materiel)  Environment

Principles for Identifying Dual Use Research  Dual use concerns pertain to misapplication of information or technologies yielded by the research, not the conduct of the research itself  A designation of research as “dual use research of concern” simply means that it may warrant special consideration regarding conduct and oversight  It does not mean, a priori, that the work should not be performed or that the results should not be published

Principles for Identifying Dual Use Research  The “threshold” for being dual use research of concern takes into account scope and immediacy of potential threat  Results can be directly misapplied (immediacy)  Misapplication would have broad consequences (scope)  Evaluation of dual use potential should be based on:  Current understanding regarding the implications of the research results  Reasonable anticipation that research results could be misapplied

Draft Criteria for Identifying Dual Use Research of Concern  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  Agriculture  Plants  Animals  Environment  Materiel

Research Areas of Special Concern  Careful consideration should be given to the potential for producing information, products, or technologies that could:  Enhance the harmful consequences of a biological agent or toxin  Disrupt immunity or the effectiveness of an immunization without a clinical and/or agricultural justification  Confer to a biological agent or toxin, resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin, or facilitate their ability to evade detection methodologies

Research Areas of Special Concern  Increase the stability, transmissibility, or the ability to disseminate a biological agent or toxin  Alter the host range or tropism of a biological agent or toxin  Enhance the susceptibility of a host population  Generate a novel pathogenic agent or toxin, or reconstitute an eradicated or extinct biological agent

Tools for Responsible Dual Use Research CommunicationCommunication

Controversial Manuscripts: 1918 Pandemic Influenza Virus

“1918 Flu and Responsible Science” Science Editorial Vol. 310, 7 October 2005 Philip A. Sharp “I firmly believe that allowing the publication of this information was the correct decision in terms of both national security and public health.”

New York Times Op-Ed October 17, 2005 Ray Kurzweil and Bill Joy contributors New York Times Op-Ed October 17, 2005 Ray Kurzweil and Bill Joy contributors “The 1918 flu genome: Recipe for Destruction” “This is extremely foolish. The genome is essentially the design of a weapon of mass destruction.”

Life Sciences Research and Communication  Open communication: tradition and foundation of life sciences  Stimulates progress  Publish in sufficient detail to validate/repudiate  Dynamic nature of research  Research not predictable  Builds on previous findings  Unfettered communication as a 1 st amendment right  Grey area between classified and unclassified  Limited scope of Federal control

Responsible Communication of Dual Use Research: Key Concepts  Decisions about whether to communicate need not be binary (Yes/No)  Range of communication options  Communicate as is  Delay until certain actions taken  Communicate in part  Communicate with modifications  Don’t communicate  A communication plan is critical part of decision to communicate  It’s not just what you say, but how you say it  Public understanding  Public trust

Assessment Framework  Current format is “points to consider,” but can be re-formatted for specific purposes  E.g., questionnaire to be completed  Key Features:  Overview of research information with dual use potential  Risk analysis (no need to continue if no risks identified)  Benefit analysis  Risk vs. benefit analysis  Formulation of recommendation regarding communication

Assessment Framework: Formulation of Recommendation re: Communication Decision should address content, timing and extent of distribution of the information Content Communicate as is Addition of contextual Information Modify or remove substantive information Timing Communicate immediately Delay communication Distribution No limit on distribution Limit distribution on a ‘need to know basis’ Don’t communicate

Communication Tools: Possible Uses  Review  Research proposals  Manuscripts  Presentations (oral, abstract, poster)  Internet postings  Education tool  Raise awareness of DUR issues within the scientific community  Ethics training

Oversight Framework Development (in progress)  NSABB will be recommending the features and characteristics of a proposed oversight framework  Attributes of review and oversight entities  Processes for local and federal review and oversight  Develop tools and guidance for these processes

Oversight Framework Development Approach:  Expert input  Extant oversight models  Recombinant DNA research, human subjects research, animal research  IBC functions and oversight  Integrate NSABB products into oversight framework  Consult other NSABB members as needed  Consultations with stakeholders

Oversight Issues to be Addressed  Review of research for dual use potential  Risk assessment  Risk management  Institutional administration  Review of issues by US Government and/or NSABB

Mitigating the potential for deliberate misuse of information Sharing of information and technologies underpins scientific progress 1 - The Need for Balance

Government The public The public The Media The Media The scientific community The scientific community 2- The “dual use” issue is more than just science.