RS–IAP-ICSU, September 2006RS–IAP-ICSU, September 2006

NSABBNSABB

National Science AdvisoryNational Science AdvisoryBoard on BiosecurityBoard on Biosecurity

Dual Use Research:Dual Use Research:Scope, Criteria and CommunicationScope, Criteria and Communication

The “Dual Use” IssueThe “Dual Use” Issue

Good science can be put to

bad uses

Anthrax Letter AttacksOctober 2001

Photo credit: Dr. John EzzellPhoto credit: Dr. John Ezzell

October 2001Inhalational Anthrax

Florida Victim

October 2001Inhalational Anthrax

Florida Victim

The Ames Strain

NRC Report on Dual Use ResearchNRC 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”“The Fink Report”

Fink Report – “Experiments of Concern”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 BiosecurityLife 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 National Science Advisory Board for Biosecurity (NSABB)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 ChargesNSABB 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 ChargesNSABB 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 OperationsNSABB 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 ApproachNSABB’s Approachto Fulfilling its Missionto 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 ResearchLife Sciences Research

Dual Use Research of Concern

Guidelines for Oversight of Dual Use

Research Review Process

Responsible Communication of Dual

Use Research

Trainingand

Education

Criteria

Code of Conduct for Life Science Researchers

Risk Management

Risk Assessment

Identifying Identifying Dual Use ResearchDual Use Research

CriteriaCriteriaCriteriaCriteria

Identifying Dual Use ResearchIdentifying Dual Use Research

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 SecurityKey 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 Principles for Identifying Dual Use ResearchDual 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 Principles for Identifying Dual Use ResearchDual 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 Draft Criteria for Identifying Dual Use Research of ConcernDual 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 ConcernResearch 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 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 Tools for Responsible Dual Use ResearchDual Use Research

CommunicationCommunicationCommunicationCommunication

Controversial Manuscripts:Controversial Manuscripts: 1918 Pandemic Influenza Virus1918 Pandemic Influenza Virus

““1918 Flu and Responsible 1918 Flu and Responsible Science”Science”

Science Editorial Vol. 310, 7 October 2005 Philip A. Sharp

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-EdOctober 17, 2005Ray Kurzweil and Bill Joy contributors

New York Times Op-EdOctober 17, 2005Ray Kurzweil and Bill Joy contributors

““The 1918 flu genome:The 1918 flu genome:Recipe for Destruction”Recipe for Destruction”

“This is extremely foolish. The genome is essentially the design of a weapon of mass destruction.”

Life Sciences Research Life Sciences Research and Communication 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 1st amendment right Grey area between classified and unclassified Limited scope of Federal control

Responsible Communication ofResponsible Communication ofDual Use Research: Key ConceptsDual 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 FrameworkAssessment 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 Assessment Framework: Formulation of Recommendation re: CommunicationRecommendation 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: Communication Tools: Possible UsesPossible 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 Oversight Framework Development (Framework Development (in progressin 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 DevelopmentOversight 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 AddressedOversight 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

GovernmentGovernment

Thepubli

c

Thepubli

c

TheMediaThe

Media

The scientificcommunity

The scientificcommunity

2- The “dual use”issue is more

than just science.

http://www.biosecurityboard.govhttp://www.biosecurityboard.gov