Sept. 14, 2017

FOR IMMEDIATE RELEASE

Policies Governing Dual-Use Research in the Life Sciences Are Fragmented; Most Scientists Have Little Awareness of Issues Related to Biosecurity

WASHINGTON -- A new report from the National Academies of Sciences, Engineering, and Medicine examines policies and practices governing dual-use research in the life sciences – research that could potentially be misused to cause harm – and its findings identify multiple shortcomings. While the U.S. has a solid record in conducting biological research safely, the policies and regulations governing the dissemination of life sciences information that may pose biosecurity concerns are fragmented. Evidence also suggests that most life scientists have little awareness of biosecurity issues, the report says, stressing the importance of ongoing training for scientists. 

Since 2001, when letters containing anthrax were mailed to some members of Congress and the media, there have been no public reports of serious biosecurity incidents in the U.S., the report notes. Nonetheless, concerns persist that a serious incident could occur. Controversies have arisen over whether certain life sciences research should be published – for example, a 2005 paper that described research to reconstruct the virus responsible for the 1918 Spanish Flu epidemic and two 2011 papers that identified genetic mutations that increase the transmissibility of H5N1 avian influenza.  In light of such controversies, the National Academies were asked to review the current landscape of policies and regulations and to consider options for dealing with dual-use research; the Academies were not tasked with offering recommendations.

The Academies’ report acknowledges the difficulty of guarding against misuse of research findings while preserving the benefits of open dissemination, which can alert relevant communities to a risk, aid the development of countermeasures, and support scientific advances that can yield significant public health benefits. “Optimizing policies that encourage scientific openness while in appropriate cases limiting the dissemination of research results that might be misused is a difficult challenge, and there is significant debate about whether and how to limit dissemination,” said Harold Varmus, Lewis Thomas University Professor at Weill Cornell Medicine, New York City, and co-chair of the committee that wrote the report. “We hope that our report will inform future discussions and policies on managing dual-use research.”

For scientists carrying out federally funded research or working at institutions that receive federal funds, federal policies and the National Science Advisory Board for Biosecurity offer guidance in developing risk mitigation plans when appropriate, the report says. But the current policy emphasis and definition of dual-use research of concern (DURC) – which focuses on 15 select agents and toxins and seven types of experiments -- do not capture biosecurity concerns in all relevant areas of life sciences research, especially in emerging areas such as synthetic biology and the engineering of gene drives. Moreover, the current policies can, in some instances, constrain research that need not be subject to oversight. 

In addition, there is no established process by which those not receiving federal funding -- such as private-sector researchers and journal editors – can seek advice from U.S. government experts on managing manuscripts or research activities that raise potential biosecurity concerns.  “A key issue we identified was how to provide researchers -- and particularly journal editors -- with guidance about potentially problematic research findings or manuscripts,” said Richard Meserve, co-chair of the committee that wrote the report and Senior Of Counsel at Covington & Burling LLP.

Even more likely to be effective, the report says, is intervention at an early stage – before the research is carried out, or during research when an unusual finding is encountered. Identifying such research in its early phases could produce appropriate actions -- for example, a decision not to fund the research, classification, or mitigation plans -- in advance of a need to make decisions about publication.

A lack of awareness about dual-use issues among many life scientists is hampering efforts to implement policies to address biosecurity risks, said the committee. Those training to become life scientists are rarely introduced to the topic in a systematic way. Education and training programs at the undergraduate, graduate, and postgraduate levels generally do not include courses or discussions about dual-use research, unless the student or trainee is involved with a select agent; even in these cases, the primary focus is on biosafety rather than security issues.

Also, policy activity at the international level has declined recently, despite ongoing concerns and discussions about specific technologies such as CRISPR-Cas9, the report says. No international organization is currently giving systematic attention to developing policy or guidance regarding dual-use research. Potential institutions exist that could fulfill this function, such as the World Health Organization or the Biological Weapons Convention, among others. 

The committee identified multiple elements as important in dealing with dual-use research of concern:

Some of these options may be contentious, the committee acknowledged, and a clearer understanding of the risks, benefits, and trade-offs involved in these options is needed before policy can be successfully implemented. Implementation may also require additional resources, the establishment of best practices, refinement of policies and guidance, adoption of new laws, appropriately positioned and empowered advisory bodies, and broader stakeholder engagement. “At the same time, any new policies must be respectful of the strong First Amendment protections for speech,” said Meserve.   

The study was sponsored by the Burroughs Wellcome Fund, the Gordon and Betty Moore Foundation, the Alfred P. Sloan Foundation, and the Federal Bureau of Investigation of the U.S. Department of Justice.  The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln. For more information, visit http://national-academies.org. A committee roster follows.

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THE NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE
 
Policy and Global Affairs Division
Standing Committee on Science, Technology, and Law
 
Committee on Dual-Use Research of Concern: Options for Future Management

 

Richard A. Meserve1 (co-chair)
Senior Of Counsel
Covington & Burling LLP
Washington, D.C.

Harold E. Varmus2,3 (co-chair)
Lewis Thomas University Professor
Weill Cornell Medicine
Cornell University
New York City

Arturo Casadevall3
Professor and Chair
Harry Feinstone Department of Molecular Microbiology and Immunology
Bloomberg School of Public Health
Johns Hopkins University
Baltimore

Denise Chrysler
Director
Network for Public Health Law – Mid-States Region
School of Public Health
University of Michigan
Ann Arbor

Anuj C. Desai
William Voss-Bascom Professor of Law
School of Law
University of Wisconsin
Madison

Michael Ettenberg1
Managing Partner
DOLCE Technologies
New York City

David Fidler
James Louis Calamaras Professor of Law
Maurer School of Law
Indiana University
Bloomington

Claire Fraser3
Director
Institute for Genome Sciences, and
Professor of Medicine
School of Medicine
University of Maryland
Baltimore

Michael Hopmeier
President
Unconventional Concepts Inc.
Mary Esther, Fla.

James Le Duc
Professor
Department of Microbiology and Immunology, and
Director
Galveston National Laboratory
University of Texas Medical Branch
Galveston

Ian Lipkin
John Snow Professor of Epidemiology and Professor of Neurology and Pathology, and
Director
Center for Infection and Immunity
Mailman School of Public Health
Columbia University
New York City 

Stephen S. Morse
Professor of Epidemiology and Director
Infectious Disease Epidemiology Certificate Program
Mailman School of Public Health
Columbia University
New York City

 

STAFF

Anne-Marie Mazza
Study Director

 

1 Member, National Academy of Engineering
2 Member, National Academy of Sciences
3 Member, National Academy of Medicine