Dual Use Research of Concern in the Life Sciences Current Issues and Controversies (2017) / Chapter Skim
Currently Skimming:
2 The Current Policy Environment
2 The Current Policy Environment
Pages 23-44
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 23... ...
2 National Security Council, National Strategy to Counter Biological Threats (Washington, DC, 2009)
|
From page 24... ...
was spent on life sciences research.b 46% of publications in the United States are in medi cal and biological fields.c It is estimated that, in 2013, there were 21.1 million individuals in the United States with a bachelor's or higher level degree in a science or engineering field. Of this number, 2.4 million people held degrees in the life sciences.d The U.S.
|
From page 25... ...
4. After the life sciences, the next great est amount is spent on engineering (17% or $11 billion)
|
From page 26... ...
Department of Health and Human Services; MERS = Middle East respiratory syndrome; SARS = S evere acute respiratory syndrome; NIH = National Institutes of Health. SOURCE: National Science Advisory Board for Biosecurity, Recommendations for the Evaluation and Oversight of Proposed Gain-of-Function Research (Washington, DC, 2016)
|
From page 27... ...
and U.S. Government, United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, 2014 (available at http://www.phe.gov/ s3/dualuse/Documents/durc-policy.pdf)
|
From page 28... ...
.8 Controls on certain types of unclassified information are also laid out in specific statutes. These include sensitive security information,9 unclassified controlled nuclear information,10 and protected critical infrastructure information.11 6 National Security Decision Directive 189 (NSDD-189)
|
From page 29... ...
Investigative journalists and others have used FOIA as a means to obtain information about institutional research, animal research, and biosafety records residing with agencies.14 However, if the federal government is not in possession of federally funded information (e.g., DURC) held by researchers, it is not required to obtain such information from researchers in response to a FOIA request.15 Export controls are another mechanism by which dissemination of scientific information may be managed or restricted.
|
From page 30... ...
Department of Agriculture and the Department of Health and Human Services regarding listing select agents and safeguarding them during transfer. The Select Agent Program developed under the PATRIOT Act and the Public Health Security and Bioterrorism Preparedness and Response Act focuses on the handling of pathogens and toxins of concern; neither includes guidelines or requirements for the dissemination 16 Commission on Scientific Communication and National Security, Security Controls on Scientific Information and the Conduct of Scientific Research: A White Paper of the Commission on Scientific Communication and National Security (Washington, DC: Center for Strategic and International Studies, June 2005)
|
From page 31... ...
. In particular, after the controversy over publication of work on influenza viruses with enhanced transmission properties, the April 2012 version of the charter removed the NSABB's capacity to "Review and provide guidance on specific experiments insofar as they exemplify a significant or particularly complex permutation of an existing category of dual-use research, or represent a novel category of dual-use research that requires additional guidance from the NSABB."20 NSABB activities during the board's first 10 years included issuing recommendations on the oversight of life sciences research of dual use concern in general21 and on synthetic biology and gain-of-function (GOF)
|
From page 32... ...
the conduct of dual-use biological research. This includes strategies • Advise on the Federal Select Agent for addressing national security Program, as requested.
|
From page 33... ...
• Review and provide guidance on specific experiments insofar as they exemplify a significant or particularly complex permutation of an existing category of dual-use research, or represent a novel category of dual use research that requires additional guidance from the NSABB. • Respond to requests submitted by research institutions for the interpretation and application of the guidelines to specific research proposals in instances where a proposal has been denied by an IBC and the institution seeks additional advice.
|
From page 34... ...
This resulted in the creation of the special category of research termed "dual use research of concern."25 The NSABB also addressed the communication and dissemination of research results, emphasizing the importance of monitoring research for dual use potential from experimental design through publication. In 2007, the board released a report titled Responsible Communication of Life Sciences Research with Dual-Use Potential.26 That report offered an approach to "facilitate consistent decision making about the responsible communication of research information with dual use potential" and provided a "tool set" that includes: (1)
|
From page 35... ...
In 2012, the U.S. government released the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern.
|
From page 36... ...
Department of Health and Human Services Funding Decisions About Research Proposals with the Poten 34 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern. 35 For DURC that is proposed and not yet funded, departments and agencies will assess whether to incorporate risk mitigation measures in the grant, contract, or agreement.
|
From page 37... ...
Depart ment of Health and Human Services Funding Decisions About Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses That Are Transmissible Among Mammals by Respiratory Droplets (Washington, DC, 2013)
|
From page 38... ...
.44 For federally sponsored research, the guidance recommends that agencies adopt the dissemination policies that currently apply to DURC research under the March 2012 DURC policy (i.e., "venue and mode" restrictions for risk mitigation, voluntary redactions, or classification)
|
From page 39... ...
In January 2017, the White House Office of Science and Technology Policy issued policy guidance recommending pre-funding review mechanisms for federal agencies that conduct or support the creation, transfer, or use of enhanced pathogens of pandemic potential. a See National Security Decision Directive 189 (NSDD-189)
|
From page 40... ...
, which was signed in 1972 and entered into force in 1975. It built upon the Geneva Protocol banning use of chemical and biological agents in war and was the first international disarmament treaty to ban an entire class of weapons.48 The BWC prohibits development, production, stockpiling, and transfer of biological weapons, or the means of their delivery.49 The BWC has provided a forum for discussions of dual use issues in the context of oversight of research (see Chapter 3)
|
From page 41... ...
This was followed by a workshop in 2006 on "Life Science Research and Global Health Security."54 Additionally, a number of collaborative activities included regional workshops that addressed both biosafety and biosecurity issues. The final major WHO product prior to its involvement in the GOF controversy was a 2010 guidance document that provided a self-assessment tool for researchers and laboratories to evaluate their oversight of dual use research.55 The recommendations of such documents are not binding on member states.
|
From page 42... ...
In principle, the WHO could, in the future, take up the issue of research oversight as it affects global health security. The WHO could provide an important complement to the BWC.
|
From page 43... ...
The largest U.S. assistance program, the Cooperative Biological Engagement Program's mission is to "establish and maintain international research collaborations with global partners to inform and enhance operational biosurveillance, enhance global health security, and foster safe, secure and sustainable bioscience capability with partner countries" (see p.
|
From page 44... ...
Nevertheless, despite years of effort, there are some who still do not believe that the current federal approach is adequate to address concerns raised by current and emerging dual use research in the life sciences. use risks, mitigate biological proliferation and deliberate use threats, and ensure safe transfer of biological agents; and country-specific biosafety and biosecurity legislation, laboratory licensing, and pathogen control measures are in place as appropriate." But its success is to be measured by the "number of countries who have completed/Completion of a national framework and comprehensive oversight system for pathogen biosafety and biosecurity, strain collections, containment laboratories and monitoring systems that includes identification and storage of national strain collections in a minimal number of facilities." See Global Health Security Agenda Action Packages at https://www.ghsagenda.org/packages/p3-biosafety-biosecurity.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.