Section 1. Introduction
Life sciences research is essential to the scientific advances that underpin improvements in
public health and safety, agriculture (including crops and other plants and animals) the
environment, materiel
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, and national security. Despite its value and benefits, certain types of
research conducted for legitimate purposes can be utilized for both benevolent and harmful
purposes. Such research is called “dual use research.” For the purposes of this Policy, dual use
research of concern (DURC) is a subset of dual use research defined as life sciences research
that, based on current understanding, can be reasonably anticipated to provide knowledge,
information, products, or technologies that could be directly misapplied to pose a significant
threat with broad potential consequences to public health and safety, agricultural crops and
other plants, animals, the environment, materiel, or national security.
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Materiel includes food, water, equipment, supplies, or material of any kind.
In general, there are risks associated with life sciences research, such as accidental exposure of
personnel or the environment to a pathogen or toxin. Many existing and complementary
statutes, regulations, and guidelines are in place to address risks associated with biosafety,
physical security, and personnel reliability.
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Some risks relate directly to the characteristics of
DURC – the risk that knowledge, information, products, or technologies resulting from the
research could be used in a manner that results in harm or threatens society. DURC should be
evaluated for possible risks, as well as benefits, in all these domains, to ensure that risks are
appropriately managed and benefits realized. This Policy addresses dual use research risks
holistically, that is, the risk that knowledge, information, products, or technologies generated
from life sciences research could be used in a manner that results in harm.
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E.g., the select agent regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331); NIH Guidelines on Research
Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines,
http://osp.od.nih.gov/office-
biotechnology-activities/biosafety/nih-guidelines); Biosafety in Microbiological and Biomedical Laboratories
(BMBL), 5th Edition (http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf).
Funders of life sciences research and the institutions and scientists who receive those funds
have a shared responsibility for oversight of DURC and for promoting the responsible conduct
and communication of such research. A comprehensive oversight system must include both
the U.S. Government (USG) and institutional oversight processes. The goal of oversight is to
preserve the benefits of life sciences research while minimizing the risk that knowledge,
information, products, or technologies generated by such research could be used in a manner
that results in harm. On March 29, 2012, the USG issued its “Policy for Oversight of Life
Sciences Dual Use Research of Concern” (March 2012 DURC Policy).
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That policy formalized a
process of regular USG review of USG-funded or -conducted research with certain high-
consequence pathogens and toxins to identify DURC and implement risk mitigation measures,
where applicable.
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The United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern, March 29, 2012,
http://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf.
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