Two policy documents released for public comment on Dual Use Research of Concern agents

The government recentlty released two policy documents, regarding Dual Use agents, in response to a pair of articles detailing the increase in pathogenicity modification of H5N1 virus.  The documents were announce in the Federal Register, one from the Office of Science and Technology Policy (OTSP), and one from the Department of Health and Human Services (DHHS).

The OTSP document describes is a “proposed Policy [that] establishes institutional review and oversight requirements for certain categories of life sciences research at institutions that accept Federal funding for such research. These requirements are intended to address risks of dual use research not addressed under existing Federal regulations or guidelines. Requirement for compliance with this Policy, once finalized, will be incorporated by Federal funding agencies in accordance with their relevant statutory authorities, into the terms and conditions of awards with funded institutions that conduct research falling into the categories identified in the Policy. The public input provided through this Notice will inform future deliberations and issuance of a final Policy.”  As stated, comments to the proposed policy and specific questions are due by April 23, 2013. The proposed Policy is available here, and is illustrated by this flow chart:

DURC Flow Chart

The DHHS document, entitled “A Framework for Guiding U.S. Department 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 ” is also being used to gather public comments.  From the Summary: “The Federal Government is sponsoring a public consultation to engage the scientific community and research organizations in a discussion of a framework for the oversight of dual use life sciences research proposed by the National Science Advisory Board for Biosecurity (NSABB), which is an advisory committee to the Federal Government. In its report, the NSABB posed a series of questions on which the Board encouraged the Federal Government to solicit public comment. These questions concerned such matters as the clarity of the criteria proposed by the Board for identifying dual use research of concern, institutional oversight responsibilities, who should make determinations regarding dual use research of concern, and how to balance appropriate controls with academic freedom and scientific exchange. This public consultation is an opportunity for members of the scientific community and general public to provide input on these important issues.”  The one day public consultation will be held on July 15, 2008, from 8:30 a.m. to 5 p.m.  The proposed Policy is available here, and is illustrated by this flow chart:

Funding Agency Consideration of HPAI H5N1 Research Proposal

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