NIH Policy on Mitigating Risks of Life Sciences Dual Use Research of Concern

Notice Number: NOT-OD-13-107

Key Dates
Release Date: August 28, 2013

Issued by
National Institutes of Health (NIH)

Purpose

On March 29, 2012, the Federal government issued a policy for the oversight of life sciences “Dual Use Research of Concern” (DURC). The purpose of this Guide Notice is to implement the March 2012 policy establishing federal review of United States government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be DURC in order to mitigate risks where appropriate and collecting information needed to inform the development of an updated policy, as needed, for the oversight of DURC.

Background

DURC is 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. Despite its value and benefits, some research may be misused for harmful purposes. The fundamental aim of this oversight policy is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

The policy applies to research that involves one or more of 15 listed pathogens and toxins that are being used in projects with specified experimental aims that may result in research products, technology or information that could be misused to pose particular risks. The policy requires that Federal agencies continually monitor funded research for dual use research potential. When DURC is identified, Federal agencies are to work with the institutions and investigators conducting the research to develop an appropriate risk mitigation plan.

NIH Policy

If a project is determined to be DURC a risk mitigation plan will be required. In these instances, institutions, Project Directors, and Principal Investigators will develop a plan that includes mitigation measures and procedures to implement them with the aim of minimizing the risk of misuse of the knowledge, information, products, or technologies generated by the research. If during the course of the research, the research becomes DURC, the grantee is required to inform the NIH immediately of the change in DURC status and develop a risk mitigation plan as outlined above. Risk mitigation plans must be submitted to the appropriate NIH Grants Management Officer for administrative review and approval.

A copy of the full policy and other related information may be found at: http://oba.od.nih.gov/biosecurity/bio_usg_activities.html.   

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