Created by on 4/10/2012 12:00:00 AM

On March 29th, the Department of Health and Human Services released a new government-wide policy regarding the oversight of dual use research of concern (DURC). DURC is defined by the National Science Advisory Board on Biosecurity as any life sciences research that can be reasonably anticipated to provide knowledge that could be misapplied and pose a threat with potential consequences to public health and safety, agricultural crops, animals, the environment, or national security. The purpose of this policy is to establish regular review of U.S. Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be DURC and it is intended to complement existing regulations.
Under the new policy, federal agencies that perform or fund life sciences research would be required to conduct a review of all projects that utilize high-consequence pathogens and toxins, determine if these projects meet the definition of DURC, assess the risk and benefits of such projects, and develop a risk mitigation plan if necessary. A risk mitigation plan may include a number of measures such as modifying the design of the research or applying enhanced biosecurity or biosafety measures. If risk cannot be adequately mitigated, the policy states that federal agencies could request voluntary redaction of the research publication or classification of the research.
Within 90 days of issue of the policy, federal agencies are required to report to the President’s Assistant for Homeland Security and Counterterrorism: 1) the number of projects utilizing any of these high-consequence pathogens and toxins, 2) the number of projects utilizing these pathogens and toxins which aim to produce a potentially harmful effect (e.g., disrupts effectiveness of an immunization against an agent or toxin or increases transmissibility), and 3) a summary of risk mitigation measures already in place. Following the completion of the initial reporting requirements, biannual reviews assessing these same factors will be requested.