Regulatory Background
United State Government’s Policy
On September 24, 2014, the US Government released its Policy for institutional oversight of Dual Use Research of Concern (“DURC”). The Policy addresses institutional oversight of DURC and identifies the criteria for what qualifies as DURC by listing specific agents and toxins and descriptions of the types of experiments which, when combined, define the parameters for research considered DURC. Compliance with The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (Policy) commenced on September 24, 2015.
The United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (PDF) (DURC Policy, March 2012) established regular review by federal agencies of U.S. government-funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern. In collaboration with non-governmental institutions or researchers conducting U.S. government funded DURC, federal departments and agencies must conduct a risk assessment and develop a risk mitigation plan to apply any necessary and appropriate risk mitigation measures to ensure the research is properly conducted and communicated.
The United States Government Policy for Institutional Oversight of Dual Use Research of Concern (PDF) (DURC Policy, effective September 24, 2015) applies to institutions within the United States that receive funding for life sciences research from the U.S. government. The DURC Policy requires these institutions to review all life sciences research projects at their institutions and determine whether any such research involves the agents or toxins identified in the DURC Policy, regardless of the funding source. Institutions conducting life sciences research using one or more of the listed select agents or toxins must have an Institutional Review Entity in place, train their research personnel in managing DURC and maintain records of such training. In addition, they must report to NIH any DURC that is being funded by non-government sources.
Such research is subject to additional institutional review and oversight to determine whether it also involves any of the seven categories of experiments listed in the DURC Policy and if so, whether it meets the definition of dual use research of concern (see above). Research meeting this definition is subject to risk mitigation measures to ensure the research is properly conducted and communicated. Institutions outside the U.S. must also conduct this review and oversight if the U.S. government directly funds research that involves any of the agents or toxins in the DURC Policy.
Please be aware that there are select agents that overlap with or are not considered human pathogens, including animal and plant pathogens. However, it is very possible that a non-select agent may fall under dual use concerns. Please visit the Federal Select Agent Program Website for additional information.