the WHITE HOUSEPresident Barack Obama

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Strengthening Safety and Security across the U.S. Life Sciences Research Enterprise

Summary: 
Research and discoveries in the life sciences have expanded our understanding of the natural world and led to major advances in medicine, agriculture, environmental protection, and overall quality of life.

Research and discoveries in the life sciences have expanded our understanding of the natural world and led to major advances in medicine, agriculture, environmental protection, and overall quality of life. While this robust area of research has provided and continues to provide extraordinary benefits to society, the scientific community recognizes that some of its products can, in the wrong hands, be misused for unintended purposes. Research giving rise to such products or technologies is known as “dual use” research. Dual use research of concern, or DURC, is a subset of dual use research defined as life sciences research that 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, agriculture, the environment, or national security.

Additionally, the recent series of lab incidents at U.S. facilities has prompted the Administration to take decisive steps to strengthen biosafety and biosecurity, and has reminded us of how important it is to have in place robust and effective oversight processes that facilitate identification and mitigation of risks associated with certain types of life sciences research.

Today, the Obama Administration issued a U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern to help ensure that our Nation’s vitally important research efforts in the life sciences are carried out safely and in ways that minimize the risk of misuse.

The institutional policy released today builds on the Federal government’s previous DURC policy released in March 2012, which formalized a process for periodic Federal review of U.S. Government-funded or -conducted life sciences research involving 15 high-consequence agents and toxins, and seven categories of experiments. Today’s policy formalizes the roles and responsibilities of institutions and principal investigators in overseeing life sciences DURC involving this same subset of agents and toxins.

The Policy calls on all Federal agencies, institutions that receive Federal funding for life sciences research that conduct research with any of the 15 agents and toxins listed in the Policy, to, within one year, put into place the infrastructure, policies, procedures, education, and training to ensure that DURC is identified and appropriate risk-mitigation measures are implemented.

The Policy reflects substantial input solicited from the public, non-governmental experts, and stakeholders, including institutions that will be subject to this policy.   In the coming year, as institutions begin to implement the Policy, the Administration will continue to solicit feedback and evaluate the Policy’s impact on the life sciences research enterprise. This input will help determine whether additional steps can be taken to assist facilities with implementation and whether further modifications are needed. While the policy released today focuses on mitigating risks associated with the potential misuse of certain types of life sciences research, it complements a broader suite of policies that govern safety and security in laboratories. For additional information on the Federal government’s comprehensive approach to strengthening U.S. biosafety and biosecurity, please see the Science Safety Security website.

Life sciences research is making important contributions to the development of new diagnostics, preventive measures, and treatments for diseases; enhancing emergency preparedness and response efforts; and providing countless other benefits to people around the world. The Administration looks forward to continuing to work with the life sciences community to strengthen the safety of this vitally important research.

Read the Policy here.

Dr. Andrew Hebbeler is Assistant Director for Biological and Chemical Threats at the White House Office of Science and Technology Policy

Dr. Jo Handelsman is Associate Director for Science at the White House Office of Science and Technology Policy

Dr. Pat Falcone is Associate Director for National Security and International Affairs at the White House Office of Science