Additional Requirement – 33: United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern

On September 24, 2014, the Federal government issued a policy for the oversight of life sciences “Dual Use Research of Concern” (DURC) and required this policy to be implemented by September 24, 2015. DURC is defined as life sciences research that, based on current under-standing, 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. 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 DURC policy can be found at https://www.phe.gov/s3/dualuse.

The DURC policy applies to recipients in the United States that receive Federal funding for life sciences research and that conduct or sponsor research involving one or more of the 15 agents or toxins listed in the policy. This policy also applies to foreign recipients that receive Federal funding to conduct or sponsor research involving one of these 15 agents or toxins. Research funded by CDC involving these agents or toxins must be reviewed to determine if it involves one or more of the listed experimental effects and if so, whether it meets the definition of DURC. This review must be completed by an Institutional Review Entity (IRE) identified by the funded institution. Many institutions task their Institutional Biosafety Committees with this responsibility.

Recipients also must establish an Institutional Contact for Dual Use Research (ICDUR). The award recipient must maintain records of institutional DURC reviews and completed risk mitigation plans for the term of the research grant, cooperative agreement or contract plus three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation.

If a project is determined to be DURC, a risk/benefit analysis must be completed. CDC will work collaboratively with the award recipient to develop a risk mitigation plan that the CDC must approve. For example, CDC may request that institutions periodically review a project for its DURC potential, propose any modifications to the risk mitigation plan, and share any resulting draft manuscripts with their Program Official prior to submitting to a journal for publication. CDC’s Institutional Biosafety Board is responsible for approval of all DURC risk mitigation plans. The award recipient is responsible for adhering to the risk mitigation plan, as approved by CDC.

Non-compliance with this Policy may result in suspension, limitation, restriction, or termination of USG funding, or loss of future USG funding opportunities for the non-compliant USG-funded research project and of USG funds for other life sciences research at the institution, consistent with existing regulations and policies governing USG funded research, and may subject the institution to other potential penalties under applicable laws and regulations.