OSTP today released for public review and comment a proposed policy aimed at maximizing the benefits of life sciences research while minimizing the odds that the results of such research will be misused. The proposed policy, posted on the U.S. Department of Health and Human Services Science Safety Security (S3) Website, was crafted collaboratively by several Federal agencies and is now open for public comment for 60 days.
The proposed policy responds to concerns that some important and otherwise beneficial avenues of life science research have the potential to generate information or capacities that, in the wrong hands, could be misused for harmful purposes.
Specifically, the newly proposed policy focuses on the very small fraction of studies with the highest risk of potential misuse, known as dual use research of concern (DURC). For oversight purposes, DURC is defined as “Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products or technology 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 Federal Government has already taken a number of actions to reduce the risks posed by DURC. Last March, the Administration initiated an internal policy that requires agencies to review research proposals that will be funded and those already funded; identify those that qualify as DURC; and ensure that acceptable risk-reducing mitigation plans are in place before the work is conducted.
The proposed “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern,” released today, would complement that internal policy by establishing certain oversight responsibilities for universities and other research institutions that receive Federal funding. Specifically, such institutions would be required to review their current life sciences research involving those pathogens or toxins deemed to be the most dangerous or most amenable to misuse, and then work with the researchers and funding agencies to develop appropriate risk mitigation plans.
Together, the two policies can help the United States manage the risks of potential misuse throughout the research lifecycle—from the initial filing of a grant application to the conclusion of research and communication of results.
We are seeking comments on the proposed policy and welcome the input of researchers, institutions, consumers, security experts, and other stakeholders.
Please visit OSTP’s announcement of the proposed policy in the Federal Register for instructions on how to submit comments.
Franca Jones is Assistant Director for Chemical and Biological Countermeasures at OSTP