If my time in the U.S. government has taught me anything, it is the vital importance of checking in on how the policies we craft are being implemented by our stakeholders. Policies should not be set in stone, especially when they apply to fast moving areas of science, and we need to hear from the affected community what is or is not working.
When the U.S. government and institutional stakeholders gathered at the NIH in July 2015 to discuss the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC), it was still months until the policy would come into effect. Yet this face-to-face exchange of questions, ideas, perceived challenges, and initial experiences with federal policy implementation was invaluable to providing investigators, institutions, and federal funding agencies with a clearer understanding of their individual and shared responsibilities to identify and manage DURC. As productive as that meeting was, at that point, it was still impossible to predict the impact of the yet-to-be implemented institutional DURC policy.
To leverage the benefits that come with hindsight, and two years of experiences, the U.S. government is hosting a two day stakeholder workshop on September 25-26, 2017, in Chicago, Illinois to engage with boots-on-the-ground implementers of the institutional DURC policy. The purpose of this workshop is to learn how the DURC policy is being implemented at different institutions, hear about any challenges encountered and strategies devised and, perhaps most importantly, facilitate the sharing of best practices among research institutions and investigators in order to make compliance with the policy easier.
The safety and security of life sciences research is absolutely dependent upon the shared role of scientists, research administrators, compliance officers, and oversight bodies. Hearing about the various ways these groups function to achieve the goals of supporting beneficial research while mitigating risks associated with DURC should be a great practical resource to those institutions participating, as well as a great value to NIH and the U.S. government. I encourage individuals and institutions with a stake in research subject to the DURC policy to register, come share their views, and be active participants in the discussions in Chicago. I hope to see you there!
Maximizing the benefits of life sciences research while minimizing the potential risks associated with conducting that research is an important and ongoing topic of conversation within the science policy community. For example, developing lifesaving treatments for infectious diseases often requires working directly with infectious pathogens. This presents inherent risks to lab workers, which can be managed with proper biocontainment and safety practices. Scientific information can also pose risks if communicating the research involves findings that could be misused for nefarious purposes.
All research has some “dual use” potential, but so-called dual use research of concern (DURC) is legitimate research with the greatest potential for generating information that could be misused and result in significant harmful consequences. Recognizing the need for oversight of DURC, the U.S. government issued two policies aimed at managing risks associated with this small universe of research. One policy, issued in 2012 focuses on the responsibilities of federal funding agencies to identify DURC and manage risks accordingly. The other, and the focus of this blog, was issued in 2014 and focuses on the responsibilities of research institutions. Together, these complementary policies establish a system of shared responsibility for DURC oversight among federal funding agencies, institutions, and researchers.
Prior to the institutional DURC Policy’s 2015 implementation date, the U.S. government held a workshop to engage stakeholders and address questions. Now, just over a year later, the U.S. Government is interested in learning more about how researchers and institutions are implementing the Policy. What are the challenges being encountered? Are there best practices for identifying DURC or managing risks? To help answer these and other questions, the National Science Advisory Board for Biosecurity (NSABB) is being asked to help the U.S. Government further solicit feedback by hosting a series of regional stakeholder meetings. These meetings will focus on how institutions are implementing the DURC policy and what challenges they are facing.
The NSABB will discuss this new task at its next full Board meeting, a teleconference on November 4th, 2016 from 12:00 pm – 3:00 pm ET. This teleconference is open to the public and time will be reserved on the agenda for public comments. If you can’t participate on Nov. 4th, there will be additional opportunities to engage the NSABB to discuss the institutional DURC policy in the coming months. Additionally, we invite interested stakeholders to submit comments to the NSABB at any time by emailing email@example.com.