The U.S. Department of Health and Human Services (HHS) and the White House are currently reconsidering existing policy to manage “dual use research of concern” and research that would enhance potential pandemic pathogens, with expected new guidance in January.
As biotechnology has advanced with remarkable speed and impact, so have the needs and demands for benefits, along with concerns about risks. Policy for managing these tradeoffs and mitigating risks has not kept up.
Today, two researchers at Stanford’s Freeman Spogli Institute for International Studies, David Relman and Megan Palmer, are among the co-authors on a Policy Forum article that appears in Science magazine, entitled “Strengthen Oversight of Risky Research on Pathogens.”
The article calls for a series of specific measures to enhance U.S. policy and spur the development of policy elsewhere in the world to address the serious gaps and challenges of the current guidance framework.
The recommendations include:
- The ‘dual use research of concern’ (DURC) framework should apply to all human pathogens, not just the 15 agents currently listed.
- Improved review processes must evaluate the risk and potential consequences of accidents, theft or insider diversions.
- Research proposals should be required to go through independent, government-led risk–benefit assessments to determine whether the work should proceed and under what conditions.
- The U.S. government should seek nongovernmental expertise for the review process. Currently, the HHS process involves only governmental experts, and the identity of these individuals is not publicly available.
- All U.S. agencies and institutions that fund work related to the enhancement of potential pandemic pathogens should have that work evaluated under the revised enhanced potential pandemic pathogens framework.
In addition to Relman and Palmer, the other co-authors are Jassi Pannu, Anita Cicero, and Tom Inglesby at the Johns Hopkins Center for Health Security, and Marc Lipsitch at the Harvard School of Public Health.
“It is vital to get these policies right, not only for the US, but to inspire policy development in other countries with growing life science and biotechnology sectors,” write the authors. “Few countries have policies that fully manage these issues.”
Media Contact: Ari Chasnoff, Associate Director for Communications, Freeman Spogli Institute for International Studies