NIH Published Draft Recommendation for Pandemic Pathogen Research

As public health officials become increasingly concerned about potential pandemic pathogen (PPP) research, the NIH has published a draft recommendation to guide future research policies and practices. The guidance analyzes and assesses the current biosafety, biocontainment, and biosecurity oversight systems in the United States.

The document acknowledges the critical importance of pathogen research for the rapid detection, response, and recovery from biological threats; however, it notes that the reassessment of oversight systems is vital to minimize the risks of PPP research.

These recommendations came from two groups from the National Science Advisory Board for Biosecurity (NSABB). The groups analyzed the efficacy of the governing frameworks focused on research with enhanced PP and dual-use research of concern (DURC).

After a critical analysis, the groups listed recommendations in two phases. Phase one recommendations included amending Potential Pandemic Pathogen Care and Oversight (P3CO) policies, requiring that any research reasonably anticipated to spread or transmit pathogens undergo a federal review. This recommendation begs the question, what is reasonable anticipation? As mentioned in recommendations by the Government Accountability Office (GAO), the definitions for reasonable anticipation are typically unclear, leading to inconsistent reporting.

Additional phase one recommendations also included the following:

• removing blanket exclusions on surveillance and vaccine development
• specifying the roles and responsibilities of researchers and research organizations throughout the review process
• harmonious compliance procedures
• adequate financial and technical support
• increased transparency
• developing analogous policies for identifying and reviewing relevant research
• reviewing pathogens that may impact animals, plants, and their products, leading to long-term impacts on human health, food security, economic security, and more

Phase two recommendations, which focused more on DURC, included the continued sharing of best practices and experiences regarding DURC, involving stakeholders in updates to DURC policy, amending DURC definitions to exclude the term “directly misapplied,” and developing integrated approaches to oversight that focuses on biosafety and biosecurity. The brief also explained many other recommendations, justifying them with existing data.

The authors of the draft concluded that the NSAAB working groups evaluated the P3CO and DURC oversight frameworks and provided recommendations based on consultation with pathogen research, administration, and biosafety experts. The groups also considered public commentary.