Plan for More Oversight of Pathogen-Related Research Passes Hurdle

On Friday, federal advisors endorsed new recommendations for improving the biosecurity oversight of scientific research involving potential pandemic-causing pathogens.

The board of directors of the National Science Advisory Board for Biosecurity (NSABB) voted to approve a proposed framework requiring federal departments to review any research that could potentially enhance the transmissibility or virulence of a pathogen.

To accomplish this, the committees that drafted the report suggested expanding the definition of potential pandemic pathogens (PPP) to include any moderately or highly transmissible or virulent pathogen capable of spreading uncontrollably in human populations or causing significant morbidity or mortality in humans.

“The current definitions of PPP and enhanced PPP are too narrow, so instead we wanted to be a bit more broad and expand that definition to essentially any pathogen that is also likely moderately or highly transmissible, and capable of wide and uncontrollable spread in humans,” according to Syra Madad, DHSc, MSc, MCP, senior director for System-wide Special Pathogens Program at NYC Health + Hospitals and a co-chair of the Potential Pandemic Pathogen Care and Oversight working group that drafted the report.

She also emphasized the need for a more expanded and working understanding of what a potential pandemic-level virus could be when it comes to oversight and review processes on both the federal and local levels.

“When we talk about pandemic potential pathogens it’s not a list-based approach,” Madad told MedPage Today. “We can’t go with a list-based approach because that becomes moot very, very quickly. We live in a world where we’re constantly discovering new viruses, and there’s new technologies expanding research and the like.”

“It’s giving enough flexibility and oversight that it can encompass future health threats that we have not even encountered yet,” she added. She noted that part of the goal is to prevent investigators and reviews from becoming hyperfocused on one subset of pathogens or field of research.

The NSABB report was approved with the understanding that revisions will be made to incorporate requested clarification of language on certain recommendations prior to the report being finalized. The report will then be sent to the NIH for review and implementation.

The draft report included a total of 13 recommendations for purposed changes to the government’s approaches to monitoring research and use of PPP and enhanced PPP. Those recommendations included several changes:

• Removing the current “blanket exclusions” for research associated with pathogen surveillance or vaccine development and production
• Increasing transparency in the federal- and local-level review processes and funding decisions
• Mandated oversight of research of enhanced PPP at international institutions receiving U.S. funding for life sciences research
• Expanding the scope of research requiring review to include any research that directly involves any pathogens, toxins, or agents from humans, animals, or plants
• Developing an integrated approach to oversee research that raises significant biosafety and biosecurity concerns, and clearly defining the responsibilities of federal, institutional, and investigator groups in the oversight and review processes

During the public comment portion of the meeting, several individuals expressed concern that these recommendations would hamper resources and funding for researchers seeking to experiment in the fields listed in the report. The committee members acknowledged those concerns and emphasized that the recommendations are intended to guide oversight and not prevent research in any fields.

Madad highlighted the importance of healthcare professionals when it came to drafting these recommendations, especially in light of experiences during the COVID-19 pandemic. She also noted that the COVID-19 pandemic informed some of their approach to these recommendations, but the committees were primarily focused on prevention measures for future PPP.

Earlier, this month, a separate report from the HHS Office of Inspector General (OIG) revealed that the NIH and EcoHealth Alliance did not effectively monitor the awards they granted to researchers, which led to missed opportunities for proper oversight. The report highlighted that the OIG found deficiencies in the organizations’ compliance with the previously established monitoring procedures.

The deficiencies listed in the report included improper termination of a grant, EcoHealth’s failure to obtain necessary scientific documentation and an improper use of grant funding, totaling nearly $90,000 in “unallowable costs.” The report concluded that “[w]ith improved oversight, NIH may have been able to take more timely corrective actions to mitigate the inherent risks associated with this type of research.”