Expert panel proposes stringent biosecurity oversight to avert future pandemics

By Neha MathurJan 25 2023Reviewed by Aimee Molineux

According to a recent report, the National Science Advisory Board for Biosecurity (NSABB) issued draft recommendations to the National Institutes of Health (NIH) on January 20, 2023, on the effectiveness of two biosecurity policy frameworks existent in the United States (US) governing:

1. Research with enhanced potential pandemic pathogens (ePPPs)
2. Dual Use Research of Concern (DURC)

Two NSABB Working Groups were actively involved in developing these findings and recommendations for NIH. The members of this outside expert panel considered relevant existing policies and public comments; additionally, they checked with experts in pathogen research before presenting this proposal, which the group will discuss in a meeting scheduled for January 27, 2023.

The NIH clarified that this review is a routine periodic reassessment of Potential Pandemic Pathogen Care and Oversight (P3CO) & DURC oversight frameworks, not undertaken to alleviate concerns that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) originated from a lab.

Background

Research involving pathogens raises the possibility of laboratory accidents and the intentional misuse of the data or lab-generated products. Moreover, a biological threat could also arise naturally or accidentally.

Thus, a biosafety oversight system exists in the US to protect laboratory workers. It also ensures the safety of the public, the environment, and national security. The US government periodically reassesses this framework to ensure it effectively handles all the existing and emerging biosecurity concerns while supporting research-based innovation. In this regard, the NSABB has played a crucial role in the past few decades.

In 2012, they recommended not publishing contentious gain-of-function (GOF) studies involving H5N1 avian flu virus. In their 2016 report, they emphasized considering ethical and societal values, not just the scientific merit of GOF research, before publishing to ensure biosecurity. Furthermore, the NSABB outlined the principles guiding funding decisions for GOF research, primarily based on the attributes of a pathogen resulting from such research.

NSABB findings and recommendations

In their findings, NSABB found definitions of PPP narrow, overemphasizing 'highly virulent' and 'highly transmissible.' As a consequence, the focus of experts could shift from research works involving enhanced PPP (ePPP). On the contrary, there should be more focus on assessing ePPP research, especially scientific methods or approaches that could produce a potential ePPP.

Further, the NSABB experts found the current P3CO policy framework inadequate for identifying and reviewing the roles of investigators and institutions in the ongoing oversight of ePPP research. They also found P3CO framework inadequate to oversee research involving enhanced animal or plant pathogens.

Regarding DURC, the NSABB experts found that government policies sufficiently strengthened oversight; however, the scope of research appraised for impending DURC remains limited, covering a fraction of life sciences research.

In addition, they found that insufficient attention is being paid to responsible communication, including the time, modes, and venues of communication, concerning most of the research falling under the DURC policies. Furthermore, these experts found a substantial overlap between the ePPP and DURC oversight frameworks; thus, it needs reconciliation.

The NSABB experts made several recommendations for improving the  P3CO & DURC oversight frameworks. First, they proposed that federal department-level review be made mandatory for research that might enhance the transmissibility and virulence of any pathogen, PPP or non-PPP, to avert any threat to public health and national security.

Second, they recommended that vaccine research and surveillance studies should not be excluded from review by federal departments, which currently enjoy blanket exclusions. The third recommendation emphasized harmonizing regional and institutional compliance procedures and articulating specific responsibilities for institutions and people tasked with investigations in the identification and assessment of research involving ePPPs. To this end, if required, they should be able to seek help from a US government office with adequate resources.

The fourth recommendation required aligning the White House Office of Science and Technology Policy (OSTP) P3CO Policy guidance with the Belmont Report. It would give extra attention to all seven categories of research and ensure the elimination of unnecessary risks and their replacement with other viable methods of attaining the pertinent benefits from the proposed research work.

Recommendation five emphasized increasing transparency in the review process and sharing of primary determinants that guided ePPP research funding verdicts. Other recommendations highlighted the need to develop analogous policies to oversee research threatening animal or plant health. Regarding DURC, the experts recommended that researchers continue to share experiences and best practices. More importantly, they should execute their responsibilities effectively by adhering to mechanisms and processes ensuring the same.

Another was eliminating all DURC definitions that might limit the identification of research posing significant biosecurity threats. However, oversight should be able to reasonably anticipate a research work likely to culminate in any of the seven pre-specified experimental effects (e.g., reconstitute an extinct agent or toxin or enhance its harmful effects). Overall, the NSABB experts recommended developing an all-inclusive approach to oversee all research that raised biosecurity concerns, including ePPP research and DURC, much more stringently.