While we once held a glimmer of hope that the second Trump administration would enforce much-needed regulations on ‘dangerous gain-of-function’ research, it seems our expectations fell flat. The administration’s nominees for top health roles were critics of this hazardous research, hinting at its possible connection to the SARS-CoV-2 outbreak in Wuhan, China. In theory, this research aims to strengthen pandemic protection, but it only renders us more exposed due to the high risk of accidental leakage.
Expectantly, these stringent restrictions have not yet materialized. The deadlines that were set for the establishment of these new rules have passed with no new policies in sight. Concerns have risen as the NIH appears to continue channeling resources into this risky virological research. Critics of gain-of-function research, initially hopeful of its regulation, now fear that the Trump administration may not follow through.
Preceding three presidents had placed certain limitations on this type of research, providing a glimmer of responsible governance. There was a short-lived ‘halt’ on this research in 2014, focusing mainly on MERS, SARS, and influenza viruses. This stop on funding was brief, however, as a 2017 framework allowed financial support for such research to resume.
Numerous critics point out these policies’ failure to truly curb the most hazardous gain-of-function experiments. During the 2014 hiatus, the NIH still sponsored research on SARS-like coronaviruses at the Wuhan Institute of Virology. This sort of under-regulated research received little to no checks from the assigned review panel.
Underwhelming to note, this panel, charged with overseeing such studies, only reviewed a few of them, scarcely preventing any from moving forward. A 2024 policy sought to provide clarity on experimental criteria, but still left the index of decisions to funding bodies such as the NIH.
The autonomy given to NIH in overseeing these perilous experiments did little to prevent potential outbreaks. The Trump administration suspended this 2024 policy even before it could come into effect. Moreover, individuals assigned to guide the NIH on oversight measures were let go in August.
Recent indications from the NIH illustrate a disconnection with the administration’s direction. NIH’s priorities seemingly conformed entirely with the administration’s order and had no hand in guiding hazardous gain-of-function research policy.
Following this, it’s troubling to see the lackadaisical approach to policy implementation by the Office of Science and Technology Policy (OSTP). It failed to publish any policy and ignored the early August deadline for announcing a fresh or amended policy concerning the transfer of synthetic nucleic acids.
Those advocating for regulatory measures can only wonder about the reasons behind the lack of progress. Is it simple lack of focus, or something more? The necessary policy doesn’t need a complex structure; merely a clear affirmation and definition of what constitutes dangerous gain-of-function research.
Clear enforcement mechanisms are needed to monitor this research and ensure the discontinuation of federal funding from institutions that defy the policy. Rumors suggest that an internal resistance within the NIH to the new administration could have contributed to the delay in enforcing restrictions.
Regardless of the reasoning behind this lack of action, the consequences remain. The inherent danger of gain-of-function research persists, with its risks remaining high. It is as likely as ever to trigger a pandemic, cause mass casualties, and yield heavy economic damages.
Even if such research were to be conducted on US soil, it would still carry the same potential for catastrophic harm. One can only hope that the necessary policies and regulations come into effect soon.
In essence, the failure to regulate this area could lead us down a troubling path. Little has been done to mitigate the potential danger, and the NIH, a body that should take responsibility, appears hesitant to enforce stringent oversight. The need for a robust set of restrictions is clear, and time is of the essence.
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