GAIN OF FUNCTION RESEARCHTrump Administration Issues Restrictive Executive Order to Govern Gain-of-Function Research
Last week President Trump signed an executive order which imposes new restrictions on gain-of-function (GoF) research. Scientists and biosecurity experts say it is not unreasonable to review the security measures governing GoF research, but that the administration has used a definition of GoF which is too broad, vague, and inaccurate, raising the concern that the United States will become less safe, and less prepared for unforeseen biothreats, as essential research and important studies would be hobbled because of the wide net cast by the executive order.
Last week President Trump signed an executive order which promises greater transparency with regard to gain-of-function (GoF)research, more severe penalties for scientists who violate federal rules and guidelines, and a ban on federal funding for GoF research in countries of concern, such as China.
The executive order was praised by those, mostly outside the scientific community, who worry that GoF research could lead to uncontrolled outbreaks or pandemic. President Trump is in the habit of claiming, without any supporting evidence, that this is how the COVID-19 pandemic began.
Scientists and biosecurity experts, however, worry that the Trump administration has used a definition of GoF which is too broad, vague, and inaccurate, raising the concern that important low risk studies would be hobbled because of the wide net cast by the executive order.
Gregory Koblentz, director of GMU Biodefense Graduate Program, discussed the new executive order with Science. He explained that, given Trump’s willingness to use federal research funding as a weapon in other battles, the executive order could cause substantial problems for legitimate pathogen research. “There is a high likelihood that research institutions will simply curtail such research for fear of running afoul of poorly worded policies and regulations that would impose draconian penalties on the institution,” he said. Koblentz noted that it is not yet clear how many additional layers of review and oversight academic researchers and their institutions can even manage amid massive budget cuts.
Others were more critical of the executive order.
Global Biodefensewrites:
Crippling Critical Research on Emerging Threats
The executive order’s sweeping ban on federally funded gain-of-function research stands to jeopardize essential work being done by U.S. agencies and institutions on the frontlines of pandemic preparedness. Programs led by the National Institute of Allergy and Infectious Diseases (NIAID), the Centers for Disease Control and Prevention (CDC), and federally funded academic research centers play a central role in studying high-risk pathogens—including select agents like Ebola, Nipah virus, and highly pathogenic avian influenza strains.
Many of these programs rely on gain-of-function approaches to understand how emerging viruses could evolve to become more transmissible or virulent in humans. For example, NIAID-supported research has used GoF methods to identify key mutations in H5N1 avian influenza that could allow airborne transmission in mammals—critical knowledge for designing vaccines and early-warning surveillance systems.