Can We Prepare for the Next Pandemic Without Studying Dangerous Pathogens? Experts Question New Gain-of-Function Policy

The Trump administration's new policy ending federally funded "dangerous gain-of-function" (DGOF) research is raising concerns among infectious disease and biosafety experts, who argue that the restrictions could weaken the nation's ability to prepare for future outbreaks despite the administration's goal of strengthening biosecurity.

The United States Government Policy for Stopping High-Risk Life Sciences Research, scheduled to take effect in mid-November 2026, ends federal support for research the government classifies as gain-of-function and establishes new oversight requirements for certain international scientific collaborations. While the administration says the policy is intended to reduce biosafety and national security risks, several experts warn that limiting carefully regulated research may create unintended public health consequences.

"Infection prevention and control inherently prioritizes prevention," Shahbaz Salehi, MD, MPH, MSHIA, director of infection prevention and control and employee health for Foothill Regional Medical Center in Tustin, California. "While establishing strict safeguards around high-risk research is necessary, completely ending funding for gain-of-function studies undermines our primary defense. To prevent infectious threats before we are forced to control them, we must continue safely researching the very pathogens that pose the greatest risk to the community."

His comments reflect a broader concern that preventing high-risk research altogether differs significantly from strengthening oversight of that research.

Similarly, Brenna Doran, PhD, MA, ACC, CIC, AL-CIP, consultant/coach for Innovative Partners Institute in San Francisco, California, questioned whether additional layers of oversight address a demonstrated gap in existing biosafety systems. "Biosecurity demands flexible research, not just rules. Existing safeguards already support safe science. Before establishing another oversight committee, we need to know what specific gap it fills, and who chooses who sits at the table."

A Shift in Federal Policy

Gain-of-function research involves modifying infectious agents or toxins to better understand characteristics such as transmissibility, virulence, or host range. Scientists have long argued that these studies improve understanding of pathogen evolution, guide vaccine development, and help researchers prepare for future infectious disease threats.

The new policy stems from a May 2025 executive order directing federal agencies to strengthen oversight of high-risk biological research. According to the policy, life sciences research remains essential for biotechnology, agriculture, public health, and national preparedness. However, the administration concluded that certain studies present risks that outweigh their scientific benefits.

"Life sciences research is necessary to ensure the United States maintains global leadership in biotechnology, biosecurity, and health and agricultural research, as well as readiness against biological threats," the policy states. "However, there are clear cases in which the potential benefits of life sciences research do not outweigh the potential risks, and such research should not be undertaken domestically or abroad in any circumstance."

New Oversight Requirements

Under the policy, federally funded research determined to have dangerous gain-of-function potential will undergo review by a newly established federal oversight board before funding decisions are made.

Principal investigators will also assume expanded responsibilities, including continuously evaluating whether their research falls within the categories of dangerous gain-of-function or international research of concern. Researchers must disclose key personnel, institutional affiliations, foreign collaborators, and research activities conducted outside the United States.

"The decision to end federally funded high-risk gain-of-function research reflects an emphasis on reducing potential biosafety and biosecurity risks while maintaining support for scientific research," said Vangie Dennis, MSN, RN, CNOR, CMLSO, FAORN, FAAN, MSN, RN, CNOR, CMLSO, FAORN, FAAN, CEO of and perioperative consultant for Perioperative Consultants, LLC, in Anderson, South Carolina."The policy highlights the importance of careful oversight, transparency, and responsible research practices as policymakers continue to balance scientific advancement with public safety and national security."

Although the administration emphasized that vaccine development, therapeutics, diagnostics, and international collaboration remain permissible, many scientists worry the policy's broad language could discourage important research beyond the specific studies targeted.

Scientists Warn of Unintended Consequences

The American Society for Microbiology (ASM) expressed similar concerns following the announcement.

In a statement, ASM said the policy "broadly defines several categories of research that, if shut down, will impede our ability as a nation to address infectious disease threats and respond to future outbreaks."

Allen Segal, JD, ASM's chief strategy officer, echoed those concerns while emphasizing that the focus should remain on strengthening biosafety rather than restricting research.

"We should be investing in facilities and training to ensure that it is being done safely, rather than taking the risk of prohibiting research to detect, prevent, and treat illness," Segal told CIDRAP News.

Looking Beyond Federal Funding

While the current policy applies only to federally funded research, the administration signaled that broader regulation may follow.

The policy directs an interagency working group to evaluate "additional regulatory, legislative or other actions" to manage dangerous gain-of-function research, including privately funded studies.

For infection preventionists, the debate extends beyond research laboratories. Understanding how pathogens evolve, identifying future pandemic threats, and developing vaccines and countermeasures all rely on continued scientific investigation conducted under rigorous biosafety standards.

As Salehi emphasized, prevention begins long before an outbreak reaches the bedside. "To prevent infectious threats before we are forced to control them, we must continue safely researching the very pathogens that pose the greatest risk to the community."

For many experts, the central question is no longer whether high-risk pathogen research requires oversight. Instead, the debate has shifted to whether limiting that research could leave healthcare systems less prepared for the next emerging infectious disease.