The U.S. Federal Government has released a new government-wide policy establishing an explicit prohibition on dangerous gain-of-function research that could pose significant risks to public health and national security.
The announcement was made on July 28, 2026, by National Institutes of Health Director Dr. Jay Bhattacharya, who described the policy as an important step toward strengthening oversight, accountability, and transparency across federally supported life sciences research.
A New Framework for Research Oversight
The U.S. Government Policy for Stopping High-Risk Life Sciences Research introduces a comprehensive, risk-based framework designed to identify and restrict research that could increase the harmful consequences of biological agents.
According to the NIH statement, the policy represents a major change in federal oversight by moving beyond project-level evaluation and introducing broader, independent assessments of research activities that could create substantial biological risks.
The framework applies across the Federal Government and includes stronger review and reporting requirements for life sciences research.
Dangerous Gain-of-Function Research Prohibited
At the centre of the new policy is a prohibition on federal support for dangerous gain-of-function research.
This category includes research that could significantly increase the ability of a biological agent to cause harm, spread more effectively, evade existing safeguards, or create serious risks for human health and national security.
The NIH statement emphasised that the policy is intended to prevent the most dangerous forms of research while allowing federally supported science to continue advancing public health.
Enhanced Reviews and Greater Accountability
The policy introduces additional oversight measures for projects that may increase the harmful effects of biological agents.
These measures include enhanced reporting requirements, stronger enforcement mechanisms, and independent top-down assessments of potentially high-risk research.
The new approach is intended to ensure that concerns are identified early and evaluated consistently across agencies and research institutions.
Researchers and institutions involved in life sciences research have been encouraged to review the policy carefully and assess how its requirements apply to their work.
International Restrictions Strengthen Global Safeguards
The policy also establishes new restrictions on certain internationally conducted research.
These provisions include prohibitions on life sciences research involving designated countries or entities, as well as restrictions on high-risk research conducted in countries without adequate oversight systems.
The international measures are intended to prevent federally supported research from being transferred to environments where safety, security, and regulatory standards may be insufficient.
NIH to Support Policy Implementation
NIH will work with federal agencies, research institutions, and members of the biomedical research community to support implementation of the policy.
The agency indicated that collaboration will be necessary to ensure that researchers understand the new requirements and that institutions establish appropriate systems for review, reporting, and compliance.
The policy is expected to affect research planning, institutional oversight, funding decisions, and international scientific collaborations involving biological agents.
Balancing Scientific Progress and Public Safety
Dr. Bhattacharya stressed that formal classifications and regulatory requirements alone cannot eliminate every potential research risk.
He called on scientists to carefully evaluate both the potential benefits and possible dangers of every experiment, including studies that do not formally meet the definition of high-risk research.
Research involving biological agents can carry inherent risks, and maintaining a culture of responsible scientific evaluation remains central to protecting researchers, communities, and the wider public.
The new policy aims to prevent research considered unacceptably dangerous while preserving the role of NIH-supported science in improving health, advancing medical knowledge, and developing treatments for common and rare diseases.
Written by Nare Hovhannisyan, MD
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