New Policy Ends Federally Supported Gain-of-Function Research

Gain-of-function research involves altered versions of infectious agents that helps scientists predict viral evolution and develop vaccines.

Key Highlights

  • The policy bans federally supported gain-of-function research that could increase pathogen transmissibility or virulence.
  • It extends restrictions to international collaborations involving research of concern, aiming to prevent biosecurity threats.
  • Researchers must evaluate their studies continuously for potential risks and report key personnel involved.
  • The American Society of Microbiology warns that these restrictions could hinder the nation's ability to respond to infectious disease outbreaks.
  • Privately funded research may also be impacted, with investigators required to adhere to new oversight and reporting standards.

A new policy put forward by the Trump administration will end federally supported “dangerous” gain-of-function (DGOF) research and strengthen oversight of life sciences research that “could pose significant risks to public health, biosecurity, or national security.” CIDRAP has the news.

Gain-of-function research is the study of infectious agents altered to increase their ability to cause disease, transmissibility, or host range to help scientists attempt to predict viral evolution, design vaccines, and develop effective countermeasures should an outbreak occur. The policy affects DGOF and “international research of concern” (IROC), which is research conducted in collaboration with non-U.S. researchers in other countries or entities of concern.

The Trump administration claims that it opens the U.S. up to security risks, but the American Society of Microbiology says that shutting down these categories of research “will impede our ability as a nation to address infectious disease threats and respond to future outbreaks.” Privately funded research may also be affected in addition to federally supported research.

Principal investigators are assigned responsibilities under this policy, such as continuously evaluating life sciences research for DGOF and IROC. They must also comply with other requirements, like including the names and affiliations of key personnel participating in studies.

About the Author

Matt MacKenzie

Associate Editor

Matt is Associate Editor for Healthcare Purchasing News.

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