The National Institutes of Health will terminate all funding for grants involving risky gain-of-function research and give researchers until the end of June to say whether their grants comply with President Donald Trump’s executive order regulating the dangerous type of experimentation that some have blamed for the COVID-19 pandemic. 

Scientists receiving funding from the NIH received notice on Wednesday that, following Trump’s executive order from last month, the biomedical research agency will terminate all funding for gain-of-function research “effective immediately.”

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Gain-of-function research has been hotly debated since the mid-2010s, when the scientific community became increasingly concerned about the potential for genetically manipulated viruses to start an epidemic or pandemic via a lab accident.

In layman’s terms, gain-of-function refers to the manipulation of a pathogen to make it more transmissible or give it the capacity to infect its host in new ways.

Debates over what constitutes gain-of-function became a flashpoint during the COVID-19 pandemic due to NIH-funded research conducted at the Wuhan Institute of Virology in China, which was located in the same city where the first identified COVID-19 outbreak started.

Five years after the start of the pandemic, a wide swath of international intelligence agencies and Trump concluded that COVID-19 likely started as a result of a lab accident. However, the evidence is far from dispositive. 

Trump’s May executive order provides a technical definition for “dangerous gain-of-function research” as any research activity altering a pathogen or toxin that “could result in significant societal consequences.”

This includes conferring new characteristics to a particular pathogen as well as “generating or reconstituting an eradicated or extinct agent or toxin.”

The executive order permanently prohibits dangerous gain-of-function research in countries designated by the director of National Intelligence as “countries of concern,” which includes China.

However, the executive order also establishes a broad framework to strengthen oversight of gain-of-function research that could produce beneficial advancements for patients. This research is often referred to as dual-use research since it can be used for good or for ill.

The NIH directive from Wednesday indicates that the agency will resume funding of gain-of-function research in nonthreatening countries when the oversight mechanism of the Trump executive order is in effect.

For grants not already identified by the NIH as fitting the Trump definition of dangerous gain-of-function, grantees are to “immediately notify the funding NIH Institute, Center, or Office” if any of the activities related to their project, including unfunded collaborations or adjacent research, meet the new definition.

The notice gives grantees until June 30 to notify the agency, only 13 days from when it was delivered. 

Stopping federal funding of gain-of-function research has been a priority of Sen. Rand Paul (R-KY).

Paul has introduced legislation multiple times to codify an independent oversight agency to review potentially risky research projects before they receive federal funding from any department funding biomedical projects, not just the NIH. 

Paul heralded the NIH announcement as “excellent news” on Thursday morning on social media.

NIH DIRECTOR GRILLED BY BOTH PARTIES FOR PROPOSED RESEARCH BUDGET CUTS

Last week, nearly 5,000 NIH scientists signed a petition against the agency’s leadership under its director, Dr. Jay Bhattacharya. 

The petition did not directly reference gain-of-function research, but it protested the abrupt shutting down of grant projects and the dissolving of international cooperation, saying that both would put the United States behind other countries in biomedical research.