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Colorized transmission electron micrograph of Avian influenza A H5N1 viruses (seen in gold) grown in MDCK cells (seen in green). Photo: Cynthia Goldsmith/CDC

The National Institutes of Health (NIH) announced today that a “funding pause” on gain-of-function (GOF) studies involving influenza, SERS and MERS viruses has been lifted.

The halt on federal funding for GOF experiments involving the three viruses was initiated in October 2014 after a series of laboratory biosafety incidents occurred at U.S. government research facilities.

The incidents “caused the federal government to re-assess the risk/benefit calculus underpinning funding decisions for a certain subset of gain-of-function research involving agents that pose a significant risk to public health,” the NIH wrote at the time of the funding pause.

GOF research involves conducting experiments with potential pandemic pathogens (PPPs). This type of research is crucial to ensuring global health and security, but also poses serious risks if mishandled or mutated. To be considered a potential pandemic pathogen, the pathogen must be capable of wide and uncontrollable spread in human populations, and is likely to cause significant morbidity and/or mortality in humans.

Additionally, an enhanced potential pandemic pathogen is defined as a PPP resulting from the enhancement of the transmissibility and/or virulence of pathogen, according to the Department of Health and Human Services. Enhanced PPPs do not include natural occurring pathogens that circulate or have been recovered from nature.

A total of 21 gain-of-function studies of influenza, MERS and SERS were initially impacted by the 2014 funding ban. Some were later exempt after it was determined that the specific experiments posed little risk, but eight influenza and three MERS studies have remained on-hold for the last three years.

During the funding pause, the NIH and other government agencies analyzed the potential benefits as well as risks and costs of GOF research.

The Department of Health and Human Services was also called upon to develop a new framework to assess GOF research proposals and deem whether they should proceed as is, be rejected, or move forward with modifications. The framework “seeks to preserve the benefits of life sciences research involving enhanced PPPs while minimizing potential biosafety and biosecurity risks.”

Some of the criteria listed by the HHS framework that should be considered when evaluating individual proposals includes an assessment of the study’s risks and benefits, deciding if the investigator and research institution can conduct the experiments safely, and determining if there is a safer alternative that could produce the same results. After the HHS makes a recommendation on an individual proposal, the NIH will also evaluate its scientific merit prior to approving grant funding.

Those with studies that have been on hold are expected to submit new proposals, as their previous projects are now likely outdated.

“GOF research is important in helping us identify, understand, and develop strategies and effective countermeasures against rapidly evolving pathogens that pose a threat to public health,” Francis Collins, director of the NIH, said in a statement.

Despite the lift on funding and the new HHS framework, GOF research in general remains a controversial subject. Critics argue that previous GOF studies haven’t proven to help prevent or improve preparedness for pandemics enough to warrant the high risk associated with the pathogens being studied and leading to an accidental or intentional outbreak.

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