A new Trump administration policy ends federally supported “dangerous” gain-of-function (DGOF) research and strengthens oversight of life sciences research that “could pose significant risks to public health, biosecurity, or national security,” a move lauded yesterday by the Department of Health and Human Services (HHS).
Gain-of-function research is the study of infectious agents or toxins that are 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 nationally occur.
The policy, which is slated for implementation in mid-November, affects two kinds of life sciences research, DGOF and “international research of concern,” (IROC) or that conducted in collaboration with non-US researchers in foreign countries or entities of concern.
“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.”
Prohibiting such research may pose its own risk
But some say the situation is more nuanced than that. In a statement today, the ASM, formerly the American Society for Microbiology, said, “The new policy from the U.S. Department of Health and Human Services… 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 chief strategy officer, told CIDRAP News that the policy is a step toward ensuring the rest of the world meets the high standards of the United States. But he added that, in the United States, “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."
While the policy currently affects only federally supported research, privately funded research may also be affected: “Additional regulatory, legislative or other actions to broadly manage the risks associated with research that has DGOF potential, including research that is privately funded, will be explored by an interagency working group,” the policy states.
