The May 10th 2024, edition of Science reported on the May 6th release of new rules in governing research on pathogens of concern and for the conduct of gain of function studies.
The rules issued by the Office of Science and Technology Policy strike a balance between strict control of experiments that may result in emergence of a pandemic virus and the need to continue basic and applied viral research.
The rules impose high levels of oversight on seven types of experiments involving fifteen high-risk human and animal viruses and bacteria referred to as ‘select agents’.
The rules were developed following Congressional hearings and considerable debate among scientists concerning dual use research on pathogens that could be used in biowarfare. The policy relating to gain of function experiments classify as Category-2 research will cover a H5N1 avian influenza virus and even seasonal influenza strains. Manipulation of any current pathogen to increase pandemic potential will be subject to extreme oversight.
In a statement supporting the White House Office of Science and Technology Policy, Dr. Monica Bertagnolli Director of the National Institutes of Health commented that the “unified and strengthened policy shows responsible science and that vigorous oversight can evolve in tandem”. Some researchers including Dr. Mark Lipsitch of Harvard University are calling on the National Institutes of Health to release at regular intervals details of studies other than gain of function experiments.
The new rules will take effect in May 2025. It is questioned why potentially dangerous gain of function experiments will continue for twelve months without coming under the restrictions of the new program.