U.S. releases stricter rules on dangerous pathogens research

The U.S. government released two documents on Thursday that lay out stricter requirements for institution- and government-oversight of studies with agents and toxins that pose "problematic" safety concerns. The White House's Office of Science and Technology Policy (OSTP) is seeking public comment on a proposed rule that would establish new oversight requirements for federally funded research that involves 15 dangerous agents and toxins, including avian influenza A (H5N1). The office's proposed rule would require institutions and researchers to review federally funded research proposals that may involve so-called dual use research of concern (DURC) -- defined as life science research that is conducted for legitimate purposes that could be misapplied for harmful purposes that pose a significant threat to public heath and safety. The institutions would be required to develop a plan to mitigate the risks, and to establish a committee to oversee "potentially problematic" projects. Comments are due April 23.

Separately, HHS published a framework to guide the agency's funding decisions for research proposals that have the potential to generate highly pathogenic H5N1 viruses that are transmissible among mammals. HHS's framework would require the agency to determine whether the proposed research meets seven criteria, including the scientific and public health significance of the research and risk mitigation strategies, before funding proposals. HHS's policy also notes the agency will only support research that can be shared publicly. ...