‘Gain-of-function’ research guidelines unclear after board vote fails

People were supposed to enter this week with a clearer idea of what the U.S. National Science Advisory Board for Biosecurity recommends for guidelines surrounding “gain-of-function” research. That has not yet happened.

The board held a virtual meeting with a panel of experts last week, where a vote on guidelines was expected. However, so many concerns were lodged at the meeting, it ended only with an agreement to modify a report the board is working on.

Once the report is finalized, the board will send it to the Department of Health and Human Services (DHHS) for consideration crafting new policy guidelines. It is unclear when that will happen.

Recommendations in the report includes:

• Increased transparency in the review process
• A more defined role for research institutions in evaluating the risks and benefits of proposed experiments
• Improved regulation of NIH-funded research performed in other countries

The report also suggests HHS officials reevaluate the departments list of 15 agents and toxins that could have ‘dual-use’ as biological weapons and therefore require special review before certain experiments can be performed. Instead, the guidelines suggest the DHHS evaluates all experiments, gain-of-function or otherwise, that could be “reasonably anticipated” to make a pathogen more transmissible or dangerous.

“Biosafety and biosecurity risks associated with undertaking research involving pathogens include the possibility of laboratory accidents and the deliberate misuse of the information or products generated,” the report says. “It is of vital importance that the risks of such research be properly assessed and appropriately mitigated and that the anticipated scientific and social benefits of such research is sufficient to justify any remaining risks.”

The experts at the meeting expressed concern with how the report’s vague language could stifle crucial research, slowing scientists’ ability to respond to public health emergencies. Other concerns include:

• How privately-funded research would be regulated
• The role of research institutions in identifying potentially dangerous research
• Whether institutions in and outside the United States would have sufficient funding to meet U.S. biosafety standards

Nature contributed to this report.