Expert recommendations on gain-of-function research aim to boost safety, transparency

"While not statutory, there are policies and guidance in place for recombinant DNA research, research with ePPPs, and dual-use research of concern, though some have raised concerns about their application and the risk of conflict of interest when these rules are being applied and adjudicated by the funding agencies," the report authors wrote. "There are fewer, if any, policies and guidelines for non-government-funded research."

While lab-acquired infections, mostly involving a few people, have occurred all over the world, none are known to have involved an ePPP, the experts wrote. "Continuous monitoring, frequent data sharing, research on the effectiveness of biosafety measures, and periodic updating of these measures are needed to ensure the scientific community is informed and safety conducts these experiments," the report said.

The scientists recommend:

• Agreement on universally accepted standardized research terminology, biorisk-management practices, mentoring, training, and reporting to enable scientists to better understand the pros and cons of proposed experiments. "The world lacks an international standard for regulating research on infectious agents in general, much less for ePPP research," the authors wrote. "Each country develops its own review and regulatory process, adding to the lack of clarity."
• Better engagement and transparency with policymakers and the public, including candid explanations that justify why GOFROC is needed to answer research questions and the steps that will be taken to safely conduct the experiments. For its part, the public should advocate for evidence-informed policies, support biosafety research funding, and participate in science cafes to stay informed and participate in the dialog. "This includes communicating the difference between short-term and long-term benefits as well as acknowledging that some benefits or concerns will not be known until well after the experiment is over," the report said.
• Stronger biorisk-management systems. Discussions should include the risk-benefit considerations for experimenting with ePPP, funding for research on biosafety, biorisk-management training, occupational medical services, enhanced buildings and procedures, and personal protective equipment. "Current administrative responses to accidents are often viewed as punitive rather than constructive," the report said. "This can lead to reticence in reporting laboratory accidents to institutions."

Some lawmakers already looking at GOFROC bans

The group didn't specify which kinds of GOFROC are justified or those that shouldn't be performed, and none suggested a halt to all such studies. They said that each situation is unique and requires thoughtful consideration.

The experts said the scientific community should review current pathogen-oversight frameworks to determine which types of decisions should be made at the institutional level, which should be raised to a higher level, and who is most qualified to make those decisions.

Such discussions are timely, as this type of research is already in danger. "Currently in the US, lawmakers at both the federal and state levels are considering (and, in Florida, have already passed legislation to prohibit or pause some gain of function research on 'potential pandemic pathogens or related risk research with potentially dangerous pathogens,' " the authors wrote.

The report acknowledges that future pandemics of natural origin are inevitable. "Science is a key defense mechanism to protect us against and respond to pandemics," it concluded. "In the end, although the workshop did not discuss exactly what oversight is needed, it highlighted helpful recommendations for the scientific community and society to consider going forward."