The American Society for Microbiology has released consensus recommendations from a workshop of leading scientists who reviewed the benefits and risks of “gain of function” research, as well as related policies and procedures, and proposed a foundation to guide discussions and improve oversight moving forward.

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The recommendations – together with a call to action for the scientific community and the general public – are intended to inform assessments of ’gain of function research of concern’, which makes up a small fraction of all biological research.

Such scientific inquiry, sometimes called enhanced potential pandemic pathogen (ePPP) research, involves the study of pathogens that are modified to give them new abilities, typically to better understand the biology of a microbe or to enable its use for treatment and prevention of disease. 

Balanced discussion

In recent years, the dialogue in the public sphere has focused on potential risks to society associated with ePPP experiments. To maintain a balanced scientific discussion between risks and the need to keep society safe from existing and future threats, the American Society for Microbiology convened a panel of leading scientists representing diverse experiences, perspectives, expertise and opinions.

Research with infectious agents has provided considerable societal benefits in the development of vaccines and therapeutics. But a very small subtype of it has also introduced concerns about the potential for negative impacts of modified pathogens on public health, such as through biosafety and biosecurity risk.

READ MORE: Engineering viruses to make the world a more dangerous place

“Because policies that impact scientific research can have long-lasting and often unforeseen ramifications on public health and society, the American Society for Microbiology was compelled to seek insights that could help inform current and future policy deliberations,” said Michael Imperiale, chair of the ASM workshop steering committee and a professor of microbiology and immunology at the University of Michigan.

”These recommendations from leading experts with various viewpoints provide a foundation with which to assess scientific inquiry and the efforts to shape that inquiry.” 

Key recommendations

Convening earlier this year, scientists from the University of Michigan, Johns Hopkins School of Public Health, Stanford University, St. Jude’s Children Hospital, University of Wisconsin-Madison, the University of Pennsylvania and elsewhere agreed to recommend:

  • The need for standardized research terminology and practices: Clear definitions will allow the scientific community to gain a better understanding of the advantages and disadvantages of a proposed experiment. Standardization of biorisk management protocols and practices for both the U.S. and international communities is also needed.
  • Increased engagement and transparency with the public on infectious agents research: Scientists need to acknowledge risks more clearly and candidly and explain and justify why using a perceived risky approach is necessary to answer certain research questions. Scientists also must do a better job of communicating procedures in place to perform experiments safely. 
  • Strengthened biorisk management systems for safe, secure and responsible research: Increased multi-stakeholder dialogue on risk-benefit considerations for ePPP research, along with funding for research on biosafety measures, biorisk management training, occupational medicine services, improved facilities and protocols, and personal protective equipment can ensure biorisk management is taken more seriously and effectively across institutions and laboratories. Such discussions must also include the issue of potential risks to the greater public.

Not if, but when

“As the world emerges and learns from the COVID-19 pandemic, we must build a research enterprise and oversight framework aimed at anticipating, preventing, and responding to disease outbreaks of all types, in a thoughtful manner,” said David Relman, professor of medicine and of microbiology and immunology at Stanford University.

“It is not a question of “if” but “when” the world will face another pandemic. Science can provide key insights and critical countermeasures in the effort to protect ourselves against and respond to pandemics. At the same time, we need to ensure that science itself does not give rise to the next pandemic.”
 
While the workshop left unresolved the issues of what types of ePPP experiments are justified, none of the scientists suggested a blanket halt to all such studies. Instead, they issued a multi-part call to action for the scientific community and the general public. Moreover, it was acknowledged that certain experiments should not be performed: each situation will be unique and will require thoughtful consideration.

Pathogen oversight

The scientific community should revisit the current pathogen oversight frameworks to determine what types of decisions about infectious agent research are appropriately made at the institutional level and what should be elevated and decide on who is most qualified to make such decisions, workshop participants wrote. 

The general public, participants wrote, should advocate for evidence-informed policies while supporting research on the effectiveness of biosafety measures, training and reporting.

The full report and recommendations can be found here. 

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