Expert Roundtable: Gain of Function Research With Infectious Agents
It is not a question of “if” but “when” the world will face the next pandemic.
Infectious agents are bacteria, fungi, viruses and parasites capable of producing infection or infectious disease. Research on infectious agents is necessary for understanding, monitoring and developing treatments and prevention measures against these agents, providing knowledge and insights that may have future applications that are presently unknown. For example, basic coronavirus and mRNA vaccine research starting in the 1980s and 1990s enabled the rapid development of vaccines for COVID-19 in the 2020s.
Gain of function (GOF) is a broad term that can encompass almost any type of research that involves modifying an infectious agent in a way that it is able to do more than it used to do, often aimed at understanding its mechanisms and functions. GOF research of concern (GOFROC) or enhanced potential pandemic pathogen (ePPP) research makes up a very small fraction of all biological research, but it raises concerns about biosafety and biosecurity risks.
Science is the best defense mechanism to protect us against and respond to the next pandemic.
Science is the key to preventing, and responding to, the next pandemic. To ensure our society is as prepared as possible, key scientists from around the world held an open discussion about the benefits and risks of research using infectious agents. They also assessed the need for better oversight and for better communication between scientists, policymakers and the public to improve safety and trust in science.
Standardized Research Terminology and Practices (i.e., Biosafety Protocols)
The term gain of function can have different meanings based on the context or the audience. Clear definitions will allow the scientific community to gain a better understanding of the advantages and disadvantages of a proposed experiment. Besides terminology, standardization of biorisk management protocols and practices for both the U.S. and international communities is needed, with scientists sharing best practices to help shape development of standard biocontainment and biosafety protocols.
Increased Transparency and Public Engagement on Research With Infectious Agents
Jargon and highly technical details can hinder effective communication between scientists, policymakers and the public. Scientists need to improve how they communicate with the public about research with infectious agents. Scientists should engage in open dialogue with policymakers and interested members of the public about the risks, benefits and safety layers to give a fuller picture of this type of research, potentially strengthening public confidence in the scientific community and informing policy decisions on public and global health.
Strengthened Systems to Protect the Safety of the Public and Laboratory Workers
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, improving the safety of the public and laboratory workers. Improved reporting systems and responses for lab accidents, such as anonymous reporting or constructive (rather than punitive) responses, can allow for more data collection on lab accidents and safety breaches, better informing the risk-benefit analysis when evaluating research with infectious agents.
Current Needs to Evaluate Research with Infectious Agents
The evaluation of research with infectious agents or ePPP projects requires high-level expertise due to the complicated nature of the issue as discussed herein. As the U.S. Department of Health and Human Services prepares modifications to its process for evaluating such research, transparency and collaboration will be required to develop effective review and approval processes.
Unresolved Issues and the Future of ePPP Research
While the workshop left unresolved the issues of what types of enchanced potential pandemic pathogen (ePPP) experiments are justified, none of the scientists suggested a blanket halt to all such studies and acknowledged that certain experiments should not be performed; each situation will be unique and require thoughtful consideration. Although international consensus and oversight is our goal, science and research decisions are largely made at a national or local level. In the abscence of international oversight, scientists must coordinate and set norms that can be translated across countries or adapted to local needs.