US biosafety and pathogen research needs more oversight, experts say

A U.S. House of Representatives subcommittee met April 27 to hear insight and recommendations from a panel of expert witnesses on how to improve U.S. biosafety and pathogen research in light of concerns surrounding the origins of COVID-19 stemming from a possible lab leak. 

The focus of the hearing largely surrounded a concern outlined in a memo noting that currently, "the United States does not have a single entity responsible for regulating high containment laboratories or risky research."

Rep. Morgan Griffith, chair of the Energy and Commerce Committee's Subcommittee on Oversight and Investigations, which held the hearing, led with opening remarks sharply criticizing the National Institutes of Health for "lack of oversight" and not enforcing guidelines more when it funds research into infectious diseases. 

"Balancing safety with innovation is an enduring challenge. Our existing oversight framework for risky research is working," Mr. Griffith said. "Whether we call it 'gain of function research' or whether it's called 'research with enhanced potential pandemic pathogens,' I fear we have not kept pace. The United States doesn't have a comprehensive regulatory system for our containment laboratories, practically speaking, the research institutions, companies and universities that operate these facilities." 

The panel of expert witnesses included Rocco Casagrande, PhD, executive chair at Gryphon Scientific; Gregory Koblentz, PhD, associate professor and director of biodefense graduate programs at Fairfax, Va.-based George Mason University; Andy Pekosz, PhD, professor of molecular microbiology and immunology at Baltimore-based Johns Hopkins University Bloomberg School of Public Health; and Robert Hawley, PhD, the former chief of safety and radiation protection division for the U.S. Army Medical Research Institute at Fort Detrick in Maryland. 

One of the primary concerns of the committee was to engage expert witnesses in discussion about how to explore and implement comprehensive oversight into future pathogen research at all private and public facilities, especially those receiving NIH or other government funding. 

Among the myriad strategies and recommendations the expert witnesses shared with the subcommittee, here some of the key takeaways each expert witness shared during their testimony: 

 

  • Dr. Casagrande: "Unlike other high-risk endeavors, like aviation and nuclear power, biosafety does not have a robust research history because there has been nearly no funding for research in biosafety over the past several decades. … Although there are general standards regarding safe practices for research … more standards are needed to define how many biosafety professionals are needed to support research facilities of various sizes and complexities and what type of training is needed to work in containment. … Currently, there is no federal agency that is in charge of biosafety funding, biosafety research, promulgating specific biosafety standards, fostering the workforce or providing oversight to all pathogen laboratories. To fix this issue, either an existing or new federal agency must be given the comprehensive mission of improving biosafety."

  • Dr. Koblentz: "All countries with high-consequence biological research facilities should have whole government bio risk management systems, including hundreds of laws, regulations and institutions to enforce these laws. The United States should also be developing national standards for field biosafety. … Our virus research overseas has simply not yet caught up with this changing threat landscape."

  • Dr. Pekosz: "Biosafety is independent of funding sources. Increased transparency about the review process and individuals making decisions about approving research of concern would also be welcomed by most scientists in the field. … We have an opportunity to strengthen the leadership position and expand it to include biosafety and research into emerging and potential pathogens. The U.S. has the engineering and manufacturing expertise to build effective safe laboratories. It has the scientific public health and clinical expertise that can continue to drive forward and improve our ability to respond to current and future outbreaks. The U.S. can set the example of how to safely do research with clear public health benefits."

  • Dr. Hawley: "Accidents, incidents or mishaps in the laboratory or in any workplace environment do not just happen — they are caused — usually because of unsafe behaviors of people, violation of rules [or] procedures, inadequate training, failure to understand the process or procedure, fatigue and mental status. Most mishaps can be mitigated or eliminated through adequate coaching, mentoring or training using the best practices for facilities equipment and procedures. ... An analysis and report of laboratory incidents could help improve laboratory safety and oversight to determine why the accidents occurred and how they can be avoided in the future. Implementing this recommendation will provide resources for generating and sharing lessons promoting the need for new or revised guidelines, practices or training."
 

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