Biology Is Dangerously Outpacing Policy

The original source of the coronavirus pandemic remains unconfirmed. While it was likely the result of a spillover from animals to humans, a lab origin cannot be ruled out. Given the uncertainty, additional scrutiny on research with pathogens that are engineered to be more transmissible or dangerous is warranted to prevent any future devastating pandemics.

In response to that risk, the United States recently took an important step toward strengthening the government’s oversight of research with viruses and other pathogens. An expert panel known as the National Science Advisory Board for Biosecurity voted unanimously in January to recommend a major overhaul of how the United States supervises what’s called dual-use research. Research is considered dual use if the intended use of the work is for peaceful purposes but there is concern it could result in a more dangerous pathogen or information that could be used maliciously.

As experts with four decades of combined experience studying biosecurity and the risks of dual-use research, we think the board’s proposals pave the way for welcome and needed changes. We hope the Biden administration will codify many of these recommendations into policy and work with Congress to secure the funding and legislation needed to implement the more far-reaching reforms.

Historically, the United States has taken a reactive and haphazard approach to preventing lab accidents and the misuse of high-risk science. A patchwork of regulations, guidance and policies exists based on the specific pathogen being researched, the type of research being conducted and the source of funding. But some research doesn’t fall under any agency, leaving an oversight vacuum.

This fragmented system has not kept pace with the evolving risk landscape. There are now more powerful tools for genetic engineering, and these tools are easier to use and more widely available than ever before. There are also more researchers interested in conducting research with engineered pathogens for scientific and medical purposes. According to the Global Biolabs Initiative, of which Dr. Koblentz is a co-director, there are more than 100 high and maximum containment labs around the world conducting high-risk research, with more planned. The United States has more such labs than any other country. Failure to update bio-risk-management policies is too great a concern.

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The board has recommended far-reaching changes that would greatly extend oversight of research that could be misused to cause harm. The proposal would expand the range of pathogens subject to oversight to include those currently considered less dangerous, and include privately funded research as well. It would also lower the threshold for genetic engineering experiments that could trigger extra scrutiny. The board also recommended this strengthened oversight system be administered by a government office that can provide guidance to researchers and transparency to the public.

The Biden administration has the authority to implement many of these recommendations, such as expanding current oversight over more pathogens and providing more transparent guidance to researchers and the public. These reforms are consistent with the administration’s biodefense strategy and should be implemented immediately. The administration has already requested $1.8 billion to strengthen biosafety and biosecurity, some of which could be used for this purpose.

But funding and implementing some of the board’s more far-reaching recommendations will likely require congressional action. Pathogens don’t care about politics, and efforts to strengthen biosafety and biosecurity should receive bipartisan support.

Currently, only a small number of private labs need to seek approval for dual-use research with a short list of pathogens. This creates a loophole that allows scientists with private funding — from a foundation, a corporation or even a crowdfunding site — to conduct unsupervised research with potential pandemic pathogens that are not on this list. For example, scientists at Boston University were able to create a chimera version of the coronavirus with enhanced properties without seeking government review because they did not use government funding to conduct the experiment. Given the potential consequences of a misstep, any institutions or researchers who work with such pathogens, regardless of their source of funding, should have their research reviewed to make sure it is being conducted safely, securely and responsibly.

The United States also needs to establish an independent government agency that has the authority and resources to regulate this research. This agency would serve a similar purpose as the National Transportation Safety Board or the Nuclear Regulatory Commission, and be dedicated to understanding the cause of accidents and mitigating risk anywhere in the United States. This would provide a central place for scientists to receive guidance about their work or to raise concerns. Such an agency could develop and promote policies so that all institutions doing this work would be held to the same standards.

Some researchers argue that these recommendations are too far-reaching and will inhibit science. But many of these measures would align the regulatory environment of the United States with those of its peers, such as Canada, Switzerland, the Netherlands, the United Kingdom and Germany. Fears that more oversight will have a chilling effect on research are belied by the robust research programs found in each of these countries. Still, the implementation of these recommendations will require a careful balancing act: fostering innovation in the life sciences while minimizing the safety and security risks.

As longtime participants in the debate about how to achieve this balance between science and security, we have been frustrated by the lack of progress for so long. Notably, the recommendations put forward by the National Science Advisory Board for Biosecurity are not substantively different from those offered by the same board in 2007. We sincerely hope it doesn’t take another 16 years, or another pandemic, to seize this opportunity for reducing the risks posed by dual-use research with viruses and other pathogens.

Dr. Gregory D. Koblentz is the director of the Biodefense Graduate Program at George Mason’s Schar School of Policy and Government and a co-director of the Global Biolabs Initiative. Dr. Rocco Casagrande is executive chairman of Gryphon Scientific and was the principal investigator of the Risk and Benefit Assessment of Gain of Function Research report.

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