The ‘Risky Research Review Act’ would do more harm than good

In an era of rapid scientific and technological advances when politicians and scientists are struggling to find the right balance between innovation and safety, Sen. Rand Paul (R-Ky.) has introduced the Risky Research Review Act (S. 4667) in an effort to navigate this treacherous terrain. But instead of providing clarity and security, this legislation threatens to cast a shadow over the future of life sciences research and slow it down.

The act proposes creating a Life Sciences Research Security Board to review federally funded life sciences research involving “high-risk” experiments and to decide if such research should be funded. But the bill’s definition of high-risk life sciences research is overly broad and ambiguous, and duplicative of existing regulations covering agents of bioterrorism concern and dual-use research. It goes beyond a list of potential pandemic pathogens and experiments to enhance pathogenic characteristics (so-called gain-of-function research), and includes pathogen collection and surveillance. The act would also cover — and it’s hard to get any broader than this — research that “could pose a threat to public health, safety, or national security.”

Research considered “high risk” under this bill includes experiments that have significant benefits, such as developing new vaccines and medical treatments, understanding how pathogens behave, and improving strategies to handle future pandemics. These advancements can save lives and lead to better responses to global infectious disease outbreaks. To be sure, all research has risk and the potential to cause harm without appropriate mitigation strategies, so some oversight is certainly warranted, especially for work with pathogens that have the potential to cause pandemics.

But this bill’s expansive scope could easily cause many research projects to be labeled high risk that aren’t, resulting in unnecessary regulatory burdens and stifling innovation in low-risk fields. To compound the problem, the bill’s definitions of key terms like “dual-use research” and “potential pandemic pathogen” are inconsistent with current and new federal policies, which could cause confusion and hinder valuable scientific research.

The proposed Life Sciences Research Security Board would have the unprecedented authority to veto funding for life sciences research, regardless of whether it is deemed high risk. This authority would effectively place the entire federally funded life sciences research enterprise under the board’s jurisdiction. This provision is particularly worrisome because it would allow the board to overrule agency decisions on a wide range of life sciences research, potentially including projects with minimal, or even no significant risk. Such extensive veto power could disrupt the research funding process, causing extensive delays that hamper scientific progress​​. This broad oversight could lead to a significant increase in the volume of research proposals subject to review by the board, further slowing down the funding process and creating bottlenecks that impede timely scientific advancements​​.

The composition of the proposed board also raises serious concerns about its ability to effectively oversee high-risk research. The board would consist of political appointees, including life scientists and national security experts, but lacks a requirement for members to have expertise in biosafety and biosecurity. This omission is critical, as effective oversight of high-risk research requires nuanced understanding and practical, hands-on experience in these areas​.

The bill’s provisions regarding conflicts of interest defined too broadly could also disqualify many well-qualified individuals from serving on the board. It would exclude scientists with experience conducting high-risk research, which could result in a board lacking the necessary knowledge, expertise, and skills to make informed decisions about the risks and benefits of life sciences research, thereby undermining its effectiveness and credibility.

Given the significant issues with the Risky Research Review Act, a more effective solution would be the establishment of an independent federal agency or unit dedicated to all aspects of biosafety and biosecurity, including oversight of research with potential pandemic pathogens. Such an institution would have the authority to oversee both publicly and privately funded research, conduct and sponsor applied research on biosafety and biosecurity, and support workforce development in these critical areas.

This independent entity would ensure consistent and expert oversight of high-risk biological research, free from the political influences that could compromise the proposed board. It would also be better positioned to conduct education and training and foster a culture of safety and security within the life sciences research community. By supporting workforce development, the agency would help build a robust pipeline of biosafety and biosecurity professionals and informed scientists to ensure long-term sustainability and effectiveness in managing these risks.

While the Risky Research Review Act aims to address legitimate concerns about the potential hazards associated with life sciences research, its current form is deeply flawed, posing significant threats to scientific progress and public safety. The broad and ambiguous definition of high-risk research, the overreach in funding decisions, and the inadequacies in the board’s composition all point to a need for a more thoughtful and effective approach. Establishing an independent federal entity dedicated to biosafety and biosecurity would provide the expert oversight necessary to protect public safety without stifling scientific innovation.

Only through such a balanced approach can we ensure that life sciences research continues to advance, bringing vital benefits to society while managing the risks responsibly.

David Gillum is associate vice president of compliance and research administration at the University of Nevada, Reno, an associate editor of Applied Biosafety, and past president of the American Biological Safety Association (ABSA) International. Rebecca Moritz is co-founder of Tutela Strategies and is the immediate past president of ABSA International. Gregory D. Koblentz is director of the Biodefense Graduate Program at George Mason’s Schar School of Policy and Government and co-director of the Global BioLabs Initiative.