Aerial view of the National Institutes of Health Clinical Center (Building 10) in Bethesda, Maryland.

National Science Advisory Board for Biosecurity Votes to Support Stricter Regulations for Risky Research

By Lillian Parr

On Friday, January 27, the National Science Advisory Board for Biosecurity (NSABB) voted unanimously to support a set of recommendations—provided that some revisions are subsequently made—to strengthen U.S. regulation of risky life sciences research. Once revisions are complete, the recommendations will be shared with the Department of Health and Human Services (HHS) for consideration.

The recommendations cover research involving enhanced pandemic potential pathogens (ePPPs), including the P3CO Policy Guidelines and the P3CO Framework, as well as dual-use research of concern (DURC), including the USG Policy for Oversight of Life Sciences DURC and the USG Policy for Institutional Oversight of Life Sciences DURC. For more background on these policies, the NSABB review process, and the risks of dual-use life sciences research, please reference CSR’s earlier blog post on the subject.

The NSABB vote took place at the end of a virtual public meeting. This meeting included dedicated time for comments from the public and for open discussion amongst NSABB members regarding their reasoning and reservations. By holding the vote and preceding discussions in an accessible, public-facing manner, the NSABB is fulfilling its commitment to transparency—a key step in gaining public trust and ensuring that changes in policy are clearly explained.

On the whole, the recommendations seek to increase oversight on dual-use research and enhance biosecurity. One of the most significant recommendations is to extend governance to apply to all dual-use research conducted in the United States, rather than just research that is federally funded. This will help reduce blindspots and loopholes. Equivalent oversight is also recommended to apply to U.S. government-funded research at international institutions. 

Another major recommendation is to expand U.S. DURC oversight beyond the 15 pathogens and toxins on the select agent list. Instead, work conducted on any human, animal, or plant pathogen that is “reasonably anticipated” to result in one or more of seven categories of experiments should be subject to review and regulation. These seven categories represent various ways in which pathogens can be made more dangerous, including increasing transmissibility and virulence, enabling pathogens to evade countermeasures, and altering pathogens’ host ranges. 

Virologists and biosecurity experts who made comments at Friday’s meeting expressed concern that the phrase “reasonably anticipated” is overly broad, and that it is very difficult to predict outcomes prior to conducting research—if the outcomes were known, the research wouldn’t be necessary. However, other experts argued that the broad term allows for important flexibility, and that focusing solely on 15 agents is insufficient. 

Another important recommendation made by the NSABB is to remove the blanket exclusions for vaccine development and surveillance-related research, though a process will be developed to quickly allow urgent ePPP research in times of emergency. Some virologists who commented at the meeting found this change concerning, as they are worried that critical work, such as current avian influenza research, could be stymied. 

In their public statements, Dr. Kari Debbink and Dr. Jeremy Kamil both stated that the largest source of dangerous viruses is nature, so it is counterproductive to increase regulations on work that can improve understanding of naturally-emerging viruses. These scientists, among others, worry that the discourse surrounding dual-use research paints virologists as reckless, when in reality they are seeking solutions for viral threats. 

Experts on the NSABB regarded some of these perceptions as misguided. NSABB member Dr. Dennis Metzger emphasized that the recommendations advocate for a bottom-up approach, and that the first step of identifying risks lies with investigators. In fact, the new recommendations actually increase the role of institutional input, as NSABB members recognize that institutions and investigators are closest to the research and best understand the risks involved. Given the wide perceived misconceptions that the role of institutions is being diminished, Dr. Metzger suggested clarifying or rewriting relevant portions of the recommendations as a part of the post-vote revision process. Furthermore, NSABB member Dr. Rachel Levinson pointed out that the recommendations do not increase the amount of time required for initial review. The emphasis is not on banning experiments, but rather on mitigating harm and finding ways to do research more safely. 

Biosecurity experts have been largely supportive of the recommendations, though some argue that there are gaps left unaddressed, including a lack of oversight on ePPP sequence information and unclear processes for responsible communication of research findings. Several changes proposed to the NSABB last year by a panel of biosecurity experts—including CSR’s Christine Parthemore and Andy Weber—are reflected in the NSABB recommendations. Dr. Tom Inglesby, who was also a signatory of these proposed changes, noted that if the NSABB recommendations are adopted, the United States will be positioned as an international leader in biosecurity—few countries have public governance on these issues. Other experts and NSABB panel members also highlighted that strengthening dual-use research policies may encourage other nations to do the same—which could be critical for global biosecurity. 

NSABB member Dr. Alex London highlighted the importance of unity across biosecurity and life sciences disciplines. There appears to be instinctive resistance on the part of some virologists to the idea of adjusting oversight, but simply resisting all change is not helpful—scientists should get involved and help make the policies work for everyone. Dr. London noted that it will take great care to operationalize the recommendations and that scientists should play a central role in guiding this process. NSABB member and Senior Advisor to CSR, Dr. Kenneth Bernard, echoed this sentiment and noted that the United States doesn’t necessarily need more intrusive oversight, just clearer and better oversight. 

Despite the unanimous vote, some panelists showed hesitation over whether to support the recommendations. NSABB member Dr. Mark Dennison was perhaps the most vocal skeptic, and voiced concern over the logistical hurdles that including so many pathogens in the overview might cause. He also suggested a clearer, narrower definition of gain-of-function research that does not include certain experiments focused on understanding antimicrobials and antimicrobial resistance. Further, he recommended a streamlined process for rapidly excluding research from oversight, recommending that if something doesn’t meet specific criteria it should immediately be exempted so as not to slow research progress. Other members proposed more cosmetic revisions, including combining recommendations to enhance clarity. Furthermore, NSABB members highlighted that having two distinct policy frameworks (P3CO and USG DURC Oversight) is confusing and redundant. While the drafted recommendations suggest better integration, panelists recognized the need to clarify how this will happen. 

The next step for the NSABB will be to agree upon the proposed revisions. It is unclear how extensive these modifications will be, and there is no clear, public plan for how and when they will occur. Once revisions are complete, HHS will take these recommendations, as well as future conversations with different government agencies, into account as they work to develop new policies. 

While the NSABB will not dictate implementation of the recommendations, members emphasized that they will be on hand throughout the rollout of new policies. Issues that arise from new policies can be resolved in future iterations of review, as the frameworks are intentionally not rigid and are meant to evolve to keep pace with the ever-changing landscape of life sciences and biosecurity. 


Overall, the policy changes recommended by the NSABB represent a positive step forward in ensuring that research is conducted in a biosecure manner without creating unnecessary burdens on scientists. However, some significant gaps remain, particularly with regard to providing clearer guidance on the communication of research findings and enhancing transparency of the research approval process. These gaps should be addressed during the revision process or in the policy-making process at HHS. It is important to note that the NSABB recommendations, while important, do not represent actual policy changes at this stage. It will be essential for scientists and other experts to remain engaged through the remainder of the policy-making and implementation processes to ensure that risky research is responsibly regulated.


Categories & Related

, ,