BIORISKSAs Science Evolves, Policy Framework Needs to as Well

The National Science Advisory Board for Biosecurity (NSABB),which advises the U.S. Department of Health and Human Services (HHS), was supposed to begin a review of gain-of-function research guidance in 2020, but the COVID-19 pandemic delayed it. “Given that enhanced pathogens could accidentally cause disease outbreaks, the need for the review is now greater than ever, some researchers say,” Max Kozlov writes in Nature.

In late February, the NIH and the White House Office of Science and Technology Policy asked the NSABB to make swift progress on its long-overdue review. The panel plans to draft a report outlining its recommendations by the end of the year.

“Although the scope of the NSABB’s new review of risky pathogen research remains similar to the one it had planned for 2020, the COVID-19 pandemic will undoubtedly have an influence. The NIH, in particular, has been scrutinized during the pandemic for its role in funding potentially risky coronavirus research,” Kozlov writes.

Dr. Lyric Jorgenson posted the following blogpost to the NIH website on 2 May 2022:

Reflections on NIH’s 27 April Virtual Meeting on USG Biosecurity Oversight Framework
Followers of this blog are probably keenly aware that the last few months have seen a flurry of activity related to biosecurity and biosafety policy. If you haven’t been following, it is worth a reminder that back in February, the Acting NIH Director reconvened the National Science Advisory Board for Biosecurity (NSABB) to help the U.S. government (USG) proactively ensure our biosecurity oversight framework keeps pace with rapid advances in scientific research. To help inform these deliberations, NIH hosted a virtual meeting and listening session on April 27 to hear stakeholder perspectives regarding USG oversight of research involving enhanced potential pandemic pathogens (ePPPs). With all this activity, I wanted to take a few moments to share my reflections on last week’s meeting and forecast what we hope to hear more about in the coming months.

First, I want to reiterate my gratitude to the speakers and public commenters who participated in this informative meeting. Given its technical nature, it was great to see that there were over 400 individuals viewing the meeting on the NIH Videocast, reinforcing the importance and timeliness of this engagement. If you weren’t able to join us last week, please bear in mind that this was only the first in a series of NIH meetings/listening sessions; you will have additional opportunities to participate and have your voice heard.

A significant focus for this meeting was to hear from experts about whether the scope of the oversight framework for ePPP research still hits the mark–are we still appropriately capturing what should be in and what should be out? Some stated that it would be beneficial to craft a more precise definition of ePPP and build in routine assessments to make sure the definition remains current. Others emphasized that a definition with built in flexibility is a better approach for evolving with new scientific discoveries. While there was no agreement on a bright line for defining the scope of ePPP, most emphasized the importance of transparency in how decisions about ePPP research are implemented. One thing is clear—continued discussions regarding this issue will be necessary.

We also heard from participants about potential strategies for balancing security measures with transparency. Something that particularly resonated with me was that many participants reinforced the importance that policymakers, researchers, and members of the public must work in tandem to achieve a successful path forward. It also was evident from the conversation that reasonable people may not perfectly agree on the path forward, but all agreed that having an open conversation about how decisions are being made and who is making them must be a priority. In a similar vein, there were some calls for increased communication regarding ePPP risk assessments, as well the specific outcomes of these assessments. However, as with all conversations around biosecurity, some of this research and information is sensitive, and some participants noted the importance of protecting the security of relevant research and the individuals conducting it.

As the last two years have shown, pandemics are a reality. We will need to continue our investment in biomedical research to bolster our readiness for, and capability to address, future potential pandemic threats. Make no mistake, the U.S. has a comprehensive biosafety and biosecurity oversight system that is based on identifying and assessing benefits and risks, and appropriately mitigating risks. However, we must also acknowledge that as science evolves, our policy framework might need to as well. We look forward to continuing these conversations with the community and working with the NSABB and across the government to preserve the critical advances of life sciences research while appropriately managing the potential risks.