Center Faculty Respond to the NSABB Document “Proposed Biosecurity Oversight Framework for the Future of Science”

January 27, 2023 – A group of senior scientists and public health experts—including three Center faculty—has responded to draft recommendations from the National Science Advisory Board on Biosecurity (NSABB) regarding oversight of research involving enhanced potential pandemic pathogens (ePPP) and life sciences dual use research of concern (DURC).* The US government (USG) is currently reviewing its policies that govern and guide this realm of research.

“The purpose of this letter is to commend recommendations made in the new NSABB draft document, including significant improvements since the September draft,” write the authors. “It is also to express continued concern about remaining policy gaps that we believe should be addressed in the final NSABB report to the USG. ”

The group highlights concern that the document does not yet address:   

• Establishing oversight of sequence information about ePPPs, the risks related to computational methods for designing PPPs, and biosafety measures related to the synthesis of ePPPs.
• Distinguishing between practical benefits and unsupported claims of benefit.
• Improving transparency throughout the approval process by using a model such as Registered Reports to allow for the public to see risk-benefit assessments and any dissenting views prior to the research commencing.

The group also urges the NSABB to incorporate the following recommendations:

• Articulate the risks that must be considered in the ePPP Framework process, including accident, deliberate misuse, and insider threat.
• Define the process for the “responsible communication of results.”
• Expand the stakeholders involved in the review and approval processes and recuse those whose agency is funding or participating in the research.
• Broaden the ePPP Framework to apply to non-federally funded research.
• Require all USG agencies to implement the ePPP Framework.
• Strengthen USG outreach to other governments to catalyze ePPP Framework and Dual Use Policy development.
• Expand the types of experiments included in USG Dual Use Policy.

The letter was written by Jaspreet Pannu, MD, fellow, Johns Hopkins Center for Health Security (CHS); Anita Cicero, JD, deputy director, CHS; David A. Relman, MD (Stanford University); Marc Lipsitch, DPhil (Harvard T.H. Chan School of Public Health), and Tom Inglesby, MD, director, CHS.

It follows previous work conducted last year, including publishing a policy forum in Science, submitting a letter responding to preliminary draft recommendations from the NSABB, and submitting recommendations intended to strengthen oversight to the White House National Security Council and Office of Science and Technology Policy, the US National Institutes of Health (NIH), and the NSABB.

Read the January 26 letter.

*For the purpose of the recommendations, the experts refer to the “ePPP Framework” as consisting of both the White House Office of Science and Technology’s (OSTP) “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO)” and the US Department of Health and Human Services’ (HHS) “Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens.”