FASEB Submits Comments on Draft NIH Biosafety Plan

By: Galen Cobb
Thursday, October 29, 2026
On October 19, FASEB submitted comments in response to a National Institutes of Health (NIH) Request for Information (RFI) on the draft NIH Policy for Research Involving Biohazards (NOT-OD-26-112). The draft policy would modernize biosafety oversight of NIH-funded research. It would extend oversight beyond the recombinant and synthetic nucleic acid research covered by the current NIH Guidelines to biohazards more broadly, with review tiered by risk across federal, institutional, and investigator levels. NIH also requested feedback on two draft implementation resources: a template for Institutional Biosafety Committee (IBC) meeting minutes and an incident reporting template.

FASEB commended NIH for the long-awaited effort to modernize biosafety oversight. It also urged the agency to ensure that new requirements are proportionate to risk and workable for the investigators who must meet them. Key recommendations include:

• Maintaining consistent scope across institutions: FASEB called for examples of in-scope research so that comparable protocols are treated similarly across institutions, along with a transition period for investigators with ongoing awards.
• Ensuring efficient review pathways: FASEB welcomed the new delegated review option but stressed the need for timely decisions. It also proposed a simpler renewal process for protocols that have not changed.
• Providing clarity for novel and synthetic systems: FASEB supported keeping Risk Groups as the baseline for risk assessment and asked for clearer guidance on engineered and synthetic constructs that are difficult to classify.
• Establishing reporting mechanisms that encourage safety: FASEB cautioned that publicly naming principal investigators in incident reports could discourage self-reporting. FASEB also suggested that reporting requirements scale with the severity of an incident.
• Providing researcher-facing guidance: Investigators will often draft the plain-language project descriptions that appear in public IBC minutes. FASEB therefore recommended that NIH provide model language to guide them, along with clearer criteria for what information should be redacted from public documents.