On August 19, 2026, the National Institutes of Health (NIH) released a Draft NIH Biosafety Policy for Research Involving Biohazards that, when finalized, is intended to replace the long-established NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The new policy would represent the most significant modernization of NIH biosafety oversight in nearly 50 years and establish a broader, risk-based framework for the management of biological hazards in research settings.
The NIH’s initiative to Modernize and Strengthen Biosafety Oversight was announced in September 2025 as a comprehensive effort to significantly update biosafety policies, practices, and oversight. The NIH gathered stakeholder input through regional listening sessions, targeted meetings, and a public comment period before developing the draft policy. For additional information, please see our NIH Biosafety Modernization Initiative blog.
Who Is Covered by the Draft NIH Biosafety Policy?
The proposed policy has broad applicability as it applies to research supported in whole or in part by the NIH, regardless of the funding level or mechanism. In addition to projects directly supported by NIH funding, the draft policy would apply to covered research involving biohazards conducted at NIH-supported institutions, regardless of whether the individual research project itself receives NIH funding. As a result, certain non-NIH-funded covered research activities at those organizations could fall within the scope of the policy.
The impact of the proposed policy may extend beyond institutions that receive NIH funding. Many local public health authorities have incorporated compliance with the NIH Guidelines into ordinances, permitting requirements, and biosafety regulations. In some jurisdictions, adherence to the NIH Guidelines is required even for research activities that are not NIH-funded.
If the draft policy is finalized, local regulators and health agencies may evaluate whether existing references to the current NIH Guidelines automatically encompass the new policy, or whether regulatory updates will be required. Institutions operating in jurisdictions that reference the NIH Guidelines should review local requirements to understand how the transition may affect existing compliance obligations.
A Broader Scope of Oversight
The most significant change is the expansion of the proposed policy’s scope. The current NIH Guidelines apply to research involving recombinant or synthetic nucleic acid molecules. Under the proposed policy, oversight would extend to NIH-supported biomedical laboratory research involving a much wider range of biohazards that present known or potential risks to human health, including:
- Wild-type biological agents that cause disease in humans.
- Genetically modified cells, viruses, or organisms (other than plants).
- Toxins, prions, and other self-aggregating proteins.
- Cells or organisms containing any of the above.
Per the NIH, this shift aligns with the broader scope of current life science research, which extends well beyond recombinant DNA technologies. The agency’s position is that emerging biotechnologies, synthetic biology, advanced cell engineering, and multidisciplinary research programs require a risk-based biosafety oversight framework capable of addressing a broader spectrum of risks.
Expanded Role of Institutional Biosafety Committees (IBCs)
The NIH is also proposing a substantially expanded role for IBCs. Historically, IBC oversight has focused largely on recombinant and synthetic nucleic acid research. Under the draft policy, IBCs would assume broader responsibility for overseeing more types of biohazardous research activities.
The proposal further seeks to establish IBCs alongside Institutional Review Boards (IRBs) and Institutional Animal Care and Use Committees (IACUCs) as one of the three primary pillars of research administration. The NIH states that this integration will improve consistency, accountability, and institutional oversight across the research community.
Delegated Review of Research Protocols
The current NIH Guidelines do not allow for delegated review of research protocols/project registrations. However, the draft policy would permit this mechanism for certain lower-risk research activities. Under the proposed approach, an individual IBC member, or a designated subset of committee members, could evaluate and approve eligible protocols on behalf of the full IBC. The NIH proposes limiting this exception to specified categories of lower-risk activities, including research involving:
- Risk Group 2 (RG2) wild-type biological agents.
- Genetically modified RG1 biological agents.
- Transgenic organisms conducted at Biosafety Level 1 (BSL-1)/Animal Biosafety Level 1 (ABSL-1).
- Plasmids or replication-incompetent, non-integrating viral vectors expressing reporter or low risk transgenes.
- Well-characterized cell lines.
- Toxin proteins not on the select agent list.
By allowing routine protocols to undergo a more streamlined review process, the proposal seeks to reduce administrative burden while enabling IBCs to devote greater attention to higher-risk research activities.
New Institutional Assurance Requirements
A significant procedural change is the proposed replacement of the current IBC registration process with a formal institutional assurance program. Rather than annual IBC submissions and updates, institutions would provide the NIH with a written assurance, signed by their Authorized Organizational Representative, affirming compliance with the biosafety policy. NIH approval would be required, and assurances would remain valid for up to four years.
Institutions would no longer be required to provide annual IBC rosters to the NIH. Instead, they must ensure that IBC meeting minutes, prepared using the new draft template, and current roster are maintained on their publicly accessible website.
Changes to Incident Reporting
The NIH is seeking to require institutions to report qualifying incidents that pose significant risks to human health using a new standardized reporting template. These reports, along with the NIH’s responses, must be made publicly available, subject to appropriate redactions for personal, proprietary, or security-sensitive information. The draft policy also identifies the specific incidents that are reportable to the NIH, including those involving:
- A confirmed or potential laboratory-acquired infection (LAI).
- Any loss of containment or release that has the potential for community risk.
- Any incident at BSL-3/ ABSL-3 and BSL-4/ABSL-4 (including potential exposures).
- Incidents at BSL-2/ABSL-2 with agent-specific treatment beyond basic first aid.
- Any compliance violations at any biosafety level or animal biosafety level such as failure to obtain or maintain IBC approval for research.
Lower risk incidents or accidents should be reported to the approved institutional offices and appropriately addressed locally, but do not require submission to the NIH.
These changes are intended to improve consistency in incident reporting, enhance institutional accountability, and provide the NIH with better data to identify trends and strengthen biosafety practices throughout the research community.
Next Steps
The NIH is accepting public comments on the proposed policy through October 19, 2026. Comments should be submitted electronically using the NIH Form. In addition to the draft policy itself, the NIH is seeking feedback on the proposed incident reporting template and meeting minutes template that would support implementation of the new framework.
Although the proposed changes are still pending, covered institutions can begin preparing now to be better positioned for implementation when the policy is finalized. Recommended actions include reviewing activities that may fall under the expanded definition of biohazardous research and evaluating whether current IBC membership provides sufficient expertise for a wider range of responsibilities. In addition, organizations should assess how existing biosafety programs align with the proposed requirements.
If finalized, the policy will significantly expand the scope of NIH biosafety oversight and introduce new requirements for institutions, IBCs, and biosafety professionals. Organizations that begin evaluating the proposed changes now will be better positioned to adapt to the final policy when it is released.
The NIH has published a comparison Table of Changes that provides a helpful summary of the draft policy’s most significant revisions. For additional guidance, help understanding the changes, or support with implementation, contact us.
This blog was written by Beth Graham, Director of Quality, Research, and Training at Safety Partners.
