There’s More to Biosafety and Biosecurity Than Select Agents

Funding News Edition: May 03, 2023
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Colorized scanning electron micrograph of Ebola virus particles both budding and attached to the surface of an infected VERO E6 cell

Biosafety and biosecurity risks are associated with undertaking research involving pathogens.

Credit: NIAID

Life sciences research involving pathogens is paramount to pandemic preparedness, strengthening society’s capacity to respond to and recover from biological outbreaks. However, biosafety and biosecurity risks are associated with undertaking research involving pathogens. Below is a rundown of several key aspects of biosafety and biosecurity with which you should be familiar.

Dual Use Research of Concern

The U.S. government defines dual use research of concern (DURC) as life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security. The scope of the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern comprises a list of agents and toxins, as well as categories of experiments involving those agents and toxins.

Principal investigators and institutions are responsible for identifying and completing internal reviews of research projects that may fall within the scope of DURC policy. Upon identifying DURC, the institution should work with the principal investigator to draft a risk mitigation plan, submit the plan to NIAID for review and approval, and ensure the risk mitigation measures therein are carried out through the course of research. Keep in mind, even for research that does not meet the definition of DURC, proposed projects involving the relevant agents, toxins, and experimental effects may necessitate additional responsibilities and reporting requirements on the part of the recipient institution.

Find tools for identifying DURC, conducting risk-benefit assessments, and developing risk mitigation plans at Tools for the Identification, Assessment, Management, and Responsible Communication of Dual Use Research of Concern.

From the time of application and throughout the project period of an award to which DURC policy applies, NIAID provides oversight and will work with the award recipient regarding adherence to the DURC policy requirements.

Enhanced Potential Pandemic Pathogens

Potential pandemic pathogens (PPP) are pathogens that satisfy the following: 1) likely highly transmissible and likely capable of wide and uncontrollable spread in human populations; and 2) likely highly virulent and likely to cause significant morbidity and/or mortality in humans. An enhanced PPP is a PPP that results from enhancing the transmissibility or virulence of a pathogen; the starting pathogen does not need to be a PPP.

HHS’s Framework for Guiding Funding Decisions About Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework) guides HHS and NIAID oversight of research involving enhanced PPP. In accordance with the HHS P3CO Framework, NIAID reviews projects it is considering for funding to determine if the research may involve experiments reasonably anticipated to create, transfer, or use an enhanced PPP. Such research is subject to a multidisciplinary, pre-funding, Departmental review based on the criteria in the HHS P3CO Framework, which may require the prospective award recipient to provide additional information and materials. HHS then provides NIAID recommendations on the acceptability of the research for funding, which inform NIAID’s funding decision as well as oversight of the research.

Select Agents

The term select agents refers to a biological agent or toxin that has the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant products. A list of select agents is maintained at Select Agents and Toxins List.

The select agents regulations also govern certain Nucleic Acids, as described in Guidance on the Regulation of Select Agent & Toxin Nucleic Acids. The U.S. Federal Select Agent Program (FSAP) describes several regulatory exceptions for Excluded Strains, Permissible Toxin Amounts, Nonregulated Nucleic Acids, and other Regulatory Exclusions.

If your proposed research project uses select agents, you’ll need to adhere to the Federal Select Agent Program Regulations, which establish requirements regarding registration, security risk assessments, biosafety plans, security plans, incident response plans, training, transfers, record keeping, inspections, notifications, and other topics.

To ensure compliance with HHS and NIAID select agent policies, we place Select Agent Terms of Award for NIAID Grants and NIAID Solicitations and Contracts in the Notice of Award. Restricted experiments with select agents, as explained in the Restricted Experiments Guidance, have a separate review process and are included in the select agent terms of award. And for awards involving non-U.S. institutions conducting select agent research, we require NIAID-coordinated site reviews, Interagency Select Agent Review Group review, and NIAID approval for use of funds before any select agent work occurs at the non-U.S. institutions, with follow-up reviews every 3 years or sooner, if required.

Learn more on our Research Using Select Agents page.

Recombinant or Synthetic Nucleic Acid Molecules

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) are a term and condition of funding for recipients that receive any support for recombinant or synthetic nucleic acid molecule research. The Guidelines specify practices for the safe construction and handling of recombinant or synthetic nucleic acid molecules, as well as cells, organisms, and viruses containing such molecules, and include information on biosafety and biocontainment requirements for research involving humans, animals, and plants. The NIH Guidelines also lay out the responsibilities of institutions, investigators, and Institutional Biosafety Committees (IBCs) for oversight.

Find more information about nucleic acid molecules policy and IBCs on the NIH Office of Science Policy website.

Learn More

The National Science Advisory Board for Biosecurity (NSABB) is a federal advisory committee that addresses issues related to biosecurity and dual use research of concern.

In March 2023, NSABB published a report titled Proposed Biosecurity Oversight Framework for the Future of Science to inform government policy evaluations and further development of detailed guidance towards a more comprehensive and integrated framework for research oversight. The recommendations therein will likely be reflected in any future changes to DURC and PPP practices, so we strongly advise you to review the report.

For further instruction on laboratory risk management, check out the Science, Safety, Security website.

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