Federal Regulations
NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES
An institution must follow the NIH Guidelines if it receives any funding from the NIH for research involving recombinant or synthetic nucleic acid molecules. Even if only one research project involving recombinant or synthetic nucleic acid molecules at an institution benefits from NIH support, all such projects conducted at or sponsored by that institution must comply with the NIH Guidelines. Also, adherence to the NIH Guidelines may be a condition of support from other federal agencies, or even private funders of research.
Finally, regardless of NIH funding, institutions may be subject to local ordinances, federal or state regulations, or agency guidelines that require compliance with the NIH Guidelines.
View NIH’s FAQ’s on Institutional Biosafety Committee (IBC) Administration page for additional information.
DURC
Biological research is considered ‘dual-use’ in nature if the methodologies, materials, or results could be used to cause harm. Dual Use Research of Concern (DURC) is a small subset of 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, materiel, or national security. For further information, please visit the NIH Office of Science Policy (OSP) webpage on Dual Use Research of Concern.
PEPP
The NIH has issued agency-specific information regarding its implementation of the U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC/PEPP Policy). The policy, which goes into effect May 6, 2025, is a unified federal oversight framework for conducting and managing certain types of federally funded life sciences research on biological agents and toxins.
The DURC/PEPP Policy requirements apply to all NIH-funded research, including grants and cooperative agreements, Research and Development (R&D) contracts, NIH intramural research projects, and other funding agreements. For more details, see the full Guide Notice.
Select Agents and Toxins
Biological agents and toxins that the Federal Select Agent Program (HHS and USDA) has determined to pose a severe threat to both human and animal health, to plant health, or to animal and plant products are known as Select Agents/Toxins. Any microorganism or toxin capable of harming living organisms or the environment, regardless of its origin (naturally occurring, engineered or synthesized) can be classified as a select agent.
The Select Agent Program maintains a List of Select Agents and Toxins along with exemptions and exclusions.
More information can be found on the NIH Select Agent Program page.