Dual-Use Research of Concern (DURC)

Dual-Use Research of Concern (DURC) is a defined regulatory category, not a general label for any research with security implications. Under the US Government’s DURC policy framework, a study is DURC only when it is (1) life-sciences research involving one of a specific, enumerated list of 15 highly dangerous select agents and toxins, and (2) reasonably anticipated to produce knowledge, products, or technology that falls into one of seven defined categories of experiments of concern — for example, work that could plausibly enhance an agent’s transmissibility or virulence, confer resistance to available medical countermeasures, or increase an agent’s stability, dispersal potential, or ability to evade detection or immune protection. A study can involve a listed agent without being DURC (most work with these agents is not), and a study can raise legitimate biosecurity concern without meeting the formal DURC definition — the two-part test is what distinguishes DURC from the broader, informal idea of “dual-use” research.

Why “dual-use” and “DURC” are not interchangeable

Almost all biomedical and life-sciences research is dual-use in the loose sense: knowledge that helps develop a vaccine could, in principle, also inform how to make a pathogen more dangerous. DURC is the US government’s attempt to narrow that broad, unworkable category down to a specific, auditable subset that institutions can actually screen for — the enumerated agent list plus the seven experiment categories. This is also why DURC review sits alongside, not inside, an institution’s routine biosafety review: a protocol can be fully compliant on containment (see Biosafety Level (BSL)) and still separately trigger DURC review because of what the experiment is designed to demonstrate, not how it is physically contained.

The US government policy framework

DURC oversight in the United States rests on a sequence of federal policies, not a single statute:

• 2012 — USG Policy for Oversight of DURC. Directed federal funding agencies to identify DURC among the projects they fund or conduct and to work with the responsible institution and investigator to develop a risk-mitigation plan before funding or continuing the work.
• 2014 — USG Policy for Institutional Oversight of Life Sciences DURC. Pushed the review obligation down to the institution itself: any US institution that receives federal funding for life-sciences research involving the 15 listed agents/toxins had to establish an institutional review process — typically run through an Institutional Review Entity (IRE), often the same body as, or working alongside, the Institutional Biosafety Committee — by September 24, 2015.
• 2024 — USG Policy for Oversight of DURC and Pathogens with Enhanced Pandemic Potential (DURC/PEPP). Replaced and combined the 2012/2014 policies with the oversight framework for gain-of-function-type research on potential pandemic pathogens (see below), broadening and updating the scope and review process. A May 5, 2025 executive order directed federal departments and agencies to revise or replace this 2024 policy, so institutions should confirm the current, agency-specific version of the DURC/PEPP framework rather than assuming the 2024 text is still the final word.

Because this policy area has changed twice in just over a decade and is under active revision again, institutional biosafety or research-security offices — not this page — are the authoritative source for exactly which version governs a given active award.

Relationship to P3CO and gain-of-function research

A related but distinct oversight track covers Potential Pandemic Pathogen Care and Oversight (P3CO) — research that could plausibly generate a pathogen with enhanced transmissibility or virulence in humans sufficient to cause a pandemic (the category popularly, if imprecisely, called “gain-of-function” research). P3CO review applies a higher, agency-level pre-funding scrutiny to a narrower set of especially high-consequence experiments than general DURC review does. The 2024 DURC/PEPP policy folded this pathogens-with-enhanced-pandemic-potential (PEPP) oversight into the same combined framework as DURC, rather than treating them as two fully separate tracks — but PEPP-level research still triggers additional, more intensive review beyond standard DURC review, not a substitute for it.

Institutional review mechanisms

Two institutional bodies typically do the work of DURC oversight, and they are not identical even where the same committee performs both roles:

• Institutional Biosafety Committee (IBC). Required under the NIH Guidelines for any institution conducting recombinant or synthetic nucleic acid research, the IBC reviews containment (Biosafety Level assignment) and lab practice. DURC review is complementary to IBC biosafety review, not a substitute for it or vice versa — a protocol can clear IBC containment review and still need separate DURC screening because of what the experiment demonstrates, not how it is contained.
• Institutional Review Entity (IRE). The body the 2014/2024 policies specifically require for DURC screening. Many institutions designate their existing IBC (sometimes expanded with additional biosecurity or national-security expertise) as the IRE rather than standing up a wholly separate committee; some maintain a distinct DURC/biosecurity review body instead. Either way, the IRE is responsible for identifying whether a project meets the two-part DURC test, and, if so, working with the investigator and funding agency on a risk-mitigation plan (which can range from added biosafety controls to review of publication or data-sharing plans before dissemination).

Export control relevance

DURC oversight and export control are separate legal regimes that frequently apply to the same project. A life-sciences project can be DURC, export-controlled, both, or neither:

• DURC status depends on the agent and the experiment category, evaluated by the IBC/IRE under NIH/USG biosecurity policy.
• Export-control status depends on whether the technology, equipment, software, or technical data involved is listed on the Commerce Control List (EAR) or US Munitions List (ITAR), evaluated by the institution’s export control office — see Export Control (EAR/ITAR) and International Research Collaboration.
• A project involving DURC-relevant select agents that also involves a foreign national accessing controlled technical data or equipment can require both DURC risk mitigation and a Technology Control Plan (TCP) to manage deemed-export exposure — the two reviews run in parallel, coordinated between the biosafety and export-control offices, not one substituting for the other.

Worked example

A university virology lab studies a select-agent influenza strain to identify mutations that increase its transmissibility between mammals, in order to understand pandemic risk factors and inform vaccine design. This meets the DURC two-part test: the agent is on the select-agent list, and “enhances transmissibility” is one of the defined experiment categories. The project proceeds, but only after the IRE/IBC reviews and approves a risk-mitigation plan — which may include enhanced containment, restricted access, a data- and publication-review step, and, if any collaborator is a foreign national with access to controlled methodology, coordination with the export control office on deemed-export exposure.

Counter-example

A lab sequences a select-agent pathogen’s genome using a standard, previously published protocol solely to confirm diagnostic identification of a clinical sample. The work uses a listed agent, but the intent and anticipated outcome is diagnostic confirmation, not an outcome in any of the seven experiment-of-concern categories — standard select-agent biosafety and security controls apply, but the project does not meet the DURC definition on its own and would not, by itself, require DURC-specific review.

Related terms

See also Biosafety Level (BSL), Biosafety Level 3 (BSL-3), Biosafety Level 4 (BSL-4), Technology Control Plan (TCP), and Export Control (EAR/ITAR) and International Research Collaboration.