Dual-Use Research of Concern (DURC)

By Dr. Zubair Khalid, DVM, MS, PhD · 2026-08-28

Quick Answer

• Screen every life-science experiment for dual-use potential before starting work, using a structured risk-scoring tool that examines agent, experiment type, and information transfer pathways.
• Document your screening decision in writing, including the rationale and any mitigation measures, so the assessment is reproducible and reviewable by institutional oversight.
• A screening tool supports judgment but does not replace institutional policy, federal regulations, or the expertise of a biosafety officer or institutional review body.

At a Glance

Understanding Dual-Use Research of Concern

Dual-use research of concern refers to life-science experiments that generate information or products that could be misapplied to threaten public health, agriculture, or national security. The same experiment that helps a researcher understand how a pathogen spreads can also provide a blueprint for someone who intends to cause harm. This is not a hypothetical concern. Institutional biosafety committees, funding agencies, and publication venues now expect researchers to consider the dual-use implications of their work before they begin.

The practical problem for a biosafety officer or researcher is straightforward. You need a method to screen experiments for dual-use potential and implement mitigation strategies without slowing down legitimate research. The method must be systematic, documented, and defensible. It must also be flexible enough to apply to different kinds of experiments, from gene editing in bacteria to synthetic biology projects that assemble novel genetic circuits.

The National Library of Medicine provides a gateway to authoritative biomedical books and research-method references that can help you understand the scientific context of your work. The EQUATOR Network offers reporting guidelines that support transparent research reporting, which matters when you describe your methods and findings in a way that is both useful and responsible. The Committee on Publication Ethics core practices cover authorship, peer review, data handling, conflicts of interest, and misconduct, all of which are relevant when you publish work that has dual-use potential.

Core Principles of Dual-Use Screening

The Purpose of Screening

Screening is a decision tool. It helps you identify experiments that need additional review, not experiments that should be stopped. Most life-science research is safe and beneficial. The screening process is designed to catch the small fraction of experiments that could produce information or materials with significant dual-use potential.

The screening should be done at the planning stage, before you order materials, before you start the experiment, and before you submit a funding application. This timing matters because it is much easier to design mitigation measures into an experiment than to add them after the work is done.

The Role of Institutional Oversight

Your institution has a biosafety committee or an institutional review body that is responsible for overseeing research with biological materials. The screening you do at the laboratory level feeds into that institutional process. You are not making the final decision about whether your work is dual-use research of concern. You are providing the information and analysis that allows the institutional body to make that decision.

The National Institutes of Health grants and funding pages describe the official grant policy, application, review, and award-management context. If your research is funded by the NIH, the funding agency has specific expectations about how you manage research that could have dual-use implications. Your institutional biosafety committee will be aware of these expectations and will expect your screening to align with them.

The Distinction Between Evidence and Judgment

The screening process combines evidence and judgment. The evidence includes the properties of the agent you are working with, the nature of the experiment, and the potential outcomes. The judgment is about how to weigh that evidence and what mitigation measures are appropriate.

You should be clear about the difference between evidence and judgment in your documentation. If you are uncertain about the dual-use potential of an experiment, that uncertainty should be recorded. The institutional review body can then decide whether additional review is needed.

The Screening Checklist

Step 1: Identify the Agent and Material

The first step is to identify the agent or material you are working with. This includes the species, strain, or construct, and the properties that are relevant to dual-use potential. The properties to consider include pathogenicity, virulence, host range, transmissibility, and the ability to evade countermeasures.

For gene editing work, the agent is the editing system and the target sequence. For synthetic biology, the agent is the assembled construct or the organism that carries it. For animal research, the agent is the pathogen or the biological material that is being studied.

Step 2: Describe the Experiment

The second step is to describe the experiment in enough detail that a reviewer can understand what you are doing. This includes the experimental design, the methods, the controls, and the expected outcomes. The description should be written in plain language that a reviewer who is not a specialist in your field can understand.

The description should also include the scale of the work. A small-scale experiment in a single laboratory is different from a large-scale production run. The scale affects the risk assessment and the mitigation measures.

Step 3: Assess the Potential Outcomes

The third step is to assess the potential outcomes of the experiment. This includes the intended outcomes and the unintended outcomes. The intended outcomes are the results you expect to obtain. The unintended outcomes are the results that could occur if the experiment does not work as planned or if the results are misused.

The assessment should consider the potential for the experiment to enhance the harmful properties of the agent. This includes the potential to increase transmissibility, toxicity, or the ability to evade countermeasures.

Step 4: Evaluate the Transfer Pathways

The fourth step is to evaluate the transfer pathways. This includes the ways in which the results of the experiment could be shared or transferred. This includes publication, data sharing, material transfer, and commercial delivery.

The transfer pathway matters because it affects the risk of misuse. A result that is published in an open-access journal is more accessible than a result that is shared only with a small group of collaborators. The transfer pathway also affects the mitigation measures that are appropriate.

Step 5: Score the Risk

The fifth step is to score the risk. The scoring is a structured way to combine the information from the previous steps. The scoring is not a mathematical formula. It is a way to organize the information and to identify the experiments that need additional attention.

A simple scoring system uses a scale of 1 to 5 for each of the four elements. The scores are then added to give a total score. The total score is used to determine the level of review that is needed.

Step 6: Document the Assessment

The sixth step is to document the assessment. The documentation should include the information from the five steps, the risk score, and the rationale for the score. The documentation should also include the mitigation measures that are planned.

The documentation should be written in a way that is clear and auditable. A reviewer should be able to understand the assessment and the rationale without having to ask you for additional information.

Mitigation Strategies

Reducing the Risk of the Agent

The first mitigation strategy is to reduce the risk of the agent. This includes using a less pathogenic strain, removing the genes that contribute to pathogenicity, or using a surrogate agent that is less harmful.

This strategy is most effective when it is applied at the planning stage. If you can design the experiment to use a less harmful agent, the risk of the experiment is reduced before you begin.

Reducing the Risk of the Experiment

The second mitigation strategy is to reduce the risk of the experiment. This includes limiting the scale of the experiment, using containment measures, and using the inactivation methods.

The containment measures include the physical containment of the experiment, the use of biosafety cabinets, and the use of personal protective equipment. The inactivation methods include the chemical or physical inactivation of the agent after the experiment is complete.

Reducing the Risk of the Outcome

The third mitigation strategy is to reduce the risk of the outcome. This includes the publication of the results in a way that limits the risk of misuse. This includes the removal of the details that could be misused, the delay of the publication, or the publication of the results in a restricted venue.

The publication strategy should be discussed with the institutional review body before the results are submitted for publication. The Committee on Publication Ethics core practices provide context for the responsible handling of research results, including the handling of results that could be misused.

Reducing the Risk of the Transfer

The fourth mitigation strategy is to reduce the risk of the transfer. This includes the use of material transfer agreements, the restriction of the sharing of the material, and the use of the data-sharing agreements.

The National Institutes of Health data management and sharing policy provides the expectations for data management and sharing for NIH-funded research. The policy requires a data-management plan that addresses the sharing of the data. The plan should address the dual-use implications of the data.

Practical Implementation

When to Screen

The screening should be done at the planning stage of the experiment. This is before you order the reagents, before you begin the experiment, and before you submit the funding application. The screening should be repeated if the experiment changes in a way that affects the risk.

Who Should Screen

The screening should be done by the researcher who is responsible for the experiment. The researcher is the person who knows the details of the experiment and the potential outcomes. The researcher should consult with the biosafety officer or the institutional review committee if there is any uncertainty.

How to Document the Screening

The screening should be documented in a written form. The documentation should include the information from the four steps, the risk score, and the rationale for the score. The documentation should also include the mitigation measures that are planned.

The documentation should be kept in the laboratory records and should be available for review by the institutional review committee. The documentation should be updated if the experiment changes.

Records and Measurements

What to Record

The records should include the date of the screening, the name of the researcher who performed the screening, the description of the experiment, the risk score, and the rationale for the score. The records should also include the mitigation measures that are planned and the date of the review by the institutional review committee.

How to Use the Records

The records are used to demonstrate that the screening was done and to provide the information for the institutional review. The records are also used to track the experiments that have been screened and to identify the experiments that need additional attention.

How to Review the Records

The records should be reviewed periodically to ensure that the screening is being done consistently and that the mitigation measures are being implemented. The review should be done by the biosafety officer or the institutional review committee.

Common Failure Patterns

Failure to Screen at the Planning Stage

The most common failure is to screen the experiment after it has already begun. This is a problem because the mitigation measures are more difficult to implement after the experiment has started. The screening should be done at the planning stage.

Failure to Document the Screening

The second common failure is to do the screening but not to document it. This is a problem because the screening cannot be audited and the institutional review committee cannot review the assessment. The documentation is a required part of the screening process.

Failure to Update the Screening

The third common failure is to not update the screening when the experiment changes. This is a problem because the risk of the experiment may change when the experiment changes. The screening should be repeated if the experiment changes in a way that affects the risk.

Failure to Escalate the Assessment

The fourth common failure is to not escalate the assessment to the institutional review committee when the risk score is high. This is a problem because the institutional review committee is responsible for the final decision about the dual-use potential of the experiment. The researcher should escalate the assessment when the risk score is high.

Limitations and Professional Escalation

Limitations of the Screening

The screening is a tool to identify the experiments that need additional attention. The screening is not a substitute for the judgment of the institutional review committee. The screening is also not a substitute for the federal regulations that apply to the research.

The screening is also limited by the information that is available. If the information about the agent or the experiment is incomplete, the screening may not identify the risk. The researcher should be aware of the limitations of the screening and should escalate the assessment when there is uncertainty.

When to Escalate

The researcher should escalate the assessment to the institutional review committee when the risk score is high, when there is uncertainty about the risk, or when the mitigation measures are not sufficient. The researcher should also escalate the assessment when the experiment changes in a way that affects the risk.

How to Escalate

The escalation is done by submitting the documentation to the institutional review committee. The documentation should include the information from the four steps, the risk score, and the rationale for the score. The documentation should also include the mitigation measures that are planned.

Safety and Regulatory Context

The Role of the Institutional Biosafety Committee

The institutional biosafety committee is responsible for the review of the research that involves the biological agents. The committee reviews the research to ensure that it is conducted safely and that the risks are managed. The committee also reviews the research for dual-use potential.

The Role of the Funding Agency

The funding agency is responsible for the review of the research that is funded by the agency. The funding agency reviews the research to ensure that it is conducted responsibly. The funding agency also reviews the research for dual-use potential.

The National Institutes of Health grants and funding provides the official context for the NIH grant policy, application, review, and award-management. The NIH expects the researchers to manage the dual-use implications of their research.

The Role of the Researcher

The researcher is responsible for the conduct of the research. The researcher is responsible for the screening of the experiment for dual-use potential. The researcher is also responsible for the implementation of the mitigation measures.

The researcher is also responsible for the publication of the results. The researcher should consider the dual-use implications of the results before the publication. The Committee on Publication Ethics core practices provide the context for the ethical considerations of the publication.

A Practical Decision Framework for Escalation and Mitigation Selection

The screening checklist identifies experiments that need attention, but it does not tell you what to do next. A distinct decision framework helps you move from risk score to concrete action. This framework separates experiments into three tiers and links each tier to specific mitigation measures and escalation requirements.

Tier Assignment Based on Risk Score

Assign each screened experiment to one of three tiers. The tier determines the level of review and the mitigation measures that apply.

Tier 1: Routine Research

Tier 1 applies to experiments with a total risk score of 4 to 8. These experiments use agents with low pathogenicity, involve minimal amplification or modification, and have restricted transfer pathways. The outcomes do not suggest any enhancement of harmful properties.

For Tier 1 experiments, the researcher documents the screening and proceeds with standard biosafety practices. No additional institutional review is required beyond the normal biosafety approval. The documentation stays in the laboratory records and is available for audit.

Tier 2: Enhanced Review

Tier 2 applies to experiments with a total risk score of 9 to 14. These experiments involve agents with moderate pathogenicity, some amplification or modification, or transfer pathways that are controlled but not restricted. The outcomes may suggest some enhancement of harmful properties.

For Tier 2 experiments, the researcher must submit the screening documentation to the institutional biosafety committee or the designated review body before starting the work. The review body determines whether the experiment qualifies as dual-use research of concern and which mitigation measures are required. The researcher cannot begin the experiment until the review is complete.

Tier 3: Institutional Escalation

Tier 3 applies to experiments with a total risk score of 15 to 20. These experiments involve highly pathogenic agents, significant amplification or modification, or open transfer pathways. The outcomes suggest significant enhancement of harmful properties.

For Tier 3 experiments, the researcher must escalate the assessment to the institutional review body immediately. The review body must determine whether the experiment qualifies as dual-use research of concern and whether the work should proceed at all. The researcher must not begin the experiment until the review body issues a written decision.

Selecting Mitigation Measures by Risk Element

The tier tells you the level of review, but you still need to select specific mitigation measures. Use the highest-scoring element from your screening to guide the selection.

When the agent score is high

If the agent score is 4 or 5, focus on reducing the risk of the agent. Use a less pathogenic strain, remove the genes that contribute to pathogenicity, or use a surrogate agent that is less harmful. Document the substitution in the screening form and note the reason for the change.

When the experiment score is high

If the experiment score is 4 or 5, focus on reducing the risk of the experiment. Limit the scale of the work, use additional containment measures, or add inactivation steps after the experiment is complete. The containment measures include physical containment, biosafety cabinets, and personal protective equipment.

When the outcome score is high

If the outcome score is 4 or 5, focus on reducing the risk of the outcome. This includes the publication strategy. Discuss the publication plan with the institutional review body before you submit the results. The Committee on Publication Ethics core practices provide context for the responsible handling of research results, including the handling of results that could be misused.

When the transfer score is high

If the transfer score is 4 or 5, focus on reducing the risk of the transfer. Use material transfer agreements, restrict the sharing of the material, and use data-sharing agreements that address the dual-use implications. The National Institutes of Health data management and sharing policy provides the expectations for data management and sharing for NIH-funded research.

A Worked Example for Gene Editing

Consider a researcher who plans to edit a gene in a moderately pathogenic strain of bacteria to study its virulence mechanisms. The agent score is 3 because the strain has moderate pathogenicity. The experiment score is 4 because the editing could enhance the harmful properties of the strain. The outcome score is 3 because the results could inform countermeasure development but could also be misused. The transfer score is 2 because the results will be published in an open-access journal.

The total score is 12, which places the experiment in Tier 2. The researcher must submit the screening documentation to the biosafety committee before starting the work. The committee reviews the assessment and requires the researcher to use a less pathogenic strain where possible, limit the scale of the experiment, and delay the publication until the committee has reviewed the results.

A Worked Example for Synthetic Biology

Consider a researcher who plans to assemble a novel genetic circuit that could produce a toxin. The agent score is 5 because the construct involves a toxin gene. The experiment score is 5 because the assembly involves significant modification. The outcome score is 5 because the construct could produce a harmful product. The transfer score is 3 because the results will be shared with a small group of collaborators.

The total score is 18, which places the experiment in Tier 3. The researcher must escalate the assessment to the institutional review body immediately. The review body determines that the experiment qualifies as dual-use research of concern and requires the researcher to use a non-toxic surrogate gene, restrict the sharing of the construct, and publish the results in a restricted venue.

Recording the Decision

The decision framework requires a separate record from the screening form. The record should include the tier assignment, the rationale for the tier, the mitigation measures selected, and the date of the institutional review. The record should also include the name of the reviewer who approved the tier and the mitigation measures.

The record should be kept with the screening documentation in the laboratory records. The record should be updated if the experiment changes in a way that affects the tier or the mitigation measures.

Common Failure Patterns in the Decision Framework

The most common failure is to assign an experiment to the wrong tier. This happens when the researcher does not score the elements accurately or does not consider the transfer pathway. The second common failure is to select mitigation measures that do not address the highest-scoring element. The third common failure is to begin the experiment before the institutional review is complete. The fourth common failure is to not update the tier when the experiment changes.

When to Escalate Beyond the Framework

The framework is a decision tool, not a substitute for judgment. You should escalate the assessment to the institutional review body when the risk score is high, when there is uncertainty about the risk, or when the mitigation measures are not sufficient. You should also escalate the assessment when the experiment changes in a way that affects the risk. The institutional review body is responsible for the final decision about the dual-use potential of the experiment.

Frequently Asked Questions

What is dual-use research of concern?

Dual-use research of concern is life-science research that may generate information or products that could be misused to threaten the public, agriculture, or national security. The same experiment that enables a researcher to understand a pathogen can also provide information that could be used to cause harm.

Who is responsible for the screening of the experiments?

The researcher who is responsible for the experiment is responsible for the screening. The researcher should screen the experiment at the planning stage and document the assessment. The researcher should also escalate the assessment to the institutional review committee when the risk score is high.

What is the role of the institutional biosafety committee?

The institutional biosafety committee is responsible for the review of the research that involves biological agents. The committee reviews the research to ensure that the research is conducted safely and that the risks are managed. The committee also reviews the research for dual-use potential.

What is the role of the funding agency?

The funding agency is responsible for the review of the research that is funded by the agency. The funding agency reviews the research to ensure that the research is conducted with the appropriate oversight. The funding agency also reviews the research for dual-use potential.

What is the role of the publication venue?

The publication venue is responsible for the review of the research that is submitted for publication. The publication venue reviews the research to ensure that the research is reported in a way that is responsible. The publication venue also reviews the research for dual-use potential.

What are the mitigation measures for dual-use research?

The mitigation measures include the reduction of the risk of the agent, the reduction of the risk of the experiment, the reduction of the risk of the outcome, and the reduction of the risk of the transfer. The mitigation measures are implemented by the researcher and the institutional review committee.

What are the limitations of the screening?

The screening is a tool that identifies the risk of the experiment. The screening is not a substitute for the judgment of the institutional review committee. The screening is also not a substitute for the federal regulations. The screening is limited by the information that is available.

When should the researcher escalate the assessment?

The researcher should escalate the assessment when the risk score is high, when there is uncertainty about the risk, or when the mitigation measures are not sufficient. The researcher should also escalate the assessment when the experiment changes in a way that affects the risk.

Related Articles

• Understanding Internal Validity in Research: Threats and Mitigation Strategies
• Intercoder Reliability in Research: A Practical Guide
• Ethical Considerations in Research: A Practical Guide for Scientists
• Reproducible Research in R: A Practical Guide for Life Scientists
• What Is a Data Dictionary? A Practical Guide for Research Teams

References and Further Reading

• Research Methods Resources. National Library of Medicine.
• EQUATOR Network. EQUATOR Network.
• Core Practices. Committee on Publication Ethics.
• NIH Grants and Funding. National Institutes of Health.
• ORCID for Researchers. ORCID.
• Data Management and Sharing Policy. National Institutes of Health.
• NCBI Literature Resources. National Center for Biotechnology Information.
• PubMed. National Library of Medicine.

This article is educational and does not replace institutional policy, professional advice, or applicable safety and regulatory requirements.