Dual-Use Research

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. The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research. For further information, please visit the NIH Office of Science Policy (OSP) webpage on Dual Use Research of Concern. Additional resources on DURC are available on the HHS Science Safety and Security (S3) website.

Oversight Related to Dual Use Research within the Intramural Research Program

Education

Sensitivity regarding the potential dual use implications of any research is discussed with all scientific research personnel and is imparted through regular training in the responsible conduct of research. The Office of Scientific Policy (OSP) has an online resource page for dual use research, and gain-of-function (GOF) research recommended NIH-wide for all new scientific staff. A set of educational tools including case studies, FAQs and a training slide set has been developed to assist institutions, investigators, and IREs in the development of policies and practices for the effective oversight of DURC. These materials also include a Companion Guide, entitled Tools for the Identification, Assessment, Management, and Responsible Communication of Dual Use Research of Concern, that is recommend as a useful resource for staff. The DURC review process is structured to identify dual use concerns early in the screening process (e.g., concept, pre-IBC review, etc.), and for institutional leadership to work closely with Principal Investigators (PIs) to ameliorate dual use concerns well before publication review.

Oversight and Review of DURC and PPP at NIH

The Dual Use Research of Concern Institutional Review Entity (DURC-IRE) implements internal policies and practices that provide for the identification and the effective oversight of DURC and Pathogen of Pandemic Potential (PPP) within the NIH intramural research program. The Director, Division of Occupational Health and Safety (DOHS), NIH, serves as the NIH Institutional Contact for Dual Use Research (ICDUR) as specified within the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. The DURC-IRE is the authority for the review of all dual-use matters, including oversight and approval for work that falls into the P3CO Framework. The DURC-IRE delegates the preliminary review of all research for potential DURC, with the exception of research including any of the 15 agents subject to the USG policy, to the Institutional Biosafety Committees (IBC). Research protocols involving any of the 15 agents will be immediately sent to the IRE for review, in parallel to IBC review. The IBC reviews all biological registrations for DURC, not just those involving the 15 specified biological agents as required by the policy and requires the PI to consider dual use concerns on an annual basis during the conduct of research. Investigators must carefully consider whether their research can be reasonably anticipated to produce one or more of the seven “experimental effects” listed in the policy (see list below).

The DURC-IRE committee will be the NIH authoritative review body for any research that may meet the definition of DURC after review by any of the IBCs and shall review all projects including the 15 agents as outlined in the USG policy, as well as research that may create a PPP. Research proposals potentially related to DURC, or PPP research will require a Dual Use Research Mitigation plan (DURMP) be completed, if not already done for the initial IBC review. The DURC-IRE may also be convened for manuscript clearances for research results that have been flagged as potential DURC or involve any of the experimental effects described in the policy. The DURC-IRE is the final authority to determine if the proposed mitigation plan is acceptable and research or publication may proceed. The conduct and/or communication of the research findings must adhere to the risk management approaches outlined in the plan with ongoing oversight by the IBCs at the location of the research laboratory.

Seven Experimental Effects

Researchers are asked whether their research can be reasonably anticipated to produce one or more of the seven experimental effects/categories listed below. These questions are answered during the NIH electronic biological registration submission process and considered during the annual review of research. A Dual Use Screening Survey form is available for illustrative purposes that summarizes these questions.

Will the intermediate or final products of your research:

1. Enhance the harmful consequences of the agent or toxin?
2. Disrupt immunity or the effectiveness of an immunization against the agent or toxin?
3. Confer to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitate their ability to evade detection methodologies?
4. Increase the stability, transmissibility, or ability to disseminate the agent or toxin?
5. Alter the host range or tropism of the agent or toxin?
6. Enhance the susceptibility of a host population to the agent or toxin?
7. Generate or reconstitute an eradicated or extinct agent or toxin or will synthetic biology techniques be used to construct a pathogen, toxin, or potentially harmful product?

Affirmative answers do not automatically indicate research is DURC, nor will it usually delay experimental progress, it will indicate further consideration or awareness is warranted as the research advances, or as research results are published. For any question answered ‘yes’, investigators are asked to provide additional information to explain how the concern is addressed, and to allow for an assessment of all parameters related to the experimental result to demonstrate whether DURC criteria are met. If the criteria defining DURC is potentially met (in that the immediate products of the research could be readily used to do harm), the IRE will work with the PI to perform a risk assessment and develop the DURMP for IRE review.

Manuscript Clearance

Prior to submitting a manuscript for publication, the Principal Investigator (PI) must submit a Manuscript Clearance Form through the Scientific Director, which specifically monitors for potential dual use issues. If there is concern about dual use issues, the matter is referred to the IRE.