Navigating Dual Use Research of Concern in 2024

Key Takeaways

• Dual Use Research of Concern (DURC) is a small subset of life sciences research that poses potential risks.
• The Dual Use Research of Concern Institutional Review Entity (DURC-IRE) oversees DURC and delegates preliminary review to Institutional Biosafety Committees.
• Researchers must consider whether their work can produce “experimental effects” that could be misused.
• The DURC-IRE is the final authority to determine if a Dual Use Research Mitigation plan is acceptable.
• A Manuscript Clearance Form is required before submitting a manuscript to monitor potential dual use issues.

Understanding Dual Use Research of Concern (DURC)

Dual Use Research of Concern (DURC) is a key topic in life sciences. It’s about research that could be used for harm, like threats to health or national security¹. This research is a worry because it’s hard to tell when it could be used for good or bad.

Defining DURC and Dual Use Research

Dual use research is when studies could help or hurt². DURC is a part of this research that could cause big problems if misused. It’s important to know the difference to manage research safely.

Scope and Potential Risks of DURC

DURC covers many areas, like studying dangerous agents and toxins². These studies could lead to bad effects, like making diseases worse or spreading them further². The risks are huge, from health crises to threats to national security. That’s why we need strong rules and ways to reduce risks.

“Dual use research of concern is a critical issue at the intersection of life sciences research, public health, and national security. Navigating this complex landscape requires a collaborative and proactive approach from researchers, institutions, and policymakers.”

Regulatory Framework for DURC Oversight

The United States has a detailed system to watch over dual-use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPPs). This system has changed over time. The government updates its rules to meet new challenges and keep oversight effective. The latest changes aim to make DURC and PEPP research in the United States more unified and efficient³.

Evolution of DURC Policies in the United States

The U.S. Government’s watch over DURC has seen big changes over the years. The first policy started in 2015 and has been updated several times, with the latest changes on April 29, 2024³. These updates show the government’s effort to keep up with DURC and PEPP challenges.

The changing rules for DURC oversight in the United States show the government’s dedication to tackling the tough issues of dual-use research and PEPPs. By making its policies better and strengthening oversight at institutions, the U.S. aims to ensure this important research is done safely and responsibly.

Navigating Dual Use Research of Concern in 2024

Unified Policy Guidance for DURC and Pandemic Potential Pathogens

The updated policy from the Office of Science and Technology Policy (OSTP) makes it clear what the U.S. stands on Dual Use Research of Concern (DURC) and pandemic pathogens⁵. It gives detailed advice to everyone in the research process, from lead researchers to review boards. It also makes OSTP the main body in charge of this important policy⁵.

Transition Period and Implementation Strategies

The new DURC policy will have a one-year transition before it fully starts on May 6, 2025⁵. During this time, OSTP will work closely with researchers, institutes, and funding agencies to help them adjust to the new policy⁵. This teamwork will help the research world get used to the changes and make sure the new policy works well⁵.

The OSTP’s unified policy aims to give a clear and consistent way to handle DURC and pandemic pathogens in 2024 and later⁵. This approach will help make sure life sciences research is done responsibly and reduce risks from dual-use technologies⁵.

Expanding the Scope of DURC Review

The new policy on Dual Use Research of Concern (DURC) has two risk categories. These categories are broader than before. Synthetic biology and new technologies mean we need to review DURC more widely.

For agents without a risk group or Biosafety Level, a risk assessment is needed. This is done by an institutional body to find the right Biosafety Level for the experiment⁶. If an agent needs Biosafety Level 3 or 4, it’s seen as Category 1 or 2. This means it gets more careful review.

• The new DURC policy tackles the complex risks of synthetic biology and other life sciences research⁷.
• It looks at a broader range of pathogens and agents that could be dangerous⁷.
• The changes aim to make oversight smoother across different rules, combining DURC, P3CO, and other policies⁸.

The aim is to keep the DURC review strong and flexible. This matches the fast pace of life sciences and tech innovations⁷. Institutions and researchers must identify and assess risks in their work. They will get help from updated policies and resources.

By broadening DURC review, the policy aims to protect public health and national security. It also aims to keep scientific research honest while pushing forward in the life sciences⁸.

Risk Assessment and Mitigation Strategies

Dealing with Dual Use Research of Concern (DURC) in 2024 needs a strong plan for risk assessment and mitigation. The new policy outlines clear steps for assessing potential risks. It explains what it means to “reasonably anticipate” risks and how this will be applied². It says experts in science would expect certain outcomes to happen, but not with complete certainty. This approach makes everyone share the responsibility of weighing risks and benefits.

Determining Appropriate Biosafety Levels

Researchers must check if their work involves dangerous agents or could lead to harmful effects². The Institutional Review Entity (IRE) looks over research on 15 DURC agents and toxins². The IRE tells the PI and the U.S. funding agency if research is DURC within 30 days². Every year, the IRE reviews all DURC Risk Mitigation Plans at the University².

Export licenses are needed for DURC agents and to limit foreign access to related info². Getting a license takes at least six weeks². Main institutions must make sure sub-awardees follow DURC rules, and a stricter standard applies if there’s a difference².

There are many government policies and guides on DURC oversight, like the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern². The DURC policy covers 15 specific pathogens and toxins, including Highly pathogenic avian influenza viruses, Bacillus anthracis, and Ebola virus⁹. It lists seven types of experiments, like those that make agents more harmful or change where they can infect⁹.

If a policy is broken, the government can take away funding, affecting one person or the whole institution⁹. Right now, there are a few hundred government-funded projects on the 15 listed agents, but only a few are seen as DURC under the 2012 policy⁹. Even non-government-funded research on these agents must follow the policy if they get government funds for other research⁹.

The process for DURC includes a 90-day risk assessment and a 60-day plan for risk mitigation⁹. The deadline to answer the Request for Information (RFI) on DURC and P3CO is October 16, 2023, at 11:59 p.m. Eastern Time⁸. It’s advised to keep responses under ten (10) pages in 12 point or larger font⁸.

Redefining “Reasonably Anticipated” Outcomes

The new policy changes how we look at scientific research. It updates the term “reasonably anticipated” to mean “an assessment of an outcome that experts in the field would expect to happen with some chance¹⁰. It’s not about being sure the outcome will happen. It’s about what experts think might happen, but not with certainty¹⁰. This approach makes everyone share the responsibility for looking at the risks and benefits of research¹⁰.

This system means researchers and government agencies work together. Researchers lead the way, and government agencies help with resources and checks¹⁰. This is especially true for research that could have both good and bad.

Shared Responsibility in Risk-Benefit Evaluation

Now, researchers and government agencies share the duty of looking at the risks and benefits of research. Researchers must be proactive in spotting and reducing risks. At the same time, government agencies offer advice, tools, and oversight to make sure research is done right¹⁰.

This new way of doing things aims to balance scientific progress with careful risk management. It encourages a sense of shared responsibility in the research world.

Institutional Oversight and Review Mechanisms

The DURC oversight is led by the Dual Use Research of Concern Institutional Review Entity (DURC-IRE). This committee makes sure to check and manage DURC and Pathogen of Pandemic Potential (PPP) in the NIH’s research⁸. The DURC-IRE is in charge of reviewing all dual-use research, following the P3CO Framework⁸.

The DURC-IRE has set up a system to check research for possible DURC before the final review. This task is given to the Institutional Biosafety Committees (IBC) for most research, except for work with certain dangerous agents⁸. This way, the review process is thorough and ensures the NIH’s research is safe and sound.

Ongoing Policy Review and Harmonization

The review of DURC oversight policies has three main goals. First, it aims to combine different Federal policies into one. Second, it looks at broadening the policy to cover more pathogens and toxins. Third, it focuses on improving oversight for life sciences research⁸. The U.S. Government believes that good institutional review and research oversight builds trust in life sciences research⁸.

The Office of Science and Technology Policy (OSTP) is working with various groups to improve DURC oversight policies⁸. They want to make sure the policies stay up-to-date and meet the needs of researchers. Learn more about the DURC-IRE and its role in protecting institutional review and research oversight.

“Effective oversight helps maintain public trust in the life sciences research enterprise.”

Education and Training on DURC

Getting a good grasp on DURC education and sensitivity training is key. It helps researchers see the possible risks of their work. Dual Use Research of Concern (DURC) training is a must for everyone working with certain agents or toxins. This is because of the U.S. Government Policy¹¹.

The Office of Scientific Policy (OSP) has an online guide for dual-use and gain-of-function research. It suggests NIH-wide training for all new staff¹¹. There are also educational tools like case studies and FAQs to help with DURC policies and practices¹¹.

Integrating DURC Awareness into Research Curricula

Adding DURC training to research curricula is vital. It teaches future scientists about responsibility and awareness. Biosafety and NIH Guidelines training are a must for research staff¹². The DURC review process checks for risks early, with the DURC-IRE making the final call on safety plans¹¹.

By putting DURC education in research programs, we make sure the next scientists are ready. They learn how to handle the tricky parts of dual-use research¹²¹³. This way, we build a culture of ethics and responsibility in science. It makes the scientific community stronger in facing DURC challenges¹¹.

“Comprehensive DURC education and sensitivity training are essential to ensure researchers understand the potential dual-use implications of their work.”

International Collaboration and Harmonization

The United States is leading in updating its pandemic research policy. It’s key to work together with the world on international DURC collaboration and policy harmonization. The European Commission has proposed four steps to improve the EU’s export controls on dual-use¹⁴. The U.S. plans to work with its partners to make sure research is done safely and responsibly.

The U.S. has made more global health partnerships in the last three years. It now works with 50 countries to prevent, detect, and control outbreaks¹⁵. Another 50 countries get support from the U.S. to save lives and lessen economic losses in health crises¹⁵. This teamwork is strengthened by the U.S. leading the Pandemic Fund. This fund has raised $2 billion from 27 contributors to improve global health security¹⁵.

The next few years will be important for making policies work together worldwide. The U.S. will work with its partners on DURC oversight and pandemic readiness. The DoD is facing challenges in bringing allies and partners together in a strong defense network. But, focusing on international teamwork will be a top priority¹⁶.

“The Vision Statement of the U.S. Global Health Security Strategy aims for a world where all people are protected from health security threats, particularly those posed by infectious diseases.”

By working together on international DURC collaboration and policy harmonization, the United States can set a global standard for safe and responsible research. This will help the world be better prepared and resilient against future health crises.

Policy Review and Revision Process

The new DURC policy starts a thorough review and revision process. This ensures it stays effective in handling the changing world of dual use research and new technologies¹⁷. It will involve input from many stakeholders, like researchers, institutions, security experts, health professionals, and international partners¹⁷.

The policy’s Implementation Guidance will be checked every two years. The OSTP can also make updates at these times¹⁷. This regular review and revision are key to keeping the policy current and effective in dealing with the fast-changing dual use research issues¹⁷.

The policy will be updated with feedback from various stakeholders. This ensures a deep understanding of new challenges and solutions¹⁷. By working with the research community, policymakers, and global partners, the DURC policy can stay relevant. It helps protect public health and national security¹⁷.

As dual use research grows, this ongoing review and update process is vital. It keeps the DURC policy’s core values of transparency, accountability, and flexibility¹⁷. This approach helps the policy stay strong in dealing with the complex ethical and legal issues of dual use research¹⁷.

Share your thoughts on the proposedDURC policy. Help shape the future of this important research oversight area¹⁷.

Emerging Technologies and Future Considerations

The science and technology world is changing fast. The policy’s way of looking at “reasonably anticipated” outcomes is promising. It supports researchers and makes sure everyone is accountable. The review and update process is key to keeping the policy useful and up-to-date with new tech and future needs in dual use research of concern¹⁸.

New technologies like advanced materials, biotechnology, advanced medicine, Future Generation wireless technology, and human-machine interfaces change how we use tech for both civilians and the military. The U.S. government sees the value in these dual-use technologies. They have plans like the Third Offset Strategy and the National Defense Strategy to keep up with these important areas¹⁹.

• Artificial Intelligence: AI is bringing new ideas to many fields but also brings up worries about self-driving weapons and AI misuse. The policy needs to look at the ethical and security sides of AI, making sure there are enough safeguards¹⁹.
• Quantum Technology: Quantum computing, sensing, and communication breakthroughs could change things like cryptography, navigation, and secure data sharing. The policy must balance encouraging innovation with managing the risks of quantum tech¹⁹.
• Biotechnology: Advances in gene editing, synthetic biology, and research on possible pandemic pathogens are big for health and science. But, they also bring up biosecurity and misuse worries. The policy should have good oversight and risk management for these biotech challenges¹⁹.

As the policy gets reviewed and updated, it’s important for policymakers, industry leaders, and researchers to work together. This way, the policy can stay flexible and keep up with new tech. By working together, the policy can handle the tricky mix of innovation, national security, and public welfare with new tech¹⁸.

“The policy review and revision process will be crucial to ensuring it remains adaptable and effective in addressing emerging technologies and future considerations in the field of dual use research of concern.”

Conclusion

The US Government has made a big move with its new policy on Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential²⁰. This policy gives clear guidance to researchers. It makes sure research in life sciences is safe and doesn’t cause harm²⁰.

This policy makes it clear what research needs extra attention. It also sets up strong checks to make sure research is done right²⁰. This way, we can enjoy the benefits of research without risking our safety²⁰.

The policy is important as research changes over time²⁰. It will help us handle DURC safely and keep up with new discoveries²⁰. The National Science Advisory Board for Biosecurity (NSABB) has been key in making these changes²¹.

Everyone involved must work together to make this policy work²⁰. Researchers, schools, and groups that make rules all have a role²⁰.

This policy encourages being open and working together to keep us safe and advance science¹⁷. As new tech comes along, we must stay alert and work together on DURC issues²⁰.

Source Links

1. https://new.nsf.gov/policies/pappg/23-1/ch-2-proposal-preparation
2. https://blink.ucsd.edu/research/policies-compliance-ethics/compliance/durc.html
3. https://policies.iu.edu/policies/rp-11-007-dual-use-research-concern/index.html
4. https://www.lsuhsc.edu/administration/academic/ors/ibc/au_ire_durc.aspx
5. http://ibc.research.ufl.edu/dual-use-research-of-concern-durc/
6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10117134/
7. https://www.niaid.nih.gov/grants-contracts/share-your-views-proposed-revisions-biosafety-policy
8. https://www.federalregister.gov/documents/2023/09/01/2023-18906/request-for-information-potential-changes-to-the-policies-for-oversight-of-dual-use-research-of
9. https://www.cidrap.umn.edu/biosecurity-issues/us-policy-pushes-institutions-scrutinize-dual-use-research
10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5853790/
11. https://oir.nih.gov/sourcebook/ethical-conduct/special-research-considerations/dual-use-research
12. https://research.iu.edu/training/required/biosafety.html
13. https://www.csis.org/analysis/eight-commonsense-actions-biosafety-and-biosecurity
14. https://www.whitecase.com/insight-alert/new-dual-use-export-control-and-outbound-investment-approach-part-eus-economic
15. https://www.whitehouse.gov/wp-content/uploads/2024/04/Global-Health-Security-Strategy-2024-1.pdf
16. https://innovation.defense.gov/Portals/63/20240710 DIB Allies and Partners Study_DOD CLEARED_FINAL.pdf
17. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3440065/
18. https://arpa-h.gov/research-and-funding/ethical-legal-and-social-implications
19. https://sgp.fas.org/crs/natsec/R46458.pdf
20. https://councilonstrategicrisks.org/2024/05/07/welcome-elements-of-the-new-us-policy-update-on-durc/
21. https://www.cidrap.umn.edu/dual-use-research/white-house-unveils-revised-dual-use-and-pandemic-pathogen-research-oversight