Thrown in the Deep End: The Dual-Use Saga.

Thrown in the Deep End: The Dual-Use Saga - PMC Skip to main content An official website of the United States government Here's how you know Here's how you know Search Log in Primary site navigation Search Log in Search PMC Full-Text Archive Search in PMC Journal List User Guide As a library, NLM provides access to scientific literature. Inclusion in an NLM database does not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of Health. Learn more: PMC Disclaimer | PMC Copyright Notice Appl Biosaf . 2025 Jun 5;30(2):198–203. doi: 10.1089/apb.2024.0062 Thrown in the Deep End: The Dual-Use Saga Rebecca L Moritz 1, * Author information Article notes Copyright and License information 1 Tutela Strategies, LLC, Reno, NV, USA. * Address correspondence to: Rebecca L. Moritz, Co-Founder, Tutela Strategies, LLC, Reno, NV 89503 USA, rebecca.moritz@colostate.edu i ORCID ID ( https://orcid.org/0000-0002-7576-7316 ). Collection date 2025 Jun. Copyright 2025, ABSA International 2025 PMC Copyright notice PMCID: PMC12179359  PMID: 40548085 Abstract This reflection shares insights from a biosafety professional’s experience managing dual-use research challenges. It emphasizes the importance of proactive communication, teamwork, and transparency. In responding to high-profile, ethically complex projects involving potential pandemic pathogens, I discuss the evolving role of biosafety professionals in ensuring safety and ethical oversight while supporting scientific progress. Key lessons include the need for a proactive approach to science communication, a resilient mindset, and strategic team collaboration. Managing public scrutiny and navigating confidentiality issues underscored the necessity for transparency to foster public trust. The experience also revealed the value of biosafety professionals as essential partners in research who contribute to policy discussions and should be consulted to shape effective, responsible research practices. These lessons emphasize the need for continuous improvement in biosafety practices, promoting proactive, integrated support systems within research institutions to effectively manage complex biosafety and biosecurity challenges. Keywords: dual-use research of concern, scientific communication, transparency, biosafety, pathogen of pandemic potential Background As biosafety professionals, most of our training and education come on the job or through training provided by a variety of associations, such as the American Biological Safety Association International (ABSA) or the Eagleson Institute. Internationally, there are additional associations depending on the area of the world. Many of us are also trained scientists or laboratorians who have decided that our skills would be better suited to support research than to conduct it ourselves. An official biosafety certification program was first created in 1995 when ABSA and the American Society for Microbiology agreed to jointly develop a biological safety microbiology certification under the auspices of the National Registry of Certified Microbiologists. The initial examination was offered in 1997, and in 2019, ABSA assumed responsibility for examination development, ensuring the certification remained aligned with the evolving demands of the profession. 1 Our training as biosafety professionals is mostly focused on the details of assessing biological risk, developing risk mitigation measures, and responding to incidents and emergencies. We often handle a wide variety of issues that land on our laps or that our employers decide to place in our court. There is little time to be proactive, as most of the time we are putting out fires and figuring solutions out on the fly. After an issue is resolved, if time allows, we assess the situation and determine how we could handle it better or prevent it from happening again. Rarely do we have the opportunity to reflect and share lessons learned from our unique experiences. With renewed attention on dual-use research and experiments involving potential pandemic pathogens, I believe it is valuable to share insights from a pivotal series of experiences in my biosafety career. While these reflections are personal, sharing this kind of tacit knowledge is in line with efforts to build a collective understanding and strengthen our shared practices—efforts highlighted by Gillum in his article about the evolving role of biosafety officers. 2 I am sharing these lessons learned from my experiences to help others who may be facing similar circumstances at their institution. The Debate Back in 2011, I did not know how much my job would change and career would evolve because of the writing of a single article. 3 This article, written in conjunction with another article with the same result by a researcher at a different institution, 4 would start a debate about research with high-consequence pathogens that has continued for more than a dozen years. It was these defining articles and debate that pushed the U.S. government (USG) to create multiple frameworks and policies providing oversight for Dual-Use Research of Concern (DURC) 5 , 6 and eventually research with pathogens with enhanced pandemic potential (PEPP). A multiyear moratorium began in 2014, which assessed the risks of the research and whether it could be conducted in the future. 7 At the heart of this debate is an ethical and moral dilemma that revolves around the balance between scientific progress, pandemic preparedness, and potential harm. It is a topic that will probably never be adequately answered to anyone’s satisfaction. However, it is dressed up in many disguises and replayed again and again, depending on the narrative and goals of the speaker and audience. The COVID-19 pandemic increased concerns about research with pathogens of high consequence. There Isn’t Always a Map or Guidebook In the summer of 2011, I received a phone call from a researcher at my institution informing me that they had discovered a mammalian transmissible strain of H5N1, a highly pathogenic avian influenza virus (HPAIV). The research identified a strain of H5N1 HPAIV that could transmit between ferrets that did not come into direct physical contact with each other. Subsequent analysis showed that only four mutations caused this change. 3 The prevailing thought in the field had been that H5N1 HPAIV was not likely to cause a pandemic because it had not been shown to transmit effectively via animals in a shared space. 8 I had no idea how unprepared I was for this situation and what would come my way and be asked of me. Looking back on it now, I realize that this experience shaped my biosafety career. Not only did it push me into uncharted territory, but it also helped me develop skills and insights that drive my policy advocacy for enhanced biosafety, biosecurity, and research policy. The Best Laid Plans For a period of time, the researchers, the Responsible Official for the Federal Select Agent Program, and I were the only ones who knew the results of the experiment. Once the article was ready for submission, a team worked on a proactive communication plan to support the publication of the manuscript. Because the movie Contagion was being released in September 2011, we believed the journal would be interested in having a publication based upon factual scientific experiments to have proactive communication about pandemic preparedness. However, when a few weeks went by, it became evident that we needed a different plan. I received a phone call from the researcher while I was attending the 54th Annual Biological Safety Conference in Anaheim, California. I was informed that the manuscript had been sent to the National Scientific Advisory Board for Biosecurity (NSABB). 9 Like most other biosafety professionals at the time, I had minimal knowledge, if any, of the NSABB and their work on DURC. The NSABB posed questions to our researcher, and they were shared with me to develop responses as quickly as possible. The NSABB did not have any public meetings during this time. Their docket showed that meetings occurred on June 23, 2011 and then not again until December 15, 2011. 10 Yet the NSABB was clearly diligently working. 11 Then on December 20, 2011, the NSABB released a statement acknowledging the importance and justification of conducting this type of research and yet expressed concerns that the research results could potentially be misused for harmful purposes as follows: The U.S. government remains concerned about the threat of influenza, for the risks it poses seasonally, as well as its potential to cause a pandemic. Our domestic and global influenza surveillance efforts have become increasingly capable, along with expanded vaccine manufacturing capacity and assistance to other countries in their efforts to detect and respond to a pandemic. To enhance the detection of and response to influenza outbreaks, the U.S. government supports a broad range of domestic and global preparedness and response efforts that include research on better diagnostics, vaccines, and therapeutics… While the public health benefits of such research can be important, certain information obtained through such studies has the potential to be misused for harmful purposes. 12 The NSABB advised the U.S. Department of Health and Human Services (HHS) to request specific revisions to the manuscript. These recommendations included emphasizing the novel findings without disclosing methodologies that could facilitate replication. The NSABB also recommended incorporating language to clarify the research objectives and public health benefits and detail the safety and security protocols implemented. 12 HHS accepted these recommendations. However, the whole process led to months of public speculation and misinformation surrounding the research results and the content of the articles. The misinformation is still perpetuated today. Managing Misinformation Transitioning from reactive to proactive communication proved exceptionally challenging when research findings were embargoed, and misinformation was widespread. For several months, my institution faced the task of providing accurate information without being able to directly address the research results. Nevertheless, my institution was fortunate to have an effective team in place, equipped to adapt and respond as necessary. Amid the demands of my day job, I was also a part of the team handling every media, regulator, and policy request and question that came into the university. The workload was unrelenting, and criticism came from every direction, including from journalists and members of the public. Some criticisms took the form of personal attacks, occasionally even escalating to threats directed at the researchers and, at times, myself. Transitioning from a relatively neutral role as a biosafety professional to becoming a target for personal and professional criticism and hostility was challenging, particularly given the limited factual information available to the public. A few of these criticisms resonated deeply, leaving an impact that will likely stay with me for years; however, I developed skills essential for navigating high-pressure situations. Throughout this experience, I recognized the importance of building resilience, safeguarding my mental well-being, and ensuring my physical security as essential strategies to navigate such turbulent circumstances effectively. The articles were published in May and June 2012. 3 , 4 The studies used different methodologies yet revealed the same biological traits that were required for efficient transmission in ferrets; changes in amino acids resulted in changes in receptor binding specificity and stability of the hemagglutinin protein. Looking back, while the challenges were substantial, these experiences strengthened my resolve and reaffirmed the value of well-coordinated, proactive communication and teamwork in navigating publicly visible research controversies. No Good Deed Goes Unpunished At the time the article was submitted to Nature in 2011, there were no formal requirements to share articles with potential DURC or PEPP with funding or regulatory agencies. Anticipating the article’s potential to attract significant public attention, a proactive decision was made to share it in advance with various federal partners to avoid unexpected publicity. Unfortunately, confidentiality was not maintained, which led to a cascade of events that escalated the situation and may have resulted in the article being sent to the NSABB. While I cannot know with certainty how the situation might have unfolded had confidentiality been preserved, this experience has taught me to carefully consider the potential outcomes of going beyond established and required protocols. This and similar experiences have instilled in me a habit of meticulously evaluating potential risks and outcomes in my professional decisions. In my daily practice, I assess each situation critically, weighing the pros and cons of various approaches to support researchers while safeguarding my employer’s research interests and integrity. Science Communication Is an Important Tool The most significant lesson I gained from this experience is the true power of science communication. Recognizing my institution’s need for public speaking and media engagement, I stepped into that role. I was fortunate to be trained by two amazing research science communicators, to whom I am deeply grateful for sharing their time, expertise, best practices, and lessons. They helped shape me into a public speaker who can effectively deliver presentations and adeptly navigate challenging interviews or difficult situations. Initially, I engaged in small interviews and provided written responses, but eventually, I was fully immersed in this role. I will never forget the audience’s reception to the presentation I gave at the first National Academy of Sciences gain-of-function workshop in December 2014, 13 after the Obama administration announced the research moratorium. 7 This meeting was the first public event in the multiyear process to assess the risks and benefits of the research. It was a high-stakes environment that required meticulous preparation and execution. Numerous people, including those for and against the research, as well as members of the NSABB, were in the room. I had to be perfect. One misstep would overshadow the important contribution of this research to understanding of H5N1 transmissibility and negatively impact the communications plan. After the session was over, attendees walked up to me to ask questions about the biosafety profession. At first, I did not understand why they were asking me, because I knew they all had experienced biosafety professionals at their institutions. Then, I realized that it was possible that these researchers had not viewed their biosafety professional as a research asset who could publicly support their research in this manner. This experience made me realize how biosafety professionals are an integral partner and critical to the success of biological research. Experiences like these highlight the importance of proactive science communication and the unique role biosafety professionals can fulfill in that effort. While it may require more preparation initially, it ultimately saves resources and ensures everyone is better equipped to respond to emerging issues. This proactive approach helps prevent crisis-driven responses, reducing the chances of chaotic reactions when a story breaks or compliance updates are made public. Transparency Is Nonnegotiable At first glance, it may seem contradictory to my earlier statements, but I am a strong advocate for transparency. Transparency offers an opportunity to acknowledge the extensive hours and diverse stakeholders involved in supporting research and serves as a proactive communications tool. The presentation at the National Academies of Sciences 13 marked the first time my institution publicly shared the extensive planning and infrastructure it developed to support high-containment research. This transparency made a significant impact, shifting the narrative to one of confidence as follows: “We are not concerned about you, but about everyone else”—at least for a time. This experience solidified my commitment to openly discuss biosafety and biosecurity practices whenever possible. While zero risk is unattainable, it is essential to highlight the rigorous efforts biosafety professionals make to minimize risk to the lowest possible level. This commitment has driven me to actively seek opportunities to present the ongoing evolution of these practices and procedures and to discuss how biosafety and biosecurity policies affect the broader research enterprise. The NSABB meeting held during January 23–24, 2020, exemplified transparency in action. 14 I was invited, along with colleagues, to present on community engagement in pathogen research. This provided an opportunity to showcase the extensive efforts my institution had made to proactively communicate the safety and security measures surrounding our research and how we thoughtfully managed information hazards. Through public presentations, facility tours, and other outreach activities, we aimed to build trust and foster understanding within the community. Setting Boundaries On a personal level, it is disheartening that our professional lives sometimes encroach on our personal spaces. Early in the DURC debate, I made a conscious decision to protect my privacy by limiting my presence and personal expression on social media. I am inactive on, or simply do not use, many social media platforms, and I rarely post on LinkedIn. The limited personal information about me online is intentional; most publicly available content about me is limited to professional items authored by others or associated with my employer. Plainly put, I do not need to expose myself to the often harsh and untrue statements made about me due to my involvement in this debate and my advocacy for research policy. Safeguarding my mental health is, ultimately, my priority. It Can Be Lonely Out There Implementing a new safety policy is always challenging, no matter who you are and what institution you work at. It gets that much harder when there is no guidance and none of your colleagues have gone through it. I led the first proposal that went through the Office of Science and Technology Policy’s Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO) 15 with minimal to no guidance about what to submit. We chose to use our established process for evaluating DURC, as it was the most appropriate approach for our needs. During the Institutional Review Entity review, we were extremely careful with the language we used. We knew that any documentation could be subject to requests under the Freedom of Information Act (FOIA). Consequently, we submitted a high-level risk–benefit analysis, avoiding excessive detail to prevent inadvertently providing a blueprint for potential misuse. Unfortunately, this decision was misconstrued as a lack of seriousness in the review process. I was frustrated, knowing that the letter expressing this view would eventually become public through FOIA and that readers might take it at face value, despite it being a complete misinterpretation of our intentions. This put me in a position where I had to ensure that the actual narrative—rooted in careful, proactive planning—was clearly communicated and supported by facts. And I took action to do just that. To this day, I am unsure of the specific criteria used to evaluate our proposal or the reasons behind its eventual approval, as much of that process remained opaque to us. If I were to go through the process again, I would appreciate the opportunity to compare insights with the three other institutions that submitted proposals and received approvals. 16 Such a comparison would allow me to identify similarities and gain a clearer understanding of the factors considered in this process, particularly regarding its approach to risk–benefit analysis. Think Big Picture I have learned that being part of the biosafety profession requires a constant balancing act between advancing scientific innovation and ensuring safety and security while supporting responsible progress. As biosafety professionals, we are often deeply engaged in assessing every detail of an experiment to try and find an ideal solution. However, these ideal solutions are not always practical and sometimes require flexible approaches that are equally safe. Striving for perfection should not overshadow solutions that are safe and secure. This requires us to strategically prioritize our efforts and focus on mitigating unacceptable risks rather than striving for the ideal every time. Prioritizing our efforts and maximizing the impact of our time and energy are needed to protect the research, the researchers, the institution, and the community effectively. Biosafety professionals have a vital role to play, often more significant than is widely recognized or appreciated. Engaging with policy discussions not only allows us to bring valuable insights back to our institution and our community but also positions us to help shape more effective and informed policies in the future. This involvement provides a platform for meaningful impact and reinforces the essential contributions of our profession. It Takes a Village This journey has taught me the importance of teamwork, humility, and resilience. Ultimately, what I am most proud of during this time is the team that the public was completely unaware of. The team consisted of the researchers, an expert lawyer, fantastic science communicators, and a biosafety professional. The general public, members of the media, or policy makers might have seen a quote from the researcher or me, but it was all of us tirelessly working together behind the scenes to vet and respond to every inquiry that was received for years. It was truly a team effort and that support never wavered. I will be forever grateful for each individual’s support, expertise, and willingness to go above and beyond during this experience. A biosafety professional cannot be effective in a silo. Building a top-notch infrastructure to support an institution’s research enterprise takes subject matter experts from multiple different arenas who all have the same goal—a vested interest in the safety and security of the research and its researchers. Biosafety professionals, find your support team. Find your champions and experts—both internal and external to your institution. Make your voice heard. Share your experiences. Authors Disclosure Statement R.L.M. is a former President of ABSA and cofounder of Tutela Strategies. Acknowledgments I would like to thank David Gillum for encouraging and supporting me to finally write this piece after all these years. I would also like to thank Dr. Joanie Ryan for her expert editing skills. Author’s Contributions R.L.M.: Conceptualization, writing, editing, and visualization. Funding Information There was no funding utilized for this work. No Institutional Biosafety Committee, Institutional Review Board, or Institutional Animal Care and Use Committee review was required for this article. References 1. International ABSA. Certified Biological Safety Professional (CBSP). ABSA International; [cited 2024 Nov 13]. Available from: https://absa.org/cbsp/ [Last accessed: November 12, 2024]. [ Google Scholar ] 2. Gillum D. The making of a biosafety officer. Issues Sci Technol 2023;39(3) Available from: https://issues.org/making-biosafety-officer-gillum/ [Last accessed: November 12, 2024]. [ Google Scholar ] 3. Imai M, Watanabe T, Hatta M, et al. Experimental adaptation of an influenza H5 HA confers respiratory droplet transmission to a reassortant H5 HA/H1N1 virus in ferrets. Nature 2012;486(7403):420–428; doi: 10.1038/nature10831 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 4. Herfst S, Schrauwen EJA, Linster M, et al. Airborne transmission of influenza A/H5N1 virus between ferrets. Science 2012;336(6088):1534–1541; doi: 10.1126/science.1213362 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 5. U.S. Government. United States Policy for Oversight of Life Science DURC. 2012. March. Available from: https://www.phe.gov/s3/dualuse/Pages/USGOversightPolicy.aspx [Last accessed: November 12, 2024]. 6. U.S. Government . United States Policy for Institutional Oversight of Life Sciences DURC. 2014. September. Available from: https://www.phe.gov/s3/dualuse/Pages/InstitutionalOversight.aspx [Last accessed: November 14, 2024]. 7. U.S. Government. United States government gain-of-function deliberative process and research funding pause on selected gain-of-function research involving influenza, MERS, and SARS viruses–frequently asked questions. Office of science and technology policy. 2014. Available from: https://www.phe.gov/s3/dualuse/Documents/gof-qanda.pdf [Last accessed: November 12, 2024]. 8. Yen H-L, Lipatov AS, Ilyushina NA, et al. Inefficient transmission ofH5N1influenza viruses in a ferret contact model. J Virol 2007;81(13):6890–6898; doi: 10.1128/JVI.00170-07 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 9. Office of the Director; Notice of Charter Renewal for the National Science Advisory Board for Biosecurity. Federal Register. 2010;75(90):26258. Available from: https://www.govinfo.gov/content/pkg/FR-2010-05-11/pdf/2010-11043.pdf [Last accessed: November 12, 2024]. [ Google Scholar ] 10. National Institutes of Health, Office of Science Policy. National Science Advisory Board for Biosecurity (NSABB). Available from: https://osp.od.nih.gov/policies/national-science-advisory-board-for-biosecurity-nsabb#tab3/ [Last accessed: November 12, 2024]. 11. Science Magazine. Scientists Brace for Media Storm Around Controversial Flu Studies. Available from: https://www.science.org/content/article/scientists-brace-media-storm-around-controversial-flu-studies [Last accessed: November 14, 2024]. 12. National Institutes of Health. Press statement on the NSABB review of H5N1 research. 2011. Available from: https://www.nih.gov/news-events/news-releases/press-statement-nsabb-review-h5n1-research [Last accessed: November 12, 2024]. 13. Institute of Medicine and National Research Council. Potential Risks and Benefits of Gain-of-Function Research: Summary of a Workshop. Washington, DC: The National Academies Press; 2015. 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Articles from Applied Biosafety: Journal of the American Biological Safety Association are provided here courtesy of ABSA International and Mary Ann Liebert, Inc. ACTIONS View on publisher site PDF (541.0 KB) Cite Collections Permalink RESOURCES Similar articles Cited by other articles Links to NCBI Databases Follow NCBI NCBI on X (formerly known as Twitter) NCBI on Facebook NCBI on LinkedIn NCBI on GitHub NCBI RSS feed Connect with NLM NLM on X (formerly known as Twitter) NLM on Facebook NLM on YouTube National Library of Medicine 8600 Rockville Pike Bethesda, MD 20894 Web Policies FOIA HHS Vulnerability Disclosure Help Accessibility Careers NLM NIH HHS USA.gov Back to Top

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