Biosecurity
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Seminar Recording

About the Event: To manage the risks of potential dual use research of concern (DURC), US government policy and biorisk management professionals recommend tailoring mitigation strategies to an assessment of a given project’s risk. However, there is little empirical research on how different reviewers assess risks and recommend mitigation strategies for the same set of life sciences projects. If reviewers cannot agree on risk assessments, or if the choice of mitigation strategies does not heavily depend on risk assessments, then the purpose of assessment becomes less clear.

Using a modified version of the US government’s Companion Guide for DURC assessment, we elicited detailed reviews of the risks, benefits, and recommended risk management strategies for four real-world synthetic biology projects from 18 experienced DURC reviewers and 49 synthetic biology students. We find significant variation within and between reviewer groups and projects in both assessed DURC risk and recommended strategies for managing it. This empirical variation raises questions about the role of DURC assessment, challenges conventional conceptions of DURC assessment “expertise”, and highlights the need for experimentation in DURC management.

About the Speaker: Dr. Daniel Greene is a Senior Analyst at Gryphon Scientific, a biosecurity and public health research consultancy. Previously, he was a Postdoctoral Researcher and Fellow at the Center for International Security and Cooperation at Stanford University, where he worked with Drs. Megan Palmer and David Relman to study the societal risks and potential of life-science research. His primary research focus was on measuring and cultivating a culture of responsibility in the life sciences by using a combination of survey experiments, qualitative methods, data science, and policy analysis. Daniel has a PhD in Education from Stanford University.

 All CISAC events are scheduled using the Pacific Time Zone.

William J. Perry Conference Room

Daniel Greene CISAC
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Steve Lohr
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When the family house in Devon, Pa., caught fire, Drew Endy, then 12, carried out his most cherished possession — his personal computer.

Years later, as a graduate student, Mr. Endy was accepted to Ph.D. programs in biotechnology and political science.

The episodes seem to sum up Mr. Endy, a most unusual scientist: part engineer, part philosopher, whose conversation is laced with references to Descartes and Dylan, as well as DNA.

He’s also an evangelist of sorts. Mr. Endy, a 51-year-old professor of bioengineering at Stanford University, is a star in the emerging field of synthetic biology. He is its most articulate enthusiast, inspiring others to see it as a path to a better world, a transformational technology to feed the planet, conquer disease and combat pollution.

Continue reading here

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Drew Endy is squarely focused on the potential of redesigning organisms for useful purposes. He also acknowledges significant challenges.

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Stephen Hummel, Paul Cruickshank, Don Rassler
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The Combating Terrorism Center at West Point interviews Drew Endy, Associate Chair, Bioengineering, Stanford University, who has served on the U.S. National Science Advisory Board for Biosecurity. He argues the United States urgently needs a bio strategy to take advantage of rapid advances in biotechnology, protect against the growing danger posed by its potential malevolent use, and prevent the United States from permanently falling behind as a biopower. “First, we need to demonstrate operational mastery of cells by learning to build them. Second and third, we need to build and secure the bio net. And we have to do this now, within the decade, so that we can translate these advances as infrastructure undergirding a uniquely American bio economy that projects power while advancing life, liberty, pursuit of happiness. If we do this, then we have a chance of taking infectious disease off the table. If we don’t develop and implement a coherent bio strategy, it’s game over, not to be dramatic.

Read the interview here

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Drew Endy argues the United States urgently needs a bio strategy to take advantage of rapid advances in biotechnology, protect against the growing danger posed by its potential malevolent use, and prevent the United States from permanently falling behind as a biopower.

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Dr. Daniel Greene has been accepted as a 2022 Emerging Leaders in Biosecurity fellow from the Center for Health Security at John Hopkins University.

The Emerging Leaders in Biosecurity program supports talented career professionals in deepening their expertise, expanding their network, and building their leadership skills through a series of events coordinated by the center. The highly competitive program inspires and connects the next generation of leaders and innovators in the biosecurity community.

Dr. Daniel Greene received his Ph.D. in Education from Stanford University, and continues research focused on the societal risks and potential of the life sciences using a combination of data science, survey research, policy and analysis, and qualitative methods to help us understand our collective options for regulating life-science research. He has been a Postdoctoral Researcher in Biosecurity and Project Fellow for CISAC since 2019.

Center for Health Security Announcement

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Dr. Daniel Greene has been accepted as a 2022 Emerging Leaders in Biosecurity fellow from the Center for Health Security at John Hopkins University.

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Megan Palmer
Sam Weiss Evans
Jacob Beal
Kavita Berger
Diederik A. Bleijs
Alessia Cagnetti
Francesca Ceroni
Gerald L. Epstein
Natàlia Garcia-Reyero
David R. Gillum
Graeme Harkess
Nathan J. Hillson
Petra A. M. Hogervorst
Jacob L. Jordan
Geneviève Lacroix
Rebecca Moritz
Seán S. ÓhÉigeartaigh
Mark W. J. van Passel
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As biological research and its applications rapidly evolve, new attempts at the governance of biology are emerging, challenging traditional assumptions about how science works and who is responsible for governing. However, these governance approaches often are not evaluated, analyzed, or compared. This hinders the building of a cumulative base of experience and opportunities for learning. Consider “biosecurity governance,” a term with no internationally agreed definition, here defined as the processes that influence behavior to prevent or deter misuse of biological science and technology. Changes in technical, social, and political environments, coupled with the emergence of natural diseases such as coronavirus disease 2019 (COVID-19), are testing existing governance processes. This has led some communities to look beyond existing biosecurity models, policies, and procedures. But without systematic analysis and learning across them, it is hard to know what works. We suggest that activities focused on rethinking biosecurity governance present opportunities to “experiment” with new sets of assumptions about the relationship among biology, security, and society, leading to the development, assessment, and iteration of governance hypotheses.

Read the rest at Science

 

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Seminar Recording: https://youtu.be/P1-Q0OSo4yM

 

About this Event: The governance of big data and the prevention of their misuse is among the most topical issues in current debates among security experts. But what does it mean when security is not an issue for the stakeholders governing big biomedical data? This paper answers this question by looking at what it describes as a peculiar omission of the issue of security in the biggest harmonization cluster of biomedical research in Europe - BBMRI-ERIC. While it does treat personal data, the risks and threats are constructed through a language of anticipation and self-governance rather than security. The analysis explains why: based on document analysis, interviews, and field research, it studies (1) how are risks and threats constructed in the research with big biomedical data, (2) what regime of their governance is established in this area, and (3) what are the implications for the practices of science and the politics of security. The paper argues that this silence is a by-product of bureaucratization and responsibilization of security, which is in biobanking characteristic by discourse and practices of responsible research, ethics, and law. The paper suggests that this regime of governance precludes the prospects of addressing bigger questions that biobanks may need to deal with in the future, such as regarding the access to the biomedical data by state or private actors and their use for policing, surveillance, or other types of population governance.

 

Speaker's Biography: Dagmar Rychnovská is Marie Sklodowska-Curie Fellow at the Techno-science and societal transformation group at the Institute for Advanced Studies in Vienna. She holds a PhD in International Relations (Charles University in Prague), an MA in Comparative and International Studies (ETH Zurich and University of Zurich), and an LLM in Law and Politics of International Security (VU University Amsterdam). Her research interests lie at the intersection of international relations, security studies, and science and technology studies. Her current research explores security controversies in research and innovation governance, with a focus on bioweapons, biotechnologies, and biobanks.

Dagmar Rychnovská Institute for Advanced Studies
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This study’s purpose was to highlight the changing safety and security landscape engendered by the emergence of new genome editing technologies, help policy-makers and other stakeholders navigate this space, and illuminate broader trends in the life sciences that may impact the biosecurity landscape.

The two-year Editing Biosecurity study was led by four researchers from George Mason University and Stanford University. The centerpiece of the study was three invitation-only workshops that brought together the study leads and the core research group for structured discussions of the benefits, risks, and governance options for genome editing.

The study leads and research assistants prepared two working papers to frame the workshop discussions. The first working paper reviewed past studies that assessed the risks posed by emerging dual-use technologies. The goal of this working paper was to provide a baseline for understanding the security implications of genome editing and to identify best practices in risk assessment. The second working paper provided an overview of the current governance landscape for biotechnology and a framework for evaluating governance measures. Each workshop included a range of scientific, policy, ethics, and security experts. The study leads gathered additional information from subject-matter experts in the form of five commissioned issue briefs. Several of the study’s experts served as discussants who critically engaged the content of the issue briefs through iterative commentary and feedback. The study leads and core research group have backgrounds in various disciplines, including the life sciences, social sciences, and the humanities, an approach designed to ensure a rigorous research process underpinned by the inclusion of a variety of perspectives, and further complemented by numerous areas of expertise. The study and its products relied on unclassified, open, and publicly accessible information. The study was an independent academic work in which the charge and scope were determined by the research team. In combination, these factors were motivated by the team’s goal of producing open and accessible research outputs that can assist stakeholders in crafting more effective and informed policies.

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Megan Palmer
David Relman
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From genome editing to “hacking” the microbiome, advances in the life sciences and its associated technological revolution have already altered the biosecurity landscape, and will continue to do so. What does this new landscape look like, and how can policymakers and other stakeholders navigate this space? A new report by Stanford scholars David Relman and Megan Palmer along with George Mason University’s Jesse Kirkpatrick and Greg Koblentz assesses this emerging biosecurity landscape to help answer these questions and illustrates gaps in governance and regulation through the use of scenarios.

The report—the product of two years of workshops, issue briefs, and white papers authored by different participants—involved people from different organizations and backgrounds ranging from life sciences and medicine to social science and ethics. “The project process was just as important as the product,” said Palmer. “It was a truly interdisciplinary effort.”

Genome editing, including CRISPR, is disruptive to the biosecurity landscape, and it serves as an illustration of more general trends in the evolving landscape, the authors write. CRISPR technology does not exist in a vacuum—rather, it is enabled by, represents, and gives rise to a suite of technologies with potential benefits and that require new approaches to adaptive policy making and governance.

Scenarios illustrating governance gaps in in the report include:

  • A reckless CRISPR user who develops and markets a probiotic created with genome editing that has serious unanticipated effects for consumers;
  • An agricultural biotechnology firm conducting dual use genome editing research that lies outside current oversight, but nonetheless could have negative consequences for human health
  • An intentional release of a gene drive organism from a lab, that while having limited physical harm, feeds a state-based misinformation campaign with large economic impacts
  • An accidental release of a gene drive organism due to lack of awareness and uncertainty about the risk classifications and protocols for handling new technologies
  • A terrorist group using commercial firms that lack strong customer and order screening to use genome editing to weaponize a nonpathogenic bacteria
  • A state-sponsored program to develop biological weapons for new strategic uses, including covert assassination, using largely publicly available research
     

In each of these examples, the researchers play out a hypothetical situation exposing a number of security and governance gaps for policymakers and other stakeholders to address.

In the report, the authors conclude that genome editing has tremendous potential benefits and economic impacts. The authors note that the market for genome editing is expected to exceed $3.5 billion by 2019, but a security incident, safety lapse, reckless misadventure, or significant regulatory uncertainty could hurt growth. Increased reliance on the “bio-economy,” they write, means biosecurity is increasingly critical to economic security as well as human health.

Other key takeaways:

Genome editing has the potential to improve the human condition. Genome editing is poised to make major beneficial contributions to basic research, medicine, public health, agriculture, and manufacturing that could reduce suffering, strengthen food security, and protect the environment.

Genome editing is disruptive to the biosecurity landscape. The threat landscape has, and continues to expand to include new means of disrupting or manipulating biological systems and processes in humans, plants, and animals. Genome editing could be used to create new types of biological weapons. Further, technical advances will make misuse easier and more widespread.

CRISPR illuminates broader trends and the challenges of an evolving security landscape. An approach to biosecurity that accounts for these trends, and encompasses risks posed by deliberate, accidental, and reckless misuse, can help address the complex and evolving security landscape.

Technology must be taken seriously.  A thorough, informed, and accessible analysis of any emerging technology is crucial to considering the impact that it may have on the security landscape.

Key stakeholders must be engaged. Stakeholders in the genome editing field encompass a more diverse array of actors than those that have been involved so far in biosecurity discussions. These stakeholders range from international organizations to government agencies to universities, companies, lay communities writ large, and scientists.

Applied research is needed to create and implement innovative and effective policies. Applied research is necessary to continue the process of modifying existing governance measures, and testing and adapting new ones, as new genome editing technologies and applications are developed, new stakeholders emerge, and new pathways for misuse are identified.

Download the executive summary and full report at editingbiosecurity.org.

 

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Abstract: International cooperation has long been founded on the idea that securing a common factual understanding of things in the world is a prerequisite for deciding how to act in concert. However, in recent decades the very possibility of such agreement on the facts has come under attack both empirically, through persistent technical controversies around issues such as climate change and crop biotechnology, and theoretically, from demonstrations that facts and norms are co-produced to build alternate, coexisting worlds. The divergent self-understandings of these worlds, in which epistemic and normative order are interdependent, cannot be bridged by simply insisting on a singular “reality” that must be accepted by all.

In this talk, I use the longue durée case of international biotech regulation to suggest a different basis for long-term cooperation. Using epistemic subsidiarity rather than harmonization as the basis for making progress, I suggest how biotechnology risks might be handled in three regimes of subsidiarity: coexistence, cosmopolitanism, and constitutionalism. The advantages and limits of each regime will be exemplified and reflected upon.

Speaker bio: Sheila Jasanoff is Pforzheimer Professor of Science and Technology Studies at the Harvard Kennedy School. A pioneer in her field, she has authored more than 120 articles and chapters and is author or editor of more than 15 books, including The Fifth Branch, Science at the Bar, Designs on Nature, and The Ethics of Invention. Her work explores the role of science and technology in the law, politics, and policy of modern democracies. She founded and directs the STS Program at Harvard; previously, she was founding chair of the STS Department at Cornell. She has held distinguished visiting appointments at leading universities in Europe, Asia, Australia, and the US. Jasanoff served on the AAAS Board of Directors and as President of the Society for Social Studies of Science. She is a member of the Council on Foreign Relations. Her honors include a Guggenheim Fellowship, an Ehrenkreuz from the Government of Austria, membership in the Royal Danish Academy, and the Humboldt Foundation’s Reimar-Lüst award. She holds AB, JD, and PhD degrees from Harvard, and honorary doctorates from the Universities of Twente and Liège.

Sheila Jasanoff Professor of Science and Technology Studies Harvard University's Kennedy School of Government
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Abstract: Against a backdrop of emerging and reemerging infectious diseases of natural origin, fueled by changes in land use and global climate, there is an ongoing revolution in the life sciences with growing empowerment of the individual to decipher, genetically alter, and manufacture living things. In addition to widely-touted potential benefits, these events and developments pose challenges and risks of profound harm to humans and the rest of the planet. Yet, the United States and most other nations have failed to respond with a strategic plan, sustained resources, coherent leadership, critical self-assessment, and accountability. Why is this? A selected history of recent naturally-occurring disease outbreaks and advances in the life sciences that create new risks of potential misuse will be offered, differing perspectives from the science and policy communities described, and some of the efforts to address these challenges summarized. Forward-looking proposals for efforts to mitigate risk in the life sciences will be discussed.

Speaker Bio: David A. Relman, M.D., is the Thomas C. and Joan M. Merigan Professor in Medicine, and Microbiology & Immunology at Stanford University, and Chief of Infectious Diseases at the Veterans Affairs Palo Alto Health Care System. He is also Senior Fellow at the Freeman Spogli Institute for International Studies (FSI), and served as science co-director at the Center for International Security and Cooperation from 2013-2017. He is currently director of a new Biosecurity Initiative at FSI.

Relman identified several historically important and novel microbial disease agents, and was an early pioneer in the modern study of the human indigenous microbiota (microbiome). His lab group currently examines human microbial community assembly, and community stability and resilience.

Among policy-relevant activities, Relman is currently a member of the Intelligence Community Studies Board at the National Academies of Science (NAS), served as vice-chair of the NAS Committee that reviewed the science performed for the FBI 2001 Anthrax Letters investigation, and was a member of the National Science Advisory Board on Biosecurity. He was elected to the National Academy of Medicine in 2011. 

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Encina Hall, E209
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Senior Fellow at the Freeman Spogli Institute for International Studies
Thomas C. and Joan M. Merigan Professor
Professor of Medicine
Professor of Microbiology and Immunology
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David A. Relman, M.D., is the Thomas C. and Joan M. Merigan Professor in the Departments of Medicine, and of Microbiology and Immunology at Stanford University, and Chief of Infectious Diseases at the Veterans Affairs Palo Alto Health Care System in Palo Alto, California. He is also Senior Fellow at the Freeman Spogli Institute for International Studies (FSI) at Stanford, and served as science co-director at the Center for International Security and Cooperation at Stanford from 2013-2017. He is currently director of a new Biosecurity Initiative at FSI.

Relman was an early pioneer in the modern study of the human indigenous microbiota. Most recently, his work has focused on human microbial community assembly, and community stability and resilience in the face of disturbance. Ecological theory and predictions are tested in clinical studies with multiple approaches for characterizing the human microbiome. Previous work included the development of molecular methods for identifying novel microbial pathogens, and the subsequent identification of several historically important microbial disease agents. One of his papers was selected as “one of the 50 most important publications of the past century” by the American Society for Microbiology.

Dr. Relman received an S.B. (Biology) from MIT, M.D. from Harvard Medical School, and joined the faculty at Stanford in 1994. He served as vice-chair of the NAS Committee that reviewed the science performed as part of the FBI investigation of the 2001 Anthrax Letters, as a member of the National Science Advisory Board on Biosecurity, and as President of the Infectious Diseases Society of America. He is currently a member of the Intelligence Community Studies Board and the Committee on Science, Technology and the Law, both at the National Academies of Science. He has received an NIH Pioneer Award, an NIH Transformative Research Award, and was elected a member of the National Academy of Medicine in 2011.

Stanford Health Policy Affiliate
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Department of Medicine; CISAC, Stanford University
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