11.2 Dual-use research of concern in biotech
3 min read•july 18, 2024
in biotech can be a double-edged sword. It has the potential to advance science and improve health, but it could also be misused to create biological weapons or enhance dangerous . This dilemma raises serious ethical concerns.
Regulating dual-use research is crucial to prevent misuse while allowing beneficial work to continue. Policies and oversight bodies aim to strike this balance, but challenges remain in managing risks and maintaining in science.
Dual-Use Research of Concern (DURC) in Biotechnology
Concept of dual-use research
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- Refers to scientific research that can be used for both beneficial and malicious purposes
- Beneficial purposes advance scientific knowledge, develop new technologies (vaccines, treatments), and improve human health
- Malicious purposes create biological weapons, enhance the virulence of pathogens (anthrax, smallpox), or increase the of diseases
- In biotechnology, DURC involves research on microorganisms, toxins (botulinum toxin), or other biological agents that could potentially be misused
- Research on (Ebola, Marburg), bacteria (Yersinia pestis), or other microorganisms that could be weaponized
- Enhancing the virulence, transmissibility, or host range of pathogens (influenza, SARS-CoV-2) is also considered DURC
Examples of biotechnology DURC
- Historical examples:
- The (2001) inadvertently created a highly virulent mousepox virus while attempting to develop a contraceptive vaccine for mice
- The (2002) from scratch using publicly available genetic information, demonstrating the potential for creating viruses in the laboratory
- Contemporary examples:
- on influenza viruses increases the transmissibility or virulence to better understand their potential pandemic risk
- CRISPR-Cas9 gene editing technology has numerous beneficial applications (treating genetic disorders, improving crops) but could potentially create genetically modified organisms with enhanced pathogenic properties
Ethical implications of DURC
- The dual-use nature of the research raises concerns about the potential misuse of scientific knowledge and technologies
- Risk that the research could be used by malicious actors to create biological weapons (anthrax, smallpox) or cause harm to human health and the environment
- Publication of DURC findings could provide a "blueprint" for those seeking to misuse the information
- Potential risks associated with DURC:
- Accidental release of enhanced pathogens from research laboratories, leading to outbreaks () or pandemics
- Intentional misuse of DURC findings by state or non-state actors to develop biological weapons
- Erosion of public trust in science if DURC is not adequately regulated and communicated to the public
Regulations for DURC oversight
- (NSABB) provides advice and guidance to the U.S. government on biosecurity issues related to DURC
- Develops policies and guidelines for the identification, assessment, and oversight of DURC
- Provides recommendations on the communication and publication of DURC findings
- U.S. Government Policy for Oversight of Life Sciences Dual Use Research of Concern requires federal agencies to identify and oversee DURC projects they fund
- Institutions receiving federal funding must establish their own DURC oversight policies and procedures
- Researchers must assess their work for DURC potential and report any concerns to their institution and funding agency
- International guidelines and frameworks:
- World Health Organization (WHO) guidance on responsible life sciences research
- The Biological Weapons Convention (BWC) prohibits the development, production, and stockpiling of biological weapons by its member states (182 countries)
Key Terms to Review (27)
1977 H1N1 Influenza: The 1977 H1N1 influenza virus, also known as the 'Russian flu,' is a strain of the influenza virus that emerged in the late 1970s and caused a pandemic primarily affecting younger individuals. This particular strain raised concerns due to its unusual reappearance after being absent for nearly 30 years, linking it to the dual-use research issues in biotechnology, where research can lead to both beneficial medical advancements and potential misuse or harmful consequences.
2001 anthrax attacks: The 2001 anthrax attacks were a series of bioterrorism incidents that involved the mailing of anthrax spores through letters to several news media offices and two Democratic Senators in the United States shortly after the September 11 attacks. This event highlighted serious concerns regarding biosecurity and the potential misuse of biological research, linking directly to the ongoing discussions about the dual-use nature of biotechnology.
Bioethics committees: Bioethics committees are groups of individuals established within institutions, organizations, or governmental bodies to provide guidance and oversight on ethical issues related to biomedical research and healthcare practices. These committees play a crucial role in addressing the ethical implications of emerging biotechnologies, ensuring that research adheres to ethical standards and considers the potential consequences on society and individuals.
Biosecurity assessment: A biosecurity assessment is a systematic evaluation of risks associated with biological research and the measures in place to mitigate potential threats, particularly in contexts where research may have dual-use implications. This type of assessment ensures that biotechnology research does not inadvertently contribute to harmful applications, such as bioterrorism or the misuse of sensitive biological materials. By identifying vulnerabilities and implementing safeguards, biosecurity assessments help maintain public safety and trust in scientific advancements.
Biotechnology Regulatory Act: The Biotechnology Regulatory Act is a U.S. law that provides a framework for the regulation of biotechnology products, including genetically engineered organisms. This act ensures that these products are safe for human health and the environment, laying down guidelines for their evaluation and oversight. The act connects to bioethics by emphasizing the importance of safety and ethical considerations in the development and use of biotechnological innovations, while also addressing the dual-use concerns associated with biotechnological research.
Bioterrorism threat: A bioterrorism threat refers to the potential use of biological agents, such as bacteria, viruses, or toxins, to deliberately harm or intimidate civilians, often for political or ideological motives. This type of threat can create widespread fear and disruption, as well as cause significant public health risks, making it a crucial concern in the realm of biotechnology and public safety.
CRISPR-Cas9 Gene Editing Controversy: The CRISPR-Cas9 gene editing controversy revolves around the ethical and safety concerns surrounding the use of this powerful technology for modifying genetic material in organisms. While CRISPR-Cas9 has the potential to revolutionize medicine, agriculture, and biotechnology, it also raises significant dual-use issues, as the same techniques could be misused for harmful purposes or create unintended consequences in ecosystems and human health.
Deontological ethics: Deontological ethics is a moral theory that emphasizes the importance of following rules or duties in determining ethical behavior, rather than focusing solely on the consequences of actions. This approach asserts that some actions are inherently right or wrong, regardless of their outcomes, and it is often associated with philosophers like Immanuel Kant, who advocated for duty-based morality.
Dual-use biotechnology: Dual-use biotechnology refers to biological research and technology that can be used for both beneficial and harmful purposes. This duality raises significant ethical, safety, and regulatory concerns as advancements intended for medical or agricultural benefits can also be misapplied for malicious intent, such as bioweapons development or environmental harm. Understanding this concept is crucial for balancing innovation with safety and security measures in the field of biotechnology.
Dual-use dilemma: The dual-use dilemma refers to the ethical and security challenges that arise when research or technology developed for beneficial purposes can also be misused for harmful purposes. This concept is particularly significant in biotechnology, where advancements can lead to both medical breakthroughs and the potential for bioweapons or other malicious applications. The dilemma emphasizes the need for careful consideration of how scientific knowledge is applied and regulated to prevent misuse while promoting innovation.
Dual-use research: Dual-use research refers to scientific research that can be used for both beneficial and harmful purposes, especially in the fields of biotechnology and life sciences. This type of research presents ethical dilemmas because while it can lead to advancements in health and technology, the same knowledge or techniques can be misused for harmful applications, such as developing bioweapons or creating biohazards. The tension between fostering innovation and preventing misuse creates a complex landscape for researchers, policymakers, and ethicists.
Enhancing virulence: Enhancing virulence refers to the process of increasing the pathogenicity or disease-causing ability of an organism, often through genetic modifications or other biotechnological means. This concept raises significant ethical concerns, especially in the context of research that could be misused for harmful purposes, making it a critical topic in discussions about dual-use research in biotechnology.
Gain-of-function research: Gain-of-function research involves scientific experiments that aim to enhance the capabilities of an organism or a virus, often by increasing its transmissibility, virulence, or ability to evade the immune system. This type of research has significant implications for public health, as it can lead to potential benefits in understanding diseases but also poses risks if such enhanced organisms accidentally escape the lab or are misused.
Genetic modification: Genetic modification refers to the process of altering the genetic material of an organism to achieve desired traits or characteristics. This technology allows for precise changes at the molecular level, enabling scientists to enhance certain features such as disease resistance or crop yield. The implications of genetic modification extend to both beneficial applications and potential risks, particularly in the realm of research that could be misused, as well as how society perceives and communicates about biotechnological advancements.
Government agencies: Government agencies are organizations created by the government to implement and enforce laws, regulations, and policies within specific areas of public interest. They play a vital role in overseeing various sectors, including health, safety, and environmental protection, ensuring compliance with established standards while promoting public welfare. These agencies often collaborate with research institutions and industry stakeholders, particularly in areas such as biotechnology where dual-use research can raise ethical concerns.
Highly Pathogenic Viruses: Highly pathogenic viruses are infectious agents known for their ability to cause severe disease and high mortality rates in infected hosts, often affecting humans and animals. These viruses pose significant public health risks due to their potential for rapid transmission and outbreak potential. Understanding these viruses is crucial for developing effective prevention and control measures, especially in the context of dual-use research that can lead to both beneficial and harmful applications in biotechnology.
Institutional Review Boards: Institutional Review Boards (IRBs) are committees established to review and approve research involving human subjects to ensure that their rights and welfare are protected. These boards assess the ethical aspects of research proposals, particularly in contexts like dual-use research of concern in biotechnology, where findings could be misapplied for harmful purposes. IRBs play a crucial role in maintaining ethical standards and fostering public trust in scientific research.
Mousepox experiment: The mousepox experiment refers to a controversial scientific study conducted in the early 2000s where researchers genetically modified the mousepox virus to enhance its virulence and resistance to vaccines. This experiment raised significant concerns about dual-use research, where scientific knowledge could be misused for harmful purposes, highlighting the ethical implications of biotechnology research.
National Science Advisory Board for Biosecurity: The National Science Advisory Board for Biosecurity (NSABB) is an advisory committee in the United States that provides guidance on biosecurity and the dual-use research of concern. It aims to ensure that life sciences research is conducted responsibly and with consideration for potential misuse, particularly in areas where research could be used for harmful purposes. The NSABB plays a critical role in evaluating and recommending policies to balance scientific advancement with safety concerns.
Pathogens: Pathogens are microorganisms that can cause disease in their hosts, including bacteria, viruses, fungi, and parasites. These organisms can be dangerous in the context of biotechnology, especially when research intended for beneficial purposes inadvertently leads to harmful applications, such as the creation of bioweapons or the accidental release of harmful agents.
Public Trust: Public trust refers to the confidence that individuals and communities have in institutions, processes, and practices, especially regarding ethical conduct and decision-making in biotechnology. This trust is crucial for the acceptance of biotechnological advancements and affects regulatory frameworks, public engagement, and the overall success of innovations in the field.
Risk-Benefit Analysis: Risk-benefit analysis is a systematic approach used to evaluate the potential risks and benefits associated with a particular action or decision, especially in fields like biotechnology and medicine. This process involves weighing the likelihood of negative outcomes against the anticipated positive effects, helping decision-makers make informed choices that balance safety and efficacy.
Scientists: Scientists are individuals who systematically study the natural world through observation, experimentation, and analysis. They play a vital role in biotechnology by developing new technologies and methods that can benefit society, while also being aware of the potential risks and ethical implications of their work.
Synthesis of poliovirus: The synthesis of poliovirus refers to the artificial creation of the poliovirus genome using synthetic biology techniques. This process involves assembling the viral RNA from smaller nucleotides, allowing researchers to study the virus's biology and potential treatments or vaccines. However, this capability raises significant ethical concerns regarding dual-use research, where the same knowledge can be applied for beneficial purposes or malicious intents.
Synthetic biology: Synthetic biology is an interdisciplinary field that combines biology and engineering to design and construct new biological parts, devices, and systems. It focuses on the re-engineering of organisms to create novel functions and capabilities, raising important considerations in areas like ethics, patent law, and dual-use research.
Transmissibility: Transmissibility refers to the ability of a pathogen or organism to spread from one host to another, which is crucial in understanding how diseases can propagate through populations. This concept is key in evaluating risks associated with infectious agents, especially in the context of dual-use research, where biological knowledge can be applied for both beneficial and harmful purposes. Understanding transmissibility helps researchers assess potential threats while balancing scientific advancement and public safety.
Utilitarianism: Utilitarianism is an ethical theory that suggests the best action is the one that maximizes overall happiness or well-being. It connects to various aspects of ethical decision-making, especially in fields like biotechnology, where actions are often evaluated based on their consequences for individuals and society.