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Shravishtha Ajaykumar, “The Ethical and Security Implications of Genetic Engineering,” ORF Issue Brief No. 723, August 2024, Observer Research Foundation.
Biotechnology is making contributions to science, society, and security by promoting healthcare advancements and food security. The dual-use nature of biotechnology,[1] however, has led to issues such as the development of narcotics and biological weapons.
Similarly of dual use is genetic engineering, most commonly referring to Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology[a] that evolved from Zinc Finger Nucleases (ZFN) and Transcription Activator-Like Effector Nucleases (TALENs).[2] In the past few years, CRISPR has led to more precise genetic engineering, including through technologies such as base editing, single nucleotide substitutions, prime editing,[b] and ‘drag-and-drop’ editing for large insertions in Programmable Addition via Site-specific Targeting Elements (PASTE).[3]
As the technology is progressing, critics are calling attention to its potential social and ethical implications, including, for instance, the emergence of the notion of “designer babies”.[c],[4] The controversy surrounding CRISPR technology expanded in early 2015, both in anticipation of and in response to the first reported use of the technology to genetically modify non-viable human embryos.[5] The debate intensified in November 2018 after Chinese researcher He Jiankui confirmed the birth of twin girls whose genomes had been edited at the early embryo stage to confer resistance to HIV infection. In December 2019, the Nanshan District People’s Court in Shenzhen, China, found He and two others guilty of violating Article 336 of the Criminal Law of the People’s Republic of China, which prohibits engaging in medical activities without a licence.[6] While this is the only reported case so far of CRISPR being used to modify humans, it underscores the potential risks of genetic engineering and the urgent need for governance to ensure the responsible and ethical use of these technologies.
There are many ethical concerns in the field of biotechnology, particularly genetic engineering. For the purposes of this brief, these concerns are categorised into two areas: the social impact of biotechnology and genetic engineering, and their implications for security and warfare. Further, the brief discusses the impact of emerging technologies, existing governing tools, and ways to address gaps.
Current conversations around genetic engineering have failed to include its applications and impact on society, security, and modern warfare.[7],[8]
The main concerns around genetic engineering include the following:
Biological warfare (biowarfare), bioterrorism, and biosecurity have been central to security treaties since the 1972 Biological Weapons Convention (BWC).[13] While biological warfare is a low-probability outcome of warfare, the potential use of such agents can have a significant impact.[14] Genetic engineering technologies, particularly those that can modify the human genome, pose unique security risks. For instance, they could be used to create genetically enhanced biological agents that are more virulent or resistant to existing treatments. The concerns around the societal impact and aligned ethical concerns of genetic engineering also extend to biological weapons.
The fusion of Artificial Intelligence (AI) and biotechnology presents multiple opportunities, from regenerative medicine to drug discovery and healthcare. Indeed, the use of AI in biotech has resulted in innovations like the Xenobots, created by the University of Vermont in 2020.[21]
AI has the potential to revolutionise healthcare by enabling personalised medicine. By analysing genetic data and biological markers, AI can predict disease susceptibility, recommend interventions, and optimise drug development and consumption.[22] Moreover, AI can analyse health records to predict disease outcomes and susceptibilities in larger populations, enhancing healthcare delivery and public health initiatives.
Machine Learning (ML) and AI can positively impact co-advancement, environmental impact, climate impact, and agricultural protection. However, this convergence also raises ethical and regulatory concerns, including the potential for discriminatory practices. In India, for example, issues with pharmacogenetic diversity[k] would disadvantage southern populations, tribal groups, and certain disadvantaged castes that have fewer commonalities with European populations than northern Indian populations.[23],[24] AI can also be misused for the development of targetable biological agents.[25]
Globally, genetic engineering has variable dimensions, which are highlighted in domestic governance tools. For example, in Germany, human genome editing is a function of medicine, does not consider negative intentional and unintentional outcomes that can improve individual health, and is assessed based on a constitutional commitment to human dignity.[26] Meanwhile, Canadian law around genetic engineering focuses on assisted reproduction while safeguarding diversity and human integrity.[27] In the United States (US), the Food and Drug Association (FDA) has the primary authority to regulate clinical genome-editing applications, focusing on the safety and efficacy of cloning for food and therapeutic applications.[28] For their part, the 29 European Union (EU) countries that ratified the Oviedo Convention[l] consider human rights, human dignity, and genome integrity as fundamental. [29]
Countries have varying policies on germline genome editing. Many countries prohibit using genetically modified embryos for heritable genome editing, although no country explicitly allows heritable human genome editing.[30] However, this is hard to monitor. The heritability of genetic engineering can only be studied across generations, and the novelty of the technology makes off-target heritable impact plausible.[31]
Recent developments necessitate an understanding of the global policy landscape for heritable human genome editing, the possible repetition of such experiments, and growing public interest and policy considerations. In this context, there are multiple international standards and dialogues that oversee this subsection of modern biotechnology.
The emergence of Recombinant DNA (rDNA) technology in the early 1970s allowed the manipulation of DNA through inserting genes from one organism into the DNA of another. In this context, the Asilomar Conference on Recombinant DNA, held in February 1975 in California,[32] aimed to assess the risks of rDNA technology and establish guidelines for safe and restricted use.[33] The main concern was the GMOs escaping from laboratories in unintentional leakages, potentially causing ecological disasters or the creation of harmful pathogens.
The Asilomar Conference highlighted the importance of scientists taking responsibility for the ethical and safety implications of their research. The conference was attended by over 140 scientists and stakeholders, who formulated guidelines that are considered even today.[34] The conference established research guidelines describing containment styles for defined risks, including minimal, low, moderate, and high risk.[m],[35] It also laid the foundation for a biotechnology and genetic engineering regulatory framework and led to the establishment of the Recombinant DNA Advisory Committee (RAC) at the National Institute of Health (NIH), which oversees recombinant DNA research in the US.[36]
The Oviedo Convention, formally known as the Council of Europe Convention on Human Rights and Biomedicine, is an international treaty to protect human rights and dignity in biomedicine.[37] It was adopted in 1997 and enacted in 1999 for members across Europe.[38] The Convention aims to safeguard the dignity and fundamental rights of individuals involved in biomedicine and establish common ethical principles and standards for medicine and biomedical research[39]—the first such in biomedicine. It includes critical provisions for required informed consent for medical interventions and research involving human subjects, protections for vulnerable individuals, and the privacy and confidentiality of medical information.[40] Further, it prohibits human cloning for reproductive purposes and the modification of the human genome in germ cells, along with additional protocols for biomedical research and genetic testing.[41] The standards are mandatory for member states, which are encouraged to ratify the Convention.
The International Society for Stem Cell Research (ISSCR)[n] Guidelines aim to ensure responsible research and clinical translation of stem cell-based therapies.[42] The guidelines cover areas such as ethical standards, research oversight, informed consent, responsible communication, and clinical translation.[43] The ISSCR Guidelines are regularly reviewed and updated to reflect scientific developments and ethical considerations and serve as a global standard for ethical conduct in stem cell research.[44] They also conduct lobbying efforts to develop regulations governing stem cell research and therapy, including policy lobbying and advocacy in the US and the European Union (EU).[45] ISSCR’s recent lobbying in Australia resulted in the establishment of a framework for stricter regulations concerning the marketing and administration of unproven therapies of autologous human cell and tissue products.[46]
The Berkeley Ethics and Regulation Group for Innovative Technologies (BERGIT) is a project co-hosted by the Kavli Center for Ethics, Science, and the Public and the International Genomics Institute.[o],[47] BERGIT holds regular meetings with member scientists to discuss ethical concerns in contemporary times. Although BERGIT has not published a list of standards, it has had a notable influence in participation and discussion on emerging technologies and the applications of biotechnology; an example are the recent discussions on AI and digital information, genome editing therapies, and neurotechnology.[48]
In 2003, the United Nations Educational, Societal and Cultural Organization (UNESCO) established the International Bioethics Committee to explore the ethical implications of genome editing and its impact on human rights, human dignity, and the environment.[49]
The World Health Organization (WHO) has convened expert panels and working groups to develop guidelines for the governance and oversight of human genome editing. Their recommendations emphasise transparency, inclusivity, and international cooperation to ensure the responsible and ethical use of genetic engineering technologies. WHO has a list of considerations for countries that are in the process of establishing guidelines in biologics.[50] While this document calls for ethical considerations in regulatory applications at domestic levels, these ethics are not clarified. Additionally, WHO and UNESCO established the international, non-profit Council for International Organizations of Medical Sciences (CIOMS) in 1949 to govern health research and genetic engineering.[51] The CIOMS developed a comprehensive document on ethical guidelines for human impact studies, “International Ethical Guidelines for Health-related Research Involving Humans”, that encourage countries and private-sector participants to implement controls on clinical research, highlight the need for informed consent and benefit sharing, and encourage reimbursement for participation in different types of human-based research trials.[52]
The International Commission on the Clinical Use of Human Germline Genome Editing was formed by the US National Academy of Sciences, the US National Academy of Medicine, and the UK’s Royal Society.[53] The Commission developed a report that outlines the principles, criteria, and a framework for the clinical use of germline genome editing, emphasising the importance of safety, efficacy, and responsible conduct. However, its recommendations for neutral ethics without regular renewal have been criticised for including diseases that have alternative cures and for overlooking social aspects such as affordability and accessibility.[54] At the same time, the whistleblower feature in the report reduces the possible misuse of such technologies, thus increasing its relevance.
Although emerging technologies and alliances are an intuitive next step in the future of warfare, security guidelines are yet to account for genetic engineering, being restricted by proxy due to existing standards on scientific limits on research and trade limits on biological agents. The potential societal harm from genetic engineering and its implications for the future of warfare and security necessitate an urgent examination of these issues.[55] Although there are no specific international ethical guidelines around the use of genetic engineering in warfare, such use of modern biotechnology violates existing international conventions.
Further, research that may result in the creation of genetically motivated weapons would also fall under existing guidelines. Scientific organisations, such as the International Committee of the Red Cross (ICRC),[60] the World Medical Association (WMA),[61] and the International Science Council (ISC),[62] have ethical guidelines that prohibit the use of science for harmful purposes. The code is not legally binding but acts as a standard for medical professionals and other stakeholders.
The National Academies of Sciences, Engineering, and Medicine, by request of the US Department of Defense, formalised the Imperiale Framework in 2018.[63] The framework’s primary objective is to monitor advancements in biotechnology and its implications in warfare.[64] The framework has identified three areas of concern: recreating known pathogenic viruses, making existing bacteria more dangerous, and creating harmful biochemicals via in-situ synthesis. The first two rely on technology that is easy to use and highly accessible, while the novelty of the third makes preventing and recognising an attack difficult.[65],[66]
Existing regulatory tools that place limits on the development and use of dual-use biotechnology tools are outdated and do not discuss the potential of genetically enhanced bioweapons or chemical weapons. The gaps in standards are described in the following points:
The use of modern technologies in warfare is inevitable. Banning technology use is often ineffective, not only because bans discourage innovation but also that they target only those who already function under regulations. States that do not comply, or non-state actors who have access to emerging technologies, will remain ungoverned. However, introducing ethical guidelines and standards can control the research that drives such use. Most standards already cover beneficence and non-maleficence—that is, genetic engineering should promote the well-being of individuals and society.
The US has established a National Security Commission on Emerging Biotechnology (NSCB), which focuses on biosecurity, including genetic engineering.[72] Other domestic governments, however, continue to rely on existing global governance tools. While other countries need to set up national security commissions similar to the NSCB, this needs to be supplemented by enhancing existing governance tools to achieve holistic and well-thought-out innovations in biosecurity.
Existing treaties oversee genetic engineering as a science and attempt to maintain ethics in research, and the BWC oversees the existence, development, and use of biological agents. However, these need to expand to include genetic engineering, its co-existence with emerging technologies like AI, and its relationship with biological and chemical weapons. A regulatory tool for genetic engineering should thus include the following:
The rapid advancement of genetic engineering technology and its derivatives has raised ethical, societal, and security concerns. While these technologies hold promise for treating genetic diseases and improving human health, they also present risks, such as the largely yet-unknown effects of GMOs and enhancing bioweapons.
Existing regulatory frameworks, such as the Asilomar Conference guidelines, the Oviedo Convention, and the ISSCR Guidelines, provide a foundation for governing genetic engineering technologies. There are gaps in these regulations, however: their definitions are reductive, they lack comprehensive ethical principles, and they overlook security-based applications. The BWC should be expanded to address these challenges and establish comprehensive governance frameworks for genetic engineering to prioritise transparency, informed consent, equity, and environmental responsibility.
These frameworks should include long-term monitoring, public engagement, global collaboration, and temporary moratoriums on specific applications. Additionally, governance should be horizontally integrated, focusing on process and application areas to ensure consistent standards and prevent regulatory arbitrage.
[a] Genetic engineering involves manipulating the genetic material of organisms, typically DNA or RNA, and can include adding, deleting, or modifying specific genes to achieve desired traits or outcomes.
[b] Editing without double-stranded breaks.
[c] This term was introduced with the emergence of CRISPR-cas9 (a sub-type of CRISPR) to refer to genetically altered embryos. The process involves making genetic alterations to in-vitro early-stage embryos or gametes. Genetically modified embryos are then transferred to a uterus to initiate a pregnancy, resulting in the birth of a child with a modified genome. If the child reaches reproductive age and has offspring using their gametes, the descendants will inherit a genetically modified genome. While designer babies were introduced to remove a foetus’s susceptibility to genetic conditions such as certain types of cancers, blood disorders such as HIV, and disorders like Alzheimer’s, Parkinson’s, and Huntington’s, concerns arose on the use of such interventions to alter a child’s physical features, citing eugenics, the removal of segments of the population, and ethics surrounding intervention. See: https://doi.org/10.1016/bs.pmbts.2021.01.017; https://doi.org/10.3906/biy-1912-52
[d] While present-day population management is reserved for pests and viruses, the extension of such knowledge to human populations is not impossible.
[e] A cultural practice of marrying within one’s social group.
[f] Interleukin-4 (IL-4) is a protein that the human body produces to help fight infections and regulate the immune system.
[g] Ribonucleic acid
[h] cDNA stands for complementary DNA. During cDNA synthesis, reverse transcriptase makes a DNA copy of the messenger RNA (mRNA) molecule by using it as a template. The resulting cDNA molecule is a complementary copy of the original mRNA, which can then be used for various applications in molecular biology, such as cloning genes, studying gene expression, and making recombinant DNA molecules.
[i] While E. coli is a bacterium commonly found in human and animal intestines, E. coli Kl2 is a specific strain of E. coli that has been modified to make it useful for scientific experiments. Scientists can genetically modify E. coli Kl2 to produce specific proteins, enzymes, or other molecules for research purposes.
[j] An RNA virus with no current treatment available, often transferred to humans through rodents or infected foods.
[k] Pharmacogenetic research refers to the genetic disposition of individuals to respond to medicines and drugs in certain ways. Diversity here is important to ensure drug development does not feature a bias to a community.
[l] Officially known as the Convention on Human Rights and Biomedicine, it is an international treaty established by the Council of Europe in 1997 on protecting human rights and dignity in the context of biological trade, biotechnology and developments of medicines and treatments. The convention is discussed further in the brief.
[m] Minimal risk: Might be biohazards but can be contained once detected; Low risk: Experiments that may result in novel biotypes that do not have an ecological impact or increased pathogenicity; Moderate risk: The possibility of a biotype that is novel and highly pathogenic; High risk: The possibility of a biotype being highly pathogenic and having an immense ecological impact.
[n] The ISSCR is an international organisation that promotes stem cell research and its applications in treating diseases. While the organisation is not a governing body, it has influenced both domestic policy and private sector participation.
[o] The Innovative Genomics Institute is a joint effort between scientific research institutions on the West Coast of the US and was founded by Jennifer Dounda, Nobel Prize winner and a pioneer in genetics and biotechnology work.
[1] “Biosecurity and Dual-Use Research in the Life Sciences,” in Science and Security in a Post 9/11 World (National Academics Press, 2007) https://www.ncbi.nlm.nih.gov/books/NBK11496/.
[2] Thomas Gaj, Charles A. Gersbach, and Carlos F. Barbas, “ZFN, TALEN, and CRISPR/Cas-Based Methods For Genome Engineering,” Trends in Biotechnology, July 1, 2013, https://doi.org/10.1016/j.tibtech.2013.04.004.
[3] “Genome Editing Techniques: The Tools That Enable Scientists To Alter the Genetic Code,” Synthego, June 13, 2022, https://www.synthego.com/blog/genome-editing-techniques.
[4] Bartha Maria Knoppers and Erika Kleiderman, “‘CRISPR Babies’: What Does This Mean For Science and Canada?” Canadian Medical Association Journal, January 27, 2019, https://doi.org/10.1503/cmaj.181657.
[5] Françoise Baylis et al., “Human Germline and Heritable Genome Editing: The Global Policy Landscape,” The CRISPR Journal, October 1, 2020, https://doi.org/10.1089/crispr.2020.0082.
[6] Antonio Regalado, “The Creator Of the CRISPR Babies Has Been Released From a Chinese Prison,” MIT Technology Review, May 11, 2022, https://www.technologyreview.com/2022/04/04/1048829/he-jiankui-prison-free-crispr-babies/.
[7] Hannah Devlin, “Scientist Who Edited Babies’ Genes Says He Acted ‘Too Quickly,’” The Guardian, February 4, 2023, https://www.theguardian.com/science/2023/feb/04/scientist-edited-babies-genes-acted-too-quickly-he-jiankui.
[8] Ewan Wilson, “The Ethics and Security Challenge Of Gene Editing,” Georgetown Journal of International Affairs, July 14, 2023, https://gjia.georgetown.edu/2023/06/26/the-ethics-and-security-challenge-of-gene-editing/.
[9] Roberto Andorno et al., “Geneva Statement On Heritable Human Genome Editing: The Need For Course Correction,” Trends in Biotechnology, April 1, 2020, https://doi.org/10.1016/j.tibtech.2019.12.022.
[10] Roohi Bansal, “CRISPR-Cas9 and Designer Babies: The Ethical Debate (Part 59- CRISPR In Genetic engineering and Beyond),” Medium, February 21, 2024, https://medium.com/@bansalroohi/crispr-cas9-and-designer-babies-the-ethical-debate-part-59-crispr-in-gene-editing-and-beyond-bf040eac674e.
[11] Dr Anurag Agarwal, “Raising Bio-Tech Standards: Reimagining What It Means to Be Human,” (Panel Discussion in CYFY 2022) October 31, 2022, https://www.youtube.com/watch?v=_3fOA_ugw8A.
[12] Nicolas O. Rode et al., “Population Management Using Gene Drive: Molecular Design, Models of Spread Dynamics and Assessment of Ecological Risks,” Conservation Genetics April 1, 2019, https://doi.org/10.1007/s10592-019-01165-5.
[13] “Biological Weapons Convention (BWC),” The Nuclear Threat Initiative, March 7, 2024, https://www.nti.org/education-center/treaties-and-regimes/convention-prohibition-development-production-and-stockpiling-bacteriological-biological-and-toxin-weapons-btwc/.
[14] Mark G. Kortepeter and Gerald W. Parker, “Potential Biological Weapons Threats,” Emerging Infectious Diseases, August 1, 1999, https://doi.org/10.3201/eid0504.990411.
[15] “Why Are Some Genetic Conditions More Common In Particular Ethnic Groups?” MedlinePlus Genetics, https://medlineplus.gov/genetics/understanding/inheritance/ethnicgroup/.
[16] Shambhavi Naik, “Reevaluating Bioweapons Amid Global Political Fragility,” Policy Commons, January 4, 2023, https://policycommons.net/artifacts/3363577/reevaluating-bioweapons-amid-global-political-fragility/4162286/.
[17] William J. Broad, “Bioterror Researchers Build a More Lethal Mousepox,” The New York Times, November 1, 2003, https://www.nytimes.com/2003/11/01/us/bioterror-researchers-build-a-more-lethal-mousepox.html.
[18] David P. Clark and Nanette J. Pazdernik, “Biological Warfare: Infectious Disease and Bioterrorism,” Elsevier eBooks (2016), https://doi.org/10.1016/b978-0-12-385015-7.00022-3.
[19] “Bioterrorism: The History Of a Crisis In American Society: 2 Volume Set,” Routledge & CRC Press, December 21, 2020, https://www.routledge.com/Bioterrorism-The-History-of-a-Crisis-in-American-Society-2-Volume-Set/McBride/p/book/9780367642594.
[20] “Bioterrorism: The History Of a Crisis In American Society: 2 Volume Set.”
[21] “Team Builds the First Living Robots,” The University of Vermont, January 14, 2020, https://www.uvm.edu/news/story/team-builds-first-living-robots.
[22] Debleena Paul et al., “Artificial Intelligence In Drug Discovery and Development,” Drug Discovery Today, January 1, 2021, https://doi.org/10.1016/j.drudis.2020.10.010.
[23] David Reich et al., “Reconstructing Indian Population History,” Nature September 1, 2009, https://doi.org/10.1038/nature08365.
[24] Alice B Popejoy, “Diversity in Precision Medicine and Pharmacogenetics: Methodological and Conceptual Considerations for Broadening Participation,” Pharmacogenomics and Personalized Medicine, October 1, 2019, https://doi.org/10.2147/pgpm.s179742.
[25] Shravishtha Ajaykumar, “Global Collaboration In Integrated AI and Biotech,” Observer Research Foundation, December 14, 2023, https://www.orfonline.org/expert-speak/global-collaboration-in-integrated-ai-and-biotech.
[26] J. Benjamin Hurlbut et al., “Building Capacity For a Global Genome Editing Observatory: Conceptual Challenges.”
[27] Legislative Services Branch, “Consolidated Federal Laws Of Canada, Assisted Human Reproduction Act,” Government of Canada, June 9, 2020, https://laws-lois.justice.gc.ca/eng/acts/a-13.4/page-1.html.
[28] Center for Biologics Evaluation and Research, “Therapeutic Cloning and Genome Modification,” U.S. Food and Drug Administration, March 16, 2018, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/therapeutic-cloning-and-genome-modification.
[29] Human Rights and Biomedicine, “Oviedo Convention and Its Protocols,” Council of Europe, https://www.coe.int/en/web/bioethics/oviedo-convention.
[30] Françoise Βaylis et al., “Human Germline and Heritable Genome Editing: The Global Policy Landscape.”
[31] Michael V. Zuccaro et al., “Allele-Specific Chromosome Removal After Cas9 Cleavage in Human Embryos,” Cell December 1, 2020, https://doi.org/10.1016/j.cell.2020.10.025.
[32] Paul Van Den Berg, “Asilomar 1975: DNA Modification Secured,” Nature, September 1, 2008, https://doi.org/10.1038/455290a.
[33] Paul Van Den Berg, “Asilomar 1975: DNA Modification Secured.”
[34] Paul Van Den Berg, “Asilomar 1975: DNA Modification Secured.”
[35] Paul Berg et al., “Summary Statement Of the Asilomar Conference On Recombinant DNA Molecules,” Proceedings of the National Academy of Sciences of the United States of America, June 1, 1975, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC432675/.
[36] Nelson A. Wivel, “Historical Perspectives Pertaining To the NIH Recombinant DNA Advisory Committee,” Human Gene Therapy, January 1, 2014, https://doi.org/10.1089/hum.2013.2524.
[37] “Oviedo Convention and Its Protocols - Human Rights and Biomedicine,” Council of Europe, https://www.coe.int/en/web/bioethics/oviedo-convention.
[38] “Oviedo Convention and Its Protocols - Human Rights and Biomedicine.”
[39] “Oviedo Convention and Its Protocols - Human Rights and Biomedicine.”
[40] “Oviedo Convention and Its Protocols - Human Rights and Biomedicine.”
[41] “Oviedo Convention and Its Protocols - Human Rights and Biomedicine.”
[42] “Guidelines,” International Society for Stem Cell Research, July 14, 2022, https://www.isscr.org/guidelines/#toc.
[43] “Guidelines.”
[44] Robin Lovell‐Badge et al., “ISSCR Guidelines For Stem Cell Research and Clinical Translation: The 2021 Update,” Stem Cell Reports, June 1, 2021, https://doi.org/10.1016/j.stemcr.2021.05.012.
[45] “Active Support For Stem Cell Research Around the World,” International Society for Stem Cell Research, August 23, 2022, https://www.isscr.org/isscr-news/active-support-for-stem-cell-research-around-the-world.
[46] Therapeutic Goods Administration, “Regulatory Framework for Biologicals,” Government of Australia, June 13, 2024, https://www.tga.gov.au/regulatory-framework-biologicals.
[47] “BERGIT - Innovative Genomics Institute (IGI),” Innovative Genomics Institute (IGI), March 16, 2023, https://innovativegenomics.org/bergit/.
[48] “BERGIT - Innovative Genomics Institute (IGI).”
[49] “Universal Declaration on Bioethics and Human Rights,” UNESCO, March 1, 2023, https://www.unesco.org/en/ethics-science-technology/bioethics-and-human-rights.
[50] “Considerations In Developing a Regulatory Framework For Human Cells and Tissues and For Advanced Therapy Medicinal Products,” World Health Organization, June 20, 2024, https://www.who.int/publications/m/item/considerations-in-developing-a-regulatory-framework-for-human-cells-and-tissues-and-for-advanced-therapy-medicinal-products.
[51] National Academies Press (US), “Oversight of Human Genome Editing and Overarching Principles for Governance,” Human Genome Editing, NCBI Bookshelf, February 14, 2017, https://www.ncbi.nlm.nih.gov/books/NBK447266/.
[52] Council for International Organizations of Medical Sciences (CIOMS), “International Ethical Guidelines for Health-related Research Involving Humans,” World Health Organization (2016), https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf.
[53] “Human Germline Genome Editing Commission,” Royal Society, https://royalsociety.org/news-resources/projects/genetic-technologies/international-commission/.
[54] Misha Angrist et al., “Reactions To the National Academies/Royal Society Report on Heritable Human Genome Editing,” The CRISPR Journal, October 1, 2020, https://doi.org/10.1089/crispr.2020.29106.man.
[55] “If Misused, Synthetic Biology Could Expand the Possibility of Creating New Weapons - DOD Should Continue to Monitor Advances in the Field,” National Academies, June 19, 2018, https://www.nationalacademies.org/news/2018/06/if-misused-synthetic-biology-could-expand-the-possibility-of-creating-new-weapons-dod-should-continue-to-monitor-advances-in-the-field-new-report-says.
[56] Shravishtha Ajaykumar, “Navigating Considerations Of Global Governance, National Strategies, and Ethics In Biowarfare,” Observer Research Foundation, August 23, 2023, https://www.orfonline.org/research/navigating-considerations-of-global-governance-national-strategies-and-ethics-in-biowarfare.
[57] “Convention On the Prohibition Of the Development, Production and Stockpiling Of Bacteriological (Biological) and Toxin Weapons and On Their Destruction,” UNODA Treaties Database, https://treaties.unoda.org/t/bwc
[58] “OPCW By the Numbers,” OPCW, https://www.opcw.org/media-centre/opcw-numbers.
[59] “Customary IHL - Rule 73. Biological Weapons,” International Humanitarian Law Database, https://ihl-databases.icrc.org/en/customary-ihl/v1/rule73.
[60] “Appeal On Biotechnology, Weapons and Humanity,” ICRC, September 25, 2002, https://www.icrc.org/en/doc/resources/documents/statement/5eamtt.htm.
[61] “WMA Statement On Human Genome Editing,” World Medical Association, October 2020, https://www.wma.net/policies-post/wma-statement-on-human-genome-editing/.
[62] “The Newly Released Report Issues Recommendations On Heritable Human Genome Editing,” International Science Council, September 8, 2020, https://council.science/current/news/human-genome-editing/.
[63] Marcus A. Cunningham and John P. Geis II, “A National Strategy For Synthetic Biology,” Strategic Studies Quarterly (2020), https://www.jstor.org/stable/26937411.
[64] Marcus A. Cunningham and John P. Geis II, “A National Strategy For Synthetic Biology,” Strategic Studies Quarterly (2020), https://www.jstor.org/stable/26937411.
[65] Cunningham and Geis, “A National Strategy For Synthetic Biology.”
[66] Françoise Βaylis et al., “Human Germline and Heritable Genome Editing: The Global Policy Landscape,” The CRISPR Journal, October 1, 2020, https://doi.org/10.1089/crispr.2020.0082.
[67] Priska Gisler and Monika Kurath, “Paradise Lost? ‘Science’ and ‘the Public’ After Asilomar,” Science, Technology, & Human Values, March 2011, https://www.jstor.org/stable/41149049.
[68] Stefan Schäfer and Sean Low, “Asilomar Moments: Formative Framings In Recombinant DNA and Solar Climate Engineering Research,” Mathematical, Physical and Engineering Sciences, December 28, 2014, https://doi.org/10.1098/rsta.2014.0064.
[69] Roberto Andorno, “The Oviedo Convention: A European Legal Framework At the Intersection of Human Rights and Health Law,” Journal of International Biotechnology Law, January 26, 2005, https://doi.org/10.1515/jibl.2005.2.4.133.
[70] Oktawian Nawrot, “The Biogenetical Revolution Of the Council of Europe - Twenty Years Of the Convention on Human Rights and Biomedicine (Oviedo Convention),” Life Sciences, Society and Policy, May 16, 2018, https://doi.org/10.1186/s40504-018-0073-2.
[71] Rebecca Mackelprang and Douglas C. Friedman, “Agricultural Crop Security: Exploring US Federal Readiness and Response Capabilities,” Health Security, October 1, 2021, https://doi.org/10.1089/hs.2020.0153.
[72] Biotech, “Latest Work - Biotech,” National Security Commission on Emerging Biotechnology, January 31, 2024, https://www.biotech.senate.gov/latest-work/.
[73] Emine Saner, “‘There Is a Fear That This Will Eradicate Dwarfism’: The Controversy Over a New Growth Drug,” The Guardian, September 28, 2020, https://www.theguardian.com/science/2020/sep/28/there-is-a-fear-that-this-will-eradicate-dwarfism-the-controversy-over-a-new-growth-drug.
[74] “Gene Therapy: A Potential Cure For Growth-hormone Resistant Dwarfism,” Drug Target Review, May 6, 2022, https://www.drugtargetreview.com/news/103053/gene-therapy-a-potential-cure-for-growth-hormone-resistant-dwarfism/.
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Shravishtha Ajaykumar is Associate Fellow at the Centre for Security, Strategy and Technology. Her fields of research include geospatial technology, data privacy, cybersecurity, and strategic ...
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