Relevant bibliographies by topics / Gene editing governance

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  1. Journal articles
  2. Dissertations / Theses
  3. Book chapters
  4. Reports

Academic literature on the topic 'Gene editing governance'

Author: Grafiati
Published: 9 March 2023
Last updated: 10 March 2023

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Journal articles on the topic "Gene editing governance"

1

Marchant, Gary E. "Global Governance of Human Genome Editing: What Are the Rules?" Annual Review of Genomics and Human Genetics 22, no. 1 (August 31, 2021): 385–405. http://dx.doi.org/10.1146/annurev-genom-111320-091930.

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Human gene editing, particularly using the new CRISPR/Cas9 technology, will greatly increase the capability to make precise changes to human genomes. Human gene editing can be broken into four major categories: somatic therapy, heritable gene editing, genetic enhancement, and basic and applied research. Somatic therapy is generally well governed by national regulatory systems, so the need for global governance is less urgent. All nations are in agreement that heritable gene editing should not proceed at this time, but there is likely to be divergence if and when such procedures are shown to be safe and effective. Gene editing for enhancement purposes is not feasible today but is more controversial with the public, and many nations do not have well-developed regulatory systems for addressing genetic enhancement. Finally, different nations treat research with human embryos very differently based on deeply embedded social, cultural, ethical, and legal traditions. Several international governance mechanisms are currently in operation for human gene editing, and several other governance mechanisms have been proposed. It is unlikely that any single mechanism will alone be effective for governing human gene editing; rather, a polycentric or ecosystem approach that includes several overlapping and interacting components is likely to be necessary.
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Xue, Yang, and Lijun Shang. "Governance of Heritable Human Gene Editing World-Wide and Beyond." International Journal of Environmental Research and Public Health 19, no. 11 (May 31, 2022): 6739. http://dx.doi.org/10.3390/ijerph19116739.

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To date, the controversy surrounding the unknown risks and consequences of heritable genome editing has grown, with such work raising biosafety and ethical concerns for future generations. However, the current guideline of global governance is limited. In the context of the new framework for the governance of human genome editing developed by the World Health Organization (WHO) committee, this paper presents further analysis by highlighting predicaments of governance on germline engineering that merit the most attention: (1) building a scientific culture informed by a broader set of values and considerations in the internal scientific community at large, such as codes of ethics, and education, in addition to awareness-raising measures; and (2) reflecting on and institutionalizing policies in grassroots practice according to local conditions in external governance, such as the experimentalist governance, which is a multi-layered model of governance that establishes an open-ended framework from the top and offers stakeholders the freedom of discussion. The key to achieving these goals is more democratic deliberation between the public and the inclusive engagement of the global scientific community, which has been extensively used in the Biological and Toxin Weapons Convention (BTWC). On a global scale, we believe that practicing heritable human genome editing in accordance with the WHO and BTWC appears to be a good choice.
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Gordon, Doria R., Gregory Jaffe, Michael Doane, Aviva Glaser, Thomas M. Gremillion, and Melissa D. Ho. "Responsible governance of gene editing in agriculture and the environment." Nature Biotechnology 39, no. 9 (August 11, 2021): 1055–57. http://dx.doi.org/10.1038/s41587-021-01023-1.

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Riggan, Kirsten A., Richard R. Sharp, and Megan Allyse. "Where Will We Draw the Line? Public Opinions of Human Gene Editing." Qualitative Health Research 29, no. 12 (May 5, 2019): 1823–35. http://dx.doi.org/10.1177/1049732319846867.

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The application of gene editing technologies to prevent or mitigate genetic disease in humans is considered one of its most promising applications. However, as the technology advances, it is imperative to understand the views of the broader public on how it should be used. We conducted focus groups to understand public views on the ethical permissibility and governance of gene editing technologies in humans. A total of 50 urban and semirural residents in the upper Midwest took part in six focus groups. Participants expressed multiple concerns about nonmedical uses of gene editing and its potential for unknown harms to human health, and were divided as to whether the individual patient or “medical experts” should be charged with overseeing the scope of its application. As potential stakeholders, the perspectives from the general public are critical to assess as genome editing technologies advance toward the clinic.
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Saldaña Tejeda, Abril. "Global divisions of health; bioethical principles, practices and regulations on human genome editing and stem cell research in Latin America." Bionatura 4, no. 3 (August 15, 2019): 895–96. http://dx.doi.org/10.21931/rb/2019.04.03.2.

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Recent genetic technologies have uncovered the urgent need for global governance of health that can guarantee an ethical consensus on human genome editing and stem cell research. Although the majority of gene-transfer trials have been located in the Americas and Europe, the regulation of human somatic cell genome editing is generally limited in Latin America and largely informed by ethical concerns about genetically modified plants and animals, biopiracy, biosecurity, and use of stem cells for clinical care. Few jurisdictions in the region (i.e., Chile, Panama, Ecuador, and Colombia) have explicitly addressed somatic genome editing. Jurisdictions often address concerns regarding the use of new biotechnologies (i.e., CRISPR-Cas9) for human “enhancement” purposes rather than the prevention or cure of serious medical conditions 1.
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Macnaghten, Phil, and Michelle G. J. L. Habets. "Breaking the impasse: Towards a forward‐looking governance framework for gene editing with plants." PLANTS, PEOPLE, PLANET 2, no. 4 (May 6, 2020): 353–65. http://dx.doi.org/10.1002/ppp3.10107.

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LEONE, Luca. "Gene Editing for the EU Agrifood: Risks and Promises in Science Regulation." European Journal of Risk Regulation 10, no. 4 (October 22, 2019): 766–80. http://dx.doi.org/10.1017/err.2019.55.

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In today’s innovation-driven agrifood domain, the perspective of using so-called New Breeding Techniques (NBTs) on both non-human animals and plants calls into question the regulatory approach (process/product-based) to be used, while asking for a critical reflection on the potential impact of products on the industrial sector and citizens. A possible reconfiguration of European (EU) discipline will have to grapple with not only agrifood market’s interests and needs, but mostly and primarily with the growing quest for public and participatory discussion on the current dominant vision on life sciences. Only through restoring visibility to the intertwining of knowledge production will it be possible to obtain EU governance of gene editing that is more authoritatively reliable from a scientific stance, as well as more transparently discussed and democratically shared at legal and policy level.
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Waltz, Margaret, Eric T. Juengst, Teresa Edwards, Gail E. Henderson, Kristine J. Kuczynski, John M. Conley, Paige Della-Penna, and R. Jean Cadigan. "The View from the Benches: Scientists' Perspectives on the Uses and Governance of Human Gene-Editing Research." CRISPR Journal 4, no. 4 (August 1, 2021): 609–15. http://dx.doi.org/10.1089/crispr.2021.0038.

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Meyer, Morgan, and Cornelius Heimstädt. "The divergent governance of gene editing in agriculture: a comparison of institutional reports from seven EU member states." Plant Biotechnology Reports 13, no. 5 (October 2019): 473–82. http://dx.doi.org/10.1007/s11816-019-00578-5.

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Nawaz, Sara, and Milind Kandlikar. "Drawing Lines in the Sand? Paths Forward for Triggering Regulation of Gene-Edited Crops." Science and Public Policy 48, no. 2 (March 16, 2021): 246–56. http://dx.doi.org/10.1093/scipol/scab014.

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Abstract Researchers are making use of new gene-editing techniques in medicine, bioenergy, industrial biotechnology, and beyond, and the field of crop breeding is no exception. These techniques, which differ from genetic modification techniques, spell difficult questions for regulatory oversight: will current rules-of-play apply, or do new techniques necessitate fundamental shifts in regulations? Thus far, little explicit attention has focused on the fundamental yet elusive questions of which technical specifics currently trigger regulation of gene-edited crops, and where different jurisdictions ‘draw’ this line. Here, we trace these regulatory lines across key jurisdictions. We argue that extant regulatory definitions are crumbling in the face of emerging technologies and assert that this breakdown poses a threat to responsible governance. Drawing upon insights from responsible research and innovation, we propose a shift away from technically based regulatory approaches and toward more risk-targeted oversight based on broader societal and ecological implications.
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Dissertations / Theses on the topic "Gene editing governance"

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BONOMELLI, SARA. "L'EDITING GENETICO GERMINALE UMANO, TRA PROBLEMI ETICI E QUESTIONI DI GOVERNANCE." Doctoral thesis, Università degli Studi di Milano, 2022. http://hdl.handle.net/2434/922688.

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The dissertation aims at identifying and analyzing the scientific, legal, and ethical issues raised by the perspective of intentional modification of human germline by the potential future use of gene editing techniques in the context of human reproduction. Such a study makes it possible to formulate some critical considerations about human germline gene editing governance. The dissertation claims that the best option to regulate the use of this biotechnological innovation for reproductive purposes consists of a regulation on a state-by-state-basis, which should however be developed within an international governance framework. Several arguments are suggested to underpin this thesis, and some recent initiatives adhering to such governance pattern are examined. The research is organized in three chapters. The first chapter, which is introductive to the real research, focuses on the scientific and technical aspects of the thesis topic. More specifically, this chapter aims at laying the foundations for the subsequent discussion, by defining and explaining the notions of i) DNA, gene, chromosome; ii) genetic mutation and genetic disease; and iii) gene therapy and gene editing. Special attention is paid to this latter technology and especially to its potential use on the human germline. Such use is highly controversial, mainly – but not exclusively – since, unlike modifications made by somatic gene editing, those affecting germinal cells – namely, gametes and zygotes – are transmitted to descendants, and thus to next generations. The second chapter is divided into two sections. The first section reconstructs and analyses the existing regulations in the field of human germline gene editing at international, supranational and national level, stressing their vagueness, fragmentation and lack of specificity. Given the impossibility of extensively examining all relevant domestic laws, guidelines and policies, those of four countries only – the USA, the UK, China and Italy – have been considered in detail. This choice is motivated by the geographical and cultural representativeness of their respective regulations, as well as by the fact that, except for Italy, those countries conducted nearly all the experiments carried out so far in the field of human germline gene editing. The second section of the chapter precisely focuses on these experiments – both for research and reproductive purposes. Jiankui He’s experiment – which resulted in the birth of the world’s first gene-edited babies in 2018 – and Denis Rebrikov’s germline gene editing clinical trial project are thoroughly described and analyzed. The third and last chapter deals with the ethical issues raised by the perspective of the potential future implementation of germline gene editing interventions in the context of human reproduction. This chapter too is articulated into two sections. The first section provides the theoretical bases for the subsequent ethical analysis, by dividing the possible future uses of germline gene editing techniques into three categories: i) therapeutic interventions; ii) medical enhancement interventions; and iii) non-medical enhancement interventions. Such categorization is paramount, since the various ethical issues related to human germline gene editing do not always involve all three of these categories, and, even when they do, they tend to carry different connotations according to each category. This becomes clear in the second section of the chapter, which critically explores six main ethically problematic areas related to this biotechnological innovation and their numerous articulations. Finally, the dissertation argues that the scientific, legal and ethical issues identified and examined throughout the research must be taken into account by proper germline gene editing governance mechanisms, which should be the result of parallel and complementary regulatory initiatives promoted both at national and international level.
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Book chapters on the topic "Gene editing governance"

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Braverman, Irus. "Gene Drives, Nature, Governance." In Gene Editing, Law, and the Environment, 54–73. New York, NY : Routledge, 2017. | Series: Law, science and society: Routledge, 2017. http://dx.doi.org/10.4324/9781315168418-4.

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Ho, Calvin W. L. "Legal Governance of Genome-Editing Technologies for Human Gene and Cell Therapies in Singapore." In Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim, 363–87. Berlin, Heidelberg: Springer Berlin Heidelberg, 2019. http://dx.doi.org/10.1007/978-3-662-59028-7_17.

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Hamilton, R. Alexander, Ruth Mampuys, S. E. Galaitsi, Aengus Collins, Ivan Istomin, Marko Ahteensuu, and Lela Bakanidze. "Opportunities, Challenges, and Future Considerations for Top-Down Governance for Biosecurity and Synthetic Biology." In NATO Science for Peace and Security Series C: Environmental Security, 37–58. Dordrecht: Springer Netherlands, 2021. http://dx.doi.org/10.1007/978-94-024-2086-9_3.

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AbstractSynthetic biology promises to make biology easier to engineer (Endy 2005), enabling more people in less formal research settings to participate in modern biology. Leveraging advances in DNA sequencing and synthesis technologies, genetic assembly methods based on standard biological parts (e.g. BioBricks), and increasingly precise gene-editing tools (e.g. CRISPR), synthetic biology is helping increase the reliability of and accessibility to genetic engineering. Although potentially enabling tremendous opportunities for the advancement of the global bioeconomy, opening new avenues for the creation of health, wealth and environmental sustainability, the possibility of a more ‘democratic’ (widely accessible) bioengineering capability could equally yield new opportunities for accidental, unintended or deliberate misuse. Consequently, synthetic biology represents a quintessential ‘dual-use’ biotechnology – a technology with the capacity to enable significant benefits and risks (NRC 2004).
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Jennings, Bruce. "Bioethics Contra Biopower." In Human Flourishing in an Age of Gene Editing, 247–66. Oxford University Press, 2019. http://dx.doi.org/10.1093/oso/9780190940362.003.0018.

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This chapter engages two issues as they bear on genomic editing and the effects of biotechnology on human well-being: (1) how technology influences a reductionistic and manipulative understanding of biopower and biopolitics, fundamentally at odds with the worldview of bioethical humanism; and (2) how the reconceptualization of human flourishing in capability theories of justice bears on the ethics of biotechnology. The argument of this chapter appeals to a relational or “ecological” humanism that will assist bioethics in developing a critique of the technologies and knowledges of molecular reductionism. In the perspective of relational humanism, human beings are empowered as subjects of value and agents of self-realization, and mutual relations of interdependence and solidarity are affirmed. Along these lines, a reframed debate concerning the governance of biopower and the promotion of just human flourishing in an age of biotechnology can take place.
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Schermer, Maartje. "Reprogenetic Technologies Between Private Choice and Public Good." In Human Flourishing in an Age of Gene Editing, 212–27. Oxford University Press, 2019. http://dx.doi.org/10.1093/oso/9780190940362.003.0016.

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Much of the bioethical debate on reproductive and genetic technologies has focused on the potential risks and benefits for individuals. This chapter shifts the focus from the individualistic level towards a societal perspective. It explores how emerging reprogenetic technologies can both thwart and promote the flourishing of communities, and argues that these technologies can contribute to the public good only when certain social conditions and side-constraints are in place—which can sometimes entail influencing or even limiting individual choice. The chapter gives an account of how we should understand ‘the public good’ in this context, including values such as tolerance, inclusion, and solidarity. It explores how reprogenetic technologies can affect the public good, for better or worse. Finally it addresses the forms of governance—regulations, institutional checks and balances—we might deploy with regard to these technologies to ensure they contribute to both individual and collective flourishing.
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Hochschild, Jennifer. "Who Should Govern?" In Genomic Politics, 186–219. Oxford University Press, 2021. http://dx.doi.org/10.1093/oso/9780197550731.003.0008.

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Chapter 8 uses the GKAP surveys, expert surveys, and interviews to examine views about governance of genomics technologies. Experts collectively offer long lists of appropriate and inappropriate governing bodies; they show little convergence. Interview subjects also offer diverse views on genomics governance, but mostly agree that government actors and medical professionals are not suited to it. The public generally endorses forensic DNA databases and their governance, has mixed views on medical research involving genetics, and is cautious about gene editing, especially germline. Americans express little confidence in any potential governing actor, but they trust families and doctors somewhat more than community forums, clergy, or public officials. There is little partisan division, some racial division, and mostly division by quadrants of the basic framework.
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Reports on the topic "Gene editing governance"

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Kuiken, Todd, and Jennifer Kuzma. Genome Editing in Latin America: Regional Regulatory Overview. Inter-American Development Bank, July 2021. http://dx.doi.org/10.18235/0003410.

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The power and promise of genome editing, CRISPR specifically, was first realized with the discovery of CRISPR loci in the 1980s.3 Since that time, CRISPR-Cas systems have been further developed enabling genome editing in virtually all organisms across the tree of life.3 In the last few years, we have seen the development of a diverse set of CRISPR-based technologies that has revolutionized genome manipulation.4 Enabling a more diverse set of actors than has been seen with other emerging technologies to redefine research and development for biotechnology products encompassing food, agriculture, and medicine.4 Currently, the CRISPR community encompasses over 40,000 authors at 20,000 institutions that have documented their research in over 20,000 published and peer-reviewed studies.5 These CRISPR-based genome editing tools have promised tremendous opportunities in agriculture for the breeding of crops and livestock across the food supply chain. Potentially addressing issues associated with a growing global population, sustainability concerns, and possibly help address the effects of climate change.4 These promises however, come along-side concerns of environmental and socio-economic risks associated with CRISPR-based genome editing, and concerns that governance systems are not keeping pace with the technological development and are ill-equipped, or not well suited, to evaluate these risks. The Inter-American Development Bank (IDB) launched an initiative in 2020 to understand the complexities of these new tools, their potential impacts on the LAC region, and how IDB may best invest in its potential adoption and governance strategies. This first series of discussion documents: “Genome Editing in Latin America: Regulatory Overview,” and “CRISPR Patent and Licensing Policy” are part of this larger initiative to examine the regulatory and institutional frameworks surrounding gene editing via CRISPR-based technologies in the Latin America and Caribbean (LAC) regions. Focusing on Argentina, Bolivia, Brazil, Colombia, Honduras, Mexico, Paraguay, Peru, and Uruguay, they set the stage for a deeper analysis of the issues they present which will be studied over the course of the next year through expert solicitations in the region, the development of a series of crop-specific case studies, and a final comprehensive regional analysis of the issues discovered.
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Bagley, Margo. Genome Editing in Latin America: CRISPR Patent and Licensing Policy. Inter-American Development Bank, July 2021. http://dx.doi.org/10.18235/0003409.

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The power and promise of genome editing, CRISPR specifically, was first realized with the discovery of CRISPR loci in the 1980s.i Since that time, CRISPR-Cas systems have been further developed enabling genome editing in virtually all organisms across the tree of life.i In the last few years, we have seen the development of a diverse set of CRISPR-based technologies that has revolutionized genome manipulation.ii Enabling a more diverse set of actors than has been seen with other emerging technologies to redefine research and development for biotechnology products encompassing food, agriculture, and medicine.ii Currently, the CRISPR community encompasses over 40,000 authors at 20,000 institutions that have documented their research in over 20,000 published and peer-reviewed studies.iii These CRISPR-based genome editing tools have promised tremendous opportunities in agriculture for the breeding of crops and livestock across the food supply chain. Potentially addressing issues associated with a growing global population, sustainability concerns, and possibly help address the effects of climate change.i These promises however, come along-side concerns of environmental and socio-economic risks associated with CRISPR-based genome editing, and concerns that governance systems are not keeping pace with the technological development and are ill-equipped, or not well suited, to evaluate these risks. The Inter-American Development Bank (IDB) launched an initiative in 2020 to understand the complexities of these new tools, their potential impacts on the LAC region, and how IDB may best invest in its potential adoption and governance strategies. This first series of discussion documents: “Genome Editing in Latin America: Regulatory Overview,” and “CRISPR Patent and Licensing Policy” are part of this larger initiative to examine the regulatory and institutional frameworks surrounding gene editing via CRISPR-based technologies in the Latin America and Caribbean (LAC) regions. Focusing on Argentina, Bolivia, Brazil, Colombia, Honduras, Mexico, Paraguay, Peru, and Uruguay, they set the stage for a deeper analysis of the issues they present which will be studied over the course of the next year through expert solicitations in the region, the development of a series of crop-specific case studies, and a final comprehensive regional analysis of the issues discovered.
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