Journal articles on the topic 'Gene editing governance'

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.

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.

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.

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.

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.

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.

Organoids hold great promises for numerous applications in biomedicine and biotechnology. Despite its potential in science, organoid technology poses complex ethical challenges that may hinder any future benefits for patients and society. This study aims to analyze the multifaceted ethical issues raised by organoids and recommend measures that must be taken at various levels to ensure the ethical use and application of this technology. Organoid technology raises several serious ethics issues related to the source of stem cells for organoid creation, informed consent and privacy of cell donors, the moral and legal status of organoids, the potential acquisition of human “characteristics or qualities”, use of gene editing, creation of chimeras, organoid transplantation, commercialization and patentability, issues of equity in the resulting treatments, potential misuse and dual use issues and long-term storage in biobanks. Existing guidelines and regulatory frameworks that are applicable to organoids are also discussed. It is concluded that despite the serious ethical challenges posed by organoid use and biobanking, we have a moral obligation to support organoid research and ensure that we do not lose any of the potential benefits that organoids offer. In this direction, a four-step approach is recommended, which includes existing regulations and guidelines, special regulatory provisions that may be needed, public engagement and continuous monitoring of the rapid advancements in the field. This approach may help maximize the biomedical and social benefits of organoid technology and contribute to future governance models in organoid technology.

AbstractAt a crucial meeting during their proceedings, on 9 November 1983, the sixteen members of Britain's influential Warnock Inquiry into Human Fertilisation and Embryology reached a key decision on how to base proposals for comprehensive legislation governing this largely uncharted territory. Famously, they chose the formation of the “primitive streak” in the early embryo as the basis for the fourteen-day rule that has now served as the global benchmark for experimental research in this area for nearly thirty years. Based on newly available archival material and interviews, this article offers a sociological account of the ways in which a specific translation of biological facts became the basis for an enduring social contract governing controversial bioinnovation in the UK. In particular, the combined roles of Committee Chair Mary Warnock and biologist Anne McLaren are examined in terms of how a decision, or “iterative settlement,” was reached as to “where to draw the line” using specific “developmental landmarks” to establish a basis for legal regulation. Drawing from this analysis, I offer a broader argument concerning the sociology of biological translation and biogovernance that is germane to ongoing debates such that over how to limit CRISPR-Cas 9 gene editing. I contend also that we have yet to fully grasp the historical and sociological lessons to be drawn from the early histories of establishing governance over new forms of technological assistance to human reproduction, and in particular the formation of the “Warnock Consensus.”

<p>Abukosim, Mukhtaruddin, Ika Sasti Ferina and Claudya Nurcahaya. 2014. Ownership Structure and Firm Value : Empirical Study on Indonesia Manufacturing Listed Company. <em>Journal of Economic</em>. Vol. 5, No. 4.</p><p>Afzal, Arie. 2012. Pengaruh Keputusan Investasi, Keputusan Pendanaan, dan Kebijakan Dividen terhadap Nilai Perusahaan.<em>Skripsi Universitas Diponegoro</em>. Semarang. (tidak dipublikasikan)</p><p>Aries, Heru Prasetyo. 2011. Evaluasi Perusahaan. Jakarta Pusat. PPM.</p><p>Asmawati dan Lailatul Amanah. 2013. Pengaruh Struktur Kepemilikan, Keputusan Keuangan Terhadap Nilai Perusahaan : Profitabilitas sebagai Variabel Moderating. <em>Jurnal Ilmu dan Riset.</em>Vol. 2, No. 4.</p><p>Ashamu, S., Abiola, J., and Badmus, S. 2012. Dividend Policy as Strategic Tool of Financing in Public Firm : Evidence From Nigeria. <em>Europan Scientific Journal</em>. Vol. 8 No. 9. PP : 1-24.</p><p>Belkaoui, A.R. 2007. <em>Accounting Theory</em>. 5th Edition. Buku 2. Edisi Terjemahan. Jakarta: Salemba Empat.</p><p>Bernandhi, Riza. 2013. Pengaruh Kepemilikan Manajerial, Kepemilikan Institusional, Kebijakan Deviden, Leverage dan Ukuran Perusahaan Terhadap Nilai Perusahaan. <em>Skripsi Fakultas Ekonomi dan Bisnis Universitas Diponegoro</em>. (tidak dipublikasikan)</p><p>Brealey, R.A, Myers, S.C, Marcus, A.J.2008. <em>Dasar-Dasar Manajemen Keuangan Perusahaan Jilid I.</em>Jakarta : Erlangga.</p><p>Brigham &amp; Weston. 1998. <em>Dasar-dasar Manajemen Keuangan</em>. Terjemahan : Ali Akbar Yulianto. Jakarta : Salemba Empat.</p><p>Brigham, Eugene F. and Houston, Joel F. 2006. Dasar-Dasar Manajemen Keuangan, diterjemahkan oleh Ali Akbar Yulianto.Edisi sepuluh. Jakarta : PT. Salemba Empat.</p><p>Brigham, Eugene F. and Houston, Joel F. 2007.<em>Essentials of Financial Management</em>. Singapore : Cengage Learning.</p><p>Dewi, Putu Yunita Saputri, Gede Adi Yuniarta dan Ananta Wikrama Tungga Atmadja.2014. Pengaruh Struktur Modal, Pertumbuhan Perusahaan dan Profitabilitas terhadap Nilai Perusahaan pada Perusahaan. <em>Jurnal Akuntansi</em>. Vol. 2 No. 1.</p><p>Downes, John and Jordan Elliot Goodman,1999, Kamus Istilah Akuntansi, Jakarta, Penerbit Elex Media Komputindo.</p><p>Efni, Yulia. 2011. Pengaruh Keputusan Investasi, Keputusan Pendanaan, Kebijakan Dividen terhadap Nilai Perusahaan Studi pada Sektor Properti dan Real Estate di Bursa Efek Indonesia. <em>Jurnal Aplikasi Manajemen</em> : No. 66B/DIKTI/KEP/2011.</p><p>Faizal, Achmad.2011.Pengaruh Kebijakan Dividen, Struktur Kepemilikan dan Biaya Agensi terhadap Harga Saham.</p><p>Gultom, Robinhot dkk. 2013. Analisis Faktor-Faktor yang Mempengaruhi Nilai Perusahaan pada Perusahaan Farmasi di Bursa Efek Indonesia. <em>Jurnal Ekonomi</em>. Vol. 3 No. 1.</p><p>Ghozali, Imam. 2012. <em>Aplikasi Analisis Multivariate dengan Program SPSS</em>. Semarang : Badan Penerbit Universitas Diponegoro.</p><p>Gill, Amarjit. and Obradovich, John D. 2012. The Impact of Corporate Governance and Financial Leverage on the Value of American Firms. International Research <em>Journal of Finance and Economics</em>. PP : 91.</p><p>Harjito, Agus dan Martono. 2006. <em>Manajemen Keuangan</em>. Yogyakarta : Ekonisia.</p><p>Harqiansyah, Rizqi Faisal. 2015. Pengaruh Ukuran Perusahaan, Leverage dan Proftabilitas terhadap Nilai Perusahaan. <em>Jurnal Akuntansi</em>. (tidak dipublikasikan)</p><p>Hasnawati, Sri. 2015. Implikasi Struktur Modal dan Kepemilikan Saham Terhadap Nilai Perusahaan Publik di Bursa Efek Indonesia. <em>Jurnal Akuntansi dan Auditing Indonesia</em>.Vol. 9, No. 2.</p><p>Husnan,S.dan Pudjiastusti.2006.<em>Dasar-Dasar Manajemen Keuangan</em>. Edisi Keempat. Yogyakarta : AMP YKPN.</p><p>Honarbakhsh, S., Birjandi, H., and Birjandi M. 2013.The Effects of Dividend Policy on Market Value on Companies Listed In Tehran Stock Exchange. <em>International Review of Managementand Business Research</em>. Vol. 1, No. 1. PP : 65-75.</p><p>Irawan, Arif, Rina Arifati dan Abrar Oemar. 2016. Pengaruh Aset Berwujud, Ukuran Perusahaan, Pertumbuhan Perusahaan, Lama Perusahaan dan Probabilitas terhadap Kebijakan Hutang pada Perusahaan Manufaktur yang Terdaftar di Bursa Efek Indonesia Periode Tahun 2010-2014. <em>Jurnal Akuntansi</em>. Vol. 2 No. 2.</p><p>Irvaniawati. 2014. Analisis Pengaruh Kebijakan Hutang, Kebijakan Investasi, dan Kebijakan Deviden Terhadap Nilai Perusahaan. <em>Jurnal Ilmu dan Riset Manajemen.</em>Vol. 3, No. 6.</p><p>Jensen, M.C. and Meckling, W.H. 1976. Theory of the Firm : Mangerial Behavior, Agency Cost, and Ownership Structur. <em>Journal of Financial Economics</em>. Vol. 76, PP. 305-360.</p><p>Jogiyanto. 2013. <em>Teori Portofolio dan Analisis Investasi</em>. Edisi Ketujuh. Yogyakarta : BPFEE.</p><p>Kumar, S., Anjum B. and Nayyar S. 2012. Financing Decisions : Study of Pharmaceutical Companies of India. <em>International Journal of Marketing</em>, <em>Financial Services and Management Research</em>. Vol. 1 No. 1. PP. 14-28.</p><p>Kusumajaya, Dewa Kadek Oka. 2011. Pengaruh Struktur Modal dan Pertumbuhan Perusahaan terhadap Profitabilitas dan Nilai Perusahaan pada Perusahaan Manufaktur di Bursa Efek Indonesia. <em>Tesis Universitas Udayana</em>.</p><p>Kouki, Mondher and Hatem ben Said. 2011. Does Management Ownership Explain The Effect of Leverage on Firm Value? An Analysis of French Listed Firms. <em>Journal of Bussiness Studies Quarterly</em>. Vol. 3, No. 1.</p><p>Mandagi, S.E.A. 2010. Pengaruh Keputusan Keuangan terhadap Nilai Perusahaan Manufaktur yang terdaftar di Bursa Efek Indonesia periode 2008-2010.<em>Jurnal Bisnis.</em> Hal : 28-32.</p><p>Marhamah.2013. Pengaruh Manajemen Laba, Ukuran Perusahaan terhadap Corporate Sosial Responsibility dan Nilai Perusahaan pada Perusahaan Manufaktur yang tercatat di Bursa Efek Indonesia tahun 2007-2010. <em>Jurnal STIE Semarang</em>. Vol. 5, No. 3.</p><p>Moeljadi. 2006.<em>Manajemen Keuangan Pendekatan Kuantitatif dan Kualitatif. </em>Edisi Pertama. Malang : Banyumedia Publishing.</p><p>Moradi, Nassim S., Aldin, Mahmood M., Heyrani, F., and Iranmhad, M. 2012. The Effect of Corporate Governance, Corporate Financing Decision and Ownership Structure on Firm Performance: A Panel Data Approach from Tehran Stock Exchange. <em>International Journal of Economics and Finance</em>. Vol. 4, No. 9. PP : 86-93.</p><p>Nabela, Yoandhika.2012. Pengaruh Kepemilikan Institusional, Kebijakan Dividen, dan Profitabilitas terhadap Kebijakan Hutang pada Perusahaan Properti dan Real Estate di Bursa Efek Indonesia.<em>Jurnal Manajemen</em>. Vol. 01, No. 01.</p><p>Nuraina, Elva. 2012. Pengaruh Kepemilikan Institusional dan Ukuran Perusahaan terhadap Kebijakan Hutang dan Nilai Perusahaan. <em>Jurnal Ekonomi</em>. Vol.19 No. 2.</p><p>Pratama, I Gusti Bagus Angga dan I Gusti Bagus Wiksuana. 2016. Pengaruh Ukuran Perusahaan dan <em>Leverage</em> terhadap Nilai Perusahaan dengan Profitabilitas sebagai Variabel Mediasi. <em>Jurnal Manajemen</em>. Vol. 5 No. 2.</p><p>Priyo, Estetika Maulida. 2013. Analisis Pengaruh Return on Asset, Debt to Equty Ratio, Firm Size, Growth dan Free Cash Flow terhadap Dividen Payout Ratio studi empiris pada Perusahaan Manufaktur yang terdaftar di Bursa Efek Indonesia periode 2008-2011. <em>Disertasi Univesitas Diponegoro Semarang. </em></p><p>Ratih, I Dewa Ayu dan I Gusti Ayu Eka Damayanthi. 2016. Kepemilikan Manajerial dan Profitabilitas pada Nilai Perusahaan dengan Pengungkapan Tanggungjawab Sosial sebagai Variabel Moderasi.<em>Jurnal Akuntansi</em>.Universitas Udayana.</p><p>Rizqia, Dwita A., Aisjah S., and Sumiati.2013. Effect of Managerial Ownership, Financial Leverage, Profitability, Firm Size and Investment Opportunity on Dividend Policy and Firm Value. <em>Research Journal of Finance and Accounting</em>. Vol. 4, No. 11. PP 120-130.</p><p>Roekanah dan Paulus Wardoyo. 2012. Analisis Faktor – Faktor yang Mempengaruhi Nilai Perusahaan pada Perusahaan Go Public yang terdaftar Di Bursa Efek Jakarta. <em>Jurnal Dinamika Manajeman</em>.Vol. 1, No. 1, Maret 2012.</p><p>Safitri, Hazlina. 2015. Pengaruh Size, Growth, dengan Kebijakan Dividen sebagai Variabel Moderating terhadap Nilai Perusahaan. <em>Jurnal Manajemen</em>.Vol.4 No.6</p><p>Samisi, Komang dan Putu Agus Ardiana. 2013. Pengaruh Struktur Pendanaan terhadap Nilai Perusahaan dengan Kepemilikan Manajerial sebagai Variabel Moderasi<em>. Jurnal Akuntansi</em>.Vol. 5 No. 2.</p><p>Sartini, Luh Putu Novita dkk. 2014. Pengaruh Keputusan Investasi, Kebijakan Dividen, serta Keputusan Pendanaan terhadap Nilai Perusahaan Manufaktur di Bursa Efek Indonesia<em>. Jurnal Manajemen</em>. Vol. 8 No.2.</p><p>Sartono, Agus. 2001. Manajemen Keuangan Teori dan Aplikasi. Yogyakarta : BPEF.</p><p>Sawir, Agnes. 2004. <em>Kebijakan Pendanaan dan Restrukturisasi Perusahaan</em>. Jakarta : PT. Gramedia Pustaka Utama.</p><p>Sugiarto. 2009. <em>Struktur Modal, Struktur Kepemilikan Perusahaan, Permasalahan Keagenan dan Informasi Asimetri. </em>Yogyakarta : Graha Ilmu.</p><p>Sugiyono.2014. <em>Metode Penelitian Kuantitatif, Kualitatif, dan R&amp;D</em>. Bandung : Alfabeta.</p><p>Suryani, Milanti Vivi. 2015. Pengaruh Pertumbuhan Perusahaan dan Struktur Modal terhadap Nilai Perusahaan. <em>Skripsi Unversitas Negeri Sem</em>arang. (tidak dipublikasikan)</p><p>Uwigbe, Uwalomwa et al. 2012. Dividend Policy and Firm Performances : A Study of Listed Firm in Nigeria. <em>Journal of</em> <em>Accounting and Management Information Systems</em>. Vol. 11 No. 3. PP : 442-454.</p><p>Verawaty, Citra Indah Merina, dan Irra Kurniawati. 2016. Analisis Pengembangan <em>Corporate Value</em> berdasarkan Keputusan Investasi dan Pendanaan, Struktur Kepemilikan, serta Kewajiban Dividen Perusahaan Manufaktur yang Terdaftar di Bursa Efek Indonesia. <em>Jurnal Akuntansi</em>. Vol. 1 No. 1.</p><p>Wolk <em>et. al</em>. 2000. <em>Accounting Theory</em>: A Conceptual Institusional Approach. Fifth Edition.</p>

The rapid development of CRISPR-based gene editing has been accompanied by a polarized governance debate about the status of CRISPR-edited crops as genetically modified organisms. This article argues that the polarization around the governance of gene editing partly reflects a failure of public engagement with the current state of research in genomics and postgenomics. CRISPR-based gene-editing technology has become embedded in a narrow narrative about the ease and precision of the technique that presents the gene as a stable object under technological control. By tracing the considerably destabilized scientific understanding of the gene in genomics and postgenomics, this article highlights that this publicly mediated ontology strategically avoids positioning the “ease of CRISPR-based editing” in the wider context of the “complexity of the gene.” While this strategic narrowness of CRISPR narratives aims to create public support for gene-editing technologies, we argue that it stands in the way of socially desirable anticipatory governance and open public dialogue about societal promises and the unintended consequences of gene editing. In addressing the polarization surrounding CRISPR-based editing technology, the article emphasizes the need for engagement with the complex state of postgenomic science that avoids strategic simplifications of the scientific literature in promoting or opposing the commercial use of the gene-editing technology.

Gene editing technologies allow users to make in vivo (live) changes to an organism’s DNA. Advances in the field of gene editing have made it arguably more precise, efficient, flexible, and cheaper compared to previous technologies. This has generated an upsurge of interest in gene editing and its governance, including in livestock applications. Although gene editing in livestock promises benefits, it also raises technical, ethical, and societal questions alongside the prospect of (radical) transformation. Since the technology is still to be developed into marketable products, it is the designs, visions, or what we term “sociotechnical imaginaries” that shape gene editing technologies and that represent an important site for sociological inquiry. In this article, based on an analysis of interviews with breeding company representatives and agricultural scientists in the Netherlands, we analyze the assumptions, values, and commitments that underpin their imaginaries. These imaginaries matter, since their negotiation will help structure how the technology develops and how it will subsequently transform livestock and human–animal relations. In our analysis, we analyze the discursive practices from the interview data distilling three sociotechnical imaginaries that shape and underpin how respondents discuss gene editing in livestock. Elaborating the sociotechnical imaginary concept to make it more amenable to the emerging dynamics of gene editing in livestock, we show how imaginaries need to be studied “in place” and in terms of “material practices.” Even though each of the imaginaries frame livestock gene editing as desirable and beneficial, they nevertheless have differential effects in how they structure industry, researcher, government, and consumer/citizen relations. We conclude by discussing how and why sociotechnical imaginaries on livestock gene editing matter and their implications for governance and research.

Abstract Considerable improvements have been made to gene editing technology, which has been increasingly applied to research involving humans. Nevertheless, human heritable germline genome editing is associated with a series of potential ethical, legal, and social risks, which have generated major controversies and discussions worldwide, especially after the “gene-edited babies” incident. Influenced by this incident, China has realized the importance of ethical governance in the field of life science and technology, has accelerated legislative and policy efforts in this field, and has gradually moved toward the direction of “precautionary” ethical governance. Black letter analysis, big data public opinion analysis and other research methods are used in this paper. This paper explores the scientific background, ethical debates, and latest developments regarding China’s regulatory framework for human germline gene editing after the “gene-edited babies” controversy and provides several recommendations on the future governance system of human germline gene editing in China. This paper argues that, in recent years, the ethics governance of germline genome editing in China has been accelerated and great changes have been made. However, the regulatory system for germline genome editing requires further improvement in three aspects: coordination of legislation and agencies, establishment of an ethics review system at high levels, and public participation and education.

Global governance of emerging, disruptive biomedical technologies presents a multitude of ethical problems. The recent paper by Shoziet alraises some of these problems in the context of a discussion of what could be themostdisruptive (and most morally fraught) emerging biomedical technology—human germline genome editing. At the heart of their argument is the claim that, for something like gene editing, there is likely to be tension between the interests of specific states in crafting regulation for the technology, and disagreement about what would be necessary to meet the requirements for responsible translation of gene editing into the clinic. This complicates hopes for a tidy, algorithmic process of crafting global governance via frameworks for regulation built around core ‘ethical values and principles’ (as they are called in the WHO Framework), and also forces us to confront deeper philosophical questions about biotechnology and global health.

Biotechnologies in agriculture and food are increasingly governed by both state and nonstate actors. In this article, we explore emerging tensions and contestations in the United States over how gene-editing technologies in agriculture and food should be governed and by whom. This article is framed theoretically by the literatures examining the politics of state and nonstate governance of the agrifood and biotechnology sectors. We draw on semistructured interviews with 45 key actors in the United States, including representatives of regulatory agencies, commodity groups, consumer and environmental nongovernmental organizations (NGOs), biotechnology and food industry, and scientists. In contrast to assumptions that commodity group and industry actors would share a preference for limited or self-regulation, we find growing contestations, with some calling for novel forms of regulatory oversight. Our findings reveal new tensions, fractures, and realignments between and among government, industry, and NGOs actors over gene-editing governance. These tensions and realignments reflect and respond to demands for broader engagement of publics and greater transparency in the governance of biotechnologies in agriculture and food. We argue that these emerging tensions and realignments between and among state and nonstate actors reflect efforts by these actors to incorporate lessons from the genetically modified organism labeling fight as they seek to (re)shape the governance of gene editing in a manner that reflects their interests.

Biotechnologies in agriculture and food are increasingly governed by both state and nonstate actors. In this article, we explore emerging tensions and contestations in the United States over how gene-editing technologies in agriculture and food should be governed and by whom. This article is framed theoretically by the literatures examining the politics of state and nonstate governance of the agrifood and biotechnology sectors. We draw on semistructured interviews with 45 key actors in the United States, including representatives of regulatory agencies, commodity groups, consumer and environmental nongovernmental organizations (NGOs), biotechnology and food industry, and scientists. In contrast to assumptions that commodity group and industry actors would share a preference for limited or self-regulation, we find growing contestations, with some calling for novel forms of regulatory oversight. Our findings reveal new tensions, fractures, and realignments between and among government, industry, and NGOs actors over gene-editing governance. These tensions and realignments reflect and respond to demands for broader engagement of publics and greater transparency in the governance of biotechnologies in agriculture and food. We argue that these emerging tensions and realignments between and among state and nonstate actors reflect efforts by these actors to incorporate lessons from the genetically modified organism labeling fight as they seek to (re)shape the governance of gene editing in a manner that reflects their interests.

Gene editing is an emerging technology with diverse applications in the making, including in livestock. While the technology is commonly represented as offering unbounded possibilities and societal benefit, it remains unclear how to characterise public views and the process through which responses are developed. Rather than simply being about individual attitudes, beliefs or preferences, we explicate an interpretative approach that seeks to understand how people make sense of the technology in the form of shared cultural idioms and stories. Based on five anticipatory focus group discussions with Dutch publics, we found the prevalence of five narratives shaping public talk, namely, technological fix, the market rules, in pursuit of perfection, finding the golden mean and governance through care. We explore the implications of these findings for governance and reflect on the virtues of sophrosyne and phronesis as offering ways to reconfigure the practice and politics of gene editing.

This article traces the contours and dynamics of the debates about the politics of gene editing. It does so by providing both a quantitative and qualitative analysis of the publications on the topic. We present a scientometric analysis of scientific publications; we discuss the geographies of gene editing by analysing the scales and spatial terms mobilised; and we undertake a lexicometric analysis of how debates are framed and the public is positioned. Our scientometric analysis of scientific articles shows that the governance and regulation of gene editing is discussed across an increasing range of disciplines and countries over the years. Along with this internationalisation and “transdisciplinarisation,” we see a qualitative shift in the “grounding” of the debate: while initially, authors tend to reflect about gene editing, in more recent years, there are increasing calls to act upon current knowledge. Across the countries we studied (the United States, the United Kingdom, Germany, China, Australia, Japan, and Canada) our lexicometric analysis shows only a few differences in terms of how gene editing is discussed. While the general framing of the debate is widely shared, the differences that we observe concern for instance the applications or benefits of gene editing and the ways in which the importance of involving the public is worded. We hold that bringing together multiple methods allows a rich and multifaceted discussion of the politics of gene editing, and that this opens up fertile dialogues between geography, sociology and political science.

Abstract Biomodifying technologies—such as gene editing, induced pluripotent stem cells, and bioprinting—are being developed for a wide range of applications, from pest control to lab-grown meat. In medicine, regulators have responded to the challenge of evaluating modified ‘natural’ material as a therapeutic ‘product’ by introducing more flexible assessment schemes. Attempts have also been made to engage stakeholders across the globe on the acceptable parameters for these technologies, particularly in the case of gene editing. Regulatory flexibility and stakeholder engagement are important, but a broader perspective is also needed to respond to the potential disruption of biomodification. Our case-study technologies problematize basic ideas—such as ‘nature’, ‘product’, and ‘donation’—that underpin the legal categories used to regulate biotechnology. Where such foundational concepts are rendered uncertain, a socially responsive and sustainable solution would involve exploring evolutions in these concepts across different societies. We suggest that the global observatory model is a good starting point for this ‘Adaptive Societal Governance’ approach, in which a self-organizing network of scholars and interested parties could carry out the multi-modal (meta)analyses needed to understand societal constructions of ideas inherent to our understanding of ‘life’.

Current methods of genome editing have been steadily realising the once remote possibilities of making effective and realistic genetic changes to humans, animals and plants. To underpin this, only 6 years passed between Charpentier and Doudna’s 2012 CRISPR-Cas9 paper and the first confirmed (more or less) case of gene-edited humans. While the traditional legislative and regulatory approach of governments and international bodies is evolving, there is still considerable divergence, unevenness and lack of clarity. However, alongside the technical progress, innovation has also been taking place in terms of ethical guidance from the field of patenting. The rise of so-called “ethical licensing” is one such innovation, where patent holders’ control over genome editing techniques, such as CRISPR, creates a form of private governance over possible uses of gene-editing through ethical constraints built into their licensing agreements. While there are some immediately apparent advantages (epistemic, speed, flexibility, global reach, court enforced), this route seems problematic for, at least, three important reasons: 1) lack of democratic legitimacy/procedural justice, 2) voluntariness, wider/global coordination, and sustainability/stability challenges and 3) potential motivational effects/problems. Unless these three concerns are addressed, it is not clear if this route is an improvement on the longer, slower traditional regulatory route (despite the aforementioned problems). Some of these concerns seem potentially addressed by another emerging patent-based approach. Parthasarathy proposes government-driven regulation using the patent system, which, she argues, has more transparency and legitimacy than the ethical licensing approach. This proposal includes the formation of an advisory committee that would guide this government-driven approach in terms of deciding when to exert control over gene editing patents. There seem to be some apparent advantages with this approach (over traditional regulation and over the ethical licensing approach mentioned above—speed and stability being central, as well as increased democratic legitimacy). However, problems also arise—such as a “half-way house” of global democratic legitimacy that may not be legitimate enough whilst still compromising speed of decision-making under the “ethical licensing” approach). This paper seeks to highlight the various advantages and disadvantages of the three main regulatory options—traditional regulation, ethical licensing and Parthasarathy’s approach—before suggesting an important, yet realistically achievable, amendment of TRIPS and an alternative proposal of a WTO ethics advisory committee.

Many trends in agricultural biotechnology have extended fluidly from the first era of genetic modification using recombinant DNA techniques to the era of gene editing. But the high-profile, explicit, and assertive discourse of democratization with gene editing — especially CRISPR-Cas9 — is something new. In this paper, I draw on semi-structured interviews with gene editors, policy analysts, and communications experts as well as with critical academic and civil society experts. I use Science and Technology Studies and political ecology lenses to unpack democratization in three main parts. First is democratizing discourses: On what grounds is CRISPR said to be democratic? Who is saying so? How do dissident communities respond to these narratives? Second is agricultural applications, with a focus on the Innovative Genomics Institute’s work in developing gene-edited food crops, including a case of saveable clonal hybrid rice. Third is governance, where I contrast US Department of Agriculture regulations and the CRISPRcon conference as “closed” and “invited” spaces, respectively, for democratic participation. Next, I argue that “created spaces,” in which power is held by typically delegitimized actors and ideas, offer an opening for working out democracy on the terrain of biotechnology. I conclude with a set of principles and practices for CRISPR governance based on the idea that democratization of biotechnology requires epistemic justice. By gathering multiple, partial knowledges together, we move beyond narrow risk-benefit framings to better evaluate not just what CRISPR is and does, but what democracy means and whom it serves.

Public participation, transparency and accountability are three of the pillars of good governance. These pillars become particularly important for innovative, personalised health technologies, because of the tendency of these technologies to raise distinct scientific, ethical, legal and social issues. Genome editing is perhaps the most personal of all innovative health technologies, involving precise modifications to an individual’s genome. This article focuses on the adequacy of current requirements for public participation, transparency and accountability in the governance of the market authorisation for genome edited products. Although clinical trials for genome edited products are only just underway, lessons can be drawn from the marketing approvals pathways for related gene therapy products. This article provides a broad overview of the regulatory pathways that have been adopted by the US Food and Drugs Administration, the European Medicines Authority, and the Australian Therapeutic Goods Administration for reviewing gene therapy products for marketing approval. This analysis focuses on the extent to which public participation processes and transparency and accountability of review pathways are incorporated into marketing approval policy and practice. Following this review, the article proposes the application of Sheila Jasanoff’s “technologies of humility” as a foundation for meaningfully incorporating these pillars of good governance into regulatory processes for the review of products of genome editing. We conclude by articulating clear mechanisms for operationalising technologies of humility in the context of public participation, transparency and accountability, providing a blueprint for future policy development.

Recent gene-editing technologies are heralded by proponents as a revolution for developing gene-edited foods (GEFs) while critics demand increased governance and scrutiny of potential societal impacts. Governance of GEFs is different in the United States, where GEFs are entering the market, and Europe, which restricts GEF development. Definitive regulations for governing GEFs are not yet solidified in either region. We identify and compare how English-language media in the United States and Europe portray potential risks, benefits, and regulation of GEFs, and we explore how these portrayals may reflect their regulatory environments. Results show that the regions similarly prioritize benefit frames that emphasize the social and scientific progress GEFs may bring, and few articles express skepticism about potential benefits. Comparing samples across regions exposes differences between Europe and the United States in the risk and benefit portrayals and in governance initiatives. Both regions prioritize policy risks that are counter to their current oversight regimes: the US media sample focused on GEFs being underregulated while the European sample emphasize risks of too much regulation. This may demonstrate the power of media to reflect and even cultivate public opinion and may influence future policy revisions within these distinct regulatory environments.

There is growing interest in gene editing farm animals. Some alterations could benefit animal welfare (e.g., improved heat tolerance in cattle with the “slick” gene), the environment (e.g., reducing methane emissions from cattle with induced pluripotent stem cells), and productivity (e.g., higher weight gains in cattle with the “double muscling” gene). Existing scholarship on the acceptability of such modifications has used myriad approaches to identify societal factors that shape the ethics and governance of this technology. We argue that integrating historical approaches—particularly from the relatively new and burgeoning field of animal history—offers a form of “anticipatory knowledge” that can help guide discussions on this topic. We conducted a systematic review of the animal history literature in English, German, and Spanish to identify the influence of political, scientific, economic, social, and cultural factors on the development and acceptance of such technologies. We identified analogous structures and fault lines in past debates about farm animals that provide insights for contemporary discussions about gene editing. Those analogous structures include the market power of meatpackers or the racialized precepts in livestock breeding, and fault lines, like the disconnect between states and citizens over the direction of food systems. Highlighting these similarities demonstrates how external forces have shaped—and will continue to shape—the acceptance or rejection of emerging biotechnologies as applied to farm animals.

Photo by National Cancer Institute on Unsplash INTRODUCTION More than 20 cell and gene therapies are now available to safely minimize genetic diseases such as retinal dystrophy (LUXTURNA), some B-cell lymphomas (YESCARTA), and B-cell lymphoblastic leukemia (KYMRIAH).[1] One such gene-editing tool is Clustered Regular Inter Spaced Palindromic Repeats (CRISPR) and its associated proteins or CRISPR-Cas. Jennifer Doudna and Emmanuelle Charpentier described CRISPR’s potential as an accurate genome editing tool in 2012. The FDA approved the first cell and gene therapy in 2017.[2] The FDA is continually approving more CRISPR clinical trials, including therapies to treat sickle cell anemia, cancer, and HIV.[3] Amid the COVID-19 pandemic, the broad potential applications of CRISPR have extended beyond gene editing. CRISPR is being used in rapid diagnostic testing to determine not only whether an individual becomes infected with SARS-Cov-2 but also the specific variant.[4] As with many diagnostic tests, scientists still face challenges like speed, sensitivity (the ability of the test to detect viral load), and robustness (the ability of the test to give accurate results in the field). Nonetheless, these tests could revolutionize surveillance of the virus and help curb the spread of new variants as they arise. According to the Centers for Disease Control and Prevention, there are SARS-CoV-2 variants of interest, variants of concern, and variants of high consequence. In varying degrees, these may impact the efficacy of different vaccines and treatment plans.[5] Knowing which variant an individual has or is circulating within a population informs public health policy. l. Public Perceptions of Gene Editing Throughout the Decades Perceptions about gene editing have fluctuated, especially since the 1970s. Support has varied for recombinant DNA in which editing a bacterial genome produces human insulin to treat diabetes, genetically modified plants such as antibiotic-resistant tobacco, and other genetically modified organisms. Human gene editing has a tainted past: consider the teenager Jesse Gelsinger who tragically died in a gene therapy clinical trial in 1999.[6] Another gene therapy trial led to the development of leukemia in several young children.[7] In the last two decades, there have been significant improvements in safety and reliability. Though scientists have developed various gene therapies over the years, such as viral vector delivery of therapeutic transgenes, transcription activator-like effector nucleases (TALENS), and zinc finger nucleotides, CRISPR far surpasses them by safety, accuracy, and ease of use.[8] ll. Shifting Perceptions and Broader Applications CRISPR is controversial due to concerns of safety, misuse for non-therapeutic purposes, and uncertainty about the science and technology. Yet, there is also an underlying assumption that gene editing for therapeutic purposes would be a good use of CRISPR. There is an ethical imperative to use CRISPR therapeutically to safely reduce suffering for people with debilitating genetic diseases if proven safe. However, there is more variation in what would be considered good about uses beyond therapeutic applications, such as enhancement purposes. Enhancement is a broad and conceptually laden term. For example, Julian Savulescu defines enhancement as any change in the person’s state – biological or psychological – which in turn is experienced or judged by the person or people as good.[9] Thus, enhancement could include any gene-editing relating to physical, cognitive, aesthetic, or moral enhancement. For example, the public and the scientific community reacted with outrage to the 2018 scandal of He Jiankui, a Chinese scientist who gene-edited two baby girls to make them HIV resistant. Rather than therapeutic gene-editing, this example was widely considered enhancement. The public may perceive the uses of CRISPR for enhancement as negative, but improved public perception of CRISPR overall would be beneficial to promote its therapeutic uses. CRISPR opened an array of possibilities and consequential decisions that lie in the hands of the consumer. A qualitative study done to gauge opinions on Twitter found that “#CRISPR babies” elicited responses of sentiments ranging from positive and neutral to negative, spiking in 2018 with mostly neutral and negative sentiments.[10] As cell and gene therapies move to market treating a small number of people with rare genetic diseases, public perceptions of these technologies are already shifting and may shift more over time. The factors influencing this shift toward acceptance might include trust in science,[11] trust in the technology or the brand[12] that brings it to market, and proven safety and efficacy over time. Meanwhile, in this COVID-19 pandemic, CRISPR's beneficial services for the detection of different variants in individuals and populations may positively impact the way it is perceived and accepted by the public. Mammoth Biosciences [13] and Nanyang Technological University have developed rapid diagnostic tests called DETECTR and VaNGuard, respectively, to detect variants.[14] CRISPR and its associated proteins act as molecular scissors that have the ability to cut a specific section of genetic material with accuracy. It is the exploitation of a bacterial defense mechanism. When a virus infects bacteria, it uses CRISPR-associated proteins to cut out the bacteriophage’s RNA. The bacteria then insert some of the virus RNA into its own genome to detect and destroy it in the future. In the VaNGuard diagnostic test, the enzyme enAsCas12a targets specific sections of the SARS-CoV-2 genome. Guided by two guide RNAs, it snips a section of the virus and can detect the virus as well as two mutation sites in the virus. CONCLUSION CRISPR’s application as a diagnostic testing tool is different from its gene-editing use. However, people may not distinguish the different applications when forming their perceptions of CRISPR. Public confidence in certain technology needs only a push in a certain direction to sway opinion toward mass consumption or disapproval. Research investigating people’s perceptions is becoming central to the debates about new technologies.[15] The WHO’s Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, in their Position Paper (2021), calls for “education, engagement, and empowerment.”[16] They call on the United Nations to establish an interagency working group to facilitate global dialogue. The National Academies of Sciences, Engineering, and Medicine Consensus Study Report (2020), also calls for public engagement and education about these technologies.[17] DIY and biohacking communities have shown an inclination to understand and apply these technologies with or without the guidance of regulators, scientists, or academia.[18] Perhaps as CRISPR is used to saved lives during the pandemic, this is a pivotal moment to educate people about CRISPR and its broad applications. [1] “Approved Cellular and Gene Therapy Products,” Food and Drug Administration, June 15, 2021, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products. Jim Daley, “Gene Therapy Arrives,” Scientific American, January 1, 2020, https://www.scientificamerican.com/article/gene-therapy-arrives/. [2] Broad Institute, “CRISPR Timeline,” n.d., https://www.broadinstitute.org/what-broad/areas-focus/project-spotlight/crispr-timeline. “Who Owns CRISPR in 2021? It’s Even More Complicated Than You Think,” April 27, 2021, https://synbiobeta.com/who-owns-crispr-in-2021-its-even-more-complicated-than-you-think/. [3] Robert Sanders, “FDA Approves First Test of CRISPR to Correct Genetic Defect Causing Sickle Cell Disease,” March 30, 2021, https://news.berkeley.edu/2021/03/30/fda-approves-first-test-of-crispr-to-correct-genetic-defect-causing-sickle-cell-disease/. Laura Brzyski, “Excision BioTherapeutics Has Secured $60M to Proceed with HIV Clinical Trial,” Philadelphia Magazine, March 5, 2021, https://www.phillymag.com/healthcare-news/2021/03/05/excision-biotherapeutics-temple-hiv-clinical-trial/. [4] “A COVID-19 Test to Detect Virus Variants,” Nanyang Technological University, March 29, 2021, https://www.ntu.edu.sg/news/detail/a-covid-19-test-to-detect-virus-variants. [5] “SARS-CoV-2 Variant Classifications and Definitions,” Centers for Disease Control and Prevention, July 13, 2021, https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html. [6] Nature, “Gene-therapy trials must proceed with caution,” Nature 534, 590 (2016). https://doi.org/10.1038/534590a. [7] Fathema Uddin, Charles M. Rudin, and Triparna Sen, “CRISPR Gene Therapy: Applications, Limitations, and Implications for the Future,” Frontiers in Oncology 10 (August 7, 2020): 1387, doi:10.3389/fonc.2020.01387. [8] Ibid. [9] Savulescu, J, “Ethics and Enhancement,” Annals New York Academy of Sciences (2006), 321-338. [10] Martin Müller et al., “Assessing Public Opinion on CRISPR-Cas9: Combining Crowdsourcing and Deep Learning,” Journal of Medical Internet Research 22, no. 8 (August 31, 2020): e17830, doi:10.2196/17830. [11] Stephan Guttinger, “Trust in Science: CRISPR–Cas9 and the Ban on Human Germline Editing,” Science and Engineering Ethics 24, no. 4 (August 2018): 1077–96, doi:10.1007/s11948-017-9931-1. [12] Katherine Mobley, “How Public Perception Can Make Or Break A Brand, And What It Means For Employees,” Forbes, January 5, 2019, https://www.forbes.com/sites/forbescommunicationscouncil/2019/05/01/how-public-perception-can-make-or-break-a-brand-and-what-it-means-for-employees/?sh=7b81058ad118. [13] James P. Broughton et al., “CRISPR–Cas12-Based Detection of SARS-CoV-2,” Nature Biotechnology 38, no. 7 (July 2020): 870–74, doi:10.1038/s41587-020-0513-4. [14] “A COVID-19 Test to Detect Virus Variants.”; Kean Hean Ooi et al., “An Engineered CRISPR-Cas12a Variant and DNA-RNA Hybrid Guides Enable Robust and Rapid COVID-19 Testing,” Nature Communications 12, no. 1 (December 2021): 1739, doi:10.1038/s41467-021-21996-6. [15] Dietram A. Scheufele et al., “What We Know about Effective Public Engagement on CRISPR and Beyond,” Proceedings of the National Academy of Sciences 118, no. 22 (June 1, 2021): e2004835117, doi:10.1073/pnas.2004835117. [16] WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, “Humane Genome Editing Position Paper” (WHO, 2021). [17] International Commission on the Clinical Use of Human Germline Genome Editing et al., Heritable Human Genome Editing (Washington, DC: National Academies Press, 2020), doi:10.17226/25665. [18] Josiah Zayner, “2018 Genetic Engineering For All: The Last Great Frontier of Human Freedom,” www.leapsmag.com, January 20, 2018, https://leapsmag.com/genetic-engineering-last-great-frontier-human-freedom/particle-1.

Continuous-living-cover (CLC) agriculture integrates multiple crops to create diversified agroecosystems in which soils are covered by living plants across time and space continuously. CLC agriculture can greatly improve production of many different ecosystem services from agroecosystems, including climate adaptation and mitigation. To go to scale, CLC agriculture requires crops that not only provide continuous living cover but are viable in economic and social terms. At present, lack of such viable crops is strongly limiting the scaling of CLC agriculture. Gene editing (GE) might provide a powerful tool for developing the crops needed to expand CLC agriculture to scale. To assess this possibility, a broad multi-sector deliberative group considered the merits of GE—relative to alternative plant-breeding methods—as means for improving crops for CLC agriculture. The group included many of the sectors whose support is necessary to scaling agricultural innovations, including actors involved in markets, finance, policy, and R&amp;D. In this article, we report findings from interviews and deliberative workshops. Many in the group were enthusiastic about prospects for applications of GE to develop crops for CLC agriculture, relative to alternative plant-breeding options. However, the group noted many issues, risks, and contingencies, all of which are likely to require responsive and adaptive management. Conversely, if these issues, risks, and contingencies cannot be managed, it appears unlikely that a strong multi-sector base of support can be sustained for such applications, limiting their scaling. Emerging methods for responsible innovation and scaling have potential to manage these issues, risks, and contingencies; we propose that outcomes from GE crops for CLC agriculture are likely to be much improved if these emerging methods are used to govern such projects. However, both GE of CLC crops and responsible innovation and scaling are unrefined innovations. Therefore, we suggest that the best pathway for exploring GE of CLC crops is to intentionally couple implementation and refinement of both kinds of innovations. More broadly, we argue that such pilot projects are urgently needed to navigate intensifying grand challenges around food and agriculture, which are likely to create intense pressures to develop genetically-engineered agricultural products and equally intense social conflict.

Biotechnology describes a range of human activities in medicine, agriculture, and environmental management. One biotechnology in particular, gene technology, continues to evolve both in capacity and potential to benefit and harm society. The purpose of this article is to offer a policy bridge from unproductive descriptions of gene technology to useful methods for identifying sources of significant biological and socioeconomic risk in complex food systems. Farmers and the public could be voluntarily and involuntarily interacting with new techniques of genome editing and gene silencing in entirely new ways, limiting the usefulness of previous gene technology histories to predict safety. What we believe is a more consistent, verifiable, and practical approach is to identify the critical control points that emerge where the scale effects of a human activity diverge between risk and safety. These critical control points are where technical experts can collaborate with publics with different expertise to identify and manage the technology. The use of technical terminology describing biochemical-level phenomena discourages publics that are not technical experts from contesting the embedded cultural perspectives and uncertainty in “scientific” concepts and prejudice the risk discourse by ignoring other issues of significance to society. From our perspective as gene technologists, we confront the use of pseudo-scale language in risk discourse and propose an escape path from clashes over whether risks that arise spontaneously (from nature) can be perfectly mimicked by gene technology to a discussion on how to best control the risks created by human activity. Scale is conceptually implicit and explicit in gene technology regulation, but there is no agreement about what scales are most useful to managing risk and social expectations. Both differentiated governance (risk-tiered) and responsible research and innovation models could accommodate the critical control points mechanism that we describe.

Photo by Sangharsh Lohakare on Unsplash ABSTRACT The public should debate the ethical and social challenges arising from heritable human genome editing (HHGE). The notorious case involving He Jiankui may have led to the disfavor of gene editing and a precautionary approach. While the de facto global moratorium on HHGE is clearly justified considering our current inability to implement it safely and effectively, the difficult ethical considerations should be addressed prior to the ability to initiate widespread HHGE. This piece argues that prospective patients and other members of society beyond the scientific community must be included in the conversation. It emphasizes the potential role of those not directly participating in HHGE science, calling the broader academic community not simply to wait for scientists’ results and only afterward react. Pointing to key historical examples, I contend that scientific progress is intrinsically linked with the surrounding societal discussion and that it is not only scientists who can influence where the HHGE story ends. INTRODUCTION l. Rogue Scientists Chinese biophysicist He Jiankui announced the world’s first genetically modified babies in 2018. Naturally, the treatment aroused the attention of the world’s media, which focused on He’s reckless actions. Indeed, in setting up and carrying out the procedure in question, he flouted norms of good scientific practice on a range of levels—errors paid with time in prison. Since the He controversy, few scientists have aggressively approached heritable human genome editing (HHGE) and challenged the current research norms. The most outspoken exception is the Russian molecular biologist Denis Rebrikov of the Pirogov Russian National Research Medical University. He publicly declared his intention to apply clustered regularly interspaced short palindromic repeats (CRISPR) to embryos to help couples avoid passing serious medical conditions to their children. However, Rebrikov met fierce opposition both inside and beyond Russia and, with leading CRISPR scientists and bioethicists abroad describing him as a “cowboy” who had “weak data” and was trying to “grab some attention.”[1] So far, Rebrikov’s plans have failed to come to fruition. Although there are 126 entries listed in a registry of HHGE research recently created by the World Health Organization (WHO),[2],[3] it seems that clinical HHGE has been paused for the time being. ll. Steering the Conversation A section of the scientific community has been trying to steer the ethical debate on HHGE away from the actions of rogue scientists and back to an issue that is central to the matter—the interests of patients. The majority would agree that the most compelling potential application of germline genome editing is for the prevention of devastating genetic conditions, for example, when both parents carry Huntington’s disease, for which “genome editing offers the only prospect of bearing a healthy, genetically related child.”[4] Despite such justification for scientists to continue pursuing research in the area, there has been a notable reticence in the wider academic community regarding making the ethical case for HHGE and clarifying in which medical situations such a technique might be reasonably applied. Even among those who recognize that the HHGE cases' controversies should not be a reason for panic over designer babies, some believe that starting the ethical debate is premature. A key part of the argument is that the current technological and scientific knowledge available is far from ready to deliver on treatments. A similar stance preventing debate in the wider society is that “difficult questions” about cost, accessibility, and social justice remain.[5] Whether intended or not, the implication is that the position of wider society in the HHGE story should be a reactive one, namely waiting to see what the scientists throw at them and then dealing with it. I argue that there is not only an immediate need for broader academic and societal input on the ethical and social aspects of the HHGE debate but that there is a deep symbiosis between scientific progress and its surroundings, whereby science both shapes and is shaped by the societal environment in which it takes place. The WHO published a position paper, recommendations, and a framework for governance. The framework for governance describes global standards for the governance and oversight of HHGE.[6] The position paper emphasized the importance of global and inclusive dialogue,[7] and many other boards have also called for broad public engagement.[8] It is imperative that WHO’s governance framework meets everyone’s needs. After all, as with any medical treatment, it is not the scientist who developed the treatment or the doctor who delivers it that is most important– that honor falls to the patient. In the case of HHGE, the beneficiaries include those members of society who hope to reproduce. Yet HHGE has the potential to impact society. We all should have an opportunity to be a part of world-changing decisions that lead to the creation are made and feel a responsibility to participate. lll. Shutting Down the Academic Debate At the 30th Annual Conference of the Japanese Association for Bioethics, which took place in late 2018 after He’s experiment, the discussion about HHGE was shut down quickly. Notwithstanding the understandable issues raised with He’s case, one participant after another stood up to voice support for an outright and complete ban on the use of CRISPR.[9] The ban was based on the grounds that editing the human genome would result in a cascade of unforeseen and irreversible consequences for future generations. One participant forcefully argued that “the deoxyribose nucleic acid (DNA) rubicon should never be crossed for above all, it was deeply immoral to do so when there was no way of obtaining the consent of those who would actually stand affected—our descendants.”[10] Another saw it as putting humanity on a slippery slope toward enhancements, and some feared the catastrophic mistakes that might result from their use.[11] While the above event provides just one snapshot of the debate that was taking place around the world at the time, it captures the strong reservations in the scientific community. It is a common view, not only in Japan, that the human genome is something sacred, a relic handed down from generations, that we ought to treasure and preserve. In support of such a view, religious and other more pragmatic reasons are offered. For example, some may fear the disasters that might befall us if we choose to intervene in the process through which we pass our genetic code from one generation to another. Such arguments are certainly still at the heart of the ethical debate, but the foundations upon which they are built are by no means universally accepted. Stanford University bioethicist Henry Greely writes, “the human germline genome” does not exist; instead, each of us has a unique genome.[12] Greely argues that HHGE is no different from the changes our genomes have undergone through numerous medical interventions. For example, synthetic insulin has increased the number of people with DNA variations that lead to diabetes. Those with this condition would have died as a child in the past. However, now they live long enough to be able to reproduce. Similarly, the transition from hunting to farming centuries ago resulted in a greater number of copies in our gene pool of starch-digesting genes. Yet Greely suggested that, practically, HHGE is “not very useful in the near- to midterm” (by which he means “the next several decades”)[13] “mainly because other technologies can attain almost all the important hoped-for benefits of [HHGE], often with lower risk,” citing embryo selection and somatic gene editing as two alternative options. Greely argued that applying HHGE for enhancement beyond disease prevention and is currently not a realistic option because we lack the necessary knowledge. In Greely’s opinion, “how worried should we be [about HHGE]…? A bit, but not very and not about much.”[14] Greely’s assertions that other scientific debates should take precedence and that the concerns are not ripe for debate yet are concerning. lV. Why Shutting Down the Debate Might Not be a Good Idea First, the timeframe described by Greely seems somewhat out of line with that described by leading scientists. As far back as 2018, at the same Summit where He made his revelations, George Q. Daley stressed that HHGE is scientifically feasible here and that the ethical considerations can no longer be put off: “…a number of groups have applied gene editing now to human embryos in the context of in vitro fertilization and attempting to determine variations of a protocol that would enhance the fidelity and reduce mosaicism. I think there has been an emerging consensus that the off-target problem is manageable, and in some cases even infinitesimal. There are some interesting proofs of principles, like diseases such as beta-thalassemia that could potentially be approached with this strategy.”[15] It would also be possible to challenge Greely on various other aspects. One of which would be the number of cases to which HHGE would be relevant and the kinds of moral allowances that might be made, and each case concludes that more urgency is required in the ethical debate. Greely suggests that most people can use preimplantation genetic testing (PGD), which is the embryo selection process, and that perhaps HHGE could apply to couples where both have the same autosomal recessive gene.[16] Greely rules out considering HHGE in cases where PGD is applicable. Greely concedes PGD does not already represent the answer on this topic, as it often fails to provide couples with enough healthy embryos to transfer. As a resolution to this issue, he points to the creation of eggs using induced pluripotent stem cell (iPSC) techniques, whereby eggs can potentially be created from other cells.[17] However, given the extremely limited success of iPSCs in the clinical arena to date, in vitro gametogenesis is a highly speculative solution. Certainly, the progress of iPSC research is not such a safe bet that placing all our hopes on it at the expense of HHGE techniques is currently justified. (Also, it should be noted that making eggs using the iPSC technique is hardly an ethical problem-free area itself.) In summary, the cases of couples looking to conceive that Greely rules out by pointing to PGD should be kept on the HHGE table, as various other scholars have suggested.[18] Many of us debating HHGE are not scientists, so the best we can do is draw from the information we glean from those more technically capable. As a society, we are not just passive observers of science; we should have influence over decisions that impact society. Indeed, even if the available science is not yet at a place where we should be worried about large-scale ethical and social concerns, the story will continue to unfold in the future. While Greely is happy to see the human race “muddle through” the ethical challenges of scientific breakthroughs, such a position fails to recognize that society at large is far from powerless. V. Society Influencing Scientific Progress There are some notable examples of society’s impact on scientific progress. For example, political policies led to the development of nuclear technology for war and strategic deterrence, despite societal objections seen through demonstrations of people protesting using the slogan “no nukes.” Furthermore, the Bush administration drastically limited the use of embryonic stem cells in the 2000s due to a strong religious and cultural influence on policy.[19] Societal debate potentially serves as a powerful factor in guiding science. Where societal acceptance is ambiguous, science tends to operate on its own. But where science would impact life’s fundamental issues like war, how embryos should be valued, or the end of life, society should weigh in and influence the role of science. Societal views on the current global moratorium on HHGE could lead to a ban, as has been advocated.[20] On the other hand, societal views that value HHGE as a way to expand reproductive autonomy may justify permitting its use. Opening an ethics debate about it would enable scientists to pursue technologies that society deems justifiable as well as set limits for where they should stop. Making this process more difficult, the He affair has clearly colored public discourse on HHGE in a way that inhibits debate. In Japan, a sequence of questionnaires in 2016, 2018, and 2019 showed that the widely publicized HHGE scandal led to a significant decline in the acceptance of genome editing technology in general, particularly for human reproduction. Specifically, the surveys revealed a stark rise in disapproval of the technology’s use on fertilized human eggs—from 12 percent in 2018 to 29 percent in 2019.[21] The three scientists that conducted these surveys suggested that “the news of the twin babies in China had a substantial influence on the Japanese public,” damaging the reputation of HHGE.[22] It seems likely that the public distaste for HHGE was prompted by He’s research rather than considerations about the scientific potential of HHGE The change in public opinion may also make politicians and scientists more hesitant when it comes to taking the lead in the HHGE debate. Ultimately, this can restrict the public discussion of the central ethical challenges of the technology and hinder efforts to determine whether there is a responsible path forward other than an outright ban. Stressing the importance of the issue again to potential patients and failing to engage further with the HHGE debate is surely not something society should allow. While there are many important ongoing debates about genetics, like biohacking and DIY hobbyists, HHGE deserves attention as well. In fact, attention to the ethics of HHGE should help — more awareness of how these tools can be applied and what germline genome editing is will make people more alert to the existing danger and better understand how to mitigate it. Perhaps more importantly, a clear message from society to researchers about what objectives are reasonable to pursue regarding the HHGE technologies will facilitate good science. Having a publicly determined criterion would allow scientists to not live in fear that they might be blacklisted for seeking progress in grey areas and instead confidently chase progress where it is allowed. Vl. What Now? HHGE is here (or will be soon) and brings many ethical and social challenges. However, the challenges should not be left to individual scientists and couples in desperate situations to manage alone. Moving toward how these challenges can be met practically, it is helpful to draw a parallel with the issue of implementing human rights. In the early 21st century, political philosopher Michael Freeman of the University of Essex lamented that implementing human rights had been left to lawyers. Although legal experts were clearly essential in putting together the global human rights framework, Freeman’s concern was that they were not best placed to understand implementing human rights in various contexts. Setting out a broader, interdisciplinary approach, he called for social scientists to tackle these difficult questions, ultimately moving human rights forward around the world. Similarly, in medical technology like HHGE, scientists are crucial to the story, but at the same time, they are not trained to deal with all the accompanying challenges. Bioethicists are also important, clarifying the arguments that society needs to resolve. There is a need for even wider input from across the scholarly community. For instance, as with human rights, international and domestic regulation is required, and clearly, the legal community has a role here. Moreover, as described by Freeman, since all law is political in its creation and has impacts across society, political scientists and sociologists can provide impactful input. CONCLUSION We are in it together, and we have roles to play in the discussion of HHGE. Societal discourse does not always trail the scientific reality, but rather, it can condition the path that science will follow. Given the importance of what is at stake, not only for the potential patients, but for humanity, we should not leave the HHGE debate only to scientists, and we should not leave it until later. - [1] Cohen J. “Embattled Russian scientist sharpens plans to create gene-edited babies,” Science, 21 Oct. 2019. doi:10.1126/science.aaz9337. [2] World Health Organization. “WHO issues new recommendations on human genome editing for the advancement of public health,” News release, 12 July 2021, www.who.int/news/item/12-07-2021-who-issues-new-recommendations-on-human-genome-editing-for-the-advancement-of-public-health. [3] World Health Organization. “Human Genome Editing Registry,” https://www.who.int/groups/expert-advisory-committee-on-developing-global-standards-for-governance-and-oversight-of-human-genome-editing/registry. [4] Daley GQ, Lovell-Badge R, and Steffann J. “After the Storm–A Responsible Path for Genome Editing,” New England Journal of Medicine 380, no. 10 (2019): 897-9. doi:10.1056/NEJMp1900504. [5] Daley GQ, Lovell-Badge R, and Steffann J. “After the Storm–A Responsible Path for Genome Editing,” New England Journal of Medicine 380, no. 10 (2019): 897-9. doi:10.1056/NEJMp1900504 [6] World Health Organization. “WHO issues new recommendations on human genome editing for the advancement of public health,” News Release, July 12, 2021, www.who.int/news/item/12-07-2021-who-issues-new-recommendations-on-human-genome-editing-for-the-advancement-of-public-health. [7] WHO 2021. Human Genome Editing: Position Paper, WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. [8] Daley GQ, Lovell-Badge R, and Steffann J. “After the Storm–A Responsible Path for Genome Editing,” New England Journal of Medicine 380, no. 10 (2019): 897-9. doi:10.1056/NEJMp1900504. [9] 30th Annual Conference of the Japanese Association for Bioethics, 8-9 Dec. 2018, Kyoto Prefectural University, Kyoto. [10] 30th Annual Conference of the Japanese Association for Bioethics, 8-9 Dec. 2018, Kyoto Prefectural University, Kyoto. [11] 30th Annual Conference of the Japanese Association for Bioethics, 8-9 Dec. 2018, Kyoto Prefectural University, Kyoto. [12] Greely HT. “Why the Panic Over ‘Designer Babies’ Is the Wrong Worry,” LeapsMag, 30 Oct. 2017, leapsmag.com/much-ado-about-nothing-much-crispr-for-human-embryo-editing; Greely HT. “CRISPR’d babies: human germline genome editing in the ‘He Jiankui Affair’,” Journal of Law and the Biosciences 2019; 6(1): 111–83. doi: 10.1093/jlb/lsz010; Greely HT. CRISPR People: The Science and Ethics of Editing Humans (Massachusetts: Massachusetts Institute of Technology Press, 2021). [13] Greely HT. “Why the Panic Over ‘Designer Babies’ Is the Wrong Worry,” LeapsMag, 30 Oct. 2017, leapsmag.com/much-ado-about-nothing-much-crispr-for-human-embryo-editing. [14] Greely HT. “Why the Panic Over ‘Designer Babies’ Is the Wrong Worry,” LeapsMag, 30 Oct. 2017, leapsmag.com/much-ado-about-nothing-much-crispr-for-human-embryo-editing. [15] Daley, G. (n.d.). Genome-editing-pathways to Translation. Transcript of the Human-Genome Editing Summit 2018 Hong Kong. Retrieved March 17, 2022, from https://diyhpl.us/wiki/transcripts/human-genome-editing-summit/2018-hong-kong/george-daley-genome-editing-pathways-to-translation/ [16] Greely HT. “CRISPR’d babies: human germline genome editing in the ‘He Jiankui affair’,” Journal of Law and the Biosciences 2019: 6(1): 111–83. doi:10.1093/jlb/lsz010. [17] Greely HT. CRISPR People: The Science and Ethics of Editing Humans (Massachusetts: Massachusetts Institute of Technology Press, 2021). [18] Rasnich R. “Germline genome editing versus preimplantation genetic diagnosis: Is there a case in favour of germline interventions?.” Bioethics 2020; 34(1): 60–9. [19] Murugan, Varnee. “Embryonic stem cell research: a decade of debate from Bush to Obama.” The Yale journal of biology and medicine vol. 82,3 (2009): 101-3. [20] Lander E, Baylis F, Zhang F, et al. “Adopt a moratorium on heritable genome editing,” Nature 2019; 567(7747): 165–8. pmid:30867611. [21] Watanabe D, Sato Y, Tsuda M, and Ohsawa R. Increased awareness and decreased acceptance of genome-editing technology: The impact of the Chinese twin babies. PLoS ONE 2000; 15(1): 1-13. doi:10.1371/journal.pone.0238128. [22] Watanabe D, Sato Y, Tsuda M, and Ohsawa R. Increased awareness and decreased acceptance of genome-editing technology: The impact of the Chinese twin babies. PLoS ONE 2000; 15(1): 1-13. doi:10.1371/journal.pone.0238128.

This article explores attitudes of stakeholders involved in biotechnology towards the Responsible Innovation (RI) framework. As a framework for governance, RI has received increasing scholarly attention but has yet to be successfully integrated into U.S. research and innovation policy. Using a mixed methods approach, we analyzed the attitudes of different biotechnology stakeholders, particularly those working in areas related to genetically modified organisms (GMOs) in agriculture and the environment, towards the principles and practices of RI. Homogenous focus groups (organized by stakeholder affiliation) and pre- and post-focus group surveys were used to measure attitudes towards RI. We designed the survey questions according to the Advocacy Coalition Framework (ACF) and examined the agreement of stakeholders with policy core beliefs (general principles of RI) and secondary beliefs (implementation practices of RI). Although all stakeholder groups had neutral to positive attitudes towards RI general principles, we found significant differences in their reactions to the scholarly definitions of RI and in their attitudes towards practices to implement RI. In comparison to government and advocacy groups, stakeholders promoting biotechnology innovations–industry, trade organizations, and academics–had more negative reactions to social science definitions of RI and to RI practices that relinquish control to people outside of technology development pipelines. Qualitative analysis of focus-groups revealed barriers for implementing RI practices. For example, innovators were cynical about including external voices in innovation pathways due to inflexible funding programs and were concerned about potential delays to innovation given the highly competitive environments for financing and patents. In order to help address these tensions, we call for the co-design of RI practices between biotechnology innovators and other stakeholders. The opening-up of biotechnology innovation to RI practices of anticipation, inclusion, responsiveness and reflexivity will likely be important for future, public legitimacy of emerging genetic engineering applications such as gene editing and gene drives.