This page is a collection of resources around the regulation of CRISPR genetic editing. Please scroll below to find links to pieces of legislation and policies, resources, and academic papers. I will add further resources and commentary over time.
(Last update 25 May 2020)
Legislation and policies
- US 1986 Coordinated Framework
- California legislation “SB-180 Gene therapy kits: advisory notice and label
- EU ‘GMO directive’ 2001/18/EC and GMO legislation page
- EU opinion of Advocate General Case C‑528/16
- French Plan for Genomic Medicine 2025
- Oviedo Convention ETS No.164
Committees and agencies
- US House of Representatives
- Committee on Science, Space and Technology
- Testimony of Harold Varmus M.D. (July 2014)
- Discussion on gene editing technologies (June 2015)
- Testimony of Prof. Elizabeth McNally (June 2015)
- “An Initiative to Guide Decision Making on Human Gene-Editing Research” (June 2015)
- Testimony of Dr Kevin Solomon (March 2019)
- Committee on Science, Space and Technology
- FDA home page
- US National Library of Medicine
- National Human Genome Research Institute
- US National Science Foundation
- US National Academies of Sciences, Engineering, Medicine
- Gene Editing To Modify Animal Genomes for Research – Scientific and Ethical Considerations: A Workshop (December 2015)
- International Summit on Human Gene Editing: A Global Discussion (December 2015)
- Preparing for Future Products of Biotechnology (2017)
- Second International Summit on Human Gene Editing (November 2018)
- OECD Genome Editing Hub (June 2018 conference)
- Genetic Literacy Project
- Regulatory Affairs Professionals Society
- Nuffield Council on Bioethics (CRISPR search)
Perspectives in Biology and Medicine, Special issue on CRISPR (Winter 2020)
Nature, Adopt a moratorium on heritable genome editing (March 2019)
The Harvard Gazette, Perspectives on gene editing (January 2019)
The Lancet, Genome editing: science, ethics, and public engagement (August 2017)
Academic papers: selected abstracts
Regulatory and policy issues
The revolutionary potential of the CRISPR-Cas9 gene editing technique has created a resurgence in enthusiasm and concern in genetic research perhaps not seen since the mapping of the human genome at the turn of the century. Some such concerns and anxieties revolve around crossing lines between somatic and germline interventions as well as treatment and enhancement applications. Underpinning these concerns, there are familiar concepts of safety, unintended consequences and damage to genetic identity and the creation of designer children through pursuing human enhancement and eugenics. In the policy realm, these morally laden distinctions and anxieties are emerging as the basis for making important and applied measures to respond to the fast-evolving scientific developments. This paper argues that the dominant normative framing for such responses is insufficient for this task. This paper illustrates this insufficiency as arising from a continued reliance on misleading genetic essentialist assumptions that generate groundless speculation and over-reactionary normative responses. This phenomenon is explicit with regard to prospective human (germ line) genetic enhancements. While many normative theorists and state-of-the-art reports continue to gesture toward the influence of environmental and social influences on a person and their traits and capacities, this recognition does not extend to the substance of the arguments themselves which tend to revert to the debunked genetic determinist framework. Given the above, this paper argues that there is a pressing need for a more central role for sociological input into particular aspects of this “enhancement myth” in order to give added weight, detail and substance to these environmental influences and influence from social structures.Feeney, O. (2019). Editing the Gene Editing Debate: Reassessing the Normative Discussions on Emerging Genetic Technologies. NanoEthics, 13(3), 233-243.
CRISPR/Cas genome editing has the potential to revolutionise agricultural biotechnology and breeding. Also, it can contribute to advancing modern agriculture in multiple respects and lead to shifts in market structure. However, genetic engineering is a highly contested and controversial societal issue. Thus, CRISPR/Cas poses new questions regarding preferences of consumers and producers, food ethics and governance. Precision, easiness-to-use and low costs of CRISPR/Cas make it a viable alternative to conventional breeding. Yet, nature-identical GMOs blur the boundary between nature and technology and result in non-traceability of modifications, which calls for a rethinking of regulatory approaches. Finally, the speed with which the technology advances contrasts with the pace of related societal debates and regulatory processes.Bartkowski, B., Theesfeld, I., Pirscher, F., & Timaeus, J. (2018). Snipping around for food: economic, ethical and policy implications of CRISPR/Cas genome editing. Geoforum, 96, 172-180.
Patent issues surrounding CRISPR, the revolutionary genetic editing technology, may have important implications for the public health. Patents maintain high prices for novel therapies, limiting patient access. Relatedly, insurance coverage for expensive therapies is waning. Patents also misallocate research and development resources to profitable disease indications rather than those that necessarily impinge on the public health. And it is unclear how CRISPR therapies will figure into the current regulatory framework for biosimilars. Policy makers and physicians should consider these issues now, before CRISPR therapies become widely adopted—and entrenched—in the marketplace.Sherkow, J. S. (2017). Focus: Genome Editing: CRISPR, Patents, and the Public Health. The Yale journal of biology and medicine, 90(4), 667.
Testimony from the intelligence community in the United States connecting genome editing with national security threats was a noted departure from past assessments of the implications of modern enabling biotechnologies. Rarely are individual biotechnologies included on lists of potential security threats. When they are, a broad range of advances are usually considered collectively – in terms of both risks and benefits. Given the classified nature of the rationale as to why gene editing tools were singled out, we are unlikely to fully understand for several decades what prompted this statement. This paper considers three ways in which these tools might impact national security: i) enabling the development of advanced biological weapons; ii) facilitating the development of new bioweapons based on ecological applications of genome editing, and iii) enhancing future generations of people in ways which could have an indirect impact on security, for example by improving a nation’s cognitive ability and/or the physical endurance of its soldiers. Their implications are different and so are the possible policy and regulatory responses.Esvelt, K., & Millett, P. D. (2017). Genome editing as a national security threat. Revue scientifique et technique (International Office of Epizootics), 36(2), 459-465.
The emergence of new gene-editing technologies is profoundly transforming human therapeutics, agriculture, and industrial biotechnology. Advances in clustered regularly interspaced short palindromic repeats (CRISPR) have created a fertile environment for mass-scale manufacturing of cost-effective products ranging from basic research to translational medicine. In our analyses, we evaluated the patent landscape of gene-editing technologies and found that in comparison to earlier gene-editing techniques, CRISPR has gained significant traction and this has established dominance. Although most of the gene-editing technologies originated from the industry, CRISPR has been pioneered by academic research institutions. The spinout of CRISPR biotechnology companies from academic institutions demonstrates a shift in entrepreneurship strategies that were previously led by the industry. These academic institutions, and their subsequent companies, are competing to generate comprehensive intellectual property portfolios to rapidly commercialize CRISPR products. Our analysis shows that the emergence of CRISPR has resulted in a fivefold increase in genome-editing bioenterprise investment over the last year. This entrepreneurial movement has spurred a global biotechnology revolution in the realization of novel gene-editing technologies. This global shift in bioenterprise will continue to grow as the demand for personalized medicine, genetically modified crops and environmentally sustainable biofuels increases. However, the monopolization of intellectual property, negative public perception of genetic engineering and ambiguous regulatory policies may limit the growth of these market segments.Brinegar, K., K. Yetisen, A., Choi, S., Vallillo, E., Ruiz-Esparza, G. U., Prabhakar, A. M., … & Yun, S. H. (2017). The commercialization of genome-editing technologies. Critical reviews in biotechnology, 37(7), 924-932.
The global agricultural landscape regarding the commercial cultivation of genetically modified (GM) crops is mosaic. Meanwhile, a new plant breeding technique, genome editing is expected to make genetic engineering-mediated crop breeding more socially acceptable because it can be used to develop crop varieties without introducing transgenes, which have hampered the regulatory review and public acceptance of GM crops. The present study revealed that product-and process-based concepts have been implemented to regulate GM crops in 30 countries. Moreover, this study analyzed the regulatory responses to genome-edited crops in the USA, Argentina, Sweden and New Zealand. The findings suggested that countries will likely be divided in their policies on genome-edited crops: Some will deregulate transgene-free crops, while others will regulate all types of crops that have been modified by genome editing. These implications are discussed from the viewpoint of public acceptance.Ishii, T., & Araki, M. (2017). A future scenario of the global regulatory landscape regarding genome-edited crops. GM crops & food, 8(1), 44-56.
Regulation in the EU
Innovations in plant breeding like genome editing methods raised questions about the adequacy of established regulatory policies for plant breeding and biotechnology in view of these new breeding methods and the resulting products. Most countries follow the principle approach that only those plants will be regulated under biotech regulations that include a novel combination of genetic material following the Cartagena protocol. In contrast to this, the European Court of Justice interpreted the current EU biotech regulations in a way that these also apply to plants resulting from new mutagenesis breeding, even if these plants are indistinguishable from conventionally bred plants. This ruling created strong reactions and concerns stating that recent technical developments have made the EU GMO Directive no longer fit for purpose. The article describes ongoing policy developments on EU level that might result in an update of current regulations.Jorasch, P. (2020). Will the EU stay out of step with science and the rest of the world on plant breeding innovation?. Plant Cell Reports, 39(1), 163-167.
This article gives an overview of legal and procedural uncertainties regarding genome edited organisms and possible ways forward for European GMO policy. After a recent judgment by the European Court of Justice (ECJ judgment of 25 July 2018, C-528/16), organisms obtained by techniques of genome editing are GMOs and subject to the same obligations as transgenic organisms. Uncertainties emerge if genome edited organisms cannot be distinguished from organisms bred by conventional techniques, such as crossing or random mutagenesis. In this case, identical organisms can be subject to either GMO law or exempt from regulation because of the use of a technique that cannot be identified. Regulatory agencies might not be able to enforce GMO law for such cases in the long term. As other jurisdictions do not regulate such organisms as GMOs, accidental imports might occur and undermine European GMO regulation. In the near future, the EU Commission as well as European and national regulatory agencies will decide on how to apply the updated interpretation of the law. In order to mitigate current legal and procedural uncertainties, a first step forward lies in updating all guidance documents to specifically address genome editing specifically address genome editing, including a solution for providing a unique identifier. In part, the authorization procedure for GMO release can be tailored to different types of organisms by making use of existing flexibilities in GMO law. However, only an amendment to the regulations that govern the process of authorization for GMO release can substantially lower the burden for innovators. In a second step, any way forward has to aim at amending, supplementing or replacing the European GMO Directive (2001/18/EC). The policy options presented in this article presuppose political readiness for reform. This may not be realistic in the current political situation. However, if the problems of current GMO law are just ignored, European competitiveness and research in green biotechnology will suffer.Wasmer, M. S. (2019). Roads Forward for European GMO Policy–Uncertainties in Wake of ECJ Judgment Have to be Mitigated by Regulatory Reform. Frontiers in bioengineering and biotechnology, 7, 132.
The EU aspires to utilize the economic advantages of gene-editing technology on one hand and ensure human health and environmental safety on the other. Surrounding the fierce debates over emerging gene-edited plant, the current debate focused on the issue of whether the gene-edited crop should be within or outside the GMO law and its implication for innovation. It should not be forgotten that it is also involved in the complex patentability issues pertaining to the legal interpretation of the patent law. The gene-edited crop is governed by GMO regulations due to its potential risk to human health and environmental safety. But it is heavily patented, as patent regulations ignore its potential risk. This article examines the discrepancy of the gene-edited crop between the existing GMO law and the patent law and reveals the challenges to current EU jurisdiction, including the international trade impediment challenge, the patent monopoly challenge, the market confusion challenge, and the agricultural economy suspension challenge. In the end, this article argues that EU GMO regulations should be bridged with a patent system in facing the regulatory challenges from the gene-edited crop.Jiang, L. (2019). Commercialization of the gene-edited crop and morality: challenges from the liberal patent law and the strict GMO law in the EU. New Genetics and Society, 1-28.
Regulation in the US
Dietary DNA is generally regarded as safe to consume, and is a routine ingredient of food obtained from any living organism. Millions of naturally-occurring DNA variations are observed when comparing the genomic sequence of any two healthy individuals of a given species. Breeders routinely select desired traits resulting from this DNA variation to develop new cultivars and varieties of food plants and animals. Regulatory agencies do not evaluate these new varieties prior to commercial release. Gene editing tools now allow plant and animal breeders to precisely introduce useful genetic variation into agricultural breeding programs. The U.S. Department of Agriculture (USDA) announced that it has no plans to place additional regulations on gene-edited plants that could otherwise have been developed through traditional breeding prior to commercialization. However, the U.S. Food and Drug Administration (FDA) has proposed mandatory premarket new animal drug regulatory evaluation for all food animals whose genomes have been intentionally altered using modern molecular technologies including gene editing technologies. This runs counter to U.S. biotechnology policy that regulatory oversight should be triggered by unreasonable risk, and not by the fact that an organism has been modified by a particular process or technique. Breeder intention is not associated with product risk. Harmonizing the regulations associated with gene editing in food species is imperative to allow both plant and animal breeders access to gene editing tools to introduce useful sustainability traits like disease resistance, climate adaptability, and food quality attributes into U.S. agricultural breeding programs.van Eenennaam, A. L., Wells, K. D., & Murray, J. D. (2019). Proposed US regulation of gene-edited food animals is not fit for purpose. npj Science of Food, 3(1), 1-7.
Recent developments in gene-editing technology have enabled scientists to manipulate the human genome in unprecedented ways. One technology in particular, Clustered Regularly Interspaced Short Pallindromic Repeat (CRISPR), has made gene editing more precise and cost-effective than ever before. Indeed, scientists have already shown that CRISPR can eliminate genes linked to life-threatening diseases from an individual’s genetic makeup and, when used on human embryos, CRISPR has the potential to permanently eliminate hereditary diseases from the human genome in its entirety. These developments have brought great hope to individuals and their families, who suffer from genetically linked diseases. But there is a dark side: in the wrong hands, CRISPR could negatively impact the course of human evolution or be used to create biological weaponry. Despite these possible consequences, CRISPR remains largely unregulated due to the United States’s outdated regulatory scheme for biotechnology. Moreover, human embryo research, which is likely critical to maximizing the therapeutic applications of CRISPR, is not easily undertaken by scientists due to a number of federal and state restrictions aimed at preventing such research. This Note examines the possible benefits and consequences of CRISPR and discusses the current regulations in both the fields of biotechnology and human embryo research that hamper the government’s ability to effectively regulate this technology. Ultimately, this Note proposes a new regulatory scheme for biotechnology that focuses on the processes used to create products using CRISPR, rather than the products themselves, with a focus on enabling ethical research using human embryos to maximize the potential benefits of CRISPR.Tomlinson, T. (2018). A crispr future for gene-editing regulation: a proposal for an updated biotechnology regulatory system in an era of human genomic editing. Fordham L. Rev., 87, 437.
Genome editing for crop improvement lies at the leading edge of disruptive bioengineering technologies that will challenge existing regulatory paradigms for products of biotechnology and which will elicit widespread public interest. Regulation of products of biotechnology through the US Coordinated Framework for Biotechnology is predicated on requiring burden of proof that regulation is warranted. Although driven by considerations of newly emerging processes for product development, regulation has, for the most part, focused on characteristics of the biotechnology product itself and not the process used for its development per se. This standard of evidence and product focus has been maintained to date in regulatory considerations of genome edited crops. Those genome edited crops lacking recombinant DNA (rDNA) in the product intended for environmental release, lacking plant pest or pesticidal activity, or showing no food safety attributes different from those of traditionally bred crops are not deemed subject to regulatory evaluation. Regardless, societal uncertainties regarding genome editing are leading regulators to seek ways whereby these uncertainties may be addressed through redefinition of those products of biotechnology that may be subject to regulatory assessments. Within US law prior statutory history, language and regulatory action have significant influence on decision making; therefore, the administrative law and jurisprudence underlying the current Coordinated Framework strongly inform policy and governance when considering new plant breeding technologies such as genome editing.Wolt, J. D., & Wolf, C. (2018). Policy and governance perspectives for regulation of genome edited crops in the United States. Frontiers in plant science, 9, 1606.
The announcement of the “CRISPR babies” reignited the debate surrounding the ethical, legal and social implications of germline gene editing. Despite having been conducted in the context of a clinical trial, Dr. Jiankui He’s research appears to have violated both Chinese regulations and standard ethical procedures, as well as internationally accepted research and bioethical standards. It is within this context that our commentary surrounding the question of the enforceability of Chinese regulations in such a case. We argue that Chinese regulations do align with internationally accepted standards. Yet, the question remains, in what ways can China strengthen and update its regulatory framework to better address the benefits and challenges associated with emerging technologies, delineate clear enforcement mechanisms and specify criteria for ethics approval.Kleiderman, E., & Ogbogu, U. (2019). Realigning gene editing with clinical research ethics: what the “CRISPR Twins” debacle means for Chinese and international research ethics governance. Accountability in research, 26(4), 257-264.
Today’s debate about the use of gene-editing technologies to alter human DNA brings together two longstanding lines of inquiry in bioethics: the ethics of human enhancement, and the ethics of heritable genetic modification. This article traces that lineage by identifying key distinctions and ethics questions in these pre-existing lines of inquiry that are also employed in four recent policy and ethics statements on human gene editing. These distinctions and ethics questions can be helpful heuristics for organizing discussion, learning from existing analysis, and highlighting what is at stake with new gene-editing technologies. Yet scientists, policymakers, and others new to the ethics of emerging technologies should also be aware of both the limitations of these distinctions and past challenges in adequately addressing the ethics questions they raise. In particular, the treatment-enhancement distinction and the somatic-germline distinction are not as clear-cut as they might initially appear. More importantly, they cannot be used to definitively differentiate right from wrong uses of the technologies in question.Johnston, J. (2020). Shaping the CRISPR Gene-Editing Debate: Questions About Enhancement and Germline Modification. Perspectives in Biology and Medicine, 63(1), 141-154.
The current ethical and legal standards for human sub jects research do not adequately address human gene editing technologies, because scientific advancements in this field have outpaced regulatory policy. The Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technique allows the rewriting of life’s code, but is fraught with scientific and ethical quandaries. In particular, the genetic alteration of human embryos in vitro in China has caused worldwide repercussions. It is hard to predict the long-term effects of proposed edits, which raises an inquiry about whether it is appropriate for humans to purposely alter any aspect of their genetic future. Genome editing is moving too quickly for processes of critical reflection, such as law and regulation, to keep pace. The ethical, legal and social impli cations of the use of these technologies in humans remain uncertain.Bu, Q. (2019). Reassess the Law and Ethics of Heritable Genome Editing Interventions: Lessons for China and the World. Issues in Law & Medicine, 34(2).
Gene editing, which allows for specific location(s) in the genome to be targeted and altered by deleting, adding or substituting nucleotides, is currently the subject of important academic and policy discussions. With the advent of efficient tools, such as CRISPR-Cas9, the plausibility of using gene editing safely in humans for either somatic or germ line gene editing is being considered seriously. Beyond safety issues, somatic gene editing in humans does raise ethical, legal and social issues (ELSI), however, it is suggested to be less challenging to existing ethical and legal frameworks; indeed somatic gene editing is already applied in (pre-) clinical trials. In contrast, the notion of altering the germ line or embryo such that alterations could be heritable in humans raises a large number of ELSI; it is currently debated whether it should even be allowed in the context of basic research. Even greater ELSI debates address the potential use of germ line or embryo gene editing for clinical purposes, which, at the moment is not being conducted and is prohibited in several jurisdictions. In the context of these ongoing debates surrounding gene editing, we present herein guidance to further discussion and investigation by highlighting three crucial areas that merit the most attention, time and resources at this stage in the responsible development and use of gene editing technologies: (1) conducting careful scientific research and disseminating results to build a solid evidence base; (2) conducting ethical, legal and social issues research; and (3) conducting meaningful stakeholder engagement, education and dialogue.Howard, H. C., van El, C. G., Forzano, F., Radojkovic, D., Rial-Sebbag, E., de Wert, G., … & Cornel, M. C. (2018). One small edit for humans, one giant edit for humankind? Points and questions to consider for a responsible way forward for gene editing in humans. European Journal of Human Genetics, 26(1), 1-11.
With CRISPR/Cas9 and other genome-editing technologies, successful somatic and germline genome editing are becoming feasible. To respond, an American Society of Human Genetics (ASHG) workgroup developed this position statement, which was approved by the ASHG Board in March 2017. The workgroup included representatives from the UK Association of Genetic Nurses and Counsellors, Canadian Association of Genetic Counsellors, International Genetic Epidemiology Society, and US National Society of Genetic Counselors. These groups, as well as the American Society for Reproductive Medicine, Asia Pacific Society of Human Genetics, British Society for Genetic Medicine, Human Genetics Society of Australasia, Professional Society of Genetic Counselors in Asia, and Southern African Society for Human Genetics, endorsed the final statement. The statement includes the following positions. (1) At this time, given the nature and number of unanswered scientific, ethical, and policy questions, it is inappropriate to perform germline gene editing that culminates in human pregnancy. (2) Currently, there is no reason to prohibit in vitro germline genome editing on human embryos and gametes, with appropriate oversight and consent from donors, to facilitate research on the possible future clinical applications of gene editing. There should be no prohibition on making public funds available to support this research. (3) Future clinical application of human germline genome editing should not proceed unless, at a minimum, there is (a) a compelling medical rationale, (b) an evidence base that supports its clinical use, (c) an ethical justification, and (d) a transparent public process to solicit and incorporate stakeholder input.De Miguel Beriain, I. (2017). Legal issues regarding gene editing at the beginning of life: an EU perspective. Regenerative medicine, 12(6), 669-679.
Engagement and democratic participation issues
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.de Wit, M. M. (2020). Democratizing CRISPR? Stories, practices, and politics of science and governance on the agricultural gene editing frontier. Elem Sci Anth, 8(1).
Human germline genome editing may prove to be especially poignant for members of the rare disease community, many of whom are diagnosed with monogenic diseases. This community lacks broad representation in the literature surrounding genome editing, notably in Canada, yet is likely to be directly affected by eventual clinical applications of this technology. Although not generalizable, the literature does offer some commonalities regarding the experiences of rare disease patients. This manuscript seeks to contribute to the search for broader societal dialogue surrounding human germline genome editing by exploring some of those commonalities that comfort the notion that CRISPR may hold promise or be desirable for some members of this community. We first explore the legal and policy context surrounding germline genome editing, focusing closely on Canada, then provide an overview of the common challenges experienced by members of the rare disease community, and finally assess the opportunities of germline genome editing vis-à-vis rare disease as we advocate for the need to more actively engage with the community in our search for public engagement.Kleiderman, E., & Stedman, I. N. K. (2019). Human germline genome editing is illegal in Canada, but could it be desirable for some members of the rare disease community?. Journal of community genetics, 1-10.
The aim of the presentation is to focus on the differences between two scientific contexts: the genetic engineering context of the 1970s, with specific attention paid to the use of the recombinant DNA technique to generate genetically modified molecules, and the current genome editing context, with specific attention paid to the use of CRISPR-Cas9 technology to modify human germ line cells genetically. In both events, scientists have been involved in discussions that have gone beyond mere professional deontology touching on specific policy issues such as freedom of research, responsibility for the consequences of research, the right of the public to participate in the evaluation of the goals of research methods, the relationship between cost and benefit and possible social consequences. The comparison between these two scientific contexts suggests the need of handling such issues by defining procedures that meet the criteria of democracy and responsibility towards society. The underlying objective should be to effectively launch actions and interventions based not on a hierarchical approach but rather a reticular conception of knowledge.Rufo, F., & Ficorilli, A. (2019). From Asilomar to Genome Editing: Research Ethics and Models of Decision. NanoEthics, 13(3), 223-232.
Advances in 21st century genetic technologies offer new directions for addressing public health and environmental challenges, yet raise important social and ethical questions. Though the need for inclusive deliberation is widely recognized, institutionalized risk definitions, regulation standards, and imaginations of publics pose obstacles to democratic participation and engagement. This paper traces how the problematic precedents set by the 1975 Asilomar Conference emerge in contemporary discussions on CRISPR, and draws from a recent controversy surrounding field trial releases of genetically modified mosquitoes to explicate the ways in which these precedents undermine efforts to engage publics in decisions at the science-policy interface.Taylor, C., & Dewsbury, B. (2019). Barriers to inclusive deliberation and democratic governance of genetic technologies at the science-policy interface. Journal of Science Communication, 18(3), Y02.
The potential to genetically modify human germlines has reached a critical tipping point with recent applications of CRISPR-Cas9. Even as researchers, clinicians, and ethicists weigh the scientific and ethical repercussions of these advances, we know virtually nothing about public attitudes on the topic. Understanding such attitudes will be critical to determining the degree of broad support there might be for any public policy or regulation developed for genetic modification research. To fill this gap, we gave an online survey to a large (2,493 subjects) and diverse sample of Americans. Respondents supported genetic modification research, although demographic variables influenced these attitudes—conservatives, women, African-Americans, and older respondents, while supportive, were more cautious than liberals, men, other ethnicities, and younger respondents. Support was also was slightly muted when the risks (unanticipated mutations and possibility of eugenics) were made explicit. The information about genetic modification was also presented as contrasting vignettes, using one of five frames: genetic editing, engineering, hacking, modification, or surgery. Despite the fact that the media and academic use of frames describing the technology varies, these frames did not influence people’s attitudes. These data contribute a current snapshot of public attitudes to inform policy with regard to human genetic modification.Weisberg, S. M., Badgio, D., & Chatterjee, A. (2017). A CRISPR new world: attitudes in the public toward innovations in human genetic modification. Frontiers in public health, 5, 117. (corrigendum)
Bartkowski, B., Theesfeld, I., Pirscher, F., & Timaeus, J. (2018). Snipping around for food: economic, ethical and policy implications of CRISPR/Cas genome editing. Geoforum, 96, 172-180.
Brinegar, K., K. Yetisen, A., Choi, S., Vallillo, E., Ruiz-Esparza, G. U., Prabhakar, A. M., … & Yun, S. H. (2017). The commercialization of genome-editing technologies. Critical reviews in biotechnology, 37(7), 924-932.
Bu, Q. (2019). Reassess the Law and Ethics of Heritable Genome Editing Interventions: Lessons for China and the World. Issues in Law & Medicine, 34(2).
De Miguel Beriain, I. (2017). Legal issues regarding gene editing at the beginning of life: an EU perspective. Regenerative medicine, 12(6), 669-679.
van Eenennaam, A. L., Wells, K. D., & Murray, J. D. (2019). Proposed US regulation of gene-edited food animals is not fit for purpose. npj Science of Food, 3(1), 1-7.
Esvelt, K., & Millett, P. D. (2017). Genome editing as a national security threat. Revue scientifique et technique (International Office of Epizootics), 36(2), 459-465.
Feeney, O. (2019). Editing the Gene Editing Debate: Reassessing the Normative Discussions on Emerging Genetic Technologies. NanoEthics, 13(3), 233-243.
Howard, H. C., van El, C. G., Forzano, F., Radojkovic, D., Rial-Sebbag, E., de Wert, G., … & Cornel, M. C. (2018). One small edit for humans, one giant edit for humankind? Points and questions to consider for a responsible way forward for gene editing in humans. European Journal of Human Genetics, 26(1), 1-11.
Ishii, T., & Araki, M. (2017). A future scenario of the global regulatory landscape regarding genome-edited crops. GM crops & food, 8(1), 44-56.
Jiang, L. (2019). Commercialization of the gene-edited crop and morality: challenges from the liberal patent law and the strict GMO law in the EU. New Genetics and Society, 1-28.
Johnston, J. (2020). Shaping the CRISPR Gene-Editing Debate: Questions About Enhancement and Germline Modification. Perspectives in Biology and Medicine, 63(1), 141-154.
Jorasch, P. (2020). Will the EU stay out of step with science and the rest of the world on plant breeding innovation?. Plant Cell Reports, 39(1), 163-167.
Kleiderman, E., & Ogbogu, U. (2019). Realigning gene editing with clinical research ethics: what the “CRISPR Twins” debacle means for Chinese and international research ethics governance. Accountability in research, 26(4), 257-264.
Kleiderman, E., & Stedman, I. N. K. (2019). Human germline genome editing is illegal in Canada, but could it be desirable for some members of the rare disease community?. Journal of community genetics, 1-10.
Rufo, F., & Ficorilli, A. (2019). From Asilomar to Genome Editing: Research Ethics and Models of Decision. NanoEthics, 13(3), 223-232.
Sherkow, J. S. (2017). Focus: Genome Editing: CRISPR, Patents, and the Public Health. The Yale journal of biology and medicine, 90(4), 667.
Taylor, C., & Dewsbury, B. (2019). Barriers to inclusive deliberation and democratic governance of genetic technologies at the science-policy interface. Journal of Science Communication, 18(3), Y02.
Tomlinson, T. (2018). A crispr future for gene-editing regulation: a proposal for an updated biotechnology regulatory system in an era of human genomic editing. Fordham L. Rev., 87, 437.
Wasmer, M. S. (2019). Roads Forward for European GMO Policy–Uncertainties in Wake of ECJ Judgment Have to be Mitigated by Regulatory Reform. Frontiers in bioengineering and biotechnology, 7, 132.
Weisberg, S. M., Badgio, D., & Chatterjee, A. (2017). A CRISPR new world: attitudes in the public toward innovations in human genetic modification. Frontiers in public health, 5, 117.
de Wit, M. M. (2020). Democratizing CRISPR? Stories, practices, and politics of science and governance on the agricultural gene editing frontier. Elem Sci Anth, 8(1).
Wolt, J. D., & Wolf, C. (2018). Policy and governance perspectives for regulation of genome edited crops in the United States. Frontiers in plant science, 9, 1606.