Since its development in 2012, CRISPR provided a radical innovation in the way synthetic biology is carried out. The opportunities that are offered by CRISPR are outstanding, as well as the challenges that the technique poses because of its effects on individuals, the society ad the environment. This project aims to investigate the governance and regulation of genetic editing through CRISPR as a tool of synthetic biology.
Outputs of the project:
- Paper “Uncertainty, institutions and regulatory responses to emerging technologies: CRISPR Gene editing in the US and the EU (2012–2019)” published in Regulation & Governance (26/6/2020)
- Paper “A bibliometrics analysis of research on CRISPR in social sciences and humanities” (under review)
- Paper “The role of externalities and uncertainties in policy design: evidence from the regulation of genome editing” (under review)
- Presentation at the University of London Global MBA Guest Speaker Series (29/5/2020)
(Last update 1 May 2021)
Below is a collection of resources on the regulation of CRISPR genetic editing, including pieces of legislation and policies, web resources, and academic papers.
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
- Human Genome Editing Initiative
- 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)
- A simple guide to CRISPR, one of the biggest science stories of the decade (Vox, December 2018)
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 on regulation of CRISPR
Akpoviri, F., Zainol, Z., & Baharum, S. (2020). Synthetic Biology and Biosafety Governance in the European Union and the United States. IIUM Law Journal, 28(1), 37-71.
Annas, G. J. (2020). Genome Editing 2020: Ethics and Human Rights in Germline Editing in Humans and Gene Drives in Mosquitoes. American Journal of Law & Medicine, 46(2-3), 143-165.
Arguedas-Ramírez, G. (2020). Ethics and Global Governance of Human Germline Genome Editing: The Problem of Techno-Scientific Colonialist Paternalism. The CRISPR Journal, 3(2), 83-88.
van Beers, B. C. (2020). Rewriting the Human Genome, Rewriting Human Rights Law? Human Rights, Human Dignity, and Human Germline Modification in the CRISPR Rra. Journal of Law and the Biosciences. (online 9/6/2020)
Bertka, C. M. (2020). The CRISPR Apple on the Tree of Knowledge Conference Highlights: CRISPR in Science, Ethics, and Religion. Zygon, 55(2), 444-458.
Cohen, J. (2020). Narrow path charted for editing genes of human embryos. Science (New York, NY), 369(6509), 1283-1283.
Doxzen, K., & Halpern, J. (2020). Focusing on Human Rights: a framework for CRISPR germline genome editing ethics and regulation. Perspectives in Biology and Medicine, 63(1), 44-53.
Firestone, J. (2020). The need for soft law to regulate synthetic biology. Jurimetrics, 60(2), 139-173.
Garland-Thomson, R. (2020). How We Got to CRISPR: The Dilemma of Being Human. Perspectives in Biology and Medicine, 63(1), 28-43.
Isa, N. M., Zulkifli, N. A., & Man, S. (2020). Islamic perspectives on CRISPR/Cas9-mediated human germline gene editing: a preliminary discussion. Science and Engineering Ethics, 26(1), 309-323.
Jiang, L. (2020). 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, 39(2), 191-218.
Johnston, J. (2020). Shaping the CRISPR Gene-Editing Debate: Questions About Enhancement and Germline Modification. Perspectives in Biology and Medicine, 63(1), 141-154.
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.
Ladu, L. (2020). The governance of genome editing techniques for the European bio-based industry. Journal of Environmental Policy & Planning, 1-16.
Martin, P., Morrison, M., Turkmendag, I., Nerlich, B., McMahon, A., de Saille, S., & Bartlett, A. (2020). Genome editing: the dynamics of continuity, convergence, and change in the engineering of life. New Genetics and Society, 39(2), 219-242.
Meyer, M. (2020). The fabric of the public in debates about gene editing. Environmental Communication, 1-5.
Nestor, M. W., & Wilson, R. L. (2020). Beyond Mendelian genetics: anticipatory biomedical ethics and policy implications for the use of CRISPR together with gene drive in humans. Journal of Bioethical Inquiry, 1-12.
Padden, C., & Humphries, J. (2020). Who Goes First? deaf people and CRISPR germline editing. Perspectives in Biology and Medicine, 63(1), 54-65.
Patrick, S. M. (2020). Can We Learn to Incentivize Morality?: A Discussion of Biotechnology on an International Level. Emory Int’l L. Rev., 34, 859.
Purnhagen, K., & Wesseler, J. (2020)EU Regulation of New Plant Breeding Technologies and Their Possible Economic Implications for the EU and Beyond. Applied Economic Perspectives and Policy.
Safaei, M., Mobini, G. R., Abiri, A., & Shojaeian, A. (2020). Synthetic biology in various cellular and molecular fields: applications, limitations, and perspective. Molecular Biology Reports, 1-10.
Shozi, B., & Dhai, A. (2020). A Critical Review of the Ethical and Legal Issues in Human Germline Gene Editing: Considering Human Rights and a Call for an African Perspective. South African Journal of Bioethics and Law, 13(1), 54-59.
Soni, S. (2020). CRISPR and the Law: A South African Perspective. The CRISPR Journal, 3(2), 81-82.
Thizy, D., Coche, I., & de Vries, J. (2020). Providing a policy framework for responsible gene drive research: an analysis of the existing governance landscape and priority areas for further research. Wellcome Open Research, 5(173), 173.
Townsend, B. A. (2020). Human genome editing: how to prevent rogue actors. BMC Medical Ethics, 21(1), 1-10.
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).
Wollert, D. (2020). The Fascinating & Controversial New Science of CRISPR. The American Biology Teacher, 82(5), 279-288.
Alsaigh, T., Nicholson, L., & Topol, E. (2019). What Should Clinicians Do to Engage the Public About Gene Editing?. AMA Journal of Ethics, 21(12), 1089-1097.
Blasimme, A. (2019). Why Include the Public in Genome Editing Governance Deliberation?. AMA Journal of Ethics, 21(12), 1065-1070.
Boggio, A., Knoppers, B. M., Almqvist, J., & Romano, C. P. (2019). The human right to science and the regulation of human germline engineering. The CRISPR Journal, 2(3), 134-142.
Bratlie, S., Halvorsen, K., Myskja, B. K., Mellegård, H., Bjorvatn, C., Frost, P., … & Malnes, R. S. (2019). A novel governance framework for GMO: A tiered, more flexible regulation for GMO s would help to stimulate innovation and public debate. EMBO reports, 20(5), e47812.
Braun, M., & Meacham, D. (2019). The trust game: CRISPR for human germline editing unsettles scientists and society. EMBO reports, 20(2), e47583.
Brokowski, C., & Adli, M. (2019). CRISPR ethics: moral considerations for applications of a powerful tool. Journal of molecular biology, 431(1), 88-101.
Conley, J. M. (2019). Introduction: A Lawyer’s Guide to CRISPR. North Carolina Law Review, 97(5), 1041.
Cunningham, A. (2018). A Cleaner, CRISPR Constitution: Germline Editing and Fundamental Rights. Wm. & Mary Bill Rts. J., 27, 877.
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.
Feeney, O. (2019). Editing the gene editing debate: Reassessing the normative discussions on emerging genetic technologies. NanoEthics, 13(3), 233-243.
Greely, H. T. (2019). CRISPR’d babies: human germline genome editing in the ‘He Jiankui affair’. Journal of Law and the Biosciences, 6(1), 111-183.
Gumer, J. M. (2019). The wisdom of germline editing: an ethical analysis of the use of CRISPR-Cas9 to edit human embryos. The New Bioethics, 25(2), 137-152.
Halpern, J., O’Hara, S. E., Doxzen, K. W., Witkowsky, L. B., & Owen, A. L. (2019). Societal and Ethical Impacts of Germline Genome Editing: How Can We Secure Human Rights?. The CRISPR journal, 2(5), 293-298.
Hashmi, F. (2019). Necessity or Vanity: Designer Babies, CRISPR, and the Future of Genetic Modifications. International Journal of Scientific Research and Management, 7(11).
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.
Knoppers, B. M., & Kleiderman, E. (2019). “CRISPR babies”: What does this mean for science and Canada?. CMAJ, 191(4), E91-E92.
Lassoued, R., Macall, D. M., Smyth, S. J., Phillips, P. W., & Hesseln, H. (2019). Risk and safety considerations of genome edited crops: Expert opinion. Current Research in Biotechnology, 1, 11-21.
Martin-Laffon, J., Kuntz, M., & Ricroch, A. E. (2019). Worldwide CRISPR patent landscape shows strong geographical biases. Nature biotechnology, 37(6), 613-620.
Marcon, A., Master, Z., Ravitsky, V., & Caulfield, T. (2019). CRISPR in the North American popular press. Genetics in Medicine, 21(10), 2184-2189.
Matthews, K. R., & Iltis, A. S. (2019). Are we ready to genetically modify a human embryo? Or is it too late to ask?. Accountability in research, 26(4), 265-270.
McConnell, S. C. (2019). An Exclusive Interview With CRISPR. AMA Journal of Ethics, 21(12), 1079-1088.
Morrison, M., & de Saille, S. (2019). CRISPR in context: towards a socially responsible debate on embryo editing. Palgrave Communications, 5(1), 1-9.
Muller, M., Schneider, M., Salathé, M., & Vayena, E. (2019). Combining Crowdsourcing and Deep Learning to Assess Public Opinion on CRISPR-Cas9. BioRxiv, 802454.
Peters, T. (2019). Are we closer to free market eugenics? The crispr controversy. Zygon®, 54(1), 7-13.
Rufo, F., & Ficorilli, A. (2019). From Asilomar to Genome Editing: Research Ethics and Models of Decision. NanoEthics, 13(3), 223-232.
Scott, C. T., & Selin, C. (2019). What to Expect When Expecting CRISPR Baby Number Four. The American Journal of Bioethics, 19(3), 7-9.
Sherkow, J. S. (2019). Controlling CRISPR Through Law: Legal Regimes as Precautionary Principles. The CRISPR journal, 2(5), 299-303.
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.
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.
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.
Brokowski, C. (2018). Do CRISPR germline ethics statements cut it?. The CRISPR journal, 1(2), 115-125.
Ceccarelli, L. (2018). CRISPR as agent: a metaphor that rhetorically inhibits the prospects for responsible research. Life sciences, society and policy, 14(1), 24.
Duensing, N., Sprink, T., Parrott, W. A., Fedorova, M., Lema, M. A., Wolt, J. D., & Bartsch, D. (2018). Novel features and considerations for ERA and regulation of crops produced by genome editing. Frontiers in bioengineering and biotechnology, 6, 79.
Faunce, T., Ray, A., Gardiner, C., Preiss, T., & Burgio, G. (2018). Regulating RNA Research and CRISPR Gene Drives to Combat Biosecurity Threats. Journal of law and medicine, 26(1), 208-213.
Feeney, O., Cockbain, J., Morrison, M., Diependaele, L., Van Assche, K., & Sterckx, S. (2018). Patenting foundational technologies: Lessons from CRISPR and other core biotechnologies. The American Journal of Bioethics, 18(12), 36-48.
Gao, C. (2018). The future of CRISPR technologies in agriculture. Nature Reviews Molecular Cell Biology, 19(5), 275-276.
Gelinsky, E., & Hilbeck, A. (2018). European Court of Justice ruling regarding new genetic engineering methods scientifically justified: a commentary on the biased reporting about the recent ruling. Environmental Sciences Europe, 30(1), 52.
Globus, R., & Qimron, U. (2018). A technological and regulatory outlook on CRISPR crop editing. Journal of cellular biochemistry, 119(2), 1291-1298.
Greene, M., & Master, Z. (2018). Ethical issues of using CRISPR technologies for research on military enhancement. Journal of bioethical inquiry, 15(3), 327-335.
Guerrini, C. J., Spencer, G. E., & Zettler, P. J. (2018). DIY CRISPR. NCL Rev., 97, 1399.
Gutmann, A., & Moreno, J. D. (2018). Keep CRISPR safe: regulating a genetic revolution. Foreign Aff., 97, 171.
Guttinger, S. (2018). Trust in science: CRISPR–Cas9 and the ban on human germline editing. Science and engineering ethics, 24(4), 1077-1096.
Hebert, M. D. (2018). Opening a Can of Genetically-Modified Worms: Funding and Regulating CRISPR Technology. Valparaiso University Law Review, 52(3), 3.
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.
LaManna, C. M., & Barrangou, R. (2018). Enabling the rise of a CRISPR world. The CRISPR journal, 1(3), 205-208.
Lovell, K. (2017). CRISPR/Cas-9 Technologies: A Call for a New Form of Tort. San Diego Int’l LJ, 19, 407.
Medvedieva, M. O., & Blume, Y. B. (2018). Legal regulation of plant genome editing with the CRISPR/Cas9 technology as an example. Cytology and Genetics, 52(3), 204-212.
Mosby, H. (2018). Biotechnology’s Great Divide: Strengthening the Relationship between Patent Law and Bioethics in the Age of CRISPR-Cas9. Minn. JL Sci. & Tech., 19, 565.
Novak, B. J., Maloney, T., & Phelan, R. (2018). Advancing a new toolkit for conservation: from science to policy. The CRISPR journal, 1(1), 11-15.
Pillay, S., & Thaldar, D. W. (2018). CRISPR: Challenges to South African biotechnology law. South African Journal of Bioethics and Law, 11(2), 89-92.
Schultz-Bergin, M. (2018). Is CRISPR an ethical game changer?. Journal of Agricultural and Environmental Ethics, 31(2), 219-238.
Shew, A. M., Nalley, L. L., Snell, H. A., Nayga Jr, R. M., & Dixon, B. L. (2018). CRISPR versus GMOs: Public acceptance and valuation. Global food security, 19, 71-80.
Smalley, E. (2018). As CRISPR–Cas adoption soars, summit calls for genome editing oversight.
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.
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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.
Zhang, D., & Lie, R. K. (2018). Ethical issues in human germline gene editing: a perspective from China. Monash Bioethics Review, 36(1-4), 23-35.
Andoh, C. T. (2017). Genome editing technologies: ethical and regulation challenges for Africa. International Journal of Health Economics and Policy, 2(2), 30-46.
de Araujo, M. (2017). Editing the genome of human beings: CRISPR-Cas9 and the ethics of genetic enhancement. Journal of Evolution and Technology, 27, 24-42.
Barnett, S. A. (2016). Regulating Human Germline Modification in Light of CRISPR. U. Rich. L. Rev., 51, 553.
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.
Cribbs, A. P., & Perera, S. M. (2017). Focus: Genome Editing: Science and Bioethics of CRISPR-Cas9 Gene Editing: An Analysis Towards Separating Facts and Fiction. The Yale journal of biology and medicine, 90(4), 625.
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Kozubek, J. (2017). Crispr-Cas9 is Impossible to Stop. Geo. J. Int’l Aff., 18, 112.
de Lecuona, I., Casado, M., Marfany, G., Baroni, M. L., & Escarrabill, M. (2017). Focus: genome editing: gene editing in humans: towards a global and inclusive debate for responsible research. The Yale Journal of Biology and Medicine, 90(4), 673.
Melillo, T. R. (2017). Gene editing and the rise of designer babies. Vand. J. Transnat’l L., 50, 757.
Mulvihill, J. J., Capps, B., Joly, Y., Lysaght, T., Zwart, H. A., & Chadwick, R. (2017). Ethical issues of CRISPR technology and gene editing through the lens of solidarity. British medical bulletin, 122(1), 17-29.
Ormond, K. E., Mortlock, D. P., Scholes, D. T., Bombard, Y., Brody, L. C., Faucett, W. A., … & Musunuru, K. (2017). Human germline genome editing. The American Journal of Human Genetics, 101(2), 167-176.
Peck, A. (2017). Re-framing biotechnology regulation. Food and Drug Law Journal, 72(2), 314-340.
Rai, A. K., & Cook-Deegan, R. (2017). Racing for academic glory and patents: Lessons from CRISPR. Science, 358(6365), 874-876.
Sherkow, J. S. (2017). Focus: Genome Editing: CRISPR, Patents, and the Public Health. The Yale Journal of Biology and Medicine, 90(4), 667.
Shinwari, Z. K., Tanveer, F., & Khalil, A. T. (2017). Ethical issues regarding CRISPR mediated genome editing. Curr Issues Mol Biol, 26, 103-110.
Wang, K. (2017). CRISPR and the future of genome engineering: A bold new world. Intersect: The Stanford Journal of Science, Technology, and Society, 10(3).
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.
Ellison, T. (2016). Why Genetics Is CRISPR Than It Used to Be: Helping the Novice Understand Germ Line Modification and Its Serious Implications. S. Cal. Interdisc. LJ, 26, 595.
Hrouda, B. E. (2016). Playing God: An Examination of the Legality of CRISPR Germline Editing Technology under the current International Regulatory Scheme and the Universal Declaration on the Human Genome and Human Rights. Ga. J. Int’l & Comp. L., 45, 221.
Williams, E. E. (2016). CRISPR: Redefining GMOs-One Edit at a Time. UALR L. Rev., 39, 437.