The ethics councils of three major European nations—France, Germany, and the UK—jointly authored this statement on the ethics of human germline genome editing. The statement identifies momentum toward allowing the clinical use of heritable genome editing but argues that this use would require “a level of public ethical reflection that is not yet met by current initiatives.” Accordingly, the three ethics bodies call for broad societal debate and deliberation and argue that this deliberation must focus more on ethical questions and principles.
This is one of two articles published on the same day in the Guardian that suggests an emerging strategy to modify the UK’s Human Fertilisation and Embryology Act. Based on notable contributions from Robin Lovell-Badge, a leading figure in global discussions about the future of genome editing, this article discusses expected impending recommendations from the Human Fertilisation and Embryology Authority (HFEA) to update the 1990 Act.
Following a meeting at the Brocher Foundation in Switzerland, a group of public interest advocates released this statement on heritable human genome editing. They viewed this statement as a corrective to the many statements released by experts in the sciences and bioethics. The authors object to endorsements from these groups to proceed with heritable genome editing research.
This article in The CRISPR Journal represents an extensive survey of 106 nations regarding their policies on early-stage embryo genome editing research. It is the product of a collaboration between bioethicists at Dalhousie University and members of the Center for Genetics and Society. The authors argue that international policies about heritable genome editing were previously underreported. Their findings suggest that there is indeed some global consensus around the prohibition of heritable human genome editing.
This is one of two articles published on the same day in the Guardian that suggests an emerging strategy to modify the UK’s Human Fertilisation and Embryology Act. This article identifies recent developments in life science research—specifically, genome editing, synthetic embryos, mitochondrial transfer, and lab-grown gametes—and suggests that revisions to the 1990 Act would need to account for progress in these areas. The article argues that scientific progress in each of these domains necessitates “future-proofing” legislation so that these technologies can be translated into the clinic.
Following a UNESCO meeting in Paris, the International Bioethics Committee (IBC) released this report, which clarifies its stance on recent research related to human genomics. It includes special considerations for heritable genome editing and specifically calls for a moratorium on such applications. The reasoning the IBC provides is that such interventions raise “serious concerns,” including threats to human dignity and the prospect of eugenic applications.
This treaty is more commonly known as the “Oviedo Convention,” after the city in Spain where it was ratified. The Oviedo Convention is based on the European Convention of Human rights and is the only legally binding international instrument for protecting human rights in biology and medicine, covering both clinical and research settings and giving special consideration to human dignity. It lays out the rights of patients and research subjects for Europe, focusing largely on individual rights of informed consent and privacy but also mandating consideration of equitable access to health care.
In 2021, the Council of Europe determined that it was necessary to clarify the provisions of the Oviedo Convention pertaining to human genome editing. These clarifications were designed to clear up ambiguity surrounding the applicability of Article 13 of the Oviedo Convention to research and in particular, the use of the terms “preventive, diagnostic and therapeutic.” The clarifications approved by the Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO) specify that Article 13’s restrictions apply to human genome editing for both clinical and research purposes.
This piece uses the framework of anticipatory governance to analyze the existing scholarly discourse on the governance of human genome editing. The authors argue that this governance discourse almost without exception does not meet the standards of anticipatory governance and are often content to merely call for greater public participation in governance without further elaboration. They argue that implementing anticipatory governance within the space of human genome editing would be a step toward aligning its development with social needs and values.
In an analysis based largely on the proceedings of the first two International Summits on Human Genome Editing, Morgan Meyer theorizes the process of “irresponsibilization.” Much of this theorization revolves around He Jiankui’s experiments and how they spurred responses and calls for further action at the Second International Summit.
This statement was released by the organizing committee of the Second International Summit on Human Genome Editing in Hong Kong in 2018, immediately following the revelation of He Jiankui’s heritable genome editing experiments. Though a scandal was emerging, the statement does not repeat the language from the first summit statement about the need for “broad societal consensus” to proceed with heritable genome editing. Instead, it says that its clinical use “remains irresponsible at this time” and beings the work of anticipating a path forward.
This statement was released by the organizing committee of the Third International Summit on Human Genome Editing in London in 2023. It continues the trend from the second summit statement of laying out a path to clinical applications of human genome editing. One of the ways in which the organizers accomplish this is by making a distinction between heritable genome editing for reproductive purposes and germline genome editing for research purposes.
ISSCR released this statement shortly before the publication of CRISPR research on nonviable human embryos. It suggests a moratorium on clinical germline genome editing research. The statement asserts that in addition to the lack of understanding of safety and risk, more social and ethical deliberation are necessary in order to determine whether the clinical use of germline editing will ever be permissible.
This news item from Nature describes a new ethics statement from the State Council of China. Bioethicists read this statement as a response to the He Jiankui affair and his recent release from prison following a three-year sentence. The statement is the first publicized product of the National Science and Technology Ethics Committee that was established in the wake of the revelation of He’s experiments. It seeks to address the ambiguous nature of the regulatory environment in which He conducted his experiments.
The World Health Organization established an international and multi-disciplinary expert panel, composed largely of biomedical researchers, clinicians, and bioethicists, to assess the “scientific, ethical, social, and legal challenges with human genome editing (both somatic and germline)" (2019:1).
Writing in the Journal of the American Medical Association, biomedical scientist Eli Adashi and legal scholar Glenn Cohen detail some of the arguments against moratoria from the perspective of leading genome editing scientists. They criticize moratoria for several reasons: slowing scientific progress, withholding potential medical treatments, increasing medical tourism, favoring ideology over pure scientific inquiry, being overly broad and thus producing unintended effects, and simply being unnecessary given the capacity of scientists to self-regulate.
Two of the scientists responsible for the Asilomar conference support a similar voluntary moratorium on human germline genome editing.
A collection of prominent scientific researchers call for open discourse on the potential applications of CRISPR/Cas9 to modify the human genome. These researchers, among whom are several organizers of the Asilomar Conference on Recombinant DNA, also gathered in California—a bit north of Asilomar, in Napa—to discuss the prospects of an emerging technology of concern. Following this meeting, the authors make several recommendations.
Bioethicist Françoise Baylis draws attention to the revised 2021 ISSCR guidelines for stem cell research and clinical translation, for leaving open the question of the permissibility of human genome editing. For Baylis, the “review categories” of the guidelines are ambiguous on whether heritable human genome editing would be allowed.
Sharon Begley chronicles the calls for a moratorium on heritable human genome editing from prominennt members of the scientific community. Begley also notes the absence of notable figures in genome editing, including Jennifer Doudna. In an interview, Doudna said she prefers “’strict regulation that precludes use’” rather than a moratorium, which does not provide a clear pathway to “’possible responsible use.’” Begley dives into this ambiguity around the word moratorium and some scientists’ strong reactions against the word.
Jon Cohen, writing for Science, describes the divisiveness of Lander et al.’s call for a moratorium within the biological research community. While many threw their support behind the call, Nobel Laureate and Asilomar organizer David Baltimore was a notable exception.
In this brief opinion piece, one of CRISPR/Cas9’s lead developers, Jennifer Doudna, marks the one-year anniversary of the reveal of He Jiankui’s experiments. Doudna identifies the response form the global scientific community as “encouraging,” believing that it created the possibility for broade4r conversations about CRISPR’s applications. However, she also orients this conversation toward transparency and responsible application of CRISPR and foregrounds health and safety concerns.
Alongside Lander et al.’s call for a voluntary moratorium on human germline genome editing, the leaders of three advisory bodies—the US National Academies of Sciences and Medicine and the UK’s Royal Academy—voiced their support.
Observatory Co-Director Ben Hurlbut argues in Nature that reaction in the wake of the reveal of He Jiankui’s CRISPR/Cas9 experiments risks presuming the inevitability of human germline genome editing. It thereby prematurely forecloses broader debate about whether germline editing should happen at all. Hurlbut highlights the Global Observatory’s efforts as one “modest experiment” to challenge this foreclosure and, following Hannah Arendt, help us build the capacities to think and speak more clearly that which we do.
Global Observatory Co-Director Ben Hurlbut uses the etymology of governance—from an ancient Greek nautical term meaning “to steer the ship”—to discuss the course of human germline genome editing. This metaphor allows the concept of governance to capture not only its direction, but its tools, currents, and personnel. Hurlbut identifies a shortening of the ethical horizon of genetic modification over the last half-century, as bioethics has increasingly focused on the near future, specific technologies—like CRISPR—and their immediate applications.
The International Society for Stem Cell Research (ISSCR) revised its guidelines for research on Heritable Human Genome Editing in 2021. These guidelines identify the implantation of gene-edited embryos as belonging to Category 3A because it is “currently unsafe or raise[s] unresolved ethical issues.” The authors note that there may be a potential pathway to allowing such research in the future.
The Directors of the Global Observatory argue that calls for a moratorium on human germline genomic engineering from the scientific community must be accompanied by broad public debate on the ethics and politics of biotechnology.
Following the reveal of He Jiankui’s experiments, Eric S. Lander and colleagues—a collection of scientists and bioethicists across seven countries—argue in favor of a global moratorium on heritable human genome editing. The moratorium that they call for beings as absolute, but following the development of an international framework, permissions to engage in human germline editing would be decided on a nation-by-nation basis. They suggest the World Health Organization (WHO) as a potential institution to oversee the construction of a global framework via an international panel.
This 2015 study describes an experiment that utilized CRISPR/Cas9 to modify human embryos in vitro. These embryos were pre-implantation and nonviable, and the study identified technical difficulties with embryonic CRISPR modification, including poor DNA repair and off-target effects. Nonetheless, the publication of this research prompted the US National Academies of Sciences and Medicine to organize the first International Summit on Human Gene Editing later that same year.
In Nature Biotechnology, Vivien Marx provides a reminder that the children that resulted from He Jiankui’s CRISPR experiments—the twins “Lulu” and “Nana” and a third, younger child, here called “Amy”—are now toddlers. She uses this reminder as an opportunity to discuss the outlook of their lives as the first gene-edited humans, soliciting the advice of scientific experts.
This statement followed the first three-day International Summit on Human Gene Editing convened by the National Academies of Sciences and Medicine. It summarizes the Organizing Committee’s conclusions, including the conclusion that “it would be irresponsible to proceed with any clinical use of germline editing." It identifies the need for “broad societal consensus” before such research should be pursued and suggests that the subject should be revisited regularly.
The National Academies of Sciences and Medicine convened a committee to summarize the important considerations for the future of human gene editing, including both somatic and germline editing. They lump these considerations into three categories: the scientific, the medical, and the ethical. They note that public engagement is especially important in the case of germline editing.
Produced by a joint commission of leading science advisory bodies in the USA and UK, this was the first major advisory report to be spurred by news that gene-edited twins had been born in China in 2018. While cautioning that relevant criteria for safety had not yet been met, the report sought to define a "responsible translational pathway" by which heritable human genome editing (HHGE) could be applied in a clinical setting. This pathway emphasizes a risk/benefit framework, balancing risks to individuals against the potential benefits of treating monogenic diseases.
This report from the independent UK Nuffield Council on Bioethics takes a broad view of the practical and ethical significance of genome editing. It responds in part to the development of CRISPR/Cas9 and examines applications of genome editing well beyond the human. It divides its analysis into several different “fields of activity” in which CRISPR/Cas9 and genome editing more broadly have anticipated impacts.
The UK’s independent Nuffield Council on Bioethics prepared this 2018 report in response to recent developments in biological genome editing techniques. The report provides background, speculation on future directions of the technology, an analysis of a range of ethical considerations, and recommendations for governance of human germline genome editing. The report broadly determines that the important ethical considerations limit the range of applications for germline editing.
Reflecting on Lander et al.’s call for a moratorium on human germline gene editing, biomedical ethicist G. Owen Schaefer makes several arguments why a moratorium is neither desirable nor necessary while also emphasizing the importance of greater public deliberation. Interestingly, he includes whether to impose a moratorium on human germline gene editing research as a decision that should require public input.
At the same time Lander et al. published their call for a voluntary moratorium on heritable human germline editing, two leaders of the US National Institutes of Health (NIH) voiced their support. In this brief Nature correspondence on behalf of NIH, Wolinetz, the acting Chief of Staff, and Collins, the Director, also voice support for a process of “substantive debate” and allow that this may result in a ban of human germline editing in the future. The authors also note that NIH is presently prohibited from supporting research on human germline gene editing.
In the form of an open letter published in the DIY-biologist and fablab-focused Makery, bioartist and Adam Zaretsky provides an artistic critique of not only the rationale driving the editing and implantation of human embryos, but also the rationale driving bioethics and the proposition of research moratoria. Eschewing the common tendency to ascribe the provenance of Lulu and Nana as the whims of an ambitious rogue scientist, Zaretsky conceives of their parentage well beyond strict genetic heritage.
In a chapter of her 2019 book Altered Inheritance, bioethicist and philosopher Françoise Baylis discusses how the decision the National Academies of Sciences and Medicine made not to invoke the word moratorium in their 2015 statement. This decision, Baylis argues, was partially attributable to fear of a permanent ban within the research community. However, the decision also left the door open to the softened guidance in the 2017 report released under the same National Academies initiative. He Jiankui specifically referenced this report in an application for his experimental research.