Report of the First Meeting

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).

Heritable Genome Editing: Is a Moratorium Needed?

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.

Call for moratorium on xenotransplants

Two Harvard University researchers call for a moratorium on clinical trials of xenotransplantation in a brief Nature commentary. They specifically invoke the precedent of Asilomar as a “turning point” for scientists’ approach to public responsibility. They suggest that the decisions of whether and how to proceed with such clinical trials should not be left to technical experts alone, instead requiring “an informed public debate.” They identify a single chief risk of xenotransplantation research: the potential of a pathogen to cross the species barrier.

A prudent path forward for genomic engineering and germline gene modification

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.

Leading scientists call for global moratorium on creating ‘CRISPR babies’

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.

Summary statement of the Asilomar conference on recombinant DNA molecules.

Several of the molecular biologists who gathered at the Asilomar Conference Grounds reported back on the conference shortly after its conclusion. They stated their general agreement that the voluntary moratorium called for the previous year need not continue. The researchers laid out the criteria for responsible research, focusing on managing risks (which remained largely unknown) with technical forms of containment rather than limits on risky research.

The recombinant DNA controversy: twenty years later.

Paul Berg, one of the scientists behind the original call for a voluntary moratorium on recombinant DNA research, and Maxine Singer, another molecular biologist and fellow Asilomar organizer, reflect on the legacy of Asilomar 20 years after the conference. They identify Asilomar “the beginning of an exceptional era for science and for the public discussion of science policy—one that continues unabated to this day.” They note the universal observance of the voluntary moratorium as evidence of its success.

Potential Biohazards of Recombinant DNA Molecules

A committee of prominent genetic researchers writing on behalf of the Assembly of Life Sciences and the National Research Council (NRC) call for action to address concerns around recombinant DNA. This action includes “voluntarily deferring” several types of scientific experimentation, generally involving the dissemination of potentially harmful plasmids. They also include the formation of an advisory committee to oversee experiments and develop guidelines and procedures for potentially hazardous research.

CRISPR's unwanted anniversary

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.

Agricultural Biotechnology: The U.S.-EU Dispute

In a US Congressional Research Service report, Charles Hanrahan recounts a dispute between the United States (along with Argentina and Canada) and the EU over the subject of genetically modified crops. The EU had kept a de facto moratorium on the import of genetically engineered foodstuffs, which the US argued was in violation of World Trade Organization rules and was causing economic harm to the United States both directly and through the global influence of EU policy.

Human genome editing: ask whether, not how

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.

Imperatives of Governance: Human Genome Editing and the Problem of Progress

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.

ISSCR Guidelines: Heritable Genome Editing

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.

Adopt a moratorium on heritable genome editing

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.

CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes

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.

The CRISPR children

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.

On Human Gene Editing - International Summit Statement

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.

Human Genome Editing: Science, Ethics, and Governance

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.

Heritable Human Genome 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.

Notice Announcing the Removal of the Funding Pause for Gain-of-Function Research Projects

This brief notice announced to researchers and the public that the funding moratorium on gain-of-function research instituted in 2014 would be lifted. This announcement came after the U.S. Government conducted a risk/benefit analysis on such research. Based on this analysis, the Department of Health and Human Services (HHS) established a new framework for the review of dual-use gain-of-function research with potential pandemic pathogens (PPPs). In effect, the U.S.

Genome editing: an ethical review

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.

Genome editing and human reproduction: social and ethical issues

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.

US suspends risky disease research

Science writer Sara Reardon discusses the announcement from the White House Office of Science and Technology Policy (OSTP) that it would be instituting a forced moratorium on gain-of-function research on influenza, SARS, and MERS viruses. Reardon notes the mixed reception within the scientific community, with some praising the decision as an opportunity for deliberation of the research’s risks and others characterizing the decision as an overreaction.

A case against a moratorium on germline gene 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.

A Voluntary Moratorium?

In this brief piece, then-Editor-in-Chief of Molecular Therapy draws on the occurrence of multiple adverse events in clinical trials of retrovirus-mediated gene therapies to address the question of whether a voluntary moratorium is necessary. Verma argues that it is not, on the grounds that it is difficult to identify the root causes of the adverse events and that a moratorium would be unfair to potential gene therapy patients.

US biologists adopt cloning moratorium

A brief Nature news item documents the adoption of a voluntary five-year moratorium on human cloning by the Federation of American Societies for Experimental Biology (FASEB). The moratorium made a point of distinguishing human cloning intended for implantation from human cloning for research in vitro prohibiting the former while permitting the latter. Some scientists argued that this move was intended to assuage public concerns about human cloning and preempt legislative bans that could affect in vitro research, claims that FASEB officials denied.

U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses - October 17, 2014

In 2014, the White House Office of Science and Technology Policy (OSTP) made the decision to pause funding on certain types of gain-of-function research. Gain-of-function research alters pathogenic organisms to test the ability of pathogens to acquire additional virulence. OSTP decided that the biosafety and biosecurity risks of such experiments were too great and decided to impose a moratorium on new federal funding for such research focused on pathogens with high pandemic potential: influenza, MERS, and SARS viruses.

Adjudicating the GM Food Wars: Science, Risk, and Democracy in World Trade Law

This piece was originally written by four scholars, including Observatory Director Sheila Jasanoff, as an amicus curiae brief to the World Trade Organization (WTO). The WTO was considering a legal challenge from the United States, Canada, and Argentina to the de facto moratorium on genetically modified food imports in the European Communities (EC). The challengers argued that such a moratorium was illegal on the grounds that the European Union’s actions were not based on sound science of risk assessment.

NIH supports call for moratorium on clinical uses of germline gene editing

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.

Human germline gene editing is bioart: an open letter to Lulu and Nana

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.

Slow Science

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.

Remembering the Future: Science, Law, and the Legacy of Asilomar

Global Observatory Co-Director Ben Hurlbut discusses the ways in which Asilomar crystallizes an imaginary of “governable emergence.” This imaginary posits the relationship between science and the law, where science and technology drive social change while the law lags behind and merely reacts. It also positions the scientific community as gatekeepers by giving precedence to expert assessments of technological possibility and the characterization of technological novelty. Institutionalized bioethics serves an ancillary role, focusing on the downstream consequences of novel technologies.

A Voluntary Moratorium

Sheldon Krimsky details the events surrounding the 1974 call for a voluntary moratorium that produced the following year’s Asilomar Conference on Recombinant DNA. Krimsky explains the roels that Paul Berg and David Baltimore came to play in publishing the initial call and some of the uncertainties and disputes within the research community that produced it.