Public Deliberation about Gene Editing in the Wild

This is the introduction to a special report from the Hastings Center on public deliberation about gene editing, specifically as it is used to modify organisms that are then released into the wild. The authors identify the lack of clear definition around the concepts of public engagement and public deliberation in the discourse surrounding gene editing, despite widespread acknowledgement of their importance. This incongruity makes clarifying specific approaches to public participation in the governance of gene editing a priority.

Geneva Statement on Heritable Human Genome Editing: The Need for Course Correction

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.

Human Germline and Heritable Genome Editing: The Global Policy Landscape

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.

Making science serve humanity: Jennifer Doudna, PhD, says CRISPR gene-editing technology should be accessible to all

Nobel laureate CRISPR-developer Jennifer Doudna discusses two primary ethical concerns surrounding the technology’s use: the need for internationally recognized regulations and the need to ensure that CRISPR-derived treatments are accessible worldwide. Despite the headline, in this brief interview, Doudna provides little perspective on how the latter might happen aside from addressing it at the level of “technical and scientific issues.” She displays a faith in widespread access to genome editing technologies as a public good that would be echoed at the Third International Summit in 2023.

Report of the IBC on updating its reflection on the Human Genome and Human Rights

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.

Universal Declaration on the Human Genome and Human Rights

UNESCO reacted to developments in genomics by releasing this declaration, which draws on the tradition of the United Nations’ 1948 Universal Declaration on Human Rights and is similarly framed in terms of human dignity, human rights, and fundamental freedoms. The declaration asserts that the human genome is the common heritage of humanity and establishes individual rights regarding the genome, including nondiscrimination, informed consent, and confidentiality. It identifies specific applications of genomics, namely human cloning, as contrary to human dignity.

Toward anticipatory governance of human genome editing: A critical review of scholarly governance discourse

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.

Advancing precision medicine through agile governance: Bridging innovation and regulation for the greater good

This piece focuses on the framework of “agile governance” for precision medicine. This framework suggests that governance needs to build its capacity for responding to the pace of innovation, suggesting a reactive, backfooted approach (as opposed, for example, to the more proactive approach of “anticipatory governance” (see, David Guston's 2014 article on the topic, or the related piece by John Nelson and collaborators). Bowman et al.

Taking responsibility, making irresponsibility: Controversies in human gene editing

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.

Statement by the Organizing Committee of the Second International Summit on Human Genome Editing

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.

Statement from the Organising Committee of the Third International Summit on Human Genome Editing

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.

Statement on Human Germline Genome Modification

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.

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.

New guidelines for stem cell and embryo research from the ISSCR

The authors, some of whom are ISSCR affiliates involved in the production of the 2021 guidelines, provide an overview of topics that were updated in the guidelines (chimeric embryos, mitochondrial replacement techniques, stem cell-based embryo models). They make the case that relaxing research in these arenas has great potential for medicine science. To realize such benefits, they call for a reform of research oversight policies worldwide, within ethical acceptability, as the updated guidelines of ISSCR propose.

Should the 14-day rule for embryo research become the 28-day rule?

In this commentary, the authors argue that it is time to consider if the 14-day rule can be extended to 28 days. They provide a list of arguments in favor of such an extension, including the opportunities to open up the “blackbox” of embryo development, increased knowledge about embryonic development and improvement of IVF procedures and the study of “synthetic” or stem cell-based embryos. Regarding ethical reasoning for the 14-day rule, they make several arguments.

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.

Why we should not extend the 14-day rule

The authors respond to McCully’s (2021) arguments for extending the 14-day rule to 28 days. They argue that biomedical advances do not justify changing the rule, since the reasoning of the Warnock Committee remains relevant. The authors maintain their defense of the 14-day rule on the following grounds: 1. The Warnock Committee reasoning was based on maintaining public trust and providing a moral justification for using embryos, concerns that have not changed to date; 2. Extending the 14-day rule would justify previous concerns about a slippery slope; 3.

Embryo experimentation: is there a case for moving beyond the ‘14-day rule’

The author analyzes the main justifications provided by the Warnock committee for the 14-day limit of embryo research in vitro and finds them unconvincing; discussions about extending the limit must determine whether the limit was valid in the first place. The first objection is against the argument that individuation is necessary for moral status, since it can occur later than 14 days, and an individual entity is present before any twinning.

A 14-day limit for bioethics: the debate over human embryo research

This article explores the main arguments in favor of and against extending the 14-day limit for conducting research on human embryos. Cavaliere also provides an overview of the historical roots of the 14-day rule and notes that it favored compromise between competing moral views. For the author, the potential research benefits of keeping embryos alive for longer than ever before do not suffice to extend the limit. The article presents two arguments in favor of compromise.

How to Rethink the Fourteen-Day Rule

In a column for the Hastings Center Report, bioethicist Sarah Chan opens up for discussion whether the 14-day rule could be revised, as it “was not intended to be set in stone” (2017:5). Her arguments put aside concerns about a slippery slope, because moral principles are not being readjusted; the 14-day limit did not establish a “moral bright line” (2017:5) and did not assess when or if embryos acquire moral status.

How and Why to Replace the 14-Day Rule

In this article, bioethicist Sarah Chan examines whether scientific advances in developmental biology should lead to revisiting the 14-day rule. In her view, the Warnock Committee did not arrive at a moral principle or a position on the embryo’s moral status when suggesting the 14-day rule but achieved a policy compromise between concerned parties. However, scientific developments have raised questions as to whether the rule may need to be changed.

Human embryo research, stem cell-derived embryo models and in vitro gametogenesis: Considerations leading to the revised ISSCR guidelines

In this perspective, the authors, which include a member of the ISSCR, provide a summary of the recommendations of Working Group 2, the sub-committee in charge of updating the 2021 ISSCR guidelines pertaining to oversight processes and the categories of research. They explain the change to the 2016 guidelines, including the categories of review. The new guidelines divide two of the previous three categories. Former category 1, ‘Exempt from review,’ was split in two. Category 2, ‘Requires review,’ remained unchanged.

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.

Just Say No to Human-Monkey Chimeras

The editor of the New Atlantis writes a thought-provoking essay about what he perceives as a lack of limits in biomedical research, expressing concern for research on human-monkey chimeras, and by extension, the 14-day rule of embryo culture. Among the topics that the author takes issue with are the establishment of limits and scientific self-regulation, suggesting that society should not place too much trust on scientists to act responsibly and that strong limits should be put in place.

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.

Revisiting the Warnock rule

Spurred by recent announcements that researchers in the UK and USA had sustained human embryos in culture for nearly two weeks, Nature Biotechnology collected commentaries from more than a dozen experts on whether it was time to reassess the 14-day rule. Much of the discussion focuses on the potential benefits of studying the “black box period” of human embryonic development, between about 7 days and 28 days, and on questions of who should decide whether the two-week limit might be breached in the interest of learning more about this period.

Embryology policy: Revisit the 14-day rule

In a commentary in Nature, bioethicist Insoo Hyun and research specialists Amy Wilkerson and Josephine Johnston argue that the recent development of capabilities to extend the life of cultured embryos puts research "on a collision course" (2016:170) with the 14-day rule. As a result, the authors argue that the rule and its applications need to be reevaluated. They further claim that the 14-day rule was primarily an instrument of public policy that aimed to enable research while also maintaining public trust.

Guidelines for Stem Cell Research and Clinical Translation

The International Society for Stem Cell Research (ISSCR) produces research guidelines every five years with the intention of promoting responsible advances in research and clinical applications of stem cell biology. The 2016 guidelines provide a number of recommendations on clinical and ethical principles, including protocols for provision of biomaterials, informed consent processes, documentation, safety and efficacy, privacy, reporting of clinical trials, and other matters for clinical practice.

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.

Guidelines for Stem Cell Research and Clinical Translation

The ISSCR is an international body founded in 2002 that harmonizes global ethical standards and regulation for research with embryos, stem cells and gametes. The organization updated its 2016 guidelines to accommodate scientific advances in embryo research, embryo models, organoids, chimeras, genome editing, and mitochondrial replacement techniques. Of particular interest is the relaxation of the 14-day rule for in vitro embryo culture. Recommendation of the report puts into question whether certain circumstances justify culture of embryos beyond 14 days.

ISSCR: grave omission of age limit for embryo research

The authors, renowned bioethicists, responded in June 2021 to the recent May update to the ISSCR guidelines. They argue that the shift in policy from the 2016 guidelines, which maintained the 14-day limit on embryo research, to the updated ISSCR guidelines in 2021 is without sufficient justification. In particular, the authors criticize that the 2021 guidelines do not establish limits for ex vivo embryos. As such, they remind us that limits are necessary for embryo research: “At some point, the developing human embryo reaches a stage at which it should not be used for research.

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.

Stem-cell guidelines: why it was time for an update

Robin Lovell-Badge, who chaired the ISSCR’s Task Force to Update the Guidelines, provides an overview of the methods and experts involved in the May 2021 update and defends the rationale for extending the 14-day limit on embryo research to 28 days. According to Lovell-Badge, ISSCR’s guidelines sought to reflect current science without stepping into what research boundaries should be set or were socially acceptable. This is a task would require procedures of public engagement and assessments of public support in recognition of the rule’s status as a compromise in the face of opposition.

ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update

This document was written by the 45 members of the International Society for Stem Cell Research (ISSCR) task force charged with revising the Society’s guidelines for stem cell and related biological research. Such revision was necessary, as the task force put it, to “evolve[e] with the science” (2021:1399). They explain their deliberative procedure and highlight the differences between the 2016 and 2021 editions of the guidelines.

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.

ISSCR guidelines uphold human right to science for benefit of all

A small group of ISSCR affiliates respond to letters from authors who have advocated keeping the 14-day limit. Master and colleagues argue that the 14-day limit “fails to uphold the human right to benefit from science” (2021:494), a right recognized in the 1948 Universal Declaration of Human Rights. This argument seeks to strengthen the main consideration for extending the 14-day limit, allowing science to develop biomedical innovations that would benefit society. It argues that such innovations are inhibited when research is limited.

Rethinking Human Embryo Research Policies

Published in February 2021 before the ISSCR updated its guidelines, the authors provide an overview of the history of the 14-day rule that originated in the US and the UK, followed by an exposition of the arguments in favor and against extending the rule. They also provide an overview of international legislation and raise questions about oversight mechanisms if the 14-day rule were to be extended internationally. They observe no consensus as to what mix of measures would replace the 14-day rule.

National human embryo and embryoid research policies: a survey of 22 top research-intensive countries

The authors review national policies and legislation for IVF, stem cells and human embryo research in the 22 research and development investing nations, focusing on whether they had restrictions for research on either human embryos or so-called “embryoids.” The review determined whether such research was permitted and whether time limits, such as the 14-day rule, were in place. Their comparison indicates that the adoption of the 14-day rule varies between countries. Of the 22 nations they reviewed, only 14 countries maintain a 14-day limit. Some, such as Switzerland, have a 7-day limit.

The time has come to extend the 14-day limit

The author argues for the extension of the 14-day rule based on potential biomedical and therapeutic applications and the lack of “coherent or persuasive reasons to deny researchers, and through them humanity, the knowledge and the innovation that this will generate” (2021:e66). In particular, the author argues that the use of animal models cannot fill the gaps left by the absence of human embryo research, as there are research questions that can only be addressed with their examination.

New guidelines for embryo and stem cell research

The authors, President and Director of Policy at ISSCR, provide an overview of the updates and rationale for the changes suggested in the 2021 ISSCR guidelines. The guidelines propose three categories of oversight for stem-cell and embryo research, with new distinctions between restricted research and research considered unethical until further safety considerations are determined. The authors note that the scope of the guidelines includes human embryos and embryo models, organoids, chimeric embryos, mitochondrial replacement techniques, and heritable genome editing.

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.

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.

Keep the 14-Day Rule in Stem Cell Research

Renowned theologian Ted Peters defends the 14-day rule because it places human dignity and reverence for human life at the heart of the debate, providing a counterweight to the materialism and utilitarianism pervasive in scientific research. Furthermore, the author does not find justifiable ISSCR’s arguments for extending the 14-day limit, which reflects a lack of scientists’ engagement with religious arguments that prioritize human dignity and its sacredness. This suggests that scientists consider moral concerns about scientific research unnecessary and inhibitory of scientific advancement.

Implantation barrier overcome

Stem cell biologist Jane Rossant provides an excellent explanation of efforts and publications by Shahbazi et al. (2016) and Deglincerti et al. (2016) to culture self-organizing human embryos in vitro. Rossant attributes their achievements mainly to “an improved culture medium and a better substrate for embryo attachment” (2016:182). Prior to the new developments, the period beyond one week of human embryonic development had been a blackbox, since at this point the embryo would have to be implanted.

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.

Do Human Cells Have Rights?

In a lecture given at Ormond College, Melbourne in July 1986, Mary Warnock provides a summary of the questions and moral dilemmas faced by the committee that she presided over, the Committee of Inquiry into Human Fertilization and Embryology. Warnock provides an overview of the moral reasoning behind the protection or use of human embryos in research, followed by an overview of how some of these arguments played out in the committee. These include the establishment of the appearance of a primitive streak and the 14-day rule as a cutoff for embryo policy.

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.

Natural Mothers and Other Kinds

In this seminal book, Observatory Director Sheila Jasanoff explains the reasons behind the different paths that the US, the UK, and Germany have taken in biotechnology policy and regulation. This includes different political cultures and ways of public reasoning and decision-making, which she captures with the concept of “civic epistemology.” Chapter 6 focuses on debates and moral dilemmas that surrounded the emergence of IVF and the “technological capacity to manipulate human life” (2005:146).

Making the Facts of Life

Observatory Director Sheila Jasanoff identifies that the processes of making sense of ambiguous biological entities—like human embryos—are also political processes that settle questions of ethical responsibility toward these entities. These processes draw on established national scripts for ordering the relationship between science and politics. She characterizes the formulation of the 14-day rule as an act of “ontological surgery” that drew a line at two weeks between the nonhuman and human as research subject.

Life in the Gray Zone

In chapter 4 of the book Making Sense of Life, Observatory Director Sheila Jasanoff reflects on the challenges that new entities created through biotechnology as ‘moral grey zones’ bring to democratic societies as filled with moral questions. Such biological objects include the cloning of Dolly the Sheep, “three-parent embryos,” human embryonic stem cells (hESCs), and spare embryos created for IVF purposes.

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.

Moral Status, Moral Value, and Human Embryos: Implications for Stem Cell Research

This chapter refers to the biology behind embryonic stem cell (ESC) research and the question of permissibility of using human embryos in such research. Steinbock concludes that the creation and destruction of human embryos is justified as the aim is to improve people’s lives, which is not equivalent to disrespecting human life. The chapter provides an overview of different criteria that assign moral status to human embryos, such as their biological humanity, which considers embryos as having moral status and moral rights by virtue of being members of the Homo sapiens species.