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.

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.

‘Where to draw the line?’ Mary Warnock, embryos and moral expertise

This chapter puts into perspective the sociopolitical context in which the Warnock committee in the UK was formed and the public division it was called to address, as well as key topics that informed the committee’s deliberations. The committee was unusual in broadening its membership to lay people, besides scientists and doctors; the author highlights Mary Warnock’s individual role in shaping bioethical thought in the UK, through her commitment to applied ethics, the need for external oversight, and her trajectory in civil service in previous committees.

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.

Understanding ‘anticipatory governance’

STS scholar David Guston defines, clarifies, and responds to critiques of “anticipatory governance.” Anticipatory governance is one framework that has gained currency within STS for thinking about how to build the necessary social capacity to govern emerging technologies. The term originated in policy and environmental management scholarship, but it was adapted and developed by Guston and his collaborators at the Center for Nanotechnology in Society at Arizona State University (CNS-ASU).

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.

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 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.

Self-organization of the in vitro attached human embryo

In this study led by Ali Brivanlou of Rockefeller University, scientists report the development of an in vitro “attachment platform”: a system that allows the study of the post-implantation development phase of the human embryo. In this arrangement, human blastocysts self-organize to display key events of development that occur in vivo. This novel method builds upon a previous study reported in mice.

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.

Constitutionalism at the Nexus of Life and Law

J. Benjamin Hurlbut, Sheila Jasanoff, and Krishanu Saha guest-edited the November 2020 issue of the journal Science, Technology, & Human Values. This essay introduces a collection of articles gathered under the theme of “law, science, and constitutions of life.” Together, they explore how revolutions in notions of what biological life is are eliciting correspondingly revolutionary imaginations of how life should be governed.

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.

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.

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.

Self-organization of the human embryo in the absence of maternal tissues

This study led by Magdalena Zernicka-Goetz at the University of Cambridge reports the development of an “in vitro system to culture human embryos through implantation stages” (2016:700) in the absence of maternal tissues, which were previously thought to be required to mimic the implantation of an embryo in an uterus. The scientists adapted a protocol for mouse embryo culture, using an extracellular matrix. Implantation is a milestone in human development, thought to induce remodeling of the embryo and gastrulation.

Creating the ‘ethics industry’: Mary Warnock, in vitro fertilization and the history of bioethics in Britain

The author examines Mary Warnock’s role leading her namesake committee in the UK during the 1980s to show how bioethics gained traction and became institutionalized in Britain. British bioethics responded to concerns that were different from those in the US, particularly the need to exert external oversight and scrutiny of scientific activities. Wilson’s account suggests that this oversight was necessary for research to continue.

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.

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.

New Beginnings

In Experiments in Democracy, Observatory Co-Director Ben Hurlbut traces a history of the American debates, forms of reasoning, norms, and institutional struggles that have faced the moral status of the human embryo and justified its use for research purposes. In the first chapter, he examines the ethics and politics of reproductive rights and research in the US, from the mid-1960s to 1980.

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.

The Embryo Research Debate: Science and the Politics of Reproduction

This book provides an account of the events and public debate that took place between the commissioning of the Warnock Committee in 1982, to the 1990 passage of legislation that approved embryo research under certain conditions. In the 1980s, Britain experienced lively debates about whether human embryo research should be permitted and even considered a complete ban. The book traces the efforts of groups with different ideological and moral commitments to determine the future of embryo research in the UK, from initial mistrust and disapproval to permissibility.

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.