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).

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.

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.

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.

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.

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.