Reactions to the National Academies/Royal Society Report on Heritable Human Genome Editing.

In September 2020, a detailed report on Heritable Human Genome Editing was published. The report offers a translational pathway for the limited approval of germline editing under limited circumstances and assuming various criteria have been met. In this perspective, some three dozen experts from the fields of genome editing, medicine, bioethics, law, and related fields offer their candid reactions to the National Academies/Royal Society report, highlighting areas of support, omissions, disagreements, and priorities moving forward.

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

The ability to make direct genetic changes to the DNA of future children poses profound challenges for governance. Over the last several years, efforts to establish frameworks of ethical deliberation and governance for human genome editing have focused largely on technical criteria for proceeding with research and rules and mechanisms for regulating it. Less attention has been given to the question of who decides, and on the basis of what authority. The power to decide is exercised not only in giving answers to ethical questions or suppling policy advice, but in designating what questions should (and should not) be asked in the first place. The ways problems are framed and terms of collective debate are set is a crucial element of governance. This essay examines how certain framings that have dominated in influential arenas of deliberation about human germline genome editing underwrite (false) imperatives of governance. These imperatives have shaped not only ethical deliberation and governance agendas, but the trajectory of science itself. The essay focuses in particular upon the case of He Jiankui, arguing that his project is not an aberration, but, rather, an expression of ideas about science, ethics, and progress that are widely shared within the scientific community.

Democratic Governance of Human Germline Genome Editing.

An international regulatory commission convened by scientific academies is a premature and problematic approach to governing human germline genome editing. Given the complex, international landscape of genome editing and significant cross-national differences among regulatory cultures, deferring to a single commission to set the agenda for global governance raises troublesome questions of framing and representation. Rather, democratic governance on a global level demands a new mechanism for active, sustained reflection by scientists on their own practices, conducted in partnership with scholars from other disciplines, as well as public representatives from varied social, political, and religious backgrounds. To be legitimate, ideas of the right form of governance in this emerging and highly consequential area of research need to be opened up to a wider diversity of views and voices.

The Experts Are Not Enough.

As Achim Rosemann and colleagues rightly suggest in their article "Heritable Genome Editing in Global Context: National and International Policy Challenges," in this issue of the Hastings Center Report, the scientific, ethical, and governance challenges associated with heritable genome editing are global in scope. Both the genetic interventions and the social and moral judgments about human identity and integrity associated with them will affect all humanity. Yet the worries, problems, and solutions that the study illuminates reflect only a partial picture of those challenges. That is to be expected from a study of this sort: the "stakeholders" who were consulted are a limited group and as such are bound to provide a particular, limited picture. One of the important contributions that such a study can make is in providing a picture of what problems particular kinds of experts see as the primary problems and how the framing of those problems may displace other questions and perspectives, especially when such parochial framings of problems are elevated to the level of the "global." Rosemann et al. do not explain how participants were identified as stakeholders or, indeed, how the study identified the stakes. This is a missed opportunity, and it points toward a set of questions that themselves need to be asked about how the stakeholders-and the stakes-of global governance of heritable genome editing are identified.

Response to Beriain.

Professor Beriain's criticism rests on a narrow conception of human dignity pertaining only to individuals within a society. The social relations and norms that underpin human dignity are treated as mere group interests that are secondary to the dignity of the individual. In our view, this is a false dichotomy.

Building Capacity for a Global Genome Editing Observatory: Institutional Design.

A new infrastructure is urgently needed at the global level to facilitate exchange on key issues concerning genome editing. We advocate the establishment of a global observatory to serve as a center for international, interdisciplinary, and cosmopolitan reflection. This article is the second of a two-part series.

Building Capacity for a Global Genome Editing Observatory: Conceptual Challenges.

A new infrastructure is urgently needed at the global level to facilitate exchange on key issues concerning genome editing. We advocate the establishment of a global observatory to serve as a center for international, interdisciplinary, and cosmopolitan reflection. This article is the first of a two-part series.

Erratum: Revisiting the Warnock rule.

This corrects the article DOI: 10.1038/nbt.4015.

A science that knows no country: Pandemic preparedness, global risk, sovereign science.

This paper examines political norms and relationships associated with governance of pandemic risk. Through a pair of linked controversies over scientific access to H5N1 flu virus and genomic data, it examining the duties, obligations, and allocations of authority articulated around the imperative for globally free-flowing information and around the corollary imperative for a science that is set free to produce such information. It argues that scientific regimes are laying claim to a kind of sovereignty, particularly in moments where scientific experts call into question the legitimacy of claims grounded in national sovereignty, by positioning the norms of scientific practice, including a commitment to unfettered access to scientific information and to the authority of science to declare what needs to be known, as essential to global governance. Scientific authority occupies a constitutional position insofar as it figures centrally in the repertoire of imaginaries that shape how a global community is imagined: what binds that community together and what shared political commitments, norms, and subjection to delegated authority are seen as necessary for it to be rightly governed.

Promising waste: biobanking, embryo research, and infrastructures of ethical efficiency.

Biobanks are custodial institutions that enhance the utility and value of biological materials by collecting and curating them. Their custodial functions tend to include ethical oversight and governance. This paper explores how biobanks increase the value of biological materials by standardizing routines of governance in order to engender "ethical efficiency." Focusing in particular upon banking of human embryos for research, the article offers an historical account of how human embryos came to be "waste" available for use by researchers in the US. It offers a case study of a human embryo biobank and the practices of ethical governance that the biobank employs to capture this waste and convert it into a valuable resource for research use. The article draws attention to the ways biobanks' emphasis on efficiency and resolving problems of ethical governance up front codifies otherwise contested normative relationships and authorizes uses of human biological materials that some see as ethically problematic, even as it eliminates institutionalized mechanisms of reflection in which such problems would otherwise be acknowledged and confronted.

Disease modeling using pluripotent stem cells: making sense of disease from bench to bedside.

New advances in human stem cell biology now permit the derivation of disease-specific induced pluripotent (iPS) stem cell lines, so-called "disease-in-a-dish" (DIAD) models. This is a promising approach for the study of disease phenotypes at the cellular and molecular level, both because such human cell lines may produce more faithful experimental models of disease than can be produced using non-human organisms, and because reprogrammed cell lines can provide a virtually infinite supply of cells without requiring additional tissue donation. However, expectations placed on this emerging technology privilege the laboratory over the clinic as the site for making sense of disease, thereby distracting from the socially embedded meanings of disease and reorienting how the goals of medicine are imagined. Here we identify and review the implications of this area of research for clinical approaches to disease. We argue that there is a central place for the larger medical community and patients in the very construction of experimental research programs and the expectations placed thereon. By attending to the constellation of social factors that inform understanding, treatments and experiences of disease, DIAD projects can be more effectively placed in the service of clinical goals, in both their research design and in the forms of innovation they claim to anticipate.