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In response to calls for public engagement on human genome editing (HGE), which intensified after the 2018 He Jiankui scandal that resulted in the implantation of genetically modified embryos, we detail an anticipatory approach to the governance of HGE. By soliciting multidisciplinary experts' input on the drivers and uncertainties of HGE development, we developed a set of plausible future scenarios to ascertain publics values—specifically, their hopes and concerns regarding the novel technology and its applications. In turn, we gathered a subset of multidisciplinary experts to propose governance recommendations for HGE that incorporate identified publics' values. These recommendations include: (1) continued participatory public engagement; (2) international harmonization and transparency of multiple governance levers such as professional and scientific societies, funders, and regulators; and (3) development of a formal whistleblower framework. [ABSTRACT FROM AUTHOR]

Precision medicine has evolved from the application of pharmacogenetic biomarkers to the prospective development of targeted therapies in patients with specific molecular/genetic subtypes of disease to truly "N‐of‐1" medicines targeted to very small numbers of patients – in some cases, a single identified patient. This latter iteration of precision medicine presents unprecedented opportunities for patients with severe, life‐threatening, or life‐limiting diseases. At the same time, these modalities present complex scientific, clinical, and regulatory challenges. To realize the promise of individualized medicines, a multistakeholder approach to streamlining medical diagnoses, advancing the technologies that enable development of these therapeutic modalities, and re‐envisioning collaborative environments for access and evidence generation is of critical importance. Herein, we highlight some of these challenges and opportunities. [ABSTRACT FROM AUTHOR]

The use of nonhuman animals in research has long been a source of bioethical and scientific debate. We consider the oversight and use of nonhuman animals in chimeric research. We conducted interviews with twelve members of embryonic stem cell research oversight committees, nine members of institutional animal care and use committees, and fourteen scientists involved in human–nonhuman‐animal chimeric research in different areas of the United States. Interviews addressed animal welfare and conceptual issues associated with moral status and humanization of nonhuman animals that contain human cells. Our findings suggest that concepts of enhanced moral status and consciousness are not very useful in human–nonhuman‐animal chimeric research in part because their meanings are not easily defined, which presents challenges to applying the concepts in research. Instead, scientists and oversight committee members we interviewed seemed to rely on standard assessments of changes in animal welfare when focusing on the ethics of human‐animal chimeric research. [ABSTRACT FROM AUTHOR]

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human‐nonhuman chimeric research. Led by bioethics researchers working closely with an interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human‐nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics' previous focus on human‐centered questions about the ethics of "humanization" and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less‐siloed governance and oversight and more‐comprehensive public communication. [ABSTRACT FROM AUTHOR]

Letter to the Editor [ABSTRACT FROM AUTHOR]

International discussion must guide research, urge Nicolas Rivron, Martin Pera and colleagues. International discussion must guide research, urge Nicolas Rivron, Martin Pera and colleagues. [ABSTRACT FROM AUTHOR]

The National Institutes of Health (NIH) is poised to lift its funding moratorium on research involving chimeric human/nonhuman embryos, pending further consideration by an NIH steering committee. The kinds of ethical concerns that seem to underlie this research and chimera research more generally can be adequately addressed. [ABSTRACT FROM AUTHOR]

A timely and thoughtful discussion of the ethical challenges and societal impacts presented by the recent reports demonstrating the successful in vitro generation of functional gametes from somatic and pluripotent stem cells. [ABSTRACT FROM AUTHOR]

This paper discusses exceptional circumstances under which patients outside of clinical trials are likely to receive innovative stem cell-based interventions. These circumstances involve: (1) stem cell interventions not initially amenable to a clinical trials approach; (2) expanded access to investigational stem cell products (“compassionate use”); and (3) off-label uses of FDA approved stem cell products. This paper proposes a new approach to regulating these exceptional cases. [ABSTRACT FROM AUTHOR]

In this article, authors discuss various aspects of induced pluripotent stem cells (iPSCs) research and research ethics regulations that resulted due to controversies associated with human embryonic stem cells. Potential policy challenges associated with iPSC work in different countries including Canada, Japan and Great Britain are discussed. A table highlighting several common themes in among iPSC research regulating policies, is also presented.

Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a 'patchwork of patchworks'. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application. [ABSTRACT FROM AUTHOR]

Research suggests that cloning is incapable of producing a viable embryo when it is used on primate eggs. In fact, the entity created may not qualify as an embryo at all. If the results stand, cloning avoids the moral objections typically lodged against it, and cloning is itself an "alternative source" of stem cells. [ABSTRACT FROM AUTHOR]

The article discusses issues concerning the advances in human somatic cell nuclear transfer for stem cell research in South Korea. The donation consent procedures is detailed. It is mentioned that the informed consent procedure for somatic cell donation similarly was designed to protect the liberty interests and well-being of prospective cell donors.

To be autonomous, a person must also have authentic moral values. She must act on her own values, not on values that were improperly pressed upon her. To respect a patient's autonomy, then, a caregiver must do more than carry out her requests. The caregiver must honor the patient's authentic requests. But how to do that? [ABSTRACT FROM AUTHOR]

Research that uses stem cell‐based chimeras promises to advance our understanding of human developmental biology, as well as new medical interventions, such as generating transplantable human organs in livestock. However, along with these exciting research possibilities come moral concerns about the moral humanization of animals, especially when it comes to the potential effects of human cells in the brains of experimental animals. Recent work involving neurologically chimeric mice may suggest that such worries are reasonable. However, this overlooks the crucial social and neurological conditions for enabling the development of conscious self‐awareness, the absence of which leaves us only with animal welfare to monitor and consider. [ABSTRACT FROM AUTHOR]

This corrects the article DOI: 10.1038/nbt.4015 [ABSTRACT FROM AUTHOR]

The author reflects on the need to adopt measures to govern the generation of human embryos made for research by the U.S. as of may 2014. Topics discussed include production of domestic animals via embryo-cloning technique called somatic-cell nuclear transfer (SCNT), regulatory oversight for the reproductive cloning by the U.S. Food and Drug Administration (FDA) and declaration of creating embryos for research as criminal offense in Germany and Canada.

The authors discuss the article "The argument from potentiality in the embryo protection debate: Finally 'depotentialized'?" by M. S. Stier and B. Schoene-Seifert from the volume 13 number 1, 2013 issue, which looks at the potentiality argument (PA) of the moral status of human embryo cells. Topics include tetraploid complementation assays using human induced pluripotent stem cells, cell differentiation of human and mouse stem cells, and the role of implantation in embryonic development.

The article reports a study on human pluripotent stem cells with the use of somatic cells and oocytes wherein it explores fertilized embryos without ethical concerns.

The author argues that women who donate their eggs for stem-cell research should be compensated in the same way as other healthy research volunteers. It was stated that there is a strong and presumptive reason to compensate healthy women who provide oocytes for basic research. Stem-cell banks rely on ocyte donations to further embryonic stem-cell research.