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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.

The International Society for Stem Cell Research has updated its Guidelines for Stem Cell Research and Clinical Translation in order to address advances in stem cell science and other relevant fields, together with the associated ethical, social, and policy issues that have arisen since the last update in 2016. While growing to encompass the evolving science, clinical applications of stem cells, and the increasingly complex implications of stem cell research for society, the basic principles underlying the Guidelines remain unchanged, and they will continue to serve as the standard for the field and as a resource for scientists, regulators, funders, physicians, and members of the public, including patients. A summary of the key updates and issues is presented here.

Stem cells can be coaxed to self-organize into dynamic models of human development and early embryo formation. Despite their scientific promise, might widespread use of these technologies alter people's beliefs about what it means to be a human individual? Attention to some important philosophical distinctions may help navigate our thinking. [ABSTRACT FROM AUTHOR]

The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them.

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]

Brain organoids have emerged in recent years as a powerful new tool for neuroscience research. Unfortunately, the promise of this tool has been muddied by misplaced fear and hype, born [...]

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]

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]

Discussion of the bioethics of human stem cell research has transitioned from controversies over the source of human embryonic stem cells to concerns about the ethical use of stem cells in basic and clinical research. Key areas in this evolving ethical discourse include the derivation and use of other human embryonic stem cell-like stem cells that have the capacity to differentiate into all types of human tissue and the use of all types of stem cells in clinical research. Each of these issues is discussed as I summarize the past, present, and future bioethical issues in stem cell research., The main bioethical issues associated with human stem cells involve their derivation and use for research. Although there are interesting ethical issues surrounding the collection and use of somatic (adult) [...]

Author(s): Insoo Hyun (corresponding author) [1] After more than a decade of controversy, the United States is nudging towards approving research on human-animal embryos. Last week, the National Institutes of [...]

Author(s): Insoo Hyun (corresponding author) [1] Experiments in Democracy: Human Embryo Research and the Politics of Bioethics J. Benjamin Hurlbut Columbia University Press: 2017. One of the most celebrated paintings [...]

Three independent research teams have now used cloning technology to make human embryonic stem cells carrying the genomes of existing people. The first announcement, using genomes from fetal and infant [...]

The search for a better animal model to simulate human disease has been a "holy grail" of biomedical research for decades. Recent identification of different types of pluripotent stem (PS) cells and advances in chimera research might soon permit the generation of interspecies chimeras from closely related species, such as those between humans and other primates. In this study, we suggest that the creation of human–primate chimeras—specifically, the transfer of human stem cells into (non-ape) primate hosts—could not only surpass the limitations of current monkey models of neurological and psychiatric disease but would also raise important ethical considerations concerning the use of monkeys in invasive research. Questions regarding the scientific value and ethical concerns raised by the prospect of human–monkey chimeras are more urgent in light of recent advances in PS cell research and attempts to generate interspecies chimeras between humans and animals. While some jurisdictions prohibit the introduction of human PS cells into monkey preimplantation embryos, other jurisdictions may permit and even encourage such experiments. Therefore, it is useful to consider blastocyst complementation experiments more closely in light of advances that could make these chimeras possible and to consider the ethical and political issues that are raised. [ABSTRACT FROM AUTHOR]

The article presents the discussion on guidelines for stem cell and embryo research after the first successful birth resulting from in vitro fertilization (IVF). Topics include prohibiting scientists from culturing embryos for research beyond 14 consecutive days; fetal research restrictions in utero upon a definition of the fetus as a product of conception implanted in the womb; and using embryo model systems thereby reducing the number of IVF-derived embryos needed in the future.

To the Editor: William Hurlbut and colleagues have offered what they take to be a definitive account of altered nuclear transfer (ANT) ('Seeking Consensus: A Clarification and Defense of Altered [...]

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]