Recent Developments in the Regulation of Heritable Human Genome Editing.

In 2018, the Chinese scientist He Jiankui presented his research at the Second International Summit on Human Genome Editing in Hong Kong. While it was intended that he facilitate a workshop, he was instead called on to present his research in heritable human genome editing, where he made the announcement that he had taken great strides in advancement of his research, to the extent that he had gene-edited human embryos and that this had resulted in the live births of two children. While his research ethic and methodology was interrogated, he insisted that two children, twin girls, had been born healthy and that there was another pregnancy (at the time) where birth of a third gene edited child would be imminent. This announcement generated a ripple effect in the scientific community and exposed the gaps in regulation and absence of law relating to the technology. This resulted in a flurry of activity and conversation around regulation of the technology, which scientists stated was not ready for human trials. This article reviews the Third Summit which was held in London in March 2023 and comments on the latest developments in the regulation of heritable human genome editing.

A critical view on using "life not worth living" in the bioethics of assisted reproduction.

This paper critically engages with how life not worth living (LNWL) and cognate concepts are used in the field of beginning-of-life bioethics as the basis of arguments for morally requiring the application of preimplantation genetic diagnosis (PGD) and/or germline genome editing (GGE). It is argued that an objective conceptualization of LNWL is largely too unreliable in beginning-of-life cases for deriving decisive normative reasons that would constitute a moral duty on the part of intending parents. Subjective frameworks are found to be more suitable to determine LNWL, but they are not accessible in beginning-of-life cases because there is no subject yet. Conceptual and sociopolitical problems are additionally pointed out regarding the common usage of clear case exemplars. The paper concludes that a moral requirement for the usage of PGD and GGE cannot be derived from the conceptual base of LNWL, as strong reasons that can be reliably determined are required to limit reproductive freedom on moral grounds. Educated predictions on prospective well-being might still be useful regarding the determination of moral permissibility of PGD and/or GGE. It is suggested that due to the high significance of subjective experience in the normativity of beginning-of-life bioethics, the discipline is called to more actively realize the inclusion of people with disabilities. This regards for instance research design, citation practices, and language choices to increase the accessibility of societal debates on the reproductive ethics of genetic technologies.

Shadowed by past, gene-editing summit looks to future.

London meeting touts sickle cell success, but questions about embryo editing linger.

China sets new ethics rules for human studies.

Revised regulations follow controversy over work that created genetically edited babies.

Public views on polygenic screening of embryos.

Understanding moral acceptability and willingness to use is crucial for informing policy.

Kazuto Kato: the ethics of editing humanity.

Gary Humphreys talks to Kazuto Kato about the ethical and societal challenges posed by biotechnologies that allow for the editing of the human genome.

A virtual deliberative public engagement study on heritable genome editing among South Africans: Study protocol.

This article outlines the protocol for a prospective study for virtual deliberative public engagement on heritable genome editing in humans. The study intends to create a platform for a diverse group of 25-30 South Africans to engage with a facilitator and each other on 15 policy questions regarding heritable genome editing, with a focus on: a) the prevention of heritable genetic conditions; b) editing for immunity; and c) editing for enhancement. The aim is to understand the views on these issues so as to inform further research and policy, and to analyse the process and effect of deliberation on opinion. Participants will be expected to study the provided resource materials and pass the entrance exam-aligning with the protocols of the Harvard Personal Genome Project. In this way, the commitment, openness and basic knowledge of the candidates will be tested to ascertain whether they are suitable participants for the deliberative engagement.

Ethics and regulatory considerations for the clinical translation of somatic cell human epigenetic editing.

Altering the human epigenome with gene-editing technology in attempt to treat a variety of diseases and conditions seems scientifically feasible. We explore some of the ethical and regulatory issues related to the clinical translation of human epigenetic editing arguing that such approaches should be considered akin to somatic therapies.

How the gene-editing in medicine and public health practice could stand the test of bioethics / De qué forma la tecnología de edición génica en medicina y salud pública puede ser aceptada al someterse a la reflexión bioética / Como a edição de genes na prática médica e de saúde pública poderia apoiar o teste da bioética

Abstract: 13. In recent years, gene editing is increasingly used as one of the technical means to solve public health problems. The great progress made in the field of life science and gene-editing technology has made it possible for humans to control and alter human physiological characteristics through gene-editing technology and created a broad application prospect for this technology. However, gene-editing technology has faced with many significant ethical risks, and human gene editing experiments have been banned for a long time in the past. Realistic technological breakthroughs and the emergence of real cases force the ethics circle to re-examine this issue. Through the analysis and trade-off of the potential benefits and ethical risks of human gene-editing technology, it can be found that different applications of human gene editing for different purposes are considered to have different acceptability. Among them, human gene editing for medical purposes has no fundamental moral barriers, human gene editing for purposes of enhancement cannot be allowed by ethics and reality in the current social environment, and human gene editing for purposes of transformation fundamentally violates ethical norms. Therefore, gene editing can be allowed if it is only used to solve human medical and public health problems.

Resumen: 17. En años recientes, se usa cada vez más la edición génica como medio técnico para resolver problema de salud pública. El gran progreso realizado en el campo de las ciencias de la vida y la tecnología de edición génica ha hecho posible que el ser humano controle y altere las características fisiológicas humanas, usando esta tecnología y abriéndose una amplia perspectiva de aplicación. Sin embargo, esta tecnología enfrenta problemas éticos significativos, y los experimentos de edición génica en humanos han sido prohibidos por mucho tiempo en el pasado. Los avances tecnológicos realistas y la emergencia de casos reales ejerce presión sobre el círculo de reflexión ética para volver a examinar el tema. Mediante el análisis y balance de los potenciales beneficios y riesgos éticos de la tecnología de edición génica, se puede encontrar que las diferentes aplicaciones de ésta tecnología, para propósitos diferentes, tienen distinta aceptabilidad. Entre ellos, el uso de edición génica para propósitos médicos no tiene barreras morales fundamentales; la edición génica humana para propósitos de mejoramiento no debería permitirse en la realidad social actual, y la edición génica humana para propósitos de transformación viola fundamentalmente las normas éticas. Por lo tanto, la edición génica podría permitirse solamente para resolver problemas médicos y de salud pública en humanos.

Resumo: 21. Em anos recentes, a edição de genes é cada vez mais usada como um recurso técnico para resolver problemas de saúde pública. O grande progresso feito no campo das ciências da vida e da tecnologia de edição de genes tornou possível para os humanos controlarem e alterarem as características fisiológicas humanas através da tecnologia da edição de genes e criou uma ampla perspectiva de aplicação para esta tecnologia. Entretanto, a tecnologia de edição de genes enfrentou muitos riscos éticos significativos e os experimentos de edição de genes humanos foram banidos por muito tempo no passado. Avanços tecnológicos realísticos e a emergência de casos reais forçaram o círculo ético a reexaminar esta questão. Através da análise e do equilíbrio entre os benefícios potenciais e riscos éticos da tecnologia de edição de genes humanos, pode ser encontrado que diferentes aplicações da edição de genes humanos para diferentes propósitos são consideradas ter diferentes aceitações. Dentre elas, a edição de genes humanos com objetivos médicos não tem barreiras morais fundamentais, edição de genes humanos objetivando aprimoramento não pode ser permitida pela ética e realidade do ambiente social atual, e edição de genes humanos objetivando transformação fundamentalmente viola normas éticas. Portanto, edição de genes pode ser permitida somente se usada para resolver problemas médicos humanos e de saúde pública.

What we know about effective public engagement on CRISPR and beyond.

Advances in gene editing technologies for human, plant, and animal applications have led to calls from bench and social scientists, as well as a wide variety of societal stakeholders, for broad public engagement in the decision-making about these new technologies. Unfortunately, there is limited understanding among the groups calling for public engagement on CRISPR and other emerging technologies about 1) the goals of this engagement, 2) the modes of engagement and what we know from systematic social scientific evaluations about their effectiveness, and 3) how to connect the products of these engagement exercises to societal decision or policy making. Addressing all three areas, we systematize common goals, principles, and modalities of public engagement. We evaluate empirically the likely successes of various modalities. Finally, we outline three pathways forward that deserve close attention from the scientific community as we navigate the world of Life 2.0.