Ethics and Global Governance of Human Germline Genome Editing: The Problem of Techno-Scientific Colonialist Paternalism.

I want to enrich the debate about the ethics and governance of human germline editing (HGE) by emphasizing an underappreciated, yet important, set of concerns regarding exclusionary practices, norms, and efforts that impede a broader discussion about the subject. The possibility for establishing a binding, global, regulatory framework is influenced by economic and geopolitical factors as well as historical processes and sociopolitical problems, such as anti-scientific social movements and the politicization of science. Likewise, it is influenced by different understanding, epistemic resources, and goals between the CRISPR/genome editing community and the rest of society. In this Perspective, I explain the concept of "techno-scientific colonialist paternalism" and why it negatively affects our discussion around HGE. I also discuss the pitfalls of scientific self-regulation, and finally, I advocate that the implementation of HGE should cease to allow time and care for a thoughtful global discussion to emerge.

Systematic scoping review of the concept of 'genetic identity' and its relevance for germline modification.

EU legislation prohibits clinical trials that modify germ line 'genetic identity'. 'Genetic identity' however, is left undefined. This study aims to identify the use of the term 'genetic identity' in academic literature, and investigate its relevance for debates on genetic modification. A total of 616 articles that contained the term were identified. Content analysis revealed that the term was used in various and contradicting ways and a clear understanding of the term is lacking. This review demonstrates that the EU legislation is open to interpretation, because of the diversity of meaning with which 'genetic identity' is currently used. Because of the diversity of meaning with which 'genetic identity' is used and understood, further reflection is needed. This requires further medical, legal, ethical and social debate and a coordinated response at both a European and a global level.

The Wisdom of Germline Editing: An Ethical Analysis of the Use of CRISPR-Cas9 to Edit Human Embryos.

With recent reports that a Chinese scientist used CRISPR-Cas9 to heritably edit the genomes of human embryos (i.e., germline editing) brought to term, discussions regarding the ethics of the technology are urgently needed. Although certain applications of germline editing have been endorsed by both the National Academy of Sciences (US) and the Nuffield Council (UK), this paper explores the ethical concerns related even to such therapeutic uses of the technology. Additionally, this paper questions whether the technology could ever feasibly be contained to the therapeutic realm. Consequently, this paper necessarily considers the ethical concerns related to enhancement uses of the technology even if only therapeutic applications are initially considered. In light of the concomitant risks, this paper assesses the technology's countervailing benefits to conclude they do not prevail given that similar outcomes can largely be achieved with existing technologies. Consequently, this paper recommends an international ban on germline editing.

Getting serious about the challenge of regulating germline gene therapy.

The announcement of He Jiankui's germline editing of human embryos has been followed by a torrent of almost universal criticism of the claim on scientific and ethical grounds. That criticism is warranted. There is little room for anything other than vociferous condemnation of He's announcement. Presenting the results of groundbreaking work by press conference and YouTube is not science. The issue now is not whether the work supporting the claims reported from China was done in an ethical manner. It was not. What is required to move forward is a justification for doing germline editing in humans. Many think there is none, and prohibitions abound. If such work is justifiable, a serious, rigorous framework must be imposed that insures that such research is done following the highest ethical standards that both protect human subjects and insure public trust and support.

Gene-edited babies: What went wrong and what could go wrong.

During the second World Summit of Human Gene Editing, Jiankui He presented the gene-editing project that led to the birth of two baby girls with man-made C-C chemokine receptor type 5 (CCR5) mutations. This extremely irresponsible behavior violated the ethical consensus of scientists all over the world. His presentation revealed a troubling lack not only of basic medical ethics but also of the requisite understanding of genetics and gene editing. Here, we review the rationale and design of his experiment along with the presented data, and provide our scientific criticism of this misconduct.

Germline Interventions in Humans - Challenges for Law and Ethics / Intervenciones en línea germinal en seres humanos: desafíos para el Derecho y la Ética

The discovery of new methods of genetic engineering has revolutionized genetic research and opens up new ways of gene therapies. The molecular tool known as CRISPR/Cas9 in particular allows researchers to alter the human genome with unprecedented precision. This new method is referred to as "genome editing," since the procedure is reminiscent of the correction of a text: "false" letters of the DNA can simply be replaced. Due to the precision and the simple application of this method, the focus is now on a field of application that was previously considered an absolute taboo: germline interventions. Any interference with the human germline causes the corresponding genetic changes to be passed on from generation to generation. The issue is highly controversial, and the arguments for and against interventions are diverse. Their proponents argue that future descendants will thus be freed from serious genetic diseases. Opponents, on the other hand, believe that this path must always remain off limits in order to prevent the conception of "designer children." It is clear that such interventions should not yet take place at the moment: more research is needed in order to allow for a more precise risk-benefit-assessment. In fact, the research community seemed to agree that the techniques are not yet sufficiently developed. However, the rumoured birth of two genetically modified children in China at the end of November 2018 shows that such a consensus either does not exist or, at least, that we cannot trust rely on all researchers acting in accordance with the scientific consensus. This news therefore highlights yet again how urgently we must discuss the issue: it is high time, also given the possibility of rapid improvements in the techniques' safety, to deliberate on the justifiability of germline interventions and to set clear limits. This article is intended to contribute to this debate and to sketch the main arguments

The discovery of new methods of genetic engineering has revolutionized genetic research and opens up new ways of gene therapies. The molecular tool known as CRISPR/Cas9 in particular allows researchers to alter the human genome with unprecedented precision. This new method is referred to as "genome editing," since the procedure is reminiscent of the correction of a text: "false" letters of the DNA can simply be replaced. Due to the precision and the simple application of this method, the focus is now on a field of application that was previously considered an absolute taboo: germline interventions. Any interference with the human germline causes the corresponding genetic changes to be passed on from generation to generation. The issue is highly controversial, and the arguments for and against interventions are diverse. Their proponents argue that future descendants will thus be freed from serious genetic diseases. Opponents, on the other hand, believe that this path must always remain off limits in order to prevent the conception of "designer children." It is clear that such interventions should not yet take place at the moment: more research is needed in order to allow for a more precise risk-benefit-assessment. In fact, the research community seemed to agree that the techniques are not yet sufficiently developed. However, the rumoured birth of two genetically modified children in China at the end of November 2018 shows that such a consensus either does not exist or, at least, that we cannot trust rely on all researchers acting in accordance with the scientific consensus. This news therefore highlights yet again how urgently we must discuss the issue: it is high time, also given the possibility of rapid improvements in the techniques' safety, to deliberate on the justifiability of germline interventions and to set clear limits. This article is intended to contribute to this debate and to sketch the main arguments

The ethics of clinical applications of germline genome modification: a systematic review of reasons.

STUDY QUESTION: What are the reasons for or against the future clinical application of germline genome modification (GGM)? SUMMARY ANSWER: A total of 169 reasons were identified, including 90 reasons for and 79 reasons against future clinical application of GGM. WHAT IS KNOWN ALREADY: GGM is still unsafe and insufficiently effective for clinical purposes. However, the progress made using Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)- CRISPR-associated system (Cas) has led scientists to expect to overcome the technical hurdles in the foreseeable future. This has invited a debate on the socio-ethical and legal implications and acceptability of clinical applications of GGM. However, an overview of the reasons presented in this debate is missing. STUDY DESIGN, SIZE, DURATION: MEDLINE was systematically searched for articles published between January 2011 and June 2016. Articles covering reasons for or against clinical application of intentional modification of the nuclear DNA of the germline were included. PARTICIPANTS/MATERIALS, SETTING, METHODS: Two researchers independently extracted the reported reasons from the articles and grouped them into categories through content analysis. MAIN RESULTS AND THE ROLE OF CHANCE: The systematic search yielded 1179 articles and 180 articles were included. Most papers were written by professionals in ethics, (science) journalism and biomedical sciences. Overall, 169 reasons were identified, including 90 reasons for, and 79 reasons against future clinical application of GGM. None of the included articles mentioned more than 60/169 reasons. The reasons could be categorized into: (i) quality of life of affected individuals; (ii) safety; (iii) effectiveness; (iv) existence of a clinical need or alternative; (v) costs; (vi) homo sapiens as a species (i.e. relating to effects on our species); (vii) social justice; (viii) potential for misuse; (ix) special interests exercising influence; (x) parental rights and duties; (xi) comparability to acceptable processes; (xii) rights of the unborn child; and (xiii) human life and dignity. Considerations relating to the implementation processes and regulation were reported. LIMITATIONS, REASONS FOR CAUTION: We cannot ensure completeness as reasons may have been omitted in the reviewed literature and our search was limited to MEDLINE and a 5-year time period. WIDER IMPLICATIONS OF THE FINDINGS: Besides needing (pre)clinical studies on safety and effectiveness, authors call for a sound pre-implementation process. This overview of reasons may assist a thorough evaluation of the responsible introduction of GGM. STUDY FUNDING/COMPETING INTEREST(S): University of Amsterdam, Alliance Grant of the Amsterdam Reproduction and Development Research Institute (I.D.), and Clinical Center, Department of Bioethics, National Institutes of Health Intramural Research Program (S.H.). There are no competing interests.

Edición genómica. La hora de la reflexión / Gene editing. Time to reflection

La aparición de nuevas tecnologías de edición genómica y sus especiales características han propiciado un amplio debate sobre la conveniencia y el alcance de su utilización tanto en especies vegetales y animales como en la propia especie humana. Se realiza un breve análisis de los argumentos utilizados así como un resumen de algunos de los posicionamientos más relevantes al respecto

The development of new gene editing technologies and their special characteristics have led to a passionate debate on the suitability and reliability of their use both in plant and animal species and in the human species itself. A brief analysis of the arguments used in this debate as well as a summary of some of the most relevant statements in this regard is made