Following the Second Summit on Human Gene Editing in Hong Kong in 2018, where the birth of two girls with germline genome editing was revealed, the need for a responsible pathway to the clinical application of human germline genome editing has been repeatedly emphasised. This paper aims to contribute to the ongoing discussion on research ethics issues in germline genome editing by exploring key issues related to the initial applications of CRISPR in reproductive medicine. Following an overview of the current (...) discussion on bringing germline genome editing into clinical practice, we outline the specific challenges associated with such interventions and the features that distinguish them from conventional clinical testing of new medical treatments. We then review proposed ethical requirements for initial heritable genome editing, such as the absence of reasonable alternatives, the existence of sufficient and reliable preclinical data, appropriate informed consent, requirements related to safety, and long-term follow-up. (shrink)

Bayefsky and Berkman argue in favor of evidence-based policy development for expanded prenatal genetic testing. They propose to identify what kinds of information pregnant persons, their par...

One of the most prominent justifications for the use of germline gene editing (GGE) is that it would allow parents to have a “genetically related child” while preventing the transmission of genetic disorders. However, we argue that since future uses of GGE may involve large-scale genetic modifications, they may affect the genetic relatedness between parents and offspring in a meaningful way: Due to certain genetic modifications, children may inherit much less than 50% of their DNA from each parent. We show (...) that the reduction in genetic relatedness between parents and offspring has three important social and legal implications. First, the desire for a genetically related child may end up not being the strong justification it is currently thought to be for the use of GGE. Second, prospective parents may be reluctant to use GGE because of a potential loss of genetic relatedness. Third, in some jurisdictions, parents who would not pass on “enough” DNA to their child may not be recognized as the child's legal parents. We further argue that the reduction in genetic relatedness challenges current conceptions of genetic parenthood that rely on the quantity of DNA shared with the child or on whether the child was directly derived from the parent's genes. We suggest that genetic parenthood should instead be determined based on the nature of the genetic modifications and whether the child's numerical identity has been preserved after the editing process. (shrink)

Should we use human germline genome modification only when serious diseases are involved? This belief is the underlying factor in the article written by Kleiderman, Ravitsky and Knoppers to which I now respond. In my opinion, the answer to this question should be negative. In this paper, I attempt to show that there are no good reasons to think that this technology should be limited to serious diseases once it is sufficiently proven to be safe and efficient. In fact, opting (...) otherwise would negatively harm human beings’ right to the highest standard of health that unmodified embryos could promote. Therefore, the issue should not be so much to define adequately what a serious disease is, but rather to elucidate whether this concept should play any role beyond the context of preimplantation genetic testing. This paper argues that we should not accept the similarity between technologies such as PGT and HGGM because they face different challenges and offer totally different possibilities. Therefore, we are in urgent need to build a completely new ethical architecture that covers the application of germline editing in human embryos. As a part of that process, a much deeper debate on the necessity of distinguishing different disease types is required. (shrink)

In "Implementing Expanded Prenatal Genetic Testing: Should Parents Have Access to Any and All Fetal Genetic Information?," Bayefsky and Berkman argue in favor of establishing three categorie...

In this reply, we wish to defend our original position and address several of the points raised by two excellent responses. The first response questions the relevance of the notion of ‘serious’ within the context of human germline genome modification. We argue that the ‘serious’ factor is relevant and that there is a need for medical and social lenses to delineate the limits of acceptability and initial permissible applications of HGGM. In this way, ‘serious’ acts as a starting point for (...) further discussions and debates on the acceptability of the potential clinical translation of HGGM. Therefore, there is a pressing need to clarify its scope, from a regulatory perspective, so as to prevent individuals from using HGGM for non-therapeutic or enhancement purposes. The second response criticizes the narrow interpretation of the objectivist approach and the apparent bias towards material innovations when discussing the right to benefit from scientific advancements. As an in-depth discussion of the objectivist and constructivist approaches was beyond the scope of our original paper, we chose to focus on one specific objectivist account, one which focuses on biological and scientific facts. We agree, however, with the critique that material innovations should not be the sole focus of the right to benefit from scientific advancements, which also incorporates freedom of scientific research and access to scientific knowledge scientific freedom and knowledge, including the influence of these on ethical thinking and cultures. (shrink)

Human evolution sits at several important thresholds. In organic evolution, interplay between exogenous environmental and genetic factors rendered new phenotypes at rates limited by genetic variation. The interplay took place on adaptive fitness landscapes determined by correspondence of genetic and environmental relationships. Human evolution involved important emergences that altered the adaptive landscape: language, writing, organized societies, science, and the internet. These endogenous factors ushered in transformative periods leading to more rapidly evolving emergences. I explore the impact of development of emerging (...) biotransformative technologies capable of being applied to effect self-genetic modification and artificial intelligence-augmented cognition on the evolutionary landscape of phenotypes important to cognitive plasticity. Interaction effects will yield unanticipated emergences resulting in hyperrealm adaptive landscapes with more rapid evolutionary processes that feed back upon more fundamental levels while vastly outpacing organic evolution. Emerging technologies exist that are likely to impact the evolution of cognitive plasticity in humans in ways and at rates that will lead to societal upheaval. I show that the theoretical contribution of organic evolution in future human evolution is expected to become comparatively insignificant relative to that made by endogenous environmental factors such as external cognition aids and manipulation of the human genome. The results support the conclusion of a strong recommendation of a moratorium on the adoption of any technology capable of completely altering the course of human evolution. (shrink)

In their paper ‘The “serious” factor in germline modification’, Kleiderman, Ravitsky and Knoppers rightly highlight the ambiguity in the oft-utilised term ‘serious’ in legal discussions of human germline genome modification.1 They suggest interpretation of this term may benefit from a framework based on human rights rather than solely objectivist or constructivist frameworks. In this response, I show the authors provide a narrow and hasty dismissal of objectivist frameworks by defining objectivism broadly as ‘based on biological facts’ early on but later (...) criticising genetic treatment lists, a single narrow implementation of only some of the facts. Furthermore, I will show their consideration of the right to science is biassed towards the material innovations of science, the authors succeed in recognising but fail in elaborating on the knowledge gained from scientific progress; knowledge which may ultimately update moral intuitions and change the nature of ethical conversation across cultures. (shrink)