Two problems related to the biological identity of living beings are faced: the who-problem (which are the biological properties making that living being unique and different from the others?); the persistence-problem (what does it take for a living being to persist from a time to another?). They are discussed inside a molecular biology framework, which shows how epigenetics can be a good ground to provide plausible answers. That is, we propose an empirical solution to the who-problem and to the persistence-problem (...) on the basis of the new perspectives opened by a molecular understanding of epigenetic processes. In particular, concerning the former, we argue that any living being is the result of the epigenetic processes that have regulated the expression of its genome; concerning the latter, we defend the idea that the criterion for the persistence of its identity is to be indicated in the continuity of those epigenetic processes. We also counteract possible objections, in particular (1) whether our approach has something to say at a metaphysical level; (2) how it could account for the passage from the two phenotypes of the parental gametes to the single phenotype of the zygote; (3) how it could account for the identity of derivatives of one living being that continue to live disjoined from that original living being; (4) how it could account for higher mental functions. (shrink)

In some views, philosophy’s glory days in bioethics are over. While philosophers were especially important in the early days of the field, so the argument goes, the majority of the work in bioethics today involves the “simple” application of existing philosophical principles or concepts, as well as empirical work in bioethics. Here, we address this view head on and ask: What is the role of philosophy in bioethics today? This paper has three specific aims: (1) to respond to skeptics and (...) make the case that philosophy and philosophers still have a very important and meaningful role to play in contemporary bioethics, (2) to discuss some of the current challenges to the meaningful integration of philosophy and bioethics, and (3) to make suggestions for what needs to happen in order for the two fields to stay richly connected. We outline how bioethics center directors, funders, and philosopher bioethicists can help. (shrink)

The application of genetic editing techniques for the prevention or cure of disease is a highly promising tool for the future of humanity. However, its implementation contains a number of ethical and legal challenges that should not be underestimated. On this basis, some sectors have already asked for a veto on any intervention that modifies the human germ line, while supporting somatic line editing. In this paper, I will support that this suggestion makes no sense at all, because the somatic/germ (...) line disjunctive has no moral relevance and, therefore, it should not play any role in legal terms. I will provide a number of reasons to hold this assumption, such as the non‐sacred nature of the germ line, the difference between germ line and human genome modification, or the moral importance of the presence of a will to create modified descendants. While doing so, I will provide some examples of the different approaches to germ line editing adopted by different regulations so as to demonstrate that, contrary to what is sometimes stated, a general ban on this practice is not the rule, but the exception. Additionally, I will show how alternative options which currently exist, such as a selective ban based on criteria different to the germ line/somatic line distinction, match better with the need to conciliate research needs and legitimate ethical concerns. Finally, I will introduce some further suggestions to this same purpose. (shrink)

The ease and applicability of CRISPR/Cas9––a new and precise gene editing and reproductive technology––have garnered hype and heightened concern about its potential ‘unprecedented and horrific consequences’ and have led many scientific leaders to call for a moratorium on its research and use. CRISPR appears distinctly more controversial than previous technological innovations, with a greater reach and speed of human treatment and enhancement; however, we have seen similarly inflated hopes and fears in response to other medical innovations for well over a (...) century. One intervention that has both historically and recently incited alarm––vaccines––serves as a pertinent example of what could go wrong if a technology's reach is shortened due to inflated fears. By comparing the vaccine controversy and the CRISPR debate, we can help separate the hype from the realistic potential of these technologies. How our society grapples with such innovations will determine the extent to which their impact on our individual and collective health will be beneficial. We must recognise the need for a tempered approach to CRISPR conversation leading to regulation and ethical application. Although CRISPR's reach will continue expanding with ongoing research, thus requiring continuous evaluation, the lessons we have learned from the vaccine controversy demonstrate that our approach must not be to shut down regulation and application now, but to thoughtfully conjoin productive debate and action so that therapeutic gene editing can alleviate suffering as soon as possible without precipitating social outcomes we would belatedly deplore. (shrink)

Although germline editing has been the subject of debate ever since the 1980s, it tended to be based rather on speculative assumptions until April 2015, when CRISPR/Cas9 technology was used to modify human embryos for the first time. This article combines knowledge about the technical and scientific state of the art, economic considerations, the legal framework and aspects of clinical reality. A scenario will be elaborated as a means of identifying key ethical implications of CRISPR/Cas9 genome editing in humans and (...) possible ways of dealing with them. Unlike most other discussions of CRISPR/Cas9 germline editing, which are generally based on deontological arguments, the focus in this case will be on a consequentialistic argument against certain applications of germline and somatic editing that takes not only the potential benefits and risks but also socioeconomic issues into consideration. The practical need for an indication catalogue, guidelines for clinical trials, and for funding of basic research will be pointed out. It will be argued that this need for regulatory action and discussion does not stem primarily from the fact that CRISPR/Cas9 germline editing is revolutionary in terms of its ethical implications and potential for human therapy, although this is the prevailing view in the current discussion. Understanding the value and interest dependency of arguments put forward by different stakeholders and learning from past debates related to similar technologies might prove a fruitful method of reaching judgments and decisions that come closer to a consensus upon which society as a whole can agree - which after all should be the true goal of an ethical debate and of bioethics. (shrink)

Volume 20, Issue 8, August 2020, Page 32-36.

We welcome Blumenthal-Barby’s et al. (2022) plaidoyer for the integration of philosophy in bioethics because of a perceived mutual benefit. Drawing on experience from a collaborative project, funde...

In his insightful review, Eugene V. Koonin discusses various aspects of CRISPR-Cas systems with a strong focus on their qualities as "adaptive immune systems". The CRISPR-Cas system is most famous for its application as a gene-editing tool. Koonin provides a deeper insight into its biological function in bacteria, which is to immunize the cell against parasite DNA. I shall comment on one issue discussed in the text, in two steps. First, I shall elaborate on CRISPR-Cas systems and their supposed Lamarckian (...) character. Criteria for calling biological phenomena genuinely Lamarckian will be narrowed down and then applied to the CRISPR-Cas system, considering interference-driven spacer acquisition as an instantiation of a truly Lamarckian paradigm. Second, I shall consider whether Lamarckian and "canonical" instances of inheritance are a case of theoretical pluralism, being two non-reducible, yet interconnected paradigms. (shrink)

Ever since the publication of Derek Parfit’s Reasons and Persons, bioethicists have tended to distinguish between two different ways in which reproductive technologies may have implications for the...

There are ethical obligations to conduct research that contributes to generalisable knowledge and improves reproductive health, and this should include embryo research in jurisdictions where it is permitted. Often, the controversial nature of embryo research can alarm ethics committee members, which can unnecessarily delay important research that can potentially improve fertility for patients and society. Such delay is ethically unjustified. Moreover, countries such as the UK, Australia and Singapore have legislation which unnecessarily captures low-risk research, such as observational research, in (...) an often cumbersome and protracted review process. Such countries should revise such legislation to better facilitate low-risk embryo research.We introduce a philosophical distinction to help decision-makers more efficiently identify higher risk embryo research from that which presents no more risks to persons than other types of tissue research. That distinction is between future person embryo research and non-future person embryo research. We apply this distinction to four examples of embryo research that might be presented to ethics committees.Embryo research is most controversial and deserving of detailed scrutiny when it potentially affects a future person. Where it does not, it should generally require less ethical scrutiny. We explore a variety of ways in which research can affect a future person, including by deriving information about that person, and manipulating eggs or sperm before an embryo is created. (shrink)

There are ethical obligations to conduct research that contributes to generalisable knowledge and improves reproductive health, and this should include embryo research in jurisdictions where it is permitted. Often, the controversial nature of embryo research can alarm ethics committee members, which can unnecessarily delay important research that can potentially improve fertility for patients and society. Such delay is ethically unjustified. Moreover, countries such as the UK, Australia and Singapore have legislation which unnecessarily captures low-risk research, such as observational research, in (...) an often cumbersome and protracted review process. Such countries should revise such legislation to better facilitate low-risk embryo research. We introduce a philosophical distinction to help decision-makers more efficiently identify higher risk embryo research from that which presents no more risks to persons than other types of tissue research. That distinction is between future person embryo research and non-future person embryo research. We apply this distinction to four examples of embryo research that might be presented to ethics committees. Embryo research is most controversial and deserving of detailed scrutiny when it potentially affects a future person. Where it does not, it should generally require less ethical scrutiny. We explore a variety of ways in which research can affect a future person, including by deriving information about that person, and manipulating eggs or sperm before an embryo is created. (shrink)

The aim of the presentation is to focus on the differences between two scientific contexts: the genetic engineering context of the 1970s, with specific attention paid to the use of the recombinant DNA technique to generate genetically modified molecules, and the current genome editing context, with specific attention paid to the use of CRISPR-Cas9 technology to modify human germ line cells genetically. In both events, scientists have been involved in discussions that have gone beyond mere professional deontology touching on specific (...) policy issues such as freedom of research, responsibility for the consequences of research, the right of the public to participate in the evaluation of the goals of research methods, the relationship between cost and benefit and possible social consequences. The comparison between these two scientific contexts suggests the need of handling such issues by defining procedures that meet the criteria of democracy and responsibility towards society. The underlying objective should be to effectively launch actions and interventions based not on a hierarchical approach but rather a reticular conception of knowledge. (shrink)

CRISPR is widely considered to be a disruptive technology. However, when it comes to the most controversial topic, germline genome editing (GGE), there is no consensus on whether this technology has any substantial advantages over existing procedures such as embryo selection after in vitro fertilization (IVF) and preimplantation genetic diagnosis (PGD). Answering this question, however, is crucial for evaluating whether the pursuit of further research and development on GGE is justified. This paper explores the question from both a clinical and (...) a moral viewpoint, namely whether GGE has any advantages over existing technologies of selective reproduction and whether GGE could complement or even replace them. In a first step, I review an argument of extended applicability. The paper confirms that there are some scenarios in which only germline intervention allows couples to have (biologically related) healthy offspring, because selection will not avoid disease. In a second step, I examine possible moral arguments in favour of genetic modification, namely that GGE could save some embryos and that GGE would provide certain benefits for a future person that PGD does not. Both arguments for GGE have limitations. With regard to the extended applicability of GGE, however, a weak case in favour of GGE should still be made. (shrink)

How epigenetic mechanisms regulate genome output and response to stimuli is a fundamental question in development and disease. Past decades have made tremendous progress in deciphering the regulatory relationships involved by correlating aggregated (epi)genomics profiles with global perturbations. However, the recent development of epigenetic editing technologies now enables researchers to move beyond inferred conclusions, towards explicit causal reasoning, through 'programing’ precise chromatin perturbations in single cells. Here, we first discuss the major unresolved questions in the epigenetics field that can be (...) addressed by programable epigenome editing, including the context‐dependent function and memory of chromatin states. We then describe the epigenetic editing toolkit focusing on CRISPR‐based technologies, and highlight its achievements, drawbacks and promise. Finally, we consider the potential future application of epigenetic editing to the study and treatment of specific disease conditions. (shrink)

Determinations of the ethical acceptability of genetic therapy have relied on several distinctions in attempts to separate ethically acceptable genetic therapy from those possible therapies that could lead to genetic modifications of future human beings. One distinction that has been proposed is that genetic modifications of human somatic cells is ethically acceptable but that Germ-Line genetics modifications would be ethically objectionable. This paper examines several serious difficulties which call into question the ethical relevance of a somatic/Germ-Line distinction.

Determinations of the ethical acceptability of genetic therapy have relied on several distinctions in attempts to separate ethically acceptable genetic therapy from those possible therapies that could lead to genetic modifications of future human beings. One distinction that has been proposed is that genetic modifications of human somatic cells is ethically acceptable but that Germ-Line genetics modifications would be ethically objectionable. This paper examines several serious difficulties which call into question the ethical relevance of a somatic/Germ-Line distinction. Keywords: double effect, (...) future generations, Germ-Line modification CiteULike Connotea Del.icio.us What's this? (shrink)

The bioethical principle of autonomy is problematic regarding the future of the embryo who lacks the ability to self-advocate but will develop this defining human capacity in time. Recent experiments explore the use of clustered regularly interspaced short palindromic repeats /Cas9 for germline engineering in the embryo, which alters future generations. The embryo’s inability to express an autonomous decision is an obvious bioethical challenge of germline engineering. The philosopher Joel Feinberg acknowledged that autonomy is developing in children. He advocated that (...) to reserve this future autonomy, parents should be guided to make ethical decisions that provide children with open futures. Here, Feinberg’s 1980 open future theory is extended to the human embryo in the context of CRISPR germline engineering. Although the embryo does not possess the autonomous decision-making capacity at the time of germline engineering, the parental decision to permanently change the unique genetic fabric of the embryo and subsequent generations disregards future autonomy. Therefore, germline engineering in many instances is objectionable considering Feinberg’s open future theory. (shrink)

Sperm, eggs and embryos are made up of more than genes, and there are indications that changes to non‐genetic structures in these elements of the germline can also be inherited. It is, therefore, a mistake to treat phrases like ‘germline inheritance’ and ‘genetic inheritance’ as simple synonyms, and bioethical discussion should expand its focus beyond alterations to the genome when considering the ethics of germline modification. Moreover, additional research on non‐genetic inheritance draws attention to a variety of means whereby differences (...) can be inherited in offspring generations that do not rely on differences in germline structures. Research on these diverse forms of inheritance challenges the notion that there is some special form of ethical concern that falls on germline interventions in general, and on interventions to the nuclear genome within the germline in particular. (shrink)

In his theory of evolution, Darwin recognized that the conditions of life play a role in the generation of hereditary variations, as well as in their selection. However, as evolutionary theory was developed further, heredity became identified with genetics, and variation was seen in terms of combinations of randomly generated gene mutations. We argue that this view is now changing, because it is clear that a notion of hereditary variation that is based solely on randomly varying genes that are unaffected (...) by developmental conditions is an inadequate basis for evolutionary theories. Such a view not only fails to provide satisfying explanations of many evolutionary phenomena, it also makes assumptions that are not consistent with the data that are emerging from disciplines ranging from molecular biology to cultural studies. These data show that the genome is far more responsive to the environment than previously thought, and that not all transmissible variation is underlain by genetic differences. In Evolution in Four Dimensions (2005) we identify four types of inheritance (genetic, epigenetic, behavioral, and symbol-based), each of which can provide variations on which natural selection will act. Some of these variations arise in response to developmental conditions, so there are Lamarckian aspects to evolution. We argue that a better insight into evolutionary processes will result from recognizing that transmitted variations that are not based on DNA differences have played a role. This is particularly true for understanding the evolution of human behavior, where all four dimensions of heredity have been important. (shrink)

The reported birth of genetically modified twins in late 2018 has given new fuel to debates about the ethics of germline genome editing (GGE). There is a broad consensus among stakeholders that clinical uses of GGE should be temporarily banned as the technology is not yet deemed safe for use in humans. However, the idea of a complete ban is dismissed by many based on the expectation that more research will eventually allow scientists to make the technology safe without having (...) to put humans at risk first. In this article, I will analyse this assumption and argue that it is undermined by recent developments in the postgenomic life sciences. In particular, I will argue that in a postgenomic view of germline editing a complete ban on specific uses of the technology is warranted, because the research needed to assess the safety of these interventions would not be morally defensible. (shrink)

CRISPR germline editing therapies hold unprecedented potential to eradicate hereditary disorders. However, the prospect of altering the human germline has sparked a debate over the safety, efficacy, and morality of CGETs, triggering a funding moratorium by the NIH. There is an urgent need for practical paths for the evaluation of these capabilities. We propose a model regulatory framework for CGET research, clinical development, and distribution. Our model takes advantage of existing legal and regulatory institutions but adds elevated scrutiny at each (...) stage of CGET development to accommodate the unique technical and ethical challenges posed by germline editing. (shrink)

Some suggest that gene editing human embryos to prevent genetic disorders will be in one respect morally preferable to using genetic selection for the same purpose: gene editing will benefit particular future persons, while genetic selection would merely replace them. We first construct the most plausible defence of this suggestion—the benefit argument—and defend it against a possible objection. We then advance another objection: the benefit argument succeeds only when restricted to cases in which the gene-edited child would have been brought (...) into existence even if gene editing had not been employed. Our argument relies on a standard account of comparative benefit which has recently been criticised on the grounds that it succumbs to the so-called ‘pre-emption problem’. We end by considering how our argument would be affected were the standard account revised in an attempt to evade this problem. We consider three revised accounts and argue that, on all three, our critique of the benefit argument stands. (shrink)

Some suggest that gene editing human embryos to prevent genetic disorders will be in one respect morally preferable to using genetic selection for the same purpose: gene editing will benefit particular future persons, while genetic selection would merely replace them. We first construct the most plausible defence of this suggestion—the benefit argument—and defend it against a possible objection. We then advance another objection: the benefit argument succeeds only when restricted to cases in which the gene-edited child would have been brought (...) into existence even if gene editing had not been employed. Our argument relies on a standard account of comparative benefit which has recently been criticised on the grounds that it succumbs to the so-called ‘pre-emption problem’. We end by considering how our argument would be affected were the standard account revised in an attempt to evade this problem. We consider three revised accounts and argue that, on all three, our critique of the benefit argument stands. (shrink)