The precautionary principle aims to influence decision‐making in contexts where some activity poses uncertain but potentially grave threats. This perfectly describes the controversy surrounding germline gene editing. This article considers whether the precautionary principle should influence how we weigh the risks and benefits of human germline interventions, focusing especially on the possible threats to the health of future generations. We distinguish between several existing forms of the precautionary principle, assess their plausibility and consider their implications for (...) the ethics of germline modification. We also offer a novel form of the precautionary principle: the sufficientarian precautionary principle. Some plausible versions of the precautionary principle recommend placing somewhat greater weight on avoiding threats to future generations than on achieving short‐term benefits. However, no plausible versions of the precautionary principle entail that we should outright reject the use germline gene editing in human reproduction and some, such as the sufficientarian version, might endorse its use. (shrink)

Human germline gene editing constitutes an extremely promising technology; at the same time, however, it raises remarkable ethical, legal, and social issues. Although many of these issues have been largely explored by the academic literature, there are gender issues embedded in the process that have not received the attention they deserve. This paper examines ways in which this new tool necessarily affects males and females differently—both in rewards and perils. The authors conclude that there is an urgent (...) need to include these gender issues in the current debate, before giving a green light to this new technology. (shrink)

Germline gene editing has many applications or uses. This article focuses on specific applications. Specifically, the article draws on a moral norm arising from the thinking about the value of communal relationships in the Afro-communitarian _ubuntu_ philosophy to interrogate key issues that specific applications of germline gene editing – for xeno-transplantation, agriculture and wildlife – raise. The article contends that the application of germline gene editing in these areas is justified to (...) the extent that they foster the capacity to relate with others and to be communed with by others. The article grants that our today’s decisions about germline gene editing will likely affect future humans, but will attempt to justify how this may be ethically permissible. (shrink)

Germline Gene Editing has enormous potential both as a research tool and a therapeutic intervention. While other types of gene editing are relatively uncontroversial, GGE has been strongly resisted. In this article, we analyse the ethical arguments for and against pursuing GGE by allowing and funding its development. We argue there is a strong case for pursuing GGE for the prevention of disease. We then examine objections that have been raised against pursuing GGE and argue (...) that these fail. We conclude that the moral case in favour of pursuing GGE is stronger than the case against. This suggests that pursuing GGE is morally permissible and indeed morally desirable. (shrink)

This paper describes maslahah, a fundamental concept in Islam and its application in deliberating permissibility of human germline gene editing from an Islamic perspective. This paper refers to He Jiankui’s research that led to the birth of the world’s first gene edited babies, who were edited to be protected from HIV. The objective, procedure, and output of the research were assessed against the conditions of maslahah. It can be concluded that the experiment did not meet the (...) conditions; it is inconsistent with the objectives of shariah and some fundamental Islamic teachings that it did not preserve greater benefit, hence it could be considered impermissible. (shrink)

Volume 19, Issue 7, July 2019, Page 45-47.

Volume 20, Issue 8, August 2020, Page 46-49.

Human germline gene editing is often debated in hypothetical terms: if it were safe and efficient, on what further conditions would it then be ethically acceptable? This paper takes another course. The key question is: how can scientists reduce uncertainty about safety and efficiency to a level that may justify initiation of first-time clinical trials? The only way to proceed is by well-designed preclinical studies. However, what kinds of investigation should preclinical studies include and what specific conditions (...) should they satisfy in order to be considered well-designed? It is argued that multispecies and multigenerational animal studies are needed as well as human embryo editing without implantation. In order to be possible to translate to first-time clinical trials, animal studies need to satisfy strict conditions of validity. Moreover, embryo studies intended for translation to first-time clinical trials need to correspond to the animal studies in experimental design. Only in this way can uncertainty about risk for harm and prospect of benefit in first-time clinical trials be reduced to a modest level. If uncertainty is not reduced to such a level, first-time clinical trials in germline gene editing should not be initiated. (shrink)

Bioethics, Volume 35, Issue 7, Page 688-695, September 2021.

Volume 20, Issue 8, August 2020, Page 36-38.

This discussion note offers a preliminary analysis of what recent developments in human germline gene editing tell us about the effectiveness of speculative and anticipatory modes of techno-ethics. It argues that the benefits of speculative discussions are difficult to detect thus far, and that pushing the focal point of ethical discourse well ahead of the current state of technology may prematurely undermine existing norms long before a broad consensus would justify moving beyond them.

There are good theoretical rationales for considering germline gene editing (GGE) as a recommended and perhaps even necessary procedure for future long-term human space missions. This paper examines the arguments for applying GGE in a hypothetical future scenario where future parents living on Earth make decisions about applying GGE to their future children with the goal of allowing them to participate in space missions. The paper presents an ethical rationale for GGE. The paper also recognizes an area (...) of potential moral controversy that is not so much related to the application of GGE itself, but to the risk of different perceptions of well-being by parents and children that may result in the need for genetically modified children to leave Earth against their will. (shrink)

The recent development of CRISPR/Cas9 technology has rekindled the ethical debate concerning human germline modification that has begun decades ago. This inexpensive technology shows tremendous promise in disease prevention strategies, while raising complex ethical concerns about safety and efficacy of the technology, human dignity, tampering with God’s creation, and human genetic enhancement. Germline gene editing may result in heritable changes in the human genome, therefore the question of whether it should be allowed requires deep and careful (...) discussion from various perspectives. This paper explores Islamic perspectives on the concerns raised and highlights the ethical principles in Islam that should be taken into consideration when assessing the permissibility of CRISPR/ Cas9-mediated human germline gene editing. As argued in this paper, human germline gene editing would be considered lawful for medical purpose under certain conditions. It should not be applied on humans until the safety and efficacy issues are resolved. Robust ethical guidelines and strict regulations are necessary to preserve human dignity and to prevent premature and misuse of the technology. Maqasid al-shariah’s principles of preservation of human life, lineage, and dignity and ‘preventing harm takes precedence over securing benefit’ are among the guiding principles in assessing the permissibility of CRISPR/Cas9-mediated human germline editing from an Islamic perspective. Further discussions are important to address the controversies as well as to explore the related ethical principles. (shrink)

In the wake of the advent of genome editing technology CRISPR-Cas9 (clustered regularly interspaced palindromic repeat (CRISPR)-associated protein 9), there has been a global debate around the implications of manipulating the human genome. While CRISPR-based germline gene editing is new, the debate about the ethics of gene editing is not – for several decades now, scholars have debated the ethics of making heritable changes to the human genome. The arguments that have been raised both (...) for and against the use of genetic technologies in human reproduction reiterate much of the arguments made in the pre-CRISPR debate. As such, it is instructive for South Africa to reflect on these arguments now, in considering our position on the regulation of the use of this novel biotechnology. There are two dominant schools of thought in this area, bioliberalism and bioconservatism. Bioconservatives raise concerns about the risks of genetic manipulation, and argue that it ought to be limited or prohibited to avert these risks to human health and human nature. Bioliberal scholars are more open to the prospect of genetic manipulation, because of its potential utility. In this article, I conclude that in liberal democracies such as our own, bioliberal arguments ought to be seriously considered when formulating policy on human genome editing because of the extent to which they resonate with our Constitutional values and human rights. I further suggest that there is a need for an enquiry into the relevance of African perspectives on the ethical questions that arise concerning germline genome editing. (shrink)

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerningintergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for (...) clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued. (shrink)

The ethical issues associated with germline gene modification and embryo research are some of the most contentious in current international science policy debates. In this paper, we argue that new genetic techniques, such as CRISPR, demonstrate that there is an urgent need for China to develop its own regulatory and ethical framework governing new developments in genetic and embryo research. While China has in place a regulatory framework, it needs to be strengthened to include better compliance oversight and (...) explicit criteria for how different types of research should be reviewed by regulatory authorities. We also document a variety of opinions about the new technologies among the public, scholars, and policy makers. China needs to develop its own regulations in coordination with other countries; but it is unlikely that an international consensus will be achieved in this area, given the existing differences in regulations between countries. We should aim at harmonization, not necessarily complete consensus, and the perspective from China is vital when international norms are developed and harmonized. Chinese policy makers and researchers need to be aware of the international discussions, at the same time as the international community is aware of, and accommodates, Chinese positions on important policy options. (shrink)

This chapter addresses a general question: What is responsible risking? It explores the notion of "responsible risking" as a thick moral concept, and it argues that the notion can be given moral content that could be action-guiding and add an important tool to our moral toolbox. To impose risks responsibly, on this view, is to take on responsibility in a good way. A core part of responsible risking, this chapter argues, is some version of a Forethought Condition. Such a condition (...) requires us to not make decisions or plans such that we could not deliver on our responsibility obligations. This chapter argues that three moral obligations can be derived from descriptive notions of responsibility. They are (1) the control condition, (2) the responsibility to fix condition, and (3) the responsibility to explain condition. The idea is that in order to impose risks responsibly we ought not act in ways that undermine our ability to remain in control over the risks, undermine our ability to sort out negative outcomes by reparations or compensation, or undermine our prospects of providing an explanation for our actions that also makes sense in hindsight and to those affected. This idea is then tried out on the case of germline gene editing. It is argued that such a moral notion of responsibility is also action-guiding when we do not know for certain what is the morally right or obligatory action all-things-considered due to epistemic gaps. (shrink)

Recent scientific advances in the field of gene editing have led to a renewed discussion on the moral acceptability of human germline modifications. Gene editing methods can be used on human embryos and gametes in order to change DNA sequences that are associated with diseases. Modifying the human germline, however, is currently illegal in many countries but has been suggested as a ‘last resort’ option in some reports. In contrast, preimplantation genetic diagnosis is now (...) a well-established practice within reproductive medicine. Both methods can be used to prevent children from being born with severe genetic diseases. This paper focuses on four moral concerns raised in the debate about germline gene editing and applies them to the practice of PGD for comparison: Violation of human dignity, disrespect of the autonomy and the physical integrity of the future child, discrimination of people living with a disability and the fear of slippery slope towards immoral usage of the technology, e.g. designing children for specific third party interests. Our analysis did not reveal any fundamental differences with regard to the four concerns. We argue that with regard to the four arguments analyzed in this paper germline gene editing should be considered morally as acceptable as the selection of genomes on the basis of PGD. However, we also argue that any application of GGE in reproductive medicine should be put on hold until thorough and comprehensive laws have been implemented to prevent the abuse of GGE for non-medical enhancement. (shrink)

For human germline gene editing to be a viable technique for preventing disease, it must meet a baseline level of safety. This commentary unpacks Sahotra Sarkar’s concept of specificity outlined in Cut and Paste Genetics, which he proposes as a guide for when human germline gene editing can be performed safely. The commentary raises conceptual questions to how specificity is intended to work and raises further epistemic questions for how evidenceEvidence meets the demands of (...) specificity. (shrink)

Comparisons between germline gene editing using CRISPR technology and a renewal of eugenics are evident in the current bioethical discussions. This article examines the different roles of such references to the past. In the first part, the alleged parallels between gene editing of the germline and eugenics are addressed from three perspectives: First, the historical adequacy of such comparisons is questioned. Second, it is asked whether the evils of the past can in fact be (...) attributed to (future) practices of germline gene editing. Third, it is discussed whether the alleged hazards of eugenics should in fact universally be condemned from a moral perspective. The article attempts to show that references to the eugenic past to rebut gene editing are highly selective and should be abandoned to allow for a more transparent ethical discourse. While the comparison with a eugenic past is frequently drawn by opponents of germline gene editing, the remaining part of this article investigates historic references from the proponents of germline gene editing. It is argued that they also employ different narratives of the past to justify their own liberal position. While such references are equally problematic, some lessons from the history of eugenics will be spelled out that can inform future debates on germline gene editing. (shrink)

In late 2019, He Jiankui, the Chinese scientist who created the world's first gene‐edited babies, and two embryologists were sentenced to prison and fined. Thirteen months earlier, when the world first learned about the experiment, He and his colleagues drew swift and nearly uniform international condemnation for prematurely moving to human trials, for the risks they took with the children's health, and for He's secrecy. The organizing committee for the second genome editing summit said the experiment failed to (...) conform with international norms.” In the United States, the legal picture is complex. No doubt the specific experiment He performed would have run afoul of long‐standing research regulations due to its problems with informed consent and ethical review. But other laws also affect this kind of work, in particular, a budget rider that for the past four years has been included in federal appropriations legislation. (shrink)

Though questions about whether gene editing should be done at all have dominated ethical discussion, a literature about how it can be done ethically has been growing. Work on responsible translational pathways for human germline gene editing has been criticized for focusing on the wrong questions. But questions about responsible translational pathways—questions about how gene editing could be done ethically—are, in an important sense, prior to questions about whether it is desirable and permissible. (...) Asking “whether” questions about gene editing requires a model of what responsible clinical use of gene editing would look like. (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)

When the use of CRIsPR-Cas9 to edit DNA was first reported in 2012, it was quickly heralded by scientists, policymakers, and journalists as a transformative technology. CRISPR-Cas9 provides the means to change DNA in ways that either were not generally possible using previous genetic technologies or that were orders of magnitude more laborious or inefficient to undertake. CRISPR's possible applications were readily apparent and seemingly endless, from supercharging laboratory research to modifying insects that transmit disease to eliminating genetic conditions. By (...) 2015, Wired magazine was calling the discovery "The Genesis Engine."Against a backdrop of disappointing results from gene transfer... (shrink)

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)

Gene-editing technologies, such as CRISPR/Cas9, are internationally ethically fraught. In the United States, policy surrounding gene-editing has yet to be implemented, while the science continues to speed ahead. However, it is not enough that policy be implemented: in order for policy to establish limits for the technology such that benefits are possible while threats are kept at bay, such policy must be ethical. In turn, the ethics of gene-editing is a culturally determined field of (...) inquiry. This piece presents a proposal for a study whose goal is to arrive at ethical policy recommendations for policymakers. To achieve this goal, this study proposes, what needs to be done is, first, to understand the full history and foundation of gene-editing by conducting a thorough legal, bioethical, and policy review for precedent assisted reproductive technologies and genetic reproductive technologies. Following this effort, an empirical study must be conducted involving careful surveys of key stakeholder groups on their knowledge and opinions of gene-editing. Such stakeholder groups must include bioethicists, medical geneticists, and lay persons, including those in the disability community. (shrink)

In an article in this journal, Katherine Drabiak argues that green lighting genome editing of human embryos is contrary to “fundamental human rights law.” According to the author, genome editing of human embryos violates what we should recognize as a fundamental human right to inherit a genome without deliberate manipulation. In this reply article, we assess Drabiak's legal analysis and show methodological and substantive flaws. Methodologically, her analysis omits the key international legal instruments that form the so‐called International (...) Bill of Rights and thus fails to provide a full and accurate account of the fundamental international human rights standards. Substantively, Drabiak invokes, as a basis for prohibiting gene editing of human embryos, a legal standard (the rights and integrity of the future child) that is unknown to international law. Contrary to Drabiak's account, genome editing of human embryos is not prohibited under international law. Indeed, the right to health and the right to benefit from scientific progress may be interpreted as the basis of a legal duty to provide equality of access to germline gene editing, once determined it is beneficial and safe to use. (shrink)

Genetic engineering has been a topic of discussion for over 50 years, but it is only recently that gene editing has become a reality. CRISPR biotechnologies have made gene editing much safer, precise and feasible. We have witnessed the first cases of human germline genetic modification resulting in live births, conducted by He Jiankui. In this paper, we will analyse He Jiankui’s case in relation to one of the most difficult problems in procreative ethics (or (...) the ethics of future generations): the non‐identity problem. We believe that this analysis will help us to understand the ethics involved in gene editing and hopefully allow for a better, more philosophically grounded legislation on CRISPR and other gene‐editing technologies. (shrink)

The aim of the present paper is to reinforce some of the affirmations made by Vera Lucia Raposo in a recent paper published by the Journal of Bioethical Inquiry. According to her, germline gene editing does not violate human dignity at all. This article offers some complementary ideas supporting her statement. In particular, four main arguments are stressed. Firstly, not only is the idea of human dignity unclear, but the idea of the human genome suffers from a (...) general lack of concreteness, which has dramatic consequences for the debate. Secondly, it is highlighted that if we believe that the immutability of the human genome underpins human dignity, then it should be our duty to use the tools of genetic modification to reverse any accidental changes that occur in nature. Thirdly, it is showed that if the alteration of germline constitutes an attack on human dignity, then we should also refrain from performing medical practices such as chemotherapy, which cause precisely this effect. Finally, we argue that modification of germline is not contrary to human dignity but an excellent expression of our autonomy. (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...

In light of the development of “CRISPR” technology, new promising advances in therapeutic and preventive approaches have become a reality. However, with it came many ethical challenges. The most recent worldwide condemnation of the first use of CRISPR to genetically modify a human embryo is the latest example of ethically questionable use of this new and emerging field. Monotheistic religions are very conservative about such changes to the human genome and can be considered an interference with God’s creation. Moreover, these (...) changes could cause perpetual changes to future generations. The Muslim scholars establish their decisions by addressing five foundations of Islamic law i.e. “maqāṣid al sharı̄`a”; the purposes of the law. These are dın̄, nafs, nasl, `aql and māl. To achieve this, the five principles should all be met before approval of an experiment like the Chinese embryo modifications; Qaṣd which is achieved in this case as it aims to protect the embryo from HIV. Yaqın̄ and Ḍarar were not satisfied as they require strong scientific certainty of the procedures, and evidence of safety. Ḍarūra by which the alternatives being compared; in this case more established and proven safe alternatives to protect the HIV transmission from the father are available, so this principle is not met. The final principle is `Urf, by which the social context of using any contemporary technology should be taken in consideration, and clearly this was not achieved. Collectively, germline changes are rejected from an Islamic perspective until the five principles are fulfilled. In the Chinese Twins gene editing case, there was clearly no justification or support for it according to the Muslim Jurisprudence laws. These laws and approaches can serve as an ethical checklist for such controversial research, especially in early stages of the research. (shrink)

The revolutionary potential of the CRISPR-Cas9 gene editing technique has created a resurgence in enthusiasm and concern in genetic research perhaps not seen since the mapping of the human genome at the turn of the century. Some such concerns and anxieties revolve around crossing lines between somatic and germline interventions as well as treatment and enhancement applications. Underpinning these concerns, there are familiar concepts of safety, unintended consequences and damage to genetic identity and the creation of designer (...) children through pursuing human enhancement and eugenics. In the policy realm, these morally laden distinctions and anxieties are emerging as the basis for making important and applied measures to respond to the fast-evolving scientific developments. This paper argues that the dominant normative framing for such responses is insufficient for this task. This paper illustrates this insufficiency as arising from a continued reliance on misleading genetic essentialist assumptions that generate groundless speculation and over-reactionary normative responses. This phenomenon is explicit with regard to prospective human genetic enhancements. While many normative theorists and state-of-the-art reports continue to gesture toward the influence of environmental and social influences on a person and their traits and capacities, this recognition does not extend to the substance of the arguments themselves which tend to revert to the debunked genetic determinist framework. Given the above, this paper argues that there is a pressing need for a more central role for sociological input into particular aspects of this “enhancement myth” in order to give added weight, detail and substance to these environmental influences and influence from social structures. (shrink)

This Open Access book is about the risks and the ethics of human germline gene editing, i.e., the possibility to make heritable changes to the DNA of early human embryos or germ cells. Is there something particularly morally problematic about editing the human germline? Is there something unique about germline editing, and, if so, does this suggest that we ought not to edit the human germline, or only in particular circumstances or for (...) particular purposes? What would be a wise and responsible approach to editing the human germline from a moral perspective? The book has three broad aims. First, to present an inclusive map over the current scholarly debate on the ethics of human germline gene editing. Second, to provide a philosophical and critical guide to the various ideas and arguments in this debate. Third, to apply an ethics of risk perspective and defend a morally cautious position on human germline gene editing. (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)

This open peer commentary critiques Cwik's approach to categorizing germline gene editing interventions. The authors argue that Cwik's framework, which prioritizes technical categories and dimensions to map the "ethical terrain," is fundamentally flawed by putting the technical aspects before ethical considerations. They identify four key problems with his approach: it is arbitrary in its categorizations, relies on dynamic membership that changes with scientific knowledge, requires extensive technical expertise that many bioethicists lack, and most importantly, approaches the analysis (...) "back-to-front" by starting with technical rather than ethical distinctions. The authors argue that ethical assessment should begin with examining the goals and justifications of an intervention, rather than its technical specifications. They use the example of mitochondrial replacement therapy to illustrate how classification should proceed from ethical considerations to technical ones, not vice versa. The commentary concludes that while Cwik offers a complex framework, it is both incorrectly structured and impractical to use consistently. (shrink)

As research involving gene editing continues to advance, we are headed in the direction of being able to modify the human germline. Should we reach a point where an argument can be made that the benefits of preventing unborn children and future generations from inheriting genetic conditions that cause tremendous suffering outweigh the risks associated with altering the human germline, the next step will be to design clinical trials using this technology in humans. These clinical trials (...) will likely require careful follow-up and monitoring of future generations born with altered genes. This paper addresses some of the ethical issues raised by intergenerational monitoring and sets out to show that these issues can be avoided with careful consideration and clinical trial design. (shrink)

:Since the advent of recombinant DNA technology, expectations about the potential for altering genes and controlling our biology at the fundamental level have been sky high. These expectations have gone largely unfulfilled. But though the dream of being able to control our biology is still far off, gene editing research has made enormous strides toward potential clinical use. This paper argues that when it comes to determining permissible uses of gene editing in one important medical context— (...) class='Hi'>germline intervention in reproductive medicine—issues about enhancement and eugenics are, for the foreseeable future, a red herring. Current translational goals for gene editing research involve a different kind of editing than would be required to achieve manipulation of complex traits such as intelligence, and there are more pressing questions that need attention if clinical use of gene editing in reproductive medicine ever becomes a possibility. (shrink)

Summary: Edward Lanphier and colleagues contend that human germline editing is an unethical technology because it could have unpredictable effects on future generations. In our view, such misgivings do not justify their proposed moratorium.

Two years ago, the US National Academy of Sciences and the National Academy of Medicine released a report drafted by an international committee regarding the use of gene editing in humans. Once a tedious and expensive process, gene editing has now become more accessible and cheaper using the new CRISPR technology, making the issue of its use more urgent and pressing. The committee cites general support for somatic nonheritable gene editing to correct for a (...) serious disease already present in a human being, but more controversial is germline gene editing for heritable conditions. Performing gene editing that affects an individual's descendants is at present tightly controlled in the US, but around the... (shrink)

Innovative healthcare technologies may raise ethical concerns which prevent their implementation for fear of unexpected or undesirable outcomes, even before they are introduced into usual clinical practice. Essential to innovation is therefore to analyze benefits and drawbacks from a multidisciplinary point of view (i.e., biomedical, social, financial). Value-based healthcare is currently the most comprehensive theoretical framework to evaluate the benefits of healthcare technologies on patients and society in the longer term. Technically, “the systematic evaluation of properties, effects and/or impacts of (...) health technologies” must be performed by validated procedures of Health Technology Assessment (HTA), supported by early HTA procedures to retrieve preliminary evidence and expert opinions. The aim of this study is to perform an early HTA of germline editing technologies in order to estimate their impact on patients and society, in light of the recent, controversial debate which followed the germline gene editing of human embryos. (shrink)

Gene therapy and gene editing are revolutionising the treatment of genetic diseases, most notably haematological disorders. This paper evaluates the use of both techniques in hereditary blood disorders. Many studies have been conducted in this field, especially with gene therapy, with very promising results in diseases such as haemophilia, certain haemoglobinopathies and Fanconi anaemia. The application of these techniques in clinical practice and the foreseeable development of these approaches in the coming years suggest that it might (...) be useful to evaluate the results achieved thus far. It is also essential to reflect on the possible bioethical concerns raised by the use of both techniques, especially in terms of safety issues for patients, potential side effects, treatment duration, accessibility and cost of treatment, and the heritability of genetic changes produced if germline cells are used. (shrink)

With the arrival of new methods of genome editing, especially CRISPR/cas 9, new perspectives on germline interventions have arisen. Supporters of germ line genome editing claim that the procedure could be used as a means of disease prevention. As a possible life-saving therapy, it provides benefits that outweigh its risks. Opponents of GGE claim that the medical and societal risks, especially the use of GGE for genetic enhancement, are too high. In our paper, we analyze the risks (...) and benefits of GGE. We show that the medical risk on an individual level might be reduced by further research in the near future so that they may be outweighed by the benefits. We also show that the societal risks of the procedure, i.e. genetic enhancement, are manageable by establishing a regulative framework before the GGE is implemented. Since the effects of modifying genes for the genepool of a given population are extremely difficult to model, the medical risks on the population level might be too high. (shrink)

BackgroundClustered Regularly Interspaced Short Palindromic Repeats-associated technology may allow for efficient and highly targeted gene editing in single-cell embryos. This possibility brings human germline editing into the focus of ethical and legal debates again.Main bodyAgainst this background, we explore essential ethical and legal questions of interventions into the human germline by means of CRISPR-Cas: How should issues of risk and uncertainty be handled? What responsibilities arise regarding future generations? Under which conditions can germline (...) class='Hi'>editing measures be therapeutically legitimized? For this purpose, we refer to a scenario anticipating potential further development in CRISPR-Cas technology implying improved accuracy and exclusion of germline transmission to future generations. We show that, if certain concepts regarding germline editing are clarified, under such conditions a categorical prohibition of one-generation germline editing of single-cell embryos appears not to be ethically or legally justifiable.ConclusionThese findings are important prerequisites for the international debate on the ethical and legal justification of germline interventions in the human embryo as well as for the harmonization of international legal standards. (shrink)

Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion has (...) an EU starting point and is meant as a contribution to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions that will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global‐scale responsibility and governance should be fostered by promoting cross‐disciplinary thinking and multi‐level stakeholder involvement in legal and regulatory processes. (shrink)

Given some of the various possible impacts of clinical germline editing, we can expect robust disagreement about how best to regulate it. One can point to examples of the promise of editing: “rough...

Volume 20, Issue 8, August 2020, Page 44-46.

Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion has (...) an EU starting point and is meant as a contribution to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions that will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global‐scale responsibility and governance should be fostered by promoting cross‐disciplinary thinking and multi‐level stakeholder involvement in legal and regulatory processes. (shrink)

In the fall of 2018 Jiankui He shocked the international community with the following announcement: two female babies, “Lulu” and “Nana,” whose germlines had been modified by the cutting edge, yet profoundly unsafe CRISPR-Cas9 technology had been born. This event galvanized policy makers and scientists to advocate for more explicit and firm regulation of human germline gene editing. Recent policy proposals attempt to integrate safety considerations and public input to identify specific types of diseases that may be (...) safe targets for human GGE. This paper argues these policy proposals are inadequate in different ways. While Sarkar intends to incorporate input from the disability community for the purpose of deciding the value of human GGE, I argue that his strategy for doing so is inadequate. I’ll argue that an iterative, deliberative process is a more appropriate framework for allowing the disability community to inform policy on human GGE. Further policy proposals have been framed in terms of monogenetic or single-gene diseases. I argue that this way of conceptualizing disease is not what matters for deciding which disorders are viable candidates for human GGE. Instead, what matters is that the disease in question must have genes that have a high degree of causal control with respect to the disease and alternative nucleic acid sequences variants that are likely to produce traits deemed desirable must be identified. Previous policy proposals leave unspecified. What conditions must be met for satisfying condition should not be left to individual scientists to decide for themselves. The present proposal offers some guidance on this issue. (shrink)