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Genetic Engineering and its Dangers (Essay Sample)

THE ESSAY DISCUSSES THE CONS OF GENETIC ENGINEERING. APART FROM THE POSITIVE CONTRIBUTIONS OF GENETIC ENGINEERING, IT ALSO HAS SOME NEGATIVE IMPACTS WHICH EITHER HARM THE ENVIRONMENT OR THE CONSUMERS LIKE HUMANS AND ANIMALS. In genetic engineering, the final product can end up endangering the lives of humans, animals, or plants. genetic engineering has more positive than negative impacts

Surname Course Number and Name Institution Professor Date Genetic engineering and its dangers. Genetic engineering is the artificial manipulation, modification, and recombination of DNA or RNA molecules to modify an organism or population of organisms. It is generally used to refer to methods of recombinant DNA technology. Recombinant DNA technology is the joining of DNA from two different species that are inserted into a host organism to produce a new genetic combination. A hybrid organism that expresses both the characteristics of parent organisms is developed. It is majorly applied in agriculture to boost crop yield, in pharmaceuticals to manufacture vaccines, and also in gene therapy to cure genetic disorders. In genetic engineering, the final product can end up endangering the lives of humans, animals, or plants. The dangers of genetically engineered products include: Unknown harms to the environment. Although no exact amount of harm that can be caused by genetically engineered organisms/products is known, many authors have speculated that genetically engineered products are dangerous to the environment. Another possible danger of genetic engineering is that the products may be a possible

Genetic Engineering: Dangers and Opportunities

Introduction, genetic engineering pros and cons, works cited.

As of today, the practice of genetic engineering continues to remain highly controversial. In its turn, this can be explained by the fact that there are a number of the clearly defined ethical undertones to the very idea of inducing ‘beneficial’ genetic mutations to a living organism.

After all, this idea presupposes the eventual possibility for people to realize themselves being the masters of their own biological destiny, in the evolutionary sense of this word.

Nevertheless, even though the practice in question indeed appears utterly debatable, the very objective laws of history/evolution leave only a few doubts that, as time goes on, more and more people will perceive it as being thoroughly appropriate. This paper will explore the validity of the above-stated at length.

In general, genetic engineering can be defined as: “An artificial modification of the genetic code of an organism. It changes the physical nature of the being in question radically, often in ways that would never occur in nature” (Cyriac 65).

Thus, it is most properly discussed as an umbrella term for the biotech practices that aim to alter the molecular basis of the DNA strand for a variety of different purposes, mostly concerned with allowing people to be able to enhance their lives.

As of now, we can identify three major directions, in which the ongoing progress in the field of the genetic engineering technologies (GET) has attained an exponential momentum: a) Deciphering the structure of the human genome, b) Transferring genes from the representatives of one species to another, c) Cloning. Even though GET became available since not long ago, these technologies proved thoroughly capable of benefiting humanity in a variety of different ways.

Among the most notable of them can be well mentioned:

a) Making possible the production of genetically modified foods. As Coker noted: “In the United States and elsewhere, more than 90% of soybeans, cotton, corn, and certain other crops are already genetically engineered” (24). The reason behind the growing popularity of this type of food is quite apparent – the application of getting increases the efficiency of agriculture rather drastically, which in turn contributes to solving the problem of ‘world’s hunger.’

b) Establishing the objective preconditions for the creation of drugs that could be used for treating diseases that are now being assumed incurable, such as AIDS and cancer. This, of course, presupposes that, as a result of GET being increasingly used by pharmacologists, the lifespan of an average individual should be substantially extended. The validity of this suggestion can be illustrated, in regards to the effects of such a widely used genetically modified drug as insulin, prescribed to those who suffer from diabetes.

c) Providing people with the opportunity to have their children (or pets) being ‘genetically tailored,’ in accordance with what happened to be the concerned individual’s personal wishes, in this respect. What it means is that, due to the rise of getting, the concept of eugenics became thoroughly sound once again: “Besides ensuring that our children are born without genetic defects, we will soon be able to give them genetic enhancements: they will become taller, stronger, smarter” (Anderson 23). Consequently, this will allow the biological betterment of human societies.

Nevertheless, even though there are many reasons to consider genetic engineering utterly beneficial to the well-being of humanity, some people cannot help deeming it utterly ‘wicked’ – this especially appears to be the case among religious citizens.

The reason for this is quite apparent – one’s ability to meddle with the structure of DNA, which in turn results in the emergence of the ‘tailored’ life-forms, implies that the individual in question is nothing short of God.

In the eyes of a religious individual, however, this idea appears clearly sacrilegious: “Humans must show respect for God’s dominion through attentive obedience to the immanent laws of creation” (Clague 140). There are also a number of secular (non-religious) objections to genetic engineering.

The most commonly heard one is concerned with the fact that the effects of the consumption of genetically modified foods on humans have not been thoroughly researched. This, of course, establishes a hypothetical possibility for those individuals who consume these foods to end up suffering from a number of yet unexplored side effects.

It is also often mentioned that, because GET provides married couples with the hypothetical possibility to conceive and to give birth to ‘ideal’ babies, it may eventually result in the emergence of the previously unheard forms of social discrimination against people, whose genome happened to be unmodified.

Moreover, there is a growing concern about the fact that being artificially created, the genetically altered forms of life may bring much disbalance to the surrounding natural environment, which is supposed to evolve in accordance with the Darwinian laws of natural selection.

Out of these objections, however, only the second one can be defined as being more or less plausible. After all, the availability of getting is indeed a comparatively recent phenomenon, which in turn implies that there may be some unforeseen aspects to it.

The rest of them, however, do not appear to hold much water – this especially happened to be the case with the religious one. The reason for this is that the process of just about any organism coming to life, which religion refers to as the ‘miracle of creation,’ biologists have long ago learned to perceive as nothing but the consequence of the essentially ‘blind’ flow of molecular reactions in the concerned DNA.

As Chapman pointed out: “What causes the differentiation in the genetic code? The mechanism for this – the genetic software, if you will – comes through the epigenetic markers that surround the genome” (170). In other words, the ‘miracle of creation’ is ultimately about the chain of self-inducing genetic mutations, which presupposes that there is nothing intelligent or consciously purposeful to it in the first place.

Genetic engineering, on the other hand, makes possible the thoroughly rational manipulation with the structure of DNA – hence, allowing biologists to not only remain in full control of the process of a particular genetic mutation taking place but also to define its course.

It is understood, of course, that the practice in question does undermine the epistemological integrity of the world’s monotheistic religions, but this state of affairs has been predetermined by the laws of history and not by the practice’s ‘wickedness.’

Apparently, the fact that many people continue to refer to genetic engineering with suspicion, reflected by their irrational fear of genetically modified foods, once again proves the validity of the specifically evolutionary paradigm of life.

The reason for this is that, as we are well aware of, throughout the course of history, the implementation of technological innovations always been met with much resistance. In its turn, this can be explained by the fact that due to being ‘hairless apes’, people are naturally predisposed to cling to specifically those behavioral patterns, on their part, which proved ‘luck-inducing’ in the past.

Nevertheless, as time goes on, their ‘fear of the new’ grows progressively weakened – the direct consequence of people’s endowment with intellect. We can speculate that before deciding to become ‘stock herders,’ ‘hunter-gatherers’ used to experience a great deal of emotional discomfort, as well – yet, there was simply no way to avoid the mentioned transformation, on their part.

The reason for this is that it was dialectically predetermined. In the mentioned earlier article, Coker states: “Eventually, humans took more control of animals and plants through agriculture, and then civilization took off. Today, we can hardly imagine how harsh the pre-agricultural existence must have been” (27).

The same line of reasoning will apply when it comes to assessing what would be people’s attitudes towards genetic engineering in the future. In all probability, our descendants will look down on us in the same manner that we look down on the members of some primeval indigenous tribe, who were never able to evolve beyond the Stone Age. After all, in the future, leaving the formation of one’s genome up to a chance will be considered barbaric.

Nevertheless, it is not only the laws of historical progress that presuppose the full legitimation of genetic engineering but the evolutionary ones, as well – something the exposes the sheer erroneousness of the claim that the concerned practice is ‘unnatural.’

In this respect, one may well mention the most important principle of evolution – the likelihood for a particular quantitative process to attain a new qualitative subtlety, positively relates to how long it remained active.

This principle, of course, suggests that for as long as the representatives of a particular species continue to expand the boundaries of their environmental niche (as it happened to be the case with humans), they will be experiencing the so-called ‘evolutionary jumps.’

The emergence of getting suggests that we, as humans, are about to experience such a ‘jump’ – after having undergone the GET-induced transformation, we will instantly attain the status of ‘trans-humans’ (or ‘demi-gods’). As Bostrom pointed out: “Human nature is a work-in-progress…

Current humanity need not be the endpoint of evolution… (through) Technology and other rational means we shall eventually manage to become posthuman beings with vastly greater capacities than present human beings have” (493).

Thus, even though the practice of genetic engineering continues to spark controversies, it is highly unlikely that this will also be ceased in 10-20 years from now – those proven much too slow, taking full advantage of genetic engineering, will simply be no longer around to debate its usefulness.

The earlier provided line of argumentation, in defense of the idea that genetic engineering indeed represents the way of the future, appears fully consistent with the paper’s initial thesis. Thus, it will be fully appropriate to conclude this paper by reinstating that the sooner people grow thoroughly comfortable with getting, the better.

In this respect, it will prove rather helpful for them to become aware that the emergence of genetic engineering is yet another indication that humanity remains on the pass of progress, and there is indeed nothing ‘unnatural’ about the practice in question. This paper is expected to come as an asset within the context of just about anyone gaining such awareness.

Anderson, Clifton. “Genetic Engineering: Dangers and Opportunities.” The Futurist 34.2 (2000): 20-22. Print.

Bostrom, Nick. “Human Genetic Enhancements: A Transhumanist Perspective.” Journal of Value Inquiry 37.4 (2003): 493-506. Print.

Chapman, Davd. “Beyond Genetic Determinism.” Ethics & Medicine 29.3 (2013): 167-171. Print.

Clague, Julie. “Some Christian Responses to the Genetic Revolution.” Ethics & Medicine 19.3 (2003): 135-142. Print.

Coker, Jeffrey. “Crossing the Species Boundary: Genetic Engineering as Conscious Evolution.” Futurist 46.1 (2012): 23-27. Print.

Cyriac, Kar. “Biotech Research: Moral Permissibility vs. Technical Feasibility.” IIMB Management Review 16.2 (2004): 64-68. Print.

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Genetic Engineering: A Serious Threat to Human Society

Scientists have been trying to create synthetic life, life created in lab, for many years. The first breakthrough in this process happened about thirty years ago when genetic engineers began to genetically modify organisms (Savulescu). These engineers physically move genes across species in order to improve an organism or to cause an organism to function differently. Even though this process sounds as if it happens only in fantasy games, genetically modified organisms are common. For example, genetically modified crops are used every day in the world’s food supply and genetically modified bacteria have been used in medicine, chemical manufacturing, and bio warfare (Pickrell). Slowly, genetic engineering has become a powerful tool in many different fields. Recently, genetic engineering’s potential power increased when Craig Venter, a famous geneticist and entrepreneurs, recreated a living organism out of synthetic chemicals. His success proved to genetic engineers that functioning genomes can be made purely of synthetic chemicals. This power would allow genetic engineers to build new artificial genomes instead of having to modify naturally existing genomes. Genetic engineers now have the chance to broaden their fields’ applications. However, genetic engineering is unpredictable and dangerous, and broadening the application of genetic engineering only furthers the risks. Genetically engineered organisms pose lethal and economic risks to human society.

The availability of genomic information and genetic engineering technology creates a lethal threat to humanity because terrorists can use both the information and technology to recreate deadly pathogens, such as the poliovirus. The naturally occurring poliovirus killed and paralyzed millions of people for many years. In 1988, a worldwide vaccination campaign against the virus nearly exterminated it from the environment, and this solved the poliovirus epidemic. However, in 2002, well intentioned scientists decided to recreate the poliovirus for research means. Using the genomic sequence of the poliovirus found on a public database and commercially available machines, these scientists synthesized fragments of viral genomes into a functional poliovirus (Avise 7). These scientists proved that deadly pathogens can be recreated from genetic engineering techniques. Also, the information and technology used in genetic engineering is readily available and relativity cheap (Kuzma and Tanji 3). Mixing the power to recreate a deadly pathogen with the public availability of genetic engineering information and technology creates a lethal risk to humanity when terrorist exist in society. Terrorist could use genetic engineering to reinstate the poliovirus into the environment, and the virus would kill and paralyze more people. Luckily, these scientists were filled with good intent; however, there is nothing to prevent terrorists from harming innocent lives. Recreating deadly pathogens makes genetic engineering dangerous enough; however, genetic engineers also have the potential to improve the effectiveness of deadly pathogens, such as Y. pestis.

Genetic engineers can make deadly pathogens, such as Y. pestis, resistant to modern antibiotics, and these pathogens could kill innocent people if used as a weapon. Y. pestis, also known as the black plague, wreaked havoc on humanity during the Middle Ages by killing millions of people. In response to a Y. pestis threat during the 20th century, scientists developed an effective vaccine for the pathogen. However, genetic engineers at Biopreparat, a Russian biological warfare agency, engineered a new Y. pestis strain with genetic resistance to modern antibiotics and natural human immunity (Avise 6). The genetically engineered Y. pestis was more deadly and effective than the natural Y. pestis that killed millions of people during the Middle Ages. Biopreparat’s research proved that deadly pathogens can be genetically engineered into superior forms that are resistant to modern medicine. If this strain of Y. pestis was released, a black plague would devastate current human society. Militaries could use the same genetic engineering techniques that Biopreparat used to create deadly biological weapons. With this ability to make deadly pathogens resistant to modern medicine, genetically engineered organisms become lethal weapons that cannot be stopped. Other than lethal weapons, genetically engineered organisms can produce lethal chemical compounds when they are used as a manufacturing tool in the chemical industry.

Showa Denko’s genetically modified bacteria produced a lethal L-tryptophan amino acid that killed and disabled people who took the company’s food supplements. In 1989, an epidemic of eosinophilia myalgia syndrome, a syndrome that is characterized by a high eosinophil count and severe muscle pain, struck the United States (Genetic Engineering: Too Good to Go Wrong 9). This epidemic killed a hundred people and physically disabled ten thousand patients, some of which were paralyzed. Doctors eventually discovered that L-tryptophan, an amino acid used as a food supplement, was causing the epidemic. In 1990, the Journal of the American Medical Association reported that only people who took the L-tryptophan supplement made by Showa Denko, a Japanese biotech company, came down with EMS. Showa Denko’s genetically engineered organisms produced corrupted forms of L-tryptophan that were dangerous to human health (Smith 4).

Many chemical companies want to use genetically engineered organisms to produce chemicals because it is cheaper than normal manufacturing methods. If chemical companies begin to rely on genetically engineered organisms to produce food and medical chemicals, the public could be at risk for another dangerous outbreak of lethal chemicals. Using genetically engineered organisms to cutting down manufacturing costs seems as if it will help the economy; however, genetically engineered organisms, specifically anti-material organisms, can hurt economies more than help them.

Genetic engineers possess the ability to create anti-material organisms that can degrade infrastructure and man-made materials, and malicious people can use these organisms to tear down society’s infrastructures and economies. In nature, there are many organisms with the ability to degrade infrastructure and man-made materials. These microbes cost governments and industries millions of dollars in biodeterioration and biodegradation damages. For instance, bacteria are the leading cause of road and runway deterioration. In Houston, Texas, microbes have been known to degrade the concrete in the city’s sewage systems, and the city has spent millions of dollars trying to contain the problem. High-tech companies, such as airlines and fuel companies, constantly have their facilities and machinery being degraded away by anti-material organisms. These natural organisms cause enough damage to infrastructure, and fixing the damage is expensive and time consuming (Sunshine Project 2). Similarly to the artificially made poliovirus, genetic engineers have the potential to recreate or improve these naturally occurring anti-material organisms. In theory, malicious people could unleash genetically engineered anti-material organisms on infrastructures worldwide, and this would create an expensive cleanup project for governments and companies. With these expensive damages, genetically engineered organisms can destroy economies. The same economic and environmental dangers of anti-material organisms can also be seen in genetically modified crops.

Genetically modified crops will negatively impact the economy and environment because engineered genetic resistance is ineffective at stopping natural parasites in the long term. Farmers use genetically modified crops because these crops contain a genetic resistance to parasites, such as insect pests and microbes. In evolution, two organisms that are in a parasitic relationship evolve in a balance with each other. When genetically modified plants are placed into a natural environment, parasites will evolve in a direction that allows them to bypass the genetic resistance engineered into the crops. Since the majority of crop parasites go through successive generations at a fast pace, these parasites will quickly evolve into a population that can surpass the genetic resistance. This evolutionary process makes the benefits of genetically modified crops short lived. Farmers, who pay more for genetically modified seed than natural seed, then have to pay for harmful and expensive pesticides to protect their crops. In the end, farmers will lose money due to the increased costs of buying genetically modified crops and dangerous pesticides. Also, dangerous chemicals, such as DDT, will be reintroduced into the environment (Avise 73). The ineffectiveness of genetically modified crops creates an economic and environmental risk to human society in the long run since farmers will be losing more money and introducing dangerous chemicals into the environment.

Genetically engineered organisms pose an enormous risk to human society on a lethal and economic front. Natural lethal pathogens, such as the poliovirus and Y. pestis, can be recreated or improved, and malicious people could use these genetically engineered pathogens to kill millions of people. Chemicals manufactured by genetically modified bacteria have proven to be harmful to human health, which was the case during the EMS epidemic in the United States. On an economic front, genetically engineered organisms increase costs instead of minimizing them, and they harm the environment. Anti-material organisms can be created to deteriorate infrastructures, and this would cost governments and industries millions of dollars in repair costs. Also, genetically modified crops in the long term will cost farmers more money than they save because the advantages of the genetically modified crops will be nullified by evolving parasites. Genetically engineered organisms have a huge potential to harm society. However, researching new methods and applications of genetic engineering will not stop because scientists believe in the vast opportunities of the field. In order to keep human society safe, scientists must exhaust all options before turning to the power of genetic engineering. It is an unwise idea to rely on genetic engineering since it is unpredictable and imprecise form of engineering.

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Pickrell, John. “Introduction: GM Organisms.” New Scientist . N.p., 2010. Web. 20 Sept. 2010. <http://www.newscientist.com/‌article/‌dn9921-instant-expert-gm-organisms.html>.

Savulescu, Julian. “A matter of synthetic life and death: Venter’s artificial organism invention is fraught with peril.” New York Daily News . N.p., 2010. Web. 20 Sept. 2010. <http://www.nydailynews.com/>.

Smith, Jeffrey M. "Scrambling and Gambling with the Genome." Say No To GMOs! Aug. 2005. Web. 13 Oct. 2010. <http://www.saynotogmos.org>.

Sunshine Project. "Non-Lethal Weapons Research in the US." Sunshine Project . Mar. 2002. Web. 13 Oct. 2010. <http://www.sunshine-project.org/publications/bk/bk9en.html>.

Union of Concerned Scientists. "Risks of Genetic Engineering." Union of Concerned Scientists . 2010. Web. 14 Nov. 2010. <http://www.ucsusa.org/food_and_agriculture/science_and_impacts/impacts_genetic_engineering/risks_of_genetic_engineeringeering.html#New_Allergens_in_the_Food_Supply>.

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Changing the world: Genetic Engineering Effects Essay

Technology being used in the world today has changed the world to suit us better. The changes relate on how well the people are comfortable in the world, and recount from basic needs of individuals to human aspirations such as knowledge. Changing the world does not take a basic step; it is a complicated and unpredictable process that deals with risks occurrences, unexpected costs and unexpected benefits. Technology has brought about genetic engineering.

Genetic engineering is the alteration of the genetic materials by scientific intervention in genetic process with a significance of gaining new substances or enhancing productivity in living organisms. It interferes with the genetic materials of an organism producing a different heritable materials induced outside the organism through the invasion of the DNA molecule in cells.

Genes used in genetic engineering have a high impact on health and disease, therefore the inclusion of the genetic process alters the genes that influence human behavior and traits. The establishment of genetic engineering has raised many ethical and legal questions, but its significance relies on how different individual perspire the act in their cultural, religion and ethical boundaries.

Scientist have been able to use genetic engineering as a way of creating plants, animals, and micro- organisms by manipulating genes in a way that does not occur naturally. The modified genetically organism spread though nature and interbreed with the natural organism interfering with the future generation.

Genetic engineering has its futurist obligation and its reliability on its concepts should be avoided. “For better or for worse, genetic engineering will affect the major environmental problems of our time- overpopulation, pollution, erosion and the rapid loss of biodiversity” (Anderson, 2000). We should be creative in the real world and let the world’s production be defined by nature.

Genetic engineering might cure diseases and enhance expansion of the genetic repertoire; it has enhanced food productivity and played a vital role in the agricultural sector. In genetic engineering, the DNA molecule is genetically altered through the process of gene splicing, where by the DNA strand is cut into half and joined with a strand from another species (Nuenke, 2001).

When the human DNA molecule is interfered with and joined to another strand a new DNA molecule is created and the normal genes interfered with through the convergence of the two DNA molecule strands. For example a whole chromosome may be lost or gained such as an extra copy of the small chromosome that causes Down syndrome, or part of a chromosome may ne inverted, but be fully intact.

“And they explain how dominant and recessive genes affect us and how they are transmitted from generation to generation” (Nuenke, 2001). This brings about a revolution of a new human being from its original content and transforming everything that is known in the human body.

Genetic engineering will have an effect on our world, not only on food production but will cause effects on humans and the society. From the cultural perspective, human beings are inviolable and live free according to their rights in the society.

The society accepts them the way they are and the type of life they live, therefore introducing genetic engineering in the human mode of living interferes with the basic concepts and their rights in the society: thus degrading the human subjects into objects that can be designed according to the human knowledge.

The society to accept such a change will have an effect on both the human beings and its environment which we can barely imagine. Introducing genetic engineering in the society means the interference of the parental whim and bringing an artificial generation that has different genetic material from the parental genetics.

Genetic engineering in the last few decades has tried to dominate and control nature and humans causing environmental crisis which the world faces today. Genetic engineering on plants and animal gives the power to dominate nature in an inventive and powerful way creating a lot of pressure on environmental movements. It controls nature intimidating human beings, like other species and making them objects of the manipulative control of genetic engineering.

If we cannot prevent this, then, to protect the environment will become a future burden. The environment is the main component of the relation between humans and the rest of nature. Such an environmental relationship may be soon being imposed upon us and children; hence it must take a lead in alerting the society on the dangers of genetic engineering (Anderson, 2000). Genetic engineering has the ability of transforming the children in the world from their natural assertive to being a commodity.

The application of the germline genetic engineering is believed to convert a child to a commercial product with a high degree of normality and meaning. People who will fall short of productivity will be considered as unproductive while the genetically desirable will be productive economically and politically. This would only increase discrimination in the society and the world by changing the way people live (Streiffer, 2005).

Genetic engineering has been identified with concepts such as cloning and HG E, which determines the child’s life course. The cloning system undermines the child senses and its achievement hence interfering with the genetic materials. The use of the cloning system in the society would be a disastrous concept (Streiffer, 2005).

Parents would likely make children adapt to social means with concern to physical ability, appearance and abilities, even though many of those social norms are inherently oppressive. For instance, disabled children have showed fear that the scientific technology would reduce society tolerance for those genetic losses. If genes pre-disposing people to homosexuality are discovered, it is certain that many people would attempt to engineer the genetic genes out of their offspring.

High rates of cancer and deaths will be experienced if genetic engineering is not avoided on human being. The presentation of the viral vectors that bring the alteration of the DNA molecule results to some complications such as tumors that at a later stage develop cancerous infections. When the transgenes are inverted into the genome they interfere the normal functioning of the genes and cause mutation. The introduction of genetic engineering does not predict its outcomes.

Curing diseases is one of its advantaged and certainly very few people will be against diseases such as Lesch-nyhan syndrome. Implantation genetics have been introduced in the world today to assist in the screening process of genetic diseases. This type of genetic engineering is applicable in phenotype enhancements, whereby genetic manipulation will differ on human heights or muscle mass enlargements or make people look thin.

The inventions of such genetic engineering will have an impact on people because many people will get involved in such ideas while other will neglect such ideas. Changing the inheritable genes of human will affect the structure of the society and create an economic significance through the inherited genes.

In the future generations, if genetic engineering is going to be used on human body then a total interference of the human body mechanism will be hindered. This will range from alteration of the DNA molecule which carries the genetic materials. The normal functioning of the DNA molecule will be altered by the technological introduction of genetic engineering to suit the human’s mode of life.

“A new species is characterized by the inability of its members to engage (under normal conditions) in a productive sexual union with organisms that are outside the species.” (Spier, 2002).

Scientists have come up with a way of changing the genes color, heights and body weight. Many people in the world have their own preferences according to the color, height and weight, therefore they preference having a generation that suits their preferences. Many people are in demand of having there DNA structure interfered with and undergoing a genetic engineering which alters the normal functioning of the DNA molecule (Streiffer, 2005).

Genetic engineering will transform the world completely. It has its capacity in changing the world in so many dimensions producing either positive or negative results. Concerns will be on the rise especially on our future generation especially on genetic engineering. Concerns will arise as a result of genetic engineering which will range from ethical issues to lack of enough knowledge on the effects of genetic engineering. Once the gene is altered and placed in species the process cannot be reversed again.

New introduced genes may also act differently with the natural genes and result to an effect on organism which is termed as unpredictable. After the use of genetic engineering in the world, the world will not be in the position to reverse the normal functioning of the genes, it is a process that will be continued over the next generations and to achieve the normal generation before the occurrence of genetic engineering will not be an easy process or it will not occur at all (Rabino, 2003).

In this case, scientists are ready to carry out the genetic engineering but they won’t be held responsible for the outcomes of genetic engineering. The society should be educated on the positive and negative effects of genetic engineering (Rabino, 2003).

Anderson, C. E. (2000). Genetic engineering: Dangers and opportunities. The Futurist; Mar/Apr 2000; 34, 2; ProQuest.

Nuenke, M. (2001). Improving Nature: The Science and Ethics of Genetic Engineering. Mankind Quarterly; spring 2001; 41, 3; ProQuest.

Rabino, I. (2003). Genetic Testing and Its Implications: Human Genetics Researchers Grapple with Ethical Issues. Empire State College, State University of New York Science, Technology, & Human Values, Vol. 28, No. 3 (Summer, 2003), pp. 365-402 Sage Publications, Inc.

Spier, R. E. (2002). Towards a new human species? Science; Jun 7, 2002; 296, 5574; ProQuest.

Streiffer, R. (2005). At the Edge of Humanity: Human Stem Cells, Chimeras, and Moral Status Kennedy Institute of Ethics Journal; Dec 2005; 15, 4; ProQuest pg. 347

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Essay on Genetic Engineering Its Dangers Pros & Cons | Essay Writing in English

Introduction

Genetic engineering, an advanced scientific field, allows scientists the ability to modify the genetic composition of living organisms. This transformative field empowers scientists to modify, enhance, or introduce specific traits, paving the way for breakthroughs in medicine, agriculture, and beyond. It's like upgrading the software of life.

Applications or Pros

Genetic engineering has a wide range of potential applications that can transform numerous aspects of our lives. In medicine, it enables the development of more effective treatments for diseases. In agriculture, it leads to the creation of crops that are resistant to pests and diseases, increasing food production.

Genetic engineering can enhance the health and productivity of livestock. Genetically modified organisms (GMOs) can be designed to help clean up pollution or mitigate environmental damage. It also holds promise for organ transplantation, drug production, and advancing scientific research in genetics. These are just a few examples of the vast potential that genetic engineering offers across various fields.

Dangers/Challenges or Cons

Genetic engineering introduces GMOs, or Genetically Modified Organisms, offering incredible possibilities alongside significant challenges. There are concerns about the safety of genetically modified organisms (GMOs) for consumption, and possible allergic reactions.

Genetic engineering raises ethical concerns regarding the manipulation of life forms. It may also widen the gap between wealthy and poorer communities in accessing advanced technologies. Overuse of modified crops can harm biodiversity and agriculture's resilience to pests.

In conclusion, genetic engineering has the potential to bring about many positive changes. Yet, it must be handled with care and responsibility to benefit both nature and humanity. Through its mindful use, we can create a better world.

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The Dangers of Genetic Engineering to Humanity

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14.4: Genetic Engineering - Risks, Benefits, and Perceptions

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Learning Objectives

Summarize the mechanisms, risks, and potential benefits of gene therapy
Identify ethical issues involving gene therapy and the regulatory agencies that provide oversight for clinical trials
Compare somatic-cell and germ-line gene therapy

Many types of genetic engineering have yielded clear benefits with few apparent risks. Few would question, for example, the value of our now abundant supply of human insulin produced by genetically engineered bacteria. However, many emerging applications of genetic engineering are much more controversial, often because their potential benefits are pitted against significant risks, real or perceived. This is certainly the case for gene therapy, a clinical application of genetic engineering that may one day provide a cure for many diseases but is still largely an experimental approach to treatment.

Mechanisms and Risks of Gene Therapy

Human diseases that result from genetic mutations are often difficult to treat with drugs or other traditional forms of therapy because the signs and symptoms of disease result from abnormalities in a patient’s genome. For example, a patient may have a genetic mutation that prevents the expression of a specific protein required for the normal function of a particular cell type. This is the case in patients with Severe Combined Immunodeficiency (SCID), a genetic disease that impairs the function of certain white blood cells essential to the immune system.

Gene therapy attempts to correct genetic abnormalities by introducing a nonmutated, functional gene into the patient’s genome. The nonmutated gene encodes a functional protein that the patient would otherwise be unable to produce. Viral vectors such as adenovirus are sometimes used to introduce the functional gene; part of the viral genome is removed and replaced with the desired gene (Figure \(\PageIndex{1}\)). More advanced forms of gene therapy attempt to correct the mutation at the original site in the genome, such as is the case with treatment of SCID.

A diagram of gene therapy. A virus vector contains modified viral DNA that includes an inserted gene. First the vector binds to the cell membrane. The vector is then packaged in a vesicle. The vesicle then breaks down releasing the vector. The cell now makes protein using the new gene.

So far, gene therapies have proven relatively ineffective, with the possible exceptions of treatments for cystic fibrosisand adenosine deaminase deficiency, a type of SCID. Other trials have shown the clear hazards of attempting genetic manipulation in complex multicellular organisms like humans. In some patients, the use of an adenovirus vector can trigger an unanticipated inflammatory response from the immune system, which may lead to organ failure. Moreover, because viruses can often target multiple cell types, the virus vector may infect cells not targeted for the therapy, damaging these other cells and possibly leading to illnesses such as cancer. Another potential risk is that the modified virus could revert to being infectious and cause disease in the patient. Lastly, there is a risk that the inserted gene could unintentionally inactivate another important gene in the patient’s genome, disrupting normal cell cycling and possibly leading to tumor formation and cancer. Because gene therapy involves so many risks, candidates for gene therapy need to be fully informed of these risks before providing informed consent to undergo the therapy.

Gene Therapy Gone Wrong

The risks of gene therapy were realized in the 1999 case of Jesse Gelsinger, an 18-year-old patient who received gene therapy as part of a clinical trial at the University of Pennsylvania. Jesse received gene therapy for a condition called ornithine transcarbamylase (OTC) deficiency, which leads to ammonia accumulation in the blood due to deficient ammonia processing. Four days after the treatment, Jesse died after a massive immune response to the adenovirus vector. 1

Until that point, researchers had not really considered an immune response to the vector to be a legitimate risk, but on investigation, it appears that the researchers had some evidence suggesting that this was a possible outcome. Prior to Jesse’s treatment, several other human patients had suffered side effects of the treatment, and three monkeys used in a trial had died as a result of inflammation and clotting disorders. Despite this information, it appears that neither Jesse nor his family were made aware of these outcomes when they consented to the therapy. Jesse’s death was the first patient death due to a gene therapy treatment and resulted in the immediate halting of the clinical trial in which he was involved, the subsequent halting of all other gene therapy trials at the University of Pennsylvania, and the investigation of all other gene therapy trials in the United States. As a result, the regulation and oversight of gene therapy overall was reexamined, resulting in new regulatory protocols that are still in place today.

Exercise \(\PageIndex{1}\)

Explain how gene therapy works in theory.
Identify some risks of gene therapy.

Oversight of Gene Therapy

Presently, there is significant oversight of gene therapy clinical trials. At the federal level, three agencies regulate gene therapy in parallel: the Food and Drug Administration (FDA), the Office of Human Research Protection (OHRP), and the Recombinant DNA Advisory Committee (RAC) at the National Institutes of Health (NIH). Along with several local agencies, these federal agencies interact with the institutional review board to ensure that protocols are in place to protect patient safety during clinical trials. Compliance with these protocols is enforced mostly on the local level in cooperation with the federal agencies. Gene therapies are currently under the most extensive federal and local review compared to other types of therapies, which are more typically only under the review of the FDA. Some researchers believe that these extensive regulations actually inhibit progress in gene therapy research. In 2013, the Institute of Medicine (now the National Academy of Medicine) called upon the NIH to relax its review of gene therapy trials in most cases. 2 However, ensuring patient safety continues to be of utmost concern.

Ethical Concerns

Beyond the health risks of gene therapy, the ability to genetically modify humans poses a number of ethical issues related to the limits of such “therapy.” While current research is focused on gene therapy for genetic diseases, scientists might one day apply these methods to manipulate other genetic traits not perceived as desirable. This raises questions such as:

Exercise \(\PageIndex{2}\)

Which genetic traits are worthy of being “corrected”?
Should gene therapy be used for cosmetic reasons or to enhance human abilities?
Should genetic manipulation be used to impart desirable traits to the unborn?
Is everyone entitled to gene therapy, or could the cost of gene therapy create new forms of social inequality?
Who should be responsible for regulating and policing inappropriate use of gene therapies?

The ability to alter reproductive cells using gene therapy could also generate new ethical dilemmas. To date, the various types of gene therapies have been targeted to somatic cells, the non-reproductive cells within the body. Because somatic cell traits are not inherited, any genetic changes accomplished by somatic-cell gene therapy would not be passed on to offspring. However, should scientists successfully introduce new genes to germ cells (eggs or sperm), the resulting traits could be passed on to offspring. This approach, called germ-line gene therapy, could potentially be used to combat heritable diseases, but it could also lead to unintended consequences for future generations. Moreover, there is the question of informed consent, because those impacted by germ-line gene therapy are unborn and therefore unable to choose whether they receive the therapy. For these reasons, the U.S. government does not currently fund research projects investigating germ-line gene therapies in humans.

Risky Gene Therapies

While there are currently no gene therapies on the market in the United States, many are in the pipeline and it is likely that some will eventually be approved. With recent advances in gene therapies targeting p53, a gene whose somatic cell mutations have been implicated in over 50% of human cancers, 3 cancer treatments through gene therapies could become much more widespread once they reach the commercial market.

Bringing any new therapy to market poses ethical questions that pit the expected benefits against the risks. How quickly should new therapies be brought to the market? How can we ensure that new therapies have been sufficiently tested for safety and effectiveness before they are marketed to the public? The process by which new therapies are developed and approved complicates such questions, as those involved in the approval process are often under significant pressure to get a new therapy approved even in the face of significant risks.

To receive FDA approval for a new therapy, researchers must collect significant laboratory data from animal trials and submit an Investigational New Drug (IND) application to the FDA’s Center for Drug Evaluation and Research (CDER). Following a 30-day waiting period during which the FDA reviews the IND, clinical trials involving human subjects may begin. If the FDA perceives a problem prior to or during the clinical trial, the FDA can order a “clinical hold” until any problems are addressed. During clinical trials, researchers collect and analyze data on the therapy’s effectiveness and safety, including any side effects observed. Once the therapy meets FDA standards for effectiveness and safety, the developers can submit a New Drug Application (NDA) that details how the therapy will be manufactured, packaged, monitored, and administered.

Because new gene therapies are frequently the result of many years (even decades) of laboratory and clinical research, they require a significant financial investment. By the time a therapy has reached the clinical trials stage, the financial stakes are high for pharmaceutical companies and their shareholders. This creates potential conflicts of interest that can sometimes affect the objective judgment of researchers, their funders, and even trial participants. The Jesse Gelsinger case (see Case in Point: Gene Therapy Gone Wrong ) is a classic example. Faced with a life-threatening disease and no reasonable treatments available, it is easy to see why a patient might be eager to participate in a clinical trial no matter the risks. It is also easy to see how a researcher might view the short-term risks for a small group of study participants as a small price to pay for the potential benefits of a game-changing new treatment.

Gelsinger’s death led to increased scrutiny of gene therapy, and subsequent negative outcomes of gene therapy have resulted in the temporary halting of clinical trials pending further investigation. For example, when children in France treated with gene therapy for SCID began to develop leukemia several years after treatment, the FDA temporarily stopped clinical trials of similar types of gene therapy occurring in the United States. 4 Cases like these highlight the need for researchers and health professionals not only to value human well-being and patients’ rights over profitability, but also to maintain scientific objectivity when evaluating the risks and benefits of new therapies.

Exercise \(\PageIndex{3}\)

Why is gene therapy research so tightly regulated?
What is the main ethical concern associated with germ-line gene therapy?

Key Concepts and Summary

While gene therapy shows great promise for the treatment of genetic diseases, there are also significant risks involved.
There is considerable federal and local regulation of the development of gene therapies by pharmaceutical companies for use in humans.
Before gene therapy use can increase dramatically, there are many ethical issues that need to be addressed by the medical and research communities, politicians, and society at large.
1 Barbara Sibbald. “Death but One Unintended Consequence of Gene-Therapy Trial.” Canadian Medical Association Journal 164 no. 11 (2001): 1612–1612.
2 Kerry Grens. “Report: Ease Gene Therapy Reviews.” The Scientist , December 9, 2013. http://www.the-scientist.com/?articl...erapy-Reviews/ . Accessed May 27, 2016.
3 Zhen Wang and Yi Sun. “Targeting p53 for Novel Anticancer Therapy.” Translational Oncology 3 , no. 1 (2010): 1–12.
4 Erika Check. “Gene Therapy: A Tragic Setback.” Nature 420 no. 6912 (2002): 116–118.

Essay on The Dangers of Genetic Engineering

Genetic engineering has a fine line to when it becomes unethical. Ethically new research has offered to help people with disabilities and prevent them to better a persons life. The line is drawn when parents have the choice to modify their child through genomics, This may seem fine, but unfortunately parents are bettering their children to either make them smarter or more athletic. This modification endangers the child's life by unbalancing their original balance. Genomics allows a person to have their DNA modified to enhance them in certain areas such as sports or academics. Unfortunately these enhancements can have side effects that harm or endanger the life of that person. The process of modifying someone can be done while in the …show more content…

But to do so would require healthy stem cells to be cloned from. William Hurlbut stated that this will, “Mark the beginning of a whole new chapter of moral scientific controversy” (Gibson David). Is this ethical to make clones in an abnormal way? In Frankenstein the monster generates abilities such as “speech and emotion”, For example the monster finds Victors brother william and ends up acting on hate and kills him” (Shelly). Would clones be able to develop these same characteristics and control their emotions or act on them? In the book Frankenstein the monster asks Victor to make him a girl monster. Victor agrees to the request but later destroyed his work fearing they would have monstrous children together (Shelly). Should we destroy are works on genetic engineering fearing a traitorous outcome? Would creating a life in an abnormal meaning create a different breed of children if two modified beings reproduced? If this where to happen would they have special powers or abilities compared to a normal human ? How would people look at this different breed? In Frankenstein the monster finds some people a man in particular who look past his appearance and problems, and relates to him, Although some people in the book can not get over and want to kill him or hurt him (shelly). But how would people in todays society see people who are different? After all, we have had many problems with discrimination

Genetic Engineering In Mary Shelley's Frankenstein

With new technology it allows us to further research to attempt to benefit humanity and the environment people live in. As well as the genetic engineering playing a positive role in helping with “agriculture, aquaculture, bioremediation, and environmental management, both in developed and developing countries. However, deliberate or inadvertent releases of genetically engineered organisms into the environment could have negative ecological impacts under some circumstances”(Coker 24). With the engineering of plants and medicines, there seems to be no harm done if something were to go wrong and hurt the plant or the medicine just doesn’t turn out right. There comes a point when scientists cross a line and that is when they start to create designer babies. With designer babies, it gives the mother and the father the ability to change and enhance the outcome of their child. The parents are given the opportunity to improve the way their child's “eyesight could be greatly improved, perhaps even allowing [them] to see wavelengths of light that are currently ‘invisible’ to us” (Coker 26). Having a child with not only enhanced eyesight, but with them having your choice of hair color, the eye color you have chosen, or allowing them to have enhanced strength people are interrupting the natural way a child is supposed to be created. A child who has been genetically engineered to have enhanced strength is a child how going to ruin the way sports are played fairly. A child who has been born naturally and has had nothing altered about him will be no match against a genetically engineered one. Some people would take into consideration that the religious church would believe that genetically engineering anything is not moral. Inside “the moral evaluation of germ line cell therapy is different. Whatever genetic modifications are effected on the germ cells of a person will be transmitted to any potential

Genetic Engineering Argumentative Essay

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Ethical Border For Research Essay

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Why Do We Need Genetic Manipulation?

It is incredible to see how far genetic engineering has come. Humans, plants, and any living organism can now be manipulated. Scientists have found ways to change humans before they are even born. They can remove, add, or alter genes in the human genome. Making things possible that humans (even thirty years ago) would have never imagined. Richard Hayes claims in SuperSize Your Child? that genetic engineering needs to have limitations. That genetic engineering should be used for medical purposes, but not for “genetic modification that could open the door to high-tech eugenic engineering” (188). There is no doubt that genetic engineering can amount to great things, but without limits it could lead the human race into a future that no one

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The Dangers of Genetically Modified Organisms (GMO) Essay

34 Works Cited

Recently, there has been a huge uprise in reports from all over the world of new diseases that have affected much of the population today. Diseases such as obesity, Alzheimer’s, Celiac Disease, Attention Deficit Hyperactivity Disorder (ADHD), and so much more have been on the rise. Researchers have suspected the culprit of these diseases to be our food. Along with the diseases, Genetically Modified Organisms (GMO) has also been on the rise. The more poor food we eat, the greater the potential harm to our health. One of the poor foods we consume is GMO: the altering of genes in food to produce desirable effects. These effects can range from an improvement in nutritional value, texture, flavor, and a longer shelf life. These

Genetic Modification: Bad For The World

When it comes to the topic of Genetic Modification, some scientists will readily disagree that Genetic Modification is bad for the world. Some are convinced that genetically modified babies will be good for the world, while others maintain the reasoning that having genetically modified humans in our society will create problems with non-modified humans. They’re afraid there will be chaos in the world. Where this argument usually ends is on the question of, do the parents have the right reasons for genetically modifying their babies. Though I agree that genetic modification should be used, I also agree that there should be regulations put in place.

The Controversy Of Genetic Engineering

Genetic Engineering, for most individuals not knowledgeable on the topic, conjures visions of sci-fi movies and humans being grown in a lab far off in the future. What more and more individuals in the early 21st century are coming to realize is that Genetic Engineering has already exceeded our wildest imaginations in a dark corner of a lab, outside of the view of the main stream public. Indeed, in 2017, genetic engineering is in full swing on both plant and animal life. Only from hearing major news stories such as Dolly the world 's first cloned sheep or GMOs already being a major part of North America 's corn production, have the masses been made aware of the sweeping advances that science has been able to make. Now that we as a

Technology, it 's a word that defines the means and ways of everyday life today. In the 21st century, technology is a crucial thing. From plasma televisions, to ipods and iphones, technology conquers all. Apart from everyday uses of technology, science and research technology is making a huge impact in medical and research science. Teens and young adults today are unaware of these growing trend of using technology in medical science. Currently, the use of technology in gene manipulation and engineering is creating a hype. Genetic engineering is the process of taking any specific gene from a living thing and genetically manipulating it to be added into the genetic code of another living thing. This means, since plants and humans, and

Cloning has always been a symbol of advancement and intelligence in our society. Its uncertainty may cause people’ hostility towards this unknown technology. I think the exploration of cloning should be supported and we should pursue further improvement. The knowledge should be widely applied to medical, agricultural and reproduction uses, but should be withheld to the stage of physical characteristics or phenotypes modification. I think genetic engineering is a very promising scientific field which can benefit the human society profoundly especially for the medical uses. The research of genetic engineering can also largely contribute to solving scarcity and increase reproduction of limited resources to higher economy of scale. Nevertheless genetic engineering is still a very controversial problem and many opposed opinions may be raised. I will try to prove otherwise that people can obtain more advantages from mastering this technology.

The Negative Effects Of Genetic Engineering In Humans

Because of the positive results that genetic engineering in humans has brought up, it is just to say, human genetic engineering is both helpful and ethical. With this advanced technology, death in newborns will decrease and more lives will be saved. Just like everything, however, the power of human genetic engineering should be used moderately and smartly. With the use of modifying genes the people will live healthier lives.

Genetic Engineering: Therapeutic vs Enhancement Essay

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On the other hand, the other form of genetic engineering, gene enhancement is the idea of improving average typical genes to be above average. Therapeutic treatment is acceptable, if parents can prevent their child from having a serious or fatal disease, they should be able to pay for genetic treatment if they can afford to do so. However, I completely disagree with the process of genetic enhancement; a parent should not be able to alter their child’s genes from typical or average to above average. If humans even consider gene enhancement for their children, they should revise what is morally and ethically right and wrong. The thought of parents one day being able to enhance or perfect the genes of their expected child is by all means wrong. Children should not be born into a world where their ultimate choices have been made by their parents before the moment of their birth. Children’s genes should be left untouched unless there is something terribly wrong, such as a sickness or disease.

Genetic Engineering & Bioethical Concerns

Bioethics is a relational field of science that deals with the intersection of biological scientific practices and ethical concerns raised by these procedures. Genetic engineering is a relatively new scientific practice and is greatly concerned with the field of bioethics, as it raises many worries revolving around the blurred moral lines of manipulating a person’s genome.This method of engineering the human genome originated from the idea that cancers and other terminal diseases could be cured by essentially switching off harmful genes that could code for these ailments. Moreover, the origin of moral and even financial concerns with genetic engineering can be traced to the potential marketing of gene manipulation as a commercial product where parents can choose what genes to alter in their unborn child, in an order to produce a super baby. Finally, a great deal of research, as well as ethical protests, have been put into potentially altering a person’s lifespan to yield humans who exhibit the ability to live much longer lives than currently possible. Genetic engineering is a dangerous and morally wrong scientific procedure that if pursued will bring harm to the general population and destroy the ethical boundaries of science within bioethics and scientific research.

Genetic Engineering in Humans Essay

Author Chuck Klosterman said, “The simple truth is that we’re all already cyborgs more or less. Our mouths are filled with silver. Our nearsighted pupils are repaired with surgical lasers. We jam diabetics full of delicious insulin. Almost 40 percent of Americans now have prosthetic limbs. We see to have no qualms about making post-birth improvements to our feeble selves. Why are we so uncomfortable with pre-birth improvement?” Despite Klosterman’s accurate observation, there are reasons people are wearisome toward pre-birth enhancement. Iniquitous practices such as genetic engineering could lead to a degraded feeling in a child and conceivably end in a dystopian society, almost like the society Adolf Hitler had in mind. In the minds of

The Ethics Of Genetic Engineering

Genetic engineering has to do with manipulating organisms and DNA to create body characteristics. The practice of genetic DNA has shown an increasing amount over the past years. The process of genetic enhancement involves manipulating organisms by using biotechnologies. The technique is by removing a DNA from one life form and transferring it to another set of traits or organism. Certain barriers are conquered, and the procedure involves changing a form of cells, resulting from an improvement or developed organism. GMO which is a (Genetic Modified Organisms) is the operation done in a laboratory where DNA genetic from one particular species or animals is directly forced into another gene from an unrelated subject of plants or even animals.

Genetic engineering of animals: Ethical issues, including welfare concerns

The genetic engineering of animals has increased significantly in recent years, and the use of this technology brings with it ethical issues, some of which relate to animal welfare — defined by the World Organisation for Animal Health as “the state of the animal…how an animal is coping with the conditions in which it lives” ( 1 ). These issues need to be considered by all stakeholders, including veterinarians, to ensure that all parties are aware of the ethical issues at stake and can make a valid contribution to the current debate regarding the creation and use of genetically engineered animals. In addition, it is important to try to reflect societal values within scientific practice and emerging technology, especially publicly funded efforts that aim to provide societal benefits, but that may be deemed ethically contentious. As a result of the extra challenges that genetically engineered animals bring, governing bodies have started to develop relevant policies, often calling for increased vigilance and monitoring of potential animal welfare impacts ( 2 ). Veterinarians can play an important role in carrying out such monitoring, especially in the research setting when new genetically engineered animal strains are being developed.

Several terms are used to describe genetically engineered animals: genetically modified, genetically altered, genetically manipulated, transgenic, and biotechnology-derived, amongst others. In the early stages of genetic engineering, the primary technology used was transgenesis, literally meaning the transfer of genetic material from one organism to another. However, with advances in the field, new technology emerged that did not necessarily require transgenesis: recent applications allow for the creation of genetically engineered animals via the deletion of genes, or the manipulation of genes already present. To reflect this progress and to include those animals that are not strictly transgenic, the umbrella term “genetically engineered” has been adopted into the guidelines developed by the Canadian Council on Animal Care (CCAC). For clarity, in the new CCAC guidelines on: genetically-engineered animals used in science (currently in preparation) the CCAC offers the following definition of a genetically engineered animal: “an animal that has had a change in its nuclear or mitochondrial DNA (addition, deletion, or substitution of some part of the animal’s genetic material or insertion of foreign DNA) achieved through a deliberate human technological intervention.” Those animals that have undergone induced mutations (for example, by chemicals or radiation — as distinct from spontaneous mutations that naturally occur in populations) and cloned animals are also considered to be genetically engineered due to the direct intervention and planning involved in creation of these animals.

Cloning is the replication of certain cell types from a “parent” cell, or the replication of a certain part of the cell or DNA to propagate a particular desirable genetic trait. There are 3 types of cloning: DNA cloning, therapeutic cloning, and reproductive cloning ( 3 ). For the purposes of this paper, the term “cloning” is used to refer to reproductive cloning, as this is the most likely to lead to animal welfare issues. Reproductive cloning is used if the intention is to generate an animal that has the same nuclear DNA as another currently, or previously existing animal. The process used to generate this type of cloned animal is called somatic cell nuclear transfer (SCNT) ( 4 ).

During the development of the CCAC guidelines on: genetically- engineered animals used in science, some key ethical issues, including animal welfare concerns, were identified: 1) invasiveness of procedures; 2) large numbers of animals required; 3) unanticipated welfare concerns; and 4) how to establish ethical limits to genetic engineering (see Ethical issues of genetic engineering). The different applications of genetically engineered animals are presented first to provide context for the discussion.

Current context of genetically engineered animals

Genetic engineering technology has numerous applications involving companion, wild, and farm animals, and animal models used in scientific research. The majority of genetically engineered animals are still in the research phase, rather than actually in use for their intended applications, or commercially available.

Companion animals

By inserting genes from sea anemone and jellyfish, zebrafish have been genetically engineered to express fluorescent proteins — hence the commonly termed “GloFish.” GloFish began to be marketed in the United States in 2003 as ornamental pet fish; however, their sale sparked controversial ethical debates in California — the only US state to prohibit the sale of GloFish as pets ( 5 ). In addition to the insertion of foreign genes, gene knock-out techniques are also being used to create designer companion animals. For example, in the creation of hypoallergenic cats some companies use genetic engineering techniques to remove the gene that codes for the major cat allergen Fel d1: ( http://www.felixpets.com/technology.html ).

Companion species have also been derived by cloning. The first cloned cat, “CC,” was created in 2002 ( 6 ). At the time, the ability to clone mammals was a coveted prize, and after just a few years scientists created the first cloned dog, “Snuppy” ( 7 ).

With the exception of a couple of isolated cases, the genetically engineered pet industry is yet to move forward. However, it remains feasible that genetically engineered pets could become part of day-to-day life for practicing veterinarians, and there is evidence that clients have started to enquire about genetic engineering services, in particular the cloning of deceased pets ( 5 ).

Wild animals

The primary application of genetic engineering to wild species involves cloning. This technology could be applied to either extinct or endangered species; for example, there have been plans to clone the extinct thylacine and the woolly mammoth ( 5 ). Holt et al ( 8 ) point out that, “As many conservationists are still suspicious of reproductive technologies, it is unlikely that cloning techniques would be easily accepted. Individuals involved in field conservation often harbour suspicions that hi-tech approaches, backed by high profile publicity would divert funding away from their own efforts.” However, cloning may prove to be an important tool to be used alongside other forms of assisted reproduction to help retain genetic diversity in small populations of endangered species.

Farm animals

As reviewed by Laible ( 9 ), there is “an assorted range of agricultural livestock applications [for genetic engineering] aimed at improving animal productivity; food quality and disease resistance; and environmental sustainability.” Productivity of farm animal species can be increased using genetic engineering. Examples include transgenic pigs and sheep that have been genetically altered to express higher levels of growth hormone ( 9 ).

Genetically engineered farm animals can be created to enhance food quality ( 9 ). For example, pigs have been genetically engineered to express the Δ12 fatty acid desaturase gene (from spinach) for higher levels of omega-3, and goats have been genetically engineered to express human lysozyme in their milk. Such advances may add to the nutritional value of animal-based products.

Farm species may be genetically engineered to create disease-resistant animals ( 9 ). Specific examples include conferring immunity to offspring via antibody expression in the milk of the mother; disruption of the virus entry mechanism (which is applicable to diseases such as pseudorabies); resistance to prion diseases; parasite control (especially in sheep); and mastitis resistance (particularly in cattle).

Genetic engineering has also been applied with the aim of reducing agricultural pollution. The best-known example is the Enviropig TM ; a pig that is genetically engineered to produce an enzyme that breaks down dietary phosphorus (phytase), thus limiting the amount of phosphorus released in its manure ( 9 ).

Despite resistance to the commercialization of genetically engineered animals for food production, primarily due to lack of support from the public ( 10 ), a recent debate over genetically engineered AquAdvantage TM Atlantic salmon may result in these animals being introduced into commercial production ( 11 ).

Effort has also been made to generate genetically engineered farm species such as cows, goats, and sheep that express medically important proteins in their milk. According to Dyck et al ( 12 ), “transgenic animal bioreactors represent a powerful tool to address the growing need for therapeutic recombinant proteins.” In 2006, ATryn ® became the first therapeutic protein produced by genetically engineered animals to be approved by the Food and Drug Administration (FDA) of the United States. This product is used as a prophylactic treatment for patients that have hereditary antithrombin deficiency and are undergoing surgical procedures.

Research animals

Biomedical applications of genetically engineered animals are numerous, and include understanding of gene function, modeling of human disease to either understand disease mechanisms or to aid drug development, and xenotransplantation.

Through the addition, removal, or alteration of genes, scientists can pinpoint what a gene does by observing the biological systems that are affected. While some genetic alterations have no obvious effect, others may produce different phenotypes that can be used by researchers to understand the function of the affected genes. Genetic engineering has enabled the creation of human disease models that were previously unavailable. Animal models of human disease are valuable resources for understanding how and why a particular disease develops, and what can be done to halt or reverse the process. As a result, efforts have focused on developing new genetically engineered animal models of conditions such as Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and cancer. However, as Wells ( 13 ) points out: “these [genetically engineered animal] models do not always accurately reflect the human condition, and care must be taken to understand the limitation of such models.”

The use of genetically engineered animals has also become routine within the pharmaceutical industry, for drug discovery, drug development, and risk assessment. As discussed by Rudmann and Durham ( 14 ): “Transgenic and knock out mouse models are extremely useful in drug discovery, especially when defining potential therapeutic targets for modifying immune and inflammatory responses…Specific areas for which [genetically engineered animal models] may be useful are in screening for drug induced immunotoxicity, genotoxicity, and carcinogenicity, and in understanding toxicity related drug metabolizing enzyme systems.”

Perhaps the most controversial use of genetically engineered animals in science is to develop the basic research on xenotrans-plantation — that is, the transplant of cells, tissues, or whole organs from animal donors into human recipients. In relation to organ transplants, scientists have developed a genetically engineered pig with the aim of reducing rejection of pig organs by human recipients ( 15 ). This particular application of genetic engineering is currently at the basic research stage, but it shows great promise in alleviating the long waiting lists for organ transplants, as the number of people needing transplants currently far outweighs the number of donated organs. However, as a direct result of public consultation, a moratorium is currently in place preventing pig organ transplantation from entering a clinical trial phase until the public is assured that the potential disease transfer from pigs to humans can be satisfactorily managed ( 16 ). According to Health Canada, “xenotransplantation is currently not prohibited in Canada. However, the live cells and organs from animal sources are considered to be therapeutic products (drugs or medical devices)…No clinical trial involving xenotransplantation has yet been approved by Health Canada” (see http://www.hc-sc.gc.ca for details).

Ethical issues of genetic engineering

Ethical issues, including concerns for animal welfare, can arise at all stages in the generation and life span of an individual genetically engineered animal. The following sections detail some of the issues that have arisen during the peer-driven guidelines development process and associated impact analysis consultations carried out by the CCAC. The CCAC works to an accepted ethic of animal use in science, which includes the principles of the Three Rs (Reduction of animal numbers, Refinement of practices and husbandry to minimize pain and distress, and Replacement of animals with non-animal alternatives wherever possible) ( 17 ). Together the Three Rs aim to minimize any pain and distress experienced by the animals used, and as such, they are considered the principles of humane experimental technique. However, despite the steps taken to minimize pain and distress, there is evidence of public concerns that go beyond the Three Rs and animal welfare regarding the creation and use of genetically engineered animals ( 18 ).

Concerns for animal welfare

Invasiveness of procedures.

The generation of a new genetically engineered line of animals often involves the sacrifice of some animals and surgical procedures (for example, vasectomy, surgical embryo transfer) on others. These procedures are not unique to genetically engineered animals, but they are typically required for their production.

During the creation of new genetically engineered animals (particularly mammalian species) oocyte and blastocyst donor females may be induced to superovulate via intraperitoneal or subcutaneous injection of hormones; genetically engineered embryos may be surgically implanted to female recipients; males may be surgically vasectomized under general anesthesia and then used to induce pseudopregnancy in female embryo recipients; and all offspring need to be genotyped, which is typically performed by taking tissue samples, sometimes using tail biopsies or ear notching ( 19 ). However, progress is being made to refine the genetic engineering techniques that are applied to mammals (mice in particular) so that less invasive methods are feasible. For example, typical genetic engineering procedures require surgery on the recipient female so that genetically engineered embryos can be implanted and can grow to full term; however, a technique called non-surgical embryo transfer (NSET) acts in a similar way to artificial insemination, and removes the need for invasive surgery ( 20 ). Other refinements include a method referred to as “deathless transgenesis,” which involves the introduction of DNA into the sperm cells of live males and removes the need to euthanize females in order to obtain germ line transmission of a genetic alteration; and the use of polymerase chain reaction (PCR) for genotyping, which requires less tissue than Southern Blot Analysis ( 20 ).

Large numbers of animals required

Many of the embryos that undergo genetic engineering procedures do not survive, and of those that do survive only a small proportion (between 1% to 30%) carry the genetic alteration of interest ( 19 ). This means that large numbers of animals are produced to obtain genetically engineered animals that are of scientific value, and this contradicts efforts to minimize animal use. In addition, the advancement of genetic engineering technologies in recent years has lead to a rapid increase in the number and varieties of genetically engineered animals, particularly mice ( 21 ). Although the technology is continually being refined, current genetic engineering techniques remain relatively inefficient, with many surplus animals being exposed to harmful procedures. One key refinement and reduction effort is the preservation of genetically engineered animal lines through the freezing of embryos or sperm (cryopreservation), which is particularly important for those lines with the potential to experience pain and distress ( 22 ).

As mentioned, the number of research projects creating and/or using genetically engineered animals worldwide has increased in the past decade ( 21 ). In Canada, the CCAC’s annual data on the numbers of animals used in science show an increase in Category D procedures (procedures with the potential to cause moderate to severe pain and distress) — at present the creation of a new genetically engineered animal line is a Category D procedure ( 23 ). The data also show an increase in the use of mice ( 24 ), which are currently the most commonly used species for genetic engineering, making up over 90% of the genetically engineered animals used in research and testing ( 21 ). This rise in animal use challenges the Three Rs principle of Reduction ( 17 ). It has been reasoned that once created, the use of genetically engineered animals will reduce the total number of animals used in any given experiment by providing novel and more accurate animal models, especially in applications such as toxicity testing ( 25 ). However, the greater variety of available applications, and the large numbers of animals required for the creation and maintenance of new genetically engineered strains indicate that there is still progress to be made in implementation of the Three Rs principle of Reduction in relation to the creation and use of genetically engineered animals ( 21 ).

Unanticipated welfare concerns

Little data has been collected on the net welfare impacts to genetically engineered animals or to those animals required for their creation, and genetic engineering techniques have been described as both unpredictable and inefficient ( 19 ). The latter is due, in part, to the limitations in controlling the integration site of foreign DNA, which is inherent in some genetic engineering techniques (such as pro-nuclear microinjection). In such cases, scientists may generate several independent lines of genetically engineered animals that differ only in the integration site ( 26 ), thereby further increasing the numbers of animals involved. This conflicts with efforts to adhere to the principles of the Three Rs, specifically Reduction. With other, more refined techniques that allow greater control of DNA integration (for example, gene targeting), unexpected outcomes are attributed to the unpredictable interaction of the introduced DNA with host genes. These interactions also vary with the genetic background of the animal, as has frequently been observed in genetically engineered mice ( 27 ). Interfering with the genome by inserting or removing fragments of DNA may result in alteration of the animal’s normal genetic homeostasis, which can be manifested in the behavior and well-being of the animals in unpredictable ways. For example, many of the early transgenic livestock studies produced animals with a range of unexpected side effects including lameness, susceptibility to stress, and reduced fertility ( 9 ).

A significant limitation of current cloning technology is the prospect that cloned offspring may suffer some degree of abnormality. Studies have revealed that cloned mammals may suffer from developmental abnormalities, including extended gestation; large birth weight; inadequate placental formation; and histological effects in organs and tissues (for example, kidneys, brain, cardiovascular system, and muscle). One annotated review highlights 11 different original research articles that documented the production of cloned animals with abnormalities occurring in the developing embryo, and suffering for the newborn animal and the surrogate mother ( 28 ).

Genetically engineered animals, even those with the same gene manipulation, can exhibit a variety of phenotypes; some causing no welfare issues, and some causing negative welfare impacts. It is often difficult to predict the effects a particular genetic modification can have on an individual animal, so genetically engineered animals must be monitored closely to mitigate any unanticipated welfare concerns as they arise. For newly created genetically engineered animals, the level of monitoring needs to be greater than that for regular animals due to the lack of predictability. Once a genetically engineered animal line is established and the welfare concerns are known, it may be possible to reduce the levels of monitoring if the animals are not exhibiting a phenotype that has negative welfare impacts. To aid this monitoring process, some authors have called for the implementation of a genetically engineered animal passport that accompanies an individual animal and alerts animal care staff to the particular welfare needs of that animal ( 29 ). This passport document is also important if the intention is to breed from the genetically engineered animal in question, so the appropriate care and husbandry can be in place for the offspring.

With progress in genetic engineering techniques, new methods ( 30 , 31 ) may substantially reduce the unpredictability of the location of gene insertion. As a result, genetic engineering procedures may become less of a welfare concern over time.

Beyond animal welfare

As pointed out by Lassen et al ( 32 ), “Until recently the main limits [to genetic engineering] were technical: what it is possible to do. Now scientists are faced with ethical limits as well: what it is acceptable to do” (emphasis theirs). Questions regarding whether it is acceptable to make new transgenic animals go beyond consideration of the Three Rs, animal health, and animal welfare, and prompt the discussion of concepts such as intrinsic value, integrity, and naturalness ( 33 ).

When discussing the “nature” of an animal, it may be useful to consider the Aristotelian concept of telos, which describes the “essence and purpose of a creature” ( 34 ). Philosopher Bernard Rollin applied this concept to animal ethics as follows: “Though [ telos ] is partially metaphysical (in defining a way of looking at the world), and partially empirical (in that it can and will be deepened and refined by increasing empirical knowledge), it is at root a moral notion, both because it is morally motivated and because it contains the notion of what about an animal we ought to at least try to respect and accommodate” (emphasis Rollin’s) ( 34 ). Rollin has also argued that as long as we are careful to accommodate the animal’s interests when we alter an animal’s telos, it is morally permissible. He writes, “…given a telos, we should respect the interests which flow from it. This principle does not logically entail that we cannot modify the telos and thereby generate different or alternative interests” ( 34 ).

Views such as those put forward by Rollin have been argued against on the grounds that health and welfare (or animal interests) may not be the only things to consider when establishing ethical limits. Some authors have made the case that genetic engineering requires us to expand our existing notions of animal ethics to include concepts of the intrinsic value of animals ( 35 ), or of animal “integrity” or “dignity” ( 33 ). Veerhoog argues that, “we misuse the word telos when we say that human beings can ‘change’ the telos of an animal or create a new telos ” — that is to say animals have intrinsic value, which is separate from their value to humans. It is often on these grounds that people will argue that genetic engineering of animals is morally wrong. For example, in a case study of public opinion on issues related to genetic engineering, participants raised concerns about the “nature” of animals and how this is affected (negatively) by genetic engineering ( 18 ).

An alternative view put forward by Schicktanz ( 36 ) argues that it is the human-animal relationship that may be damaged by genetic engineering due to the increasingly imbalanced distribution of power between humans and animals. This imbalance is termed “asymmetry” and it is raised alongside “ambivalence” as a concern regarding modern human-animal relationships. By using genetically engineered animals as a case study, Schicktanz ( 36 ) argues that genetic engineering presents “a troubling shift for all human-animal relationships.”

Opinions regarding whether limits can, or should, be placed on genetic engineering are often dependent on people’s broader worldview. For some, the genetic engineering of animals may not put their moral principles at risk. For example, this could perhaps be because genetic engineering is seen as a logical continuation of selective breeding, a practice that humans have been carrying out for years; or because human life is deemed more important than animal life. So if genetic engineering creates animals that help us to develop new human medicine then, ethically speaking, we may actually have a moral obligation to create and use them; or because of an expectation that genetic engineering of animals can help reduce experimental animal numbers, thus implementing the accepted Three Rs framework.

For others, the genetic engineering of animals may put their moral principles at risk. For example costs may always be seen to outweigh benefits because the ultimate cost is the violation of species integrity and disregard for the inherent value of animals. Some may view telos as something that cannot or should not be altered, and therefore altering the telos of an animal would be morally wrong. Some may see genetic engineering as exaggerating the imbalance of power between humans and animals, whilst others may fear that the release of genetically engineered animals will upset the natural balance of the ecosystem. In addition, there may be those who feel strongly opposed to certain applications of genetic engineering, but more accepting of others. For example, recent evidence suggests that people may be more accepting of biomedical applications than those relating to food production ( 37 ).

Such underlying complexity of views regarding genetic engineering makes the setting of ethical limits difficult to achieve, or indeed, even discuss. However, progress needs to be made on this important issue, especially for those genetically engineered species that are intended for life outside the research laboratory, where there may be less careful oversight of animal welfare. Consequently, limits to genetic engineering need to be established using the full breadth of public and expert opinion. This highlights the importance for veterinarians, as animal health experts, to be involved in the discussion.

Other ethical issues

Genetic engineering also brings with it concerns over intellectual property, and patenting of created animals and/or the techniques used to create them. Preserving intellectual property can breed a culture of confidentiality within the scientific community, which in turn limits data and animal sharing. Such limits to data and animal sharing may create situations in which there is unnecessary duplication of genetically engineered animal lines, thereby challenging the principle of Reduction. Indeed, this was a concern that was identified in a recent workshop on the creation and use of genetically engineered animals in science ( 20 ).

It should be noted that no matter what the application of genetically engineered animals, there are restrictions on the methods of their disposal once they have been euthanized. The reason for this is to restrict the entry of genetically engineered animal carcasses into the natural ecosystem until the long-term effects and risks are better understood. Environment Canada ( http://www.ec.gc.ca/ ) and Health Canada ( http://www.hc-sc.gc.ca/ ) offer specific guidelines in this regard.

Implications for veterinarians

As genetically engineered animals begin to enter the commercial realm, it will become increasingly important for veterinarians to inform themselves about any special care and management required by these animals. As animal health professionals, veterinarians can also make important contributions to policy discussions related to the oversight of genetic engineering as it is applied to animals, and to regulatory proceedings for the commercial use of genetically engineered animals.

It is likely that public acceptance of genetically engineered animal products will be an important step in determining when and what types of genetically engineered animals will appear on the commercial market, especially those animals used for food production. Veterinarians may also be called on to inform the public about genetic engineering techniques and any potential impacts to animal welfare and food safety. Consequently, for the discussion regarding genetically engineered animals to progress effectively, veterinarians need to be aware of the current context in which genetically engineered animals are created and used, and to be aware of the manner in which genetic engineering technology and the animals derived from it may be used in the future.

Genetic engineering techniques can be applied to a range of animal species, and although many genetically engineered animals are still in the research phase, there are a variety of intended applications for their use. Although genetic engineering may provide substantial benefits in areas such as biomedical science and food production, the creation and use of genetically engineered animals not only challenge the Three Rs principles, but may also raise ethical issues that go beyond considerations of animal health, animal welfare, and the Three Rs, opening up issues relating to animal integrity and/or dignity. Consequently, even if animal welfare can be satisfactorily safeguarded, intrinsic ethical concerns about the genetic engineering of animals may be cause enough to restrict certain types of genetically engineered animals from reaching their intended commercial application. Given the complexity of views regarding genetic engineering, it is valuable to involve all stakeholders in discussions about the applications of this technology.

Acknowledgments

The authors thank the members of the Canadian Veterinary Medicine Association Animal Welfare Committee for their comments on the draft, and Dr. C. Schuppli for her insight on how the issues discussed may affect veterinarians.

Use of this article is limited to a single copy for personal study. Anyone interested in obtaining reprints should contact the CVMA office ( gro.vmca-amvc@nothguorbh ) for additional copies or permission to use this material elsewhere.

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Published: 20 April 2022

Beyond safety: mapping the ethical debate on heritable genome editing interventions

Mara Almeida ORCID: orcid.org/0000-0002-0435-6296 1 &
Robert Ranisch ORCID: orcid.org/0000-0002-1676-1694 2 , 3

Humanities and Social Sciences Communications volume 9 , Article number: 139 ( 2022 ) Cite this article

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Medical humanities
Science, technology and society

Genetic engineering has provided humans the ability to transform organisms by direct manipulation of genomes within a broad range of applications including agriculture (e.g., GM crops), and the pharmaceutical industry (e.g., insulin production). Developments within the last 10 years have produced new tools for genome editing (e.g., CRISPR/Cas9) that can achieve much greater precision than previous forms of genetic engineering. Moreover, these tools could offer the potential for interventions on humans and for both clinical and non-clinical purposes, resulting in a broad scope of applicability. However, their promising abilities and potential uses (including their applicability in humans for either somatic or heritable genome editing interventions) greatly increase their potential societal impacts and, as such, have brought an urgency to ethical and regulatory discussions about the application of such technology in our society. In this article, we explore different arguments (pragmatic, sociopolitical and categorical) that have been made in support of or in opposition to the new technologies of genome editing and their impact on the debate of the permissibility or otherwise of human heritable genome editing interventions in the future. For this purpose, reference is made to discussions on genetic engineering that have taken place in the field of bioethics since the 1980s. Our analysis shows that the dominance of categorical arguments has been reversed in favour of pragmatic arguments such as safety concerns. However, when it comes to involving the public in ethical discourse, we consider it crucial widening the debate beyond such pragmatic considerations. In this article, we explore some of the key categorical as well sociopolitical considerations raised by the potential uses of heritable genome editing interventions, as these considerations underline many of the societal concerns and values crucial for public engagement. We also highlight how pragmatic considerations, despite their increasing importance in the work of recent authoritative sources, are unlikely to be the result of progress on outstanding categorical issues, but rather reflect the limited progress on these aspects and/or pressures in regulating the use of the technology.

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Abbie Jedwab, Danya F. Vears, … Christopher Gyngell

essay on genetic engineering and its dangers

Between desire and fear: a qualitative interview study exploring the perspectives of carriers of a genetic condition on human genome editing

Wendy Geuverink, Carla van El, … Linda Martin

The interplay of ethics and genetic technologies in balancing the social valuation of the human genome in UNESCO declarations

Hristina Gaydarska, Kayo Takashima, … Jusaku Minari

Introduction

The ability to alter a sequence of genetic material was initially developed in microorganisms during the 1970s and 1980s (for an overview: Walters et al., 2021 ). Since then, technological advances have allowed researchers to alter DNA in different organisms by introducing a new gene or by modifying the sequence of bases in the genome. The manipulation of the genome of living organisms (typically plants) continues a course that science embraced more than 40 years ago, and may ultimately allow, if not deliberately curtailed by societal decisions, the possibility of manipulating and controlling genetic material of other living species, including humans.

Genetic engineering can be used in a diverse range of contexts, including research (e.g., to build model organisms), pharmacology (e.g., for insulin production) and agriculture (e.g., to improve crop resistance to environmental pressures such as diseases, or to increase yield). Beyond these applications, modern genetic engineering techniques such as genome editing technologies have the potential to be an innovative tool in clinical interventions but also outside the clinical realm. In the clinical context, genome editing techniques are expected to help in both disease prevention and in treatment (Porteus, 2019 ; Zhang, 2019 ). Nevertheless, genome editing technology raises several questions, including the implications of its use for human germline cells or embryos, since the technology’s use could facilitate heritable genome editing interventions (Lea and Niakan, 2019 ). This possible use has fuelled a heated debate and fierce opposition, as illustrated by the moratoriums proposed by researchers and international institutions on the use of the technology (Lander et al., 2019 ; Baltimore et al., 2015 ; Lanphier et al., 2015 ). Heritable human germline modifications are currently prohibited under various legislations (Baylis et al., 2020 ; Ledford, 2015 ; Isasi et al., 2016 ; König, 2017 ) and surveys show public concerns about such applications, especially without clear medical justification (e.g., Gaskell et al., 2017 ; Jedwab et al., 2020 ; Scheufele et al., 2017 ; Blendon et al., 2016 ).

To analyse some implications of allowing heritable genome editing interventions in humans, it is relevant to explore underlying values and associated ethical considerations. Building on previous work by other authors (e.g., Coller, 2019 ; de Wert et al., 2018 ; van Dijke et al., 2018 ; Mulvihill et al., 2017 ; Ishii, 2015 ), this article aims to provide context to the debates taking place and critically analyse some of the major pragmatic, categorical and sociopolitical considerations raised to date in relation to human heritable genome editing. Specifically, we explore some key categorical and sociopolitical considerations to underline some of the possible barriers to societal acceptance, key outstanding questions requiring consideration, and possible implications at the individual and collective level. In doing so, we hope to highlight the predominance of pragmatic arguments in the scientific debate regarding the permissible use of heritable genome editing interventions compared to categorical arguments relevant to broader societal debate.

Human genome editing: a brief history of CRISPR/Cas9

Human genome editing is an all-encompassing term for technologies that are aimed at making specific changes to the human genome. In humans, these technologies can be used in embryos or germline cells as well as somatic cells (Box 1 ). Concerning human embryos or germline cells, the intervention could introduce heritable changes to the human genome (Lea and Niakan, 2019 ; Vassena et al., 2016 ; Wolf et al., 2019 ). In contrast, an intervention in somatic cells is not intended to result in changes to the genome of subsequent generations. It is worth noting that intergenerational effects occur only when the modified cells are used to establish a pregnancy which is carried to term. Thus, a distinction has been made between germline genome editing (GGE), which may only affect in vitro embryos in research activity, and heritable genome editing (HGE), which is used in reproductive medicine (e.g., Baylis et al., 2020 ). HGE could be used to prevent the transmission of serious genetic disease; however, other applications could be imagined, e.g., creating genetic resistance or even augmenting human functions.

In the last decade, prominent technical advances in genome engineering methods have taken place, including the zinc-finger nucleases (ZFNs) and TAL effector nucleases (TALENs), making human genome modification a tangible possibility (Gaj et al., 2013 ; Li et al., 2020 ; Gupta and Musunuru, 2014 ). In 2012, a study showed that the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), combined with an enzyme called Cas9, could be used as a genome‐editing tool in human cell culture (Jinek et al., 2012 ). In 2013, the use of CRISPR/Cas9 in mammalian cells was described, demonstrating the application of this tool in the genome of living human cells (Cong et al., 2013 ). In 2014, CRISPR/Cas9 germline modifications were first used in non-human primates, resulting in the birth of gene-edited cynomolgus monkeys (Niu et al., 2014 ). This was followed in 2015 by the first-ever public reported case of genome modification in non-viable human embryos (tripronuclear zygotes) (Liang et al., 2015 ). This study has caused broad concerns in the scientific community (Bosley et al., 2015 ) with leading journals rejecting publication for ethical reasons. Five years after these initial experiments were conducted, more than 10 papers have been published reporting the use of genome editing tools on human preimplantation embryos (for an overview: Niemiec and Howard, 2020 ).

Compared to counterpart genome technologies (e.g., ZFNs and TALENs), CRISPR/Cas9 is considered by many a revolutionary tool due to its efficiency and reduced cost. More specifically, CRISPR/Cas9 seems to provide the possibility of a more targeted and effective intervention in the genome involving the insertion, deletion, or replacement of genetic material (Dance, 2015 ). The potential applicability of CRISPR/Cas9 technique is considered immense, since it can be used on all type of organisms, from bacteria to plants, non-human cells, and human cells (Barrangou and Horvath, 2017 ; Hsu et al., 2014 ; Doudna and Charpentier, 2014 ; Zhang, 2019 ).

Box 1 Difference associated with germline cells and somatic cells.

For the purposes of the analysis presented in this article, one of the main differences is the heritability of genes associated with either type of cell. Germline cells include spermatozoa, oocytes, and their progenitors (e.g., embryonic cells in early development), which can give rise to a new baby carrying a genetic heritage coming from the parents. Thus, germline are those cells in an organism which are involved in the transfer of genetic information from one generation to the next. Somatic cells, conversely, constitute many of the tissues that form the body of living organisms, and do not pass on genetic traits to their progeny.

Germline interventions: the international debate

As a reaction to the 2015 study with CRISPR/Cas9, several commentaries by scientists were published regarding the future use of the technology (e.g., Bosley et al., 2015 ; Lanphier et al., 2015 ; Baltimore et al., 2015 ). Many of them focused on germline applications, due to the possibility of permanent, heritable changes to the human genome and its implications for both individuals and future generations. These commentaries included position statements calling for great caution in the use of genome editing techniques for heritable interventions in humans and suggested a voluntary moratorium on clinical germline applications of CRISPR/Cas9, at least until a broad societal understanding and consensus on their use could be reached (Brokowski, 2018 ; Baltimore et al., 2015 ; Lander, 2015 ). Such calls for a temporary ban were often seen as reminiscent of the “Asilomar ban” on recombinant DNA technology in the mid-1970s (Guttinger, 2017 ). Other commentaries asked for research to be discouraged or halted all together (Lanphier et al., 2015 ). More firmly, the United States (US) National Institutes of Health (NIH) released a statement indicating that the NIH would not fund research using genome editing technologies on human embryos (Collins, 2015 ).

In December 2015, the first International Summit on Human Gene Editing took place, hosted by the US National Academy of Sciences, the US National Academy of Medicine, the UK Royal Society, and the Chinese Academy of Sciences (NASEM). The organizing committee issued a statement about appropriate uses of the technology that included the following: “It would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application” (NASEM, 2015 ).

Following this meeting, initiatives from different national bodies were organized to promote debate on the ethical issues raised by the new genome editing technologies and to work towards a common framework governing the development and permissibility of their use in humans. This included an ethical review published in 2016 by the Nuffield Council on Bioethics, addressing conceptual and descriptive questions concerning genome editing, and considering key ethical questions arising from the use of the technology in both human health and other contexts (Nuffield Council on Bioethics, 2016 ). In 2017, a committee on human genome editing set up by the US National Academy of Sciences (NAS) and the National Academy of Medicine (NAM) carried out a so-called consensus study “Human Genome Editing: Science, Ethics, and Governance” (NASEM, 2017 ). This study put forward a series of recommendations on policies and procedures to govern human applications of genome editing. Specifically, the study concluded that HGE could be justified under specific conditions: “In some situations, heritable genome editing would provide the only or the most acceptable option for parents who desire to have genetically related children while minimizing the risk of serious disease or disability in a prospective child” (NASEM, 2017 ). The report stimulated much public debate and was met with support and opposition since it was seen as moving forward on the permissibility of germline editing in the clinical context (Ranisch and Ehni, 2020 ; Hyun and Osborn, 2017 ).

Following the report in 2016, the Nuffield Council on Bioethics published a second report in 2018. Similar to the NASEM 2017 report, this report emphasizes the value of procreative freedom and stresses that in some cases HGE might be the only option for couples to conceive genetically related, healthy offspring. In this document, the Nuffield Council on Bioethics maintains that there are no categorical reasons to prohibit HGE. However, it highlights three kinds of interests that should be recognized when discussing prospective HGE. They are related to individuals directly affected by HGE (parents or children), other parts of society, and future generations of humanity. In this context, two ethical principles are highlighted as important to guide future evaluations of the HGE use in specific interventions: “(...) to influence the characteristics of future generations could be ethically acceptable, provided if, and only if, two principles are satisfied: first, that such interventions are intended to secure, and are consistent with, the welfare of a person who may be born as a consequence, and second, that any such interventions would uphold principles of social justice and solidarity (…)” (Nuffield Council on Bioethics, 2018 ). This report was met with criticism for (implicitly) advocating genetic heritable interventions might be acceptable even beyond the boundaries of therapeutic uses. This is particularly controversial and goes well beyond the position previously reached by the NASEM report (which limited permissible uses of genome editing at preventing the transmission of genetic variants associated to diseases) (Drabiak, 2020 ). On the other hand, others have welcomed the report and, within it, the identification of explicit guiding ethical principles helpful in moving forward the debate on HGE (Gyngell et al., 2019 ).

As a follow-up to the 2015 conference, a second International Summit on Human Gene Editing was scheduled for November 2018 in Hong Kong (National Academies of Sciences, Engineering, and Medicine, 2019 ). The event, convened by the Hong Kong Academy of Sciences, the UK Royal Society, the US National Academy of Sciences and the US National Academy of Medicine, was supposed to focus on the prospects of HGE. Just before the Summit began, news broke that He Jiankui, a Chinese researcher and invited speaker at the Summit, created the world’s first genetically edited babies resulting from the use of CRISPR/Cas9 in embryos (Regalado, 2018 ; Lovell-Badge, 2019 ). Although an independent investigation of the case is still pending, his experiments have now been reviewed in detail by some scholars (e.g., Greely, 2019 , 2021 ; Kirksey, 2020 ; Davies, 2020 ; Musunuru, 2019 ). These experiments were globally criticized, since they did not follow suitable safety procedures or ethical guidelines (Wang and Yang, 2019 ; Lovell-Badge, 2019 ; Krimsky, 2019 ), nor considered the recommendations previously put forward by international reports (NASEM, 2017 ; Nuffield Council on Bioethics, 2018 ) and legal frameworks (Araki and Ishii, 2014 ; Isasi et al., 2016 ). Different reactions were triggered, including another call by scientists for a global moratorium on clinical human genome editing, to allow time for international discussions to take place on its appropriate uses (Lander et al., 2019 ) or an outright ban on the technology (Botkin, 2019 ). There were also calls for a measured analysis of the possible clinical applications of human genome editing, without the imposition of a moratorium (Daley et al., 2019 ; Dzau et al., 2018 ).

Most countries currently have legal frameworks to ban or severely restrict the use of heritable genome editing technologies (Araki and Ishii, 2014 ; Isasi et al., 2016 ; Baylis et al., 2020 ). However, since He’s experiment, the possibility that researchers might still attempt (with some likelihood of success) to use the technology in human embryos, became a growing concern, particularly since some scientists have already announced their interest in further clinical experiments (Cyranoski, 2019 ). For many, He’s experiments highlighted the ongoing risks associated with the use of modern genome editing technology without proper safety protocols and regulatory frameworks at an international level (Ranisch et al., 2020 ). This has triggered the need to develop clear and strict regulations to be implemented if these tools are to be used in the future. This incident also led to the formation of several working groups, including the establishment of an international commission on the Clinical Use of Human Germline Genome Editing set up by the US National Academy of Medicine, the US National Academy of Sciences, and the UK’s Royal Society. In 2020, the commission published a comprehensive report on HGE, proposing a translational pathway from research to clinical use (National Academy of Medicine, National Academy of Sciences, and the Royal Society, 2020 ). Likewise, a global expert Advisory Committee was established by the World Health Organization (WHO) with the goal of developing recommendations on governance mechanisms for human genome editing. Although the committee insisted in an interim recommendation that “it would be irresponsible at this time for anyone to proceed with clinical applications of human germline genome editing” (WHO, 2019 ), it did not express fundamental concerns on the possibility that some forms of HGE will one day become a reality. In 2021, the WHO’s Advisory Committee issued some publications, including a “Framework for governance” report and a “Recommendations” report (WHO, 2021 ). Building on a set of procedural and substantive values and principles, the “Framework for Governance” report discusses a variety of tools and institutions necessary for developing appropriate national, transnational, and international governance and oversight mechanisms for HGE. Specifically, the report considers the full spectrum of possible applications of human genome editing (including epigenetic editing and human enhancement) and addresses specific challenges associated with current, possible and speculative scenarios. These range from somatic gene therapy for the prevention of serious hereditary diseases to potentially more controversial applications reminiscent of the He Jiankui case (e.g., the use of HGE in reproductive medicine outside regulatory controls and oversight mechanisms). Additionally, the “Recommendations” report proposes among other things whistleblowing mechanisms to report illegal or unethical research. It also highlights the need for a global human genome editing registry, that should also cover basic and preclinical research on different applications of genetic manipulation, including HGE. The report also emphasises the need of making possible benefits of human genome editing widely accessible.

The idea of a human genome editing registry has also been supported by the European Group on Ethics in Science and New Technologies (EGE), an advisory board to the President of the European Commission. After an initial statement on genome editing published in 2016, still calling for a moratorium on editing of human embryos (EGE, 2016 ), the EGE published a comprehensive Opinion in 2021 (EGE, 2021 ). Although the focus of this report is on the moral issues surrounding genome editing in animals and plants, HGE is also discussed. Similar to the WHO Advisory Committee, the EGE recommends for HGE not to be introduced prematurely into clinical application and that measures should be taken to prevent HGE’s use for human enhancement.

Overall, when reviewing reports and initiatives produced since 2015, common themes and trajectories can be identified. A key development is the observation that the acceptance of the fundamental permissibility of such interventions appears to be increasing. This constitutes an important change from previous positions, reflecting the fact that human germline interventions have long been considered a ‘red line’ or at least viewed with deep scepticism (Ranisch and Ehni, 2020 ). In particular, while there is agreement that it would be premature to bring HGE into a clinical context, key concerns expressed by authoritative international bodies and committees are now associated with acceptable uses of the technology, rather than its use per se. Consideration is now being given to the conditions and objectives under which germline interventions could be permissible, instead of addressing the fundamental question of whether HGE may be performed at all. The question of permissibility is often linked to the stage of technological development. These developments are remarkable, since the key ethical aspects of genome editing are now frequently confined to questions of safety or cost–benefit ratios, rather than categorical considerations.

Another common issue can also be found in recent reports: the question of involving society in the debate. There is consensus on the fact that the legitimacy and governance of HGE should not be left solely to scientists and other experts but should involve society more broadly. Since germline interventions could profoundly change the human condition, the need for a broad and inclusive public debate is frequently emphasized (Iltis et al., 2021 ; Scheufele et al., 2021 ). The most striking expression of the need for public engagement and a “broad societal consensus” can be found in the final statement by the 2015 International Summit on Human Gene Editing organizing committee, as previously quoted (NASEM, 2015 ). Furthermore, the EGE and others also stresses the need for an inclusive societal debate before HGE can be considered permissible.

The pleas for public engagement are, however, not free of tension. For example, the NASEM’s 2017 report was criticised for supporting HGE bypassing the commitment for the broad societal consensus (Baylis, 2017 ). Regarding HGE, some argue that only a “small but vocal group of scientists and bioethicists now endorse moving forward” (Andorno et al., 2020 ). Serious efforts to engage the public on the permissibility and uses of HGE have yet to be made. This issue not only lacks elaboration on approaches to how successful public participation can occur, but also how stop short of presenting views on how to translate the public’s views into ethical considerations and policy (Baylis, 2019 ).

Potential uses of heritable genome editing technology

HGE is expected to allow a range of critical interventions: (i) preventing the transmission of genetic variants associated with severe genetic conditions (mostly single gene disorders); (ii) reducing the risk of common diseases (mostly polygenic diseases), with the promise of improving human health; and (iii) enhancing human capabilities far beyond what is currently possible for human beings, thereby overcoming human limitations. The identification of different classes of potential interventions has shifted the debate to the applications considered morally permissible beyond the acceptable use of HGE (Dzau et al., 2018 ). Specifically, there are differences in the limits of applicability suggested by some of the key cornerstone publications discussed above. For example, the NASEM ( 2017 ) report suggests limiting the use of HGE to the transmission of genetic variants linked to severe conditions, although in a very regulated context. In a very similar way, the 2020 report from the International Commission on the Clinical Use of Human Germline Genome Editing suggests that the initial clinical use of HGE should be limited to the prevention of serious monogenic diseases. By contrast, the 2018 Nuffield Council on Bioethics Report does not seem to limit the uses of genome editing to specific applications, though suggests that applications should be aligned with fundamental guiding ethical principles and need to have followed public debate (Savulescu et al., 2015 ). The same report also discusses far-reaching and speculative uses of HGE that might achieve “other outcomes of positive value” (Nuffield Council on Bioethics, 2018 ). Some of these more speculative scenarios include “built-in genetic resistance or immunity to endemic disease”; “tolerance for adverse environmental conditions” and “supersenses or superabilities” (Nuffield Council on Bioethics, 2018 , p. 47).

There have been different views on the value of HGE technology. Some consider that HGE should be permissible in the context of therapeutic applications, since it can provide the opportunity to treat and cure diseases (Gyngell et al., 2017 ). For example, intervention in severe genetic disorders is considered as therapeutic and hence morally permissible, or even obligatory. Others consider HGE to be more like a public health measure, which could be used to reduce the prevalence of a disease (Schaefer, 2020 ). However, others maintain that reproductive uses of HGE are not therapeutic because there is no individual in a current state of disease which needs to be treated, rather a prospective individual to be born with a specific set of negative prospective traits (Rulli, 2019 ).

Below, HGE is discussed in the context of reproductive uses and conditions of clinical advantage over existent reproductive technologies. The HGE applications are explored regarding their potential for modifying one or more disease-related genes relevant to the clinical context. Other uses associated with enhancement of physical and mental characteristics, which are considered non-clinical (although the distinction is sometimes blurred), are also discussed.

Single gene disorders

An obvious application of HGE interventions is to prevent the inheritance of genetic variants known to be associated with a serious disease or condition. Its potential use for this purpose could be typically envisaged through assisted reproduction, i.e., as a process to provide reproductive options to couples or individuals at risk of transmitting genetic conditions to their offspring. Critics of this approach often argue that other assisted reproductive technologies (ARTs) and preimplantation screening technologies e.g., preimplantation genetic diagnosis (PGD), not involving the introduction of genetic modifications to germline cells, are already available for preventing the transmission of severe genetic conditions (Lander, 2015 ; Lanphier et al., 2015 ). These existent technologies aim to support prospective parents in conceiving genetically related children without the condition that affect them. In particular, PGD involves the creation of several embryos by in vitro fertilization (IVF) treatment that will be tested for genetic anomalies before being transferred to the uterine cavity (Sermon et al., 2004 ). In Europe, there is a range in the regulation of the PGD technology with most countries having restrictions of some sorts (Soini, 2007 ). The eligibility criteria for the use of PGD also vary across countries, depending on the range of heritable genetic diseases for which it can be used (Bayefsky, 2016 ).

When considering its effectiveness, PGD presents specific limitations, which include the rare cases in which either both prospective parents are homozygous carriers of a recessive genetic disease, or one of the parents is homozygous for a dominant genetic disease (Ranisch, 2020 ). In these cases, all embryos produced by the prospective parents will be affected by the genetic defect, and therefore it will not be possible to select an unaffected embryo after PGD. Currently, beyond adoption of course, the options available for these prospective parents include the use of a third-party egg or sperm donors.

Overall, given the rarity of cases in which it is not applicable, PGD is thought to provide a reliable option to most prospective parents for preventing severe genetic diseases to be transmitted to their offspring, except in very specific cases. HGE interventions have been suggested to be an alternative method to avoid single gene disorders in the rare cases in which selection techniques such as PGD cannot be used (Ranisch, 2020 ). It has also been proposed to use tools such as CRISPR/Cas9 to edit morphologically suitable but genetically affected embryos, and thus increase the number of embryos available for transfer (de Wert et al., 2018 ; Steffann et al., 2018 ). Moreover, HGE interventions are considered by some as a suitable alternative to PGD, even when the use of PGD could be possible. One argument in this respect is that, although not leading to the manifestation of the disease, the selected embryos can still be carriers of it. In this respect, differently from PGD, HGE interventions can be used to eliminate unwanted, potential future consequences of genetic diseases (i.e., by eliminating the critical mutation carried out in the selected embryo), with the advantage of reducing the risks of further propagation of the disease in subsequent future generations (Gyngell et al., 2017 ).

Overall, HGE interventions are thought to offer a benefit over PGD in some situations by providing a broader range of possible interventions, as well as by providing a larger number of suitable embryos. The latter effect is usually important in the cases where unaffected embryos are small in number, making PGD ineffective (Steffann et al., 2018 ). Whether these cases provide a reasonable ground to justify research and development on the clinical use of HGE remain potentially contentious. Some authors have suggested that the number of cases in which PGD cannot be effectively used to prevent transmission of genetic disorders is so marginal that clinical application of HGE could hardly be justified (Mertes and Pennings, 2015 ). Particularly when analyzing economic considerations (i.e., the allocation of already scarce resources towards clinical research involving expensive techniques with limited applicability) and additional risks associated with direct interventions. In either case of HGE being used as an alternative or a complementary tool to PGD, PGD will most likely still be used to identify those embryos that would manifest the disease and would hence require subsequent HGE.

The PGD technique, however, is not itself free of criticism and possible moral advantages of HGE over PGD have also been explored (Hammerstein et al., 2019 ; Ranisch, 2020 ). PGD remains ethically controversial since, identifying an unaffected embryo from the remaining embryos (which will not be used and ultimately discarded) amounts to the selection of ‘healthy’ embryos rather than ‘curing’ embryos affected by the genetic conditions. On the other hand, given a safe and effective application of the technology, the use of HGE is considered by many morally permissible to prevent the transmission of genetic variants known to be associated with serious illness or disability (de Miguel Beriain, 2020 ). One question that remains is whether HGE and PGD have a differing or equal moral permissibility or, at least, comparable. On issues including human dignity and autonomy, it was argued that HGE and PGD interventions can be considered as equally morally acceptable (Hammerstein et al., 2019 ). This equal moral status was, however, only valid if HGE is used under the conditions of existent gene variants in the human gene pool and to promote the child health’s best interest in the context of severe genetic diseases (Hammerstein et al., 2019 ). Because of selection and ‘therapy’, moral assessments resulted in HGE interventions being considered to some extent preferable to PGD, once safety is carefully assessed (Gyngell et al., 2017 ; Cavaliere, 2018 ). Specifically, PGD’s aim is selective and not ‘therapeutic’, which could be said to contradict the aims of traditional medicine (MacKellar and Bechtel, 2014 ). In contrast to PGD’s selectivity, HGE interventions are seen as ‘pre-emptively therapeutic’, and therefore closer to therapy than PGD (Cavaliere, 2018 ). However, it is also argued that HGE does not have curative aims, and thus it is not a therapeutic application, as there is no patient involved in the procedure to be cured (Rulli, 2019 ). On balance, there appears to be no consensus on which of the approaches, HGE and PGD, is morally a better strategy to prevent the transmission of single gene disorders, with a vast amount of literature expressing diverse positions when considering different scenarios (Delaney, 2011 ; Gyngell et al., 2017 ; Cavaliere, 2018 ; Ranisch, 2020 ; Rehmann-Sutter, 2018 ; Sparrow, 2021 ).

Polygenetic conditions

HGE is also argued to have the potential to be used in other disorders which have a polygenic disposition and operate in combination with environmental influences (Gyngell et al., 2017 , 2019 ). Many common diseases, which result from the involvement of several genes and environmental factors, fall into this category. Examples of common diseases of this type includes diabetes, coronary artery disease and different types of cancers, for which many of the genes involved were identified by studies of genome wide association (e.g., Wheeler and Barroso, 2011 ; Peden and Farral, 2011 ). These diseases affect the lives of millions of people globally, severely impacting health and often leading to death. Furthermore, these diseases have a considerable burden on national health systems. Currently, many of these diseases are controlled through pharmaceutical products, although making healthier life choices about diet and exercise can also contribute to preventing and managing some of them. Despite the interest, the use of PGD in polygenic conditions would hardly be feasible, due to the number of embryos needed to select the preferred genotype and available polygenic predictors (Karavani et al., 2019 ; Shulman and Bostrom, 2014 ).

In theory, HGE could be a potentially useful tool to target different genes and decrease the susceptibility to multifactorial conditions in current and future generations. The application of HGE to polygenic conditions is often argued by noting that the range of applicability of the technique (well beyond single gene disorders) would justify and outweigh the cost needed to develop it. However, to do so, a more profound knowledge of genetic interactions, of the role of genes and environmental factors in diverse processes would be needed to be able to modify such interconnected systems with limited risk to the individual (Lander, 2015 ). Besides, it is now understood that, depending on the genetic background, individuals will have different risks of developing polygenetic diseases (risk-associated variants), but hardly any certainty of it. In other words, although at the population level there would most likely be an incidence of the disease, it is not possible to be certain of the manifestation of the disease in any specific individual. As a result, the benefits of targeting a group of genes associated to a disease in a specific individual would have to be assessed in respect to the probability of incidence of the disease. The risk-benefit ratio for HGE is considerably increased for polygenic conditions compared to monogenic disorders. Additionally, the risks of adverse effects, e.g., off-target effects, increases with the number of genes targeted for editing. The latter effects make the potential benefits of HGE in polygenic diseases more uncertain than in single gene disorders.

Genetic enhancement

A widespread concern regarding the use of HGE is that such interventions could be used not only to prevent serious diseases, but also to enhance desirable genetic traits. Currently, our knowledge on how to genetically translate information into specific phenotypes is very limited and some argue that it might never be technically feasible to achieve comprehensive genetic enhancements using current gene editing technologies (Janssens, 2016 ; Ranisch, 2021 ). Similar to many diseases, in which different genetic and other factors are involved, many of the desirable traits to be targeted by any enhancement will most likely be the result of a combination of several different genes influenced by environment and context. Moreover, the implications for future generations of widespread genetic interventions in the human population and its potential impact on our evolutionary path are difficult to assess (Almeida and Diogo, 2019 ). Nevertheless, others argue that genetic enhancement through HGE could be possible in the near future (de Araujo, 2017 ).

There has been much discussion regarding the meaning of the terms and the conceptual or normative difference between ‘therapy’ and ‘enhancement’ (for an early discussion: Juengst, 1997 ; Parens, 1998 ). There are mainly three different meanings of ‘enhancement’ used in the literature. First, ‘enhancement’ is sometimes used to refer to measures that go beyond therapy or prevention of diseases, i.e., that transcend goals of medicine. Second, ‘enhancement’ is used to refer to measures that equip a human with traits or capacities that they typically do not possess. In both cases, the term points to equally controversial and contrasting concepts: on the one hand, those of ‘health’, ‘disease’ or ‘therapy’, and on the other, those of ‘normality’ or ‘naturalness’. Third, ‘enhancement’ is sometimes also used as an umbrella-term describing all measures that have a positive effect on a person’s well-being. According to this definition, the cure, or prevention of a disease is then also not opposed to an enhancement. Here again, this use refers to the controversial concept of ‘well-being’ or a ‘good life’.

It is beyond the scope of this article to provide a detailed review of the complex debate about enhancement (for an overview: Juengst and Moseley, 2019 ). However, three important remarks can be made: first, although drawing a clear line between ‘enhancement’ and ‘therapy’ (or ‘normality’, etc.) will always be controversial, some cases can be clearly seen as human enhancement. This could include modifications to augment human cognition, like having a greater memory, or increasing muscle mass to increase strength, which are not considered essential for human health (de Araujo, 2017 ).

Second, it is far from clear whether a plausible account of human enhancement would, in fact, be an objectivist account. While authors suggest that there is some objectivity regarding the conditions that constitute a serious disease (Habermas, 2003 ), the same might not be true for what constitutes an improvement of human functioning. It may rather turn out that an enhancement for some might be seen as a dis-enhancement for others. Furthermore, the use of the HGE for enhancement purposes can be considered at both an individual and a collective level (Gyngell and Douglas, 2015 ; Almeida and Diogo, 2019 ), with a range of ethical and biological implications. If HGE is to be used for human enhancement, this use will be in constant dependence on what we perceive as ‘normal’ functioning or as ‘health’. Therefore, factors such as cultural and societal norms will have an impact on where such boundaries are drawn (Almeida and Diogo, 2019 ).

Third, it should be noted that from an ethical perspective the conceptual question of what enhancement is, and what distinguishes it from therapy, is less important than whether this distinction is ethically significant in the first place. In this context, it was pointed out that liberal positions in bioethics often doubt that the distinction between therapy and enhancement could play a meaningful role in determining the limits of HGE (Agar, 1998 ). The consideration of genetic intervention for improving or adding traits considered positive by individuals have raised extreme positions. Some welcome the possibility to ameliorate the human condition, whilst others consider it an alarming attempt to erase aspects of our common human ‘nature’. More specifically, some authors consider HGE a positive step towards allowing humans the opportunity to obtain beneficial traits that otherwise would not be achievable through human reproduction, thus providing a more radical interference in human life to overcome human limitations (de Araujo, 2017 ; Sorgner, 2018 ). The advocates of this position are referred to as ‘bioliberals’ or ‘transhumanists’ (Ranisch and Sorgner, 2014 ), and its opponents are referred to as ‘bioconservatives’ (Fukuyama, 2002 ; Leon, 2003 ; Sandel, 2007 ). Transhumanism supports the possibility of humans taking control of their biology and interfering in their evolution with the use of technology. Bioconservatism defends the preservation and protection of ‘human essence’ and expresses strong concerns about the impact of advanced technologies on the human condition (Ranisch and Sorgner, 2014 ).

For the general public, HGE used in a clinical context seems to be less contentious compared when used as a possible human enhancement tool. Specifically, some surveys indicate that the general-public typically exhibits a reduced support for the use of genome editing interventions for enhancement purposes compared to therapeutic purposes (Gaskell et al., 2017 ; Scheufele et al., 2017 ). In contrast, many technologies and pharmaceutical products developed in the medical context to treat patients are already being used by individuals to ‘enhance’ some aspect of their bodies. Some examples include drugs to boost brain power, nutritional supplements, and brain-stimulating technologies to control mood, even though their efficiency and safety is not clear. This could suggest that views on enhancement may vary depending on the context and on what is perceived as an enhancement by individuals. It may be informative to carry out detailed population studies to explore whether real ethical boundaries and concerns exist, or whether these are purely the result of the way information is processed and perceived.

Heritable genome editing: Mapping the ethical debate

Even though genome editing methods have only been developed in the last decade, the normative implication of interventions into the human germline have been discussed since the second half of the 20th century (Walters et al., 2021 ). Some even argue that, virtually, all the ethical issues raised by genetic engineering were already being debated at that time (Paul, 2005 ). This includes questions about the distinction between somatic and germline interventions, as well as between therapy and enhancement (e.g., Anderson, 1985 ). Nevertheless, as it has been widely noted, it is difficult to draw clear lines between these two categories (e.g., McGee, 2020 ; Juengst, 1997 ), and alternative frameworks have been proposed, particularly in the context of HGE (Cwik, 2020 ). Other questions include the normative status of human nature (e.g., Ramsey, 1970 ), the impossibility of consent from future generations (e.g., Lappe, 1991 ), possible slippery slopes towards eugenics (e.g., Howard and Rifkin, 1977 ), or implications for justice and equality (e.g., Resnik, 1994 ).

When discussing the ethics of HGE, roughly three types of considerations can be distinguished: (i) pragmatic, (ii) sociopolitical, and iii) categorical (Richter and Bacchetta, 1998 ; cf. Carter, 2002 ). Pragmatic considerations focus on medical or technological aspects of HGE, such as the safety or efficacy of interventions, risk–benefit ratio, possible alternatives or the feasibility of responsible translational research. Such considerations largely depend on the state of science and are thus always provisional. For example, if high-risk technologies one day evolve into safe and reliable technologies, some former pragmatic considerations may become obsolete. Sociopolitical aspects, on the other hand, are concerned with the possible societal impact of technologies, e.g., how they can promote or reduce inequalities, support or undermine power asymmetries, strengthen, or threaten democracy. Similar to pragmatic considerations, sociopolitical reasons depend on specific contexts and empirical factors. However, these are in a certain sense ‘outside’ the technology—even though technologies and social realities often have a symbiotic relationship. While sociopolitical considerations can generate strong reasons against (or in favour of) implementing certain technologies, most often these concerns could be mitigated by policies or good governance. Categorical considerations are different and more akin to deontic reasons. They emphasise categorical barriers to conduct certain deeds. It could be argued, for instance, that the integrity of the human genome or the impossibility to obtain consent from future generation simply rule out certain options to modify human nature. Such categorical considerations may persist despite technological advances or changing sociopolitical conditions.

Comparing the bioethical literature on genetic engineering from the last century with the ongoing discussions shows a remarkable shift in the ethical deliberation. In the past, scholars from the field of medical ethics, as well as policy reports, used to focus on possible categorical boundaries for germline interventions and on possible sociopolitical consequences of such scenarios. For instance, the influential 1982 report “Splicing Life” from the US President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioural Research prominently discussed concerns about ‘playing God’ against the prospects of genetically engineering human beings, as well as possible adverse consequences of such interventions. Although this study addresses potential harms, pragmatic arguments played only a minor role, possibly due to the technical limitations at the time.

With the upcoming availability of effective genome editing techniques, the focus on the moral perspective seems to have been reversed. Increasingly, the analysis of the permissibility of germline interventions is confined to questions of safety and efficacy. This is demonstrated by the 2020 consensus study report produced by an international commission convened by the US National Academy of Medicine, the US National Academy of Sciences, and the UK’s Royal Society, which aimed at defining a translational pathway for HGE. Although the report recognizes that HGE interventions does not only raise pragmatic questions, ethical aspects were not explicitly addressed (National Academy of Medicine, National Academy of Sciences, and the Royal Society, 2020 ).

Similarly, in 2019, a report on germline interventions published by the German Ethics Council (an advisory body to the German government and parliament) emphasizes that the “previous categorical rejection of germline interventions” could not be maintained (Deutscher Ethikrat, 2019 , p. 5). The German Ethics Council continues to address ethical values and societal consequences of HGE. However, technical progress and the development of CRISPR/Cas9 tools seem to have changed the moral compass in the discussion about germline interventions.

For a comprehensive analysis of HGE to focus primarily on pragmatic arguments such as safety or efficacy would be inadequate. In recent years, developments in the field of genome editing have occurred at an incredibly fast pace. At the same time, there are still many uncertainties about the efficacy of the various gene editing methods and unexpected effects in embryo editing persist (Ledford, 2015 ). Social and political implication also remain largely unknown. To date, it has been virtually impossible to estimate how deliberate interventions into the human germline could shape future societies and to conduct a complete analysis of the safety aspects of germline interventions.

Moreover, as the EGE notes, we should be cautious not to limit the complex process of ethical decision-making to pragmatic aspects such as safety. The “‘safe enough’ narrative purports that it is enough for a given level of safety to be reached in order for a technology to be rolled out unhindered, and limits reflections on ethics and governance to considerations about safety” (EGE, 2021 , p. 20). Consequently, the EGE has highlighted the need to engage with value-laden concepts such as ‘humanness’, ‘naturalness’ or ‘human diversity’ when determining the conditions under which HGE could be justified. Even if a technology has a high level of safety, its application may still contradict ethical values or lead to undesirable societal consequences. Efficacy does not guarantee compatibility with well-established ethical values or cultural norms.

While concepts such as ‘safety’ or ‘risk’ are often defined in scientific terms, this does not take away the decision of what is ethically desirable given the technical possibilities. As Hurlbut and colleagues put it in the context of genome editing: “Limiting early deliberation to narrowly technical constructions of risk permits science to define the harms and benefits of interest, leaving little opportunity for publics to deliberate on which imaginations need widening, and which patterns of winning and losing must be brought into view” (Hurlbut et al., 2015 ). Therefore, if public engagement is to be taken seriously, cultural norms and values of those affected by technologies must also be considered (Klingler et al., 2022 ). This, however, means broadening the narrow focus on pragmatic reasons and allowing categorical as well as sociopolitical concerns in the discourse. Given the current attention on pragmatic reasons in current debates on HGE, it is therefore beneficial to revisit the categorical and sociopolitical concerns that remain unresolved. The following sections provide an overview of relevant considerations that can arise in the context of HGE and that underline many of the societal concerns and values crucial for public engagement.

Human genome ‘integrity’

Heritability seems to be one of the foremost considerations regarding germline genome editing, as it raises relevant questions on a ‘natural’ human genome and its role in ‘human nature’ (Bayertz, 2003 ). This follows an ongoing philosophical debate on ‘human nature’, at least as defined by the human genome. This has ensued a long debate on the value of the human genome and normative implications associated with its modification (e.g., Habermas, 2003 ). Although a comprehensive discussion of these topics goes beyond the scope of this paper, the human genome is viewed by many as playing an important role in defining ‘human nature’ and providing a basis for the unity of the human species (for discussion: Primc, 2019 ). Considering the implications for the individual and the collective, some affirm the right of all humans to inherit an unmodified human genome. For some authors, germline modification is considered unethical, e.g., a “line that should not be crossed” (Collins, 2015 ) or a “crime against humanity” (Annas et al., 2002 ).

The Universal Declaration on the Human Genome and Human Rights (UDHGHR) states that “the human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity” (Article 1, UNESCO, 1997 ). The human genome is viewed as our uniquely human collective ‘heritage’ that needs to be preserved and protected. Critics of heritable genetic interventions argue that germline manipulation would disrupt this natural heritage and therefore would threaten human rights and human equality (Annas, 2005 ). Heritable human genome editing creates changes that can be heritable to future generations. For many, this can represent a threat to the unity and identity of the human species, as these modifications could have an impact on the human’s gene pool. Any alterations would then affect the evolutionary trajectory of the human species and, thus, its unity and identity.

However, the view of the human genome as a common heritage is confronted with observations of the intrinsic dynamism of the genome (Scally, 2016 ). Preservation of the human genome, at least in its current form, would imply that the genome is static. However, the human genome is dynamic and, at least in specific periods of environmental pressure, must have naturally undergone change, as illustrated by human evolution (Fu and Akey, 2013 ). The genome of any individual includes mutations that have occurred naturally. Most of them seem to be neither beneficial nor detrimental to the ability of an individual to live or to his/her health. Others can be detrimental and limiting to their wellbeing. It has been shown that, on average, each human genome has 60 new mutations compared to their parents (Conrad et al., 2011 ). At the human population level, a human genome can have in average 4.1–5 million variants compared to the ‘reference’ genome (Li and Sadler, 1991 ; Genomes Project C, 2015 ). The reference genome itself is thus a statistical entity, representing the statistic distribution of the probability of different gene variants in the whole genome. Human genomic variation is at the basis of the differences in the various physical traits present in humans (e.g., eye colour, height, etc.), as well as specific genetic diseases. Thus, the human population is comprised of genomes with a pattern of variants and not of ‘one’ human genome that needs to be preserved (Venter et al. 2001 ). The human genome has naturally been undergoing changes throughout human history. An essentialist view of nature seems to be the basis for calling for the preservation of genome integrity. However, in many ways, this view is intrinsically challenged by the interpretation portrayed by evolutionary biology of our genetic history already more than a century ago. Nevertheless, despite the dynamic state of the human genome, this in itself cannot justify the possibility of modifying the human genome. It is also worth considering that the integrity of the human genome could also be perceived in a ‘symbolic’ rather than biological literal meaning. Such an interpretation would not require a literally static genome over time, but instead suggest a boundary between ‘naturally’ occurring variation and ‘artificially’ induced change. This is rather a version of the ‘natural’/unnatural argument, rather than an argument for a literally unchanged genetic sequence.

The modification of the human genome raises complex questions about the characterization of the human species genome and if there should be limits on interfering with it. The options to modify the human genome could range from modifying only the genes that are part of the human gene pool (e.g., those genes involved in severe genetic diseases such as Huntington’s disease) to adding new variants to the human genome. Regarding variants which are part of the common range of variation found in the human population (although it is not possible to know all the existent variations), the question becomes whether HGE could also be used in any of them (e.g., even the ones providing some form of enhancement) or only in disease-associated variants and thus be restricted to the prevention of severe genetic diseases. In both cases, the integrity of the human genome is expected to be maintained with no disruption to human lineage. However, it could be argued that this type of modification is defending a somewhat conservative human nature argument, since it is considering that a particular genetic make-up is ‘safe’ or would not involve any relevant trade-offs. In contrast, a different conclusion could be drawn on the integrity of the human genome when introducing genotypical and phenotypical traits that do not lie within the common range of variation found in the population (Cwik, 2020 ). In all cases, since the implications of the technology are intergenerational and consequently, it will be important to carry out an assessment of the risks that we, as a species, are willing to take when dealing with disease and promoting health. For this, we will need to explore societal views, values and cultural norms associated with the human genome, as well as possibly existing perceptions of technology tampering with ‘nature’. To support such an assessment, it would be useful to draw on a firm concept of human nature and the values it implies, beyond what is implied by genetic aspects.

Human dignity

In several of the legally binding and non-binding documents addressing human rights in the biomedical field, human dignity is one of the key values emphasized. There are concerns that heritable genome interventions might conflict with the value of human dignity (Calo, 2012 ; Melillo, 2017 ). The concerns are considered in the context of preserving the human genome (Nordberg et al. 2020 ). More specifically, the recommendation on Genetic Engineering by the Council of Europe (1982) states that “ the rights to life and to human dignity protected by Articles 2 and 3 of the European Convention on Human Rights imply the right to inherit a genetic pattern which has not been artificially changed” (Assembly, 1982 ). This is supported by the Oviedo Convention on Human Rights and Biomedicine (1997), where Article 13 prohibits any genetic intervention with the aim of introducing a modification in the genome of any descendants. The Convention is the only international legally binding instrument that covers human germline modifications among the countries which have ratified it (Council of Europe, 1997 ). However, there have been some authors disputing the continued ban proposed by the Oviedo Convention (Nordberg et al. 2020 ). Such authors have focused on the improvements of safety and efficacy of the technology in contrast to authors focusing on its value for human dignity (Baylis and Ikemoto, 2017 ; Sykora and Caplan, 2017 ). The latter authors seem to highlight the concept of human dignity to challenge heritable interventions to the human genome.

But a question in debate has been to demonstrate how ‘human dignity’, described in such norms, relates to heritable genome interventions. The concept of the human genome as common genetic heritage, distinguishing humans from other species seems one of the main principles implied by such norms. In this view, the human genome determines who belongs to the human species and who does not, and thus confers an individual the dignity of being a human by association. This creates an inherent and strong link between the concept of human genome and the concept of human dignity and its associated legal rights (Annas, 2005 ). It could be argued that a genetic modification to an individual may make it difficult for him/her to be recognized as a human being and therefore, preservation of the human genome being important for human dignity to be maintained. This simple approach, or at least interpretation, however, ignores the fact that the human genome is not a fixed or immutable entity, as exemplified by human evolution (as discussed in the previous section). As a result, the view that HGE interventions are inherently inadmissible based on the need to preserve human dignity is contested (Beriain, 2018 ; Raposo, 2019 ). More broadly, the idea that biological traits are the basis for equality and dignity, supporting the need for the human genome to be preserved, is often challenged (Fenton, 2008 ).

It is argued that to fully assess the impact of the HGE interventions on human dignity, it will be necessary to have a better understanding of the concept of human dignity in the first place (Häyry, 2003 ; Cutas, 2005 ). For some, however, human dignity is a value that underlies questions of equality and justice. Thus, the dignity-based arguments could uncover relevant questions in the discussion of ethical implications on modifying the human genome (Segers and Mertes, 2020 ). In the Nuffield Council on Bioethics Report (2018) principles of social justice and solidarity, as well as welfare, are used to guide the debate on managing HGE interventions. Similarly, the concept of human dignity could, therefore, provide the platform upon which consideration of specific values could be discussed, broaden the debate on HGE to values shared by society.

Right of the child: informed consent

In many modern societies, every individual, including children, have the rights to autonomy and self-determination. Therefore, each person is entitled to decide for themselves in decisions relating to their body. These rights are important for protecting the physical integrity of a person. When assessing the implication of allowing individuals to take (informed) decisions relative to the use of heritable genetic interventions on someone else’s body, it is useful to reflect on the maturity of existing medical practices and, more broadly, on the additional complexities associated with the heritability of any such intervention.

In modern health-care systems, informed consent provides the opportunity for an individual to exercise autonomy and make an informed decision about a medical procedure, based on their understanding of the benefits and risks of such procedure. Informed consent is thus a fundamental principle in medical (research) ethics when dealing with human subjects (Beauchamp and Childress, 2019 ).

Heritable genome interventions present an ethical constraint on the impossibility of future generations of providing consent to an intervention on their genome (Smolenski, 2015 ). In other words, future generations cannot be involved in a decision which could limit their autonomy, since medical or health-related decisions affecting them are placed on the present generation (and, in the case of a child to be born, more specifically, on his/her parents). However, many other actions taken by parents of young children also intentionally influence the lives of those children and have been doing so for millennia (Ranisch, 2017 ). Although these actions may not involve altering their genes, many of such actions can have a long-lasting impact on a child’s life (e.g., education and diet). However, it could be argued that they do not have the irreversible effect that HGE will have in the child and future generations. In cases where parents act to expand the life choices of their children by eliminating disease (e.g., severe genetic diseases), this would normally be thought to outweigh any possible restriction on autonomy. In these cases, if assuming HGE benefits will outweigh risks regarding safety and efficacy, the use of HGE could be expected to contribute to the autonomy of the child, as him/her would be able in the future to have a better life, not constrained by the limitations of the disease. As a result, even if it is accepted that these technologies may in one way reduce the autonomy of future generations, some believe that this will often be outweighed by other effects increasing autonomy (Gyngell et al., 2017 ). In other words, it is reasonable to suppose that, when taken by parents based on good information and understanding of risks and impacts, the limitation in the autonomy of unborn children associated with heritable genetic interventions would be compensated by the beneficial effects of increasing their autonomy when born (Gyngell et al., 2017 ).

It has often been emphasized that possible genetic interventions must not curtail the future possibilities of offspring to live their lives according to their own idea of a good life. This view originated in the liberal tradition and is associated with the “right to an open future”, defended by Joel Feinberg ( 1992 ). That is an anticipatory autonomy right that parents can violate, even though the offspring could exercise it only in the future. Feinberg has discussed the right to an open future in the context of religious education. However, various authors have applied this argument to the question of permissible and desirable genetic interventions (Buchanan et al., 2000 ; Glover, 2006 ; Agar, 1998 ). Accordingly, germline modifications or selection would have to allow the offspring to have a self-determined choice of life plans. It would therefore be necessary to provide offspring with genetic endowments that represent the so-called all-purpose goods. These goods are “useful and valuable in carrying out nearly any plan of life or set of aims that humans typically have” (Buchanan et al., 2000 , p. 167). While this claim is certainly appealing, in reality it will be difficult to identify phenotypes that will only broaden and do not narrow the spectrum of life plans. Take, for example, body size: a physique favourable for a basketball player would at the same time be less favourable in successfully riding horses as a professional jockey and vice versa. Increasing some opportunities often means reducing other ones.

The arguments of informed consent and open future need to be explored outside the realm of severe genetic diseases by considering other scenarios (including scenarios of genetic enhancement). Hereby, the effects of the interventions on the autonomy of future generations can be assessed more comprehensively. As for enhancement, decisions outside the realm of health can be more controversial, as the traits that parents see fit to generate enhancement may inadvertently condition a child’s choices in the future in an undesirable way.

If HGE is to be used, questions on how the consent and information should be provided to parents to fully equip them to decide in the best interests of the child will need to be assessed (Evitt et al., 2015 ). This is evident if considering the informed consent used in the study conducted by He Jiankui. One of the many criticisms of the study was the inadequacy of the informed consent process provided to the parents, which did not meet regulatory or ethical standards (Krimsky, 2019 ; Kirksey, 2020 ). This raises questions on how best to achieve ethical and regulatory compliance regarding informed consent in applications of HGE (Jonlin, 2020 ).

Discrimination of people with disabilities

For many years, there has been an effort to develop selective reproduction technologies to prevent genetic diseases or conditions leading to severe disabilities. These forms of reproductive genetic disease prevention are based on effectively filtering and eradicating embryos or foetuses affected by genetic diseases. There are divergent views regarding the use of these technologies. For example, the disability rights movement argues that the use of technologies such as prenatal testing (PNT) and PGD discriminates against people living with a disability (Scully, 2008 ; Asch and Barlevy, 2012 ). The key arguments presented supporting this view are: (i) the limited value of a genetic trait in respect to the life of an embryo (Parens and Asch, 2000 ) and (ii) the ‘expressivist’ argument (Buchanan, 1996 ; Shakespeare, 2006 ). The first argument is based on the critique that a disabling trait is viewed as being more significant than the life of an embryo/foetus. This argument was initially used in the context of prenatal testing and selective termination, and has also been applied in the context of new technologies like PGD (Parens and Asch, 2000 ). The second, the ‘expressivist’ argument, argues that the use of these technologies expresses negative or discriminatory views on the disabling conditions they are targeting and subsequently on the people living with these conditions (Asch and Wasserman, 2015 ). The expressivist argument, however, has been challenged by stressing the importance of differentiating between the disability itself and the people living with disability (Savulescu, 2001 ). The technology’s use is aimed at reducing the incidence of disability, and it does not have a position of value on the people that have a specific condition.

When applying the same arguments to the use of HGE in comparison with other forms of preventing heritable genetic diseases, some important considerations can be made. Regarding the first argument, in contrast to selective reproduction technologies, HGE may allow the removal of the disabled trait with the aim of ensuring survival of the affected embryo. However, most likely, PGD would be used before and after the editing of the embryos to help the identification of the ones requiring intervention and verifying the efficiency of the genetic intervention (de Miguel Beriain, 2018 ; Ranisch, 2020 ). Similarly, the expressivist argument continues to be challenged if the application of human HGE is envisaged in the context of severe genetic diseases (e.g., Tay-Sachs and Huntington’s disease). It has been argued that the choice to live without a specific genotype neither implies discriminating people living with a respective condition nor considering the life of people living with the disease not worth living or less valuable (Savulescu, 2001 ). In other words, the expressivist argument is not a valid or a sufficiently strong ethical argument for prospective parents not to have the option to have a future child without a genetic disease.

It is worth noting that the debate on the use of reproduction technologies for the prevention of genetic diseases is not at all new, and that modern HGE techniques only serve to highlight ethical concerns that have been expressed for a long time. In the case of preventing genetic diseases, the application of both arguments to HGE intervention could be considered not to provide sufficiently strong ethical arguments to limit the use of the technology in the future. However, it is worth exploring whether scientific innovations like HGE are either ameliorating or reinvigorating ethical concerns expressed so far, for example in creating a future that respects or devalues disability as a part of the human condition. Perhaps even more importantly, given their potential spectrum of possible intervention and efficacy, it is important to reflect on whether the broad use of HGE could have an impact on concepts of disability and ‘normality’ as a whole distorting an already unclear ethical line between clinical and non-clinical interventions. Moreover, research work exploring the relationship between disability and identity indicated that personhood with disability can be an important component to people’s identity and interaction with the world. In the case of heritable human genome editing, it is not yet known how this technology will impact the notions of identity and personhood in people who had their germline genome modified (Boardman and Hale, 2018 ). For further progress on these issues public engagement might be important to gather different views and perceptions on the issue.

Justice and equality

Beside the limits of applicability, another common ethical concern associated with the use of genome editing technologies, as with many new technologies, is the question of accessibility (Baumann, 2016 ). Due to the large investments that will need to be made for continuing development of the technology, there is a (perceived) risk of it becoming an expensive technology that only a few wealthy individuals in any population (and/or only citizens in comparatively rich countries) can access. In addition, there is concern that patenting of genome editing technologies will delay widespread access or lead to unequal distribution of corresponding benefits (Feeney et al., 2018 ). This may, consequently, contribute to further increases in existing disparities, since individuals or countries with the means of accessing better health treatments may have economic advantages (Bosley et al., 2015 ). This could enhance inequality at different levels, depending on the limits of applicability of the technology. Taken to its extreme, the use of the technology could allow germline editing to create and distinguish classes of individuals that could be defined by the quality of their manipulated genome.

The concern that the possibility of germline interventions in humans could entrench or even increase inequalities has accompanied the discussion about ethics of genetic interventions from the very beginning until today (e.g. Resnik, 1994 ). In ‘Remaking Eden’ Lee Silver envisioned a divided future society, consisting of a genetically enhanced class, the “genRich”, and a genetic underclass, the “naturals” (Silver, 1997 ). Françoise Baylis recently echoed such concerns regarding future HGE interventions, namely that “unequal access to genome-editing technologies will both accentuate the vagaries of the natural lottery and introduce an unjust genetic divide that mirrors the current unjust economic and social divide between rich and poor individuals” (Baylis, 2019 , p. 67). At the same time, the possibility to genetically intervene in the ‘natural lottery’ has also been associated with the hope of countering natural inequalities and increase equality of opportunities. Robert Sinsheimer may be among the first to envision such a ‘new’ individualistic type of ‘eugenics’ that “would permit in principle the conversion of all of the unfit to the highest genetic level” (Sinsheimer, 1969 , p. 13). More recently, in the book ‘From chance to choice: Genetics and justice’ (2000) it is argued that “equality of opportunity will sometimes require genetic interventions and that the required interventions may not always be limited to the cure or prevention of disease” (Buchanan et al., 2000 , p. 102). When discussing issues related to justice and equality, it will be important to involve a broad spectrum of stakeholders to better evaluate the economic effects of the commercialization of the technology.

Conclusions

With ongoing technological developments and progress with guiding and regulating its acceptable use, the possibility of HGE interventions in the human genome is closer than ever to becoming a reality. The range of HGE applicability can go from preventing the transmission of genetic variants associated with severe genetic conditions (mostly single gene disorders but also, to a lesser extent, polygenic diseases) to genetic enhancements. The permissibility of HGE has often been considered on the basis of possible uses, with therapeutic uses generally considered more acceptable than non-therapeutic ones (including human enhancement). When compared with other technologies with similar therapeutic uses (e.g., PGD) already in use, HGE presents similarities and differences. However, from an ethical acceptability perspective, there is currently no consensus on whether HGE is more or less acceptable than PGD.

An important conclusion of this study is that, along with the technological development of genome germline editing techniques, a shift in the focus of analyses on its applicability has been observed. More specifically, the emphasis on pragmatic considerations seems to have increased substantially compared with the previous emphasis on categorical and sociopolitical arguments. Many of the most recent publications from authoritative advisory committees and institutions discuss the permissibility of HGE interventions primarily on the basis of pragmatic arguments, in which safety and efficacy are the main focus. Since germline interventions could profoundly change the human condition, the need for a broad and inclusive public debate on this topic has also been frequently emphasized. However, limited consideration has been given to approaches to carry out such action effectively, and on how to consider their outcomes in relevant policies and regulations.

It is currently not entirely clear whether: (i) the pragmatic position championed by such authoritative sources builds on the premise that the ethical debate has reached sufficient maturity to allow a turning point; (ii) the lack of progress has somewhat hampered further consideration of issues still considered controversial; (iii) regulatory pressure is somewhat de facto pushing forward the introduction of such technologies despite critical, unresolved ethical issues. Based on the analysis presented in this paper, a combination of the latter factors (ii and iii) seems more likely. In engaging the public in societal debates on the acceptability of such technologies, unresolved questions are likely to re-emerge. Specifically, it is possible that categorical and sociopolitical considerations will gain renewed focus during public engagement. In other words, when involving the public in discussions on HGE, it is possible that cultural values and norms, not only questions of safety and efficacy, will re-emerge as crucial to the acceptance of the technology (What is meant by natural? What is understood by humanity? etc.).

HGE interventions put into question specific biological and moral views of individuals, including views on the value of the human genome, on human dignity, on informed consent, on disability and on societal equality and justice. The range of ethical issues affected by the introduction of such technology, often still characterised by non-convergent, and at times conflicting, positions, illustrate the importance of further consideration of these issues in future studies and public engagement activities. As a result, society’s moral uncertainties will need to be assessed further to support the regulation of HGE technologies and form a well-informed and holistic view on how they can serve society’s common goals and values.

Data availability

This statement is not applicable.

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Acknowledgements

This work was supported by Fundação para Ciência e a Tecnologia (FCT) of Portugal [UIDP/00678/2020 to M.A]. We thank Dr. Michael Morrison for his comments and Dr. Gustav Preller for his proofreading of this manuscript.

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Almeida, M., Ranisch, R. Beyond safety: mapping the ethical debate on heritable genome editing interventions. Humanit Soc Sci Commun 9 , 139 (2022). https://doi.org/10.1057/s41599-022-01147-y

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Genetic engineering of animals: Ethical issues, including welfare concerns

Current context of genetically engineered animals

Companion animals

Wild animals

Farm animals

Research animals

Ethical issues of genetic engineering

Concerns for animal welfare

Large numbers of animals required

Unanticipated welfare concerns

Beyond animal welfare

Other ethical issues

Implications for veterinarians

Acknowledgments

Beyond safety: mapping the ethical debate on heritable genome editing interventions

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Introduction

Human genome editing: a brief history of CRISPR/Cas9

Box 1 Difference associated with germline cells and somatic cells.

Germline interventions: the international debate

Potential uses of heritable genome editing technology

Single gene disorders

Polygenetic conditions

Genetic enhancement

Heritable genome editing: Mapping the ethical debate

Human genome ‘integrity’

Human dignity

Right of the child: informed consent

Discrimination of people with disabilities

Justice and equality

Conclusions

Data availability

Acknowledgements

Author information

Corresponding author

Ethics declarations

Ethical approval

Informed consent

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