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Essays on Genetic Engineering

What makes a good genetic engineering essay topic.

When it comes to writing a captivating genetic engineering essay, the topic you choose is paramount. It not only grabs the reader's attention but also allows for effective exploration of the subject matter. So, how can you brainstorm and select a standout essay topic? Here are some recommendations:

• Brainstorm: Kickstart your ideas by brainstorming topics related to genetic engineering. Consider the latest advancements, ethical concerns, controversial issues, or potential future applications. Jot down any ideas that come to mind.
• Research: Once you have a list of potential topics, conduct thorough research to gather relevant information and understand different perspectives. This will help you evaluate the feasibility and depth of each topic.
• Consider Interest: Choose a topic that genuinely piques your interest. Writing about something you are passionate about will make the entire process more enjoyable and motivate you to delve deeper into the subject matter.
• Relevance: Ensure that the chosen topic is relevant to genetic engineering. It should align with the scope of the subject and allow you to explore various aspects related to it.
• Uniqueness: Strive for a unique and imaginative topic that stands out from the ordinary. Steer clear of generic subjects and instead focus on specific areas or emerging trends within genetic engineering.
• Controversy: Controversial topics often generate more interest and discussion. Consider exploring ethical dilemmas, potential risks, or societal impacts of genetic engineering to add a thought-provoking element to your essay.
• Depth and Scope: Assess the depth and scope of each topic. Make sure it provides enough material for a comprehensive essay without being too broad or too narrow.
• Audience Appeal: Keep your target audience in mind. Choose a topic that would captivate readers, whether they are experts in the field or individuals with limited knowledge about genetic engineering.
• Originality: Strive for originality in your topic selection. Look for unique angles, lesser-known areas, or innovative applications of genetic engineering that can make your essay stand out.
• Personal Connection: If possible, choose a topic that connects with your personal experiences or future aspirations. This will enhance your engagement and make your essay more meaningful.

Igniting Thought: The Finest Genetic Engineering Essay Topics

Below are some of the most captivating genetic engineering essay topics to consider:

• Genetic Engineering and the Future of Human Evolution
• The Ethical Dilemmas of Designer Babies
• Genetic Engineering in Agriculture: Balancing Benefits and Concerns
• CRISPR-Cas9: Unleashing Revolutionary Potential in Genetic Engineering
• The Potential of Genetic Engineering in Cancer Treatment
• Genetic Engineering's Role in Creating Sustainable Food Sources
• Genetic Engineering and Animal Welfare: Navigating Ethical Considerations
• Genetic Engineering and its Impact on Biodiversity
• The Social and Economic Implications of Genetic Engineering
• Genetic Engineering's Influence on Human Longevity
• Enhancing Athletic Performance: The Power of Genetic Engineering
• Genetic Engineering Techniques for Disease Prevention and Treatment
• Genetic Engineering's Role in Environmental Conservation
• Genetic Engineering and the Preservation of Endangered Species
• The Psychological and Societal Effects of Genetic Engineering
• The Pros and Cons of Genetic Engineering for Non-Medical Purposes
• Exploring the Potential Risks and Benefits of Genetic Engineering in Space Exploration
• Genetic Engineering and the Creation of Biofuels
• The Morality of Genetic Engineering: Insights from Religious and Philosophical Perspectives
• Genetic Engineering's Role in Combating Climate Change

Thought-Provoking Genetic Engineering Essay Questions

Consider these stimulating questions for your genetic engineering essay:

• How does genetic engineering impact the concept of natural selection?
• What are the potential consequences of genetic engineering on human genetic diversity?
• Is it ethically justifiable to use genetic engineering for cosmetic purposes?
• How does genetic engineering contribute to the development of personalized medicine?
• What are the social implications of genetically modifying animals for human consumption?
• How does the use of genetic engineering in agriculture affect food security?
• Should genetic engineering be used to resurrect extinct species?
• What are the potential risks and benefits of genetically modifying viruses for medical purposes?
• How does genetic engineering influence the balance between individual rights and societal well-being?
• Can genetic engineering be the solution to eradicating genetic diseases?

Provocative Genetic Engineering Essay Prompts

Here are some imaginative and engaging prompts for your genetic engineering essay:

• Imagine a world where genetic engineering has eliminated all hereditary diseases. Discuss the potential benefits and drawbacks of such a scenario.
• You have been granted the ability to genetically engineer one aspect of yourself. What would you choose and why?
• Write a fictional story set in a future where genetic engineering is widespread and explore the consequences it has on society.
• Reflect on the ethical considerations of genetically modifying animals for entertainment purposes, such as creating glow-in-the-dark pets.
• Create a persuasive argument for or against the use of genetic engineering in enhancing human intelligence.

Answering Your Genetic Engineering Essay Queries

Q: Can I write about the history of genetic engineering?

A: Absolutely! Exploring the historical context of genetic engineering can provide valuable insights and set the foundation for your essay.

Q: How can I make my genetic engineering essay engaging for readers with limited scientific knowledge?

A: Simplify complex concepts and terminologies, provide relevant examples, and use relatable analogies to help readers grasp the information more easily.

Q: Can I express my personal opinion in a genetic engineering essay?

A: Yes, expressing your personal opinion is encouraged as long as you support it with logical reasoning and evidence from reputable sources.

Q: Are there any potential risks associated with genetic engineering that I should discuss in my essay?

A: Yes, incorporating a discussion on the potential risks and ethical concerns surrounding genetic engineering is essential to provide a balanced perspective.

Q: Can I include interviews or case studies in my genetic engineering essay?

A: Absolutely! Interviews or case studies can add depth and real-life examples to support your arguments and make your essay more compelling.

Remember, when writing your genetic engineering essay, let your creativity shine through while maintaining a formal and engaging tone.

The Ethics of Genetic Engineering

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Ethical Issues of Genetic Engineering

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The Issue of The Use of Genetic Modification of Humans

Reasons why genetic engineering should be banned, genetic engineering: an overview of the dna/rna and the crispr/cas9 technology, review of human germline engineering, get a personalized essay in under 3 hours.

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Positional Cloning of Genetic Disorders

Engineering american society: the lesson of eugenics, bioethical issues related to genetic engineering, cloning and ethical controversies related to it, genetic editing as a possibility of same-sex parents to have children, adhering to natural processes retains the integrity of a natural human race  , genetically modified organisms: soybeans, gene silencing to produce milk with reduced blg proteins, the role of crispr-cas9 gene drive in mosquitoes, the life of gregor mendel and his contributions to science, eugenics, its history and modern development, morphological operation hsv color space tree detetction, cytogenetics: analysis of comparative genomic hybridization and its implications, genetically engineered eucalyptus tree and crispr, review of the process of dna extraction, review of the features of the process of cloning, heterologous gene expression as an approach for fungal secondary metabolite discovery, review of the genetic algorithm searches, genetic engineering: clustered regularly interspaced short palindromic repeats, crispr technology - the potential tool for curing huntington’s disease.

Genetic engineering (also called genetic modification) is a process that uses laboratory-based technologies to alter the DNA makeup of an organism.

Genetic engineering as the direct manipulation of DNA by humans outside breeding and mutations has only existed since the 1970s. In 1972, Paul Berg created the first recombinant DNA molecules by combining DNA from the monkey virus SV40 with that of the lambda virus. The first field trials of genetically engineered plants occurred in France and the US in 1986, tobacco plants were engineered to be resistant to herbicides.

It is a set of technologies used to change the genetic makeup of cells, including the transfer of genes within and across species boundaries to produce improved or novel organisms. New DNA is obtained by either isolating and copying the genetic material of interest using recombinant DNA methods or by artificially synthesising the DNA. Used in research and industry, genetic engineering has been applied to the production of cancer therapies, brewing yeasts, genetically modified plants and livestock, and more.

Relevant topics

• Engineering
• Natural Selection
• Space Exploration
• Mathematics in Everyday Life
• Time Travel
• Stephen Hawking
• Charles Darwin

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Gene Therapy and Genetic Engineering

Section menu, introduction.

The cells of a human being or other organism have parts called “genes” that control the chemical reactions in the cell that make it grow and function and ultimately determine the growth and function of the organism.  An organism inherits some genes from each parent and thus the parents pass on certain traits to their offspring.

Gene therapy and genetic engineering are two closely related technologies that involve altering the genetic material of organisms. The distinction between the two is based on purpose. Gene therapy seeks to alter genes to correct genetic defects and thus prevent or cure genetic diseases. Genetic engineering aims to modify the genes to enhance the capabilities of the organism beyond what is normal.

Ethical controversy surrounds possible use of the both of these technologies in plants, nonhuman animals, and humans.  Particularly with genetic engineering, for instance, one wonders whether it would be proper to tinker with human genes to make people able to outperform the greatest Olympic athletes or much smarter than Einstein.

Confusing Terminology

If genetic engineering is meant in a very broad sense to include any intentional genetic alteration, then it includes gene therapy.  Thus one hears of “therapeutic genetic engineering” (gene therapy) and “negative genetic engineering” (gene therapy), in contrast with “enhancement genetic engineering” and “positive genetic engineering” (what we call simply “genetic engineering”).

We use the phrase “genetic engineering” more narrowly for the kind of alteration that aims at enhancement rather than therapy.  We use the term “gene therapy” for efforts to bring people up to normalcy and “genetic engineering” or “enhancement genetic engineering” for efforts to enhancement people’s capabilities beyond normalcy.

Somatic Cells and Reproductive Cells

Two fundamental kinds of cell are somatic cells and reproductive cells. Most of the cells in our bodies are somatic – cells that make up organs like skin, liver, heart, lungs, etc., and these cells vary from one another.  Changing the genetic material in these cells is not passed along to a person’s offspring.  Reproductive cells are sperm cells, egg cells, and cells from very early embryos.  Changes in the genetic make-up of reproductive cells would be passed along to the person’s offspring.  Those reproductive cell changes could result in different genetics in the offspring’s somatic cells than otherwise would have occurred because the genetic makeup of somatic cells is directly linked to that of the germ cells from which they are derived.

Techniques of Genetic Alteration

Two problems must be confronted when changing genes.  The first is what kind of change to make to the gene.  The second is how to incorporate that change in all the other cells that are must be changed to achieve a desired effect.

There are several options for what kind of change to make to the gene.  DNA in the gene could be replaced by other DNA from outside (called “homologous replacement).  Or the gene could be forced to mutate (change structure – “selective reverse mutation.”)  Or a gene could just be added.  Or one could use a chemical to simply turn off a gene and prevent it from acting.

There are also several options for how to spread the genetic change to all the cells that need to be changed.  If the altered cell is a reproductive cell, then a few such cells could be changed and the change would reach the other somatic cells as those somatic cells were created as the organism develops.  But if the change were made to a somatic cell, changing all the other relevant somatic cells individually like the first would be impractical due to the sheer number of such cells.  The cells of a major organ such as the heart or liver are too numerous to change one-by-one.  Instead, to reach such somatic cells a common approach is to use a carrier, or vector, which is a molecule or organism.  A virus, for example, could be used as a vector.  The virus would be an innocuous one or changed so as not to cause disease.  It would be injected with the genetic material and then as it reproduces and “infects” the target cells it would introduce the new genetic material.  It would need to be a very specific virus that would infect heart cells, for instance, without infecting and changing all the other cells of the body.  Fat particles and chemicals have also been used as vectors because they can penetrate the cell membrane and move into the cell nucleus with the new genetic material.

Arguments in Favor of Gene Therapy and Genetic Engineering

Gene therapy is often viewed as morally unobjectionable, though caution is urged.  The main arguments in its favor are that it offers the potential to cure some diseases or disorders in those who have the problem and to prevent diseases in those whose genes predisposed them to those problems.  If done on reproductive cells, gene therapy could keep children from carrying such genes (for unfavorable genetic diseases and disorders) that the children got from their patients.

Genetic engineering to enhance organisms has already been used extensively in agriculture, primarily in genetically modified (GM) crops (also known as GMO --genetically modified organisms).  For example, crops and stock animals have been engineered so they are resistant to herbicides and pesticides, which means farmers can then use those chemicals to control weeds and insects on those crops without risking harming those plants.  In the future genetic enhancement could be used to create crops with greater yields of nutritional value and selective breeding of farm stock, race horses, and show animals.

Genetically engineered bacteria and other microorganisms are currently used to produce human insulin, human growth hormone, a protein used in blood clotting, and other pharmaceuticals, and the number of such compounds could increase in the future.

Enhancing humans is still in the future, but the basic argument in favor of doing so is that it could make life better in significant ways by enhancing certain characteristics of people.  We value intelligence, beauty, strength, endurance, and certain personality characteristics and behavioral tendencies, and if these traits were found to be due to a genetic component we could enhance people by giving them such features.  Advocates of genetic engineering point out that many people try to improve themselves in these ways already – by diet, exercise, education, cosmetics, and even plastic surgery.  People try to do these things for themselves, and parents try to provide these things for their children.  If exercising to improve strength, agility, and overall fitness is a worthwhile goal, and if someone is praised for pursuing education to increase their mental capabilities, then why would it not be worthwhile to accomplish this through genetics? 

Advocates of genetic engineering also see enhancement as a matter of basic reproductive freedom.  We already feel free to pick a mate partly on the basis of the possibility of providing desirable children.  We think nothing is wrong with choosing a mate whom we hope might provide smart, attractive kids over some other mate who would provide less desirable children.  Choosing a mate for the type of kids one might get is a matter of basic reproductive freedom and we have the freedom to pick the best genes we can for our children.  Why, the argument goes, should we have less freedom to give our children the best genes we can through genetic enhancement?

Those who advocate making significant modification of humans through technology such as genetic engineering are sometimes called “transhumanists.”

Arguments Against Gene Therapy

Three arguments sometimes raised against gene therapy are that it is technically too dangerous, that it discriminates or invites discrimination against persons with disabilities, and that it may be becoming increasingly irrelevant in some cases.

The danger objection points out that a few recent attempts at gene therapy in clinical trials have made headlines because of the tragic deaths of some of the people participating in the trials.  It is not fully known to what extent this was due to the gene therapy itself, as opposed to pre-existing conditions or improper research techniques, but in the light of such events some critics have called for a stop to gene therapy until more is known.  We just do not know enough about how gene therapy works and what could go wrong.  Specific worries are that

• the vectors may deliver the DNA to cells other than the target cells, with unforeseen results
• viruses as vectors may not be as innocuous as assumed and may cause disease
• adding new genes to a nucleus does not guarantee they will go where desired, with potentially disastrous results if they insert in the wrong place
• if the changes are not integrated with other DNA already in the nucleus, the changes may not carry over to new cells and the person may have to undergo more therapy later
• changing reproductive cells may cause events not seen until years later, and undesirable effects may have already been passed on to the patient’s children

The discrimination objection is as follows.  Some people who are physically, mentally, or emotionally impaired are so as the result of genetic factors they have inherited.  Such impairment can result in disablement in our society.  People with disabilities are often discriminated against by having fewer opportunities than other people.  Be removing genetic disorders, and resulting impairment, it is true that gene therapy could contribute to removing one of the sources of discrimination and inequality in society.  But the implicit assumption being made, the objection claims, is that people impaired through genetic factors need to be treated and made normal.  The objection sees gene therapy as a form of discrimination against impaired people and persons with disabilities.

The irrelevance objection is that gene therapy on reproductive cells may in some cases already be superseded by in-vitro fertilization and selection of embryos.  If a genetic disorder is such that can be detected in an early embryo, and not all embryos from the parent couple would have it, then have parents produce multiple embryos through in-vitro fertilization and implant only those free from the disorder.  In such a case gene therapy would be unnecessary and irrelevant.

Arguments Against Genetic Engineering

Ethicists have generally been even more concerned about possible problems with and implications of enhancement genetic engineering than they have been about gene therapy.  First, there are worries similar to those about gene therapy that not enough is known and there may be unforeseen dangerous consequences.  These worries may be even more serious given that the attempts are made not just toward normalcy but into strange new territory where humans have never gone before.  We just do not know what freakish creatures might result from experiments gone awry.

Following are some other important objections:

• Genetic engineering is against the natural or supernatural order.  The thought here is that God, or evolution, has created a set of genes for human beings that are either what we should have or that offer us the best survival value.  It is against what God or nature intended to tinker with this genetic code, not to bring it up to normal (as in gene therapy), but to create new kinds of beings. This type of objection is compatible both with “creationism,” the belief that God created humans just as they are, and also the belief in evolution.  On the latter view, humans consciously enhancing their genes is considered different than allowing the natural process of evolution to “choose” the genes we have.
• Genetic engineering is dehumanizing because it will create nonhuman, alienated creatures.  Genetically engineered people will be alienated from themselves, or feel a confused identify, or no longer feel human, or the human race will feel alienated from itself.  Genetically engineered people won’t have a sense of being part of the human race but they will not have enough in common with other such creatures to feel like they belong with any of them either.  People will be alienated even from their radically different genetically engineered children, who could very well be a separate species.
• Genetic engineered creatures will suffer from obsolescence.  Computers become obsolete quickly as newer models are introduced.  But this could happen to genetically engineered people.  The hot gene enhancement of one year will be old news several years later.  Parents will be obsolete by the standards of their children, and teenagers will be hopelessly outclassed by their younger siblings.
• Genetic engineering is a version of eugenics and evokes memories of the historical eugenics movement of the earlier part of the twentieth century in America and Nazi Germany.  “Eugenics” is the view that we should improve the genetics of the human race; often advocated are such practices as selective breeding, forced sterilization of “defectives” and “undesirables” (people with genetic disorders or undesirable characteristics or traits, people with disabilities, people of other races, people of other ethnic groups, homosexuals), and euthanasia of such populations.  It probably reached an extreme form in Nazi Germany, where mass exterminations took place, but eugenics sentiments existed prior to that in the U.S.  These practices are now largely viewed as morally abhorrent.  Critics of genetic engineering see it as an attempt at eugenics through technology.

Gene therapy is becoming a reality as you read this.  Genetic engineering for enhancement is still a ways off.  Plenty of debate is sure to occur over both issues.

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121 Genetic Engineering Topics & Essay Examples

Welcome to our list of genetic engineering essay topics! Here, you will find everything from trending research titles to the most interesting genetic engineering topics for presentation. Get inspired with our writing ideas and bonus samples!

🔝 Top 10 Genetic Engineering Topics for 2024

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• Changing the world: Genetic Engineering Effects
• The Ethical Issues of Genetic Engineering
• Is Genetically Engineered Food the Solution to the World’s Hunger Problems?
• Human Genetic Engineering: Key Principles and Issues
• Mitochondrial Diseases Treatment Through Genetic Engineering
• Genetic Engineering: Is It Ethical to Manipulate Life?
• Biotechnology and Genetic Engineering
• Genetic Engineering in the Movie “Gattaca” by Niccol
• Religious vs Scientific Views on Genetic Engineering
• Genetic Engineering Using a Pglo Plasmid
• Managing Diabetes Through Genetic Engineering Genetic engineering refers to the alteration of genetic make-up of an organism through the use of techniques to introduce a new DNA or eliminate a given hereditable material. What is the role of genetic engineering […]
• The Role of Plant Genetic Engineering in Global Security Although it can be conveniently stated that the adequacy, abundance and reliability of the global food supply has a major role to play in the enhancement of human life, in the long run, they influence […]
• Significance of Human Genetic Engineering The gene alteration strategy enables replacing the specific unwanted genes with the new ones, which are more resistant and freer of the particular ailment, hence an essential assurance of a healthy generation in the future.
• Is the World Ready for Genetic Engineering? The process of manipulating genes has brought scientists to important discoveries, among which is the technology of the production of new kinds of crops and plants with selected characteristics. The problem of the advantages and […]
• Genome: Bioethics and Genetic Engineering Additionally, towards the end of the documentary, the narrator and some of the interviewed individuals explain the problem of anonymity that is also related to genetic manipulations.
• Is Genetic Engineering an Environmentally Sound Way to Increase Food Production? According to Thomas & Earl and Barry, genetic engineering is environmentally unsound method of increasing food production because it threatens the indigenous species.
• Gattaca: Ethical Issues of Genetic Engineering Although the world he lives in has determined that the only measure of a man is his genetic profile, Vincent discovers another element of man that science and society have forgotten.
• A Major Milestone in the Field of Science and Technology: Should Genetic Engineering Be Allowed? The most controversial and complicated aspect of this expertise is Human Genetic Engineering- whereby the genotype of a fetus can be altered to produce desired results.
• Genetic Engineering Is Ethically Unacceptable However, the current application of genetic engineering is in the field of medicine particularly to treat various genetic conditions. However, this method of treatment has various consequences to the individual and the society in general.
• Designer Genes: Different Types and Use of Genetic Engineering McKibben speaks of Somatic Gene Therapy as it is used to modify the gene and cell structure of human beings so that the cells are able to produce certain chemicals that would help the body […]
• A Technique for Controlling Plant Characteristics: Genetic Engineering in the Agriculture A cautious investigation of genetic engineering is required to make sure it is safe for humans and the environment. The benefit credited to genetic manipulation is influenced through the utilization of herbicide-tolerant and pest-safe traits.
• The Dangers of Genetic Engineering and the Issue of Human Genes’ Modification In this case, the ethics of human cloning and human genes’ alteration are at the center of the most heated debates. The first reason to oppose the idea of manipulation of human genes lies in […]
• Genetically Engineered Food Against World Hunger I support the production of GMFs in large quality; I hold the opinion that they can offer a lasting solution to food problems facing the world.
• Genetic Engineering in Food: Development and Risks Genetic engineering refers to the manipulation of the gene composition of organisms, to come up with organisms, which have different characteristics from the organic ones.
• Genetic Engineering in the Workplace The main purpose of the paper is to evaluate and critically discuss the ethical concerns regarding the implementation of genetic testing in the workplace and to provide potential resolutions to the dilemmas.
• Designer Babies Creation in Genetic Engineering The creation of designer babies is an outcome of advancements in technology hence the debate should be on the extent to which technology can be applied in changing the way human beings live and the […]
• Genetic Engineering and Eugenics Comparison The main idea in genetic engineering is to manipulate the genetic make-up of human beings in order to shackle their inferior traits. The concept of socially independent reproduction is replicated in both eugenics and genetic […]
• The Film “Gattaca” and Genetic Engineering In the film, it is convincing that in the near future, science and technology at the back of genetic engineering shall be developed up to the level which makes the film a reality.
• Future of Genetic Engineering and the Concept of “Franken-Foods” This is not limited to cows alone but extends to pigs, sheep, and poultry, the justification for the development of genetically modified food is based on the need to feed an ever growing population which […]
• Ecological Effects of the Release of Genetically Engineered Organisms Beneficial soil organisms such as earthworms, mites, nematodes, woodlice among others are some of the soil living organisms that are adversely affected by introduction of genetically engineered organisms in the ecosystem since they introduce toxins […]
• Benefits of Genetic Engineering as a Huge Part of People’s Lives Genetic Engineering is said to question whether man has the right to manipulate the course and laws of nature and thus is in constant collision with religion and the beliefs held by it regarding life.

Trying to choose a topic for your essay with no luck? Here are some tips to help you decide:

• Choose an exciting research area. Make sure you genuinely enjoy researching the topic because it can elevate your writing process and the results.
• Narrow it down. Find some subcategory within the research area you pick. A narrow topic is easier to work on than a broad one with endless information sources.
• Check if the topic is up-to-date. It doesn’t have to be the trendiest and most discussed issue, but it’s a good idea to check if your topic is relevant.

Here’s a bonus for you – our top 4 essay prompts:

• You can discuss the main aspects of the genetic engineering process. For example, try focusing on gene isolation and cloning.
• Write about the applications of genetic engineering in modern health care.
• Express your opinion about genetically modified crops and the use of herbicides.
• Discuss the regulations the US government imposes regarding genetically modified produce and herbicides.
• Perfect Society: The Effects of Human Genetic Engineering

Genetic Engineering and Forensic Criminal Investigations

• Biotechnology Assignment and Genetic Engineering
• Genetic Engineering and Genetically Modified Organisms
• Bio-Ethics and the Controversy of Genetic Engineering
• Health and Environmental Risks of Genetic Engineering in Food
• Genetic Engineering and the Risks of Enforcing Changes on Organisms
• Genetic Engineering and How It Affects Globel Warming
• Cloning and Genetic Engineering in the Food Animal Industry
• Genetic Engineering and Its Impact on Society
• Embryonic Research, Genetic Engineering, & Cloning
• Genetic Engineering: Associated Risks and Possibilities
• Issues Concerning Genetic Engineering in Food Production
• Genetic Engineering, DNA Fingerprinting, Gene Therapy
• Cloning: The Benefits and Dangers of Genetic Engineering
• Genetic Engineering, History, and Future: Altering the Face of Science
• Islamic and Catholic Views on Genetic Engineering
• Gene Therapy and Genetic Engineering: Should It Be Approved in the US
• Exploring the Real Benefits of Genetic Engineering in the Modern World
• Genetic Engineering and Food Security: A Welfare Economics Perspective
• Identify the Potential Impact of Genetic Engineering on the Future Course of Human Immunodeficiency Virus
• Genetic Engineering and DNA Technology in Agricultural Productivity
• Human Genetic Engineering: Designing the Future
• Genetic Engineering and the Politics Behind It
• The Potential and Consequences of Genetic Engineering
• Genetic Engineering and Its Effect on Human Health
• The Moral and Ethical Controversies, Benefits, and Future of Genetic Engineering
• Gene Therapy and Genetic Engineering for Curing Disorders
• Genetic Engineering and the Human Genome Project
• Ethical Standards for Genetic Engineering
• Genetic Engineering and Cryonic Freezing: A Modern Frankenstein
• The Perfect Child: Genetic Engineering
• Genetic Engineering and Its Effects on Future Generations
• Agricultural Genetic Engineering: Genetically Modified Foods
• Genetic Engineering: The Manipulation or Alteration of the Genetic Structure of a Single Cell or Organism
• Analyzing Genetic Engineering Regarding Plato’s Philosophy
• The Dangers and Benefits of Human Cloning and Genetic Engineering
• Genetic Engineering: Arguments of Both Proponents and Opponents and a Mediated Solution
• Genetic and How Genetic Engineering Is Diffusing Individualism
• Finding Genetic Harmony with Genetic Engineering

In case you need some ideas for research questions about genetic engineering, here are the hottest examples:

• How has genetic engineering affected horticulture? Genetic engineering is the reason modern crops are more resistant to pests and have higher nutrition than before. Discuss the main aspects of using it to level up the horticulture game.
• What’s the main issue with genetic engineering methanogens? The development in the area of methanogens has slowed down and almost stopped. What’s the main reason behind it? What tools can help the progress start up again?
• What role does genetic engineering play in modern medicine? Revolutionary methods of treatment are discovered in healthcare areas every day. What’s the role of genetic engineering in all this? Discuss the recent developments in this area.
• Why is genetic engineering essential for solving food insecurity? Today, climate change affects crops more than ever before. How can genetic engineering tools be applied to save produce in harsh climates? Analyze the most effective options on the market and make sure to back up your ideas with good arguments.
• How ethical is genetic engineering? GMOs have been used to provide the abundance of food you see in your local grocery stores. However, the ways genetic engineering is done raise questions. Discuss them and provide reliable sources for your statements.
• What Is Genetic Engineering?
• Do You Think Genetically Modified Food Could Harm the Ecosystems of the Areas in Which They Grow?
• How Agricultural Research Systems Shape a Technological Regime That Develops Genetic Engineering?
• Can Genetic Engineering for the Poor Pay Off?

How Does Genetic Engineering Affect Agriculture?

• Do You Think It’s Essential to Modify Genes to Create New Medicines?
• How Can Genetic Engineering Stop Human Suffering?
• Can Genetic Engineering Cure HIV/AIDS in Humans?
• How Has Genetic Engineering Revolutionized Science and the World?
• Do You Think Genetic Engineering Is Playing God and That We Should Leave Life as It Was Created?
• What Are Some Advantages and Disadvantages of Genetic Engineering?
• How Will Genetic Engineering Affect the Human Race?
• When Does Genetic Engineering Go Bad?
• What Are the Benefits of Human Genetic Engineering?
• Does Genetic Engineering Affect the Entire World?
• How Does the Christian Faith Contend with Genetic Engineering?
• What Are the Ethical and Social Implications of Genetic Engineering?
• How Will Genetic Engineering Impact Our Lives?
• Why Should Genetic Engineering Be Extended?
• Will Genetic Engineering Permanently Change Our Society?
• What Are People Worried About Who Oppose Genetic Engineering?
• Do You Worry About Eating GM (Genetically Modified) Food?
• What Do You Think of the Idea of Genetically Engineering New Bodily Organs to Replace Yours When You Are Old?
• Should Genetic Engineering Go Ahead to Eliminate Human Flaws, Such as Violence, Jealousy, Hate, etc.?
• Does the Government Have the Right to Limit How Far We Modify Ourselves?
• Why Is Genetic Food Not Well Accepted?
• What Is the Best in the Genetic Modification of Plants, Plant Cell, or Chloroplasts, and Why?
• How Do You Feel About Human Gene Editing?
• Does Climate Change Make the Genetic Engineering of Crops Inevitable?
• What Do You Think About Plant Genetic Modification?

Plant Genetic Modification

Genetic modification of plants is the process of inserting new DNA into the cells. After this, the plants grow normally and inherit the new traits that are passed down through the seeds. The most well-known example is corn, which is now resistant to pests because it produces specific toxins.

Genetic Modification Methods

There are 3 main ways to modify genes: replacement, deletion, and insertion. Additional genetic modification techniques include gene targeting, mutagenesis, and zinc finger nuclease. The choice of the method depends on the gene location and possible impact on the surrounding genes.

Nuclear Genome Transformation vs. Plastome Transformation

Genome editing is a powerful tool used to alter plants for specific needs. Nuclear and plastid genomes were created via genetic engineering to change plants’ features. However, the differences between them are so noticeable that they affect all aspects of the genetic transformation.

Gene Therapy

Gene therapy is a revolutionary method of treating a wide range of illnesses. The first step is taking the blood stems. Then, the working copy of the damaged gene is put back in the patient’s DNA. Similar ways of gene therapy include adding a healthy gene and canceling the faulty one

Genome Editing

Genome editing is a genetic engineering tool used to remove, replace, or edit the DNA of living organisms. This method is believed to have fantastic potential for treating incurable genetic diseases, but it poses questions regarding ethics and safety. Consequently, this technology should be protected from people with malicious intentions.

• Gene Drives and Pest Control
• The Benefits of Genetically Modified Organisms
• Challenges of Gene Editing for Rare Genetic Diseases
• The Use of Genetic Engineering to Treat Human Diseases
• Ethical Considerations and Possibilities of Designer Babies
• How Genetic Engineering Can Help Restore Ecosystems
• Basic Techniques and Tools for Gene Manipulation
• Latest Advancements in Genetic Engineering and Genome Editing
• Will Engineering Resilient Organisms Help Mitigate Climate Change?
• Creation of Renewable Resources through Genetic Engineering

Genetic engineering can prevent low soil quality and crop loss. GMO plants are more resistant to pests, which results in bigger crop yields than regular plants. In your presentation, you can compare the benefits and risks of using genetic engineering tools in agriculture.

Genetic Alterations and Cancer

Cancer might be a genetic disease because the changes in genes are inherited. Even though they are activated under certain conditions, heredity plays a significant role. The changes occur when something goes wrong during the cell’s split.

Police has been using genetic engineering tools for a while now. It helps them catch way more criminals than before. DNA profiling is what forensic scientists use on a regular basis. Even a strand of hair left on a crime scene helps resolve the case.

Designer Babies Creation in Genetic Engineering

Science has gone as far as editing embryo genomes to fix genetic conditions. Children who grow up after such interventions are called designer babies. Genetic engineers have started manipulating DNA in hopes of preventing diseases. Discuss how it led to an ethical controversy and why the project was labeled medically unnecessary.

Benefits of Genetic Engineering

The advantages of using genetic engineering spread across multiple areas of our lives. In agriculture, crops are protected from pests, and yields are increasing thanks to GMOs. Food in grocery stores has a longer shelf life and better taste due to the wonders of bioengineering.

• Genetic Engineering Approach to Drought and Pest Resistance
• Genetic Engineering Use in DNA Analysis and Identification
• Synthetic Microorganisms and Biofactories for Sustainable Bioproduction
• Stem Cells’ Potential for Regenerative Medicine
• The Role of Genetic Modification in Vaccine Development
• Can Genetic Engineering Help Eradicate Invasive Species Responsibly?
• Genetic Engineering for Enhancing the Body’s Defense Mechanisms
• Advancements in Transplantation Medicine and Creating Bioengineered Organs
• Genetic Editing of Microbes for Environmental Cleanup
• Is It Possible to Develop Living Detection Systems?
• Infertility Essay Topics
• Bioethics Titles
• Genetics Research Ideas
• Epigenetics Essay Titles
• Morality Research Ideas
• Stem Cell Essay Titles
• Biochemistry Research Topics
• Evolution Topics
• Chicago (A-D)
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Genetic Engineering

• Practice Questions

Genetic engineering, a vital field in biotechnology , involves modifying an organism’s DNA to achieve desired traits. This technology enables scientists to insert, delete, or alter genetic material, revolutionizing medicine, agriculture, and industry. Applications include creating genetically modified organisms (GMOs), developing gene therapy for diseases, and producing bioengineered pharmaceuticals. Genetic engineering holds immense potential for innovation, improving crop yields, and advancing medical treatments, making it a cornerstone of modern biotechnology.

What is Genetic Engineering?

Genetic engineering is the deliberate modification of an organism’s genetic material using biotechnology. It involves manipulating DNA to alter genes, enabling the creation of organisms with desired traits, such as disease resistance in crops or the production of insulin by bacteria.

Genetic Engineering Examples

• Golden Rice
• AquaBounty Salmon
• Herbicide-Resistant Soybeans
• Flavr Savr Tomato
• CRISPR-Cas9
• Insulin-Producing Bacteria
• Papaya Ringspot Virus-Resistant Papaya
• Spider Silk-Producing Goats
• Antithrombin-Producing Goats
• Drought-Tolerant Maize
• Genetically Engineered Mosquitoes
• Humanized Mouse Models
• Roundup Ready Crops
• Blight-Resistant Potatoes
• Virus-Resistant Squash
• Fast-Growing Trees
• Omega-3 Producing Pigs
• Glyphosate-Resistant Canola
• Vitamin D-Enriched Tomatoes
• Low-Allergen Peanuts
• Biofortified Cassava
• Stress-Tolerant Wheat
• HIV-Resistant Babies (via CRISPR)

Types of Genetic Engineering

1. Recombinant DNA Technology

Recombinant DNA technology involves combining DNA from two different sources to create a new genetic combination. This technique utilizes competent cells to uptake and express foreign DNA and is widely used in biotechnology for producing insulin, growth hormones, and other therapeutic proteins..

2. Gene Cloning

Gene cloning is the process of making multiple copies of a specific gene. This technique allows researchers to study the function of genes and produce large quantities of a gene product.

3. CRISPR-Cas9

CRISPR-Cas9 is a revolutionary gene-editing tool that allows for precise modifications to DNA. It is used for correcting genetic defects, studying gene function, and developing genetically modified organisms (GMOs).

4. Gene Therapy

Gene therapy involves inserting, altering, or removing genes within an individual’s cells to treat or prevent disease. This approach holds promise for treating genetic disorders like cystic fibrosis and hemophilia.

5. RNA Interference (RNAi)

RNA interference is a technique that silences specific genes by degrading their mRNA. It is used in research to study gene function and has potential therapeutic applications for conditions such as cancer and viral infections.

6. Transgenic Technology

Transgenic technology involves introducing foreign genes into an organism to give it new traits. This method is commonly used in agriculture to create crops with improved resistance to pests, diseases, and environmental conditions.

7. Somatic Cell Nuclear Transfer (SCNT)

SCNT is a cloning method where the nucleus of a somatic cell is transferred into an egg cell whose nucleus has been removed. This technique is used in cloning animals and for therapeutic cloning to produce stem cells.

8. Gene Knockout

Gene knockout involves inactivating a specific gene to study its function by observing the effects of its absence. This technique is essential for understanding gene roles in development, physiology, and disease.

Genetic engineering continues to evolve, offering new possibilities and ethical considerations. Its diverse techniques are transforming medicine, agriculture, and biotechnology.

Genetic engineering in Humans

• Gene Therapy in Humans – Uses genetic engineering to insert or alter genes in cells to treat or cure genetic disorders and diseases.
• CRISPR-Cas9 in Human Health – Employs precise gene-editing to correct genetic mutations, potentially curing inherited diseases and improving health outcomes.
• Human Genome Editing – Involves altering the human genome to prevent genetic diseases, enhance traits, and study gene functions.
• Somatic Cell Gene Editing – Targets specific cells in the body to treat diseases without affecting the patient’s germline or future generations.
• Germline Genetic Engineering – Modifies genes in human embryos, potentially preventing inherited diseases but raising ethical considerations.

Challenges of Genetic Engineering

• Ethical Concerns – Genetic engineering raises ethical issues regarding human modification, consent, and potential long-term effects on future generations.
• Technical Limitations – Current technology lacks precision and can cause unintended genetic changes, leading to unforeseen health and environmental consequences.
• Regulatory Hurdles – Strict regulations and lengthy approval processes hinder the development and application of genetic engineering innovations.
• Public Perception – Misunderstanding and fear of genetic engineering technologies can lead to public resistance and decreased funding for research.
• Cost – High costs associated with genetic engineering limit accessibility and widespread application, particularly in developing countries.

Benefits of Genetic Engineering

• Medical Advancements – Genetic engineering, guided by cell theory principles, enables the development of gene therapy, potentially curing genetic disorders and diseases.
• Agricultural Improvements – Enhances crop yields, pest resistance, and nutritional content, ensuring food security and reducing pesticide use.
• Environmental Protection – Creates genetically modified flora that can clean up pollutants and reduce environmental impact.
• Pharmaceutical Production – Allows for the mass production of essential medicines, such as insulin and vaccines, improving global health.
• Scientific Research – Facilitates the study of gene function and genetic diseases, leading to new discoveries and innovations in biology.

Importance of Genetic Engineering

• Disease Treatment – Genetic engineering provides innovative solutions for treating genetic disorders, cancers, and other diseases through gene therapy and targeted treatments.
• Food Security – Enhances crop yields, improves resistance to pests and diseases, and boosts nutritional content, addressing global hunger and malnutrition.
• Environmental Sustainability – Develops organisms that can break down pollutants, reduce waste, and decrease reliance on chemical pesticides and fertilizers.
• Biopharmaceuticals – Enables the production of vital medicines, such as insulin and vaccines, at a large scale, ensuring availability and affordability.
• Scientific Understanding -Advances knowledge of genetic functions and mechanisms, driving research in genetics, molecular biology, and biotechnology, and leading to new technological innovations, including studies on the effects of hypotonic solutions on cells.

Applications of Genetic Engineering

• Medical Applications – Genetic engineering develops gene therapies, creates vaccines, and produces insulin and other essential biopharmaceuticals.
• Agricultural Applications – Enhances crop yields, improves pest resistance, and increases nutritional content of food.
• Industrial Applications – Produces biofuels, biodegradable plastics, and enzymes for various industrial processes.
• Environmental Applications – Creates organisms to clean up pollutants and reduce environmental impact.
• Research Applications – Advances genetic research, enabling the study of gene function and the development of new biotechnology tools.
• Animal Husbandry – Improves livestock traits, such as disease resistance and growth rates.

Pros and Cons of Genetic Engineering

How does genetic engineering work?

It involves the addition, removal, or alteration of genetic material within an organism’s genome.

What are the benefits of genetic engineering?

Benefits include improved crop yields, disease resistance, and medical advancements like gene therapy.

What are the risks of genetic engineering?

Risks include ethical concerns, potential environmental impact, and unintended genetic consequences.

Is genetic engineering safe?

It can be safe when conducted under strict regulations and scientific guidelines.

What is CRISPR?

CRISPR is a precise genetic editing tool that allows for targeted modifications in DNA.

What are GMOs?

GMOs, or genetically modified organisms, are organisms whose genetic material has been altered using genetic engineering techniques.

Can genetic engineering cure diseases?

It holds potential for curing genetic diseases through gene therapy and other interventions.

What is gene therapy?

Gene therapy is a technique that uses genetic engineering to treat or prevent diseases by correcting defective genes.

Are genetically engineered foods safe to eat?

Genetically engineered foods are generally considered safe to eat when properly regulated.

What is a transgenic organism?

A transgenic organism contains genes from another species inserted into its genome.

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University student reflection: Let’s take a balanced ethical and scientific look at genetic engineering

Although the idea of engineering genes has been on the minds of science fiction writers, ethicists, and biochemists alike for decades, only recently has gene-editing science fully entered the glare of the public spotlight. This is, in part, due to a recent successful account of gene editing: the modification of a single DNA strand in multiple human embryos. As a result, fear of the impending race of designer human beings has been trickling into the public psyche. But how warranted is this fear? And, more importantly, what are the ethical implications of any of this?

To me, genetic engineering is as fascinating as it is complicated. Although I understand why people would pick different sides when it comes to supporting progress in the field, I am a fan (to a certain extent). Yes, it is ethically and scientifically complex, but if utilized intelligently and responsibly, it ultimately has the capacity to do more good than harm.

In order to explore the ethical dimensions of genetic engineering, it’s important to give a bit of background on how far along we are in terms of gene editing at the moment. The New York Times has a handy and fun way to  test your knowledge of modern gene editing  and the internet can certainly conjure up more than a few examples, but the gist is this: we’re not particularly advanced at gene editing, especially when it comes to humans.

Genetic engineering was first developed in 1973, and since then it has undergone a multitude of advancements and changes. Many of these have been applied to food and agriculture: for example, scientists at Pennsylvania State University have recently developed a  type of mushroom  that doesn’t turn brown after slicing, and they’re currently working on doing the same for potatoes. The market for genetically modified organisms (GMOs) is  expected to grow  from 112 million tons to 130 million tons by 2021, especially in countries in need of larger, more nutritious or drought-resistant food. Gene editing has also been  applied to diseases , such as diabetes in mice (for the eventual application to humans).

Don’t get too nervous or excited though: The process remains arduous and difficult, mostly because there are so many genes that influence a given plant or animal. For example, the number of genes influencing something like height is incredibly vast—some estimates go as high as 93,000 genetic variations. With our current capabilities (which, again, have only allowed for the modification of one genetic mutation in humans), there is no way that we could modify and test each of those different genes for height enough to make a significant difference. Even though it can take very little time to alter a single gene, altering thousands, and figuring out which thousands to alter, is incredibly time-consuming. So if you’re worrying that non-designer children will have to compete with a generation of Michael Jordans and Marie Curies, that fear, at least, should be assuaged.

What is more complicated is the potential uses of gene-editing technology for repairing genetic diseases, such as cystic fibrosis, some cases of early-onset Alzheimer’s, and even blindness. Because, as great as it is to make such astounding scientific advancements, access to such tools will likely be extremely limited, and thus extremely expensive. So, as with so many other things, genetic engineering could lead to an increasingly large economic divide. The best healthcare is already privileged to those of greater economic means, and this could be extended to genetic engineering for disease eradication. This is the source of a lot of fear—warranted fear—for a lot of people.

It’s extremely important to keep the social impact of genetic engineering in mind, especially when it comes to disease eradication. But this does not mean we should halt all scientific inquiry into the field. It’s a little scary to imagine banning scientific studies on the basis that results could be exclusive. With this mentality, any once-expensive cure that has been subsidized or improved so as to make more widely available wouldn’t exist. So while the socioeconomic implications are incredibly important, I don’t believe they should be the reason for the demise of gene-editing research.

And I don’t think too many people are arguing that we shouldn’t continue to research on the sole basis that the results could be really expensive and unavailable to most people. I think the main concern about genetic engineering has to do with the other potentially radical consequence: designer babies.

There’s something that feels wholly wrong about the idea of parents choosing how to make their children act and look, giving their offspring an advantage stemming not from the randomness of genetics but from deliberate choice, the cutting-and-pasting of genes. Follow the trajectory of this idea into the future, and you find yourself looking into the face of a terrifying potential reality: the divide between “designed” people and “natural” people strict and cutting, with economic, gendered, and racial consequences. This idea is terrifying.

I will note though, that as I mentioned before, trains of thought like this one are still much closer to science fiction than science, not least because no one has any idea how to deliberately design a child. Also, the  number and size of conferences  covering the ethics of genetic engineering in the past half-decade are reassuringly large—scientists are aware of the ethical considerations and are taking them into account. This is not to say that we should remove attention from the issue and let the scientist handle it. We should continue to pay attention and we have to hold scientists accountable—just without deterring work that has the capacity to do real good.

Natural selection takes millions of years. From the point that life first evolved on this planet—some three billion years ago—the process of mutation, diversification, evolution, and extinction has taken so long, it’s physically impossible to comprehend. And humans have only been around for 200,000 years of that history of life. So if you’re wondering why you still have an appendix or a tailbone, or you’re not well-suited to the really hot climate in which you live, it’s because evolution essentially takes forever. Given enough time, humans will adapt and change to suit our environments, it just takes a really, really long time.

But what if we could speed up the process of adaptation?

Adaptation is rooted in socio-biological trends, and this is demonstrated by the subtle, but nonetheless prevalent, adaptive differences in humans from a variety of regions. National Geographic described this in an  article about the process of self-evolution, noting that the ancestors of modern Australian and Tasmanian Aboriginals developed adaptations allowing them to survive in freezing temperatures at night, in addition to blistering temperatures during the day. The ancestors of Sherpas living near the Himalayas adapted greater lung capacities that allowed them to climb extreme heights. Across the continents, human genetic variation is based on changes that have happened over thousands and thousands of years.

Through decisions ancient humans made and the ones we make today, our species has self-evolved. Although these improvements were not through technological means, self-evolution is nothing new to our species. As such, taking it to the next level may not be as large a jump as we think.

With climate change as a looming force on the horizon, what if we could self-adapt to survive in warmer temperatures or wetter environments? With rising sea levels, what if we could adapt towards better lung capacity? As humans, we could bypass the long and random process of evolution—which will happen to us anyway, whether we like it or not—and choose ways in which we can meet the demands of our environment. If the focus of genetic engineering was not on making humans into perfect beings, but rather allowing humans to survive in harsh environmental conditions or remain free of life-threatening diseases, it could be the exact tool we need.

While this is only a hypothetical solution for the future, it nonetheless has implications for the present. It is more important than ever that we continue responsible and ethical research into genetic engineering. To put it bluntly, genetic engineering isn’t just about potentially advancing the species: it’s about saving us from ourselves.

Emmy Hughes is a sophomore at Wesleyan University, where she studies English and Earth and Environmental Science. She’s the Assistant News Editor for The Argus, Wesleyan’s student newspaper. Follow her on Twitter @emmyughes .

A version of this article was originally published on the Wesleyan Argus’ website as “ The Case for Responsible Genetic Engineering ” and has been republished here with permission from the author.

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• Senior Thesis

For an A.B. degree, a research thesis is strongly encouraged but not required; a thesis is necessary to be considered for High or Highest Honors. Additionally, a thesis will be particularly useful for students interested in pursuing graduate engineering research. 

In the S.B. degree programs, every student completes a design thesis as part of the required senior capstone design course (ES 100hf). During the year-long course students design and prototype a solution to an engineering problem of their own choice.

The guide below provides an overview of the requirement for a thesis in Biomedical Engineering:

• Thesis Guide

Some recent thesis examples across all of SEAS can be found on the Harvard DASH (Digital Access to Scholarship at Harvard) repository .

Biomedical Engineering (A.B.) Senior thesis examples:

• Engineering a Functionalized Biofilm-Based Material for Modulating Escherichia Coli’s Effects in the Mammalian Gastrointestinal Tract
• The MiR-130/301 Family Controls Cellular Survival in Pulmonary Hypertension
• The Role of Cell Compaction in Radiation Therapy for Breast Cancer
• Towards 3D Bioprinting of a Vascularized Convoluted Proximal Tubule
• Biomechanical Therapy: A Soft Robotic Drug Delivery Device
• The Clean Cut: Design, Synthesis, Assay Optimization, and Biological Evaluation of Compounds That Can Produce Double Strand Breaks in Deoxyribonucleic Acid
• Dilating Health, Healthcare, and Well-Being: Experiences of LGBTQ+ Thai People (Joint with Women and Gender Studies)

Biomedical Engineering (S.B.) Senior thesis examples:

• Predicting the Severity of Levodopa-Induced Dyskinesia of Parkinson’s Patients Through Template Matching
• Development of 3D-Printed Bony Implants for Biomimetic Ear Canal Wall Reconstruction
• Powassan Nanobody Diagnostic
• Microfluidic-based In-droplet Transcript Barcoding Platform for Identification of T Cell Receptors and Target Epitopes
• Adjustable stiffness splint based on principles of laminar jamming
• Oil-Infused Silicone Tympanostomy Tube as a Novel Treatment of Recurrent Otitis Media
• Cardiac Fibrosis-on-a-Chip: Fibrotic Cardiac Tissues on Biomimetic Nanofiber Scaffolds for Anti-fibrosis Drug Screening
• In Vitro Model for the Placental Barrier
• Multi-drug Device for Improved Diabetic Control
• Correlation of Core to Skin Temperature for Temp-Sensing Wearable Device
• Alginate Hydrogels for Topical Delivery of Ultra-High Concentrations of Antibiotics in Burn Wounds
• Cellular Invasion into Three-Dimensional, RGD-Functionalized PTFE Mesh
• Insulin transdermal patch
• Handheld Device for Dermatological Diagnosis
• Estimating Limb Propulsion

Engineering A.B. Thesis Extensions and Late Submissions

Thesis extensions will only be granted in extraordinary circumstances, such as hospitalization or grave family emergency. An extension may only be granted by the DUS (who may consult with thesis advisor, resident dean, and readers). For joint concentrators, the other concentration should also support the extension. To request an extension, please email your ADUS or DUS, ideally several business days in advance. Please note that any extension must be able to fall within our normal grading, feedback, and degree recommendation deadline, so extensions of more than a few days are usually impossible.

Late submissions of thesis work will not be accepted. A thesis is required for joint concentrators, and a late submission will prevent a student from fulfilling this requirement. Please plan ahead and submit your thesis by the required deadline.

Senior Thesis Submission Information for A.B. Programs

Senior A.B. theses are submitted to SEAS and made accessible via the Harvard University Archives and optionally via  DASH  (Digital Access to Scholarship at Harvard), Harvard's open-access repository for scholarly work.

In addition to submitting to the department and thesis advisors & readers, each SEAS senior thesis writer will use an online submission system to submit an electronic copy of their senior thesis to SEAS; this electronic copy will be kept at SEAS as a non-circulating backup. Please note that the thesis won't be published until close to or after the degree date. During this submission process, the student will also have the option to make the electronic copy publicly available via DASH.  Basic document information (e.g., author name, thesis title, degree date, abstract) will also be collected via the submission system; this document information will be available in  HOLLIS , the Harvard Library catalog, and DASH (though the thesis itself will be available in DASH only if the student opts to allow this). Students can also make code or data for senior thesis work available. They can do this by posting the data to the Harvard  Dataverse  or including the code as a supplementary file in the DASH repository when submitting their thesis in the SEAS online submission system.

Whether or not a student opts to make the thesis available through DASH, SEAS will provide an electronic record copy of the thesis to the Harvard University Archives. The Archives may make this record copy of the thesis accessible to researchers in the Archives reading room via a secure workstation or by providing a paper copy for use only in the reading room.  Per University policy , for a period of five years after the acceptance of a thesis, the Archives will require an author’s written permission before permitting researchers to create or request a copy of any thesis in whole or in part. Students who wish to place additional restrictions on the record copy in the Archives must contact the Archives  directly, independent of the online submission system. 

Students interested in commercializing ideas in their theses may wish to consult Dr. Fawwaz Habbal , Senior Lecturer on Applied Physics, about patent protection. See Harvard's policy for information about ownership of software written as part of academic work.

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Governing Heritable Human Genome Editing: A Textual History and a Proposal for the Future

Leroy walters.

1 Kennedy Institute of Ethics, Georgetown University, Washington, DC, USA

Robert M. Cook-Deegan

2 Consortium for Science, Policy, and Outcomes, Arizona State University, Washington, DC, USA

Eli Y. Adashi

3 Department of Medical Science, Brown University, Providence, Rhode Island, USA.

Associated Data

Heritable human genome editing (HHGE) has become a topic of intense public interest, especially since 2015. In the early 1980s, a related topic—human genetic engineering—was the subject of sustained public discussion. There was particular concern about germline genetic intervention. During the 1980s debate, an advisory committee to the Director of the National Institutes of Health (NIH)—the Recombinant DNA Advisory Committee (RAC)—agreed to provide initial public review of proposals for deliberate introduction of DNA into human beings. In 1984 and 1985, the RAC developed guidelines for research involving DNA transfer into patients. The committee also commented on the possibility of deliberately altering the human germline. We track the textual changes over time in the RAC's response to the possibility of germline genetic intervention in humans. In 2019, the NIH RAC was abolished. New techniques for genome editing, including CRISPR-based techniques, make both somatic and germline alterations much more feasible. These novel capabilities have again raised questions about oversight. We propose the creation of a new structure for the public oversight of proposals to perform HHGE. In parallel with a technical review by a regulatory agency, such proposals should also be publicly evaluated by a presidentially appointed Bioethics Advisory Commission.

Introduction

Heritable human genome editing (HHGE) has become a topic of intense public interest and international controversy, especially since 2015. 1 , 2 A similar debate about introducing genetic changes into humans occurred in the 1980s. Here, we review that earlier history, with particular attention to the specific texts that guided U.S. policy—and with an eye to proposing a public oversight framework for HHGE.

In 1982, human genetic engineering was a major topic of public discussion. During that year, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research published a report titled “Splicing Life: A Report on the Social and Ethical Issues of Genetic Engineering with Human Beings.” 3 Representative Albert Gore, Jr. (D-TN), then chair of the Subcommittee on Investigations and Oversight of the House Committee on Science and Technology, also led a three-day hearing on human genetic engineering in November 1982—a hearing that featured the “Splicing Life” report. 4

In this article, we follow the decision by the National Institutes of Health (NIH) to conduct public reviews of proposals to transfer recombinant DNA molecules into humans—an intervention that at that time was referred to as “human gene therapy.” That history can be tracked because the debates about NIH policy were matters of public record. We devote particular attention to what an advisory committee to the NIH Director said about deliberate attempts to perform germline genetic interventions. This textual history presages the current debate about what is called HHGE in the September 2020 report of the U.K. Royal Society and the U.S. National Academies of Sciences and Medicine. 5

NIH Review of Germline Genetic Alterations: A Textual History

In 1982, at the NIH, the work of the Recombinant DNA Advisory Committee (RAC) was in some ways winding down. Laboratory research using recombinant DNA (rDNA) had proven to be generally safe, thereby reducing fears about the major concern of the late 1970s: the inadvertent release of harmful rDNA or rDNA-containing organisms into the environment. In the early 1980s, attention shifted to the use of rDNA methods for the production of biologicals such as insulin and to the deliberate release of genetically modified organisms into the environment. The “Splicing Life” report suggested a possible new mission for the RAC: reviewing protocols for DNA transfer into humans.

In 1983 and 1984, the novel field of human gene transfer research and the role of the NIH RAC converged. At its meeting on April 11, 1983, the RAC agreed to assist the NIH in responding to the “Splicing Life” report. 6 An interdisciplinary working group, meeting in June and December 1983, recommended that the RAC accept a role in overseeing the initial stages of human gene transfer research (see pp. 176–177 of Milewski 6 ). The working group's proposal was published in the Federal Register on January 5, 1984. 7 According to the proposed plan, the NIH Director, Dr. James B. Wyngaarden, would appoint a RAC subcommittee to perform an initial review of clinical protocols involving human gene transfer. The RAC itself would then review the recommendations of the subcommittee and forward its advice to the NIH Director. At its meeting on February 6, 1984, the RAC endorsed this proposal (see p. 177 of Milewski 6 ). In April 1984, the NIH Director concurred, and Dr. Wyngaarden asked the RAC to proceed. 8

During the summer of 1984, the initial members of the RAC subcommittee were appointed. They included four laboratory scientists, three clinicians, three ethicists, three lawyers, and two public policy experts (see Table 1 ). 9 The RAC subcommittee, designated the Working Group on Human Gene Therapy, held its first public meeting on October 12, 1984 (see pp. 177–178 of Milewski 6 ).

Members of the Working Group on Human Gene Therapy, October 1984

There was a sense of urgency at that initial meeting of the Working Group. In 1980, UCLA clinician-researcher Martin J. Cline had made premature attempts to administer genetically modified cells to two patients: one patient in Israel and a second in Italy. 10 Several laboratories were also known to be undertaking preclinical studies of gene therapy. During its first meeting, the Working Group discussed a 13-page draft document: “Points to Consider in the Design and Submission of Human Gene Therapy Protocols.” 9

At its meeting on October 29, 1984, the RAC parent committee reviewed the Working Group's draft and made suggestions for improvement. On November 16, 1984, the Working Group held its second public meeting and produced a revised 11-page draft, “Points to Consider in the Design and Submission of Human Somatic Cell Gene Therapy Protocols” (emphasis added). 9 The addition of the words “somatic cell” clearly conveyed the Working Group's view that germline intervention should not be undertaken at this early stage of research on human gene transfer. The phrase “somatic cell” also echoed a central thesis of the “Splicing Life” report—namely that somatic cell gene therapy was not an intervention to be feared. In fact, somatic cell gene therapy was analogous to bone-marrow transplantation. The reproductive (germline) cells of the recipient would not be affected, at least not deliberately.

NIH Director Wyngaarden approved the revised draft of the Working Group and forwarded it to the Federal Register . The “Points to Consider” document was duly published in the January 22, 1985, Federal Register with a request for public comment. 11

At its meeting on April 1, 1985, the Working Group considered the 15 comments it had received on the “Points to Consider.” Most comments focused on minor technical issues. There was, however, one central question that had not thus far been addressed: Would the Working Group and the RAC make any formal statement about germline genetic intervention?

During the lunch break of the meeting on April 1, three members of the Working Group—Susan K. Gottesman, James F. Childress, and Alexander M. Capron—conferred about the germline question. They proposed this text:

A distinction is usually drawn between making genetic changes in somatic cells, the purpose of which is to treat individual patients, and germ-line alterations, which would affect the genes passed on to the offspring of the persons treated. The RAC and its Working Group will not, at present, entertain porposals [sic] for intentional germ-line treatments, but will review and approve somatic-cell proposals that satisfy the points raised in the following document. (Attachment VII, “Minutes of the RAC Working Group on Human Gene Therapy meeting, April 1, 1985”; see Supplementary Material ).

At the post-lunch discussion, W. French Anderson suggested that the first words of the text should read “A distinction should be drawn.” He also commented that the second sentence should read as follows:

The RAC and its Working Group will not, at present, entertain proposals for germ-line treatments, but will consider for approval protocols for somatic cell gene therapy. 9

The Working Group accepted Dr. Anderson's proposed revisions.

Between the meeting on April 1, 1985, of the Working Group and the meeting on May 3, 1985, of the RAC, the text of that key paragraph was further refined. The language describing somatic and germline interventions was expanded, and the word “alterations” was substituted for “treatments.” The revised text read:

A distinction should be drawn between making genetic changes in somatic cells and in germ-line cells. The purpose of somatic cell gene therapy is to treat an individual patient, e.g., by inserting a properly-functioning gene into a patient's bone marrow cells in vitro and then reintroducing the cells into the patient's body. In germ-line alterations, a specific attempt is made to introduce genetic changes into the germ (reproductive) cells of an individual, with the aim of changing the set of genes passed on to the individual's offspring. The RAC and its working group will not, at present, entertain proposals for germ-line alterations but will consider for approval protocols involving somatic-cell gene therapy. (see Supplementary Material )

This language was approved by the RAC on May 3, 1985, and was subsequently published in the Federal Register on August 19, 1985. 12

In 1986, the Working Group on Human Gene Therapy was renamed the Human Gene Therapy Subcommittee. During that year, the subcommittee and the RAC reviewed and updated the “Points to Consider.” At its meeting on September 29, 1986, the RAC approved the revisions suggested by the subcommittee. However, the paragraph that discussed germline genetic intervention remained unchanged. 13

In January 1989, the subcommittee and the RAC reviewed a Preclinical Data Document submitted by W. French Anderson and a gene-marking protocol submitted by Steven A. Rosenberg et al . 14 The time seemed ripe for a review and update of the “Points to Consider.” A special RAC subcommittee was appointed to undertake this review. The subcommittee met on March 31, 1989 (see Supplementary Material ). On July 31, 1989, the Human Gene Therapy Subcommittee reviewed the special subcommittee's draft (minutes unavailable). 15 The draft was published in the Federal Register on September 1, 1989, and forwarded to the RAC, which approved the revisions, with a modification of the document title, at its meeting on October 6, 1989. The revised “Points to Consider” were then published in the Federal Register on March 1, 1990. 16 The revised document was also reprinted in the inaugural issue of a new journal, Human Gene Therapy . 17

On the topic of germline genetic intervention, the 1989 version of the “Points to Consider” included no substantive changes to the 1986 version. However, the sequence of the sentences in the critical paragraph was altered, accentuating the RAC's decision not to review proposals involving germline modification (see Supplementary Material ). The 1989 revision reads:

The RAC and its Subcommittee will not at present entertain proposals for germ-line alterations but will consider for approval protocols involving somatic cell gene therapy. The purpose of somatic cell gene therapy is to treat an individual patient, e.g., by inserting a properly functioning gene into a patient's somatic cells. In germ-line alterations, a specific attempt is made to introduce genetic changes into the germ (reproductive) cells of an individual, with the aim of changing the set of genes passed on to the individual's offspring. 18

This text remained unchanged in the “Points to Consider” from 1989 until April 26, 2019, when the RAC's oversight role concluded, and the “Points to Consider” no longer guided researchers proposing to undertake federally funded gene transfer studies. 19 The unaltered text was last published in the Federal Register on March 22, 2016, with the other sections of the “Points to Consider.” 20

Historical Context and Implications for the Current Debate

The language crafted by three members of a RAC working group over lunch on April 1, 1985, proved to be remarkably durable and, with minor tweaks, seems to have guided NIH policy on germline intervention from 1985 through 2019. It may be worthwhile to reconstruct the context in which the language was formulated and to ponder the scope of this paragraph.

In 1982 and 1983, the question of human genetic engineering was provoking a policy debate. Despite the reassuring “Splicing Life” report, activists such as Jeremy Rifkin continued to raise alarms about possible misuses of genetic technologies. On June 8, 1983, Rifkin's organization, the Foundation on Economic Trends, published “The Theological Letter Concerning the Moral Arguments Against Genetic Engineering of the Human Germline Cells.” 21 This letter was signed by 51 religious leaders and theologians, as well as by five natural scientists and a social scientist. On June 10, 1983, Senator Mark O. Hatfield (R-OR) entered the full text of Rifkin's letter into the Congressional Record. 22 Hatfield also spoke in support of the theological letter, adding:

Recently, I had an enlightening and troubling 3-hour conversation with several of the Nation's top geneticists. It is likely that soon not only genetic corrections—somatic engineering—will be commonplace, but that sex cell gene removal and replacement—will be possible. No one knows the long-range implications of offspring born of eugenically engineered individuals. 23

As the Working Group on Human Gene Therapy prepared the “Points to Consider” in 1985, it sought to create a safe haven for somatic cell gene transfer research that aimed to treat disease without transmitting genetic changes from parent to child. One way of achieving this goal was to make clear to the public and the press that its guidelines covered only research protocols that involved somatic cells.

The “Points to Consider” were also an effort to extend the RAC's oversight activities from the late 1970s. During that era, both the public and private sectors, with only a few exceptions, complied with NIH's voluntary public oversight role in reviewing laboratory research with recombinant DNA. The RAC's proposed public review of gene transfer protocols involving human participants expanded on that tradition. In effect, as an advisory committee, NIH's RAC was offering to serve as a national Institutional Review Board (IRB) for the initial stage of human gene transfer research. This offer forestalled the creation of a new regulatory agency for the field of human genetics—an option being advocated by several congressional leaders in the mid-1980s. 24

Several other features of the germline paragraph also merit attention. The paragraph clearly referred to nuclear DNA, not mitochondrial DNA. The current discussion of mitochondrial replacement (MR), also known as mitochondrial donation, was not yet envisioned in 1985. In addition, the paragraph was gently worded. The phrase “at present” suggested that the RAC was not making a statement for all time. Future developments in biomedical research might create new facts on the ground that would justify a re-examination of the “no germline changes” policy. Moreover, the paragraph did not entirely rule out the possibility of germline changes in the reproductive cells of people who receive somatic cell gene transfer for the treatment of their diseases. There would be, in those cases, no “specific intent” to modify germline cells.

The “Points to Consider” became Appendix M to the NIH “Guidelines for Research Involving Recombinant DNA Molecules.” As such, they created requirements for investigators funded by the NIH. However, the “Points to Consider” were never formally promulgated as federal regulations. The “Points to Consider” did not preempt federal, state, or local law. They also did not prohibit the conduct of germline gene transfer research that was privately funded, but merely offered the option of voluntary RAC review.

We should note that the oversight role of the RAC changed between 1984 and 2019. In 1996, the NIH and the U.S. Food and Drug Administration (FDA) agreed that the FDA would assume sole responsibility for the regulatory review of human gene transfer protocols. From 1996 forward, researchers could submit their protocols confidentially to the FDA while notifying NIH of their submissions. Between 1996 and 2019, the RAC continued to conduct public reviews of novel protocols. It also provided a public forum for the discussion of the serious adverse events that occurred in several gene transfer studies. In many ways, the RAC had evolved into a public advisory committee for the FDA. 25

The Legal Status of Germline Genome Editing in the United States

On April 28, 2015, NIH Director Francis S. Collins released a public statement on “NIH Funding of Research Using Gene-Editing Technologies in Human Embryos.” 26 Dr. Collins based his opposition to germline genome editing on three arguments. First, the Dickey–Wicker Amendment “prohibits the use of appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed” (H.R. 2880, Sec. 128). Second, “the NIH Guidelines state that the Recombinant DNA Advisory Committee ‘ will not at present entertain proposals for germ line alteration ’” (italics in original). Third, the FDA has the authority to regulate cell and gene therapy products, and the gene editing of human embryos cannot legally proceed in the United States without an Investigational New Drug (IND) application being in effect for the proposed research.

Dr. Collins's first argument lies beyond the scope of this article. However, we will briefly comment on the second and third arguments. The RAC and its working group did indeed make the statement that Dr. Collins quotes in 1985. However, in 2019, the RAC was disbanded, and there is currently no parallel public advisory body that fulfills the public protocol review role that the RAC played, at either the NIH or elsewhere in the U.S. federal government. The statement that the RAC will not review proposals therefore has no current practical application.

Regarding Dr. Collins's third argument, about the need for an IND review by the FDA, the legal situation in the United States is complicated. Since 2016, a rider to the federal appropriation bills that fund the FDA precludes the FDA from acknowledging receipt of an IND application that seeks to produce heritable genetic modifications in humans. The original target of the rider was the genetic modification of human embryos, but its effects spilled over to outlaw proposals for MR as well. In MR, nuclear DNA from the oocytes of a woman who is at high risk for transmitting mitochondrial disease to her offspring is combined with mitochondrial DNA from a donor woman whose mitochondrial DNA would not transmit the disease. MR can be carried out in vitro either before or after the fertilization of the recipient woman's oocytes. 27 An alternative approach to achieving the same goal would be to perform in vitro genome editing on the mitochondrial DNA of the intending mother's oocytes. 28 However, the use of either MR or mitochondrial genome editing for human reproduction would constitute a germline genome modification because it is heritable by matrilineal transmission from an affected woman. The net effect of the rider is thus to ban any attempt to perform genome editing in the reproductive context in the United States, including MR or the pre-fertilization editing of mitochondrial DNA. 29

Recent International and Intranational Discussions

The 2012 publication of a groundbreaking article by Emmanuelle Charpentier, Jennifer Doudna, and colleagues launched a new era in the history of human gene transfer. 30 For the first time, genetic changes could be induced in cells in a more precise and targeted way using the CRISPR Cas-9 system. The National Library of Medicine recognized this advance when it added the term “gene editing” to its MeSH vocabulary in 2017. Professors Doudna and Charpentier received the 2020 Nobel Prize in Chemistry in recognition of their research.

The interest of scientists and the public in the promise of this new research tool has led to two international summits. The first meeting, the “International Summit on Human Gene Editing,” was held in Washington, DC, in December 2015. 31 A subsequent meeting, the “Second International Summit on Genome Editing,” was held in Hong Kong in November 2018. 32 A third summit is scheduled to occur in March 2022 and will be held in London. 33

Beginning in 2015, public advisory groups have advanced the discussion of ethical, legal, and public policy issues in what is now customarily called “genome editing.” 34 Of these reports and position statements, seven are particularly noteworthy and influential. In September 2016, the Nuffield Council on Bioethics published “Genome Editing: An Ethical Review.” 35 This report was followed in February 2017 by a study from the National Academies of Sciences, Engineering, and Medicine (NASEM), “Human Genome Editing: Science, Ethics, and Governance.” 36 In July 2018, the Nuffield Council on Bioethics published a second, more comprehensive, report entitled “Genome Editing and Human Reproduction: Social and Ethical Issues.” 37 The German Ethics Council (Ethikrat) continued the public discussion in May 2019 with “Intervening in the Human Germline: Report” (“Eingriffe in die menschliche Keimbahn: Stellungnahme”). 38 In 2020 and 2021, three major international reports on germline genome editing were published. In September 2020, the U.K. Royal Society and the U.S. Academies of Sciences and Medicine released “Heritable Human Genome Editing.” 5 , 39 And in July 2021, the World Health Organization's Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing released two reports – regarding both the scientific aspects of this field. 40 , 41

The Royal Society/NASEM report proposed a model for overseeing the clinical development of germline genome editing. This model is based on the oversight currently provided for MR by the U.K.'s Human Fertilisation and Embryology Authority. 5

A Plan for Public Oversight

Oversight of human gene transfer research by an advisory committee to the director of a funding agency (NIH) was in many ways a historical anomaly. A more reasonable approach to the regulation of germline genome editing in humans—an approach that builds on the RAC's experience—would include three components: (1) a technical review of the proposed research, (2) an evaluation of the social and ethical dimensions of that research, and (3) periodic international meetings that would summarize the global state of the art for genome editing. In the paragraphs that follow, we propose a three-part oversight structure for germline genome editing (see Fig. 1 ).

The complementary roles of the Technical Advisory Committee and the Bioethics Advisory Commission. This oversight structure comports with the recommendations of the WHO Expert Advisory Committee in its two recent reports. Graphic created by Adriane Inocencio at Arizona State University, edited by Michael Matason at Georgetown University. HHGE, heritable human genome editing.

The first component of our proposed oversight structure would be regular public review of the state of the art in genome editing by an advisory committee to a regulatory agency. In the United States, that regulatory agency would be the FDA. We envision a Technical Advisory Committee (TAC) that would meet three times a year to review evidence about the safety and efficacy of somatic and germline genome editing. Meetings of the TAC would be held in public, and the FDA would have the authority to invite researchers to present both the challenges and successes of their recent studies. Specific topics to be addressed by the TAC closely parallel those identified by the Royal Society/National Academies report (see Supplementary Fig. S1 ):

• Evidence that genome editing is specific (hits the site intended and only that site);
• Evidence that genome editing works (percent success rate of alterations);
• Evidence of few or no off-target effects; and
• Evidence that the intended changes will produce the expected clinical outcomes.

The public meetings of the TAC would inform the FDA's confidential review of specific applications to perform research in humans that involves genome editing. As envisioned, this new advisory committee would perform a RAC-like role for genome editing.

A second critical component of effective oversight would be a national Bioethics Advisory Commission (BAC) for germline genome editing. Specific roles for the BAC would include:

• Mediating public engagement, with systematic “listening posts” attuned to the views of affected constituencies;
• Soliciting the perspectives of public interest advocates and religious and civic organizations;
• Reviewing and perhaps sponsoring, empirical social-scientific research to assess the degree of social consensus regarding germline genome editing in humans 42 ; and
• Articulating criteria for determining when social consensus is sufficient to warrant the initiation of clinical germline genome editing protocols.

The BAC would report its findings to the Secretary of Health and Human Services (HHS), who would then transmit its advice to the FDA Commissioner. The findings of the commission would be published in the Federal Register . There would then be a 60-day period for public comments. Like the National Commission for the Protection of Human Subjects of the 1970s and the President's Commission on Bioethics of the early 1980s, the BAC would have response-forcing authority. That is, the Secretary of HHS would have a legal duty to respond to the commission's reports and recommendations and the public comments within 180 days of Federal Register publication. This commission should be authorized by the U.S. Congress and funded as a separate executive-branch agency to ensure its independence. Its members should be appointed by the President. The HHS Secretary should have final authority to approve or disapprove specific research protocols.

The work of the BAC would be informed by the reviews performed by the FDA's TAC and the confidential analyses and decisions of the regulatory agency regarding specific research applications. However, as noted above, the mandate of the BAC would be different. Its focus would be centered on the social and ethical implications of germline genome editing. Under this framework, a proposal to perform HHGE in a particular nation would require both the technical review of safety and efficacy for a particular protocol and the approval of that nation's bioethics advisory group.

A third and final component of our oversight proposal is a global forum that would meet every three to five years. At these public events, the scientific and public-policy developments of the intervening years could be systematically reviewed. The 2015 and 2018 international summits on human genome editing are examples of what can be achieved at such global meetings. In the proposed model, this global forum would collect and disseminate information, as well as inventory how different nations manage genome editing technologies. This international entity, logically sited at the World Health Organization or established as a collaboration of international organizations and academies, would facilitate information exchange. It would convene science experts, stakeholders, and civic action organizations, rather than having a regulatory role.

In the late 1980s and the 1990s, the NIH RAC and its subcommittee created space for the innovative field of somatic cell human gene transfer. By today's standards, the methods employed for transferring genes in the 1980s and 1990s were relatively crude. The horizons opened by more precise techniques for genome editing have again raised a topic that the RAC decided to defer: HHGE. International meetings, committee reports, books, and articles from 2015 to the present have thoughtfully considered the technical, ethical, and public policy questions that methods for more precise germline genome editing raise. In this article, we propose a model for national public oversight of this important scientific arena.

Supplementary Material

Acknowledgments.

We are grateful for the helpful comments of colleagues on earlier drafts of this article: Françoise Baylis, Alexander M. Capron, James F. Childress, Susan K. Gottesman, Eric Juengst, Julie Gage Palmer, and Henry Greely's Stanford Law School seminar students. Eugene Rosenthal and Robert Jambou at the NIH provided access to difficult-to-find historical documents. Adriane Inocencio at Arizona State University and Michael Matason at Georgetown University prepared Figure 1 .

Author Disclosure Statement

The authors declare that they have no conflicts of interest.

Funding Information

This work was supported by National Cancer Institute, 5R01CA237118: The Sulston Project: Making the Knowledge Commons for Interpreting Cancer Genomic Variants More Effective (Robert M. Cook-Deegan and Amy L. McGuire, Co-Principal Investigators).

Supplementary Information

Supplementary Figure S1

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Harvard researchers, others share their views on key issues in the field

Medicine is at a turning point, on the cusp of major change as disruptive technologies such as gene, RNA, and cell therapies enable scientists to approach diseases in new ways. The swiftness of this change is being driven by innovations such as CRISPR gene editing , which makes it possible to correct errors in DNA with relative ease.

Progress in this field has been so rapid that the dialogue around potential ethical, societal, and safety issues is scrambling to catch up.

This disconnect was brought into stark relief at the Second International Summit on Human Genome Editing , held in Hong Kong in November, when exciting updates about emerging therapies were eclipsed by a disturbing announcement. He Jiankui, a Chinese researcher, claimed that he had edited the genes of two human embryos, and that they had been brought to term.

There was immediate outcry from scientists across the world, and He was subjected to intense social pressure, including the removal of his affiliations, for having allegedly disregarded ethical norms and his patients’ safety.

Yet as I. Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, has said, gene editing comes in many varieties, with many consequences. Any deep ethical discussion needs to take into account those distinctions.

Human genome editing: somatic vs. germline

The germline editing He claimed to have carried out is quite different from the somatic gene therapies that are currently changing the frontiers of medicine. While somatic gene editing affects only the patient being treated (and only some of his or her cells), germline editing affects all cells in an organism, including eggs and sperm, and so is passed on to future generations. The possible consequences of that are difficult to predict.

Somatic gene therapies involve modifying a patient’s DNA to treat or cure a disease caused by a genetic mutation. In one clinical trial, for example, scientists take blood stem cells from a patient, use CRISPR techniques to correct the genetic mutation causing them to produce defective blood cells, then infuse the “corrected” cells back into the patient, where they produce healthy hemoglobin. The treatment changes the patient’s blood cells, but not his or her sperm or eggs.

Germline human genome editing, on the other hand, alters the genome of a human embryo at its earliest stages. This may affect every cell, which means it has an impact not only on the person who may result, but possibly on his or her descendants. There are, therefore, substantial restrictions on its use.

Germline editing in a dish can help researchers figure out what the health benefits could be, and how to reduce risks. Those include targeting the wrong gene; off-target impacts, in which editing a gene might fix one problem but cause another; and mosaicism, in which only some copies of the gene are altered. For these and other reasons, the scientific community approaches germline editing with caution, and the U.S. and many other countries have substantial policy and regulatory restrictions on using germline human genome editing in people.

But many scientific leaders are asking: When the benefits are believed to outweigh the risks, and dangers can be avoided, should science consider moving forward with germline genome editing to improve human health? If the answer is yes, how can researchers do so responsibly?

CRISPR pioneer Feng Zhang of the Broad Institute of Harvard and MIT responded immediately to He’s November announcement by calling for a moratorium on implanting edited embryos in humans. Later, at a public event on “Altering the Human Genome” at the Belfer Center at Harvard Kennedy School (HKS), he explained why he felt it was important to wait:

“The moratorium is a pause. Society needs to figure out if we all want to do this, if this is good for society, and that takes time. If we do, we need to have guidelines first so that the people who do this work can proceed in a responsible way, with the right oversight and quality controls.”

Professors at the University’s schools of medicine, law, business, and government saw He’s announcement as a turning point in the discussion about heritable gene therapies and shared their perspectives on the future of this technology with the Gazette.

Here are their thoughts, issue by issue:

Aside from the safety risks, human genome editing poses some hefty ethical questions. For families who have watched their children suffer from devastating genetic diseases, the technology offers the hope of editing cruel mutations out of the gene pool. For those living in poverty, it is yet another way for the privileged to vault ahead. One open question is where to draw the line between disease treatment and enhancement, and how to enforce it, considering differing attitudes toward conditions such as deafness.

Robert Truog , director of the Center for Bioethics at Harvard Medical School (HMS), provided context:

“This question is not as new as it seems. Evolution progresses by random mutations in the genome, which dwarf what can be done artificially with CRISPR. These random mutations often cause serious problems, and people are born with serious defects. In addition, we have been manipulating our environment in so many ways and exposing ourselves to a lot of chemicals that cause unknown changes to our genome. If we are concerned about making precise interventions to cure disease, we should also be interested in that.

“To me, the conversation around Dr. He is not about the fundamental merits of germline gene editing, which in the long run will almost certainly be highly beneficial. Instead, it’s about the oversight of science. The concern is that with technologies that are relatively easy to use, like CRISPR, how does the scientific community regulate itself? If there’s a silver lining to this cloud, I think it is that the scientific community did pull together to be critical of this work, and took the responsibility seriously to use the tools available to them to regulate themselves.”

When asked what the implications of He’s announcement are for the emerging field of precision medicine, Richard Hamermesh, faculty co-chair of the Harvard Business School/Kraft Precision Medicine Accelerator, said:

“Before we start working on embryos, we have a long way to go, and civilization has to think long and hard about it. There’s no question that gene editing technologies are potentially transformative and are the ultimate precision medicine. If you could precisely correct or delete genes that are causing problems — mutating or aberrant genes — that is the ultimate in precision. It would be so transformative for people with diseases caused by a single gene mutation, like sickle cell anemia and cystic fibrosis. Developing safe, effective ways to use gene editing to treat people with serious diseases with no known cures has so much potential to relieve suffering that it is hard to see how anyone could be against it.

“There is also commercial potential and that will drive it forward. A lot of companies are getting venture funding for interesting gene therapies, but they’re all going after tough medical conditions where there is an unmet need — [where] nothing is working — and they’re trying to find gene therapies to cure those diseases. Why should we stop trying to find cures?

“But anything where you’re going to be changing human embryos, it’s going to take a long time for us to figure out what is appropriate and what isn’t. That has to be done with great care in terms of ethics.”

George Q. Daley  is dean of HMS, the Caroline Shields Walker Professor of Medicine, and a leader in stem cell science and cancer biology. As a spokesperson for the organizing committee of the Second International Summit on Human Genome Editing, he responded swiftly to He’s announcement in Hong Kong. Echoing those remarks, he said:

“It’s time to formulate what a clinical path to translation might look like so that we can talk about it. That does not mean that we’re ready to go into the clinic — we are not. We need to specify what the hurdles would be if one were to move forward responsibly and ethically. If you can’t surmount those hurdles, you don’t move forward.

“There are stark distinctions between editing genes in an embryo to prevent a baby from being born with sickle cell anemia and editing genes to alter the appearance or intelligence of future generations. There is a whole spectrum of considerations to be debated. The prospect includes an ultimate decision that we not go forward, that we decide that the benefits do not outweigh the costs.”

Asked how to prevent experiments like He’s while preserving academic freedom, Daley replied:

“For the past 15 years, I have been involved in efforts to establish international standards of professional conduct for stem cell research and its clinical translation, knowing full well that there could be — and has been — a growing number of independent practitioners directly marketing unproven interventions to vulnerable patients through the internet. We advocated so strongly for professional standards in an attempt to ward off the risks of an unregulated industry. Though imperfect, our efforts to encourage a common set of professional practices have been influential.

“You can’t control rogue scientists in any field. But with strongly defined guidelines for responsible professional conduct in place, such ethical violations like those of Dr. He should remain a backwater, because most practitioners will adhere to generally accepted norms. Scientists have a responsibility to come together to articulate professional standards and live by them. One has to raise the bar very high to define what the standards of safety and efficacy are, and what kind of oversight and independent judgment would be required for any approval.

“We have called for an ongoing international forum on human genome editing, and that could take many shapes. We’ve suggested that the national academies of more countries come together — the National Academy of Sciences in the U.S. and the Royal Society in the U.K. are very active here — because these are the groups most likely to have the expertise to convene these kinds of discussions and keep them going.”

Cohen , speaking to the legal consequences of germline human genome editing, said:

“I think we should slow down in our reaction to this case. It is not clear that the U.S. needs to react to Dr. He’s announcement with regulation. The FDA [Food and Drug Administration] already has a strong policy on germline gene editing in place. A rider in the Consolidated Appropriations Act of 2016 — since renewed — would have blocked the very same clinical application of human germline editing He announced, had it been attempted in the U.S.

“The scientific community has responded in the way I’d have liked it to. There is a difference between ‘governance’ and ‘self-governance.’ Where government uses law, the scientific community uses peer review, public censure, promotions, university affiliations, and funding to regulate themselves. In China, in Dr. He’s case, you have someone who’s (allegedly) broken national law and scientific conventions. That doesn’t mean you should halt research being done by everyone who’s law-abiding.

“Public policy or ethical discussion that’s divorced from how science is progressing is problematic. You need to bring everyone together to have robust discussions. I’m optimistic that this is happening, and has happened. It’s very hard to deal with a transnational problem with national legislation, but it would be great to reach international consensus on this subject. These efforts might not succeed, but ultimately they are worth pursuing.”

Professor Kevin Eggan of Harvard’s Department of Stem Cell and Regenerative Biology said, “The question we should focus on is: Will this be safe and help the health of a child? Can we demonstrate that we can fix a mutation that will cause a terrible health problem, accurately and without the risk of harming their potential child? If the answer is yes, then I believe germline human genome editing is likely to gain acceptance in time.

“There could be situations where it could help a couple, but the risks of something going wrong are real. But at this point, it would be impossible to make a risk-benefit calculation in a responsible manner for that couple. Before we could ever move toward the clinic, the scientific community must come to a consensus on how to measure success, and how to measure off-target effects in animal models.

“Even as recently as this past spring and fall, the results of animal studies using CRISPR — the same techniques Dr. He claimed to have used — generated a lot of confusion. There is disagreement about both the quality of the data and how to interpret it. Until we can come to agreement about what the results of animal experiments mean, how could we possibly move forward with people?

“As happened in England with mitochondrial replacement therapy, we should be able to come to both a scientific and a societal consensus of when and how this approach should be used. That’s missing.”

According to Catherine Racowsky, professor of obstetrics, gynecology and reproductive biology at Brigham and Women’s Hospital, constraints on the use of embryos in federally funded research pose barriers to studying the risks and benefits of germline editing in humans. She added:

“Until the work is done, carefully and with tight oversight, to understand any off-target effects of replacing or removing a particular gene, it is inappropriate to apply the technology in the clinical field. My understanding of Dr. He’s case is that there wasn’t a known condition in these embryos, and by editing the genes involved with HIV infection, he could also have increased the risks of susceptibility to influenza and West Nile viruses.

“We need a sound oversight framework, and it needs to be established globally. This is a technology that holds enormous promise, and it is likely to be applied to the embryo, but it should only be applied for clinical purposes after the right work has been done. That means we must have consensus on what applications are acceptable, that we have appropriate regulatory oversight, and, perhaps most importantly, that it is safe. The only way we’re going to be able to determine that these standards are met is to proceed cautiously, with reassessments of the societal and health benefits and the risks.”

Asked about public dialogue around germline human genome editing, George Church , Robert Winthrop Professor of Genetics at HMS, said:

“With in vitro  fertilization (IVF), ‘test tube babies’ was an intentionally scary term. But after Louise Brown, the first IVF baby, was born healthy 40 years ago, attitudes changed radically. Ethics flipped 180 degrees, from it being a horrifying idea to being unacceptable to prevent parents from having children by this new method. If these edited twins are proven healthy, very different discussions will arise. For example, is a rate of 900,000 deaths from HIV infection per year a greater risk than West Nile virus, or influenza? How effective is each vaccine?”

Science, technology, and society

Sheila Jasanoff , founding director of the Science, Technology, and Society program at HKS, has been calling for a “global observatory” on gene editing, an international network of scholars and organizations dedicated to promoting exchange across disciplinary and cultural divides. She said:

“The notion that the only thing we should care about is the risk to individuals is very American. So far, the debate has been fixated on potential physical harm to individuals, and not anything else. This is not a formulation shared with other countries in the world, including practically all of Europe. Considerations of risk have equally to do with societal risk. That includes the notion of the family, and what it means to have a ‘designer baby.’

“These were not diseased babies Dr. He was trying to cure. The motivation for the intervention was that they live in a country with a high stigma attached to HIV/AIDS, and the father had it and agreed to the intervention because he wanted to keep his children from contracting AIDS. AIDS shaming is a fact of life in China, and now it won’t be applied to these children. So, are we going to decide that it’s OK to edit as-yet-to-be children to cater to this particular idea of a society?

“It’s been said that ‘the genie is out of the bottle’ with germline human genome editing. I just don’t think that’s true. After all, we have succeeded in keeping ‘nuclear’ inside the bottle. Humanity doesn’t lack the will, intelligence, or creativity to come up with ways for using technology for good and not ill.

“We don’t require students to learn the moral dimensions of science and technology, and that has to change. I think we face similar challenges in robotics, artificial intelligence, and all kinds of frontier fields that have the potential to change not just individuals but the entirety of what it means to be a human being.

“Science has this huge advantage over most professional thought in that it has a universal language. Scientists can hop from lab to lab internationally in a way that lawyers cannot because laws are written in many languages and don’t translate easily. It takes a very long time for people to understand each other across these boundaries. A foundational concept for human dignity? It would not be the same thing between cultures.

“I would like to see a ‘global observatory’ that goes beyond gene editing and addresses emerging technologies more broadly.”

To learn more:

Technology and Public Purpose project, Belfer Center for Science and International Affairs, Harvard Kennedy School of Government, https://www.belfercenter.org/tapp/person

Concluding statement from the Second International Summit on Human Genome Editing. http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11282018b

A global observatory for gene editing: Sheila Jasanoff and J. Benjamin Hurlbut call for an international network of scholars and organizations to support a new kind of conversation. https://www.nature.com/articles/d41586-018-03270-w

Building Capacity for a Global Genome Editing Observatory: Institutional Design. http://europepmc.org/abstract/MED/29891181

Glenn Cohen’s blog: How Scott Gottlieb is Wrong on the Gene Edited Baby Debacle. http://blog.petrieflom.law.harvard.edu/2018/11/29/how-scott-gottlieb-is-wrong-on-the-gene-edited-baby-debacle/

Gene-Editing: Interpretation of Current Law and Legal Policy. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5651701/

Forum: Harvard T.H. Chan School of Public Health event on the promises and challenges of gene editing, May 2017: https://theforum.sph.harvard.edu/events/gene-editing/

Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies: http://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference

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