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{{short description|Genetically modified human embryo}}
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A '''designer baby''' is an [[embryo]] or [[fetus]] whose [[genetics|genetic makeup]] has been intentionally selected or altered, often to exclude a particular [[gene]] or to remove genes associated with disease, to achieve desired traits.<ref>Veit, W. (2018). Procreative Beneficence and Genetic Enhancement – KRITERION – Journal of Philosophy 32(1):75-92. https://doi.org/10.13140/RG.2.2.11026.89289</ref><ref>{{cite journal |last1=Pang |first1=Ronald T.K. |last2=Ho |first2=P.C. |title=Designer babies |journal=Obstetrics, Gynaecology & Reproductive Medicine |date=2016 |volume=26 |issue=2 |pages=59–60 |doi=10.1016/j.ogrm.2015.11.011|hdl=10722/234869 |hdl-access=free }}</ref> This process usually involves [[pre-implantation genetic diagnosis|preimplantation genetic diagnosis]] (PGD), which analyzes multiple human [[embryos]] to identify genes associated with specific [[disease]]s and characteristics, then selecting embryos that have the desired genetic makeup.<ref>{{cite journal |last1=Verlinsky |first1=Yury |title=Designing babies: what the future holds |journal=Reproductive BioMedicine Online |date=2005 |volume=10 |pages=24–26 |doi=10.1016/S1472-6483(10)62200-6 |pmid=15820003}}</ref> While screening for single genes is commonly practiced, advancements in polygenic screening are becoming more prominent, though only a few companies currently offer it. This technique uses an algorithm to aggregate the estimated effects of numerous genetic variants tied to an individual's risk for a particular condition or trait.<ref>{{Cite web |last=Gilbert |first=Susan |date=2021-10-20 |title=Polygenic Embryo Screening: Ethical and Legal Considerations |url=https://www.thehastingscenter.org/polygenic-embryo-screening-ethical-and-legal-considerations/ |access-date=2022-07-31 |website=The Hastings Center |language=en-US}}</ref> Other methods of altering a baby's genetic information involve directly [[genome editing|editing the genome]] before birth, using technologies such as [[CRISPR]]. A controversial example of this can be seen in the 2018 case involving Chinese twins [[Lulu and Nana]], which had their genomes edited to resist HIV infection, sparking widespread criticism and legal debates.<ref name="BMJLuluNanaCriticism">{{cite news |date=30 November 2018 |title=Researcher who edited babies' genome retreats from view as criticism mounts |url=https://www.bmj.com/content/363/bmj.k5113 |journal=BMJ |pages=k5113 |language=en |doi=10.1136/bmj.k5113 |vauthors=Dyer O}}</ref>

This highlights the implications of [[human germline engineering|germline engineering]], which involves introducing the desired genetic material into the embryo or parental [[Germ cell|germ cells]]. This process is typically prohibited by law, however, regulations vary globally.<ref name="Med&Law">{{cite book | vauthors = Kannan K |title=Medicine and the law |date=2014 |isbn=9780198082880 |doi=10.1093/acprof:oso/9780198082880.001.0001 }}</ref> Editing embryos in this manner can result in genetic changes that are [[heritable|passed down to future generations]], raising significant controversy and ethical concerns.<ref name = "IVF to immortality">{{cite book |title=From IVF to immortality : controversy in the era of reproductive technology |publisher=Oxford University Press |isbn=9780199219780|date=2008-02-03 }}</ref> While some scientists advocate for its use in treating genetic diseases, others warn that it could lead to misuse for non-medical purposes, such as cosmetic enhancements and [[human enhancement|modification of human traits]].<ref name="Guardianethics1" />

==Pre-implantation genetic diagnosis==
{{Main|Pre-implantation genetic diagnosis}}

Pre-implantation genetic diagnosis (PGD or PIGD) is a procedure in which embryos are screened prior to [[implantation (human embryo)|implantation]]. The technique is used alongside [[in vitro fertilisation|''in vitro'' fertilisation]] (IVF) to obtain embryos for evaluation of the genome – alternatively, [[Oocyte|oocytes]] can be screened prior to [[fertilisation]]. The technique was first used in 1989.<ref name="handyside1990">{{cite journal | vauthors = Handyside AH, Kontogianni EH, Hardy K, Winston RM | title = Pregnancies from biopsied human preimplantation embryos sexed by Y-specific DNA amplification | journal = Nature | volume = 344 | issue = 6268 | pages = 768–770 | date = April 1990 | pmid = 2330030 | doi = 10.1038/344768a0 | s2cid = 4326607 | bibcode = 1990Natur.344..768H }}</ref>
 
PGD is used primarily to select embryos for implantation in the case of possible [[Birth defect|genetic defects]], allowing identification of [[mutation|mutated]] or disease-related [[alleles]] and selection against them. It is especially useful in embryos from parents where one or both carry a [[genetic disorder|heritable disease]]. PGD can also be used to select for embryos of a certain sex, most commonly when a disease is more strongly associated with one sex than the other (as is the case for [[sex linkage|X-linked disorders]] which are more common in males, such as [[haemophilia]]). Infants born with traits selected following PGD are sometimes considered to be designer babies.<ref name="PGD Ethnography">{{cite book | vauthors = Franklin S, Roberts C |title=Born and Made: An Ethnography of Preimplantation Genetic Diagnosis. |date=2006 |publisher=Princeton University Press |isbn=9780691121932 |url=https://press.princeton.edu/titles/8313.html}}</ref>

One application of PGD is the selection of '[[Savior sibling|saviour siblings]]', children who are born to provide a [[organ transplant|transplant]] (of an organ or group of cells) to a sibling with a usually life-threatening disease. Saviour siblings are conceived through IVF and then screened using PGD to analyze genetic similarity to the child needing a transplant, to reduce the risk of [[transplant rejection|rejection]].<ref name="savioursibs">{{cite web |title=Embryo and the Law: Saviour Siblings |url=https://embryo-ethics.smd.qmul.ac.uk/tutorials/embryo-and-the-law/saviour-siblings/ |website=Embryo ethics}}</ref>

===Process===
[[File:PGD process.png|300px|thumb|left|Process of pre-implantation genetic diagnosis. ''In vitro'' fertilisation involves either incubation of sperm and oocyte together, or injection of sperm directly into the oocyte. PCR - polymerase chain reaction, FISH - fluorescent ''in situ'' hybridisation.]]
Embryos for PGD are obtained from IVF procedures in which the oocyte is artificially fertilised by sperm. [[Oocyte|Oocytes]] from the woman are harvested following [[controlled ovarian hyperstimulation]] (COH), which involves fertility treatments to induce production of multiple oocytes. After harvesting the oocytes, they are fertilised ''[[in vitro]]'', either during incubation with multiple sperm cells in culture, or ''via'' [[intracytoplasmic sperm injection]] (ICSI), where sperm is directly injected into the oocyte. The resulting embryos are usually cultured for 3–6 days, allowing them to reach the [[blastomere]] or [[blastocyst]] stage.<ref name="Sermon2004">{{cite journal | vauthors = Sermon K, Van Steirteghem A, Liebaers I | title = Preimplantation genetic diagnosis | journal = Lancet | volume = 363 | issue = 9421 | pages = 1633–1641 | date = May 2004 | pmid = 15145639 | doi = 10.1016/S0140-6736(04)16209-0 | s2cid = 22797985 }}</ref>

Once embryos reach the desired stage of development, cells are biopsied and genetically screened. The screening procedure varies based on the nature of the disorder being investigated.

[[Polymerase chain reaction]] (PCR) is a process in which [[DNA]] sequences are amplified to produce many more copies of the same segment, allowing screening of large samples and identification of specific genes.<ref name="PCR2013">{{cite journal | vauthors = Garibyan L, Avashia N | title = Polymerase chain reaction | journal = The Journal of Investigative Dermatology | volume = 133 | issue = 3 | pages = 1–4 | date = March 2013 | pmid = 23399825 | pmc = 4102308 | doi = 10.1038/jid.2013.1 }}</ref> The process is often used when screening for [[Genetic disorder#Single gene disorder|monogenic disorders]], such as [[cystic fibrosis]].

Another screening technique, [[fluorescent in situ hybridisation|fluorescent ''in situ'' hybridisation]] (FISH) uses fluorescent probes which specifically bind to highly [[Complementarity (molecular biology)#DNA and RNA base pair complementarity|complementary sequences]] on [[chromosomes]], which can then be identified using [[fluorescence microscope|fluorescence microscopy]].<ref name="FISH2010">{{cite journal| vauthors = Bishop R |title=Applications of fluorescence in situ hybridization (FISH) in detecting genetic aberrations of medical significance|journal=Bioscience Horizons|volume=3|issue=1|year=2010|pages=85–95|issn=1754-7431|doi=10.1093/biohorizons/hzq009|doi-access=free}}</ref> FISH is often used when screening for chromosomal abnormalities such as [[aneuploidy]], making it a useful tool when screening for disorders such as [[Down syndrome]].

Following the screening, embryos with the desired trait (or lacking an undesired trait such as a mutation) are transferred into the mother's [[uterus]], then allowed to [[embryonic development|develop naturally]].

===Regulation===

PGD regulation is determined by individual countries' governments, with some prohibiting its use entirely, including in [[Austria]], [[China]], and [[Ireland]].<ref name="PGDtreatment">{{cite web |title=Pre-implantation genetic diagnosis (PGD) |url=https://fertility.treatmentabroad.com/tests-and-investigations/preimplantation-genetic-diagnosis-pgd |website=Fertility treatment abroad |publisher=LaingBuisson International Limited}}</ref>

In many countries, PGD is permitted under very stringent conditions for medical use only, as is the case in [[France]], [[Switzerland]], [[Italy]] and the [[United Kingdom]].<ref name="Bayefsky2016">{{cite journal | vauthors = Bayefsky MJ | title = Comparative preimplantation genetic diagnosis policy in Europe and the USA and its implications for reproductive tourism | journal = Reproductive Biomedicine & Society Online | volume = 3 | pages = 41–47 | date = December 2016 | pmid = 28959787 | pmc = 5612618 | doi = 10.1016/j.rbms.2017.01.001 }}</ref><ref name="GianaroliCrivello2014">{{cite journal | vauthors = Gianaroli L, Crivello AM, Stanghellini I, Ferraretti AP, Tabanelli C, Magli MC | title = Reiterative changes in the Italian regulation on IVF: the effect on PGD patients' reproductive decisions | journal = Reproductive Biomedicine Online | volume = 28 | issue = 1 | pages = 125–132 | date = January 2014 | pmid = 24268726 | doi = 10.1016/j.rbmo.2013.08.014 | doi-access = free }}</ref> Whilst PGD in Italy and Switzerland is only permitted under certain circumstances, there is no clear set of specifications under which PGD can be carried out, and selection of embryos based on sex is not permitted. In France and the UK, regulations are much more detailed, with dedicated agencies setting out framework for PGD.<ref name="HFEA">{{cite web |title=PGD conditions |url=https://www.hfea.gov.uk/pgd-conditions/ |website=Human Fertilisation and Embryology Authority |access-date=2019-03-18 |archive-date=2018-02-18 |archive-url=https://web.archive.org/web/20180218150624/https://www.hfea.gov.uk/pgd-conditions/ |url-status=dead }}</ref><ref name="Agence">{{Cite web|url=https://www.agence-biomedecine.fr/?lang=fr|title=Agence de la biomédecine|website=www.agence-biomedecine.fr}}</ref> Selection based on sex is permitted under certain circumstances, and genetic disorders for which PGD is permitted are detailed by the countries' respective agencies.

In contrast, the [[United States]] federal law does not regulate PGD, with no dedicated agencies specifying regulatory framework by which healthcare professionals must abide.<ref name="Bayefsky2016" /> Elective sex selection is permitted, accounting for around 9% of all PGD cases in the U.S., as is selection for desired conditions such as [[deafness]] or [[dwarfism]].<ref name="BaruchKaufman2008">{{cite journal | vauthors = Baruch S, Kaufman D, Hudson KL | title = Genetic testing of embryos: practices and perspectives of US in vitro fertilization clinics | journal = Fertility and Sterility | volume = 89 | issue = 5 | pages = 1053–1058 | date = May 2008 | pmid = 17628552 | doi = 10.1016/j.fertnstert.2007.05.048 | doi-access = free }}</ref>

=== Polygenic risk score (PRS) screening ===
In the 2020s, companies such as Orchid Bioscience began offering [[Polygenic score|polygenic risk scores (PRS)]] analysis for embryos during IVF. PRS estimates the likelihood of complex traits, such as height and intelligence, or diseases like diabetes, by summarizing data from thousands of genetic markers.<ref>{{cite web |last1=Hercher |first1=Laura |title=A New Era of Designer Babies May Be Based on Overhyped Science |url=https://www.scientificamerican.com/article/a-new-era-of-designer-babies-may-be-based-on-overhyped-science/ |website=Scientific American |date=2021-10-01}}</ref> However, many geneticists and bioethicists argue that PRS predictions lack clinical validity and promote eugenic practices that can prioritize socially desirable characteristics. They believe this approach risks reinforcing societal biases that may not be realistic and limits the autonomy and identity of the child as it restricts their life within a framework of genetic predictions. A 2021 study found that PRS explains only 5-10% of variance in educational attainment, highlighting its limited predictive ability.<ref>{{cite journal |last1=Lee |first1=James J. |title=Gene discovery and polygenic prediction from a genome-wide association study of educational attainment in 1.1 million individuals |journal=Nature Genetics |date=2018 |volume=50 |pages=1112–1121|pmid=30038396 }}</ref>

== Pre-implantation Genetic Testing ==
Based on the specific analysis conducted:

'''PGT-M (Preimplantation Genetic Testing for monogenic diseases)''' is a technique used during IVF to detect hereditary diseases caused by [[mutation|mutations]] or alterations of the DNA sequence with a single gene.<ref>{{Citation |last1=Parikh |first1=Firuza |title=Preimplantation Genetic Diagnosis |date=2007 |url=http://dx.doi.org/10.5005/jp/books/10067_13 |work=Atlas of Human Assisted Reproductive Technologies |pages=169 |access-date=2023-10-23 |publisher=Jaypee Brothers Medical Publishers (P) Ltd. |last2=Madon |first2=Prochi |last3=Athalye |first3=Arundhati |last4=Naik |first4=Nandkishor|doi=10.5005/jp/books/10067_13 |isbn=978-81-8061-954-0 |url-access=subscription }}</ref> 

'''PGT-A (Preimplantation Genetic Testing for aneuploidy)''': It is used to diagnose numerical abnormalities ([[Aneuploidy|aneuploidies]]).<ref>{{Cite journal |last1=Vasquez |first1=Andres |last2=Mistry |first2=Neville |last3=Singh |first3=Jasvindar |date=2014 |title=Impact of Intravascular Ultrasound in Clinical Practice |url=http://dx.doi.org/10.15420/icr.2014.9.3.156 |journal=Interventional Cardiology Review |volume=9 |issue=3 |pages=156–163 |doi=10.15420/icr.2014.9.3.156 |pmid=29588795 |issn=1756-1477|pmc=5808501 }}</ref>

==Human germline engineering==
{{Main|Human germline engineering}}
Human germline engineering is a process in which the human genome is edited within a [[germ cell]], such as a sperm cell or oocyte (causing heritable changes), or in the [[zygote]] or embryo following fertilization.<ref name="germline eng book">{{cite book | vauthors = Stock G, Campbell J |title=Editing the Human Germline |date=2000 |publisher=Oxford University Press |url=https://the-eye.eu/public/Books/BioMed/Engineering%20the%20Human%20Germline%20-%20G.%20Stock%2C%20J.%20Campbell%20%28Oxford%2C%202000%29%20WW.pdf }}</ref> Germline engineering results in changes in the genome being incorporated into every cell in the body of the offspring (or of the individual following embryonic germline engineering). This process differs from [[somatic cell]] engineering, which does not result in heritable changes. Most human germline editing is performed on individual cells and non-viable embryos, which are destroyed at a very early stage of development. In November 2018, however, a Chinese scientist, [[He Jiankui]], announced that he had created the first human germline genetically edited babies.<ref name="GuardianJiankui1">{{cite news |title=World's first gene-edited babies created in China, claims scientist |url=https://www.theguardian.com/science/2018/nov/26/worlds-first-gene-edited-babies-created-in-china-claims-scientist |agency=The Guardian |date=26 Nov 2018}}</ref>

Genetic engineering relies on a knowledge of human genetic information, made possible by research such as the [[Human Genome Project]], which identified the position and function of all the genes in the human genome.<ref name="HGP">{{cite journal | vauthors = Hood L, Rowen L | title = The Human Genome Project: big science transforms biology and medicine | journal = Genome Medicine | volume = 5 | issue = 9 | pages = 79 | date = 13 Sep 2013 | pmid = 24040834 | pmc = 4066586 | doi = 10.1186/gm483 | doi-access = free }}</ref> As of 2019, [[high-throughput sequencing]] methods allow [[genome sequencing]] to be conducted very rapidly, making the technology widely available to researchers.<ref name="nextgenseq">{{cite journal | vauthors = Straiton J, Free T, Sawyer A, Martin J | title = From Sanger sequencing to genome databases and beyond | journal = BioTechniques | volume = 66 | issue = 2 | pages = 60–63 | date = February 2019 | pmid = 30744413 | doi = 10.2144/btn-2019-0011 | doi-access = free }}</ref>

Germline modification is typically accomplished through techniques which incorporate a new gene into the genome of the embryo or germ cell in a specific location. This can be achieved by introducing the desired DNA directly to the cell for it to be incorporated, or by replacing a gene with one of interest. These techniques can also be used to remove or disrupt unwanted genes, such as ones containing mutated sequences.

Whilst germline engineering has mostly been performed in [[mammals]] and other animals, research on human cells ''in vitro'' is becoming more common. Most commonly used in human cells are [[germline gene therapy]] and the engineered nuclease system [[CRISPR gene editing|CRISPR/Cas9]].
 
===Germline gene modification===
[[Gene therapy]] is the delivery of a [[nucleic acid]] (usually DNA or [[RNA]]) into a cell as a pharmaceutical agent to treat disease.<ref name="genetherapyNIH">{{cite web |title=What is gene therapy? |url=https://ghr.nlm.nih.gov/primer/therapy/genetherapy |website=NIH: U.S. National Library of Medicine}}</ref> Most commonly it is carried out using a [[vectors in gene therapy|vector]], which transports the nucleic acid (usually DNA encoding a therapeutic gene) into the target cell. A vector can [[transduction (genetics)|transduce]] a desired copy of a gene into a specific location to be [[gene expression|expressed]] as required. Alternatively, a [[transgene]] can be inserted to deliberately disrupt an unwanted or mutated gene, preventing [[transcription (biology)|transcription]] and [[translation (biology)|translation]] of the faulty gene products to avoid a disease [[phenotype]].

Gene therapy in patients is typically carried out on somatic cells in order to treat conditions such as some [[leukaemias]] and [[vascular diseases]].<ref name="Leukaemia1">{{cite journal| vauthors = Ledford H |title=Cell therapy fights leukaemia|journal=Nature|year=2011|issn=1476-4687|doi=10.1038/news.2011.472}}</ref><ref name="Leukaemia2">{{cite news | vauthors = Coghlan A |title=Gene therapy cures leukaemia in eight days |url=https://www.newscientist.com/article/mg21729104-100-gene-therapy-cures-leukaemia-in-eight-days/ |agency=New Scientist |date=26 March 2013}}</ref><ref name="genetherapyPAD">{{cite journal | vauthors = Shimamura M, Nakagami H, Taniyama Y, Morishita R | title = Gene therapy for peripheral arterial disease | journal = Expert Opinion on Biological Therapy | volume = 14 | issue = 8 | pages = 1175–1184 | date = August 2014 | pmid = 24766232 | doi = 10.1517/14712598.2014.912272 | s2cid = 24820913 }}</ref>
Human germline gene therapy in contrast is restricted to ''in vitro'' experiments in some countries, whilst others prohibited it entirely, including [[Australia]], [[Canada]], [[Germany]] and Switzerland.<ref name="embryoprotectionlaw">{{cite web |title=Embryo Protection Law |url=http://www.dnapolicy.org/policy.international.php?action=showall |archive-url=https://web.archive.org/web/20150218025115/http://www.dnapolicy.org/policy.international.php?action=showall |url-status=dead |archive-date=2015-02-18 |website=Genes and Public Policy Center}}</ref>

Whilst the [[National Institutes of Health]] in the US does not currently allow ''[[Uterus|in utero]]'' germline gene transfer clinical trials, ''in vitro'' trials are permitted.<ref name="FDA gene therapy">{{cite web |title=Therapeutic Cloning and Genome Modification |url=https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/therapeutic-cloning-and-genome-modification |website=U.S. Food and Drug Administration|date=20 March 2019 }}</ref> The NIH guidelines state that further studies are required regarding the safety of gene transfer protocols before ''in utero'' research is considered, requiring current studies to provide demonstrable efficacy of the techniques in the laboratory.<ref name="NIH gene therapy guide">{{cite web |title=Germline Gene Transfer |url=https://www.genome.gov/10004764/ |website=National Human Genome Research Institute}}</ref> Research of this sort is currently using non-viable embryos to investigate the efficacy of germline gene therapy in treatment of disorders such as inherited [[mitochondrial diseases]].<ref name="mt gene therapy">{{cite journal | vauthors = Tachibana M, Amato P, Sparman M, Woodward J, Sanchis DM, Ma H, Gutierrez NM, Tippner-Hedges R, Kang E, Lee HS, Ramsey C, Masterson K, Battaglia D, Lee D, Wu D, Jensen J, Patton P, Gokhale S, Stouffer R, Mitalipov S | display-authors = 6 | title = Towards germline gene therapy of inherited mitochondrial diseases | journal = Nature | volume = 493 | issue = 7434 | pages = 627–631 | date = January 2013 | pmid = 23103867 | pmc = 3561483 | doi = 10.1038/nature11647 | bibcode = 2013Natur.493..627T }}</ref>

Gene transfer to cells is usually by vector delivery. Vectors are typically divided into two classes – [[viral vectors|viral]] and [[vectors in gene therapy#Non-viral methods|non-viral]].

====Viral vectors====

[[Viruses]] infect cells by transducing their genetic material into a host's cell, using the host's cellular machinery to generate viral proteins needed for replication and proliferation. By modifying viruses and loading them with the therapeutic DNA or RNA of interest, it is possible to use these as a vector to provide delivery of the desired gene into the cell.<ref name="viralvectors">{{cite journal | vauthors = Robbins PD, Ghivizzani SC | title = Viral vectors for gene therapy | journal = Pharmacology & Therapeutics | volume = 80 | issue = 1 | pages = 35–47 | date = October 1998 | pmid = 9804053 | doi = 10.1016/S0163-7258(98)00020-5 }}</ref>

[[Retroviruses]] are some of the most commonly used viral vectors, as they not only introduce their genetic material into the host cell, but also copy it into the host's genome. In the context of gene therapy, this allows permanent integration of the gene of interest into the patient's own DNA, providing longer lasting effects.<ref name="retroviral vectors">{{cite journal | vauthors = Barquinero J, Eixarch H, Pérez-Melgosa M | title = Retroviral vectors: new applications for an old tool | journal = Gene Therapy | volume = 11 | issue = S1 | pages = S3–S9 | date = October 2004 | pmid = 15454951 | doi = 10.1038/sj.gt.3302363 | doi-access = free }}</ref>

Viral vectors work efficiently and are mostly safe but present with some complications, contributing to the stringency of regulation on gene therapy. Despite partial inactivation of viral vectors in gene therapy research, they can still be [[immunogenic]] and elicit an [[immune response]]. This can impede viral delivery of the gene of interest, as well as cause complications for the patient themselves when used clinically, especially in those who already have a serious genetic illness.<ref name="JesseGelsinger">{{cite news | vauthors = Stolberg SG |title=The Biotech Death of Jesse Gelsinger |url=https://www.nytimes.com/1999/11/28/magazine/the-biotech-death-of-jesse-gelsinger.html |work=The New York Times |date=28 Nov 1999}}</ref> Another difficulty is the possibility that some viruses will randomly integrate their nucleic acids into the genome, which can interrupt gene function and generate new mutations.<ref name="RandomIntegration">{{cite journal | vauthors = Bushman FD | title = Retroviral integration and human gene therapy | journal = The Journal of Clinical Investigation | volume = 117 | issue = 8 | pages = 2083–2086 | date = August 2007 | pmid = 17671645 | pmc = 1934602 | doi = 10.1172/JCI32949 }}</ref>
This is a significant concern when considering germline gene therapy, due to the potential to generate new mutations in the embryo or offspring.

====Non-viral vectors====

Non-viral methods of nucleic acid [[transfection]] involved injecting a naked DNA [[plasmid]] into cell for incorporation into the genome.<ref name="nonviralvectors">{{cite journal | vauthors = Ramamoorth M, Narvekar A | title = Non viral vectors in gene therapy- an overview | journal = Journal of Clinical and Diagnostic Research | volume = 9 | issue = 1 | pages = GE01–GE06 | date = January 2015 | pmid = 25738007 | pmc = 4347098 | doi = 10.7860/JCDR/2015/10443.5394 }}</ref> This method used to be relatively ineffective with low frequency of integration, however, efficiency has since greatly improved, using methods to enhance the delivery of the gene of interest into cells. Furthermore, non-viral vectors are simple to produce on a large scale and are not highly immunogenic.

Some non-viral methods are detailed below:

*[[Electroporation]] is a technique in which high voltage pulses are used to carry DNA into the target cell across the [[cell membrane|membrane]]. The method is believed to function due to the formation of pores across the membrane, but although these are temporary, electroporation results in a high rate of [[cell death]] which has limited its use.<ref name="electroporation">{{cite journal | vauthors = Lambricht L, Lopes A, Kos S, Sersa G, Préat V, Vandermeulen G | title = Clinical potential of electroporation for gene therapy and DNA vaccine delivery | journal = Expert Opinion on Drug Delivery | volume = 13 | issue = 2 | pages = 295–310 | year = 2015 | pmid = 26578324 | doi = 10.1517/17425247.2016.1121990 | s2cid = 207490403 }}</ref> An improved version of this technology, electron-avalanche transfection, has since been developed, which involves shorter (microsecond) high voltage pulses which result in more effective DNA integration and less cellular damage.<ref name="electronavalanche">{{cite journal | vauthors = Chalberg TW, Vankov A, Molnar FE, Butterwick AF, Huie P, Calos MP, Palanker DV | title = Gene transfer to rabbit retina with electron avalanche transfection | journal = Investigative Ophthalmology & Visual Science | volume = 47 | issue = 9 | pages = 4083–4090 | date = September 2006 | pmid = 16936128 | doi = 10.1167/iovs.06-0092 | doi-access = free }}</ref>
*The [[gene gun]] is a physical method of DNA transfection, where a DNA plasmid is loaded onto a particle of [[heavy metals|heavy metal]] (usually [[gold]]) and loaded onto the 'gun'.<ref name="genegun">{{cite journal | vauthors = Yoshida A, Nagata T, Uchijima M, Higashi T, Koide Y | title = Advantage of gene gun-mediated over intramuscular inoculation of plasmid DNA vaccine in reproducible induction of specific immune responses | journal = Vaccine | volume = 18 | issue = 17 | pages = 1725–1729 | date = March 2000 | pmid = 10699319 | doi = 10.1016/S0264-410X(99)00432-6 }}</ref> The device generates a force to penetrate the cell membrane, allowing the DNA to enter whilst retaining the metal particle.
*[[Oligonucleotides]] are used as chemical vectors for gene therapy, often used to disrupt mutated DNA sequences to prevent their expression.<ref name="oligogenetherapy">{{cite journal | vauthors = Stein CA, Castanotto D | title = FDA-Approved Oligonucleotide Therapies in 2017 | journal = Molecular Therapy | volume = 25 | issue = 5 | pages = 1069–1075 | date = May 2017 | pmid = 28366767 | pmc = 5417833 | doi = 10.1016/j.ymthe.2017.03.023 }}</ref> Disruption in this way can be achieved by introduction of small RNA molecules, called [[siRNA]], which signal cellular machinery to cleave the unwanted [[mRNA]] sequences to prevent their transcription. Another method utilises double-stranded oligonucleotides, which bind [[transcription factors]] required for transcription of the target gene. By competitively binding these transcription factors, the oligonucleotides can prevent the gene's expression.

=== ZFNs ===
{{Main|Zinc finger nuclease}}

[[Zinc finger nuclease|Zinc-finger nucleases]] (ZFNs) are enzymes generated by fusing a zinc finger DNA-binding domain to a DNA-cleavage domain. Zinc finger recognizes between 9 and 18 bases of sequence. Thus by mixing those modules, it becomes easier to target any sequence researchers wish to alter ideally within complex genomes. A ZFN is a [[Macromolecule|macromolecular]] complex formed by monomers in which each subunit contains a zinc domain and a [[FokI|FokI endonuclease domain.]] The FokI domains must dimerize for activities, thus narrowing target area by ensuring that two close DNA-binding events occurs.<ref name=":0">{{cite web |title=Genome Editing with CRISPRs, TALENs and ZFNs |url=https://www.biocompare.com/editorial-articles/144186-genome-editing-with-crisprs-talens-and-zfns/ |website=Biocompare |vauthors=Perkel JM}}</ref>

The resulting cleavage event enables most genome-editing technologies to work. After a break is created, the cell seeks to repair it.

* A method is [[Non-homologous end joining|NHEJ]], in which the cell polishes the two ends of broken DNA and seals them back together, often producing a frame shift.
* An alternative method is [[Homology directed repair|homology-directed]] repairs. The cell tries to fix the damage by using a copy of the sequence as a backup. By supplying their own template, researcher can have the system to insert a desired sequence instead.<ref name=":0" />

The success of using ZFNs in gene therapy depends on the insertion of genes to the chromosomal target area without causing damage to the cell. Custom ZFNs offer an option in human cells for gene correction.

===CRISPR/Cas9===
{{Main|CRISPR gene editing}}
[[File:GRNA-Cas9-colourfriendly.png|thumb|CRISPR-Cas9. PAM (Protospacer Adjacent Motif) is required for target binding.]]
The CRISPR/Cas9 system ([[CRISPR]] – Clustered Regularly Interspaced Short Palindromic Repeats, [[Cas9]] – CRISPR-associated protein 9) is a genome editing technology based on the [[bacterial]] antiviral CRISPR/Cas system. The bacterial system has evolved to recognize viral nucleic acid sequences and cut these sequences upon recognition, damaging infecting viruses. The gene editing technology uses a simplified version of this process, manipulating the components of the bacterial system to allow location-specific gene editing.<ref name="CRISPR NIH">{{cite web |title=What are genome editing and CRISPR/Cas9? |url=https://ghr.nlm.nih.gov/primer/genomicresearch/genomeediting |website=Genetics Home Reference |publisher=NIH}}</ref>

The CRISPR/Cas9 system broadly consists of two major components – the Cas9 [[nuclease]] and a [[guide RNA]] (gRNA). The gRNA contains a Cas-binding sequence and a ~20 [[nucleotide]] spacer sequence, which is specific and complementary to the target sequence on the DNA of interest. Editing specificity can therefore be changed by modifying this spacer sequence.<ref name="CRISPR NIH" />

[[File:DNA Repair-colourfriendly.png|thumb|upright=1.3|DNA repair after double-strand break]]
Upon system delivery to a cell, Cas9 and the gRNA bind, forming a [[Nucleoprotein#Ribonucleoproteins|ribonucleoprotein]] complex. This causes a [[conformational change]] in Cas9, allowing it to cleave DNA if the gRNA spacer sequence binds with sufficient [[sequence homology#Identity, similarity, and conservation|homology]] to a particular sequence in the host genome.<ref name="Addgene CRISPR">{{cite web |title=CRISPR Guide |url=https://www.addgene.org/crispr/guide/ |website=AddGene}}</ref> When the gRNA binds to the target sequence, Cas will cleave the [[locus (genetics)|locus]], causing a [[DNA repair#Double-strand breaks|double-strand break]] (DSB).

The resulting DSB can be [[DNA repair|repaired]] by one of two mechanisms –

*[[Non-homologous end joining|Non-Homologous End Joining]] (NHEJ) - an efficient but error-prone mechanism, which often introduces insertions and deletions ([[indels]]) at the DSB site. This means it is often used in [[gene knockout|knockout]] experiments to disrupt genes and introduce loss of function mutations.
*[[Homology directed repair|Homology Directed Repair]] (HDR) - a less efficient but high-fidelity process which is used to introduce precise modifications into the target sequence. The process requires adding a DNA repair template including a desired sequence, which the cell's machinery uses to repair the DSB, incorporating the sequence of interest into the genome.

Since NHEJ is more efficient than HDR, most DSBs will be repaired ''via'' NHEJ, introducing gene knockouts. To increase frequency of HDR, inhibiting genes associated with NHEJ and performing the process in particular [[cell cycle]] phases (primarily [[S phase|S]] and [[G2 phase|G2]]) appear effective.

CRISPR/Cas9 is an effective way of manipulating the genome ''[[in vivo]]'' in animals as well as in human cells ''in vitro'', but some issues with the efficiency of delivery and editing mean that it is not considered safe for use in viable human embryos or the body's germ cells. As well as the higher efficiency of NHEJ making inadvertent knockouts likely, CRISPR can introduce DSBs to unintended parts of the genome, called off-target effects.<ref name="offtarget CRISPR">{{cite journal | vauthors =  | title = Keep off-target effects in focus | journal = Nature Medicine | volume = 24 | issue = 8 | pages = 1081 | date = August 2018 | pmid = 30082857 | doi = 10.1038/s41591-018-0150-3 | doi-access = free }}</ref> These arise due to the spacer sequence of the gRNA conferring sufficient sequence homology to random loci in the [[genome]], which can introduce random mutations throughout. If performed in germline cells, mutations could be introduced to all the cells of a developing embryo.

There are developments to prevent unintended consequences otherwise known as off-target effects due to gene editing.<ref name=":4">{{cite journal | vauthors = Naeem M, Majeed S, Hoque MZ, Ahmad I | title = Latest Developed Strategies to Minimize the Off-Target Effects in CRISPR-Cas-Mediated Genome Editing | journal = Cells | volume = 9 | issue = 7 | pages = 1608 | date = July 2020 | pmid = 32630835 | pmc = 7407193 | doi = 10.3390/cells9071608 | doi-access = free }}</ref> There is a race to develop new gene editing technologies that prevent off-target effects from occurring with some of the technologies being known as biased off-target detection, and Anti-CRISPR Proteins.<ref name=":4" /> For biased off-target effects detection, there are several tools to predict the locations where off-target effects may take place.<ref name=":4" /> Within the technology of biased off-target effects detection, there are two main models, Alignment Based Models that involve having the sequences of gRNA being aligned with sequences of genome, after which then the off-target locations are predicted.<ref name=":4" /> The second model is known as the Scoring-Based Model where each piece of gRNA is scored for their off-target effects in accordance with their positioning.<ref name=":4" />

====Regulation on CRISPR use====

In 2015, the International Summit on Human Gene Editing was held in [[Washington D.C.]], hosted by scientists from China, the UK and the U.S. The summit concluded that genome editing of somatic cells using CRISPR and other genome editing tools would be allowed to proceed under [[FDA]] regulations, but human germline engineering would not be pursued.<ref name="FDA gene therapy" />

In February 2016, scientists at the [[Francis Crick Institute]] in [[London]] were given a license permitting them to edit human embryos using CRISPR to investigate early development.<ref name = "NatureCrickCRISPR">{{cite news | vauthors = Callaway E |title=UK scientists gain licence to edit genes in human embryos |url=https://www.nature.com/news/uk-scientists-gain-licence-to-edit-genes-in-human-embryos-1.19270 |publisher=Nature |date=1 Feb 2016}}</ref> Regulations were imposed to prevent the researchers from implanting the embryos and to ensure experiments were stopped and embryos destroyed after seven days.

In November 2018, Chinese scientist [[He Jiankui]] announced that he had performed the first germline engineering on viable human embryos, which have since been brought to term.<ref name="GuardianJiankui1" /> The research claims received significant criticism, and Chinese authorities suspended He's research activity.<ref name="CNNJiankui suspension">{{cite news | vauthors = Berlinger J, Jiang S, Regan H |title=China suspends scientists who claim to have produced first gene-edited babies |url= https://edition.cnn.com/2018/11/29/health/china-gene-editing-he-jiankui-intl/index.html |publisher=CNN |date=29 Nov 2018}}</ref> Following the event, scientists and government bodies have called for more stringent regulations to be imposed on the use of CRISPR technology in embryos, with some calling for a global [[moratorium (law)|moratorium]] on germline genetic engineering. Chinese authorities have announced stricter controls will be imposed, with [[Communist Party of China|Communist Party]] general secretary [[Xi Jinping]] and [[Government of China|government]] premier [[Li Keqiang]] calling for new gene-editing legislations to be introduced.<ref name = "Guardian moratorium">{{cite news |title=Scientists call for global moratorium on gene editing of embryos |url=https://www.theguardian.com/science/2019/mar/13/scientists-call-for-global-moratorium-on-crispr-gene-editing |work=The Guardian |date=13 Mar 2019}}</ref><ref name="FT ChinaCRISPR">{{cite news |title=China set to tighten regulations on gene-editing research |url=https://www.ft.com/content/a464bd9c-f869-11e8-af46-2022a0b02a6c |publisher=Financial Times |date=25 Jan 2019}}</ref>

As of January 2020, germline genetic alterations are prohibited in 24 countries by law and also in 9 other countries by their guidelines.<ref>{{cite journal | vauthors = Ayanoğlu FB, Elçin AE, Elçin YM | title = Bioethical issues in genome editing by CRISPR-Cas9 technology | journal = Turkish Journal of Biology | volume = 44 | issue = 2 | pages = 110–120 | date = 2020-04-02 | pmid = 32256147 | pmc = 7129066 | doi = 10.3906/biy-1912-52 }}</ref> The [[Council of Europe]]'s Convention on Human Rights and Biomedicine, also known as the Oviedo Convention, has stated in its article 13 "Interventions on the human genome" as follows: "An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants".<ref>{{cite journal | vauthors = de Lecuona I, Casado M, Marfany G, Lopez Baroni M, Escarrabill M | title = Gene Editing in Humans: Towards a Global and Inclusive Debate for Responsible Research | journal = The Yale Journal of Biology and Medicine | volume = 90 | issue = 4 | pages = 673–681 | date = December 2017 | pmid = 29259532 | pmc = 5733855 }}</ref><ref>{{cite journal | vauthors =  | title = Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine (adopted by the Committee of Ministers on 19 November 1996). Council of Europe Convention of Biomedicine | journal = Human Reproduction | volume = 12 | issue = 9 | pages = 2076–2080 | date = September 1997 | pmid = 9363733 | doi = 10.1093/humrep/12.9.2076 | doi-access = free }}</ref> Nonetheless, wide public debate has emerged, targeting the fact that the Oviedo Convention Article 13 should be revisited and renewed, especially due to the fact that it was constructed in 1997 and may be out of date, given recent technological advancements in the field of genetic engineering.<ref>{{cite journal | vauthors = Sykora P, Caplan A | title = Germline gene therapy is compatible with human dignity | journal = EMBO Reports | volume = 18 | issue = 12 | pages = 2086 | date = December 2017 | pmid = 29141985 | pmc = 5709747 | doi = 10.15252/embr.201745378 }}</ref>

In 2020, Canada amended its Human Reproduction Act to criminalize heritable genome edits, in which penalties include fines up to CAD$500,000 and 10 years imprisonment. <ref>{{cite journal |last1=Knoppers |first1=Bartha Maria |title=CRISPR Babies: What Does This Mean for Science and Canada? |journal=Canadian Medical Association Journal |date=2019 |volume=191 |issue=4 |pages=E91–E92 |doi=10.1503/cmaj.181657|pmid=30692104 |pmc=6342697 }}</ref> The [[World Health Organization]] established a global registry for such practices in 2021 to enhance transparency<ref>{{cite web |title=WHO issues new recommendations on human genome editing |url=https://www.who.int/news/item/12-07-2021-who-issues-new-recommendations-on-human-genome-editing-for-the-advancement-of-public-health |website=World Health Organization |date=2021-07-12}}</ref>

====Recent Advancements====
Following the 2018 incident of the first CRISPR-edited babies by [[He Jiankui]], efforts to strengthen regulatory oversights have helped to improve the precision of the procedure. These advancements in [[genome editing]] now reduce off-target effects, allowing for more controlled and predictable modifications. Techniques such as [[prime editing]] and [[base editing]] have offered greater accuracy and fewer unintended mutations. <ref>{{cite journal |last1=Allemailem |first1=Khaled S. |title=Recent Updates of the CRISPR/Cas9 Genome Editing System |journal=International Journal of Nanomedicine |date=2024 |volume=19 |pages=5335–5363 |doi=10.2147/IJN.S455574 |doi-access=free |pmid=38859956|pmc=11164216 }}</ref> Even so, ethical concerns persist as regulatory enforcement remains inconsistent in nations without strict biosafety laws <ref>{{cite journal |last1=Cyranoski |first1=David |title=The CRISPR-baby scandal: what's next for human gene-editing |journal=Nature |date=2019 |volume=566 |issue=7745 |pages=440–442 |doi=10.1038/d41586-019-00673-1|bibcode=2019Natur.566..440C }}</ref>

==Lulu and Nana controversy==
{{Main|He Jiankui affair}}

[[File:He Jiankui at Second International Summit on Human Genome Editing (cropped).jpg|thumb|He Jiankui speaking at the Second International Summit on Human Genome Editing, November 2018]]
The Lulu and Nana controversy refers to the two Chinese twin girls born in November 2018, who had been genetically modified as embryos by the Chinese scientist He Jiankui.<ref name="GuardianJiankui1" /> The twins are believed to be the first genetically modified babies. The girls' parents had participated in a clinical project run by He, which involved IVF, PGD and genome editing procedures in an attempt to edit the gene [[CCR5]]. CCR5 encodes a protein used by [[HIV]] to enter host cells, so by introducing a specific mutation into the gene [[CCR5#CCR5-Δ32|CCR5 Δ32]] He claimed that the process would confer [[innate resistance to HIV]].<ref name = "MarchioneAPNews">{{cite news | vauthors = Marchione M |title=Chinese researcher claims first gene-edited babies |url=https://www.apnews.com/4997bb7aa36c45449b488e19ac83e86d |publisher=AP News |date=26 Nov 2018}}</ref><ref name="HIVdelta32">{{cite journal | vauthors = de Silva E, Stumpf MP | title = HIV and the CCR5-Delta32 resistance allele | journal = FEMS Microbiology Letters | volume = 241 | issue = 1 | pages = 1–12 | date = December 2004 | pmid = 15556703 | doi = 10.1016/j.femsle.2004.09.040 | doi-access = free }}</ref>

The project run by He recruited couples wanting children where the man was [[HIV-positive people|HIV-positive]] and the woman uninfected. During the project, He performed IVF with sperm and eggs from the couples and then introduced the CCR5 Δ32 mutation into the genomes of the embryos using CRISPR/Cas9. He then used PGD on the edited embryos during which he sequenced biopsied cells to identify whether the mutation had been successfully introduced. He reported some [[mosaicism]] in the embryos, whereby the mutation had integrated into some cells but not all, suggesting the offspring would not be entirely protected against HIV.<ref name="statnewsJiankui">{{cite news | vauthors = Begley S |title=Amid uproar, Chinese scientist defends creating gene-edited babies |url=https://www.statnews.com/2018/11/28/chinese-scientist-defends-creating-gene-edited-babies/ |publisher=Stat News |date=28 Nov 2018}}</ref> He claimed that during the PGD and throughout the pregnancy, [[Cell-free fetal DNA|fetal DNA]] was sequenced to check for off-target errors introduced by the CRISPR/Cas9 technology, however the NIH released a statement in which they announced "the possibility of damaging off-target effects has not been satisfactorily explored".<ref name = "NYtimesdefence">{{cite news | vauthors = Belluck P |title=Chinese Scientist Who Says He Edited Babies' Genes Defends His Work |url= https://www.nytimes.com/2018/11/28/world/asia/gene-editing-babies-he-jiankui.html |work=The New York Times |date=28 Nov 2018}}</ref><ref name="NIHJiankuiStatement">{{cite news |title=Statement on Claim of First Gene-Edited Babies by Chinese Researcher |url=https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-claim-first-gene-edited-babies-chinese-researcher |agency=National Institutes of Health |publisher=U.S. Department of Health and Human Services |date=28 Nov 2018}}</ref> The girls were born in early November 2018, and were reported by He to be healthy.<ref name="statnewsJiankui" />

His research was conducted in secret until November 2018, when documents were posted on the Chinese clinical trials registry and ''[[MIT Technology Review]]'' published a story about the project.<ref name="MIT CRISPR review">{{cite news | vauthors = Regalado A |title=EXCLUSIVE: Chinese scientists are creating CRISPR babies |url=https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/ |work=MIT Technology Review |date=25 Nov 2018 |language=en}}</ref> Following this, He was interviewed by the ''[[Associated Press]]'' and presented his work on 27 November at the Second International Human Genome Editing Summit which was held in [[Hong Kong]].<ref name="MarchioneAPNews" />

Although the information available about this experiment is relatively limited, it is deemed that the scientist erred against many ethical, social and moral rules but also China's guidelines and regulations, which prohibited germ-line genetic modifications in human embryos, while conducting this trial.<ref>{{cite journal | vauthors = Greely HT | title = CRISPR'd babies: human germline genome editing in the 'He Jiankui affair' | journal = Journal of Law and the Biosciences | volume = 6 | issue = 1 | pages = 111–183 | date = October 2019 | pmid = 31666967 | pmc = 6813942 | doi = 10.1093/jlb/lsz010 }}</ref><ref name=":2">{{cite journal | vauthors = Li JR, Walker S, Nie JB, Zhang XQ | title = Experiments that led to the first gene-edited babies: the ethical failings and the urgent need for better governance | journal = Journal of Zhejiang University. Science. B | volume = 20 | issue = 1 | pages = 32–38 | date = January 2019 | pmid = 30614228 | pmc = 6331330 | doi = 10.1631/jzus.B1800624 }}</ref> From a technological point of view, the CRISPR/Cas9 technique is one of the most precise and least expensive methods of gene modification to this day, whereas there are still a number of limitations that keep the technique from being labelled as safe and efficient.<ref name=":2" /> During the First International Summit on Human Gene Editing in 2015 the participants agreed that a halt must be set on germline genetic alterations in clinical settings unless and until: "(1) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (2) there is broad societal consensus about the appropriateness of the proposed application".<ref name=":2" /> However, during the second International Summit in 2018 the topic was once again brought up by stating: "Progress over the last three years and the discussions at the current summit, however, suggest that it is time to define a rigorous, responsible translational pathway toward such trials".<ref name=":2" /> Inciting that the ethical and legal aspects should indeed be revisited G. Daley, representative of the summit's management and Dean of Harvard Medical School depicted Dr. He's experiment as "a wrong turn on the right path".<ref name=":2" />

The experiment was met with widespread criticism and was very controversial, globally as well as in China.<ref name="China reactionNature">{{cite news | vauthors = Cyranoski D, Ledford H |title=How the genome-edited babies revelation will affect research |url=https://www.nature.com/articles/d41586-018-07559-8 |journal=Nature |date=27 November 2018 |language=EN |doi=10.1038/d41586-018-07559-8}}</ref><ref name="STATnewsreactions">{{cite news | vauthors = Begley S | title=Claim of CRISPR'd baby girls stuns genome editing summit |url=https://www.statnews.com/2018/11/26/claim-of-crispred-baby-girls-stuns-genome-editing-summit/ |work=STAT News |date=26 November 2018}}</ref> Several [[bioethicists]], researchers and medical professionals have released statements condemning the research, including [[Nobel laureate]] [[David Baltimore]] who deemed the work "irresponsible" and one pioneer of the CRISPR/Cas9 technology, biochemist [[Jennifer Doudna]] at [[University of California, Berkeley]].<ref name="NYtimesdefence" /><ref name="SanFranBerkeley">{{cite news | vauthors = Leuty R |title=Why 2 key gene-editing voices in Berkeley condemn Chinese scientist's designer babies 'stunt' |url=https://www.bizjournals.com/sanfrancisco/news/2018/11/26/gene-editing-jennifer-doudna-uc-berkeley-crisp.html |publisher=San Francisco Business Times |date=26 Nov 2018}}</ref> The director of the NIH, [[Francis S. Collins]] stated that the "medical necessity for inactivation of CCR5 in these infants is utterly unconvincing" and condemned He Jiankui and his research team for 'irresponsible work'.<ref name="NIHJiankuiStatement" /> Other scientists, including [[geneticist]] [[George M. Church|George Church]] of [[Harvard University]] suggested gene editing for disease resistance was "justifiable" but expressed reservations regarding the conduct of He's work.<ref name="CNBC CRISPR">{{cite news | vauthors = Farr C  |title=Chinese CRISPR baby gene-editing 'criminally reckless': bio-ethicist |url= https://www.cnbc.com/2018/11/26/chinese-crispr-baby-gene-editing-criminally-reckless-bio-ethicist.html |work=CNBC |date=26 November 2018}}</ref>

The Safe Genes program by DARPA has the goal to protect soldiers against gene editing war tactics.<ref name=":5">{{Cite web | vauthors = Cheever A | date = | title = Safe Genes |url=https://www.darpa.mil/program/safe-genes|access-date=2021-11-20 | work =  Defense Advanced Research Projects Agency (DARPA) | publisher = U.S. Department of Defense }}</ref> They receive information from ethical experts to better predict and understand future and current potential gene editing issues.<ref name=":5" />{{primary inline|date=September 2022}}

The [[World Health Organization]] has launched a global registry to track research on human genome editing, after a call to halt all work on genome editing.<ref>{{cite news|url=https://www.wired.com/story/the-world-health-organization-says-no-more-gene-edited-babies/|title=The World Health Organization Says No More Gene-Edited Babies|date=2019-07-30|magazine=[[WIRED]]|access-date=2019-11-26}}</ref><ref>{{cite news|url=https://www.voanews.com/a/science-health_who-create-registry-genetic-research/6174846.html|title=WHO To Create Registry for Genetic Research|date=2019-08-29|work=[[Voice of America]]|access-date=2019-11-28}}</ref><ref>{{cite news|url=https://www.reuters.com/article/us-health-who-gene-editing/who-panel-calls-for-registry-of-all-human-gene-editing-research-idUSKCN1R02IC|title=The WHO panel calls for registry of all human gene editing research|date=2019-03-20|work=[[Reuters]]|access-date=2019-11-28}}</ref>

The [[Chinese Academy of Medical Sciences]] responded to the controversy in the journal [[The Lancet|''Lancet'']], condemning He for violating ethical guidelines documented by the government and emphasizing that germline engineering should not be performed for reproductive purposes.<ref>{{cite journal | vauthors = Wang C, Zhai X, Zhang X, Li L, Wang J, Liu DP | title = Gene-edited babies: Chinese Academy of Medical Sciences' response and action | journal = Lancet | volume = 393 | issue = 10166 | pages = 25–26 | date = January 2019 | pmid = 30522918 | doi = 10.1016/S0140-6736(18)33080-0 | doi-access = free }}</ref> The academy ensured they would "issue further operational, technical and ethical guidelines as soon as possible" to impose tighter regulation on human embryo editing.
[[File:Drawing of boy with Duchenne muscular dystrophy.png|thumb|231x231px|Illustration of seven-year-old boy with Duchenne muscular dystrophy, showing pseudohypertrophy of the lower limbs, thinness of the arms, and lumbar hyperlordosis.]]
As of 2023, He has resumed research in genetic medicine after his three year imprisonment by the Chinese government for his "illegal medical practices."<ref name=":7">{{Cite news |title=His baby gene editing shocked ethicists. Now he's in the lab again |url=https://www.npr.org/2023/06/08/1178695152/china-scientist-he-jiankui-crispr-baby-gene-editing |access-date=2025-04-08 |work=NPR |language=en}}</ref> He has since shifted his focus to the treatment of genetic diseases, including [[Duchenne muscular dystrophy|Duchenne muscular dystrophy (DMD)]], after his release. Despite backlashes from the Lulu and Nana case, he has been appointed as the inaugural director of the Genetic Medicine Institute at Wuchang University of Technology in Wuhan in September 2023.<ref name=":7" /> He's application to work in Hong Kong was initially granted a visa, however, it was later revoked due to ongoing ethical and legal challenges surrounding his career.<ref name=":7" />

==Ethical considerations==
{{See also|Human germline engineering#Ethical and moral debates}}

Editing embryos, germ cells and the generation of designer babies is the subject of ethical debate, as a result of the implications in modifying genomic information in a heritable manner. This includes arguments over unbalanced gender selection and gamete selection.<ref>{{cite journal |last1=Hisan |first1=Urfa Khairatun |last2=Romero |first2=Cyril B. |title=Designer Babies are No Longer Science Fiction: What are The Ethical Considerations? |journal=Bincang Sains Dan Teknologi |date=2023 |volume=2 |issue=3 |pages=124–132 |doi=10.56741/bst.v2i03.437 |doi-access=free}}</ref>

Despite regulations set by individual countries' governing bodies, the absence of a standardized regulatory framework leads to frequent discourse in discussion of germline engineering among scientists, ethicists and the general public. [[Arthur Caplan]], the head of the Division of Bioethics at [[New York University]] suggests that establishing an international group to set guidelines for the topic would greatly benefit global discussion and proposes instating "religious and ethics and legal leaders" to impose well-informed regulations.<ref name="for against des baby">{{cite news |title=Designer babies: the arguments for and against |url=https://www.theweek.co.uk/95108/designer-babies-the-arguments-for-and-against |work=The Week UK |date=17 Jul 2018 |language=en}}</ref>

In many countries, editing embryos and germline modification for reproductive use is illegal.<ref name=":6">{{cite journal | vauthors = Ishii T | title = Germline genome-editing research and its socioethical implications | journal = Trends in Molecular Medicine | volume = 21 | issue = 8 | pages = 473–481 | date = August 2015 | pmid = 26078206 | doi = 10.1016/j.molmed.2015.05.006 }}</ref>  As of 2017, the U.S. restricts the use of germline modification and the procedure is under heavy regulation by the FDA and NIH.<ref name=":6" />  The American [[National Academy of Sciences]] and [[National Academy of Medicine]] indicated they would provide qualified support for human germline editing "for serious conditions under stringent oversight", should safety and efficiency issues be addressed.<ref>{{Cite news|url=https://www.nytimes.com/2017/02/14/health/human-gene-editing-panel.html|title=Human Gene Editing Receives Science Panel's Support| vauthors = Harmon A |date=2017-02-14|newspaper=The New York Times|access-date=2017-02-17|issn=0362-4331}}</ref>  In 2019, World Health Organization called human germline genome editing as "irresponsible".<ref name=":WHOcall">{{cite journal | vauthors = Reardon S | title = World Health Organization panel weighs in on CRISPR-babies debate | journal = Nature | volume = 567 | issue = 7749 | pages = 444–445 | date = March 2019 | pmid = 30914808 | doi = 10.1038/d41586-019-00942-z | bibcode = 2019Natur.567..444R | doi-access = free }}</ref>

Since genetic modification poses risk to any [[organism]], researchers and medical professionals must give the prospect of germline engineering careful consideration. The main ethical concern is that these types of treatments will produce a change that can be passed down to future generations and therefore any error, known or unknown, will also be passed down and will affect the offspring.<ref name=":3">{{cite journal | vauthors = Anderson WF | title = Human gene therapy: scientific and ethical considerations | journal = The Journal of Medicine and Philosophy | volume = 10 | issue = 3 | pages = 275–291 | date = August 1985 | pmid = 3900264 | doi = 10.1093/jmp/10.3.275 | doi-access = free }}</ref>  Theologian [[Ronald Michael Green|Ronald Green]] of [[Dartmouth College]] has raised concern that this could result in a decrease in [[genetic diversity]] and the accidental introduction of new diseases in the future.<ref name = "Green 2007">{{cite book | vauthors = Green RM | title = Babies By Design: The Ethics of Genetic Choice | publisher = Yale University Press | year = 2007 | location = New Haven | pages = [https://archive.org/details/babiesbydesignet00gree/page/96 96–97] | id = 129954761 | isbn = 978-0-300-12546-7 | url-access = registration | url = https://archive.org/details/babiesbydesignet00gree/page/96 }}</ref>

When considering support for research into germline engineering, ethicists have often suggested that it can be considered unethical not to consider a technology that could improve the lives of children who would be born with [[congenital disorders]]. Geneticist George Church claims that he does not expect germline engineering to increase societal disadvantage, and recommends lowering costs and improving education surrounding the topic to dispel these views.<ref name = "Guardianethics1">{{cite news | vauthors = Sample I |title=Genetically modified babies given go-ahead by UK ethics body |url=https://www.theguardian.com/science/2018/jul/17/genetically-modified-babies-given-go-ahead-by-uk-ethics-body |work=The Guardian |date=17 July 2018}}</ref> He emphasizes that allowing germline engineering in children who would otherwise be born with congenital defects could save around 5% of babies from living with potentially avoidable diseases. Jackie Leach Scully, professor of social and [[bioethics]] at [[Newcastle University]], acknowledges that the prospect of designer babies could leave those living with diseases and unable to afford the technology feeling marginalized and without medical support.<ref name="Guardianethics1" /> However, Professor Leach Scully also suggests that germline editing provides the option for parents "to try and secure what they think is the best start in life" and does not believe it should be ruled out. Similarly, [[Nick Bostrom]], an [[University of Oxford|Oxford]] [[philosopher]] known for his work on the risks of [[artificial intelligence]], proposed that "super-enhanced" individuals could "change the world through their creativity and discoveries, and through innovations that everyone else would use".<ref name = "Bolstrom2014">{{cite journal | vauthors = Shulman C, Bostrom N |title=Embryo Selection for Cognitive Enhancement: Curiosity or Game-changer? |journal=Global Policy |date=February 2014 |volume=5 |issue=1 |pages=85–92 |doi=10.1111/1758-5899.12123}}</ref>

Many bioethicists emphasize that germline engineering is usually considered in the best interest of a child, therefore associated should be supported. [[James Hughes (sociologist)|Dr James Hughes]], a bioethicist at [[Trinity College (Connecticut)|Trinity College, Connecticut]], suggests that the decision may not differ greatly from others made by parents which are well accepted – choosing with whom to have a child and using contraception to denote when a child is conceived.<ref name = "BusInsiderEthics">{{cite news | vauthors = Kincaid E |title=Designer babies will just be a logical continuation of the way we've long approached parenting |url=https://www.businessinsider.com/designer-babies-are-an-exercise-of-parents-reproductive-freedom-2015-6?r=US&IR=T |work=Business Insider |date=24 Jun 2015}}</ref> [[Julian Savulescu]], a bioethicist and philosopher at Oxford University believes parents "should allow selection for non‐disease genes even if this maintains or increases social inequality", coining the term [[Julian Savulescu#Procreative beneficence|''procreative beneficence'']] to describe the idea that the children "expected to have the best life" should be selected.<ref name = "SavulescuPB">{{cite journal | vauthors = Savulescu J | title = Procreative beneficence: why we should select the best children | journal = Bioethics | volume = 15 | issue = 5–6 | pages = 413–426 | date = October 2001 | pmid = 12058767 | doi = 10.1111/1467-8519.00251 }}</ref> The [[Nuffield Council on Bioethics]] said in 2017 that there was "no reason to rule out" changing the DNA of a human embryo if performed in the child's interest, but stressed that this was only provided that it did not contribute to societal inequality.<ref name="Guardianethics1" /> Furthermore, Nuffield Council in 2018 detailed applications, which would preserve equality and benefit humanity, such as elimination of hereditary disorders and adjusting to warmer climate.<ref name = "NuffieldReview">{{cite news |title=Bioethics of Designer Babies: Pros and Cons |url=https://genomecontext.com/to-edit-or-not-to-edit-at-the-brink-of-newborn-genome-editing/ |work=Genome Context |date=20 March 2019}}</ref> Philosopher and Director of Bioethics at non-profit Invincible Wellbeing [[David Pearce (transhumanist)|David Pearce]]<ref>{{Cite web|title=Meet The Team|url=https://www.invinciblewellbeing.com/staff|archive-url=https://web.archive.org/web/20211022211355/https://www.invinciblewellbeing.com/staff|archive-date=October 22, 2021|access-date=February 21, 2022|website=Invincible Wellbeing}}</ref> argues that "the question [of designer babies] comes down to an analysis of risk-reward ratios - and our basic ethical values, themselves shaped by our evolutionary past." According to Pearce,"it's worth recalling that each act of old-fashioned sexual reproduction is itself an untested genetic experiment", often compromising a child's wellbeing and pro-social capacities even if the child grows in a healthy environment.<ref>{{Cite book|last=Pearce|first=David|title=Can Biotechnology Abolish Suffering?|year=2017|editor-last=Vinding|editor-first=Magnus|chapter=The Reproductive Revolution|asin=B075MV9KS2|author-link=David Pearce (transhumanist)}}</ref> Pearce thinks that as technology matures, more people may find it unacceptable to rely on "genetic roulette of natural selection".<ref>{{Cite magazine|last=Lomeña|first=Andrés|date=December 2007|title=Transhumanism; Nick Bostrom and David Pearce Talk to Andrés Lomeña|url=https://literalmagazine.com/transhumanism-nick-bostrom-and-david-pearce-talk-to-andres-lomena/|magazine=Literal, Latin American Voices|issue=31|archive-url=https://web.archive.org/web/20211208162630/https://literalmagazine.com/transhumanism-nick-bostrom-and-david-pearce-talk-to-andres-lomena/|archive-date=December 8, 2021|access-date=February 21, 2022}}</ref>

Conversely, several concerns have been raised regarding the possibility of generating designer babies, especially concerning the inefficiencies currently presented by the technologies. Green stated that although the technology was "unavoidably in our future", he foresaw "serious errors and health problems as unknown genetic side effects in 'edited' children" arise.<ref name = "Guardianethics2">{{cite news | vauthors = Ball P |title=Designer babies: an ethical horror waiting to happen? |url=https://www.theguardian.com/science/2017/jan/08/designer-babies-ethical-horror-waiting-to-happen |work=The Guardian |date=8 January 2017}}</ref> Furthermore, Green warned against the possibility that "the well-to-do" could more easily access the technologies "..that make them even better off". This concern regarding germline editing exacerbating a societal and financial divide is shared amongst other researches, with the chair of the Nuffield Bioethics Council Professor Karen Yeung stressing that if funding of the procedures "were to exacerbate social injustice, in our view that would not be an ethical approach".<ref name="Guardianethics1" />

Since 2020, there have been discussions about American studies that use embryos without embryonic implantation with the CRISPR/Cas9 technique that had been modified with HDR (homology-directed repair), and the conclusions from the results were that gene editing technologies are currently not mature enough for real world use and that there is a need for more studies that generate safe results over a longer period of time.<ref>{{cite journal | vauthors = Uddin F, Rudin CM, Sen T | title = CRISPR Gene Therapy: Applications, Limitations, and Implications for the Future | journal = Frontiers in Oncology | volume = 10 | pages = 1387 | date = 2020 | pmid = 32850447 | pmc = 7427626 | doi = 10.3389/fonc.2020.01387 | doi-access = free }}</ref>

An article in the journal ''Bioscience Reports'' discussed how health in terms of genetics is not straightforward and thus there should be extensive deliberation for operations involving gene editing when the technology gets mature enough for real world use, where all of the potential effects are known on a case-by-case basis to prevent undesired effects on the subject or patient being operated on.<ref>{{cite journal | vauthors = Hirakawa MP, Krishnakumar R, Timlin JA, Carney JP, Butler KS | title = Gene editing and CRISPR in the clinic: current and future perspectives | journal = Bioscience Reports | volume = 40 | issue = 4 | date = April 2020 | pmid = 32207531 | pmc = 7146048 | doi = 10.1042/BSR20200127 }}</ref>

Social aspects also raise concern, as highlighted by Josephine Quintavelle, director of ''Comment on Reproductive Ethics'' at [[Queen Mary University of London]], who states that selecting children's traits is "turning parenthood into an unhealthy model of self-gratification rather than a relationship".<ref name="BMJDesBab">{{cite journal | vauthors = Biggs H |title=Designer babies: where should we draw the line? |journal=Journal of Medical Ethics |date=1 December 2004 |volume=30 |issue=6 |pages=e5 |doi=10.1136/jme.2003.004465 |pmc=1733977 }}</ref> In addition, some disability advocates argue that selecting against traits like deafness reinforces societal stigma. This promotes a narrow definition of normalcy. They also warn of the consequences of increased inequality if genetic enhancements become solely accessible to the wealthy.<ref>{{cite journal |last1=Asch |first1=Adrienne |date=2003 |title=Disability Equality and Prenatal Testing |journal=Journal of Medical Ethics |doi=10.1136/jme.2003.007054|pmc=1733841 }}</ref>

One major worry among scientists, including [[Marcy Darnovsky]] at the [[Center for Genetics and Society]] in [[California]], is that permitting germline engineering for correction of disease phenotypes is likely to lead to its use for cosmetic purposes and enhancement.<ref name="Guardianethics1" /> Meanwhile, [[Henry Greely]], a bioethicist at [[Stanford University]] in California, states that "almost everything you can accomplish by gene editing, you can accomplish by embryo selection", suggesting the risks undertaken by germline engineering may not be necessary.<ref name="Guardianethics2" /> Alongside this, Greely emphasizes that the beliefs that genetic engineering will lead to enhancement are unfounded, and that claims that we will enhance intelligence and personality are far off – "we just don't know enough and are unlikely to for a long time – or maybe for ever".

=== Religious Opinions ===
Religious worries also arise over the possibility of editing human embryos. In a survey conducted by the [[Pew Research Centre]], it was found that only a third of the Americans surveyed who identified as strongly [[Christianity|Christian]] approved of germline editing.<ref name="Morality DesBabies">{{cite web |date=28 July 2016 |title=The Morality of "Designer" Babies |url=https://www.themonastery.org/blog/2016/07/morality-of-designer-babies/ |website=Universal Life Church Monastery Blog}}</ref> Catholic leaders are in the middle ground. This stance is because, according to Catholicism, a baby is a gift from God, and Catholics believe that people are created to be perfect in God's eyes. Thus, altering the genetic makeup of an infant is unnatural. In 1984, Pope John Paul II addressed that genetic manipulation in aiming to heal diseases is acceptable in the Church. He stated that it "will be considered in principle as desirable provided that it tends to the real promotion of the personal well-being of man, without harming his integrity or worsening his life conditions".<ref name=":1">{{Cite web |title=Designer babies, anyone? |url=http://natcath.org/NCR_Online/archives2/1999d/102299/102299j.htm |website=National Catholic Reporter |vauthors=Schaeffer P}}</ref> However, it is unacceptable if designer babies are used to create a super/superior race including cloning humans. The Catholic Church rejects human cloning even if its purpose is to produce organs for therapeutic usage. The Vatican has stated that "The fundamental values connected with the techniques of artificial human procreation are two: the life of the human being called into existence and the special nature of the transmission of human life in marriage".<ref>{{Cite web |title=INSTRUCTION ON RESPECT FOR HUMAN LIFE IN ITS ORIGIN AND ON THE DIGNITY OF PROCREATION |url=https://www.catholicnewsagency.com/document/instruction-on-respect-for-human-life-in-its-origin-and-on-the-dignity-of-procreation-117 |url-status=dead |archive-url=https://web.archive.org/web/20150905170649/http://www.catholicnewsagency.com/document/instruction-on-respect-for-human-life-in-its-origin-and-on-the-dignity-of-procreation-117/ |archive-date=September 5, 2015}}</ref> According to them, it violates the dignity of the individual and is morally illicit.

In Islam, a positive view towards genetic engineering is based on the general principle that Islam aims at facilitating human life. However, according to Islamic law, gene editing can only be permitted if several conditions are met, such as definitively proving the safety and efficacy of the procedures in question. Nevertheless, some researchers consider genetic engineering a promising field of research that is capable of meeting the conditions mentioned above in the future.<ref>{{Cite journal |last1=Isa |first1=Noor Munirah |last2=Zulkifli |first2=Nurul Atiqah |last3=Man |first3=Saadan |date=2020-02-01 |title=Islamic Perspectives on CRISPR/Cas9-Mediated Human Germline Gene Editing: A Preliminary Discussion |url=https://link.springer.com/article/10.1007/s11948-019-00098-z |journal=Science and Engineering Ethics |language=en |volume=26 |issue=1 |pages=309–323 |doi=10.1007/s11948-019-00098-z |issn=1471-5546 |pmid=30830592|url-access=subscription }}</ref> In addition, a negative view comes from the process used to create a designer baby. Oftentimes, it involves the destruction of some embryos, which may be against the teaching of the Qur'an, Hadith, and Shari'ah law, that stress the responsibility to protect human life. However, there is a consensus among Islamic scholars that [[ensoulment]] occurs 120 days after conception, well after the embryonic stage of development.<ref>{{Cite web |date=2017-12-08 |title=Islam and the Beginning of Human Life |url=https://petrieflom.law.harvard.edu/2017/12/08/islam-and-the-beginning-of-human-life/ |access-date=2025-03-14 |website=petrieflom.law.harvard.edu |language=en-US}}</ref> Some scholars see the procedure as "acting like God/Allah" and a violation of the religious prohibition against "changing God's/Allah's creation". Other arguments include the possibility of introducing unforeseen mutations and genetic deficiencies, which would be counter to the principle of protecting human life, and undermining the traditional institutions of lineage, marriage and childbirth.<ref>{{Cite journal |last=Rispler-chaim |first=Vardit |date=1998 |title=Genetic Engineering in Contemporary Islamic Thought |url=https://www.cambridge.org/core/journals/science-in-context/article/abs/genetic-engineering-in-contemporary-islamic-thought/6B7B5BF334CAB973F5C45CEE2658625D |journal=Science in Context |language=en |volume=11 |issue=3–4 |pages=567–573 |doi=10.1017/S0269889700003215 |issn=1474-0664|url-access=subscription }}</ref> With the idea that parents could choose the gender of their child, some Muslims believe that humans have no decision to choose the gender, and that "gender selection is only up to God".<ref>{{Cite book |title=Contemporary Bioethics |vauthors=Ali AB |publisher=Cham Springer |year=2015 |isbn=978-3-319-18428-9}}</ref>{{contradictory inline|date=May 2023}}

===Public Opinon===
Surveys of public attitudes towards designer babies and genetic editing have revealed concerns against the technological advancements, showing fears of eugenics and socioeconomic inequality. A 2018 [[Pew Research Center]] study found that 72% of the U.S. adults believed non-medical uses of the technologies would be taking it too far, with many drawing parallels to historical [[Eugenics|Eugenic practices]].<ref>{{Cite web |last=Hefferon |first=Cary Funk and Meg |date=2018-07-26 |title=Public Views of Gene Editing for Babies Depend on How It Would Be Used |url=https://www.pewresearch.org/science/2018/07/26/public-views-of-gene-editing-for-babies-depend-on-how-it-would-be-used/ |access-date=2025-04-08 |website=Pew Research Center |language=en-US}}</ref> Similarly, a 2020 international survey published in ''[[Science (journal)]]'' reported widespread public concern about the unintended health consequences of genetically modified children and the potential erosion of genetic diversity.<ref>{{Cite journal |last=Scheufele |first=Dietram A. |last2=Krause |first2=Nicole M. |last3=Freiling |first3=Isabelle |last4=Brossard |first4=Dominique |date=June 2021 |title=What we know about effective public engagement on CRISPR and beyond |url=https://www.pnas.org/doi/10.1073/pnas.2004835117 |journal=Proceedings of the National Academy of Sciences |volume=118 |issue=22 |pages=e2004835117 |doi=10.1073/pnas.2004835117 |pmc=8179128 |pmid=34050014}}</ref> 

Scientists and policymakers have called for a more inclusive and transparent approach in regulation of the technologies, which underscores the need for collaborative governance frameworks and communication between scientists, policymakers, and the people.

== See also ==
{{col div|colwidth=30em}}
* [[Biohappiness]]
* [[Directed evolution (transhumanism)]]
* [[Genetic disorder#Epidemiology|Epidemiology of genetic disorder]]
* [[Eugenics]]
** [[New eugenics]]
* [[Genetically modified organism]]
* [[Human enhancement]]
* [[Human genetic engineering]]
* [[Human germline engineering]]
* [[Lulu and Nana]] (Gene edited babies in China 2018)
* [[Moral enhancement]]
* [[Reprogenetics]]
* [[Transhumanism]]
{{colend}}

== References ==
{{reflist}}

== Further reading ==
{{refbegin}}
* {{cite web | vauthors = Bonsor K | url = http://science.howstuffworks.com/designer-children.htm | work = Howstuffworks | title = How Designer Children Will Work | date = 10 May 2001 }}
* {{cite journal | vauthors = Buchanan A | url = https://www.cambridge.org/core/journals/cambridge-quarterly-of-healthcare-ethics/article/why-we-should-defend-gene-editing-as-eugenics/00B15AEB625379F8543C43E286160B87 | title = Beyond Humanity: The Ethics of Biomedical Enhancement | journal = Cambridge Quarterly of Healthcare Ethics | publisher = Oxford University Press | date = 2011 | volume = 28 | issue = 1 | pages = 9–19 | doi = 10.1017/S0963180118000336 | pmid = 30570459 | s2cid = 58195676 | url-access = subscription }}
* {{cite web | vauthors = Savulescu J | url = https://podcasts.ox.ac.uk/designer-babies | title = Designer Babies }}
* {{cite book| vauthors = Stevens T, Newman S | author-link2 = Stuart Newman | title = Biotech Juggernaut: Hope, Hype, and Hidden Agendas of Entrepreneurial Bioscience | date = 2019 | publisher = [[Routledge]] | location = New York, NY | url = https://www.routledge.com/Biotech-Juggernaut-Hope-Hype-and-Hidden-Agendas-of-Entrepreneurial-BioScience/Stevens-Newman/p/book/9781138043237/}}  
* {{cite web | vauthors = Strongin L | url = http://savinghenry.com/ |title = Saving Henry | archive-url = https://web.archive.org/web/20190510014114/http://savinghenry.com/ | archive-date = 2019-05-10 }} A non-fiction account of Strongin's pioneering use of IVF and PGD to have a healthy child whose cord blood could save the life of her son Henry
{{refend}}

[[Category:1989 introductions]]
[[Category:2018 introductions]]
[[Category:Bioethics]]
[[Category:Fertility medicine]]
[[Category:Genetic engineering]]
[[Category:Genome editing]]
[[Category:Human reproduction]]
[[Category:Transhumanism]]