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dNOTES:

-Some countries (Canada & Mexico) already given out legislative bans on germline editing

GENE-EDITING TECH:

-somatic cells--> change fundamental traits of individual

-germline cells--> change heritable traits

-

MLA FORMAT: Benston, Shawna. “Everything in Moderation, Even Hype: Learning from Vaccine Controversies to Strike a Balance with CRISPR.” Journal of Medical Ethics, vol. 43, no. 12, 2017, pp. 819–23. JSTOR, https://www.jstor.org/stable/26879628. Accessed 13 Nov. 2025.

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NOTES:

-patent dispute: a legal battle where a patent holder sues another party for infringing on their exclusive rights to an invention by making, using, or selling it without permission

-CHINA-->allowed CRISPR-Cas9 technology to gene edit on human embryos

-CANADA--> strict laws against it

-EUROPE--> cautious-placing restrictions that are leading to confusion

-USA--> laws based on patent disputes, restrictions, and certain ethical considerations that play a huge role in deciding and making government laws/policies on gene editing

-In US, gene editing laws are more based on the moral/ethical

view

MLA CITATION: Torrance, Andrew W. “At Law: CRISPR Becomes Clearer.” The Hastings Center Report, vol. 47, no. 5, 2017, pp. 5–6. JSTOR, http://www.jstor.org/stable/26628303. Accessed 13 Nov. 2025.

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NOTES:

-parents can alter the genes of an embryo to give their wanted qualities

-UK: made legal the use of mitochondrial donation-spiking talk within the FDA about research allowed in this field

-if the research continues to expand, we will have to look into the permissibility

MLA CITATION: Ossareh, Tandice. “WOULD YOU LIKE BLUE EYES WITH THAT? A FUNDAMENTAL RIGHT TO GENETIC MODIFICATION OF EMBRYOS.” Columbia Law Review, vol. 117, no. 3, 2017, pp. 729–66. JSTOR, http://www.jstor.org/stable/44177168. Accessed 14 Nov. 2025.

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NOTES:

-global prohibition calls:

-1997 Oviedo Convention--> adresses human rights in biomedical development

-somatic editing effects only the person underneath the therapy

-nuclear DNA go gametes/early embryos: effect felt in every cell of the human body

-preamble suggests: advances in genetics=hope for cure/prevention of diseases-->unwanted social affects | loss of human integrity

-even in the best conditions--> convention doesn't allow "germline" edits that would allow for the individuals descedants to be affected

MLA CITATION: Charo, R. Alta. “GERMLINE ENGINEERING AND HUMAN RIGHTS.” AJIL Unbound, vol. 112, 2018, pp. 344–61. JSTOR, https://www.jstor.org/stable/27003864. Accessed 14 Nov. 2025.

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NOTES:

-"The wave is coming. Let's paddle out and ride it together"- need for society to adapt

-germline trials could happen but only under strict view & under the law

-Oviedo Convention: "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 the genome of any descendants"

- Sweden & Finland-->gene editing in plants (biologists)

-Europeans--> confusing everyone w/ policies

-

MLA CITATION: Torrance, Andrew W. “At Law: CRISPR Becomes Clearer.” The Hastings Center Report, vol. 47, no. 5, 2017, pp. 5–6. JSTOR, http://www.jstor.org/stable/26628303. Accessed 17 Nov. 2025.

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Notes:

-"For example, 29 countries have signed and ratified the European Oviedo Convention ( https://www.coe.int/en/web/bioethics/oviedo-convention ), which specifically outlaws heritable genome editing (20, 21).

-

MLA CITATION: Coller, Barry S. “Ethics of Human Genome Editing | Annual Reviews.” Anualreviews.Org, 2019, www.annualreviews.org/content/journals/10.1146/annurev-med-112717-094629.

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NEWSON, AINSLEY, and ANTHONY WRIGLEY. “Being Human: The Ethics, Law, and Scientific Progress of Genome Editing.” AQ: Australian Quarterly, vol. 87, no. 1, 2016, pp. 3–40. JSTOR, http://www.jstor.org/stable/24877806. Accessed 9 Dec. 2025.

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Source 9: (Mrs. Broach)-Nurse Manager, WCH NICU 3 Downtown | Wolfson Children’s Hospital

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Source 9: (Mrs. Broach)-Nurse Manager, WCH NICU 3 Downtown | Wolfson Children’s Hospital

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In the future do you think germline editing (heritable for future gens) will be common?:

"I think we'll get here eventually. It's just a matter of time. It's because we as humans, like, want to push the envelope. We want to know more. It's a desire. Otherwise we wouldn't have gotten to where we are. You know, you would not be in clothes, you would not have this technology. We are constantly curious. So I think genetic altering is going to come at some point, especially the way that IVF is going. What I think will be interesting is once the baby is born and is old enough, is there a way to genetically mutate?"

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notes:

-Center for Genetics & Society (social justice org.) --> been pressing for prohibition | goes against basic human rights

-most opinions are focused on science an technical perspective, legal & social affects are rarely discussed

Cite: Darnovsky, Marcy, et al. “CRISPR REGULATION.” Issues in Science and Technology, vol. 35, no. 4, 2019, pp. 5–12. JSTOR, https://www.jstor.org/stable/26949035. Accessed 21 Nov. 2025.

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CRISPR. When I first learned about CRISPR about a decade ago, the technology and the future possibilities were just amazing. A few years after that, I had the joy of meeting Dr. Jennifer Doudna at a small meeting at NHGRI, and we knew at that time that we were talking to a future Nobel Prize winner and, indeed, she got that very recently. This class of enzymes from bacteria has many, many uses, and I thought I'd pick one just for its timeliness. It provided the simple method for detection of COVID ribonucleic acid -- or RNA -- without making copies up front or performing gene amplification, or sometimes called PCR. And that's just a nice impactful example of so many places that this discovery has been important.

Mike Smith, Ph.D.

Division of Genome Sciences

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CRISPR. When I first learned about CRISPR about a decade ago, the technology and the future possibilities were just amazing. A few years after that, I had the joy of meeting Dr. Jennifer Doudna at a small meeting at NHGRI, and we knew at that time that we were talking to a future Nobel Prize winner and, indeed, she got that very recently.

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Mechanism and Applications of CRISPR/Cas-9-Mediated Genome Editing

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Clustered regularly interspaced short palindromic repeat (CRISPR) and their associated protein (Cas-9) is the most effective, efficient, and accurate method of genome editing tool in all living cells and utilized in many applied disciplines. Guide…

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notes:

-"Federal law prohibits the use of federal funds for research on human germline gene therapy."

WHY?

-->people who aren't born yet don't have a say on if they receive treatment (right to choose-your body your choice)

-no law that prohibits gene editing if funded privately

-if trying to sell this therapy in US, an FDA approval for clinical studies and marketing is necessary

-"In 2019, US Senators introduced a bipartisan resolution encouraging international standards for germline gene editing to “prevent unethical researchers from moving to whichever country has the loosest regulations.”'

cite: https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/united-states-embryonic-germline-gene-editing/

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Germline gene editing is banned in the United States by acts of Congress although there is no federal legislation that dictates protocols or restrictions regarding human genetic engineering. Federal controls exist for allocating government funding of research projects, manipulating human embryos and running gene therapy clinical trials. There are no germline gene therapy products in the US. The Food and Drug Administration's position on gene editing, according to the government website:

The idea of germline gene therapy is controversial. While it could spare future generations in a family from having a particular genetic disorder, it might affect the development of a fetus in unexpected ways or have long-term side effects that are not yet known. Because people who would be affected by germline gene therapy are not yet born, they can't choose whether to have the treatment. Because of these ethical concerns, the U.S. Government does not allow federal funds to be used for research on germline gene therapy in people.

There is no law or regulation that bans germline gene editing conducted through private funding. In theory, you could operate a privately funded lab and conduct non-clinical, human gene therapy research. However, if someone wanted to sell that therapy in the US, they would need FDA approval for clinical studies and marketing. No proposals have been submitted.

After a Chinese scientist altered the DNA of human embryos that were carried to term, multiple American researchers joined an international call in 2019 for a global moratorium on all clinical uses of germline editing. Separately, over 60 scientists, ethicists, and biotechnology leaders sent a letter supporting a moratorium to the Secretary of the Department of Health and Human Services (DHHS). However, other scientists and ethicists object to a moratorium, arguing that it might impede research on or use of germline gene editing indefinitely because moratoriums and temporary bans tend to be difficult to change. It may impede funding for research that could help scientists understand whether germline gene editing could be safe and effective for certain conditions. In addition, a moratorium could stigmatize children that are born with genetic modifications, either illegally or in countries that choose not to ban germline gene editing. Instead, they suggest germline gene editing be tightly regulated for safety and efficacy, like other assisted reproductive technologies.

In 2019, US Senators introduced a bipartisan resolution encouraging international standards for germline gene editing to "prevent unethical researchers from moving to whichever country has the loosest regulations."
Products/Research

Embryos without a gene that causes blindness: Researchers at Columbia University used CRISPR to eliminate the gene for retinitis pigmentosa, an inherited form of blindness in embryos, for research purposes only. The embryos are not being carried to term.

Embryos without a fatal heart mutation: Researchers at the Oregon Health & Science University used CRISPR to eliminate a gene that causes cardiomyopathy, a potentially fatal heart condition, for research purposes only.

Regulatory Timeline
2019: NIH director states that germline gene editing experiments are irresponsible and unethical and that the NIH supports the moratorium proposed in 2019 by leading scientists from seven countries, who called for a five-year international moratorium on the use of gene editing to modify the human germline for clinical purposes.

2019: Patient advocates and scientists launch push to lift ban on mitochondrial replacement therapy, popularly known as 'three-parent IVF', with recommendations to loosen restrictions on some forms of human germline therapy.

2019: US Senators introduce resolution condemning the Chinese experiments resulting in gene edited embryos that were carried to term, encouraging international standards for germline gene editing.

2019: International group of researchers calls for a global moratorium on all clinical uses of germline editing of embryos after a Chinese scientist genetically edited embryos during fertility treatments and at least two were carried to term.

2018: Associated Press poll finds 7 in 10 Americans support gene-editing technology to prevent a child from inheriting an incurable or fatal disease.

2017: The National Academy of Sciences releases report on guidelines for editing the human genome to treat diseases and other applications, concluding that clinical trials could be appropriate under the right conditions, including the need to avert a serious disease or condition, lack of reasonable alternatives, and strict oversight.

2015: In riders attached to the funding of the FDA, Congress passes the first of yearly bans altering the genome of human embryos intended for pregnancies.

2015: National Institutes of Health (NIH) announces it would "not fund any use of gene-editing techniques in human embryos," citing the Dickey-Wicker Amendment.

2015: Group of scientists and bioethicists call for examination of the benefits and risks of germline gene editing.

1996: Dickey-Wicker Amendment passes, which prevents federal funding of research involving the creation or destruction of human embryos.

1964: Declaration of Helsinki, a non-binding codification of various ethical standpoints on human experimentation, is formed, but it is only operative when cited in national regulations. US observed it until 2006 when FDA eliminated all references in national regulations.
NGO Reaction
Most US faith groups and advocacy organizations, such as the Council for Responsible Genetics, argue that germline gene editing is an unethical practice, potentially dangerous and could lead to a new era of eugenics. Other organizations and an increasing number of scientists support allowing some forms of somatic gene editing, including mitochondrial replacement therapy.
Additional Resources

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Germline gene editing is banned in the United States by acts of Congress although there is no federal legislation that dictates protocols or restrictions