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
- Genes and Science’s FAQ on gene editing
- Library of Congress summary of United States gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- Heritable Genome Editing and the Downsides of a Global Moratorium
