Legal Pitfalls

Timeline of Laws and Legislation : Biomedical Research

1996 - The Dickey-Wicker Amendment

The Dickey-Wicker Amendment, passed by Congress in 1996, banned federal funding for the creation of human embryos for research purposes or for research in which human embryos are destroyed.

2001 - Bush's Executive Order

President George W. Bush issued an executive order which restricted federal funding for research on stem cells obtained from human embryos primarily because the technology required the destruction of human life. Because embryos must be destroyed in order to extract stem cells, Bush expressed concerts that such research devalued human life. Bush's policy ultimately hampered progress in the field of biomedical research, particularly stem cell research, by prohibiting government funding and driving top scientists to study in labs abroad.

2009 - Obama's Executive Order

In 2009, President Barack Obama signed an executive order which revoked Bush era restrictions, making it possible for federally funded researchers and scientists to experiment on hundreds of viable cells previously restricted under the Bush administration. Although Obama's revocation of Bush's policy significantly broadened the research possibilities for the scientific community, it did not reverse the Dickey Wicker Amendment.

2011 - Sherley vs Sebelius

The U.S District Court for the District of Columbia ruled in favor of embryonic stem cell research in Sherley vs Sebelius. This case was arguably the most noteworthy court case regarding the government's funding of embryonic stem cell research and the court's ruling signified a huge step forward for the scientific community and biomedical research.

2017 - Creation of First Genetically Modified Embryo in U.S

A team of scientists in Oregon recently saw success in modifying the DNA of human embryos using Crispr technology. This was the first time any procedure of this kind was done in the United States. A team in China had previously done so in 2015 but saw limited success. The researchers, led by Shoukhrat Mitalipov from Oregon Health and Science University, had altered the gene behind an unspecified inherited disease in a number of one-cell embryos. Because the Oregon team used non-federal money from their institutions, and donations from several small non-profits, there were no legal issues surrounding the procedure.

Current Laws and Legislation

Currently, the Food and Drug Administration, Centers for Medicare and Medicaid Services, and the Federal Trade Commission regulate genetic testing and research in the United States. But there are surprisingly no laws expressly forbidding genetic modification in humans in the United States.

In Western Europe, 15 countries out of 22 ban any attempts to change the human germ line—a term referring to sperm, eggs, and other cells that can transmit genetic information to future generations.In Canada it is considered a major offense for researchers to use gene editing tools for heritable traits in humans. Penalties for this include up to 10 years in prison. No such stance exists in the United States.

The Food and Drug Administration is prohibited from reviewing “research in which a human embryo is intentionally created or modified to include a heritable genetic modification.” But the FDA's approval is only necessary for medical treatments, like Crispr, that are used on actual human beings. Simple laboratory research where the embryo is not implanted, however, is allowed as there is no law to directly prevent this.

"The FDA has the appropriate authority and they're exercising it well and thoughtfully, so I don't see any need for any change in legislation," was spoken in a senate committee meeting in late 2017 (GenomeWeb.com)