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About US Federal Policies & Human Biotechnology


Federal regulations on most human biotechnologies are inadequate, falling far short of the kind of comprehensive approach that is needed. This situation is due to the unique social and policy challenges posed by human biotechnologies, to the anti-regulatory environment of recent years, and to the divisive politics and religious beliefs that accompany issues involving human embryos.

One regulatory failure is Congress's inability to pass a law prohibiting human reproductive cloning. Nine in ten Americans oppose it, as does every member of Congress and nearly every reputable scientist. Bills that would prohibit reproductive cloning have been introduced several times, but have failed because of disagreements over research cloning.

Another failure is assisted reproduction's scant regulation and oversight. Despite numerous reported abuses and billions of dollars in revenues, federal oversight remains limited to collecting data on success rates.

Medical gene transfer (also called gene therapy) is slightly different. The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are supposed to oversee each clinical trial. But researchers have often ignored this requirement, as revealed most dramatically after the death of 18-year-old Jesse Gelsinger in a gene transfer experiment.

The most publicized aspect of federal biotechnology policy have been the limitation on federal funding of embryonic stem cell research that was imposed by President Bush in 2001 and removed by President Obama in 2009.



We Are This Close to "Designer Babies"[cites CGS' Marcy Darnovsky]by Nina Liss-SchultzMother JonesFebruary 8th, 2016Issues to consider in light of the UK's approval of using CRISPR gene editing on human embryos for research.
A Cautious Approach to Mitochondrial Replacementby Françoise BaylisImpact EthicsFebruary 3rd, 2016While the motivation with mitochondrial replacement (MRT) is distinct from cloning, the transfer technology is the same. MRT can legitimately be seen as a “quiet way station” in which to refine the techniques essential for other genetic interventions (including cloning).
Pentagon to Offer Plan to Store Eggs and Sperm to Retain Young Troopsby Michael S. SchmidtThe New York TimesFebruary 3rd, 2016A pilot program will pay for troops to have their gametes frozen, in an effort to make military service more appealing and family friendly.
Center for Genetics and Society Comments on Just-Released Report on Germline Mitochondrial Manipulations[Press statement]February 3rd, 2016The National Academy of Medicine's report conclusion – that no ethical or policy considerations stand in the way of clinical investigations going forward – seems at odds with the many cautions, risks, and concerns that it raises.
We Are Not Ready to Edit Human Embryos Yetby J. Craig VenterTimeFebruary 2nd, 2016Due to our insufficient knowledge, the slippery slope to human enhancement, and the global ban on human experimentation, we need to better understand the software of life before we begin re-writing this code.
DNA Got a Kid Kicked Out of School—And It’ll Happen Againby Sarah ZhangWiredFebruary 1st, 2016Genetic discrimination. Get used to those two words together. With DNA tests cheap and readily available, the potential for discrimination based on the results has gone way up.
We Need More Proof That Prenatal Gene Screens Are Beneficialby The EditorsScientific AmericanFebruary 1st, 2016Results from screening tests can be misleading. Industry and federal regulators are not doing enough to ensure that people get all the information they need.
A Monkey Circles in a Cageby Elliot Hosman, Biopolitical TimesJanuary 29th, 2016Researchers created transgenic monkeys with a gene duplication associated with Rett Syndrome autism in humans, raising concerns of the limits and ethics of using animal models in biomedical research.
Who's Looking to Profit from Human Germline Changes?by Pete ShanksBiopolitical TimesJanuary 28th, 2016Billionaire Randal Kirk has assembled the components to commercialize heritable human genetic modification.
Human Genetic Alteration and Gold Mines: California's Stem Cell Agency Takes a Hard Look at Research Standardsby David JensenCalifornia Stem Cell ReportJanuary 27th, 2016The $3 billion California stem cell agency will convene a livestreamed day-long meeting to examine agency policies dealing with human gene editing.
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