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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.



Synthetic Biology Is What, Exactly?by Pete ShanksBiopolitical TimesOctober 1st, 2014The European Commission is the latest body to struggle with defining the term synthetic biology, and has produced a 65-page report.
US Doctors Update Gamete Donation Guidelinesby Michael CookBioEdgeSeptember 28th, 2014The American Society for Reproductive Medicine has updated its guidelines for gamete donation in the light of the growing recognition that offspring may have a right to know their genetic parents.
White House Issues New Regulations for Dangerous Biological Researchby Donald G. McNeilThe New York TimesSeptember 24th, 2014The Obama administration issued new guidelines intended to strengthen the oversight of federally funded biology research that could inadvertently produce bioweapons.
Experts Provide Much-Needed Policy Analysis for Clinical Integration of Next Generation Sequencing by Glenna PictonBaylor College of Medicine NewsSeptember 22nd, 2014As genetic sequencing becomes part of clinical care, there is a critical need to establish appropriate policies and regulatory frameworks to address potential challenges.
A New Generation of GMOsby Josie GarthwaiteEnsiaSeptember 18th, 2014Is synthetic biology on its way to our farms, markets and tables?
If We Create Life, Who Will Control It?by Marcelo GleiserNPRSeptember 17th, 2014It is the world of the future, and we must have some control over where it's going. But how?
Surrogates and Couples Face a Maze of Laws, State by Stateby Tamar LewinThe New York TimesSeptember 17th, 2014Surrogacy remains a polarizing and charged issue. There is nothing resembling a national consensus on how to handle it and no federal law, leaving the states free to do as they wish.
Shame and Scandal in the 23andMe Familyby Pete ShanksBiopolitical TimesSeptember 17th, 2014In response to its problems with the FDA and news about family traumas triggered by its tests' "close relatives" option, 23andMe is hiring new executives, including a Chief Privacy Officer.
On the Horns of the GMO Dilemmaby Antonio RegaladoMIT Technology ReviewSeptember 2nd, 2014Can genome-editing technology revive the idea of genetically modified livestock?
US agency updates rules on sharing genomic databy Richard Van NoordenNature NewsSeptember 1st, 2014Changes clarify procedures for telling participants in NIH-funded studies how their data might be used.
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