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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.



Why We Should Teach the History of Eugenicsby Jonathan ChernoguzBiopolitical TimesOctober 28th, 2014Two prominent universities have launched initiatives to focus on the history of eugenics.
Technology and Inequalityby David RotmanMIT Technology ReviewOctober 21st, 2014Profound wealth disparities in Silicon Valley highlight the "new world order" in which technological development exacerbates inequality instead of diminishing it.
How Should the U.S. Regulate Genetic Testing?by Jessica CussinsBiopolitical TimesOctober 16th, 2014The question, addressed at a conference at Stanfordís Center for Law and the Biosciences, is both complicated and critical.
When Racism Was a Scienceby Joshua A. KrischThe New York TimesOctober 13th, 2014Haunted Files: The Eugenics Record Office recreates a dark time in a laboratory's past.
Reproducing Raceby Dov FoxThe Huffington PostOctober 6th, 2014It is troubling for donor services to accentuate race in ways that invite parents to exclude wholesale from their consideration all donors of a particular race.
Lawsuit: Wrong Sperm Delivered to Lesbian Coupleby Meredith RodriguezChicago TribuneOctober 1st, 2014An Ohio woman is suing her sperm bank, alleging that the company mistakenly gave her vials from an African-American donor, a fact that she said has made it difficult to raise her daughter in an all-white community.
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.
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