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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.



High-Risk Brain Research Wins NSF Backingby Sara ReardonNature NewsAugust 18th, 2014The US National Science Foundation is supporting new research into the properties of neural circuits.
New CRG Report: Genetic Privacy and Non-Forensic BiobanksCouncil for Responsible GeneticsAugust 12th, 2014Do You Know Where Your DNA Is? Genetic Privacy and Non-Forensic Biobanks explores the various forms of biobanks in the US, their privacy limitations, the current state of regulation and the need for reform.
Should we Open the Door to Genetically Modified Babies?by Jessica CussinsCNBCAugust 11th, 2014There has been a lot of confusion around this controversial issue, but as we are now facing a historic crossroads, it is important to set the record straight.
Tuskegee Todayby Jessica CussinsThe Huffington PostAugust 8th, 2014Last week marked the 42nd anniversary of the Tuskegee syphilis study and many people took the opportunity to examine its relevance to the treatment of human research subjects today.
F.D.A. Acts on Lab Tests Developed In-Houseby Andrew PollackThe New York TimesJuly 31st, 2014The FDA will start regulating medical laboratory testing, saying that tests used to make important treatment decisions must be vetted before they go into use.
Making Sense of the BRAINby Jessica CussinsBiopolitical TimesJuly 24th, 2014As criticisms of the brain projects on both sides of the Atlantic ramp up, what lessons can be learned from the successes and failures of the Human Genome Project?
Failures and Risks in Biosafety Regulationby Pete ShanksBiopolitical TimesJuly 24th, 2014Accidents at CDC and elsewhere point up the difficulties in regulating potentially dangerous releases of genetically modified organisms, which scientists are, quite responsibly, discussing.
A Paragraph in Slow Motion: Three-Person IVF in The New York Timesby George Estreich, Biopolitical Times guest contributorJuly 10th, 2014A close look at the rhetoric used to justify experimental technologies, and particularly at the way reasonable objections are dismissed.
Protecting Genetic Data - A Primer for Employersby Jeremy GruberCouncil for Responsible Genetics BlogJuly 2nd, 2014It is critical that employers have a full understanding of current genetic privacy and nondiscrimination protections, to ensure their workplaces are in full compliance with federal and state laws.
About That Creepy Biometric Database, FBI, We'd Like to Know a Bit Moreby J.D. TuccilleReasonJune 26th, 2014The FBI's facial recognition database, into which it wants to put 52 million of our mugs by the end of 2015, is only part of its larger Next Generation Identification program.
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