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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.



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.
Judge warns privacy of DNA at stake after rulingby Ian DuncanThe Baltimore SunAugust 30th, 2014As Maryland's highest court upheld a rape conviction based on DNA collected at a police station, a veteran judge issued a stark warning about the consequences of the ruling.
Stem cell industry's 'huge development' in Bay Areaby Stephanie M. LeeSan Francisco ChronicleAugust 29th, 2014Almost three years after Geron shut down the world's first clinical trial of a therapy using embryonic stem cells, a subsidiary of another Bay Area company is reviving the work.
When Big Data & Infants' Privacy Collideby  Alison DianaInformation WeekAugust 25th, 2014Technology allows researchers to discover newborns' genetic secrets, but the long-term repercussions worry some parents and privacy advocates.
Medical dilemma of 'three-parent babies': Fertility clinic investigates health of teenagers it helped to be conceived through controversial IVF techniqueby Steve ConnorThe Independent (UK)August 25th, 2014A private fertility clinic in the United States has launched an investigation into the health of 17 teenagers who were born as a result of a controversial IVF technique that produced the world’s first “three-parent” embryos more than 15 years ago.
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.
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.
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