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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.



Bill Banning Mitochondrial Replacement Therapy Consideredby Tanya LewisThe ScientistMay 19th, 2016A US Senate committee is considering extending a ban on mitochondrial DNA transfer.
UK should freeze mitochondrial replacement as Egli paper ID’s serious problemby Paul KnoepflerThe NicheMay 19th, 2016New research showing that transfer of one egg's nucleus into another egg might also bring along diseased mitochondria has renewed calls to freeze 3-person IVF.
It's not just stem cell research that's overhyped— medical science spin is a widespread problemby Kelly CroweCBS NewsMay 18th, 2016The International Society for Stem Cell Research is urging scientists to manage public's expectations.
Top scientists hold closed meeting to discuss building a human genome from scratch[citing CGS' Marcy Darnovsky]by Ike SwetlitzSTATMay 13th, 2016If we can build a synthetic genome — and eventually, a creature — from the ground up, then what does it mean to be human?
Federal Microbiome Project Aims to Solve Tiny Riddles of Scienceby Gardiner HarrisNew York TimesMay 12th, 2016The latest federal scientific "moonshot" will focus on microbiomes, with the hope of medical, environmental, and agricultural benefits.
After rivals’ IPOs, will CRISPR Therapeutics go public or stay buttoned-down?by Damian GardeSTATMay 12th, 2016Like CRISPR Therapeutics, Intellia and Editas were once cagey about their development pipelines, but in documents filed prior to their IPOs, they had to spell out their work.
In science, follow the money – if you canby Paul D. Thacker & Curt FurbergThe Los Angeles TimesMay 12th, 2016Disclosure and restrictions do not harm academic freedom. These policies still allow scientists to pursue research, while ensuring that public health is not put at risk in service of corporate profit.
Three Cambridge startups are on a mission to fix broken genesby Robert WeismanThe Boston GlobeMay 11th, 2016Editas, Intellia & CRISPR Tx aim to cure diseases from cancer to blood disorders, but these would-be gene editors also must navigate a new round of ethical questions.
Meet The Scientists Fighting For More Studies On Genes And Racial Differences In Healthby Peter AldhousBuzzFeedMay 11th, 2016Many question if medicine should seek genetic differences based on a social construct like race, diverting research away from environmental health impacts.
Public Opposes Human Germline “Enhancement” by Overwhelming Majorityby Pete ShanksBiopolitical TimesMay 5th, 2016New polls confirm that the public remains opposed to "enhancement" and is still not convinced about other proposed genetic interventions.
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