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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.

Scientists Find Gene Editing with CRISPR Hard to Resist[quotes Marcy Darnovsky and Pete Shanks]by Cameron ScottHealthlineSeptember 29th, 2015CRISPR, a new technique for editing DNA, is so cheap and easy to use, we may be genetically engineering human embryos before we have time to decide if we should.
DARPA Gives MIT Lab $32 Million to Program Living Cellsby Alexandra OssolaPopular ScienceSeptember 29th, 2015Synthetic biology lab the Broad Institute Foundry announced a new defense contract to join computer scientists and companies in "chemicals, pharmaceuticals, food, energy, agriculture, and biotechnology," but the work remains vague.
The Messy, Complicated Nature of Assisted Reproductive Technology[cites CGS's Marcy Darnovsky]by J. Wesley JuddPacific StandardSeptember 28th, 2015California court case is a representative example of a bigger issue with assisted reproductive technology in this country: It's largely unregulated and ambiguous.
Considering CRISPR: Putting a thumb on the scale?by Pete ShanksBiopolitical TimesSeptember 24th, 2015The National Academies have announced the date for their International Summit on Human Gene Editing. Are some of the organizers trying to predetermine the outcome?
The Life of a Professional Guinea Pigby Cari RommThe AtlanticSeptember 23rd, 2015Phase 1 trials are almost always where the money is. Is paying vulnerable populations to participate in dangerous drug studies the equivalent of coercion?
Blueprint in hand, NIH embarks on study of a million peopleby Jocelyn KaiserScience InsiderSeptember 17th, 2015As the Precision Medicine Initiative million-person study moves forward, an NIH committee is urging the recruitment of any willing volunteers.
Why there’s an urgent need for a moratorium on gene editingby Vivek WadhwaWashington PostSeptember 8th, 2015Changing human DNA creates a frightening ethical grey zone; no one is prepared for an era when editing DNA is as easy as editing a Microsoft Word document.
To Freeze or Not to Freeze? [Australia]ABC AustraliaSeptember 6th, 2015Women in their 20s, 30s and 40s are choosing to freeze their eggs while they wait for the perfect partner or navigate the ideal career path.
Kuwait's War on ISIS and DNAby Dawn FieldOxford University Press BlogSeptember 3rd, 2015Amid other national genomic projects, Kuwait's mandatory DNA collection is the first use of DNA testing at the national-level for security reasons, counter-terrorism.
Personal Responsibilityby EditorialNatureSeptember 1st, 2015The US Precision Medicine Initiative needs to tread carefully when revealing health and genetic data to participants.
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