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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.



Fix the Flaws in Forensic Scienceby Eric S. LanderThe New York TimesApril 21st, 2015A Justice Department review found that F.B.I. testimony about hair identification was fundamentally flawed in 96% of the cases it examined. Of those defendants, 33 received the death penalty and nine have been executed so far.
Genome Editing: Time to Ask the Tough Questionsby Silvia CamporesiThe Huffington PostApril 14th, 2015It is a bit disheartening that we seem not to have made any progress when it comes to governing science in 40 years, and that we refer to Asilomar as the exemplar of practice of governing science.
Panel discussion on the Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases (March/April 2015) [VIDEO][With CGS's Marcy Darnovsky]
Calling for “More than a Moratorium” on Human Germline Modificationby Jessica CussinsBiopolitical TimesApril 9th, 2015A broader array of critical responses and policy suggestions follows recent reports that the gene-editing technique CRISPR has been used to genetically modify human sperm, eggs or embryos.
DARPA, Synthetic Biology and Human Germline Engineering by Pete ShanksBiopolitical TimesApril 9th, 2015The Defense Advanced Research Projects Agency is committed to synthetic biology as one of its four main project areas, and may be involved in human germline experiments.
Incurious about Ethics?by Marcy DarnovskyBiopolitical TimesApril 9th, 2015An Institute of Medicine committee is studying the “ethical and social policy” implications of germline mitochondrial manipulation. Why do most of its members seem uninterested in social or policy questions?
Baby Genes to be Mapped at Birth in Medical Firstby Helen ThomsonNew ScientistApril 8th, 2015Could genome sequencing of newborns give valuable insight or do harm? That's the question US doctors are trying to answer in a pioneering trial starting this month.
Human Genetic Engineering Demands more than a Moratoriumby Sheila Jasanoff, J. Benjamin Hurlbut and Krishanu SahaThe GuardianApril 7th, 2015Expert calls for a moratorium on germline gene engineering are no substitute for richer public debate on the ethics and politics of our biotechnological futures.
The Pentagon Is Putting Big Money Into Synthetic Biologyby Dan VerganoBuzzFeed NewsMarch 30th, 2015Genetically engineered bacteria, bionic limbs, and synthetic vaccines will help the U.S. build a more powerful military, according to DARPA, the Pentagon’s futuristic research arm.
Bioethics Commission Releases Final Neuroscience Report as Part of BRAIN Initiativeby Misti Ault AndersonThe blog of the Presidential Commission for the Study of Bioethical Issues March 26th, 2015The report focuses on topics that must be addressed if neuroscience is to progress and be applied ethically.
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