Overhaul Recommended for Gene-Therapy Review
By Erika Check Hayden,
Nature
| 12. 05. 2013
The US National Institutes of Health (NIH) should refocus its oversight of gene-transfer research, the US Institute of Medicine (IOM) says in a report released today.
The analysis concludes that the NIH’s Recombinant DNA Advisory Committee, or RAC, should no longer review most gene-therapy research. But there are some areas that it says the RAC should still oversee — such as studies that involve new gene-transfer vectors or that pose particular safety worries. The panel adds that the NIH should also give the committee a broader remit to review any kind of emerging research in humans that deserves special scrutiny because it raises safety or ethical issues.
The report is a point in favour of
researchers who requested the review, saying that gene therapy should no longer be singled out for special public scrutiny. It is now up to the NIH to decide what to do.
The agency will take a close look at the findings, NIH Director Francis Collins said in a statement today. “The field has evolved greatly over the past two decades, and an examination of...
Related Articles
It’s been a busy couple of months in biopolitics, with developments in the US, UK, China, Japan, and implicitly on Mars. Time for a brief roundup.
• • •
Bioethics needs an update
The National Research Act is now 50 years old. It was signed into law on July 12, 1974, as a direct response to publicity about the 1932 “Tuskegee Study of Untreated Syphilis in the Negro Male.” The Hastings Bioethics Forum celebrated its anniversary with an...
Image courtesy National Human Genome Research Institute
The U.S. Food and Drug Administration (FDA) is supposed to encourage effective medical advances while also ensuring that patients and research subjects are protected. This dual mandate demands tricky judgment calls that are made more difficult by outside pressures of several kinds, political, judicial, and especially commercial. This April story at Bloomberg examines one deeply troubling pattern of regulatory capture:
Americans Are Paying Billions to Take Drugs That Don’t Work
Companies are increasingly...
By Elizabeth Chuck, NBC News | 07.09.2024
A Netflix docuseries has put a spotlight on the unregulated world of sperm donation, particularly the lack of stopgap measures that might prevent donors who have been banned by one country from simply going elsewhere to donate more.
Released earlier...
By Amanda Becker and Shefali Luthra, The 19th | 07.08.2024
Image by Duke University Archives from Flickr
Republicans have adopted a slate of policy positions ahead of next week’s convention that does not call for a federal legislative abortion ban, but opens the door to establishing fetal personhood.
The Republican...