Eight Years after Jesse’s Death, Are Human Research Subjects Any Safer?
By Paul Gelsinger and Adil E. Shamoo,
Hastings Center Report
| 04. 04. 2008
It has been more than eight years since Jesse Gelsinger, Paul's son, died in a gene therapy clinical trial. But despite the press exposure and public outcry that followed, no progress has been made in fixing the broken system of protections for human research subjects. These people are no safer today than they were eight years ago-they are still at serious risk of exploitation and harm.
Many things stand in the way of better protection, but perhaps the greatest obstacle is the lack of adequate federal oversight. Not all human research is subject to federal regulations, since the regulations apply only to studies that are federally funded or that involve new drugs and devices for which applications have been filed with the Food and Drug Administration. An estimated 30 percent of studies are not covered. In
contrast, each and every experiment involving animals is regulated by the federal government under the Animal Welfare Act.
Further, the federal oversight that does exist offers minimal protection. Last year, a report by the inspector general of the Department of Health and Human Services...
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...