CGS-authored
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...