Paying for research related injuries in the USBMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7541.610 (Published 09 March 2006) Cite this as: BMJ 2006;332:610
- Mark Hochhauser, readability consultant (MarkH38514@aol.com)
- Golden Valley, MN 55422 USA
EDITOR—That the United Kingdom considers clinical trial patients to be covered by consumer contract law puts it at odds with the United States.1 2 Because the US Food and Drug Administration (FDA) does not consider the informed consent process to be a contract between researchers and subjects, US subjects are not protected by consumer laws.
Standard consent form language tells US subjects that “By signing this consent form you do not waive any of your legal rights” but does not describe those rights. In 11 years on …