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Tuesday, July 10, 2012

Justice for Injured Research Subjects

By Carl Elliott, MD, PhD
The New England Journal of Medicine-Perspective
Originally published July 5, 2012

Critics have long argued that U.S. ethics guidelines protect researchers more than they protect research subjects. The U.S. system of oversight, writes Laura Stark, was developed as a “technique for promoting research and preventing lawsuits.” Consider, for example, the obligations of U.S. research sponsors when a study goes wrong. If a research subject is seriously injured, neither the researcher nor the sponsor has any legal obligation to pay for that subject's medical care. In fact, only 16% of academic medical centers in the United States make it a policy to pay for the care of injured subjects. If a subject is permanently disabled and unable to work, sponsors have no obligation to pay compensation for his or her lost income. If a subject dies, sponsors have no financial obligations to his or her family. Not a single academic medical center in the United States makes it a policy to compensate injured subjects or their families for lost wages or suffering. These policies do not change even if a subject is injured in a study that is scientifically worthless, deceptive, or exploitative.


Thanks to Gary Schoener for this information.