Before Karen Maschke boarded a plane for Haiti several years ago, she received several routine vaccinations for whooping cough, tetanus and hepatitis B from a local medical school clinic. Maschke, a bioethicist at the Hastings Center in Garrison, New York, who edits the journal IRB: Ethics & Human Research, obtained the shots with the comfort of knowing that if something went wrong she would be eligible for compensation under the US National Vaccine Injury Compensation Program. But she worried about the estimated 2 million Americans participating in clinical trials each year who receive much riskier, experimental treatments. For these people, Maschke notes, anyone “who feels she has been harmed has few recourses.”
Currently, US research sponsors have no obligations to pay for patients’ medical care if they are harmed during a clinical trial (although a handful of organizations have voluntarily agreed to provide free, short term care for injured subjects). Carl Elliott, a bioethicist at the University of Minnesota in Minneapolis, wants such compensation schemes to become mandatory. “There are powerful economic interests in the status quo, and injured research subjects have few advocates,” Elliott told Nature Medicine in an email. “The fact that an injured subject in an exploitative research study can be required to pay for his or her own medical bills is, quite frankly, a disgrace.”.....
Commentary - New England Journal of Medicine
N Engl J Med 2012; 367:6-8
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.”1 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.2 In fact, only 16% of academic medical centers in the United States make it a policy to pay for the care of injured subjects.3 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.Continue reading @ NEJM
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