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.”
Elliott’s criticisms are just the latest in a long line of attacks on the US’s policy for not compensating injured research subjects. Several government-commissioned panels, beginning with the Tuskegee syphilis panel in 1973, have convened and recommended possible reimbursement protocols. Last year, for example, the US Presidential Commission for the Study of Bioethical Issues released a scathing report of the federal government’s treatment of Guatemalan patients in the 1940s. The report suggested implementing a system modeled after the National Vaccine Injury Compensation Program for all trial participants. To date, however, no actions have been taken.
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