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.
In a commentary published this week in the New England Journal of Medicine, Elliott calls on US officials to create a compulsory system akin to that in place elsewhere in the world in which sponsors would have to buy insurance or agree to indemnify injured participants before trials can proceed. This proposal is similar to one outlined earlier this year by Elizabeth Pike, a bioethics fellow at the US National Institutes of Health in Bethesda, Maryland, in the American Journal of Law and Medicine.
In the UK, such a move was adopted last week by a consortium of industry and governmental organizations that released a guidance document that requires research sponsors conducting phase 1 trials to purchase multi-billion dollar insurance plans to cover medical treatment for complications or injuries incurred during the course of the research.
According to David Magnus, director of the Center for Biomedical Ethics at Stanford University in California, such insurance coverage plans could easily be worked into the stipulations set forth by institutional review boards across the country. But given the varying nature of clinical trials, Magnus argues that compensation plans need to be tailored specifically to fit certain types of experiments. “We may need to move away from ‘one-size-fits-all solutions’ to create different compensation plans to address different categories of trials,” he says. Thus, even after decades of calls for “justice for injured research subjects” (as the title of Elliott’s piece demands), “the real ethical work in the US has not yet been addressed,” Magnus notes.
Image courtesy of Lightspring via Shutterstock