Study Finds Most Publicly Funded Research Does Not Compensate Research Subjects Who Become Injured
Contact: Gina M. Digravio, 617-638-8491 | email@example.com
(Boston) – Researchers at Boston University School of Medicine (BUSM) have found most American medical schools fail to protect subjects from the financial burden of research-related injury. The study, which appears in the February 2005, issue of the American Journal of Medicine, also found the informed consent language regarding research-related injury was particularly complex and difficult to understand.
According to the BUSM researchers, no national policy currently exists to compensate subjects for research-related injuries. To fill this void, each institution has developed their own policy for managing these types of injuries.
The researchers reviewed and evaluated details regarding financial liability and informed consent language for research-related injury at 113 American medical schools and found no school offered to provide financial compensation for research-related injury. Notably, 72 percent of informed consent forms specifically rule out financial compensation. No mention of compensation for research-related injuries was made at 18 percent of the schools.
Additionally, the mean readability for the informed consent text regarding injury and compensation was higher than the mean reading grade level of the other paragraphs. Of the 106 injury and compensation texts evaluated for readability, five percent were found
to be below an eighth grade reading level, while 75 percent were found to be at least at a twelfth grade reading level.
The researchers also found when medical schools host a study paid for by industrial sponsors, they generally ensure indemnification arrangements are in place. However, when they host research paid by the NIH, most do not maintain this standard.
“We all benefit from medical research and there is a small but real chance that research subjects can become injured,” said lead author Michael Paasche-Orlow, MD, MPH, an assistant professor of medicine, section of general internal medicine at BUSM.
The researchers propose that research institutions help shoulder the burden of risk for subjects in NIH sponsored research by providing at least the cost of medical care and rehabilitation, regardless of fault, until federal protection is initiated. “Such a policy will affirm our social contract with these invaluable volunteers, simplify the relationship between subjects and the researcher, and establish candor as the cornerstone of consent,” added Paasche-Orlow.