Clinical research studyAssessment of medical school institutional review board policies regarding compensation of subjects for research-related injury
Section snippets
Data sources
All data were obtained from publicly available websites between 2001 and 2002. The websites of medical school institutional review boards (N = 123) were surveyed for any suggested text for research-related injuries in informed consent documentation. Of the 123 medical schools in the 50 states and the District of Columbia, we were unable to identify policies for research-related injuries in 10 for the following reasons: website restricted to intranet access (n = 6), website without mention of
Results
Informed consent language for research-related injury was identified in 92% (n = 113) of medical school websites. Indemnification arrangements are negotiated between private sponsors and the office for research administration at the medical schools on a case-by-case basis. As such, many schools do not present template language for sponsored studies. Of the 113 medical schools, 90% (n = 102) provide template language for federally sponsored studies and 34% (n = 38) provide template language for
Discussion
Our findings demonstrate that the language employed in U.S. medical school informed consent forms depicts policies that generally fail to protect subjects from the financial burden of research-related injury and that fall short of IOM-touted ideals. Subjects at approximately three quarters of U.S. medical schools sign forms that reject institutional responsibility for the direct or indirect costs of research-related injury. In programs where subjects are offered some form of financial relief,
Acknowledgment
The authors thank Dr. Paul Lietman, Johns Hopkins University School of Medicine, Baltimore, Maryland, for encouragement and review of the manuscript.
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Dr. Brancati was supported by a Mid-Career Investigator Award in Patient Oriented Research (K24DK62222).