Clinical research study
Assessment of medical school institutional review board policies regarding compensation of subjects for research-related injury

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Purpose

Although the Institute of Medicine (IOM) calls for research organizations to compensate subjects for research-related injury, administrators may fear that candid presentation of such policies would create financial risk. We hypothesized that informed consent language at U.S. medical schools would be particularly complex and fall short of IOM goals, especially for projects without industry sponsorship.

Methods

Medical school websites (N = 123) were surveyed for informed consent language for research-related injury. Text was extracted from 113 sites (92%) and evaluated for details regarding financial liability for research-related injury. When sufficient template text was available (n = 106), the readability of liability policies was compared with the readability of other standardized passages using Flesch-Kincaid analysis.

Results

Coverage for medical bills is offered at 61% (23/38) of schools when there is an industry sponsor as compared with 22% (22/102) when there is none (P <0.001). When coverage is offered in studies with no industry sponsor, it is limited to emergency bills in half (11/22) of these policies. Seventy-two percent (81/113) of medical school consent forms specifically rule out the possibility of monetary compensation. The mean (± SD) reading grade level of liability text in consent forms is higher than that in other template paragraphs (11.5 ± 1.4 vs. 10.6 ± 1.4; P = 0.0001).

Conclusion

Federally funded research at most U.S. medical schools is conducted with consent form language that is particularly complex and that fails to protect subjects from the financial burden of research-related injury. Few schools meet IOM standards.

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).

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