Michael K Paasche-Orlow1, Frederick L Brancati. 1. Department of Medicine, Boston University School of Medicine, Boston, Massachusetts 02118, USA. michael.paascheorlow@bmc.org
Abstract
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.
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.
Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: Alice K Fortune-Greeley; N Chantelle Hardy; Li Lin; Joëlle Y Friedman; Janice S Lawlor; Lawrence H Muhlbaier; Mark A Hall; Kevin A Schulman; Jeremy Sugarman; Kevin P Weinfurt Journal: Circ Cardiovasc Qual Outcomes Date: 2010-01-12