|
RESEARCHERS FIND MOST AMERICAN MEDICAL SCHOOLS FAIL TO PROTECT SUBJECTS
14 February 2005 - Boston University
| Researchers at Boston University School of Medicine 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.
http://www.bu.edu/
About: Boston University
Boston University has a well-deserved reputation for excellence in research in a wide range of disciplines and a demonstrated commitment to fostering innovative interdisciplinary research. The Office of the Associate Provost for Research and Graduate Education supports the University in facilitating research at the both the student and faculty levels.Our mission is to enhance and encourage research at Boston University and to provide a climate conducive to maintaining the University at the cutting edge of research and scholarly activities. We work with the Boston University community to plan and coordinate interdisciplinary research and represent the University in research matters related to Inter-University consortia. To encourage new, innovative, and cross-disciplinary efforts, this office administers the Special Program for Research Initiation Grants (SPRInG). We showcase graduate research at Science & Technology Day. This annual event features nearly 200 research posters by graduate students from both the Medical and Charles River Campuses working in a wide range of disciplines. Our annual research magazine, Research at Boston University, informs a wide audience about a selection of our significant research findings and ongoing studies at Boston University. We also maintain a strong presence on the web through this site and through the Science Coalition’s website, which brings our research successes to the attention of Congress and other policy makers in the federal government. To assist Boston University researchers, this office oversees the Undergraduate Research Opportunities Program and coordinates with the Office of Sponsored Programs on the Charles River Campus , the research administration on the Medical Campus, the Office of Research Compliance, and the various graduate programs. For the development of commercially viable ideas, we administer the Provost's Innovation Fund and work closely with the Office of Technology Transfer. We also coordinate proposals where there are institutional limits to the number of proposals that may be submitted, cost sharing requirements, significant laboratory renovations, or other special circumstances. This office assists departments and centers to achieve a diverse faculty and graduate student body through our membership and activities with the Northeast Alliance for Graduate Education and the Professoriate and through our affiliation with the Clare Boothe Luce program of the Henry Luce Foundation. |
More News:
• For February 2005
• From Boston University
• For University
|
