Bioethics programs' future uncertain.

Clinical research has undergone remarkable and beneficial expansion in the past 25 years, but with this growth has come an unprecedented increase in workload for the human subjects protection system. Recently, a major change in federal oversight of local institutional review boards (IRBs) became evident. Although it was not announced publicly, in 1998 and 1999 federal regulatory actions against local IRBs increased threefold. Particularly notable was the marked increase in regulatory actions taken against the IRBs of academic medical centers (1 in 1997 compared with 14 in 1999). Ironically, this apparent federal crackdown began at the same time that two federal review panels called for major changes in the regulations governing local IRBs. A key factor in the current crisis in the function of local IRBs is the ascendance of multicenter clinical trials as the dominant form of clinical research. Local IRBs were not designed to handle the initial evaluation and ongoing review required by the rapidly increasing number of multicenter clinical trials. Furthermore, local IRB review of the thousands of safety reports from multicenter clinical trials monopolizes resources without promoting patient safety. Instead of rigid enforcement of outmoded regulations that do not contribute to patient safety, the responsibilities of the local IRB in the oversight of multicenter clinical trials must be systematically evaluated.

Academic Medical Centers↗

PubMed2001

African-American and white head and neck carcinoma patients in a university medical center setting. Are treatments provided and are outcomes similar or disparate?

Racial and ethnic disparities occur in many areas of the health care management system in the United States. These disparities include disease incidence, access to health and medical services, treatments provided, and disease outcomes. Health care delivery organizations have limited resources. Encounters between patients and providers in health care delivery organizations typically are cross-cultural. Access to care, quality of care, and equity may be affected by limited resources and cross-cultural encounters. This impacts the diagnosis, treatments provided, and outcomes, with African-American patients faring poorly compared with white patients. African Americans are 15% more likely to develop cancer than whites and are about 34% more likely to die of cancer than whites in the United States. The purpose of this study was to determine and compare the characteristics of African-American patients and white patients with carcinoma of the head and neck at the University of Cincinnati Medical Center, an equal-access facility, reporting similarities and disparities in disease stage at the time of diagnosis, treatment received, and patient outcomes.

Academic Medical Centers↗