IRB: Ethics & Human Research

Community Hospital Oversight of Clinical Investigators’ Financial Relationships

The considerable attention to financial interests in clinical research has focused mostly on academic medical centers, even though the majority of clinical research is conducted in community practice settings. To fill this gap, this article maps the practices and policies in 73 community hospitals and several hundred specialized facilities around the country for reviewing clinical investigators’ financial relationships with research sponsors. Community hospitals face a substantially different mix of issues than academic medical centers do because their physician researchers are usually not employees, and more of their studies are later-phase, multicenter trials. Accordingly, community physicians stand to benefit personally from per capita payments, but they tend to have less direct influence over research findings when compared with their academic peers. These and other contrasts require separate guidance for community-based organizations that takes into account their particular needs, circumstances, and institutional capacities.

Key words/concepts: conflicts of interest, human subjects research, research oversight, community hospitals

Mark A. Hall, Kevin P. Weinfurt, Janice S. Lawlor, Joëlle Y. Friedman, Kevin A. Schulman, and Jeremy Sugarman, “Community Hospital Oversight of Clinical Investigators’ Financial Relationships,” IRB: Ethics & Human Research 31, no. 1 (2009): 7-13.