Compact versus contract--industry sponsors' obligations to their research subjects.

Recent events have elevated concerns about financial ties between investigators, academic medical centers, and industry sponsors, and disquieting findings have emerged about the legal relationships these entities form to conduct clinical trials. Tort litigation brought by injured research subjects has accentuated the legal dimensions of clinical research relationships. These areas of focus converged in Abney v. Amgen, an important case decided in March 2006 by the U.S. Court of Appeals for the Sixth Circuit. The dispute centered on the legal obligation of an industry sponsor to provide clinical trial participants with an investigational medication following study termination. The court held that, notwithstanding a provision in the consent form stating that subjects could elect to continue taking the study drug for up to two years after the trial ended, the sponsor had no obligation to provide the drug. It grounded this conclusion in a determination that the plaintiffs had not entered into a legal relationship with the sponsor that would bind Amgen to fulfill this promise. The Abney case raises weighty legal issues for academic medical centers and their research faculty, as well as troublesome ethical questions. The case underscores that, notwithstanding its advantages, the arms-length relationship between academic investigators and industry sponsors has undesirable legal consequences. Academic medical centers must recognize the substantial risk of conflicts and contradictions within the web of contracts governing research relationships. They face liability exposure if they fail to monitor these conflicts and make promises to subjects that cannot be fulfilled.