Compact versus Contract - Industry Sponsors' Obligations to Their Research Subjects

TitleCompact versus Contract - Industry Sponsors' Obligations to Their Research Subjects
Publication TypeJournal Article
Year of Publication2007
AuthorsMello, MM, Joffe, S
JournalThe New England Journal of Medicine
ISSN Number0028-4793
AbstractThe article discusses the complexity of ethical issues involved in clinical research. The authors examine the case of Abney v. Amgen decided in March 2006 by the U.S. Court of Appeals for the Sixth Circuit that focused on the obligation of an industry sponsor to provide clinical trial participants with an investigational medication after the termination of a study. The court held that despite a provision in the consent form stating that subjects could elect to continue taking the study drug for up to 2 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 authors look at the ethical issues raised by this case for academic medical centers and their research faculty, and the undesirable legal consequences that can occur in academic/industry relationships of this kind.
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