Legal liabilities in research: early lessons from North America.

"Conflict of Interest In the case of Gelsinger, the complaint alleged, among other things, that the university was to receive an ownership stake in Genovo (the sponsor) in lieu of funding of the gene transfer research program and that the University and various physicians associated with the research program had substantial financial and equity interests with respect to the vectors employed in the research [10]. The extent of these financial interests were not disclosed to Jesse Gelsinger before he made his decision to participate in the research as a subject [11]. If this case had not settled and instead proceeded to a trial, one of the key issues would have been the circumstances under which an undisclosed conflict of interest will result in liability for the individual(s) and/or entities who are in the conflict position and whether other parties who know of the conflict or who ought reasonably to know about the conflict and are in a position of authority have a legal obligation to intervene to prevent the research from proceeding on the basis of the conflict. The existence of an undisclosed conflict of interest may also put a plaintiff in the position of being able to argue that the consent given was not truly informed. Competing interests The author(s) declare that they have no competing interests."