Assuntos
Ensaios de Uso Compassivo , Terapia Genética , Ensaios de Uso Compassivo/economia , Ensaios de Uso Compassivo/ética , Ensaios de Uso Compassivo/legislação & jurisprudência , Terapia Genética/economia , Terapia Genética/ética , Terapia Genética/legislação & jurisprudência , Humanos , Estados Unidos , United States Food and Drug AdministrationRESUMO
In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system.
