Michele A. Carter, Ph.D.2011-12-202008-06-172011-12-202007-07-262007-07-27etd-07262007-170345http://hdl.handle.net/2152.3/191Currently, research with human subjects is going through a period of tremendous upheavals. In many cases these upheavals have created a variety of unmet expectations and have given rise to the perception that trust in the research enterprise is eroding. Trust is vital to the responsible conduct of research and without it many believe that the entire system of research with humans will inevitably fail. Inherent in the practice of research with humans is a diverse set of physical, social, and psychological risks, the disclosure of which affects a subject’s understanding and voluntary agreement to participate. Generally, trust asserts that research personnel can be relied upon to act with integrity, discretion, and competence in their relationships with subjects and the public. Trust in the research process is generated through the subject-investigator relationship and is warranted when role-specific obligations such as respecting the rights and welfare of participants are met. Crucial among these obligations is the ethical requirement to respect the autonomy of individual subjects through an ethically competent informed consent process. Using the Jesse Gelsinger case as an illustration, I will argue that when the doctrine of informed consent is inadequately applied not only can research volunteers be unjustly harmed but the foundation of trust is also betrayed.electronicengCopyright © is held by the author. Presentation of this material on the TDL web site by The University of Texas Medical Branch at Galveston was made possible under a limited license grant from the author who has retained all copyrights in the works.research ethicsJesse Gelsingerinformed consenthuman subject researchtext