This is an in-depth examination of core concepts such as fairness in subject selection, minimization of risk, value, alternate means of acquiring new knowledge, informed consent and conflict of interest. The focus of the course is on the responsibility of the research team and institution to the research subjects. The course reviews the Nuremberg Code, the Declaration of Helsinki and the Belmont Report. Analysis of the Tuskegee Syphilis study and the Willowbrook State Hospital study are conducted. The roles of the principal investigator and study coordinator are examined. The relationship between the sponsor and the investigators is scrutinized. Students are taught to critically evaluate the ethical component of a proposed study.