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Published online by Cambridge University Press: 28 June 2012
Medicine has made great advances in the past decade, and is now opening the frontiers of brain resuscitation. Coinciding with the advances in medicine, society has witnessed great changes. There is an increasing awareness of patients' rights, an increasing desire for self determination, a rejection of the once-accepted paternal role of the physician, and an increasing willingness to challenge physicians in the courts. At the same time, government regulation of biomedical research has been expanding rapidly. The origin of this regulation dates back to the post-World War II Nuremburg trials. In 1974, the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The evolving concern about human experimentation has led to the current Department of Health and Human Services (DHHS) and the Federal Drug Administration (FDA) regulations which became effective July 27,1981. All biomedical research supported by federal funds must conform to these legal requirements. One aspect of these regulations is that all research protocols be approved by an institutional review board (IRB) established at the institution where the research is conducted.