Clinical research is necessary to advance medical knowledge and to test new drugs or devices. It is therefore vital to society, and ethically imperative, that clinical studies be performed if patients are to have access to safe and effective treatments. However, clinical research by its very nature involves risk. Subjects who volunteer in clinical studies may receive no benefit; in fact, they may be seriously harmed or even die as a result of their participation. Indeed, research-related injuries and deaths, though relatively few in number (1), have become the subject of much controversy in recent years (2). Thus, the protection of human research subjects must be given the highest priority by researchers, their institutions, and the government and regulatory bodies charged with overseeing the clinical research process. Central to this process is the institutional review board (IRB) in the United States (U.S.), or research ethics board as it is known in Canada. (For the purpose of this paper, the term "IRB" will be used to refer to both American and Canadian boards.) The IRB has frequently been referred to as the "first line of defense" in research subject protection (3), yet the specific roles and responsibilities of this board and its members are not clear (4). Defining these roles and responsibilities is more important now than ever before, for several reasons.
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