Regulating Creativity: Research and Survival in the IRB Iron Cage

The article explores the history of the U.S. Institutional Review Board (IRB) system and its penetration into local institutions. The author found that the Code of Federal Regulations Governing the Protection of Human Subjects in Research develops categories of risk for which various types of medical research are required. In this regard, research or reviews identified with the highest level of assessed risk can only be considered by a convened panel of IRB members. To allow scope for locally specific techniques for implementing the Code and to prevent creating a centralized bureaucracy, legislators placed the primary review function at the local institution level.