Regulating research with human subjects--is the system broken?

There has been a great deal of criticism of the system to regulate research and protect the interests of research participants. Structural problems in the system result from the nature of current research and the regulatory process that was created over thirty years ago. Procedural problems exist because local IRBs show wide variation in practices, resources, quality and experience. Assessment of performance is perhaps the most important problem facing the system since there are no standard measures of outcome or performance for the system as a whole or to assess local IRBs. Is the system broken? No, but it is straining under the weight of a changed research environment and inadequate resources. It has the capacity to respond to the concerns of both the research community and the public by the thoughtful application of present regulations and the creation of performance assessment strategies.