Changing the paradigm: new directions in federal oversight of human research.

The system of institutional review boards (IRBs) was established about 30 years ago for the protection of human subjects and as a mechanism for assuring an independent peer review of research activities. To keep pace with an evolving environment, a new model for human research oversight is needed that focuses less on achieving regulatory compliance and more on applying our conscience to the responsible conduct of research. The recent implementation of a unified federal registration system for IRBs and a new assurance system point the way to a more effective structure for the oversight of clinical trials.