Clinical research regulation: challenges to the institutional review board system.

The system in place to ensure the ethical conduct of human subject research in accordance with federal regulations has drawn great criticism from all sides, to include clinical investigators, administrators, research subjects, and legislators. The administrative requirements associated with clinical trials has changed dramatically in the last several decades, as has the complexity of the science being regulated. The institutional review board (IRB) system, however, appears to be struggling to keep pace, and has even been labeled a "system in jeopardy" by a national committee of experts. This contribution outlines the current obstacles and critique of IRBs, providing a discussion of the structure of the IRB system and strategies to meet these challenges.