The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation

Harold Edgar and David J. Rothman

Over the past two decades, institutional review boards (IRBs) have transformed the conduct of clinical research, in the process protecting human subjects and setting an admirable standard for monitoring the ethics of science. Nevertheless, the very proliferation of these committees, in addition to changing the character and sponsorship of new research, suggests that a "one size fits all" approach to the governance of human experimentation may have outlived its usefulness. It may be time to remove the "I" from the IRB and create a system with greater national oversight. Whether such a change can be accomplished within the current political climate is debatable. But the need for such a shift is becoming increasingly apparent.