Human protection gathers momentum: RAC as adverse event watchdog

There is broad agreement in HHS and among key members of Congress that the Institutional Review Board (IRB) system for protecting human subjects is unable to meet the challenges posed by expanding workloads, rapidly emerging technologies and shifting financial structures. But a consensus on how the IRB system should be repaired has yet to become clear.

It is also clear, however, that there is a mood for action. Several initiatives intended to strengthen protections of human subjects in clinical trials were announced last week by HHS. Other discussions by advisory committees that report to President Clinton and to the director of NIH, as well as legislation introduced in Congress, made it clear that additional steps will be taken in the coming months. ...