Institutional Review Boards: A Crisis in Confidence

There is a sense of crisis in the country about theeffectiveness of the nationwide system that protects the rights and welfare of human research subjects. Re-ports of problems appear on television or in newspapers almost weekly and focus attention on the system’s cen-terpiece, the institutional review board (IRB). University hospitals ’ entire research programs have been suspended on grounds of inadequate IRB performance, and gov-ernmental agencies have found that the IRB system is incapable of coping with its workload. In this issue, Burman and coworkers (1) identify the enormous increase in the number and complexity of multicentered randomized clinical trials (RCTs) as the root cause of the crisis (1). We must be concerned about the capabilities of IRBs to cope with contemporary problems, such as multicentered trials. I disagree, how