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Institutional Review Boards: A Crisis in Confidence
There is a sense of crisis in the country about the effectiveness of the nationwide system that protects the rights and welfare of human research subjects. Reports of problems appear on television or in newspapers almost weekly and focus attention on the system's centerpiece, the institutional review board (IRB). University hospitals' entire research programs have been suspended on grounds of inadequate IRB performance, and governmental 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, however, that RCTs are the major problem. Institutional review boards have difficulties because low-yield, time-consuming tasks dissipate their energies. This and other factors are eroding the motivation of academics to serve as IRB members.
Many of the aforementioned reports call attention to important problems, but many others stir up needless concerns. About a year ago, several public officials made much of a report stating that no one could estimate the total number of human research subjects in the United States. As one put it, “They can tell us exactly how many animals were used in research! Why do they care more about animals than humans?” Experienced IRB members explained that this was a non sequitur; counting subjects cannot be considered evidence of caring for them. The number of animals is known because they are purchased with grant money and the government requires an annual accounting of how such funds are spent. The IRB members also pointed out that no one had ever before suggested that enumeration of research subjects would …
