Was the institutional review board system a mistake?

To the Editor—The statement by the Infectious Diseases Society of America (IDSA) [1] is the keenest analysis of the institutional review board (IRB) system ever published in a medical journal. It describes a regulatory regime swamped with pointless paperwork (eg, the Health Insurance Portability and Accountability Act [HIPAA]), multiple IRBs making irreconcilable decisions whose inconsistency reveals the absence of workable guidelines, duplicate adverse-event reporting, risk-averse interpretations of rules that hurt the very people (children) the system aspires to protect, and mission creep that leads IRBs to assert ever broader authority (eg, over hospitals' attempts to improve the care they provide). What ought a diagnostician make of symptoms like fruitless paperwork, bureaucratic imperialism, and arbitrary de-cisions? These are the indicia of a notorious malady—a regulatory agency fatally infected with the standard pathologies of government bureaucracies. Regulation is often necessary and often works satisfactorily , but the IDSA statement raises pressing questions about whether the IRB system is fundamentally misconceived. The most basic requirement for any regulatory bureaucracy is to do more good than harm. The IDSA statement takes a pioneering step by raising the issue of the IRB system's costs. It reminds us that research has saved and can still save " hundreds of thousands of lives " [1, p 328] and that the IRB regime delays, damages, and even destroys research. It does so—as the statement powerfully demonstrates—by demanding endless paperwork, by making decisions capriciously, by enforcing rules with mechanical rigidity, and by seizing authority over areas that IRBs have neither the time nor the competence to regulate. What benefits has the IRB system provided to justify such costs? As is customary in discussions of IRBs, the IDSA statement invokes the " unfortunate history of abuse of vulnerable subjects in research " [1, p 329]. We favor harsh punishments for unethical researchers. But the question is not whether there have been instances of shameful abuse, it is whether the risk of serious abuse is great enough to require that every instance of human-subject research be approved in advance by a bureaucracy operating without ascertainable standards, without due process, and without accountability. We have never located a systematic attempt to answer that question, and the IDSA statement makes us wonder what the answer would be. For example, the statement points out that HIPAA cannot find justification in any examples of abuse. The statement points out that " investigator fraud or inattention …