The institutional review board is an impediment to human research: the result is more animal-based research

This article seeks to explore and bind together four fundamental concepts: 1. Human-based research has been neglected in favor of animal-based research. 2. Human-based research offers clear benefits compared to animal-based research. 3. Physician-scientists believe that Institutional Review Boards (IRBs) are more difficult to deal with than Institutional Animal Care and Use Committees (IACUCs). 4. The difficulty in dealing with IRBs force many physician-scientists, who prefer human research, to perform research with animals.Numerous groups have endorsed the reduction or elimination of nonhuman animals (hereafter referred to as animals) from research, but judging by the best estimates, this has not happened [1-3]. Indeed, the number of animals used in research is skyrocketing. Although the exact number of animals used per year in the USA have never been available, estimates for use in 1980 were approximately 20 million [4]. Estimates now approximate a half-billion [1,3] with genetically-modified animals counting for the majority. Clearly, efforts to reduce the total number of animals used in research have failed. This failure has been explored by others [5-10]. The explanations include, among others, tradition, institutional inertia, the large amounts of money involved in the process, the fact that it is statistically more likely to get animal-based research funded by the National Institutes of Health and other funding agencies than human-based research, overall lack of societal concern for animals, and animals in labs offer the researcher better control over variables. I will introduce what I believe to be the first essay proposing a regulatory-based explanation for the continued use of animal models in university-based research in spite of evidence that they may not be good models for human disease: regulatory burden.Greek and Greek's recent article in this journal [7] brought new attention to a 1986 National Academy Press publication [11] that made public the fact