The current practice is that industry (with some input from expert consultants) designs clinical trials, the US Food and Drug Administration (FDA) reviews them, and then the sponsor then seeks sites for these trials. As Miller and Shorr1 point out, clinical trials have seen a tremendous change in recent times, moving away from academic medical centers and toward private practice settings. The scrutiny of IRB applications for these trials is different given the context of an independent IRB relative to the academic IRB. There is a potential and very real problem of “IRB shopping” with the obvious benefit that sponsors can have clinical trials conducted, unopposed and without modification. IRBs, both local and independent, are under extreme pressure to review protocols quickly and without requesting modification. By contrast, there is a strong tradition and clear need for local control of IRBs so that their actions reflect the communities that they serve. However, Miller and Shorr1 have pointed out the universal nature of the ethical dilemma confronting the investigators, the IRB, and the sponsor. Obviously, these groups did not meet this ethical challenge in the mometasone trial.