I was a mole in an IRB.

摘要

The need to ensure the maximal safety of patients participating in clinical research has led to a number of regulations and oversight measures. None of these has had a more profound effect on the way such research is carried out in the United States than the establishment of the Institutional Review Board (IRB) system. While the individual rights of patients must be respected and confidentiality assured, such official scrutiny may actually inhibit the ability of physicians to initiate and conduct clinical research, thus defeating, at times, the very purpose of this research: the ultimate improvement in patient care. The experiences of one physician attempting to operate under this system and later taking part in administering it as an IRB member may offer some insights into both positive and negative aspects of the system.