臨床研究と生命倫理ジャーナル

概要

Sometimes Non-IRB Approved Research Deserves A Second Look

Neil R Smalheiser

The institutional review board system was born in the desire to prevent abuses from unethical research. However, the current system has no provision for taking a second look at non-IRB approved research even in extenuating circumstances. I describe a case of innocuous and potentially significant human subjects’ research that involved informed consent and probably would have been approved had it had the opportunity to have been examined by an IRB. I suggest that IRB regulations should offer a place for scientists who operate outside the institutional mainstream.