Violations of the ethical canons of research have been reported with increasing frequency in recent years. Nowhere have the reported incidents been so numerous or so troubling or attracted so much Congressional attention as in biomedical research. Research ethics, once “something everyone agrees about,” has become the subject of disagreement now that issues of culpability and enforcement are demanding attention. How to distinguish mistakes from fraud has stopped being theoretically obvious and has become a practical problem.

Defining culpable research misconduct has proved to be controversial. Good definitions are a prerequisite for intelligent discourse and sensible regulations. Regulations based on unclear or misdirected definitions stimulate resistance, hostility and evasiveness. The case in point is the definition of what it is that a research institution must investigate and report to the appropriate federal funding agency if allegations of misconduct are received.