Research misconduct and its federal regulation: the origin and history of the Office of Research Integrity--with personal views by ORI's former associate director for investigative oversight.

Misconduct in science and research became the subject of significant public attention and Congressional scrutiny beginning in the 1970s and 1980s, which led to public statements, policies, and finally formal federal regulations being promulgated by Government agency officials. The Office of Research Integrity (ORI) in the Department of Health and Human Services was a major and very visible component of this process. This article provides a detailed history of the first two decades of federal research misconduct regulations and of ORI's history (under extremely difficult and unfair challenges), including personal views by the former ORI chief investigator and associate director.