What is scientific misconduct, who has to (dis)prove it, and to what level of certainty?

This article traces the regulation of [U.S.] Public Health Service ("PHS")-funded research from changes begun with the proposal (1999) and then adoption (2000) of a basic, Uniform Federal ("research misconduct") Policy. It argues that the PHS misconduct regulations deny due process of law and are fundamentally unfair because they fail to specify the level of culpability for guilt, force accused researchers to prove that they are innocent, and, although admittedly quasi-criminal, adopt a standard of proof that tolerates nearly a 50 percent probability of false convictions. The regulations' infirmities will be demonstrated by applying them to facts relating to the central charge in the misconduct case pressed by the University of Arizona in 1997 through 2003 against then Arizona Regents' Professor Marguerite Kay, which facts are set forth in our companion piece in this theme issue.