Dishonesty, misconduct and fraud in clinical research: an international problem.

Clinical research misdemeanours include a broad spectrum of misdeeds that misappropriate an unfair advantage or harm the rights of others. There is no internationally accepted definition of such malpractices and no generalized procedure to facilitate their reporting or correction. Those who do report research misdemeanours are often stigmatized as 'whistleblowers', a term that has acquired many negative connotations. Frequently, whistleblowers encounter many personal conflicts and/or may suffer victimization in their working environment. There remains a need for an internationally harmonized approach to manage these unacceptable problems. Resolution of such important issues should be catalysed by the impending need for European Union states to implement Good Clinical Practice Directive 2001/20/EC into national law.