Fraud and Misconduct

3. Prevention of Misconduct

Tackling research misconduct

Prevention.
Detection.
Investigation.
Prosecution.

For research involving clinical trials, standards were set in the ICH Good Clinical Practice (GCP) guidelines.

In Europe, these standards are set in the EC Directives on Clinical Trials (2001/20/EC)* and on Good Clinical Practice (GCP) (2005/28/EC), which encompass ICH¬GCP. These are now enacted throughout Europe. All Clinical trials guidelines, guidance documents and underlying legislation can be found in Volume 10 of the publication "The rules governing medicinal products in the European Union". Link to the publication: EudraLex - Volume 10 (europa.eu)

*In 2014 the European Commission adopted the new Clinical Trial Regulation (EU No 536/2014), repealing Directive 2001/20/EC. Although it was adopted and entered into force in 2014 the timing of its application depends on confirmation of full functionality of Clinical Trials Information System (CTIS) through an independent audit (expected 2021 – 2022).

Misconduct and fraud destroy the trust of the public in clinical research and harms the patients treated on the basis of invented or unreliable study results. Therefore, misconduct and fraud must be prevented if ever possible. If it happens, it needs to be detected, carefully investigated and rigorously prosecuted where appropriate.