title: The role of an independent and interdisciplinary assessment of research studies with human subjects in Europe and worldwide.
abstract: The author reviews the history of human experimentation beginning as documented by holes in human sculls 6000 years before, addressing the first controlled experiments by James Lind and Edward Jenner in the 18th century and ending with the inhuman experiments in Nazi Camps and the Tuskegee case in Alabama in the 20th century. Resting on the Declaration of Helsinki, quite a number of declarations, scientific, national and international guidelines was issued since aiming at enhancing medical research as well as protecting the subjects from harm. Now a dense ethical, legal, scientific and social network exists for investigator initiated and commercial trials for a rich market of the Pharmaceutical Industry. However, pitfalls still occur (e.g., the cases of thalidomide, VIOXX and TGN 1412) as examples that can only be prevented by even more stringent rules and well informed, conscientious, compassionate and responsible performance of all parties involved.
authors.affiliation: Board of Representatives of Medical Ethics Committees in Germany, c/o Institut für Rechtsmedizin, Am Pulverturm 3, D-55131 Mainz, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Rittner
mesh_terms: D002986:Clinical Trials as Topic; D028744:Ethics Committees, Research; D005060:Europe; D006381:Helsinki Declaration; D049671:History, 18th Century; D049672:History, 19th Century; D049673:History, 20th Century; D049690:History, Ancient; D006805:Human Experimentation / Q000941:ethics / Q000266:history*; D006801:Humans; D007258:Informed Consent