Clinical trials in our unit are conducted according to international guidelines and recommendations. In detail, research on humans is regulated by the following documents.
The “Declaration of Helsinki – Ethical Principles for Medical Research on Humans” was published in 1964 by the 18th General Assembly of the World Medical Association (WMA). In 2008, the most recent amendment was accepted by the 59th General Assembly of the WMA in Seoul. This document can be found here.
The “International Conference on Harmonistaion of Technical Requirements for Registration of Pharmaceuticals for Human Use” (ICH) transformed the WMA declaration into a detailed “Guideline for Good Clinical Practice” (ICH-GCP) for clinical research in humans. The most recent version E6(R1) was published in May 1996 and can be found here.
The principles gained obligatory character for the licensing of investigational products when the European Medicines Agency (EMA) published the “Note for guidance on good clinical practice (CPMP(ICH/135/95) in January 1997.
On a political level, the principles were adopted by the European Parliament and the European Council on April 4th, 2001 in the document XXX and by the European Commission on April 8th, 2005 with the directive 2005/28/EC.
This directive has been transformed into German law by the GCP-Verordnung (GCP-V), last version November 3rd, 2006.
Furthermore the German Arzneimittelgesetz regulates the conduct of clinical trials with investigational products that are heading for licensing.