freiburger    
ethik-kommission

founded 1980

international

About feki

The freiburg ethics commission international (feki) was founded in 1980 through a private initiative.

 

The work for, and in, the freiburg ethics commission international was a complete new experience. For this reason, guidelines for the commission were developed at its very beginning. The most important underlying principles of the guidelines were: 

 

  1. The  feki should be comprised of  interdisciplinary  members and should operate under international ethical standards. 
  2. The ratio between doctors and non-medical professionals should be balanced. 
  3. The review of the study protocol should always take place orally in a group.
  4. The expert review of the clinical study should contain constructive suggestions for improvement for the sponsor and the study doctor in the form of recommendations and requirements. 
  5. A protocol about the meeting should be prepared and all members who were present at the meeting should be mentioned by name in the expert review. 
  6. The feki´s work should not be profit oriented.  The compensation paid for work done by its members should remain within the bounds of  customary practice.

 

From day one, the feki was comprised of representatives from the medical, legal and theological faculties and members of both sexes. The interdisciplinary discussion about ethical problems with the submitted studies could begin. 

 

The first study protocol which feki received for review in 1980 consisted of only one page. The title, substance, dosage and art of application were filled out as well as the times when blood should be taken. The criteria for inclusion was ?healthy subject?. There was no mention of informed consent.  Our work was cut out for us!

 

The described work of the frieburg ethics commission international  consists, in accordance with its statutes, principally of providing an expert review of clinical studies with human subjects which are still in the planning stages. These studies are sent to the feki by representatives from the pharmaceutical industry, pharmacological institutes or similar organisations for inspection and review. The absolute independence from the sponsor and study doctors is a matter of course and is set down in the statutes. The commission´s independence is provided for not only by the composition of its membership, but  through its underlying principal of  complete impartiality.

 

Since 1980, the members of the freiburg ethics commission international have been meeting regularly every Monday to orally review the documents which have been submitted regarding clinical studies on human beings. 

 

 

 
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Letztes update:  12.06.2005