Last update:

   10-May-2010
 

Arch Hellen Med, 27(2), March-April 2010, 230-238

SPECIAL ARTICLE

Deontological problems in clinical research: The Informed Consent Document

F.A. TZAVELLA
Department of Nursing, University of the Peloponnese, Sparta, Greece

Clinical research, that is to say research on human beings, has contributed considerably to the improvement of the health of society, but has also caused the appearance of a variety of problems in the wider sector of the sociology of health. The experiments of the Nazis during the Second World War, the Nuremberg Trials, the Code of Nuremberg and the Helsinki Declaration have been some of the most important landmarks in the moral considerations of clinical research. One of the most important theoretical problems in the area of clinical research is the Informed Consent Document (ICD) of volunteer participants in research. Historically, the ICD is associated with the consensus concept, paternalism and the principle of autonomy. Nowadays, taking into consideration the terms of modern social conflicts in the western world, the ICD constitutes a thorough text aimed at the protection of both the participating volunteers and the researchers.

Key words: Clinical research, Deontology, Informed Consent Document, Social sciences.


© Archives of Hellenic Medicine