[Experimental treatment or medical research?].
If in the Netherlands a doctor offers experimental treatment to patients purely because it is in their patients' best interest, thus without serving any scientific goal, this does not fall under the scope of the Dutch Medical Research involving Human Subjects Act (WMO), but under specifications on the medical treatment agreement (WGBO) laid down in the civil code. If the doctor deviates from professional standards and the current protocols and guidelines, he or she must be able to account for that. The WMO applies as soon as doctors offer experimental treatments within the context of a research protocol, or perform research interventions such as randomization or the removal of extra tissue. Then specific provisions regarding medical ethical protocol review and written informed consent should be met.
Ploem
M C Corette
MC
Academisch Medisch Centrum, Afd. Sociale Geneeskunde, Amsterdam, The Netherlands. c.ploem@amc.uva.nl
Terwiel
Jim
J
D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic; D004992:Ethics, Medical; D032984:Ethics, Research; D006801:Humans; D035703:Therapies, Investigational / Q000941:ethics