title: [Experimental treatment versus scientific research: data collection is not fundamentally different].
abstract: The authors of a recent article in the Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine) suggest that experimental treatment should only be performed if the effects and side effects are monitored and described systematically, and a report is published. I believe this may intuitively be the right thing to do, but that there are nevertheless many problems. It would become impossible to differentiate experimental treatment from scientific research, resulting in problems concerning the informed consent of the patient, for example. Their approach would imply that more assessments are necessary for studying the effects of an experimental treatment than there would be in a standard treatment context. These measurements can only be performed with the informed consent of the patient. But if the patient refuses to consent, he or she will not receive the experimental treatment. This situation seriously compromises the voluntary status of informed consent. Therefore, more discussion is needed before this proposal is adopted.
authors.affiliation: Universitair Medisch Centrum Utrecht, Julius Centrum voor Gezondheidswetenschappen en Eerstelijns Geneeskunde, Utrecht, the Netherlands. j.j.m.vandelden@umcutrecht.nl
authors.forename: J J M Hans
authors.initials: JJ
authors.lastname: van Delden
mesh_terms: D006801:Humans; D007883:Legislation, Medical; D011787:Quality of Health Care; D035703:Therapies, Investigational / Q000592:standards*