title: [Vigilance in experimental treatment].
abstract: When all standard care options are exhausted, it may be justifiable to carry out an experimental treatment. In the Netherlands, experimental treatment is distinguished from medical research; the latter primarily serves the public interest (obtaining medical knowledge), while the former does not. In experimental treatment, it is a doctor's duty to explain the treatment to the patient carefully and to obtain the patient's explicit consent. In addition, the doctor needs to list all relevant aspects of the treatment in the patient's medical record. A medical practitioner who abides by these rules has acted in accordance with the Dutch law. But, given the sometimes highly risky nature of experimental treatments, is this enough? We do not think so and therefore argue for two additional conditions which are focused on transparency. First, there is a need for a service to ensure that experimental treatments are registered. Second, the effects and side effects of each experimental treatment should be reported. We envision the further elaboration of these conditions to be not only a task for the medical profession but possibly also for government-appointed institutions.
authors.affiliation: Afd. Sociale Geneeskunde, Academisch Medisch Centrum, Amsterdam, the Netherlands. m.c.ploem@amc.uva.nl
authors.forename: M C Corrette
authors.initials: MC
authors.lastname: Ploem
authors.forename: M Rien
authors.initials: MR
authors.lastname: Vermeulen
mesh_terms: D035843:Biomedical Research; D006801:Humans; D007883:Legislation, Medical; D009426:Netherlands; D011787:Quality of Health Care; D035703:Therapies, Investigational / Q000009:adverse effects / Q000592:standards*