title: [Clinical trials on medical products for human use in the case of acutely incapacitated patients within the fields of neurology and neurosurgery; implications of the new European legislation].
abstract: To comply with the European directive on clinical trials on medical products for human use, an amendment to the Dutch Medical Research Involving Human Beings Act was formally submitted in the Netherlands on the 27th February 2003. The objective is harmonisation of legislation and the protection of patients participating in clinical trials within the European Union. An important element of the directive is additional protection for incapacitated patients. In the fields of neurology and neurosurgery much research, mainly phase III, is conducted into the safety and efficacy of pharmaceutical products in emergency situations such as traumatic skull-brain injury or an acute cerebral infarct. Future emergency research in patients with acute cerebral disorders will be hindered by the (shortly legal) requirement that prior proxy consent is mandatory and the fact that individual patients must directly benefit as a result of their participation. This unintended negative effect may be considered contrary to the ethical principals for conducting good scientific research to improve treatment results. Also, it may lead to a scientific backlog compared to countries outside of the European Union. In the case of emergency phase-III research among acutely incapacitated patients we recommend that the Central Committee on Research Involving Human Subjects [Dutch acronym: CCMO] tests the research, that trials have an independent committee to monitor the data and safety, that an independent physician may grant consent for the patient to participate and that the consent of the patient's representative(s) is obtained within 24 hours of the patient being included in the trial.
authors.affiliation: Afd. Neurochirurgie, Erasmus Medisch Centrum, Postbus 2040, 3000 CA Rotterdam. e.j.o.kompanje@erasmusmc.nl
authors.forename: E J
authors.initials: EJ
authors.lastname: Kompanje
authors.forename: A I
authors.initials: AI
authors.lastname: Maas
authors.forename: D W
authors.initials: DW
authors.lastname: Dippel
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005062:European Union; D006801:Humans; D009426:Netherlands; D012449:Safety; D036302:Therapeutic Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence*; D020458:Third-Party Consent / Q000941:ethics; D016896:Treatment Outcome
vernacular_title: Klinisch geneesmiddelenonderzoek bij acuut beslissingsonbekwame patiënten in de neurologie en de neurochirurgie; implicaties van nieuwe Europese regelgeving.