title: [Clinical research in surgery departments: back to the past].
abstract: In recent decades, numerous prospective randomized surgical trials have been performed in the Netherlands. Due to the unexpected high mortality rate in the PROPATRIA-trial, legislation pertaining to research involving human subjects has recently been changed. The resulting considerable legal and administrative burdens and financial consequences now necessitate a different way of organising clinical research in non-academic hospitals.
authors.affiliation: Isala Klinieken, afd. Chirurgie, Zwolle, The Netherlands. e.g.j.m.pierik@isala.nl
authors.forename: E G J M
authors.initials: EG
authors.lastname: Pierik
authors.forename: Willem A
authors.initials: WA
authors.lastname: Bemelman
mesh_terms: D035843:Biomedical Research / Q000379:methods / Q000592:standards; D013502:General Surgery; D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence*; D012107:Research Design / Q000592:standards*