title: [Enrolment of intensive care patients in clinical studies. Ethical, legal and organizational problems from an interdisciplinary point of view].
abstract: Nowadays, most patients in hospital die in the intensive care unit from sepsis and multiple organ failure. Clinical research in this critically ill and vulnerable patient population bears a lot of ethical and legal problems; however, it remains a must in order to develop evidence-based diagnostic and therapeutic strategies for life-threatening diseases with special respect to limited health care resources. With regard to the Declaration of Helsinki, good clinical practice guidelines (GCP) from the European Medicines Agency (EMA) and the German medical drug law (AMG) this article discusses ethical and legal aspects of patient inclusion for clinical trials as well as incentives for appropriate patient recruitment from an interdisciplinary point of view.
authors.affiliation: Klinik für Allgemein- und Visceralchirurgie, Klinikum St. Georg gGmbH, Delitzscher Str. 141, 04129, Leipzig. arved.weimann@sanktgeorg.de
authors.forename: A
authors.initials: A
authors.lastname: Weimann
authors.forename: B R
authors.initials: BR
authors.lastname: Kern
authors.forename: M
authors.initials: M
authors.lastname: Löffler
authors.forename: A
authors.initials: A
authors.lastname: Sablotzki
authors.forename: F
authors.initials: F
authors.lastname: Thiele
authors.forename: F M
authors.initials: FM
authors.lastname: Brunkhorst
mesh_terms: D003299:Cooperative Behavior; D003422:Critical Care / Q000941:ethics* / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D032984:Ethics, Research; D019317:Evidence-Based Medicine; D005858:Germany; D019983:Guideline Adherence; D006381:Helsinki Declaration; D006801:Humans; D033183:Interdisciplinary Communication; D009102:Multiple Organ Failure / Q000401:mortality / Q000628:therapy*; D018579:Patient Selection / Q000941:ethics*; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence*; D018805:Sepsis / Q000401:mortality / Q000628:therapy*