Clinical Studies
The seminar „Clinical Studies“ is held each semester (rarely only in the winter semester) in the N094 and N790 curricula. Course language is English. The seminar gives an outline of the history and design of clincal trials, clinical drug development, the „Good Clincal Practice Guideline“ and pharmacovigilance issues. Further issues are common abbreviations in clinical research and the rules of evidence-based medicine. The seminar consists of four lecture days and one exam day (written exam on the last day of the course).
Ethics in Medicine and Good Scientific Practice
The lecture series „Ethics and Good Scientific Practice“ is held each semester in the N094 and N790 curricula. Course language is English. It provides an outline of the history and function of ethics committees, as well as an introduction to relevant international documents and legislation. Furthermore, the current guidelines of the Medical University of Vienna regarding „Good Scientific Practice“ (including definitions of scientific misbehavior) are presented. The lecture series consists of four lecture days and one exam day (written exam on the last day of the course).
Beiträge in Zeitschriften
Brunner M, Zezula J. Was sind die häufigsten Ursachen für Verzögerungen …? Wünsche der Ethikkommission an die Researcher. Spectrum Onkologie. 2017 Jul;4:16-7.
Druml C, Singer E. Consent in emergency care research. Lancet. 2011 Jul 2: 378(9785): 26-7.
Heckenberg A, Druml C. Gender aspects in medical publication - the Wiener klinische Wochenschrift. Wien Klin Wochenschr. 2010 Mar;122(5-6):141-5.
Druml C. Stem cell research: toward greater unity in Europe? Cell. 2009 Nov 13;139(4):649-51.
Druml C, Wolzt M, Pleiner J, Singer EA. Research ethics committees in Europe: trials and tribulations. Intensive Care Med. 2009 Sep;35(9):1636-40.
Wolzt M, Druml C, Leitner D, Singer EA. Protocols in expedited review: tackling the workload of ethics committees. Intensive Care Med. 2009 Apr;35(4):613-5.
Wiedermann CJ, Druml C. End-of-life decisions in Austria's intensive care units. Intensive Care Med. 2008 Jun;34(6):1142-4.
Davies H, Wells F, Druml C. How can we provide effective training for research ethics committee members? A European assessment. J Med Ethics. 2008 Apr;34(4):301-2.
Druml C. [30th year of the Ethics Commission of the Medical University of Vienna: guarantee for integrity and transparent research]. Wien Klin Wochenschr. 2008;120(21-22):645-6.
Jansen TC, Kompanje EJ, Druml C, Menon DK, Wiedermann CJ, Bakker J. Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not? Intensive Care Med. 2007 May;33(5):894-900.
Liddell K, Bion J, Chamberlain D, Druml C, Kompanje E, Lemaire F, Menon D, Vrhovac B, Wiedermann CJ. Medical research involving incapacitated adults: implications of the EU Clinical Trials Directive 2001/20/EC. Med Law Rev. 2006 Autumn;14(3):367-417.
Druml C, Singer EA, Wolzt M. The decline of academic medicine. Lancet. 2006 Jul 22;368(9532):285.
Druml C, Singer EA, Wolzt M. Report of the 1st meeting of the "Vienna Initiative to Save European Academic Research (VISEAR)". Wien Klin Wochenschr. 2006 Apr;118(5-6): Suppl 1-12.
Liddell K, Chamberlain D, Menon DK, Bion J, Kompanje EJ, Lemaire F, Druml C, Vrhovac B, Wiedermann CJ, Sterz F. The European Clinical Trials Directive revisited: the VISEAR recommendations. Resuscitation. 2006 Apr;69(1):9-14.
Liddell K, Kompanje EJ, Lemaire F, Vrhovac B, Menon DK, Bion J, Chamberlain D, Wiedermann CJ, Druml C; Working Group of the Vienna Initiative to Save European Academic Research. Recommendations in relation to the EU clinical trials directive and medical research involving incapacitated adults. Wien Klin Wochenschr. 2006 Apr;118(5-6):183-91.
Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo J, Matamis D, Pesenti A, Pimentel J, Ranieri M; ESICM Task Force on Legislation Affecting Clinical Research in the Critically Ill Patient. The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient. Intensive Care Med. 2005 Mar;31(3):476-9.
Singer EA, Druml C. Collateral damage or apocalypse now for European academic research. Intensive Care Med. 2005 Feb;31(2):271.
Druml C. Informed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive. Curr Opin Crit Care. 2004 Dec;10(6):570-3.
Singer EA, Druml C. Compulsory registration of clinical trials: maybe European research should be protected. BMJ. 2004 Oct 30;329(7473):1044.
Silverman HJ, Druml C, Lemaire F, Nelson R; European Union Directive. The European Union Directive and the protection of incapacitated subjects in research: an ethical analysis. Intensive Care Med. 2004 Sep;30(9):1723-9.
Druml C, Singer EA. The European Directive: a further blow to science in intensive care medicine in Austria. Intensive Care Med. 2004 Feb;30(2):335.
Singer EA. The necessity and the value of placebo. Sci Eng Ethics. 2004 Jan;10(1):51-6.
Druml C. Arbeit und Effizienz von Ethikkommissionen. Der Onkologe. 2003 Dec; 9(12): 1349-54.
Sterz F, Singer EA, Bottiger B, Chamberlain D, Baskett P, Bossaert L, Steen P. A serious threat to evidence based resuscitation within the European Union. Resuscitation. 2002 Jun; 53(3) 237-8.
Singer EA, Müllner M. Implications of the EU directive on clinical trials for emergency medicine. BMJ. 2002 May 18;324(7347):1169-70.
Sass HM. [Is there a need for new clinical-ethical models in medical research?]. Wien Klin Wochenschr. 2001 Nov 15;113(22):863-6.
Mannhalter C, Druml C, Singer EA; Ethik-Kommission der Medizinischen Fakultät der Universität Wien und des Allgemeinen Krankenhauses der Stadt Wien-AKH. [Practice guidelines for formulation of patient or subject information and for the declaration of consent in genetic studies (inclusive of pharmaceutical genetics]. Wien Klin Wochenschr. 2001 Nov 15;113(22):867-9.
Druml C, Svolba G, Singer EA, Bonkovsky FO, Bauer P. Twenty years of the ethics committee at the medical faculty of the University of Vienna. An interim report. Wien Klin Wochenschr. 1999 Dec 23;111(24):1019-26.
Druml C, Eichler HG. Multicentre clinical trials. Lancet. 1999 Mar 13;353(9156):929-30.
Eichler HG, Druml C. Conducting Clinical Trials in Austria. Applied Clinical Trials, 1998 Apr, 69-74.
Buchbeiträge
Druml C, Singer EA. Onkologische Studien aus der Sicht der Ethikkommission. Ethische Aspekte in der onkologischen Forschung. Marckmann G, Meran JG (Herausgeber); Deutscher Ärzteverlag 2006
Druml C. Frauen und klinische Forschung aus Sicht von Ethikkommissionen, Hochleitner M. (Herausgeber), Gender Medicine, Band 1, Facultas 2008
Druml C. Ethical issues - The role of national ethics committees. Buchbeitrag in: Patient Safety and Quality of Care in Intensive Care Medicine. J.D. Chiche, R. Moreno, C. Putensen, A. Rhodes (Ed.) European Society of Intensive Care Medicine. (Medizinisch Wissenschaftliche Verlagsgesellschaft - Kongressband für ESICM September 2009)
Druml C. Ist die ethische Dauerreflexion institutionalisierbar? Über die politische und rechtliche Funktion von Ethikkommissionen – eine persönliche Betrachtung. Buchbeitrag in Richtlinien, Ethikstandards und kritisches Korrektiv. Eine Topographie ethischen Nachdenkens im Kontext der Medizin, Inthorn J (Herausgeber), Band 7 der Edition Ethik. Herausgegeben von Reiner Anselm und Ulrich H.J.Körtner, Edition Ruprecht, Göttingen 2010
Druml C, Singer EA. Ethics in clinical research, in Müller, Markus [Herausgeber] : Clinical pharmacology: current topics and case studies / Markus Müller ed.: Springer, 2010
Druml C. Ethikkommissionen - Richtlinien, "scientific integrity" und Reformbedarf, in Körtner, Ulrich H.J.; Kopetzki, Christian; Druml, Christiane (Herausgeber) Ethik und Recht in der Humanforschung, Schriftenreihe Ethik und Recht in der Medizin, Band 5 Springer 2011.
Bücher
Druml C. Ethikkommissionen und medizinische Forschung – Ein Leitfaden für alle an medizinischer Forschung Interessierte, facultas.wuv, Wien 2010