Education and training

A) For sponsors/investigators

Instead of Swissmedic, swissethics is competent for the recognition of GCP courses as of 1 January 2014.

Other documents and offers:

B) for members of ECs

  • Concept for the training and further education for members of Ethics Committees (in German): .pdf
  • Concept for the training and further education for members of Ethics Committees (resume, in German): .pdf
  • GCP-courses for members of ECs and researchers: Swiss Clinical Trial Organisation
  • D Training/further education for members of ECs at the MIG of the University of Bern.
  • TRREE training programme (Ethics, GCP) (e-learning recognized by Swissmedic, FMH and FPH, multilingual D/F/E)
  • ZURICH: Training at the Clinical Trial Center (Module 1), University of Zurich. More information: Link
  • BASEL: Comprehensive range of courses and further education in clinical research at the Clinical Trial Unit in Basel.
  • Selection of recommended literature for members of EC
    • Basic principles
      • Beauchamp TL, Childress JF (2012), Principles of biomedical ethics, 7th edition. Oxford: Oxford University Press, ICH-GCP: www.ich.org
      • Jones D et al, Ethics and Clinical research – The 50th anniversary of Beecher`s Bombshell, NEJM 2016; 374: 2393-2398 (web link)
      • Emanuel E et al., What makes clinical research ethical? JAMA 2000; 283:2701-2711
      • Emanuel E, Reform of clinical trial regulation, finally, NEJM 2015; 373:2296-2299 (web link)
      • Schweizerische Akademie der Medizinischen Wissenschaften (SAMW) 2015, Forschung mit Menschen. Ein Leitfaden für die Praxis, 2. überarbeitete Auflage (web link)
      • International Ethical Guidelines for Health-related Research Involving Humans. Fourth Edition; Council for International Organizations of Medical Sciences (CIOMS); Geneva 2016 (web link)
      • Word Medical Association (WMA), www.wma.net
      • Helsinki-Declaration (1964/2013) Ethical principles for medical research involving human subjects (link)
      • Taipeh-Declaration (2016): WMA declaration of Taipeh on ethical considerations regarding health databases and biobanks (web link)
    • Informed Consent
      • Miller FG (2010): Consent to clinical research. In: F.G. Miller / A. Wertheimer (Ed.): The ethics of consent. Theory and Practice. Oxford: Oxford University Press
      • Grady C, Enduring and emerging challenges of informed consent, NEJM 2015; 372: 855-862
      • Grady C et al, Informed Consent, NEJM 2017 276 (9):856-867 (web link)
      • Krones, Tanja, Ist die unvollständige Aufklärung von Versuchspersonen ethisch vertretbar? Schweiz Med Forum 2014;95:222 (link)
      • Drazen J et al., Informed consent and support, NEJM 2013, 368(20): 1929-1931 (web link)
    • Risk – benefit
      • Wendler D, Glantz L. A standard for assessing the risks of pediatric research: pro and con. J Pediatr 2007; 150: 579-582 (link)
      • Rid A et al, Evaluating the risks of clinical research, JAMA 2010; 304(13):1472-1479
      • Rid A et Wendler D, Risk-benefit assessment in medical research – critical review and open questions, Law, Probability an Risk 2010;9:151-177
      • Bernabe et al, The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods, BMC Medical Ethics 2012; 13:6, (web link)
    • Scientific quality
      • Kleist P. Drei Fallgruben bei Nicht-Unterlegenheitsstudien. Swiss Medical Forum 2011; 11: 697-700 (Link)
      • Kleist P. Vorsicht bei Subgruppenanalysen in klinischen Studien. Swiss Medical Forum 2007; 7: 794-799 (Link)
      • Kleist P. Das Intention-to-treat-Prinzip. Swiss Medical Forum 2009; 9: 450-453 (Link)
      • Kleist P. Bias in Beobachtungsstudien. Swiss Medical Forum 2010; 10: 580-583 (Link)
      • Kleist P, Randomisiert, Kontrolliert. Doppelblind. Warum? Schweiz Med Forum 2006; 6: 46-48 (link)
      • Kleist P, Vier Effekte, Phänomene und Paradoxe in der Medizin, Schweiz Med Forum 2006; 6: 1023-1027 (link)
      • Kleist P, Zehn Anforderungen an therapeutische Äquivalenzstudien, Schweiz Med Forum 2006; 6: 814-819 (link)
      • Kleist P, Vier Schritte zu mehr Transparenz in der klinischen Forschung; Schweiz Med Forum 2013; 94:483-486 (link)
      • Temple R and Ellenberg SS, Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues; Annuals of Internal Medicine 2000; 133:455-463 (link)
      • Ellenberg SS and Temple R, Placebo-controlled trials and active-control trials in the evaluation of new treatments, Part 2: Practical Issues and Specific Cases; Annuals of Internal Medicine 2000; 133: 464-470 (link)
      • Miler FG et Joffe S, Equipoise and the dilemma of randomizes clinical trials, NEJM 2011; 364; 5: 476-480
    • Legal basis and comments
      • Ordinance on Organisational Aspects of the Human Research Act of 20 September 2013 (Status as of 1 January 2014)
      • Federal Act on Research involving Human Beings of 30 September 2011 (Status as of 1 January 2014)
      • Ordinance on Clinical Trials in Human Research of 20 September 2013 (Status as of 1 May 2017)
      • Ordinance on Human Research with the Exception of Clinical Trials of 20 September 2013 (Status as of 1 January 2014)
      • Rütsche B, Handkommentar zum Humanforschungsgesetz, Stämpfli Verlag, 2015