Library swissethics for EC members
The Library swissethics has to be used by the members of the 7 Swiss ethics committees on research, exclusively. The Library swissethics fullfills the requirements for the members of the ethics committes of art. 2 of the Organisatoin Ordinance HRA (OrgO-HRA).
The Library swissethics should in no way be used by the research teams (Investigators, Sub-Investigatoren, etc.) to document their GCP trainings.
Link to the Library swissethics.
Concept for the training and further education for members of Ethics Committees
Concept for the training and further education for members of Ethics Committees
Deutsch
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updated: 29.08.2017
Resume of the concept for the training and further education for members of Ethics Committees
resume
Deutsch
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updated: 31.10.2017
Français
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updated: 31.10.2017
Italiano
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updated: 31.10.2017
Selection of recommended literature for EC-members
- Beauchamp TL, Childress JF (2012), Principles of biomedical ethics, 7th edition. Oxford: Oxford University Press
- 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)
- „International Ethical Guidelines for Health-related Research Involving Humans“. CIOMS, Genf 2016.
- Word Medical Association (WMA) (web link)
- Helsinki-Declaration (1964/2013) Ethical principles for medical research involving human subjects (link)
- Kleist P, Nadal D, Ist die medizinische Forschung mit Kindern ethisch vertretbar? BioFokus Juli 2018; Nr. 95. (link)
- 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)
- 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 (web link)
- 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)
- Wendler D et Miller FG, Assessing research risks systematically: the net risks test, Journal of Medical Ethics 33:8, 2007 (web link)
- Weijer C et Miller PB, Refuting the net risks test: a response to Wendler and Miller’s “Assessing research risks systematically”, Journal of Medical Ethics 33:8, 2017 (link)
- 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)
- Miler FG et Joffe S, Equipoise and the dilemma of randomizes clinical trials, NEJM 2011; 364; 5: 476-480 (web link)
- Bundesgesetz über die Forschung am Menschen vom 30. September 2011 (web link)
- Verordnung über klinische Versuche in der Humanforschung vom 20. September 2013 (web link)
- Verordnung über die Humanforschung mit Ausnahme der klinischen Versuche vom 20. September 2013 (web link)
- Organisationsverordnung zum Humanforschungsgesetz vom 20. September 2013 (web link)
- Rütsche B, Handkommentar zum Humanforschungsgesetz, Stämpfli Verlag, 2015 (web link)
- Explanatory report on the ordinances of the Human Research Act (HRA) (in German) (link)