International ethical regulations on placebo-use in clinical trials: A comparative analysis

Bioethics

Volumn 22, Issue 1, 2008, Pages 64-74

  Ehni, Hans Jörg ^a   Wiesing, Urban ^a  

^a Institut fur Ethik und Geschichte der Medizin   (Germany)

Author keywords

Ethical acceptability; International regulations; Placebo control; Research ethics

Indexed keywords

PLACEBO;

ARTICLE; COMPARATIVE STUDY; HEALTH HAZARD; HUMAN; MEDICAL ETHICS; MEDICAL RESEARCH; PATIENT CARE; RISK;

CONTROL GROUPS; CONTROLLED CLINICAL TRIALS AS TOPIC; HELSINKI DECLARATION; HUMANS; PLACEBOS; RESEARCH DESIGN;

EID: 37249011993     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2007.00587.x     Document Type: Article

References (26)

1. The European Group on Ethics in Science and New Technologies to the European Commission. 2003. Opinion on the ethical aspects of research in developing countries. Luxembourg: Office for Official Publications of the European Communities.
2. Nuffield Council on Bioethics. 2002. The ethics of research related to healthcare in developing countries.
3. National Bioethics Advisory Commission. 2001. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Bethseda, Maryland.
4. See Section 5. The availability of proven treatment as a condition for the use of placebo.
5. World Medical Association. 2002. Declaration of Helsinki.
6. Council for International Organizations of Medical Sciences CIOMS in collaboration with the World Health Organization. 2002. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva.
7. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2000. ICH Harmonised Tripartite Guideline. Choice of Control Group and Related Issues in Clinical Trials. E 10.
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12. K.J. Rothmann et al. For and against. BMJ 2000; 321: 442-445.
13. We are only using simplified formulations of each criterion to illustrate each principle with an example. These formulations are neither exactly corresponding to one of the guidelines nor to our preferences for detailed, elaborated ethical principles.
14. K.B. Michels et al. The Continuing Unethical Use of Placebo Controls. NEJM 1994; 331: 394-398.
15. Cf. e.g. R.V. Carlson et al. The revision of the Declaration of Helsinki: past, present and future. BrJClinPharmacol 2004; 57: 700.
16. E.g. K. Michels et al. Update on unethical use of placebos in randomised trials. Bioethics 2003; 17: 188-204.
17. This is the opinion of R.K. Lie et al. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J Med Ethics 2004; 30: 190.
18. E.g. W.T. Carpenter et al. The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia. AmJPsych 2003; 160: 356-362.
19. R. Macklin. 2004. Double Standards in Medical Research in Developing Countries. Cambridge: Cambridge University Press: 48.
20. C. Weijer. Placebo-controlled trials in shizophrenia: Are they ethical? Are they necessary. Schizophrenia Research 1999; 35: 211-218. Michels, op. cit. note 13.
21. Freedman, op. cit. note 10, p. 24.
22. Freedman, op. cit. note 10.
23. Macklin, op. cit. note 17.
24. The European Group on Ethics in Science and New Technologies to the European Commission op. cit. note 1, 2.10 The use of placebo.
25. The European Group on Ethics in Science and New Technologies to the European Commission op. cit. note 1.
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