What is the best standard for the standard of care in clinical research?

American Journal of Bioethics

Volumn 9, Issue 3, 2009, Pages 35-43

  Van Der Graaf, Rieke ^a   Van Delden, Johannes J M ^a  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

Clinical equipoise; Control group; Double standards; Randomized controlled trials; Research ethics; Standard of care

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ZIDOVUDINE;

ARTICLE; CONTROL GROUP; DEVELOPED COUNTRY; DEVELOPING COUNTRY; DISEASE TRANSMISSION; DRUG ADMINISTRATION; ETHICS; HEALTH CARE QUALITY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTERNATIONAL COOPERATION; METHODOLOGY; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL; RESEARCH ETHICS; STANDARD;

ANTI-HIV AGENTS; CONTROL GROUPS; DEVELOPED COUNTRIES; DEVELOPING COUNTRIES; DRUG ADMINISTRATION SCHEDULE; ETHICS, RESEARCH; GUIDELINES AS TOPIC; HIV INFECTIONS; HUMANS; INFECTIOUS DISEASE TRANSMISSION, VERTICAL; INTERNATIONALITY; QUALITY OF HEALTH CARE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; ZIDOVUDINE;

EID: 61449150546     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265160802654129     Document Type: Article

References (36)

1. Angell, M. M. 1997. The ethics of clinical research in the Third World. New England Journal of Medicine 337(12): 847-849.
2. Belsky, L., and Richardson, H. S. 2004. Medical researchers' ancillary care responsibilities. British Medical journal 328(7454): 1494-1496.
3. Benatar, S. R., and Singer, P.A. 2000. A new look at international research ethics. British Medical Journal 321(7264): 824-825.
4. Central Committee on Research involving Human Subjects (CCMO). 2003. CCMO-Notitie Verklaring van Helsinki, 13 January, 2003, The Hague, The Netherlands: CCMO.
5. College voor zorgverzekeringen (CVZ). 2007. Farmacotherapeutisch Kompas. Diemen, The Netherlands: CVZ. Available at: http://wrwwr.fk.cvz.nl/ (accessed January 11, 2009).
6. Council for International Organizations of Medical Sciences (CIOMS). 2002. International Ethical Guidelines for Biomedical Research Involving Hitman Subjects. Geneva, Switzerland: CIOMS. Available at: http://www.cioms.ch/frame-guidelines-nov-2002.htm (accessed January 11, 2009).
7. Council of Europe (COE). 2005. Additional Protocol on Biomedical Research to the Convention on Human Rights and Biomedicine Concerning Biomedical Research. Strasbourg, France: COE. Available at: http://conventions.coe. int/treaty/en/Treaties/Html/195.htm (accessed January 11, 2009).
8. Dickert, N., DeRiemer, K. Duffy, P. E. et al. 2007. Ancillary-care responsibilities in observational research: Two cases, two issues. Lancet 368: 847-877.
9. Ellenberg, S. S., and Temple, R. 2000. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: Practical issues and specific cases. Annals of Internal Medicine 133: 464-470.
10. European Commission (EC). 2003. Directive 2003/63/EC. Official journal of the European Union L159/46 EN. Available at: http://www.emea.europa.eu/ pdfs/human/pmf/2003-63EC.pdf (accessed January 11, 2009).
11. European Group on Ethics in Science and New Technologies (EGE). 2003. Opinion no. 17: Ethical Aspects of Clinical Research in Developing Countries. Brussels, Belgium: EGE. Available at: http://www.ec.europa.eu/ european-group-ethics/docs/avis17-en.pdf (accessed January 11, 2009).
12. Freedman, B. 1987. Equipoise and the ethics of clinical research. New England Journal of Medicine 317(3): 141-145.
13. Freedman, B. 1990. Placebo-controlled trials and the logic of clinical purpose. IRB: A Revieiv of Human Subjects Research 12(6): 1-6.
14. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). 2000. Guideline for Choice of Control Group and Related Issues in Clinical Trials (E10). Geneva, Switzerland: ICH. Available at: http://www.ich.org/cache/compo/475-272-l. htmWE10 (accessed January 11, 2009).
15. Joint United Nations Programme on HIV/AIDS (UNAIDS). 2000. Ethical considerations in HIV preventive vaccine research. Geneva Switzerland: UNAIDS. Available at: http://data. unaids.org/Publications/IRC-pub01/JC072- EthicalConsen.pdf (accessed January 11, 2009).
16. Levine, R. J. 2000. Revision of the CIOMS international ethical guidelines: A progress report. In Biomedical Research Ethics: Updating International Guidelines. A consultation, ed. R. J. Levine, and S. Gorovitz. Geneva, Switzerland: Council for International Organizations of Medical Sciences, 4-15.
17. Lie, R. K. 1998. Ethics of placebo-controlled trials in developing countries. Bioethics 12: 307-311.
18. Lie, R. K. 2000. Justice and international research. In Biomedical Research Ethics: Updating International Guidelines. A Consultation, ed. R. J. Levine, and S. Gorovitz. Geneva, Switzerland: Council for International Organizations of Medical Sciences, 27-40.
19. London, A. J. 2000. The ambiguity and the exigency: Clarifying 'standard of care' arguments in international research. Journal of Medicine and Philosophy 25(4): 379-397.
20. London, A. J. 2001. Equipoise and international human-subjects research. Bioethics 15(4): 313-332.
21. Luna, F. 2000. Comment in: Discussion on draft guidelines and progress report. In Biomedical Research Ethics: Updating International Guidelines. A Consultation, ed. R. J. Levine, and S. Gorovitz. Geneva: Council for International Organizations of Medical Sciences, 16-26.
22. Luna, F. 2001. Is 'best proven' a useless criterion? Bioethics 15(4): 273-288.
23. Lurie, P., and Wolfe, S. M. 1997. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. New England journal of Medicine 337(12): 853-856.
24. Macklin, R. 2004. Double Standards in Medical Research. Cambridge, UK: Cambridge University Press.
25. Marquis, D. 1983. Leaving therapy to chance. Hastings Center Report 13(4): 40-47.
26. Miller, F. G., and Brody, H. 2002. What makes placebo-controlled trials unethical? American Journal of Bioethics 2(2): 3-9.
27. National Bioethics Advisory Commission (NBAC). 2001. Ethical and Political Issues in International Research: Clinical Trials in Developing Countries. Volume I. Bethesda, MD: NBAC. Available at: http://www.bioethics. georgetown.edu/nbac/human/overvoll.pdf (accessed January 11, 2009).
28. Nuffield Council on Bioethics. 2002. The Ethics of Research Related to Healthcare in Developing Countries. London, England: Nuffield Council. Available at: http://www.nuffieldbioethics.org/go /ourwork/developingcountries/ publication-309.html (accessed January 11, 2009).
29. Nuffield Council on Bioethics. 2005. The Ethics of Research Related to Healthcare in Developing Countries: A Follow-up Discussion Paper. London, UK: Nuffield Council on Bioethics. Available at: http://www.nuffieldbioethics. org/go/ourwork/developingcountries/publication-169.html (accessed January 11, 2009).
30. Pogge, T. W. 2002. World Poverty and Human Rights: Costnopolitan Responsibilities and Reforms. Cambridge, UK: Polity.
31. Richardson, H. S., and Belsky, L. 2004. The ancillary-care responsibilities of medical researchers. An ethical framework for thinking about the clinical care that researchers owe their subjects. Hastings Center Report 34(1): 25-33.
32. Shapiro, K., and Benatar, S. R. 2005. HIV prevention research and global inequality: Steps towards improved standards of care. Journal of Medical Ethics 31(1): 39-47.
33. Steinberg, D. 2002. Clinical research should not be permitted to escape the ethical orbit of clinical care. American Journal of Bioethics 2(2): 27-28.
34. Temple, R., and Ellenberg, S. S. 2000. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part I: Ethical and scientific uses. Annals of Internal Medicine 133: 455-463.
35. Varmus, H., and Satcher, D. 1997. Ethical complexities of conducting research in developing countries. New England Journal of Medicine 337(14): 1003-1005.
36. World Medical Association (WMA). 2000. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 52nd WMA General Assembly, Edinburgh, Scotland. Available at: http://www.wma.net/e/policy/b3.htm (accessed January 11, 2009).