Protecting the vulnerable: Testing times for clinical research ethics

Social Science and Medicine

Volumn 51, Issue 6, 2000, Pages 969-977

  Schüklenk, Udo ^a  

^a UNIVERSITY OF THE WITWATERSRAND   (South Africa)

Author keywords

Bioethics; Clinical trial standards; Developing countries; Research ethics

Indexed keywords

ETHICS; HEALTH CARE; RESEARCH PROGRAM;

ARTICLE; CLINICAL RESEARCH; DEVELOPING COUNTRY; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; MENTAL DISEASE; PRACTICE GUIDELINE; PRISONER; PROFESSIONAL STANDARD;

BIOMEDICAL AND BEHAVIORAL RESEARCH; RESEARCH ETHICS; VULNERABLE POPULATIONS;

CLINICAL TRIALS; DEVELOPING COUNTRIES; ETHICS, MEDICAL; ETHICS, RESEARCH; FEMALE; GUIDELINES; HUMAN EXPERIMENTATION; HUMANS; MALE; VULNERABLE POPULATIONS;

EID: 0342657088     PISSN: 02779536     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0277-9536(00)00075-7     Document Type: Article

References (33)

1. AIDS, 1999. AIDS Treatment News. 317, April 16.
2. Annas G.J., Glantz L.H., Katz B.F. Informed consent to human experimentation. 1977;Ballinger, Cambridge, MA.
3. Annas G.J. The dominance of American law and market values over American bioethics. Grodin M.A. Meta medical ethics: The philosophical foundations of bioethics. 1995;83-96 Kluwer, Dordrecht.
4. Appelbaum P.S., Roth L.H., Lidz C., Benson P., Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Center Report. 17:(2):1987;20-24.
5. Beauchamp T.L., Childress J. Principles of biomedical ethics. 1994;Oxford University Press, New York.
6. Capron A. Ethical and human-rights issues in research on mental disorders that may affect decision-making capacity. New England Journal of Medicine. 340:1999;1430-1434.
7. International guidelines for ethical review of epidemiological studies. 1991;Council for International Organisations of Medical Sciences, WHO, Geneva.
8. International ethical guidelines for biomedical research involving human subjects. 1993;Council for International Organisations of Medical Sciences, WHO, Geneva.
9. Hellman S. The patient and the public good. Nature Medicine. 1:1995;400-402.
10. Kant I. Critique of practical reason. 1976;Garland, New York.
11. Kerin J. Double standards: principled or arbitrary? Bioethics. 12:1998;iii-vii.
12. Lasagna L. Special subjects in human experimentation. Freund P.A. Experimentation with human subjects. 1972;262-275 Allen & Unwin, London.
13. Lurie P., Wolfe S.M. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. New England Journal of Medicin. 337:1997;853-856.
14. McNeill P.M. The ethics and politics of human experimentation. 1993;Cambridge University Press, Oakleigh.
15. McNeill P.M. Experimentation in human beings. Kuhse H., Singer P. Companion to bioethics. 1998;369-378 Blackwell, Oxford.
16. Michaels R. Are research ethics bad for our mental health? New England Journal of Medicine. 340:1999;1427-1430.
17. Moreno J.D. Ethics committees and ethics consultants. Kuhse H., Singer P. Companion to bioethics. 1998;475-484 Blackwell, Oxford.
18. National Commission, 1979. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington, DC: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. US Government Printing Office.
19. Research involving persons with mental disorders that may affect decisionmaking capacity. 1998;National Bioethics Advisory Commission, Rockville, MD.
20. National statement on ethical conduct in research involving humans. 1999;National Health and Medical Research Council. AusInfo, Canberra.
21. Posner G.L., Ware J. Mengele: the complete story. 1986;McGraw-Hill, New York.
22. Proctor R.N. Nazi Doctors, Racial Medicine, and Human Experimentation. Annas G.J., Grodin M.A. The nazi doctors and the Nuremberg code. 1992;17-31 Oxford University Press, New York.
23. Richwine, L., 1999. Gore worked to soften South Africa health law. Reuters NewMedia, April 16.
24. Schüklenk U. Access to experimental drugs in terminal illness: ethical issues. 1998;Pharmaceutical Products Press, New York. reprint as paperback, 2000.
25. Schüklenk U. Unethical perinatal HIV transmission trials establish bad precedent. Bioethics. 12:1998;312-319.
26. Schüklenk U. International research ethics guidelines to be revised - in nearly complete secrecy. Monash Bioethics Review. 18:(3 Suppl.):1999;13-17.
27. Schüklenk U., Ashcroft R. Background briefing: international research ethics. Bioethics. 14:2000;158-172.
28. Trials. Trials of war criminals before the Nuremberg military tribunals under Control Council Law No 10: Nuremberg, October 1946-1949, 2 vols. 1949;US Government Printing Office, Washington, DC.
29. Unger P. Living high and letting die: our illusion of innocence. 1996;Oxford University Press, New York.
30. US News and World report. Dying for a cure. 11 October 1999.
31. Wing John. Ethics and psychiatric research. Bloch S., Chodoff P., Green S.A. Psychiatric ethics. 1999;461-477 Oxford University Press, Oxford.
32. Declaration of Helsinki. Jonsen A.R., Veatch R.M., Walters L. Source book in bioethics. 1998;13-15 Georgetown University Press, Washington, DC.
33. Young R. Personal autonomy: beyond negative and positive liberty. 1986;Croom-Helm, Kent, OH.