Hostname: page-component-78c5997874-94fs2 Total loading time: 0 Render date: 2024-11-19T02:11:59.721Z Has data issue: false hasContentIssue false
  • English
  • Français

Evolving Ethical Issues in Selection of Subjects for Clinical Research

Published online by Cambridge University Press:  29 July 2009

Charles Weijer
Charles Weijer
Affiliation:
Medical Research Council of Canada fellow with the Clinical Trials Research Group, and member of the Institutional Review Board at McGill University, Montreal, Canada.
Get access Rights & Permissions [Opens in a new window]

Extract

Wittgenstein, in his famous critique of philosophy, noted that the influence of an idea can be such that it alters the way that we see the world. “It is like a pair of glasses on our nose through which we see whatever we look at,” he said. “It never occurs to us to take them off.” This view of the power of an idea suggests that the interpretation of an event, and what response this event calls for, can depend upon the view one has of the world. A person who is naive about medical facts may, for example, interpret chest pain upon exertion as a sign that he is “overdoing it”; were he more medically knowledgeable, the same symptom might be interpreted as a possible indicator of coronary artery disease. The naive interpretation calls for rest; the informed interpretation calls for medical attention as well.

Type
Special Section: Rejuvenating Research Ethics
Information
Cambridge Quarterly of Healthcare Ethics , Volume 5 , Issue 3 , Summer 1996 , pp. 334 - 345
Copyright
Copyright © Cambridge University Press 1996

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Notes

1. Wittgenstein, L. Philosophical Investigations [Trans GEM Anscombe]. Oxford, United Kingdom: Basil Blackwell Ltd., 1991:§103.Google Scholar

2. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. OPRR Reports 1979;April 18:1–8.Google Scholar

3. See note 2. National Commission. 1979;April 18:1–8.Google Scholar

4. See note 2. National Commission. 1979;April 18:1–8.Google Scholar

5. See note 2. National Commission. 1979;April 18:1–8.Google Scholar

6. See note 2. National Commission. 1979;April 18:1–8.Google Scholar

7. See note 2. National Commission. 1979;April 18:1–8.Google Scholar

8. See note 2. National Commission. 1979;April 18:1–8.Google Scholar

9. For a detailed discussion of the different formulations of distributive justice see: Beauchamp, T. Distributive justice and morally relevant differences. In: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Appendix Volume I The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research [DHEW Publication (OS) 78–0013] Washington, DC: Department of Health, Education and Welfare, 1978:6.1–6.20.Google Scholar

10. See note 2. National Commission. 1979;April 18:1–8.Google Scholar

11. Levine, C. Has AIDS changed the ethics of human subjects research? Journal of Law, Medicine and Health Care 1988;16:167–73.CrossRefGoogle ScholarPubMed

12. Annas, GJ, Grodin, MA, Eds. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press, 1992.Google Scholar

13. Katz, J. Experimentation With Human Beings. New York: Russell Sage Foundation, 1972:9–65.Google Scholar

14. Katz, J. The regulation of human experimentation in the United States –a personal odyssey. IRB: A Review of Human Subjects Experimentation 1987;9:1–6.CrossRefGoogle ScholarPubMed

16. Jones, JH. Bad Blood: The Tuskegee Syphilis Experiment. New York: Free Press, 1993.Google Scholar

17. Jonas, H. Philosophical reflections on experimenting with human beings. In: Philosophical Essays: From Ancient Creed to Technological Man. Chicago: University of Chicago, 1974:105–31.Google Scholar

18. See note 17. Jonas, . 1974:105–31.Google Scholar

19. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Institutional Review Boards [DHEW Publication (OS) 78–0008]. Washington, DC: Department of Health, Education, and Welfare, 1978:22.Google Scholar

20. See note 2. National Commission. 1979;April 18:1–8.Google Scholar

21. Department of Health and Human Services. Protection of Human Subjects. Title 45, Code of Federal Regulation. Part 46: Revised. 1991;06 18: 46.111(a).Google Scholar

22. Levine, RJ. Ethics and Regulation of Clinical Research, 2nd ed.Baltimore, Maryland: Urban & Schwarzenberg, 1986:72.Google Scholar

23. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Appendix to Report and Recommendations: Institutional Review Boards [DHEW Publication (OS) 78–0009], Washington, DC: Department of Health, Education, and Welfare, 1978:1.120.Google Scholar

24. See note 19. National Commission. 1978:64–5.Google Scholar

25. Levine, RJ. The impact of HIV infection on society's perception of clinical trials. Kennedy Institute of Ethics Journal 1994;4:93–8.CrossRefGoogle ScholarPubMed

26. Levine, C, Dubler, NN, Levine, RJ. Building a new consensus: ethical principles and policies for clinical research on HIV/AIDS. IRB: A Review of Human Subjects Research 1991; 13(1–2): 1–17.CrossRefGoogle ScholarPubMed

27. See note 26. Levine, et al. 1991;13:1–17.Google Scholar

28. Cardon, PV, Dommel, FW, Truble, RR. Injuries to research subjects: a survey of investigators. New England Journal of Medicine 1976;295:650–4.CrossRefGoogle ScholarPubMed

29. Zarafonetis, CJD, Riley, PA, Willis, PW et al. , Clinically significant adverse effects in a phase one testing program. Clinical Pharmacology and Therapeutics 1978;24:127–32.CrossRefGoogle Scholar

30. McCann, DJ, Pettit, JR. A report on adverse effects insurance for human subjects. In: President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Compensating for Research Injuries: the Ethical and Legal Implications of Programs to Redress Injuries Caused By Biomedical and Behavioral Research (Appendices). Washington, DC: US Government Printing Office, 1982.Google Scholar

31. Arnold, JD. Incidence of injury during clinical pharmacology research and indemnification of injured research subjects at the Quincy Research Center. In: President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Compensating for Research Injuries: the Ethical and Legal Implications of Programs to Redress Injuries Caused By Biomedical and Behavioral Research (Appendices). Washington, DC: US Government Printing Office, 1982.Google Scholar

32. See note 29. Zarafonetis, et al. 1978;24:127–32.Google Scholar

33. See note 31. Arnold, . 1982.Google Scholar

34. See note 28. Cardon, et al. 1976;295:650–4.Google Scholar

35. Macklin, R, Friedland, G. AIDS research: the ethics of clinical trials. Law, Medicine and Health Care 1986;14:273–80.CrossRefGoogle ScholarPubMed

36. See note 26. Levine, et al. 1991; 13(1–2): 1–17.Google Scholar

37. See note 35. Macklin, Friedland. 1986;14:273–80.Google Scholar

38. See note 11. Levine, . 1988;16:167–73.Google Scholar

39. See riote 26. Levine, et al. 1991;13(1–2):1–17.Google Scholar

40. Office for Protection from Research Risk. Protecting Human Research Subjects: Institutional Review Board Guidebook. Washington, DC: US Government Printing Office, 1993:3.26.Google Scholar

41. Hayes, GJ, Hayes, SC, Dykstra, T. A survey of university institutional review boards: characteristics, policies, and procedures. IRB: A Review of Human Subjects Research 1995; 17(3): 1–6.CrossRefGoogle Scholar

42. Freedman, B. Multicenter trials and subject eligibility: should local IRBs play a role? IRB: A Review of Human Subjects Research 1994; 16(1–2): 1–6.CrossRefGoogle ScholarPubMed

43. See note 35. Macklin, et al. 1986;14:273–80.Google Scholar

44. See note 26. Levine, et al. 1991; 13(1–2): 1–17.Google Scholar

45. Levine, C. Women and HIV/AIDS research: the barriers to equity. IRB: A Review of Human Subjects Research 1991; 13(1–2): 18–22.CrossRefGoogle Scholar

46. Dresser, R. Wanted single, white male for medical research. Hastings Center Report 1992;22:24–9.CrossRefGoogle ScholarPubMed

47. See note 46. Dresser, . 1992;22:24–9.Google Scholar

48. See note 46. Dresser, . 1992;22:24–9.Google Scholar

49. Food and Drug Administration. Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs. Federal Register 1993;58:39406–16.Google Scholar

50. Department of Health and Human Services, National Institutes of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Federal Register 1994;59:14508–13.Google Scholar

51. See note 50. NIH. 1994;59:14508–13.Google Scholar

52. As outlined in a letter to IRB chairs from Gary Ellis, Director of the Office for Protection from Research Risk, April 25, 1994.

53. General Accounting Office. Women's Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing [Publication GAO/HRD–93–17]. Washington, DC: US Government Printing Office, 1992.Google Scholar

54. Bird, CE. Women's representation as subjects in clinical studies: a pilot study of research published in JAMA in 1990 and 1992.Google Scholar In: Mastroianni, AC, Faden, R, Federman, D, Eds. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies (Volume 2). Washington, DC: National Academy Press, 1994:151–73.Google Scholar

55. Svensson, CK. Representation of American blacks in clinical trials of new drugs. Journal of the American Medical Association 1989;261:263–5.CrossRefGoogle ScholarPubMed

56. Kennedy, BJ. Needed: clinical trials for older patients. Journal of Clinical Oncology 1991;9:718–20.CrossRefGoogle ScholarPubMed

57. Gurwitz, JH, Col, NF, Avorn, J. The exclusion of the elderly and women from clinical trials in acute myocardial infarction. Journal of the American Medical Association 1992;268:1417–61.CrossRefGoogle ScholarPubMed