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Drug Trials, Doctors, and Developing Countries: Toward a Legal Definition of Informed Consent

Published online by Cambridge University Press:  29 July 2009

Adina M. Newman
Affiliation:
Received her law degree from Georgetown University Law Center In 1995 and plans to attend Columbia University's Postbaccalaureate Premedlcal Program.

Extract

Assume this hypothetical situation: an American pharmaceutical company, Maxwell Fisch Pharmaceuticals, Inc. (Maxwell), wishes to perform clinical trials involving a new antipsychotic medication, Klezac. Klezac is in its third phase of the clinical stage of the drug research process. Once the testing is complete, Maxwell plans to submit a New Drug Application, the official request to begin marketing Klezac, to the Food and Drug Administration (FDA). The new drug is expected to receive FDA approval in 2 or more years. The company decides to shift its research and development activities to Z, a small, developing country. In doing so, Maxwell is following the course taken by numerous other drug companies who wish to take advantage of faster governmental approval in foreign sites and ensuing cheaper research costs.

Type
Special Section: Rejuvenating Research Ethics
Copyright
Copyright © Cambridge University Press 1996

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References

Notes

1. Temkin, O, Temkin, C, Eds. Ancient Medicine: Selected Papers of Ludwig Edelstein. Baltimore, Maryland: Johns Hopkins University Press, 1967.Google Scholar In: Stover, E, Nightingale, E, Eds. The Breaking of Bodies and Minds: Torture, Psychiatric Abuse, and the Health Professions. New York: W.H. Freeman and Company, 1985:266.Google Scholar

2. Meibach, RC. Why does it take so long now for drugs to get to the marketplace? Journal of the California Alliance for the Mentally III 1994;5:63–4.Google Scholar

3. [Anonymous]. International regulatory harmonization: a new era in prescription drug approval [Note]. Vanderbilt Journal of Transnational Law 1992;25:489.Google Scholar

4. However, the author has located sources describing unauthorized and abusive testing involving other forms of drugs, particularly reproductive and HIV treatments. For example, the World Health Organization recently investigated allegations of a new AIDS drug being administered to about 100 HIV-positive children, most of whom are orphans. See Dickman, S, Aldhous, P. WHO concern over new drug. Nature 1990;347:606.Google ScholarPubMed Some countries place little or no regulatory restrictions on clinical trials conducted within their borders. For example, in South Africa clinical trials may proceed for up to 6 months before authorities are notified. Deutsch E. Controlled clinical trials in drug research: starting by permission, v. notification. Medicine and Law 1985;4:493–6.Google Scholar

5. See Vienna Convention on the Law of Treaties, entered into force Jan 27, 1980, 1155 UNTS 331.Google Scholar

6. International Covenant on Civil and Political Rights, entered into force March 23, 1966, art. 7, 999 UNTS 717.Google Scholar

7. Nowak, M, Ed. U.N. Covenant on Civil and Political Rights: CCPR Commentary. Kehl: N.P. Engel, 1993.Google Scholar

8. See note 7. Nowak, . 1993.Google Scholar

9. General Comment No. 20 (44) (art. 7), UN GAOR, Human Rights Committee, 47th Session, Suppl No 40, UN Document A/47/40, 1992:194.

10. Rosenthal, E. Discrimination based on mental disability. In: Sklar, M, Ed. The Status of Human Rights in the United States. Washington, DC: American Association for the Advancement of Science, 1995:75.Google Scholar

11. Rosenthal, E. The international covenant on civil and political rights and its relevance to human experimentation. Accountability in Research: Policies and Quality Assurance 1996;4:253.CrossRefGoogle Scholar

12. Principles for the Protection of Persons with Mental Illness and for the Improvement of Mental Health Care. Principle 9(3) and (4). G.A. Res. 119. UN GAOR, 46th Session, Suppl No 49, Annex, at 188–92. UN Document A/46/49, 1991 (MI Principles).Google Scholar

13. Rosenthal, E, Rubenstein, LS. International human rights advocacy under the “principles for the protection of people with mental illness.” International Journal of Law and Psychiatry 1993; 16:257, 265.CrossRefGoogle ScholarPubMed

14. See note 12. MI Principles, Principle 10(1).

15. See note 12. MI Principles, Principle 11(1).

16. See note 12. Ml Principles, Principle 11(6) (a), (b), and (c).

17. See note 12. Ml Principles, Principle 11(7), (8), (13), and (15).

18. See note 13. Rosenthal, Rubenstein. 1993;16:268.Google Scholar

19. See note 13. Rosenthal, Rubenstein. 1993;16:272.Google Scholar

20. See note 13. Rosenthal, Rubenstein. 1993;16:280–2.Google Scholar

21. Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No 10, Vol 2, 1949:181–2.

22. U.S. Adjutant General's Department. Trials of war criminals under Control Council Law No 10 (Oct 1946–April 1949), Vol 2, The Medical Case. Washington, DC: US Government Printing Office, 1947.Google Scholar

23. World Medical Assembly. Declaration of Helsinki. 1964.Google Scholar

24. 41st World Medical Assembly. Declaration of Helsinki IV, I Basic Principles 9, 1989.Google Scholar

25. See note 22. Declaration of Helsinki IV, I Basic Principles 11.

26. Perley, S, Fluss, SS, Bankowski, A et al. , The Nuremberg Code: an international overview. In: Annas, GJ, Grodin, MA, Eds. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press, 1992:149-73.Google Scholar

27. See note 24. Declaration of Helsinki IV, II Medical Research Combined with Professional Care 5.

28. Annas, GJ. The changing landscape of human experimentation: Nuremberg, Helsinki, and beyond. Health Matrix 1992;2:122–3.Google ScholarPubMed

29. Universal Declaration of Human Rights, adopted Dec 10,1948, art. 5. UN Document A/810,1948:71.Google Scholar

30. Eide, A, Alfredsson, G, Melander, G et al. , Eds. The Universal Declaration of Human Rights: A Commentary. Stockholm: Scandinavian University Press, 1992:102–3.Google Scholar

31. Convention Against Torture and Other Cruel, Inhuman and Degrading Treatment of Punishment, entered into force 06 26, 1987, art. 1(1), 39 UN GAOR Suppl No 51, 1987:197.Google Scholar

32. Restatement (Third) of the Foreign Relations Law of the United States § 102(2), 1987. See also North Sea Continental Shelf Cases (W. Ger. v. Den.; W. Ger. v. Neth.), ICJ 1969:3, 44.Google Scholar

33. World Psychiatric Association. Declaration of Hawaii. 1977.Google Scholar In: WPA Bulletin 1990; 1:44.Google Scholar

34. World Psychiatric Association. Declaration of Hawaii II. 1983.Google Scholar In: WPA Bulletin 1990; 1:44.Google Scholar

35. See note 34. Declaration of Hawaii II.

36. Caplan, AL. Are existing safeguards adequate? Journal of California Alliance for the Mentally III 1994;5:36–8Google ScholarPubMed; Shamoo, AE. Our responsibilities toward persons with mental illness as human subjects In research. Journal of the California Alliance for the Mentally III 1994;5:14–6.Google ScholarPubMed

37. See note 36. Shamoo, AE. 1994;5:14.Google Scholar

38. Federal Policy for the Protection of Human Subjects. 7 CFR § lc.116, § lc.117, 1995.

39. See note 38. 7 CFR § lc.H6(c), § lc.H7(c).

40. See note 38. 7 CFR § lc.102.

41. Levine, RJ. Ethics and Regulation of Clinical Research. 2d ed.Baltimore/Munich: Urban ' Schwarzenberg, 1986:121–2.Google Scholar

42. Smith, ML. Power, advocacy, and informed consent forms. Journal of the California Alliance for the Mentally III 1994;5:25–7.Google ScholarPubMed

43. Meisel, A. The “exceptions” to the informed consent doctrine: striking a balance between competing values in medical decisionmaking. Wisconsin Law Review 1979;2:413–88.Google Scholar

44. Lazarus, J. Critical ethical issues and conflicts. Journal of the California Alliance for the Mentally III 1994;5:20.Google ScholarPubMed

45. See Rennie v. Klein, 462 F. Supp. 1131,1145 (DNJ 1978), modified, 653 F.2d 836 (3d Cir. 1981), vacated, 458 U.S. 1119 (1986).Google ScholarWeinstock, R, Copelan, R, Bagheri, A. Competence to give informed consent for medical procedures. Bulletin of the American Academy of Psychiatry 1984;12:117–24.Google ScholarPubMedCulver, CM, Ferrell, RB, Green, RM. ECT and special problems of informed consent. American Journal of Psychiatry 1980;137:586.Google ScholarPubMed

46. See note 41. Levine, . 1986:261.Google Scholar

47. See note 41. Levine, . 1986:262–5.Google Scholar

48. Brown, P. Psychiatric treatment refusal, patient competence, and informed consent. International Journal of Law and Psychiatry 1986;8:83–9.CrossRefGoogle ScholarPubMed

49. See note 44. Lazarus, . 1994;5:21.Google Scholar

50. United Nations, Economic and Social Council, Commission on Human Rights, Subcommission on Prevention of Discrimination and Protection of Minorities: Principles, Guidelines, and Guarantees for the Protection of Persons Detailed on Grounds of Mental Ill-Health or Suffering from Mental Disorders. UN Document E/CN.4/Sub.2/1983/17 at 48 (prepared by Erica-Irene Daes). See note 28. Annas. 1992;2:137–9.Google ScholarPubMed

51. Brief for Respondent, Washington v. Harper, 494 US 210 (1990) (No. 88–599).Google Scholar

52. See note 41. Levine, . 1986:265.Google Scholar

53. Donnelly, J. Cultural relativism and universal human rights. Human Rights Quarterly 1984;6:400, 410–9.CrossRefGoogle Scholar

54. Nickel, JW. Making Sense of Human Rights: Philosophical Reflections on the Universal Declaration of Human Rights. Berkeley: University of California Press, 1987:74-9.Google Scholar

55. Angell, M. Ethical imperialism? Ethics in international collaborative clinical research. New England Journal of Medicine 1988;319:1081–2.CrossRefGoogle ScholarPubMed

56. See note 55. Angell, . 1988;319:1081–2.Google Scholar

57. Ijsselmuiden, CB. Research and informed consent in Africa another look. New England Journal of Medicine 1992;326:830–2.CrossRefGoogle ScholarPubMed

58. See note 55. Angell, . 1988;319:1082.Google Scholar See note 57. Ijsselmuiden, . 1992;326:833.Google Scholar

59. Macklin, R. Universality of the Nuremberg Code. In: Annas, GJ, Grodin, MA, Eds. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press, 1992:240-57.Google Scholar

60. See note 59. Macklin, . 1992:249.Google Scholar

61. Levine, RJ. Informed consent: some challenges to the universal validity of the western model. Law, Medicine ' Health Care 1991;19:207–13.CrossRefGoogle ScholarPubMedAdityanjee Dr. Informed consent: issues for developing countries. Medicine, Science, and the Law 1986;26:305–7.CrossRefGoogle Scholar

62. See note 61. Levine, . 1991;19:210.Google Scholar

63. Christakis, NA, Panner, MJ. Existing international ethical guidelines for human subjects research: some open questions. Law, Medicine ' Health Care 1991;19:214–21.Google ScholarPubMed

64. Dr. Levine takes the concept of “proxy consent” even further when he says that he would not necessarily exclude wives from participation in clinical research in cultures where women traditionally do not give their own consent. See note 61, Levine, . 1991; 19:212.Google Scholar A serious deficiency of proxy consent is that it allows communities to violate the human rights of their mentally ill members, who are often ostracized and discriminated against due to their illnesses. For example, in Japan, there is a stigma of shame or dishonor associated with mental illness, and this cultural attitude may contribute to deprivations of human rights in that nation. See Gostin, L. Human rights in mental health: a proposal for five international standards based upon the Japanese experience. International Journal of Law and Psychiatry 1987;10:353–68.CrossRefGoogle ScholarPubMed

65. For an excellent discussion of ethical principles involved in clinical research, particularly among vulnerable populations, see Gostin, L. Ethical principles for the conduct of human subject research: population-based research and ethics. Law, Medicine ' Health Care 1991;19:191201.Google Scholar

66. Levine, RJ, Mariner, WK. Proposed guidelines for international testing of vaccines and drugs against HIV infection and AIDS. Prepared at the request of WHO, Global Programme on AIDS, 1990.Google Scholar

67. Howard-Jones, N. Bankowski, Z, Eds. Medical Experimentation and the Protection of Human Rights: Proceedings of the Xllth CIOMS Round Table Conference.Geneva:Council for International Organizations of Medical Science, Sandoz Institute for Health and Socio-Economic Studies,1979:57–8.Google Scholar

68. See note 67. Howard-Jones, Bankowski. 1979:57.Google Scholar

69. See note 67. Howard-Jones, Bankowski. 1979:196.Google Scholar

70. See note 67. Howard-Jones, Bankowski. 1979:196.Google Scholar

71. Egilman, DS, Reinert, A. What is informed consent? Washington Post 1994;01 14:A23.Google Scholar

72. Jones, DP. Callous experiments on “volunteers” part of pattern. Hartford Courant 1993;10 18:A1.Google Scholar

73. See note 11. Rosenthal, . 1996.Google Scholar