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Ethical Issues of Behavioral Interventions for HIV Prevention

  • Chapter
Handbook of HIV Prevention

Part of the book series: Aids Prevention and Mental Health ((APMH))

Abstract

The world was shocked by the accounts of the experiments conducted by Nazi physicians on concentration camp prisoners. These experiments included the exposure of prisoners to cold water and to extremely low air pressure,1 the injection of dye into persons’ eyes in an attempt to change their eye color, and the inoculation of prisoners with typhus bacilli.2 These events provided the impetus for the formulation of the Nuremberg Code, which enumerated ten principles to be universally applied to research involving human participants:

  1. 1

    The voluntary consent of the prospective participant is essential.

  2. 2

    The experiment must be expected to produce results beneficial, for society that cannot be obtained by any other means.

  3. 3

    The study should be based on the results of animal experimentation and a knowledge of the natural history of the disease in question so that the anticipated results justify conducting the experiment.

  4. 4

    All unnecessary physical or mental suffering or injury should be avoided during the course of the experiment.

  5. 5

    No experiment should be conducted where it is believed that death or disabling injury will occur, except where the research physicians also serve as subjects.

  6. 6

    The degree of risk should not exceed the humanitarian importance of the problem to be solved.

  7. 7

    The participant should be protected against death or injury through the use of adequate facilities and preparations.

  8. 8

    The experiment should be conducted only by scientifically qualified persons.

  9. 9

    The participant has the right to end his or her participation in the experiment if he or she has reached a point where continuation seems to be impossible.

  10. 10

    The scientist in charge must be prepared to terminate the experiment if he or she has probable cause to believe that continuation would be likely to result in the injury, disability, or death of the research participant.3

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References

  1. Applebaum PS, Lidz C, Meisel A. Informed Consent: Legal Theory and Clinical Practice. London: Oxford University Press; 1987.

    Google Scholar 

  2. Grodin MA, Kaminow PV, Sassower R. Ethical issues in AIDS research. QRB Qual Rev Bull 1986; 12:347–352.

    PubMed  CAS  Google Scholar 

  3. World Medical Association. The Nuremberg Code. Law Med Health Care 1991; 19:266.

    Google Scholar 

  4. Perley S, Fluss SS, Bankowski Z, Simon F. The Nuremberg Code: An international overview. In: Annas GJ, Grodin MA, eds. The Nazi Doctors and the Nuremberg Code. London: Oxford University Press; 1992: 149–173.

    Google Scholar 

  5. Christakis NA, Partner MJ. Existing international guidelines for human subjects research: Some open questions. Law, Med Health Care 1991; 19:214–221.

    CAS  Google Scholar 

  6. World Medical Association. Declaration of Helsinki. Law, Med Health Care 1991; 9:264–265.

    Google Scholar 

  7. Council for International Organizations of Medical Sciences. International Guidelines for Ethical Review of Epidemiological Studies. Geneva: Council for International Organizations of Medical Sciences; 1991.

    Google Scholar 

  8. Council for International Organizations of Medical Sciences, World Health Organization. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: Council for International Organizations of Medical Sciences; 1993.

    Google Scholar 

  9. Cohen J. Ethics of AZT studies in poorer countries attacked. Science 1997; 276:1022.

    Article  PubMed  CAS  Google Scholar 

  10. Gambia Govemment/Medical Research Council Joint Ethical Committee. Ethical issues facing medical research in developing countries. Lancet 1998; 351:286–287.

    Article  Google Scholar 

  11. Levine RI. Informed consent: Some challenges to the universality of the Western model. Law Med Health Care 1991; 19:207–213.

    PubMed  CAS  Google Scholar 

  12. Newton LH. Ethical imperialism and informed consent. IRB: Rev Human Subjects Res 1990; 12:10–11.

    Google Scholar 

  13. Loue S, Okello D, Kawuma M. Research bioethics in the Ugandan context: A program summary. Ethics Law Med 1996; 24:47–53.

    Article  CAS  Google Scholar 

  14. Jonsen AR. Casuistry and clinical ethics. Theor Med 1986; 7:65–74.

    Article  PubMed  CAS  Google Scholar 

  15. Arras JD. Getting down to cases: The revival of casuistry in bioethics. J Med Philos 1991; 16:29–51.

    Article  PubMed  CAS  Google Scholar 

  16. Jonsen AR, Toulmin S,. The Abuse of Casuistry: A History of Moral Reasonings. Berkeley: University of California Press; 1988.

    Google Scholar 

  17. Dworkin R. Spheres of justice: An exchange. NY Rev Books 1983; 30:44.

    Google Scholar 

  18. Habermas J. The hermeneutic claim to universality. In: Bleicher J, ed. Contemporary Hermeneutics. London: Routledge & Kegan Paul; 1980:181–211.

    Google Scholar 

  19. Nisbet R. The problem of community. In: Daly M, ed. Communitarianism: A New Public Ethics. Belmont, CA. Wadsworth, Inc; 1994:139–153.

    Google Scholar 

  20. Beauchamp TL, Childress JE. Principles of Biomedical Ethics, 4th ed. New York: Oxford University Press; 1994.

    Google Scholar 

  21. Bentham J. An Introduction to the Principles of Morals and Legislation. Oxford: Clarendon Press; 1970.

    Google Scholar 

  22. Moore GE. Principia Ethica. Cambridge: Cambridge University Press; 1903. Cited in Beauchamp TL, Childress JE. Principles of Biomedical Ethics, 4th ed. New York: Oxford University Press; 1994.

    Google Scholar 

  23. Griffin J. Well-Being: Its Meaning, Measurement,and Moral Importance. Oxford: Clarendon Press; 1986.

    Google Scholar 

  24. Carse AL. The “voice of care.” Implications for bioethics education. J Philos Med 1991; 16:5–28.

    Article  CAS  Google Scholar 

  25. Jaggar AM. Feminist ethics: Projects, problems, prospects. In: Card C, ed. Feminist Ethics. Lawrence, KS: University of Kansas Press; 1991:78–104.

    Google Scholar 

  26. Baier A. What do women want in a moral theory? Nous March 1985:53–63.

    Google Scholar 

  27. Held V. Noncontractual society. In: Hanen M, Nielsen K, eds. Science, Morality, and Feminist Theory. Calgary: University of Calgary Press; 1987:111–137.

    Google Scholar 

  28. Gilligan C. In a Different Voice: Psychological Theory and Women’s Development. Cambridge, MA: Harvard University Press; 1982.

    Google Scholar 

  29. Mendelson JH. Protection of participants and experimental design in clinical abuse liability testing. Br Med J 1991; 86:1543–1548.

    CAS  Google Scholar 

  30. Uganda National Council on Science and Technology. Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda. Kampala, Uganda: Uganda National Council on Science and Technology; 1998.

    Google Scholar 

  31. Ackerman TF. Protectionism and the new research imperative in pediatric AIDS. IRB: Rev Hum Subjects Res 1990; 12:1–5.

    Google Scholar 

  32. High DM. Research with Alzheimer’s disease subjects: Informed consent and proxy decision making. J Am Geriatrics Soc 1992: 40:950–957.

    CAS  Google Scholar 

  33. Lo B. Assessing decision-making capacity. Law Med Health Care 1990; 18:193–201.

    PubMed  CAS  Google Scholar 

  34. Herxheimer A. The rights of the patient in clinical research. Lancet 1988; 2:1128–1130.

    Article  PubMed  CAS  Google Scholar 

  35. Portney LG, Watkins MR. Foundations of Clinical Research: Applications to Practice. Norwalk, CT: Appleton & Lange; 1993.

    Google Scholar 

  36. Owens JE. Informed consent in the clinical research setting: Experimentation on human subjects. Med Trial Techniques 1987; 33:335–350.

    Google Scholar 

  37. Dubler NN, Sidel VW. On research on HIV infection and AIDS in correctional institutions. Milbank Q 1989; 67:171–207.

    Article  PubMed  CAS  Google Scholar 

  38. Siegel HA, Carlson RG, Falck R, et al. Conducting HIV outreach and research among incarcerated drug abusers: A case study of ethical concerns and dilemmas. J Subst Abuse Treat 1993; 10:71–75.

    Article  Google Scholar 

  39. Hammett TM, Dubler NN. Clinical and epidemiologic research on HIV infection and AIDS among correctional inmates: Regulations, ethics, and procedures. Eval Rev 1990; 14:482–501.

    Article  Google Scholar 

  40. Schroeder K. A recommendation to the FDA concerning drug research on prisoners. Southern Cal Law Rev 1983; 56:969–1000.

    Google Scholar 

  41. Woody KJ. Legal and ethical concepts involved in informed consent to human research. Cal West Law Rev 1981; 18:50–79.

    Google Scholar 

  42. Code of Federal Regulations, sections 46.305,.404-.408; 1997.

    Google Scholar 

  43. Sieber J. Planning Ethically Responsible Research: A Guide for Students and Internal Review Boards. Beverly Hills, CA: Sage; 1992.

    Google Scholar 

  44. Joint United Nations Programme on HIV/AIDS. Report on the Global HIV/AIDS Epidemic. Geneva: World Health Organization; June 1988.

    Google Scholar 

  45. Barton J, Wamai G Equity and Vulnerability: A Situation Analysis of Women,Adolescents, and Children in Uganda. Kampala, Uganda: Uganda National Council for Children; 1994.

    Google Scholar 

  46. Nzita R, Niwampa M. Peoples and Cultures of Uganda, 2nd ed. Kampala, Uganda: Fountain Publishers; 1995.

    Google Scholar 

  47. Wallman S Kampala Women Getting By: Well-being in the Time of AIDS. London: James Currey; 1996.

    Google Scholar 

  48. Pirouet L. Refugees in and from Uganda in the post-independence period. In: Hansen HB, Twaddle M, eds. Uganda Now: Between Decay and Development. London: James Currey; 1988:239–253.

    Google Scholar 

  49. Mutibwa P, Uganda since Independence: A Story of Unfulfilled Hopes. Kampala, Uganda: Fountain Publishers; 1992.

    Google Scholar 

  50. Loue S. Legal and Ethical Aspects of HIV-Related Research. New York: Plenum Press; 1995.

    Google Scholar 

  51. Falk TC. AIDS public health law. J Legal Med 1988; 9:529–546.

    Article  CAS  Google Scholar 

  52. . Tarasoff v Regents of the University of California, 17 Cal. 3d 425 (1976).

    Google Scholar 

  53. . McIntosh y Milano, 168 N.J. Super. 466 (1979).

    Google Scholar 

  54. . Earle y Kuklo, 26 N.J. Super. 471 (App. Div. 1953).

    Google Scholar 

  55. . David v Lhim, 124 Mich. App. 291 (1983), aff’d on rem 147 Mich. App. 8 (1985), rev’d on grounds of government immunity in Canon y Thumundo, 430 Mich. 326 (1988).

    Google Scholar 

  56. . Thompson v County of Alameda, 27 Cal. 3d 741 (1980).

    Google Scholar 

  57. . Jablonski v United States, 712 F.2d 391 (9th Cir. 1983).

    Google Scholar 

  58. Traver LB, Cooksey DR. Defense argument. In Girardi JA, Keese RM, Traver LB, Cooksey DR, eds. Psychotherapist responsibility in notifying individuals at risk for exposure to HIV. J Sex Res 1988; 25:1–27.

    Google Scholar 

  59. Knapp S, Van de Creek L. Application of the duty to protect to HIV-positive patients. Profess Psychol Res Pract 1990; 21:161–166.

    Article  Google Scholar 

  60. Appelbaum PS, Rosenbaum A. Tarasoff and the researcher: Does the duty to protect apply in the research setting? Am Psychol 1989; 44:885–894.

    Article  PubMed  Google Scholar 

  61. Francis D, Chin J. The prevention of acquired immunodeficiency syndrome in the United States. JAMA 1987; 257:1357–1366.

    Article  PubMed  CAS  Google Scholar 

  62. American Medical Association. Current opinions of the Judicial Council, Current Opinion 5.05. In: McDonald BA, ed. Ethical Problems for Physicians Raised by AIDS and HIV Infection: Conflicting Legal Obligations of Confidentiality and Disclosure. Davis: University of California; 1989:557–592.

    Google Scholar 

  63. Lamb DH, Clark C, Drunheler P, et al. Applying Tarasoff to AIDS-related psychotherapy issues. Profess Psychol Res Pract 1989; 20:37–43.

    Article  Google Scholar 

  64. Public Health Service, United States Department of Health and Human Services. A Public Health Challenge: State Issues,Policies, and Programs,vol. 1. United States Department of Health and Human Services 1987: 4–1–4–31.

    Google Scholar 

  65. Totten G, Lamb DH, Reeder GD. Tarasoff and confidentiality in AIDS-related psychotherapy. Profess Psychol Res Prac 1990; 21:155–160.

    Article  Google Scholar 

  66. Fruman LS. AIDS and the physician’s duty to warn (part 2). Med Law 1991; 10:515–526.

    PubMed  CAS  Google Scholar 

  67. Angell M. The ethics of clinical research in the Third World. N Engl J Med 1997; 337:847–849.

    Article  PubMed  CAS  Google Scholar 

  68. Lurie P, Wolfe SM. Unethical trials of interventions to reduce potential transmission of the human immunodeficiency virus in developing countries. N Engl J Med 1997; 337:853–856.

    Article  PubMed  CAS  Google Scholar 

  69. Varmus H, Satcher P. Ethical complexities of conducting research in developing countries. N Engl J Med 1997; 337:1003–1005.

    Article  PubMed  CAS  Google Scholar 

  70. Pellegrino ED. Nonabandonment: An old obligation revisited. Ann Intern Med 1995; 122:377–378.

    PubMed  CAS  Google Scholar 

  71. Quill TE, Cassel CK. Nonabandonment: A central obligation for physicians. Ann Intern Med 1995; 122:368–374.

    PubMed  CAS  Google Scholar 

  72. British HIV Association. Guidelines. Lancet 1997; 349:1086–1092.

    Article  Google Scholar 

  73. Carpenter CC, Fischl MA, Hammer SM, et al. Antiretroviral therapy for HIV infection in 1997. Updated recommendations from the International AIDS Society-USA panel. JAMA 1997; 277:1962–1969.

    Article  PubMed  CAS  Google Scholar 

  74. Macklin R, Friedland G. AIDS research: The ethics of clinical trials. Law Med Health Care 1986; 14:273–280.

    PubMed  CAS  Google Scholar 

  75. Freedman B. Suspended judgment: AIDS and the ethics of clinical trials: Learning the right lessons. Controlled Clin Trials 1992; 13:1–5.

    Article  PubMed  CAS  Google Scholar 

  76. Halbreich U, Carson SW. Drug studies in women of childbearing age: Ethical and methodological considerations. J Clin Psychopharmacol 1989; 9:328–333.

    Article  PubMed  CAS  Google Scholar 

  77. Murphy TF. Women and drug users: The changing faces of HIV clinical drug trials. QRB Qual Rev Bull 1991; 17:26–32.

    PubMed  CAS  Google Scholar 

  78. Levine C. Women and HIV/AIDS research: The barriers to equity. Eval Rev 1990; 14:447–463.

    Article  Google Scholar 

  79. Levine C. Women and HIV/AIDS research: The barriers to equity. IRB: Rev Hum Subjects 1991; 13:18–23.

    Article  Google Scholar 

  80. Buc NL. Women in clinical trials: Concluding remarks. Food Drug Law J 1993; 48:223–226.

    PubMed  Google Scholar 

  81. Merton V. The exclusion of pregnant, pregnable, and once-pregnable people (a.k.a. women) from biomedical research. Am J Law Med 1993; 19:369–451.

    PubMed  CAS  Google Scholar 

  82. Murphy D. Women in clinical trials: HIV-infected women. Food Drug Law J 1993; 48:175–179.

    PubMed  Google Scholar 

  83. Merkatz RB, Temple R, Subel S, et al. Women in clinical trials of new drugs: A change in Food and Drug Administration policy. N Engl J Med 1993; 329:292–296.

    Article  PubMed  CAS  Google Scholar 

  84. Moreno JD. Ethical issues relating to the inclusion of women of childbearing age in clinical trials. In: Mastroianni AC, Faden R, Federman D, eds. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, vol. 2. Washington, DC: National Academy Press; 1994:29–34.

    Google Scholar 

  85. Mastroianni AC, Faden F, Federman D, eds. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, vol. 1. Washington, DC: National Academy Press; 1994.

    Google Scholar 

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Authors and Affiliations

  1. Department of Epidemiology and Biostatistics, Case Western Reserve University, MetroHealth Medical Center, Cleveland, Ohio, 44109, USA

    Sana Loue

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  1. Sana Loue
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Editor information

Editors and Affiliations

  1. Georgia State University, Atlanta, Georgia, USA

    John L. Peterson Ph.D.

  2. Emory University, Atlanta, Georgia, USA

    Ralph J. DiClemente Ph.D.

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Loue, S. (2000). Ethical Issues of Behavioral Interventions for HIV Prevention. In: Peterson, J.L., DiClemente, R.J. (eds) Handbook of HIV Prevention. Aids Prevention and Mental Health. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-4137-0_16

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  • DOI: https://doi.org/10.1007/978-1-4615-4137-0_16

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4613-6855-7

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