Ethical Issues in HIV Vaccine Trials

Thomas Kerns

 

Selected Bibliography

 

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. National Commission for the Protection of Human Subjects of Biomedican and Behavioral Research, Department of Health, Education and Welfare, 1979 1979.
G. L. Ada, "Modern Vaccines", The Lancet, 335.March 3 (1990) 523-26.
L. K. Altman MD. "After Setback, First Large AIDS Vaccine Trials Are Planned." New York Times November 29 1994. B6.
G. J. Annas and M. A. Grodin, eds. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. (New York, NY: Oxford University Press, 1992) 371+xxii.
AP. "Gambian group have rare immunity to AIDS virus." The Seattle Times January 1 1995.
AP. "Illegal AIDS testing reported." Seattle Times 21 September 1995. A5.
AP. "Researchers Look to Girl, 13, for Clues on AIDS." The New York Times January 9 1995. A10.
M. Balter, "UN Readies New Global AIDS Plan", Science, 266.25 November (1994) 1312-13.
Z. Bankowski, ed. International Guiding Principles for Biomedical Research Involving Animals. (Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 1985) 28.
Z. Bankowski, ed. International Guidelines for Ethical Review of Epidemiological Studies. (Geneva: World Health Organization, 1991)
Z. Bankowski. International Ethical Guidelines for Biomedical Research Involving Human Subjects. of (Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 1993) 63.
Z. Bankowski and R. J. Levine, eds. Ethics and Research on Human Subjects: International Guidelines (Proceedings of the XXVIth CIOMS Conference, Geneva, Switzerland, 5-7 February 1992). (Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 1993) 228 + 63 + x.
S. Barnet, et al., "An AIDS-like Condition Induced in Baboons by HIV-2", Science, 266, No 5185.October 28 (1994) 642.
R. Bayer. "Confidentiality and Its Limits." Ethics and Law in the Study of AIDS. Eds. H. Fuenzalida-Puelma, A. M. L. Parada and D. S. LaVertu. (Washington, D C: Pan American Health Organization, Regional Office of the World Health Organization, 1992) Scientific Publication No. 530: 145-47.
T. L. Beauchamp and J. F. Childress. Principles of Biomedical Ethics. 3d ed. of (New York: Oxford University Press, 1989) 470+x.
R. B. Belshe, et al., "Interpreting HIV Serodiagnostic Test Results in the 1990s: Social Risks of HIV Vaccine Studies in Uninfected Volunteers", Annals of Internal Medicine, 121, # 8.15 October (1994) 584-89.
R. Berkow and A. J. Fletcher, eds. The Merck Manual of Diagnosis and Therapy. Fifteenth ed. (Rahway, NJ: Merck Sharp & Dohme Research Laboratories, 1987) 2697+xxviii.
E. Bernstein. "Forward." Medical and Health Annual, 1992. Ed. E. Bernstein. 1992 ed. Medical and Health Annual (Chicago, IL: Encyclopaedia Britannica, Inc, 1992) 1992:
G. Bjune and T. W. Gedde-Dahl, "Some problems related to risk-benefit assessments in clinical testing of new vaccines", IRB, 15, #1.January-February (1993) 1-5.
E. Blackstone. personal communication about UW's vaccine research studies. July 22, 1994 1994
E. Blackstone. personal communication about UW's vaccine studies. 22 July 1994
D. Blum. The Monkey Wars. of (New York, NY: Oxford University Press, 1994) 306+xii.
T. Brown and P. Xenos. "AIDS: Epidemic in Asia." Seattle Post-Intelligencer October 2 1994. D1,D3.
D. S. Burke, "Human HIV Vaccine Trials: Does antibody-dependent enhancement pose a genuine risk?", Perspectives in Biology and Medicine, 35, #4.Summer (1992) 511-30.
C. Burrell for the Associated Press. "Report: 'Reckless' use of Gulf War drugs." Seattle Times 8 December 1994. A3.
D. Butler, "Call for International AIDS policy", Nature, 372.24 November (1994) 308.
M. Caldwell, "The Long Shot", Discover, .August (1993) 61-69.
A. Camus. The Plague. Trans. Gilbert, Stuart. of (New York, NY: Vintage International, Random House, 1948, 1991) 308+.
N. A. Christakis, "The Ethical Design of an AIDS Vaccine Trial in Africa", Hastings Center Report, 18, #3.June/July (1988) 31-37.
J. Cohen, "At Conference, Hope for Success Is Further Attenuated", Science, 266.18 November (1994) 1154.
J. Cohen, "Bumps on the Vaccine Road", Science, 265.2 September (1994) 1371-73.
J. Cohen, "The Duesberg Phenomenon", Science, 266.9 December (1994) 1642 - 49.
S. S. Connor. "International Legal and Ethical Aspects of Developing and Distributing an HIV Vaccine." Ethics and Law in the Study of AIDS. Eds. H. Fuenzalida-Puelma, A. M. L. Parada and D. S. LaVertu. (Washington, D C: Pan American Health Organization, Regional Office of the World Health Organization, 1992) 162-69.
Cotton, "International Disunity on HIV Vaccine Efficacy Trials", JAMA, 272, #14.12 October (1994) 1990-91.
P. Cotton, "International Disunity on Vaccine Efficacy Trials", JAMA, 272.Number 14, 12 October (1994) 1090.
G. Cowley and M. Hager. "The Ever-Expanding Plague." Newsweek 22 August 1994: 37.
J. Crewdson. "AIDS Vaccine Fails Researcher." Chicago Tribune Sunday 5 September 1993. 1.
A. W. Crosby. America's Forgotten Pandemic: The Influenza of 1918. of (New York City, NY: Cambridge University Press, 1989) 337+xiv.
M. Daniel, et al., "Protective effects of a live attenuated SIV vaccine with a deletion in the nef gene", Science, 258 (1992) 1938-41.
K. M. De Cock MD, MRCP, DTM&H, et al., "The Public Health Implications of AIDS Research in Africa", JAMA, 272, #6.10 August (1994) 481-86.
G. Eddy. personal communication about HIV vaccine. July 4, 1994 1994
Editor, "Editorial", Nature, 366, # 6455.9 December (1993) 493-94.
Editor, The Bulletin of the King County Medical Society, 73, #12.December (1994) cover.
S. Efron. "Russia moves toward AIDS tests for foreigners." Seattle Times 29 October 1994. A3.
P. Ewald. The Evolution of Infectious Disease. of Oxford University Press, 1994)
P. Ewald. personal communication about virulence. July 15, 1994 1994
K. Fackelmann, "HIV's infectious nature", Science News, .14 January (1995) 22.
D. FitzSimons. Personal communication. 1994
D. P. Francis. "A Private-Sector AIDS Vaccine? Don't Hold Your Breath"." Washington Post 19 July 1994. A17.
M. B. Gardner and S.-L. Hu, "SIV vaccines, 1991 - a year in review", AIDS, 5 (supplement 2) (1991) S115-S127.
L. Garrett. The Coming Plague: Newly Emerging Diseases in a World Out of Balance. of (New York, NY: Farrar, Straus and Giroux, 1994) 750+xiv.
L. Garrett. "Unified AIDS Fight; UN combines agency efforts." Newsday 13 December 1994. A37.
W. Global Programme on AIDS. Statement from the Consultation on Criteria for International Testing of Candidate HIV Vaccines. of (Geneva: World Health Organization, 1989) 13.
W. Global Programme on AIDS. Potential for WHO-Industry Collaboration on Drug and Vaccine Development for HIV/AIDS. of (Geneva: World Health Organization, 1993) 11.
M. F. Goldsmith, "For AIDS Treatment, Vaccines, Now Think Genes", JAMA, 269, #17.5 May (1993) 2189-90.
C. Grady RN, PhD. The Search for an AIDS Vaccine. of (Indianapolis, IN: Indiana University Press, 1995) 193.
M. D. Grmek MD, PhD. History of AIDS: Emergence and Origin of a Modern Pandemic. Trans. Maulitz, Russell, and Duffin, Jacalyn. of (Princeton, NJ: Princeton University Press, 1990) 279+xii.
B. F. Haynes, "Scientific and Social Issues of Human Immunodeficiency Virus Vaccine Development", Science, 260.28 May (1993) 1279-86.
D. A. Henderson and F. Fenner. "Smallpox and Vaccinia." Vaccines. Ed. S. A. Plotkin. second ed. (Philadelphia, PA: W.B. Saunders Company, 1994) 13-40.
W. L. Heyward, et al., "Preparation for Phase III HIV vaccine efficacy trials: methods for the determination of HIV incidence", AIDS, 8, #9.September (1994) 1285-91.
D. Hodel and AIDS Action Foundation Working Group. HIV Preventive Vaccines: Social, Ethical, and Political Considerations. of AIDS Action Foundation, Office of AIDS Research, National Institutes of Health, 1994)
J. Homsy et al, "The Fe and Not CD4 Receptor Mediates Antibody Enhancement of HIV Infection in Human Cells", Science, 244 (1989) 1357-59.
D. R. Hopkins. Princes and Peasants: Smallpox in History. of (Chicago: University of Chicago Press, 1983) 380+xx.
D. R. Hopkins, et al., "Dracunculiasis eradication: Beginning of the end", American Journal of Tropical Medicine and Hygiene, 49 #3 (1993) 281-89.
D. F. Hoth, et al., "HIV Vaccine Development: A Progress Report", Annals of Internal Medicine, 8, #7.15 October (1994) 603-11.
A. R. Jonsen, "The Ethics of Using Human Volunteers for High-Risk Research", Journal of Infectious Diseases, 160.August (1989) 205-208.
A. R. Jonsen and J. Stryker, eds. The Social Impact of AIDS in the United States. (Washington, D C: National Academy Press, 1993) 322+xiv.
I. Kant. Fundamental Principles of the Metaphysic of Morals. Vol. 42 of Trans. Thomas Kingsmill Abbott. 42 of 54, (Chicago, IL: The Great Books of the Western World, Encyclopedia Britannica, Inc, 1785, 1952)
E. Kessel, "Estimating Risks and Benefits in AIDS Vaccine and Drug Trials", AIDS & Public Policy Journal, 5.#4, Winter (1990) 186-88.
S. Kierkegaard, Concluding Unscientific Postscript. Trans. D. Swenson and W. Lowrie. Princeton University Press, 1846, 1941) 577+xxii.
J. Kinsella. Covering the Plague: AIDS and the American Media. of (New Brunswick, NJ: Rutgers University Press, 1989) 299+x.
Knight-Ridder-Newspapers. "AIDS extremely contagious in early stages, study finds." The Seattle Times 6 January 1995. A7.
W. C. Koff, "Development and Testing of AIDS Vaccines", Science, 241 (1988) 426-32.
W. C. Koff, "The Next Steps Toward a Global AIDS Vaccine", Science, 266.25 November (1994) 1335-37.
M. Lappé. Evolutionary Medicine: Rethinking the Origins of Disease. of (San Francisco, CA: Sierra Club Books, 1994) 255+xii.
A. J. Levine. Viruses. of (New York, NY: Scientific American Library, 1992) 241+xii.
C. Levine, N. N. Dubler and R. J. Levine, "Building a New Consensus: Ethical Principles and Policies for Clinical Research on HIV/AIDS", IRB, 13, #1-2.January-April (1991) 1-17.
R. J. Levine. Ethics and Regulation of Clinical Research. second ed. of (New Haven, CT: Yale University Press, 1986, 1988) 452+xx.
R. J. Levine. "AIDS Research and Ethical Review Boards." Ethics and Law in the Study of AIDS. Eds. H. Fuenzalida-Puelma, A. M. L. Parada and D. S. LaVertu. (Washington, D C: Pan American Health Organization, Regional Office of the World Health Organization, 1992) 170-77.
A. Mack, ed. In Time of Plague: The History and Social Consequences of Lethal Epidemic Disease. (New York: New York University Press, 1991) 206+xii.
J. Mann and D. Tarantola. AIDS in the World: Redefining the Global HIV/AIDS Pandemic. of (New York: Oxford University Press, 1995, in press) 12.
J. Mann, D. Tarantola and T. Netter, eds. AIDS in the World. (Cambridge, MA: Harvard University Press, 1992) 1037+xvi.
E. Martin. Flexible Bodies: Tracking Immunity in American Culture, from the Days of Polio to the Age of AIDS. of (Boston: Beacon Press, 1994) 320+xxiv.
J. R. Mascola MD, J. G. McNeil MD, MPH and D. S. Burke MD, "AIDS Vaccines: Are We Ready for Human Efficacy Trials?", Journal of the American Medical Association, 272.#6, August 10 (1994) 488-89.
M. J. McElrath and L. Corey. "Current Status of Vaccines for HIV." Pediatric AIDS: The challenge of HIV infection in infants, children and adolescents. Eds. P. H. Pizzo and C. M. Wilfert. (Baltimore, MD: Williams and Wilkins, 1994) 869-887.
W. H. McNeill. Plagues and Peoples. of (Garden City, NY: Doubleday Anchor, 1976) 340+xii.
J. Miller, "Ethical Standards for Human Subject Research in Developing Countries", IRB, A Review of Human Subjects Research, 14.3, May-June (1992) 7-8.
P. Monette. Borrowed Time. of (New York, NY: Avon, 1988) 342.
E. Mozes-Kor. "The Mengele Twins and Human Experimentation: A Personal Account." The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. Eds. G. J. Annas and M. A. Grodin. (New York, NY: Oxford University Press, 1992) 53-59.
N. P. R. NPR. Program on Vaccines. 1994.
R. O'Boyle. Living With AIDS. of (Seattle, WA: The Seattle Times, 1992) 62.
J. W. Pape et. al., "The Urge for an AIDS Vaccine: Perspectives from a Developing Country", AIDS Research and Human Retroviruses, 8, #8 (1992) 1535-37.
B. Peabody. The Screaming Room. of (New York, NY: Avon, 1986) 279.
J. C. Petricciani, W. C. Koff and G. L. Ada, "Efficacy Trials for HIV/AIDS Vaccines", AIDS Research and Human Retroviruses, 8, #8 (1992) 1527-29.
P. Piot Associate Director of WHO's GPA. Lecture on Global Issues for HIV Prevention and Control. Harborview Medical Center: University of Washington, July 13, 1994.
S. A. Plotkin MD and E. A. Mortimer Jr, MD, eds. Vaccines. second ed. (Philadelphia: W.B. Saunders Company, 1994) 996 + xix.
S. L. Plotkin and S. A. Plotkin. "A Short History of Vaccination." Vaccines. Eds. S. A. Plotkin and E. A. Mortimer. second ed. (Philadelphia, PA: W.B. Saunders Co, 1994) 1-11.
J. P. Porter, M. J. Glass and W. C. Koff, "Ethical Considerations in AIDS Vaccine Testing", IRB, A Review of Human Subjects Research, 11.#3, May-June (1989) 1-4.
E. D. Prentice, et al., "Bill of Rights for Research Subjects", IRB, A Review of Human Subjects Research, 15.#2, March-April (1993) 7-9.
N. R. Rabinovich, et al., "Vaccine Technologies: View to the Future", Science, 265.2 September (1994) 1401-04.
C. A. Radin. "AIDS fight portrayed as a failure; Prevention, education efforts fall short, global specialist says." The Boston Globe 10 August 1994. 1.
A. J. H. Rains MS, FRCS. Edward Jenner and Vaccination. Pioneers of Science and Discovery. of (East Sussex: Wayland Publishers, 1974, 1980) 96.
Reuters. "WHO Approves Large-Scale AIDS Vaccine Trials." Centers for Disease Control AIDS Daily Update 14 October 1994.
A. Richardson and D. Bolle, eds. Wise Before Their Time: People from Around the World Living with AIDS and HIV Tell Their Stories. (London: HarperCollins, 1992) 144.
W. N. Rida and D. N. Lawrence, "Some Statistical Issues in HIV Vaccine Trials", Statistics in Medicine, 13 (1994) 2155-77.
I. Roitt. Essential Immunology. 7th ed. of (Oxford: Blackwell Scientific Publications, 1991) 356+xii.
R. Root-Bernstein. Rethinking AIDS: The Tragic Cost of Premature Consensus. of (New York, NY: The Free Press, Macmillan, 1993) 512 + xv.
D. J. Rothman. Strangers at the Bedside: A history of how law and bioethics transformed medical decision making. of Basic Books, HarperCollins, 1991) 303+xii.
S. Rowland-Jones, "HIV-specific Cytotoxic T-cells in HIV-exposed but Uninfected Gambian Women", Nature Medicine, 1.January (1995) 59-64.
F. Ryan MD. The Forgotten Plague: How the Battle Against Tuberculosis was Won - and Lost (published in England as The Greatest Story Never Told). of (Boston: Little, Brown and Co, 1992, 1993) 460+xx.
B. D. Schoub. AIDS & HIV in Perspective. of (New York, NY: Cambridge University Press, 1994) 268+xx.
C. Siebert. ""Smallpox is Dead, Long Live Smallpox." The New York Times Magazine 21 August 1994. section 6, 31-55.
L. M. Simons. "AIDS cure impossible this century, predicts co-discoverer of virus." The Seattle Times 8 August 1994.
S. Sontag. AIDS and Its Metaphors. of (New York: Farrar, Straus and Giroux, 1988) 95.
W. P. &. S. T. Staff. "Radiation tests involved at least 23,000." Seattle Times 22 October 1994. A1.
J. R. Starke and K. K. Connelly. "Bacille Calmette-Guérin Vaccine." Vaccines. Eds. S. A. Plotkin MD and E. A. Mortimer Jr, MD. second ed. (Philadelphia: W.B. Saunders Company, 1994) 439-73.
P. Stehr-green. personal communication about vaccines. 4 January 1995
G. Stine. Acquired Immune Deficiency Syndrome: Biological, Medical, Social and Legal Issues. 1st ed. of (Englewood Cliffs, NJ 07632: Prentice Hall, 1993) 462 + xxxii.
S. Stolberg. "Promise, Disappointment Mark AIDS Vaccine Quest." Los Angeles Times 9 August 1994. A1.
L. Thomas. The Fragile Species. of (New York, NY: Charles Scribner's Sons, 1992) 193+xii.
L. Thompson, "CDC Reorganization Prompts Concern", Science, 266.25 November (1994) 1313.
Thucydides. The History of the Peloponnesian War. Vol. 6 of Great Books of the Western World. Trans. Crawley, Richard, and Feetham, R. 6 of 54, (Chicago: Encyclopedia Britannica, 1952) 267.
M. ul Haq, ed. Human Development Report 1994. (New York, NY: Oxford University Press, 1994) 226+xii.
UNDP. Human Development Report 1994. of United Nations Development Programme, 1994)
B. G. Weniger, "Experience from HIV incidence cohorts in Thailand: implications for HIV vaccine efficacy trials.", AIDS, 8, #7 (1994) 1007-1010.
WHO. Malaria vaccine reduces disease in African children. World Health Organization, 28 October 1994.
E. B. Wilson. At the Edge of Life: an introduction to viruses. Vol. NIH Publication 80-433 of NIH Publication 80-433 of (Washington D C: US Department of Health and Human Services, Government Printing Office, 1980) 75.

 

(For citations and references, please see the printed version of this book)


email Dr Kerns

Curriculum Vita | TK homepage | Public lectures | Jenner homepage
EVT Table of contents
EVT Introduction | EVT chapter 1 | EVT chapter 2 | EVT chapter 3
EVT chapter 4 | EVT chapter 5 | EVT chapter 6 | EVT chapter 7 | EVT chapter 8
EVT chapter 9 | EVT chapter 10 | EVT chapter 11 | EVT chapter 12 | EVT chapter 13
EVT chapter 14 | EVT chapter 15 | EVT chapter 16 | EVT chapter 17 | EVT chapter 18
EVT chapter 19 | EVT chapter 20 | EVT chapter 21 | EVT chapter 22 | EVT chapter 23
EVT chapter 24 | EVT chapter 25 | EVT chapter 26 | EVT chapter 27
EVT Appendices | EVT Bibliography | Lancet Review of EVT

© copyright Dr Tom Kerns