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9 - Ethics of clinical research

Published online by Cambridge University Press:  05 June 2012

Rebecca Richards-Kortum
Affiliation:
Rice University, Houston
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Publisher: Cambridge University Press
Print publication year: 2009

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References

Bernard, C. An Introduction to the Study of Experimental Medicine. New York: Macmillan; 1927.Google Scholar
Stern, AM, Markel, H. The history of vaccines and immunization: familiar patterns, new challenges. Health Affairs (Project Hope). 2005 May–Jun; 24(3): 611–21.CrossRefGoogle ScholarPubMed
Wall, LL. The medical ethics of Dr J Marion Sims: a fresh look at the historical record. Journal of Medical Ethics. 2006 Jun; 32(6): 346–50.CrossRefGoogle Scholar
Grodin, MA, Glantz, LH. Children as Research Subjects : Science, Ethics, and Law. New York: Oxford University Press; 1994.Google Scholar
Lederer, SE. Subjected to Science : Human Experimentation in America before the Second World War. Baltimore: Johns Hopkins University Press; 1995.Google Scholar
Pierce, JR, Writer, J. Yellow Jack : How Yellow Fever Ravaged America and Walter Reed Discovered its Deadly Secrets. Hoboken, N.J.: John Wiley; 2005.Google Scholar
Phillip, S. Hench Walter Reed Yellow Fever Collection. The United States Army Yellow Fever Commission (1900–1901). 2001 August 8 [refd 2007 May 7]; Available from: http://yellowfever.lib.virginia.edu/reed/commission.html#_edn1
Chernin, E. Richard Pearson Strong and the iatrogenic plague disaster in Bilibid Prison, Manila, 1906. Reviews of Infectious Diseases. 1989 Nov–Dec; 11(6): 996–1004.Google Scholar
Hornblum, AM. Acres of Skin: Human Experiments at Holmesburg Prison : a Story of Abuse and Exploitation in the Name of Medical Science. New York: Routledge; 1998.Google Scholar
Moreno, JD. Undue Risk: Secret State Experiments on Humans. New York: W.H. Freeman; 2000.Google Scholar
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946–April 1949. Washington D.C.: U.S. G.P.O 1949–1953.
Michalczyk, JJ. Medicine, Ethics, and the Third Reich: Historical and Contemporary Issues. Kansas City, MO: Sheed & Ward; 1994.Google Scholar
Hilts, PJ. Experiments on children are reviewed. The New York Times. 1998 April 15.Google ScholarPubMed
Bernstein, N. 2 Institutions faulted for tests on children. The New York Times. 1999 June 12.Google Scholar
Bhutta, ZA. Beyond informed consent. Bulletin of the World Health Organization. 2004 Oct; 82(10): 771–7.Google ScholarPubMed
,Centers for Disease Control. US Public Health Service Syphilis Study at Tuskegee. 2007 March 27 [refd 2007 June 1]; Available from: http://www.cdc.gov/nchstp/od/tuskegee/time.htm
Levine, RJ. Ethics and Regulation of Clinical Research. 2nd edn. New Haven: Yale University Press; 1986.Google Scholar
Around the Nation; judge upholds deadline on syphilis case settlement. The New York Times. 1981 June 18.
Mitchell, A. Clinton regrets ‘clearly racist' U.S. study. The New York Times. 1997 May 17.Google Scholar
,World Medical Association. Declaration of Helsinki. 52nd World Medical Association General Assembly; 2000; Edinburgh, Scotland; 2000.Google Scholar
United States. 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. Washington: Dept. of Health, Education, and Welfare, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: for sale by the Supt. of Docs., US Govt. Print. Off. 1978.
,National Library of Medicine. Greek Medicine: The Hippocratic Oath. [refd 2007 May 9]; Available from: http://www.nlm.nih.gov/hmd/greek/greek_oath.html
Fairchild, AL, Bayer, R. Uses and abuses of Tuskegee. Science (New York, NY). 1999 May 7; 284(5416): 919–21.CrossRefGoogle ScholarPubMed
Testimony of Gary Ackerman. Hearing Before the Subcommittee on Health and Environment of the Committee on Commerce, House of Representatives. 1st Session, 11 May ed 1995:Serial No. 104–22:8.
Quinn, TC, Wawer, MJ, Sewankambo, N, Serwadda, D, Li, C, Wabwire-Mangen, F, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. The New England Journal of Medicine. 2000 Mar 30; 342(13): 921–9.CrossRefGoogle ScholarPubMed
Vogel, G. Study of HIV transmission sparks ethics debate. Science (New York, NY). 2000 Apr 7; 288(5463): 22–3.CrossRefGoogle ScholarPubMed
Connor, EM, Sperling, RS, Gelber, R, Kiselev, P, Scott, G, O'Sullivan, MJ, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. The New England Journal of Medicine. 1994 Nov 3; 331(18): 1173–80.CrossRefGoogle Scholar
Levine, RJ. Some recent developments in the international guidelines on the ethics of research involving human subjects. Annals of the New York Academy of Sciences. 2000 Nov; 918: 170–8.CrossRefGoogle ScholarPubMed
Beardsley, T. Coping with HIV's ethical dilemmas. Scientific American. 1998 July; 279(1): 106–7.CrossRefGoogle ScholarPubMed
Angell, M. The ethics of clinical research in the Third World. The New England Journal of Medicine. 1997 Sep 18; 337(12): 847–9.CrossRefGoogle ScholarPubMed
Benatar, , Singer, PA. A new look at international research ethics. BMJ (Clinical research edn). 2000 Sep 30; 321(7264): 824–6.CrossRefGoogle Scholar
Lo, B, Bayer, R. Establishing ethical trials for treatment and prevention of AIDS in developing countries. BMJ (Clinical research edn). 2003 Aug 9; 327(7410): 337–9.CrossRefGoogle ScholarPubMed
Bernard, C. An Introduction to the Study of Experimental Medicine. New York: Macmillan; 1927.Google Scholar
Stern, AM, Markel, H. The history of vaccines and immunization: familiar patterns, new challenges. Health Affairs (Project Hope). 2005 May–Jun; 24(3): 611–21.CrossRefGoogle ScholarPubMed
Wall, LL. The medical ethics of Dr J Marion Sims: a fresh look at the historical record. Journal of Medical Ethics. 2006 Jun; 32(6): 346–50.CrossRefGoogle Scholar
Grodin, MA, Glantz, LH. Children as Research Subjects : Science, Ethics, and Law. New York: Oxford University Press; 1994.Google Scholar
Lederer, SE. Subjected to Science : Human Experimentation in America before the Second World War. Baltimore: Johns Hopkins University Press; 1995.Google Scholar
Pierce, JR, Writer, J. Yellow Jack : How Yellow Fever Ravaged America and Walter Reed Discovered its Deadly Secrets. Hoboken, N.J.: John Wiley; 2005.Google Scholar
Phillip, S. Hench Walter Reed Yellow Fever Collection. The United States Army Yellow Fever Commission (1900–1901). 2001 August 8 [refd 2007 May 7]; Available from: http://yellowfever.lib.virginia.edu/reed/commission.html#_edn1
Chernin, E. Richard Pearson Strong and the iatrogenic plague disaster in Bilibid Prison, Manila, 1906. Reviews of Infectious Diseases. 1989 Nov–Dec; 11(6): 996–1004.Google Scholar
Hornblum, AM. Acres of Skin: Human Experiments at Holmesburg Prison : a Story of Abuse and Exploitation in the Name of Medical Science. New York: Routledge; 1998.Google Scholar
Moreno, JD. Undue Risk: Secret State Experiments on Humans. New York: W.H. Freeman; 2000.Google Scholar
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946–April 1949. Washington D.C.: U.S. G.P.O 1949–1953.
Michalczyk, JJ. Medicine, Ethics, and the Third Reich: Historical and Contemporary Issues. Kansas City, MO: Sheed & Ward; 1994.Google Scholar
Hilts, PJ. Experiments on children are reviewed. The New York Times. 1998 April 15.Google ScholarPubMed
Bernstein, N. 2 Institutions faulted for tests on children. The New York Times. 1999 June 12.Google Scholar
Bhutta, ZA. Beyond informed consent. Bulletin of the World Health Organization. 2004 Oct; 82(10): 771–7.Google ScholarPubMed
,Centers for Disease Control. US Public Health Service Syphilis Study at Tuskegee. 2007 March 27 [refd 2007 June 1]; Available from: http://www.cdc.gov/nchstp/od/tuskegee/time.htm
Levine, RJ. Ethics and Regulation of Clinical Research. 2nd edn. New Haven: Yale University Press; 1986.Google Scholar
Around the Nation; judge upholds deadline on syphilis case settlement. The New York Times. 1981 June 18.
Mitchell, A. Clinton regrets ‘clearly racist' U.S. study. The New York Times. 1997 May 17.Google Scholar
,World Medical Association. Declaration of Helsinki. 52nd World Medical Association General Assembly; 2000; Edinburgh, Scotland; 2000.Google Scholar
United States. 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. Washington: Dept. of Health, Education, and Welfare, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: for sale by the Supt. of Docs., US Govt. Print. Off. 1978.
,National Library of Medicine. Greek Medicine: The Hippocratic Oath. [refd 2007 May 9]; Available from: http://www.nlm.nih.gov/hmd/greek/greek_oath.html
Fairchild, AL, Bayer, R. Uses and abuses of Tuskegee. Science (New York, NY). 1999 May 7; 284(5416): 919–21.CrossRefGoogle ScholarPubMed
Testimony of Gary Ackerman. Hearing Before the Subcommittee on Health and Environment of the Committee on Commerce, House of Representatives. 1st Session, 11 May ed 1995:Serial No. 104–22:8.
Quinn, TC, Wawer, MJ, Sewankambo, N, Serwadda, D, Li, C, Wabwire-Mangen, F, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. The New England Journal of Medicine. 2000 Mar 30; 342(13): 921–9.CrossRefGoogle ScholarPubMed
Vogel, G. Study of HIV transmission sparks ethics debate. Science (New York, NY). 2000 Apr 7; 288(5463): 22–3.CrossRefGoogle ScholarPubMed
Connor, EM, Sperling, RS, Gelber, R, Kiselev, P, Scott, G, O'Sullivan, MJ, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. The New England Journal of Medicine. 1994 Nov 3; 331(18): 1173–80.CrossRefGoogle Scholar
Levine, RJ. Some recent developments in the international guidelines on the ethics of research involving human subjects. Annals of the New York Academy of Sciences. 2000 Nov; 918: 170–8.CrossRefGoogle ScholarPubMed
Beardsley, T. Coping with HIV's ethical dilemmas. Scientific American. 1998 July; 279(1): 106–7.CrossRefGoogle ScholarPubMed
Angell, M. The ethics of clinical research in the Third World. The New England Journal of Medicine. 1997 Sep 18; 337(12): 847–9.CrossRefGoogle ScholarPubMed
Benatar, , Singer, PA. A new look at international research ethics. BMJ (Clinical research edn). 2000 Sep 30; 321(7264): 824–6.CrossRefGoogle Scholar
Lo, B, Bayer, R. Establishing ethical trials for treatment and prevention of AIDS in developing countries. BMJ (Clinical research edn). 2003 Aug 9; 327(7410): 337–9.CrossRefGoogle ScholarPubMed

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