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Introduction: Vulnerability in Biomedical Research

Published online by Cambridge University Press:  01 January 2021

Abstract

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Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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References

Hotez, P. J., “Neglected Infections of Poverty in the United States of America,” PLoS Neglected Tropical Diseases 6 (2008), available at <http://www.plosntds.org/article/info:doi%2Fl0.1371%2Fjournal.pntd.0000256> (last visited October 1, 2008).Google Scholar
Beecher, H. K., “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (1966): 13541360.CrossRefGoogle Scholar
Jones, J. H., Bad Blood: The Tuskegee Syphilis Experiment (New York: Free Press, 1993).Google Scholar
Rothman, D. J. Rothman, S. M., The Willowbrook Wars (Piscataway, NJ: Aldine Transaction, 2005).Google Scholar
Heller, J., “Syphilis Victims in the U.S. Study Went Untreated for 40 Years,” New York Times, July 26, 1972, at 1, 8.Google Scholar
National Research Act of 1974, PL 93–348.Google Scholar
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 (Washington, D.C.: U.S. Government Printing Office, 1979); The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research on the Fetus (Washington, D.C.: U.S. Government Printing Office, 1974); The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Prisoners (Washington, D.C.: U.S. Government Printing Office, 1976); The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children (Washington, D.C.: U.S. Government Printing Office, 1977); The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Those Institutionalized as Mentally Infirm (Washington, D.C.: U.S. Government Printing Office, 1978).Google Scholar
45 CFR 46.111(b).Google Scholar
Levine, C. Faden, R. Grady, C. Hammerschmidt, D. Eckenwiler, L. Sugarman, J., “The Limitations of ‘Vulnerability’ as a Protection for Human Research Participants,” American Journal of Bioethics 4, no. 3 (2004): 4449.CrossRefGoogle Scholar
See Belmont Report, supra note 7, at C.3.Google Scholar
Council for International Organizations of Medical Sciences (CIOMS), “International Ethical Guidelines for Biomedical Research Involving Human Subjects,” Geneva, 2002, at Guideline 13, available at <http://www.cioms.ch/frame_guidelines_nov_2002.htm> (last visited August 12, 2008).+(last+visited+August+12,+2008).>Google Scholar
Id., at Guideline 13, commentary.Google Scholar
National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, Vol. I (Bethesda, MD: National Bioethics Advisory Commission: 2001): At iv.Google Scholar
Kipnis, K., “Vulnerability in Research Subjects: A Bioethical Taxonomy,” in National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, Vol. II (Bethesda, MD: National Bioethics Advisory Commission, 2001): At G-1-G-13.Google Scholar
See NBAC, supra note 13, at 85.Google Scholar
See supra note 8.Google Scholar
Iltis, A. S. Wall, A. Lesandrini, J. Rangel, E. Chibnall, J., “Federal Interpretation and Enforcement of Protections for Vulnerable Participants in Human Research,” Journal of Empirical Research on Human Research Ethics 4, no. 3 (2009): In press.CrossRefGoogle Scholar
See Levine, , supra note 9, at 46.Google Scholar
Id., at 47.Google Scholar
Id., at 46.Google Scholar
Beauchamp, T. L. Jennings, B. Kinney, E. D. Levine, R. J., “Pharmaceutical Research Involving the Homeless,” Journal of Medicine and Philosophy 27, no. 5 (2001): 547564; Berry, S. R., “For Purposes of Research, Palliative Care Patients Should Not Be Considered a Vulnerable Population,” Clinical Oncology 16 (2004): 223–224; Hawryluck, L., “People at the End of Life Are a Vulnerable Research Population,” Clinical Oncology 16 (2004): 225–226; Cohen, P. J., “Untreated Addiction Imposes an Ethical Bar to Recruiting Addicts for Non-Therapeutic Studies of Addictive Drugs,” Journal of Law, Medicine & Ethics 30, no. 1 (2002): 73–81; List, J., “Histories of Mistrust and Protectionism: Disadvantaged Minority Groups and Human-Subject Research Policies,” American Journal of Bioethics 5, no. 1 (2004): 53–55; Lott, J. P., “Vulnerable/Special Participant Populations,” Developing World Bioethics 5, no. 1 (2005): 30–54; Seidenfeld, J. Horstmann, E. Emanuel, E. Grady, C., “Participants in Phase 1 Oncology Research Trials: Are They Vulnerable?” Archives of Internal Medicine 168, no. 1 (2008): 16–20.CrossRefGoogle Scholar
National Bioethics Advisory Commission, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (Bethesda, MD: National Bioethics Advisory Commission, 2001); National Bioethics Advisory Commission, Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity (Bethesda, MD: National Bioethics Advisory Commission, 1998).Google Scholar
Coleman, C. H., “Vulnerability as a Regulatory Category in Human Subject Research,” Journal of Law, Medicine & Ethics 37, no. 1 (2009): 1218.CrossRefGoogle Scholar
Grady, C., “Vulnerability in Research: Individuals with Limited Financial and/or Social Resources,” Journal of Law, Medicine & Ethics 37, no. 1 (2009): 1927.CrossRefGoogle Scholar
Bustillos, D., “Limited English Proficiency and Disparities in Clinical Research,” Journal of Law, Medicine, & Ethics 37, no. 1 (2009): 2837.CrossRefGoogle Scholar
Dresser, R., “First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless,” Journal of Law, Medicine & Ethics 37, no. 1 (2009): 3850.CrossRefGoogle Scholar
Menikoff, J., “The Vulnerability of the Very Sick,” Journal of Law, Medicine & Ethics 37, no. 1 (2009): 5158.CrossRefGoogle Scholar
Tait, R. C., “Vulnerability in Clinical Research with Patients in Pain: A Risk Analysis,” Journal of Law, Medicine & Ethics 37, no. 1 (2009): 5972.CrossRefGoogle Scholar
Ford, P. J., “Vulnerable Brains: Research Ethics and Neurosurgical Patients,” Journal of Law, Medicine & Ethics 37, no. 1 (2009): 7382.CrossRefGoogle Scholar