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Special Populations

  • Frank L. Iber
  • W. Anthony Riley
  • Patricia J. Murray

Abstract

Certain patients cannot participate as readily in the informed consent process because of a language or hearing defect or because their medical condition temporarily does not permit them to do so (e.g., unconscious patients). Other patients such as children, prisoners, or the mentally infirm may be less able to give their informed consent because they are especially vulnerable to coercion or misinformation. This chapter is concerned with some issues relevant to subjects who fall in these categories and with possible solutions. Table 19 lists the types of problems to be considered in the text that follows. The conditions under which such subjects should be allowed to take part in a study are clear-cut. They include the following: (1) The person must be able to assimilate the study information and consent to participation. (2) The person must be able to give consent legally. Various levels of interference with one or the other of these key conditions are presented in Table 19.

Keywords

Minimal Risk Consent Process National Commission Informed Consent Process Deaf Patient 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Leikin, S.L., An ethical issue in biomedical research: The involvement of minors in informed consent and third party consent, Clin. Res. 31:34–40, 1983.PubMedGoogle Scholar
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    Levine, R.J., Ethics and Regulation of Clinical Research (2nd ed.), Urban & Schwarzenberg, Baltimore, 1986, p. 242.Google Scholar
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    Levine, R.J., Ethics and Regulation of Clinical Research (2nd ed.), Urban & Schwarzenberg, Baltimore, 1986, pp. 242–256.Google Scholar
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    Levine, R.J., and Holder, A.R., Legal and ethical problems in clinical research, in: The Clinical Research Process in the Pharmaceutical Industry (G.M. Matoren, ed.), Marcel Dekker, Inc., New York, 1984.Google Scholar
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    Levine, R.J., Ethics and Regulation of Clinical Research (2nd ed.), Urban & Schwarzenberg, Baltimore, 1986, p. 260.Google Scholar
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    Levine, R.J., Ethics and Regulation of Clinical Research (2nd ed.), Urban & Schwarzenberg, Baltimore, 1986, p. 269.Google Scholar

Further Reading

  1. Lebacqz, K., Reflections on the report and recommendations of the National Commission: Reflections on the fetus, Villanova Law Rev. 22:357–366, 1977.PubMedGoogle Scholar

Copyright information

© Plenum Publishing Corporation 1987

Authors and Affiliations

  • Frank L. Iber
    • 1
    • 2
  • W. Anthony Riley
    • 3
  • Patricia J. Murray
    • 4
  1. 1.Hines Veterans Administration Medical Center and Loyola University Stritch School of MedicineMayfieldUSA
  2. 2.University of Maryland School of MedicineBaltimoreUSA
  3. 3.Baltimore Medical System, Inc.BaltimoreUSA
  4. 4.BostonUSA

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