Informed Consent: Decision amid Uncertainty

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


The line between what is known and what is not known about a drug and study is blurred and hence is a difficult one to draw. Informed consent is the process by which the patient and research staff come to a common understanding about what the uncertainties might be. The informed consent process is not a formality or an empty gesture designed to satisfy risk and liability management. It is an interaction—a dialogue intended not only to satisfy the medicolegal requirement but also to use the uncertainty of the research process as a basis for developing mutual trust and an alliance with the patient. This working together in dealing with the uncertainty of the research is the first step in bringing the patient into the research team (i.e., having the patient give his consent to participate).


Research Staff Consent Process Consent Document Informed Consent Process Refusal Rate 
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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Further Reading

  1. Annas, G.J., Glantz, L.H., and Katz, P.F., Informed Consent to Human Experimentation: The Subject’s Dilemma ,Ballinger Publishing Co., Cambridge, 1977.Google Scholar
  2. Barber, B., informed Consent in Medical Therapy and Research, Rutgers University Press, New Brunswick, 1980.Google Scholar
  3. Finkel, M.J., Role of the FDA in the clinical research process, in: The Clinical Research Process in the Pharmaceutical Industry (G.M. Matoren, ed.), Marcel Dekker, Inc., New York, 1984, pp. 450–464.Google Scholar
  4. Levine, R.J., Ethics and Regulation of Clinical Research (2nd ed.), Urban & Schwarzenberg, Baltimore, 1986.Google 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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