Informed Consent: Decision amid Uncertainty
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).
KeywordsResearch Staff Consent Process Consent Document Informed Consent Process Refusal Rate
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- 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
- Barber, B., informed Consent in Medical Therapy and Research, Rutgers University Press, New Brunswick, 1980.Google Scholar
- 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
- Levine, R.J., Ethics and Regulation of Clinical Research (2nd ed.), Urban & Schwarzenberg, Baltimore, 1986.Google Scholar