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Informed Consent to Human Experimentation: The Subject's Dilemma

Robert L. Sadoff, MD
JAMA. 1978;239(4):355. doi:10.1001/jama.1978.03280310087030.
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This is a well-organized, readable book written by three lawyers with experience in medical-legal and hospital law practice. They properly begin with the Nuremberg Code and incorporate historical principles of informed consent to human experimentation, applying their findings to the vulnerable persons in our society, including children, prisoners, the unborn, and the mentally disabled. The authors focus on informed consent as the fulcrum of the relationship of the physician to his patient and to all those involved in medical research. They are careful to define such legal terms as "risk" and to provide us with relative cases, a helpful appendix, and a number of references.

In dealing with research with children, the authors developed the concept of proxy consent, ie, consent given by parents or guardians to the minor. They also differentiate between therapeutic research and nontherapeutic research, in which the conditions must be more carefully guarded and explained.



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