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The Legal Context of Medical Experimentation 

The Legal Context of Medical Experimentation
The Legal Context of Medical Experimentation
Medical Experimentation: Personal Integrity and Social Policy: New Edition

Charles Fried

, Franklin Miller

, and Alan Wertheimer


This chapter presents the principles of American law applicable to medical experimentation. Since, as Tocqueville remarked, in the United States grave public questions tend to be viewed as legal questions, this chapter goes beyond parochial concerns and introduces in a concrete and practical way the issues and concepts to be discussed more theoretically in subsequent chapters. This chapter sets out the private law, regulatory, and regulatory context of medical care in general and medical experimentation in particular. Crucial in all these contexts is the context of informed consent. The chapter examines how the law applies consent in therapeutic and non-therapeutic medical experimentation in general and randomized clinical trials in particular.

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