The first issue a book on informed consent should address is why it was written at all. Of all the current pressing topics in biomedical ethics, whether we refer to the issue of abortion, to the controversies surrounding access to health care, or to the myriad dilemmas ingredient in the area of death and dying, informed consent seems to pale as an issue. Equally, it would seem that agreement has long since been reached on the ethical necessity for the informed consent of competent patients, indicating that this is no longer a controversial issue. The law is absolutely clear about this, and so are most bioethicists. Finally, at least from the perspective of practicing clinicians, the intended audience of this series, the most that might be desired is an explanation of the law on informed consent, particularly regarding how to honor its requirements (or avoid its sanctions) at the bedside. But such "cookbook" approaches to informed consent have been offered. 1 Another is hardly needed.
This book does not offer legal advice. As we shall see, there is, in fact, no clear single, settled law regarding informed consent to explicate. Rather, legal pronouncements on and criteria for informed consent vary from state to state in the United States (where the law on informed consent is the most highly evolved). Equally, these "guidelines" often exist only within the context of specific legal cases, not in formal statutes, so that their interpretation will also have to attend to similarities or differences among various individual precedents. Further, legal guidelines regarding informed consent range from the quite specific and complex in some countries to a total absence of any legal insistence upon it in others, particularly in the third world and in totalitarian countries. Thus for the practicing clinician who is curious about "the law" regarding informed consent there is no substitute for consulting a legal colleague in the particular jurisdiction in which he practices. 2