To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.

A few years ago a battered infant was admitted to a California hospital. After a period of observation and testing, the physicians concluded that the infant had been beaten so badly that his brain was almost completely destroyed, leaving him permanently unconscious. The hospital had just adopted a policy specifying that life-sustaining treatment for permanent unconsciousness was futile and, therefore, not indicated. According to this policy, after suitable subspecialty consultations and deliberations, including efforts to gain parental agreement and documentation of (...) unanimous ethics committee support, the patient's physician had the authority to discontinue life-sustaining treatment. The infant's physician wished to do this. The mother, however, who was the prime battery suspect, insisted that the baby be kept alive. (shrink)

People do not choose to suffer from catastrophic illnesses, but considerable human choice is involved in the ways in which the participants in the process treat and conduct research on these diseases. Catastrophic Diseases draws a powerful and humane portrait of the patients who suffer from these illnesses as well as of the physician-investigators who treat them, and describes the major pressures, conflicts, and decisions which confront all of them. By integrating a discussion of "facts" and "values," the authors highlight (...) the forces which affect new developments in medicine—such as kidney and heart transplants—and the controversial issues they generate. Katz and Capron explore these issues through the use of dual conceptual perspectives. Their study first examines and evaluates the authority which should be vested in each of the chief participants in the catastrophic disease process—the physician-investigator, the patient-subject and his relatives, the professionals, and the state. Challenging questions are raised concerning medical education, informed consent, and professional responsibility. The authors next explore how the roles and capacities of the participants vary not only according to the basic issues they face but also according to the point in decision-making at which these issues arise. The process of investigating and treating catastrophic diseases, the authors believe, can thus usefully be divided into three decision-making stages—the formulation of policy, the administration of research and therapy, and the review of the decisions and their consequences. In conclusion, Katz and Capron demonstrate the need for a variety of individuals and groups with diverse values to be involved in decision-making in a manner which will not unnecessarily impede the scientific investigation of these diseases. (shrink)

Over the last decade, standards for when and how to undertake a wide range of medical interventions have poured forth from medical specialty groups, commercial and nonprofit organizations, and state and federal panels. Known by a variety of names—from practice parameters to clinical guidelines—and intended for a range of purposes—from diminishing the incidence of maloccurences in hospitals to cutting the costs of health care—these guidelines share one important feature: the intention of decreasing the range of variation in medical practice. Such (...) standardization immediately appeals to anyone interested in improving the quality of health care and, in particular, reducing inappropriate medical interventions, in light of the difficulties for a conscientious physician today in adhering to the best standard of practice when faced with ever increasing medical knowledge and the growing number and complexity of diagnostic, preventive, and therapeutic interventions. (shrink)

In 1990, I voiced strong doubts about a bill entitled the Patient Self-Determination Act, which had been introduced in the U.S. Senate by John Danforth and Daniel Patrick Moynihan. I hoped to see it defeated. In 1991, after the bill had become a small part of a massive status adopted in the waning hours of the 101st Congress, I devoted countless hours to its implementation. I wanted to see it succeed. Why the change?