In 1991, Diane Wood Middlebrook, a professor of English at Stanford University, published a biography of the poet Anne Sexton in which, among other things, she used as source material some 300 tapes of Sexton's psychotherapeutic sessions with her psychiatrist, Dr. Martin Orne. After some years of reluctance and with the concurrence of Sexton's daughter and literary executor, Linda Gray Sexton, Orne released the tapes to Professor Middlebrook. Middlebrook's picture of Sexton drew heavily on the tapes, supplemented by scrapbooks, letters, photos, clippings, unpublished poems, and hospital records.

The physician–patient relationship is anchored in trust. Historically the relationship has been a paternalistic one, with the patient expected to trust the physician's training and skills in doing what is “best” for the patient. But medical knowledge has expanded, as have treatment options and knowledge of the risks of treatment. The physician must now possess volumes of specialized knowledge about procedures and treatments, side effects and alternatives, drugs and their contraindications. Information has become a companion to trust. The patient, while still dependent on the physician's expertise, now wants information about choices and hazards in treatment. Expanded choice has made the patient a consumer of healthcare and its risks rather than a passive recipient of treatment from the professional.

More than three decades after its introduction as a legal requirement for medical treatment in the clinical setting, informed consent continues to be viewed with skepticism as to its need or effectiveness. Some maintain that it is not required because the ordinary individual believes that doctors can be trusted to behave In the best interests of their patients. This issue will be discussed in a later portion of this article. Others are persuaded that informed consent is an unattainable ideal given the limited capacity of the ordinary individual to understand the relevant information. This view is supported by studies intended to show that satisfactory understanding on the part of patients cannot be achieved. In rebuttal, Apple-baum, Lidz, and Meisel observed that:

Such statements are easily refuted by reference to studies of situations in which reasonable comprehension actually has been achieved. A sounder interpretation of all these studies might be that patients and subjects can attain a good level of understanding in many cases, but that several factors — including the manner in which disclosure is made as well as patients' limitations — may get in the way.

The Nuremberg Code of ethical principles for experiments involving human beings has as its first requirement that “the voluntary consent of the human subject is absolutely essential.” Since the time of the trials that supplied its motivation the principles have been amplified and detail and distinctions have been added. For example, the Declaration of Helsinki, adopted by the World Medical Association in 1964, again laid down general principles related to voluntariness, balance of risk and benefit, and scientific soundness. However, it also noted that the ethical issues with regard to two distinctly different types of human experiment vary. These two types are clinical research (i.e., “medical research combined with profession care”) and nonclinical biomedical research (i.e., “nontherapeutic biomedical research involving human subjects”). In actuality, we may distinguish three types of human biomedical experimentation. Two of these are therapeutic and nontherapeutic experimentation. The first is directed primarily to the benefit of the experimental subjects who are being treated with some new experimental therapy for their ailment. In the second an experiment is designed to increase medical knowledge and uses volunteers who are healthy or whose illness is not related to the experimental study. One key difference between the ethical requirements specified by the Declaration of Helsinki for therapeutic and nontherapeutic experimentation was that the second approach required participation only by volunteers whom we assume are able to and do give their informed consent. However, in the first approach if consent were not obtained, the physician must specify the reasons and present these before an independent committee.

Research is ongoing concerning the medical risks and benefits of routine neonatal male circumcision. Interpretation of the data, however, is controversial. Circumcision presents a number of challenges in obtaining informed consent because of a variety of interesting issues. It is a nonemergent, elective procedure that allows for evaluation and discussion over time. In this respect, observation of the informed consent process for circumcision is relevant to other medical decisions, such as advance directives, discussed between primary care providers and patients. Obtaining informed consent for circumcision has its constraints. The process generally occurs over a brief hospital stay. There have been recent changes in the official position regarding the procedure by professional medical societies, and it raises considerable psychologic issues for the provider and may Impact the way in which Information is provided.

No discussion of the informed consent process would be adequate without attention to dilemmas and challenges arising in research in foreign countries, particularly in the less developed countries. In an era of the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS), for example, much attention to research issues concerning devastating health conditions in developed and less developed countries has occurred with renewed vigor.

D.T. a 35-year-old woman, was found to have breast cancer. At the time of mastectomy axillary lymph nodes were positive and the cancer was classified as adenocarcinoma, grade 4. The patient underwent conventional chemotherapy. When it became apparent the disease was metastatic, the patient's oncologist contacted a well-known cancer center regarding the possibility of treating the patient with high dose chemotherapy and autologous bone marrow transplantation (HDC/ABMT). The patient's health insurance provider informed the patient, however, that the treatment—estimated to cost in the range of $150,000–200,000—was “considered experimental or research in nature” and therefore was not included in coverage. D.T. did not pursue this further. Approximately 2 years later, cancer was detected in the patient's spine. This time she applied to another well-known cancer center for HDC/ABMT. The cancer center agreed to accept her on the condition of proof of ability to pay for the treatment. Again her insurer refused coverage on the same grounds as before. D.T. found another source for the money, underwent treatment, then sued the insurance carrier. She sought a declaratory judgment that the treatment was covered under the insurance policy. The court ruled in favor of D.T. finding the contract phrase “considered experimental” ambiguous.

From time to time medical ethicists bemoan the loss of a religious perspective in medical ethics. The discipline had its origins in the thinking of explicitly religious thinkers such as Paul Ramsey and Joseph Fletcher. Furthermore, many of those who contributed to the early development of the discipline had training in theology. One thinks of Daniel Callahan, Richard McCormick, Albert Jonsen, Sam. Banks. As the discipline becomes more and more self-reflective, with attention being paid to methodological and conditional concerns, it is only natural that the roots are due for a reexamination. The time has therefore come for some reassessment. The first steps here are taken in the form of a dialogue between the coauthors to clarify authentic contributions and weed out unauthentic ones.

The past two decades have been a time of heightened interest in the moral aspects of the practice of medicine. This interest has been reflected in medical education by the establishment of medical humanities programs in both preclinical and clinical education in many medical schools. It has also been reflected in the literature with a dramatic increase in journal articles on medical ethics as well as the development of medical ethics in textbooks. A number of journals have developed that are specifically devoted to medical ethics, including The Journal of Medical Ethics, The Journal of Medicine and Philosophy, The Journal of Medical Humanities, Theoretical Medicine, Cambridge Quarterly of Healthcare Ethics, just to name a few. The literature includes both theoretical foundations and conceptual analyses of particular issues as well as practical advice and general suggestions for how to implement programs in medical humanities.

In 1991, the University of Pittsburgh Medical Center (UPMC) implemented a policy that permitted the recovery of organs from cadavers pronounced dead using standardized cardiac criteria (Non-Heartbeating Cadavers or NHBC). This policy allowed families that had made a decision to forgo life sustaining treatment to then request organ donation. This entailed taking the patient to the operating room, discontinuing therapy (typically but not necessarily a ventilator), and after the patient is pronounced dead, procuring organs.

An urgent need for standards and guidelines on genetic testing has arisen because of swift advances in research, facilitated by the Human Genome Project. The goals of the Human Genome Project include the identification of all genes and sequencing of the human genome. The project is currently ahead of schedule and under budget. We can expect an avalanche of genetic information, much of which will be relevant to human disease. In addition to the Human Genome Project, investigator-initiated research projects and commercial biotechnology laboratories are discovering human disease genes at a breathtaking pace. Technology transfer has been rapid and has led to the availability of numerous clinical tests within only a few years since the first disease gene yielded to the technique of positional cloning. Disease genes are selected for study for a number of reasons. Genes for rare diseases may be studied before more common disorders because they elucidate an important area of pathogenesis. Unfortunately, technology transfer to the clinic for rare tests is hindered by several factors. Standards need to be established to assure that genetic tests for rare diseases are not ignored or mismanaged in the rush to commercialize tests for more common human genetic diseases.

A personable teenager with Down's syndrome became a Canadian cause célèbre a few months ago when University Hospital in Edmonton, Alberta, denied him a position on the organ transplantation waiting list. Terry Urquart lacked “reasonable” intelligence, hospital officials said, a criterion for all transplant candidates at that hospital. Protests by the boy's family, and by groups active in the cause of those with developmental disabilities, became well-photographed stories on the nightly television news and in the nation's newspapers. It did not hurt the Urquart cause one bit that the 17-year-old teenager had won a gold medal in skiing at the International Special Olympics.