A History and Theory of Informed Consent, Faden, R.R., and Beauchamp, T.L. (Oxford University Press, New York, 1986), 392 pages, $29.95.

A history and theory of informed consent

During the last two decades or so, there has been a struggle over the patient's role in medical decision-making that is often characterized as a conflict between autonomy and health, between the values of the patient and the values of the physician. Seeking to curtail physician dominance, many have advocated an ideal of greater patient control.',' Others question this ideal because it fails to acknowledge the potentially imbalanced nature of this interaction when one party is sick and searching for security, and when judgments entail the interpretation of technical information.14 Still others are trying to delineate a more mutual relationship.5,6 This struggle shapes the expectations of physicians and patients as well as the ethical and legal standards for the physician's duties, informed consent, and medical malpractice. This struggle forces us to ask, What should be the ideal physician-patient relationship? We shall outline four models of the physicianpatient interaction, emphasizing the different understandings of (1) the goals of the physicianpatient interaction, (2) the physician's obligations, (3) the role of patient values, and (4) the conception of patient autonomy. To elaborate the abstract description of these four models, we shall indicate the types of response the models might suggest in a clinical situation. Third, we shall also indicate how these models inform the current debate about the ideal physician-patient relationship. Finally, we shall evaluate these models and recommend one as the preferred model. As outlined, the models are Weberian ideal types. They may not describe any particular physician-patient interactions but highlight, free from complicating details, different visions of the essential characteristics of the physician-patient interaction. 7 Consequently, they do not embody minimum ethical or legal standards, but rather constitute regulative ideals that are "higher than the law" but not "above the law."' THE PATERNALISTIC MODEL First is the paternalistic model, sometimes called the parental 9 or priestly model. In this model, the physician-patient interaction ensures that patients receive the interventions that best promote their health and well-being. To this end, physicians use their skills to determine the patient's medical condition and his or her stage in the disease process and to identify the medical tests and treatments most likely to restore the patient's health or ameliorate pain. Then the physician presents the patient with selected information that will encourage the patient to consent to the intervention the physician considers best. At the extreme, the physician authoritatively informs the patient when the intervention will be initiated. The paternalistic model assumes that there are shared objective criteria for determining what is best. Hence the physician can discern what is in the patient's best interest with limited patient participation. Ultimately, it is assumed that the patient will be thankful for decisions made by the physician even if he or she would not agree to them at the time." In the tension

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Four Models of the Physician-Patient Relationship

Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.

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What Makes Clinical Research Ethical

Protein phosphorylation regulates most aspects of cell life, whereas abnormal phosphorylation is a cause or consequence of disease. A growing interest in developing orally active protein-kinase inhibitors has recently culminated in the approval of the first of these drugs for clinical use. Protein kinases have now become the second most important group of drug targets, after G-protein-coupled receptors. Here, I give a personal view of some of the most important advances that have shaped this field.

Protein kinases--the major drug targets of the twenty-first century?

Alzheimer’s Dementia

Contents: Foreword to the Johns Hopkins Edition: The Once and Future Silent World, by Alexander Morgan Capron Preface and Acknowledgements Introduction Chapter I. Physicians and Patients: A History of Silence Chapter II. Physicians and Citizens: The Struggle for Freedom from Lay Control Chapter III. Judges, Physicians, and Patients: The Legal Doctrine of Informed Consent Chapter IV. Sharing Authority: The Willingness to Trust Chapter V. Respecting Autonomy: The Struggle over Rights and Capacities Chapter VI. Respecting Autonomy: The Obligation for Conversation Chapter VII. Acknowledging Uncertainty: The Confrontation of Knowledge and Ignorance Chapter VIII. The Abandonment of Patients: A Final Argument against Silence Appendix A. Code of Ethics of the American Medical Association (1847) Appendix B. American Medical Association Principles of Medical Ethics (1980)NotesIndex

The Silent World of Doctor and Patient

Experimentation with Human Beings

Since the 1760's, whenever judges and counsel have dined at Sargeants' Inn Hall, the traditional toast to "the glorious memory of King William" has been followed by one to "the glorious uncertainty of the law."1 The toast was first proposed in honor of Chief Justice Lord Mansfield, who had unsettled the legal community by overruling several long established legal precedents and by introducing a number of innovations in the practices of his court. The simultaneous celebration of authority and uncertainty was no accident. Nor was it a coincidence that uncertainty was celebrated when it would only engender momentary laughter before being drowned in ale and wine. This story from legal history serves as a reminder that the disquiet over uncertainty is not restricted to the medical profession. With the exception of Renee Fox's pioneering studies,2 the impact of uncertainty on professional practices has received little systematic attention from either lawyers or physicians. On reflection, this is not surprising. It is a fact of life that human beings find it difficult to maintain a consistent, self-conscious appreciation of the extent to which uncertainty accompanies them on their daily rounds and to integrate that uncertainty with whatever certainties inform their conduct. Physicians are not exempt from this human proclivity. They will acknowledge medicine's uncertainty once its presence is forced into conscious awareness, yet at the same time will continue to conduct their practices as if uncertainty did not exist.

Why Doctors Don't Disclose Uncertainty

ion of the research question tends to objectify the person-patient.27 It does so to a significantly greater extent than in therapeutic interactions, even though similar problems of objectification arise in therapeutic settings when doctors attend too much to the disease of the body in the bed and not to the person before them. The readiness with which clinical research continues to be viewed as an extension of clinical practice, both similarly grounded in the millennia-long Hippocratic commitment to the welfare of the individual patient, overlooks the transformation of medical practice since the age of medical science. Throughout most of medical history, research was limited to careful bedside observation of the effects of innovative treatments, with the interests of the individual patient as a polestar. In today's world, on the other hand, the interests of patient-subjects may yield to varying extents to the interests of science. This revolutionary development has not been accompanied by a thoroughgoing re-examination of physicians' ethical obligations in a postHippocratic age. Examples in point are the many cooperative clinical trials, generally randomized clinical trials (RCTs),30 in which institutions throughout the 27. See infra note 66 and accompanying text. 28. In a conversation between a senior physician and a medical intern, the former asked how much the intern knew about "patients as human beings." The question led to a rather nonproductive exchange which the intern ended abruptly with the exasperated comment: "I cannot answer your questions. You're interested in patients. I'm interested in the disease in the body in the bed." RAYMOND S. DUFF & AUGUST B. HOLLINGSHEAD, SICKNESS AND SOCIETY 128 (1968). 29. Medical practice has become transformed in other ways as well which should have led to greater involvement of patients in the medical decision-making process: Medicine's recent ascent from empiricism to science has brought forth spectacular technologic advances in the diagnosis and treatment of disease. Today the numerous options available for the treatment of many diseases allow patients greater choice. Moreover, the introduction into medicine of scientific reasoning, aided by the results of carefully conducted research, permits doctors to be more discriminating between knowledge, ignorance and conjecture in their recommendations for or against a treatment. For the first time in medical history, it is possible, even medically and morally imperative, to give patients a voice in medical decision making; possible, because knowledge and ignorance can be better specified; medically imperative, because a variety of treatments are available, each of which can bestow benefits or inflict harm; morally imperative, because patients, depending on the lifestyle they wish [to lead) after treatment, must be given a choice. Duty and Caring, supra note 20, at 189. 30. The randomized clinical trial (ReT) is generally regarded as the gold standard for the evaluation of therapeutic agents. The ReT has four main elements. 1) It is "controlled," i.e., one part of the subject population receives a therapy that is being tested while another part, as similar as possible ... , receives either another therapy or no therapy.... 2) The significance of its results is established through statistical analysis. . .. 3) When it is feasible, a double-blind

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Human experimentation and human rights.

This article is a substantially revised and expanded version of the first Isaac Ray Lecture delivered by Dr. Katz at the University of Pittsburgh School of Law on February 16, 1977. The 1975 Isaac Ray Award was presented to Dr. Katz by the American Psychiatric Association for his outstanding contributions to forensic psychiatry. A.similarly expanded version of Dr. Katz's second Isaac Ray Lecture, "Medicine's Vision," will appear in a subsequent issue.-The Editors.

https://digitalcommons.law.yale.edu/cgi/viewcontent.cgi?article=3909&context=fss_papers

Jay Katz

Papers

The Silent World of Doctor and Patient

Experimentation with Human Beings

Why Doctors Don't Disclose Uncertainty

Human experimentation and human rights.

Informed consent--a fairy tale? Law's vision.