Alan Meisel

Barriers to informed consent.

The law of informed consent seeks to actively involve patients in decision making. Most authorities agree that this involvement has not occurred but disagree about why. Some suggest that patients are incapable of understanding medical issues and others that physicians have not explained issues clearly or extensively enough. We observed decision making in several hospital settings and found other significant barriers to patient participation. These barriers include the fact that treatment decisions take place over a long period; there are often many decisions to be made; although patients want information about treatment, they typically believe that decision making is the physicians task; physicians do not understand the rationale for the patients role in decisions; and the medical decision-making process often involves so many people that the patient does not know who is responsible.

Ethical and Legal Issues Related to the Use of Computer Programs in Clinical Medicine

As computer programs are used with increasing frequency in the clinical setting, ethicists, lawyers, computer scientists, clinicians, and patients must confront a group of problems: In what situations is it appropriate to use a medical computer program? Who should use these programs and how should they be used? What is the legal status of a computer program that provides medical advice? Can a proper balance be achieved between confidentiality of patient information and shared access to records by health care personnel? How can regulatory agencies, physicians, and patients determine if a program is safe for human use? Will programs be able to communicate with users well enough to prevent clinically harmful misunderstandings? Because few if any definitive answers are yet available, these questions remain the subject of much discussion.

Informed Consent in Clinical Care: Practical Considerations in the Effort to Achieve Ethical Goals

INFORMED CONSENT IS A FUNDAMENTAL TENET OF THE US health care system, rooted in the ethical principles of respect for patient autonomy and enhanced patient wellbeing. As famously stated in a pivotal court case, “every human being of adult years and sound mind has a right to determine what shall be done with his own body.” Over the past century, that has come to mean that patients should be able to participate in decisions about their medical care, weighing the risks, benefits, and alternatives of a proposed intervention to ensure that the care they receive reflects their goals, preferences, and values. Although practice varies widely, the current reality of informed consent for medical and surgical interventions often falls far short of stated goals. In many settings clinical informed consent involves a laundry list of potential risks recited to a patient who has already committed to a procedure, followed by the requisite signatures on a form. It is not surprising that patient comprehension is often poor. In a recent study of patients who had just provided informed consent for elective diagnostic cardiac catheterization with possible percutaneous coronary intervention, 88% had mistaken beliefs about the benefits of the procedure. Without a basic understanding of risks, benefits, and alternatives, patients cannot meaningfully participate in decision making (although providing such information does not guarantee that patients will understand the information, use it, and use it wisely). Although failures of informed consent can have disastrous consequences, more commonly the process simply takes up valuable time and does little to promote patient autonomy or well-being, leading to cynicism of some physicians and patients who view informed consent as a legal nuisance without true meaning, and the conclusion of some scholars that expectations for patient understanding and involvement in medical care are unreasonable. Accumulating evidence suggests that the informed consent process can be improved. A recent systematic review identified 44 controlled trials of a wide range of interventions designed to improve patient comprehension in informed consent for medical and surgical procedures. While standardized measures of understanding in informed consent are lacking, the majority of these studies showed some benefit. The challenge lies in how to implement these research findings to achieve an agreed-on minimum standard of comprehension, with the overall goal of elevating the process of informed consent in clinical care to fulfill the ethical principles on which the process was founded. In this pursuit, 3 practical issues bear special consideration.

Hospital guidelines for deciding about life-sustaining treatment: dealing with health limbö

The decision to withhold life-sustaining treatment from hopelessly ill patients is fraught with ethical dilemmas and legal uncertainties. Although there are extensive published commentaries on the subject and the life is gradually becoming clearer, care-givers often need concrete guidance when confronted with actual cases. Hospital ethics committees can assist care-givers, patients, and families in resolving these dilemmas, but the committees also need some specific guidance to be relatively consistent. Therefore, the Ethics and Hunan Rights Committee of Presbyterian-University Hospital, one of the University Health Center Hospitals in Pittsburgh, has developed guidelines for deciding about life-sustaining treatment.

Evolution of clinical ethics teaching at the University of Pittsburgh

&NA; The authors explain that several years of effort, by many faculty from a variety of disciplines, were required to expand medical ethics teaching at the University of Pittsburgh School of Medicine beyond the preclinical years. Since 1986, faculty associated with the schools Center for Medical Ethics have begun a comprehensive ethics teaching program for all four years and the residency period; they also are attempting to develop an ethics consultation service. The authors describe the program, its promise and plans, and the significant difficulties involved in establishing and maintaining it, not only problems of long‐term funding but of the uninformed and negative attitudes of some students and faculty toward ethics teaching, especially in the clinical setting. Also discussed are the pros and cons of using cases in ethics teaching and the programs approaches to evaluation and to training clinical faculty in clinical ethics issues.

A “Dignitary Tort” as a Bridge between the Idea of Informed Consent and the Law of Informed Consent

More than 30 years have passed since the phrase informed consent was first uttered in a judicial opinion. Jay Katz’s own ground-breaking work on informed consent’ is now more than 10 years old, and the insights of The Silent World of Doctor and Patient’ are so constantly fresh that it is easy to forget it too was not just recently published. While trying to develop some new thoughts about informed consent for this essay-a task made virtually impossible by Jay’s work-I had reviewed an article by Professor Joseph Goldstein,f one of Jay’s frequent collaborators. Goldstein recounted discovering an index card he had written almost 30 years earlier (ironically for me, the year 1 was born) containing some notes about Harold Lasswell’s work.* Not only is law a seamless web, it is a timeless one. Jay’s work on informed consent is pervaded by a timeless theme that I wish to address here: how the dignity of the individual, the shining beacon of the idea of informed consent, is sorely neglected in the law of informed consent. Many doctors seem to believoindeed, Jay Katz may be the only exception-that informed consent is part of the plot by judges and lawyers to tell doctors how to practice medicine, and to impoverish them in the process. Unfortunately, the plaintiff’s bar sometimes lends support and credence to this mistaken view. The case law, by and large, stands only for the right to recover for bodily harm occasioned by a doctor’s failure to warn about risks. Jay constantly reminds us, however, of the nobility of law in general and of informed consent in particular. He rightly bemoans the trivialization of informed consent by the courts, reducing it to little more than a medical Miranda-warning. In retrospect, as long as the defendant-doctor warned the patient that what went wrong could have gone wrong, the patient is left without a legal remedy-in other words, something may have gone wrong, but it is not a legal wrong. The judicial and legislative version of the law of informed consent is about money: whether the doctor must pay it and the patient can get it. Lost are the values that informed consent should promote, not merely those-autonomy, individualism, self-determination-that are honored in the diica of the case law (and breached in the holdings), but the value of mutual trust and education between doctor and patient. The law of informed consent-a phrase I will use to refer primarily to the case law, but also to the legislative enactments which, for all intents and purposes are the same5-with only a few exccptions,b shows no willingness to aspire to any of the lofty goals that Jay eloquently urges on it, and which he refen to collectively as the idea of informed consent.’ The particular theme that I wish to examine is one described by Professor Goldstein as the recognition that “ a c i t izen can be w r o n g e d w i t h o u t be ing ‘harmed’. . . .’” It is a theme that runs throughout Jay’s work. It reflects the influence of his forebears and contemporaries at the Yale Law School, Fowler V. Harper and Fleming James. Sometimes this influence is conscious,S but it probably has a more ethereal component involving first absorption by the walls of the Sterling Law Buildings, where Fowler and James once taught and lived law, and then something like effluores-

Data monitoring committees: Promoting best practices to address emerging challenges:

Background and Purpose: Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials. The independence of data monitoring committees from sponsors and investigators is essential in achieving this mission. Creative approaches are needed to address ongoing and emerging challenges that potentially threaten data monitoring committees’ independence and effectiveness. Methods: An expert panel of representatives from academia, industry and government sponsors, and regulatory agencies discussed these challenges and proposed best practices and operating principles for effective functioning of contemporary data monitoring committees. Results and Conclusions: Prospective data monitoring committee members need better training. Options could include didactic instruction as well as apprenticeships to provide real-world experience. Data monitoring committee members should be protected against legal liability arising from their service. While avoiding breaches in confidentiality of interim data remains a high priority, data monitoring committees should have access to unblinded efficacy and safety data throughout the trial to enable informed judgments about risks and benefits. Because overly rigid procedures can compromise their independence, data monitoring committees should have the flexibility necessary to best fulfill their responsibilities. Data monitoring committee charters should articulate principles that guide the data monitoring committee process rather than list a rigid set of requirements. Data monitoring committees should develop their recommendations by consensus rather than through voting processes. The format for the meetings of the data monitoring committee should maintain the committee’s independence and clearly establish the leadership of the data monitoring committee chair. The independent statistical group at the Statistical Data Analysis Center should have sufficient depth of knowledge about the study at hand and experience with trials in general to ensure that the data monitoring committee has access to timely, reliable, and readily interpretable insights about emerging evidence in the clinical trial. Contracts engaging data monitoring committee members for industry-sponsored trials should have language customized to the unique responsibilities of data monitoring committee members rather than use language appropriate to consultants for product development. Regulatory scientists would benefit from experiencing data monitoring committee service that does not conflict with their regulatory responsibilities.

The Consortium Ethics Program: An approach to establishing a permanent regional ethics network

This paper describes the first three-year experience of the Consortium Ethics Program (CEP-1) of the University of Pittsburgh Center for Medical Ethics, and also outlines plans for the second three-year phase (CEP-2) of this experiment in continuing ethics education. In existence since 1990, the CEP has the primary goal of creating a cost-effective, permanent ethics resource network, by utilizing the educational resources of a university bioethics center and the practical expertise of a regional hospital council. The CEPs conception and specific components stem from recognition of the need to make each hospital a major focus of educational efforts, and to provide academic support for the in-house activities of the representatives from each institution.

Quality of life and end-of-life decisionmaking.

Since 1976, when the New Jersey Supreme Court decided the Karen Ann Quinlan case (In re Quinlan, 355 A.2d 647 (NJ), 1976 cert. denied, 429 US 922, 1976), it has been apparent that the concept of quality of life is fundamental to end-of-life decisionmaking. Yet there has been a great deal of reluctance by courts – which have been the primary engine of lawmaking in end-of-life matters – to use this concept overtly.

The "right to die": a case study in American lawmaking.

In the 20 years that have passed since the Karen Quinlan case exposed a simmering clinical issue to the light of day — more precisely, to the press and to judicial process — a consensus has developed in American law about how end-of-life decisionmaking should occur. To be sure, there are dissenting voices from this consensus, but they are often (though not always) about minor issues. By illustrating how this consensus has evolved, this paper explores how law is made in the American legal system and the roles that different legal and extra-legal institutions play in lawmaking.