Tom L. Beauchamp

An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion.

Methods and principles in biomedical ethics

The four principles approach to medical ethics plus specification is used in this paper. Specification is defined as a process of reducing the indeterminateness of general norms to give them increased action guiding capacity, while retaining the moral commitments in the original norm. Since questions of method are central to the symposium, the paper begins with four observations about method in moral reasoning and case analysis. Three of the four scenarios are dealt with. It is concluded in the “standard” Jehovah’s Witness case that having autonomously chosen the authority of his religious institution, a Jehovah’s Witness has a reasonable basis on which to refuse a recommended blood transfusion. The author’s view of the child of a Jehovah’s Witness scenario is that it is morally required—not merely permitted—to overrule this parental refusal of treatment. It is argued in the selling kidneys for transplantation scenario that a fair system of regulating and monitoring would be better than the present system which the author believes to be a shameful failure.

The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight

The rise of quality improvement research and comparative effectiveness research in health care settings constitutes progress toward the goal of what the Institute of Medicine has called a “learning healthcare system,” in which we are “drawing research closer to clinical practice by building knowledge development and application into each stage of the healthcare delivery process.” As clinical research and clinical practice move closer to a deliberately integrated system, the distinction between the two is increasingly blurred, although the sharp distinction in U.S. regulations and research ethics literature remains in place. In the 1970s and for two decades thereafter, this distinction was helpful: for some forms of research, it sheds light on which activities require ethical oversight. Research that is closely integrated with health care—notably, health delivery research—was then uncommon, however. That is no longer the case, and regulations and research ethics need to change to accommodate the new landscape. In this paper, we argue that conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice. We start with the history of the research-practice distinction in the reports of a U.S. national commission and in U.S. federal regulations, and then offer a critical assessment of five characterizations of research that have been used in policy documents and the scholarly literature to try to make a sharp distinction between research and practice. We challenge the clarity and the tenability of these characterizations as a way of distinguishing research from practice. We argue that the received view of the research-practice distinction leads to overprotection of the rights and interests of patients in some cases and to underprotection in others. We contend that a new ethical foundation needs to be developed that facilitates both care and research likely to benefit patients, and that provides oversight that, rather than being based on a distinction between research and practice, is commensurate with risk and burden in both realms.

Informed Consent, Comparative Effectiveness, and Learning Health Care

The authors argue that in a learning health care system with ethically robust oversight policies, a streamlined consent process could replace formal written informed-consent procedures for many studies, and patient consent would not be required at all for some trials.

Principlism and Its Alleged Competitors

Principles that provide general normative frameworks in bioethics have been criticized since the late 1980s, when several different methods and types of moral philosophy began to be proposed as alternatives or substitutes. Several accounts have emerged in recent years, including: (1) Impartial Rule Theory (supported in this issue by K. Danner Clouser), (2) Casuistry (supported in this issue by Albert Jonsen), and (3) Virtue Ethics (supported in this issue by Edmund D. Pellegrino). Although often presented as rival methods or theories, these approaches are consistent with and should not be considered adversaries of a principle-based account.

Informed Consent: Its History, Meaning, and Present Challenges

The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.

The Concept of Voluntary Consent

Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the circumstances and the psychological capacities of agents. We compare and evaluate several accounts of voluntariness and argue that our view, unlike other treatments in bioethics, is not a value-laden theory. We also discuss the empirical assessment of individuals’ perceptions of the degrees of noncontrol and self-control. We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research.

The OHRP and SUPPORT

A group of medical ethicists and pediatricians asks for reconsideration of the recent Office for Human Research Protections decision about informed consent in SUPPORT.

Does Ethical Theory Have a Future in Bioethics

Although there has long been a successful and stable marriage between philosophical ethical theory and bioethics, the marriage has become shaky as bioethics has become a more interdisciplinary and practical field. A practical price is paid for theoretical generality in philosophy. It is often unclear whether and, if so, how theory is to be brought to bear on dilemmatic problems, public policy, moral controversies, and moral conflict. Three clearly philosophical problems are used to see how philosophers are doing in handling practical problems: Cultural Relativity, and Moral Universality, Moral Justification, and Conceptual Analysis. In each case it is argued that philosophers need to develop theories and methods more closely attuned to practice. The work of philosophers such as Ruth Macklin, Norman Daniels, and Gerald Dworkin is examined. In the writings of each there is major methological gap between philosophical theory (or method) and practical conclusions. The future of philosophical ethics in interdisciplinary bioethics may turn on whether such gaps can be closed. If not, bioethics may justifiably conclude that philosophy is of little value.

Decision-making and informed consent: A study of the impact of disclosed information

This paper is an empirical and normative study of several problems about informed consent in the law and in biomedical ethics. Its particular focus is on the adequacy of prevailing standards of informed consent in medicine and law. These standards generally govern adequate disclosure on the physicians part, to the relative neglect of the equally significant question, ‘What constitutes a valid consent on the patients part?’ New empirical data regarding the actual decision-making behavior of patients is presented. It was gathered by studying patients considering whether to consent to the use of nonsurgical contraceptive techniques. Three hypotheses are examined regarding how disclosed information affects the decision-making process. Results indicate that disclosed information is not avowed as the prime determinant of the consent decision, that disclosed information does have some effect on the decision-making process, and that disclosed information does not impair or confuse the decision-making process. In conclusion, a number of implications for major areas of ethics and law are pointed out, with special emphasis on three areas of law: the materiality standard, causation, and the therapeutic privilege.