The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort anticipated in research (...) are not greater than those encountered during the performance of routine physical or psychological examinations or tests”. (shrink)

This is a major work in moral philosophy, the long-awaited follow-up to Parfit's 1984 classic Reasons and Persons, a landmark of twentieth-century philosophy. Parfit now presents a powerful new treatment of reasons and a critical examination of the most prominent systematic moral theories, leading to his own ground-breaking conclusion.

Background -- Evaluating the worry -- Proposed justifications -- Human interests and human causes -- Our connection to our contribution -- The value of passive contributions -- Implications -- Objections and the potential for abuse.

Clinical research with adults who are unable to provide informed consent has the potential to improve understanding and care of a number of devasting conditions. This research also has the potential to exploit some of society's most vulnerable members. Recently, a number of task forces and individual writers have proposed guidelines to ensure that such research is both possible and ethical. Yet, there is widespread disagreement over which safeguards should be adopted. In the present paper, I consider to what extent (...) these disagreements can be resolved by appeal to a general account of the interests of subjects who are unable to consent and the conditions that must be satisfied for research enrollment to constitute exploitation of their inability to make their own decisions. (shrink)

Clinical research with adults who are unable to provide informed consent has the potential to improve understanding and care of a number of devastating conditions. This research also has the potential to exploit some of society's most vulnerable members. Recently, a number of task forces and individual writers have proposed guidelines to ensure that such research is both possible and ethical. Yet, there is widespread disagreement over which safeguards should be adopted. In the present paper, I consider to what extent (...) these disagreements can be resolved by appeal to a general account of the interests of subjects who are unable to consent and the conditions that must be satisfied for research enrollment to constitute exploitation of their inability to make their own decisions. (shrink)

It is often argued that clinical research should not violate the Kantian principle that people must not be used merely as a means for the purposes of others. At first sight, the practice of clinical research itself, however, seems to violate precisely this principle: clinical research is often beneficial to future people rather than to participants; even if participants benefit, all things considered, they are exposed to discomforts which are absent both in regular care for their diseases and in other (...) areas of daily life. Therefore, in this paper we will consider whether people are used merely as a means by being enrolled in clinical research. On the basis of recent studies of Kantian scholars we will argue that clinical research is compatible with the Kantian principle if the conditions of possible consent and end-sharing have been met. Participants are not used merely as a means if they have sufficient reasons to consent to being enrolled in clinical research and can share the ends of the researchers who use them. Moreover, we will claim that even if people are used merely as a means by participating in clinical research, it may not always be morally wrong to use them in this way. (shrink)

Decision making for incompetent patients is a much-discussed topic in bioethics. According to one influential decision making standard, the substituted judgment standard, a surrogate decision maker ought to make the decision that the incompetent patient would have made, had he or she been competent. Empirical research has been conducted in order to find out whether surrogate decision makers are sufficiently good at doing their job, as this is defined by the substituted judgment standard. This research investigates to what extent surrogates (...) are able to predict what the patient would have preferred in the relevant circumstances. In this paper we address a methodological shortcoming evident in a significant number of studies. The mistake consists in categorizing responses that only express uncertainty as predictions that the patient would be positive to treatment, on the grounds that the clinical default is to provide treatment unless it is refused. We argue that this practice is based on confusion and that it risks damaging the research on surrogate accuracy. (shrink)

According to the Substituted Judgment Standard a surrogate decision maker ought to make the decision that the incompetent patient would have made, had he or she been competent. This standard has received a fair amount of criticism, but the objections raised are often wide of the mark. In this article we discuss three objections based on empirical research, and explain why these do not give us reason to abandon the Substituted Judgment Standard.

When children are too young to make their ownautonomous decisions, decisions have to be madefor them. In certain contexts we allow parentsand others to make these decisions, and do notinterfere unless the decision clearly violatesthe best interest of the child. In othercontexts we put a priori limits on whatkind of decisions parents can make, and/or whatkinds of considerations they have to take intoaccount. Consent to medical research currentlyfalls into the second group mentioned here. Wewant to consider and ultimately reject one (...) ofthe arguments put forward for putting medicalresearch into the second category. We willargue that some objections to children'sparticipation in research are either based onan implausibly restrictive conception of whatis in fact in the child's best interests orthat there is an implicit and false premisehidden in this argument; i.e., the premise thatour children have so deeply fallen into moralturpitude that we must assume that they wouldnot want to fulfill their moral obligations,or, that they will grow up to be morallydeficient and will then wish not to have actedwell while a child. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

This book is the most comprehensive treatment available of one of the most urgent - and yet in some respects most neglected - problems in bioethics: decision-making for incompetents. Part I develops a general theory for making treatment and care decisions for patients who are not competent to decide for themselves. It provides an in-depth analysis of competence, articulates and defends a coherent set of principles to specify suitable surrogate decisionmakers and to guide their choices, examines the value of advance (...) directives, and investigates the role that considerations of cost ought to play in decisions concerning incompetents. Part II applies this theoretical framework to the distinctive problems of three important classes of individuals, many of whom are incompetent: minors, the elderly and psychiatric patients. The authors' approach combines a probing analysis of fundamental issues in ethical theory with a sensitive awareness of the concrete realities of health care institutions and the highly personal and individual character of difficult practical problems. Its broad scope will appeal to health professionals, moral philosophers and lawyers alike. (shrink)