Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

Mainstream moral theories deal with situations in which the outcome of each possible action is well-determined and knowable. In order to make ethics relevant for problems of risk and uncertainty, moral theories have to be extended so that they cover actions whose outcomes are not determinable beforehand. One approach to this extension problem is to develop methods for appraising probabilistic combinations of outcomes. This approach is investigated and shown not to solve the problem. An alternative approach is then developed. Its (...) starting-point is that everyone has a prima facie moral right not to be exposed to risk. However, this right can be overridden if the risk-exposure is part of an equitable system for risk-taking that works to the advantage of the individual risk-exposed person. (shrink)

This paper examines the role of equipoise in evaluating international research. It distinguishes two possible formulations of the equipoise requirement that license very different evaluations of international research proposals. The interpretation that adopts a narrow criterion of similarity between clinical contexts has played an important role in one recent controversy, but it suffers from a number of problems. An alternative interpretation that adopts a broader criterion of similarity does a better job of avoiding both exploitation of the brute fact of (...) social deprivation and the exploitation of needy populations for the benefit of more well-off populations. It also holds out the promise of reconciling the need to find interventions that can be employed in developing world contexts with the cluster of moral values that must constrain the way such research is carried out. (shrink)

The physician who upholds the Hippocratic oath is supposed to be loyal to his or her patients. This requires choosing only the therapy that the physician believes is best for the patient. However, knowing what is best requires randomized clinical trials. Thus, clinicians must be willing to recruit their patients to be assigned at random to one of two therapies in order to determine which is best based on the highest standards of pharmacological science.

Contrary to the received view, decision theory is not primarily devoted to instrumental (ends-to-means) reasoning. Instead, its major preoccupation is the derivation of ends from other ends. Given preferences over basic alternatives, it constructs preferences over alternatives that have been modified through the addition of value object modifiers (modes) that specify probability, uncertainty, distance in time etc. A typology of the decision-theoretical modes is offered. The modes do not have (even extrinsic) value, but they transform the value of objects to (...) which they are applied. A rational agent's total set of preferences should be coherent, but from this it does not follow that her preferences over mode-containing objects have to be derivable from her preferences over mode-free objects. (shrink)

The relatively new discipline of risk analysis promises to provide objective guidance in some of the most controversial issues in modern high‐technology societies. Four conditions are discussed that must be satisfied for this promise to be fulfilled. Since none of these conditions is satisfied, risk analysis does not keep its promise. In its attempts to reduce genuinely political issues to technocratic calculations, it neglects many of the factors that should influence decisions on risk acceptance. A list of tentative guidelines is (...) given for numerical decision support that encourages democratic decision‐making instead of trying to evade it. (shrink)

Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it (...) is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration and Health and Human Services regulations. When that equipoise ends, a drug is either not approved or becomes standard care. (shrink)

This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clinical trials — the “community equipoise” strategy . The dilemma is that RCTs appear to violate a physician's duty to choose that therapy which there is most reason to believe is in the patient's best interest, randomizing patients even once evidence begins to favor one treatment. The community equipoise strategy involves the suggestion that our judgment that neither treatment is to be preferred is to (...) be assessed according to a community rather than an individual standard. Thus, though a physician may personally believe that there is some reason to prefer one treatment, patients can legitimately be randomized if there remains disagreement in the community of medical professionals. Rationales in favor of this conception include the following: medical knowledge is best understood as residing in the community, the judgments of others count as evidence, and so should change one's own opinion, subjects would not be better off outside the trial, and the point of any trial is the resolution of dispute in the medical community. I critically examine these rationales and argue that they are insufficient. Amongst the problems are tensions between various of these underlying rationales, and important ambiguities in just what the CE criterion is to amount to. Finally, I argue that even if use of CE was justified, it would not justify carrying out RCTs anywhere near long enough to discharge our duty to gain reliable knowledge on which to base safe and effective medical practice. Hence, we need some different justification for carrying out RCTs. (shrink)