A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.

Finding an effective microbicide that could substantially lower women’s risk of acquiring HIV infection is an ethical imperative. Women and girls continue to be disproportionally affected by HIV in sub-Saharan Africa. Ethics guidelines for conducting preventive HIV microbicide trials call for steps that intertwine biomedical research and public health. Ethical considerations include adequate studies of the safety of microbicides, the use of placebo controls in future trials once a microbicide is shown to be effective, whether leftover microbicide from a trial (...) that demonstrated efficacy should be made available to the public or used in the control group of a future trial, what preventive measures and treatment should be provided for trial participants during and after the research, and what constitute ‘fair benefits’ to the community or country when a trial is completed. The Global Campaign for Microbicides conducted a study of the benefits being provided to participants in microbicide trials and others, and found substantial evidence that researchers and sponsors are meeting the obligations stated in ethical guidelines. A cautionary tale of an HIV prevention trial that was prematurely halted demonstrates the need for engagement with the community where trials are carried out. (shrink)

: Following a long process of revision, a new version of the Declaration of Helsinki was approved by the World Medical Association in 2000. Two provisions of the Declaration address ongoing international controversies regarding research sponsored by industrialized countries and conducted in developing countries. Despite the issuance of the final version of the Declaration, opponents remain locked in debate. Moreover, the Declaration remained silent on other prominent controversies concerning international research. An analysis of these current controversies reveals reasons why they (...) are not likely to be readily resolved, despite apparent agreement by opponents on overarching ethical principles. (shrink)

The “fair benefits” approach to international research is designed to produce results that all can agree are fair without taking a stand on divisive questions of justice. But its appealing veneer of collaboration masks ambiguities at both a conceptual and an operational level. An attempt to put it into practice would look a lot like an auction, leaving little reason to think the outcomes will satisfy even minimal conditions of fairness.

The purpose of this paper is to examine whether randomized clinical trial (RCT) methods are necessarily morally problematic. If they are intrinsically problematic, then there may be a dilemma such that tragic choices might have to be made between this socially very useful method for making medical progress on the one hand, and patients' rights and welfare, or physicans' duties on the other. It is argued that the dilemma may be avoided if RCTs can sometimes be viewed as an honorable (...) and cooperative venture between investigators and subjects. Another dilemma may take shape, however, if too few people are willing to cooperate to maintain the structural integrity of many important RCTs. Given their importance, does this method justify easing some of the consent requirements? It is argued that RCT methods are not so ideal that special consideration should be given to them regarding consent requirements. To examine the compatibility of current consent requirements and frequently used RCT schemas, seven RCT designs are discussed. It is found that some, but not all, RCTs, are intrinsically problematic but that sufficient reason has not been found to hold all RCT schemas as intrinsically morally troubling. Keywords: randomized clinical trials, informed consent, randomization CiteULike Connotea Del.icio.us What's this? (shrink)

: Some commentators have recently proposed that "clinical equipoise," although widely accepted, is not necessary for morally acceptable research on human subjects. If this concept is rejected, however, we may find that trials not in the best medical interests of their subjects--bad deal trials--could be justified. To avoid exploiting participants, we must find a way to distribute the risks fairly, even if it means embracing radical changes in the way clinical research is conducted.

Some commentators have recently proposed that “clinical equipoise,” although widely accepted, is not necessary for morally acceptable research on human subjects. If this concept is rejected, however, we may find that trials not in the best medical interests of their subjects—”bad deal trials”—could be justified. To avoid exploiting participants, we must find a way to distribute the risks fairly, even if it means embracing radical changes in the way clinical research is conducted.

It is widely maintained that a clinical trial is ethical only if some form of equipoise between the treatments being compared obtains. To be in equipoise between two treatments A and B is to be cognitively indifferent between the statement ‘A is strictly more effective than B’ and its negation. It is natural to claim that equipoise regarding A and B is necessary for randomised assignment to treatments A and B to be beneficent and non‐maleficent and is sufficient for such (...) an assignment to be fair. Cashing this out precisely is difficult, and various forms of equipoise have been discussed which consider whose equipoise is relevant to the decision. This is to make judgement of equipoise something to be managed socially, while its prima facie significance is supposedly cognitive. Recent reconstructions of equipoise‐like concepts in epistemology give clues about how to understand equipoise cognitively. In this paper I examine some of this work and discuss how successful it has been. I suggest that while this work is promising, it still has far to go, and that while equipoise remains the best theory we have of the cognitive justification for clinical trials, it is nonetheless incoherent. (shrink)

This new edition of Charles Fried's Medical Experimentation includes a general introduction by Franklin Miller and the late Alan Wertheimer, a reprint of the 1974 text, an in-depth analysis by Harvard Law School scholars I. Glenn Cohen and D. James Greiner, and a new essay by Fried reflecting on the original text and how it applies to the contemporary landscape of medicine and medical experimentation.

This book provides an analysis of the debate surrounding cultural diversity, and attempts to reconcile the seemingly opposing views of "ethical imperialism," the belief that each individual is entitled to fundamental human rights, and cultural relativism, the belief that ethics must be relative to particular cultures and societies. The author examines the role of cultural tradition, often used as a defense against critical ethical judgments. Key issues in health and medicine are explored in the context of cultural diversity: the physician-patient (...) relationship, disclosing a diagnosis of a fatal illness, informed consent, brain death and organ transplantation, rituals surrounding birth and death, female genital mutilation, sex selection of offspring, fertility regulation, and biomedical research involving human subjects. Among the conclusions the author reaches are that ethical universals exist, but must not be confused with ethical absolutes. The existence of ethical universals is compatible with a variety of culturally relative interpretations, and some rights related to medicine and health care should be considered human rights. Illustrative examples are drawn from the author's experiences serving on international ethical review committees and her travels to countries in Africa, Asia, and Latin America, where she conducted educational workshops and carried out out her own research. (shrink)