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)
What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. Second is the situation of women, who are (...) made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. (edited). (shrink)
ABSTRACTComparative effectiveness studies, referred to here as “usual-care” trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains “unusual” care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, (...) and subjects’ safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents. (shrink)
The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination of the consent forms (...) reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of “standard of care” may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements. (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)
Rhodes seeks to defend her ‘conclusion that everyday ethics and medical ethics [are] incompatible’.1 She challenges ‘views that medical ethics is nothing more than common morality applied to clinical matters’.1 Beauchamp and Childress explicate the term ‘common morality’ at length.2 Nowhere do they claim that medical ethics is ‘nothing more than common morality applied to clinical matters’. Here is what they do say: “The origin of the norms of the common morality is no different in principle from the origin of (...) the norms of a particular morality for a medical or other profession … The primary difference is that the common morality has authority in all communities, whereas particular moralities are authoritative only for specific groups”.2 This critique discusses the seven examples Rhodes uses to illustrate her main point: that common morality and medical ethics are radically different. I contend that common morality accounts for the purported differences she cites. In ordinary life, people can simply mind their own business, whereas physicians have a duty to act in their professional setting. On this view, common morality cannot explain the moral obligation people have to prevent easily avoidable harm to others. A bystander …. (shrink)
A new political movement has arisen in bioethics, self‐consciously distingushed from the rest of the ield and characterized by a new way of writing and arguing. Unfortunately, that new method is mean‐spirited, mystical, and emotional. It claims insight into ultimate truth yet disavows reason.
In exploring the concept of vulnerability, we do not begin with a blank slate. In research involving human subjects, ethics guidelines typically provide a rough definition of the concept. For example, the commentary on Guideline 13 in the International Ethical Guidelines for Biomedical Research Involving Human Subjects, issued by the Council for International Organizations of Medical Sciences (CIOMS), says that "vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient (...) power, intelligence, education, resources, strength, or other needed attributes to protect their own interests" (CIOMS 2002). Because the CIOMS guidelines .. (shrink)
: The multicultural composition of the United States can pose problems for physicians and patients who come from diverse backgrounds. Although respect for cultural diversity mandates tolerance of the beliefs and practices of others, in some situations excessive tolerance can produce harm to patients. Careful analysis is needed to determine which values are culturally relative and which rest on an underlying universal ethical principle. A conception of justice as equality challenges the notion that it is always necessary to respect all (...) of the beliefs and practices of every cultural group. (shrink)
This paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental misunderstanding of applicable government (...) regulations and even the research enterprise. Others are the result of conceptual disagreements about the importance and application of traditional research ethics norms to ‘comparative effectiveness research’ and modern research environments. Common among these explanations, however, is a failure to appreciate when a research intervention, rather than merely an observation or review of data, is taking place. Review committees and investigators are failing to see, or choosing to ignore, interventions in the lives of research subjects. When these studies have come to light, government agencies with oversight authority have done little or backed down. Prestigious medical journals have published research results knowing that the required consent was not obtained, or they have stood by the published studies even after the inadequacy of consent is discovered. This article critically examines this erosion of consent in theory and practice and calls for restoring the requirement of informed consent to its proper place as a priority in human subjects research. (shrink)
A truly global bioethics involves cooperation and collaboration among countries. Most of the articles published in bioethics journals address a problem that exists in one or more countries, but the articles typically do not discuss solutions that require collaboration or cooperation. COVAX is one example of proposed international cooperation related to the current COVID-19. pandemic. Yet it is evident that nations have been proceeding on their own with little, if any collaboration. Despite international research ethics guidance from the World Health (...) Organization, an article published under WHO auspices violates an ethical principle rejecting “double standards” in the conduct of global research. The COVID pandemic provides an opportunity for countries to learn from the recent lack of international cooperation and employ a multi-national strategy in future global health crises. (shrink)
In recent years there has been considerable discussion and controversy concerning the concepts of mental health and mental illness. The controversy has centered around the problem of providing criteria for an adequate conception of mental health and illness, as well as difficulties in specifying a clear and workable system for the classification, understanding, and treatment of psychological and emotional disorders. In this paper I shall examine a cluster of these complex and important issues, focusing on attempts to define ‘mental health’ (...) and ‘mental illness’; diverse factors influencing the ascription of the predicates ‘is mentally ill’ and ‘is mentally healthy’; and some specific problems concerning these concepts as they appear in various theories of psychopathology. The approach here will be in the nature of a survey, directed at the specification of a number of problems—conceptual, methodological, and pragmatic—as they arise in various attempts to define and to provide criteria for applying the concepts of mental health and mental illness. (shrink)
The criteria for determining what it is to do good medical ethics are the quality of ethical analysis and ethical justifications for decisions and actions. Justifications for decisions and actions rely on ethical principles, be they the ‘famous four’ or subsidiary ethical principles relevant to specific contexts. Examples from clinical ethics, research ethics and public health ethics reveal that even when not stated explicitly, principles are involved in ethical justifications. Principles may come into conflict, however, and the resolution of an (...) ethical dilemma requires providing good reasons for preferring one principle over another. (shrink)
Jehovah's Witnesses who refuse blood transfusions on religious grounds have long created ethical dilemmas for those in the medical profession trying to serve them. A bioethicist working in a clinical setting explores how one hospital ethics committee grappled with the additional problem of pregnant Jehovah's Witnesses, including the complex interdependence of maternal and fetal rights.
Finding an effective method that can lower women’s risk of HIV infection is an ethical imperative. A vaginal microbicide is a preventive method that can be controlled by women. Well-designed scientific research has already yielded modest success, yet more research is needed in order to develop an even better product. But just as research must be scientifically sound, it must also be ethically sound. Ethical challenges in HIV microbicide research include issues of safety and level of efficacy, whether pregnant women (...) and adolescents should be included in clinical trials, and whether male partners of women participants should be involved in any way in the process of obtaining informed consent. (shrink)
ABSTRACT Fast forward 50 years into the future. A look back at what occurred in the field of bioethics since 2010 reveals that a conference in 2050 commemorated the death of bioethics. In a steady progression over the years, the field became increasingly fragmented and bureaucratized. Disagreement and dissension were rife, and this once flourishing, multidisciplinary field began to splinter in multiple ways. Prominent journals folded, one by one, and were replaced with specialized publications dealing with genethics, reproethics, nanoethics, and (...) necroethics. Mainstream bioethics organizations also collapsed, giving way to new associations along disciplinary and sub‐disciplinary lines. Physicians established their own journals, and specialty groups broke away from more general associations of medical ethics. Lawyers also split into three separate factions, and philosophers rejected all but the most rigorous, analytic articles into their newly established journal. Matters finally came to a head with global warming, the world‐wide spread of malaria and dengue, and the cost of medical treatments out of reach for almost everyone. The result was the need to develop plans for strict rationing of medical care. At the same time, recognition emerged of the importance of the right to health and the need for global justice in health. By 2060, a spark of hope was ignited, opening the door to the resuscitation of bioethics and involvement of the global community. (shrink)
What does it mean to say that ethics committees that provide prospective review of research involving human beings should be “independent”? In the United States, IRBs—which are typically located within and review research protocols at the institution for which most of their members work—cannot really be considered independent. Yet separating the IRB from the research institution may in turn mean less independence from a trial’s sponsors, as this kind of IRB is commercially motivated and paid directly by the sponsor. One (...) possible answer is to create independent IRBs that are not for profit, but how this model would attract financial and administrative support is unclear. (shrink)
Robert Baker and Rosamond Rhodes each argue against the universality “common morality,” the approach to ethics that comprises four fundamental principles and their application in various settings. Baker contends that common morality cannot account for cultural diversity in the world and claims that a human rights approach is superior in the context of global health. Rhodes maintains that bioethics is not reducible to common morality because medical professionals have special privileges and responsibilities that people lack in everyday life. Baker fails (...) to demonstrate how the human rights approach to global ethics is more sensitive to culture than the use of bioethics principles that comprise common morality. Rhodes has a narrow interpretation of “common morality,” which when understood more broadly, accounts for the special privileges and obligation of medical professionals. (shrink)
The new reproductive technologies force us to rethink the concepts ‘mother,’ ‘father,’ ‘family.’ As we draw analogies to traditional patterns, we must distinguish between ethical and conceptual questions.
It seemed like only minutes after a team of Scottish scientists announced, in late February 1997, that they had successfully cloned a sheep, that governmental officials and private citizens throughout the world called for a ban on cloning human beings. The rush to legislate or issue executive orders was so swift, it is reasonable to wonder why the news that a mammal had been cloned ignited such a stampede to prohibit, even criminalize, attempts to clone humans. These events raise a (...) series of separate, yet related questions. Why does the prospect of cloning human beings incite such strong reactions? What reasons have been proposed for enacting national laws or international conventions to prohibit cloning? Can these prohibitions be justified by sound ethical arguments? Before attempting to answer these questions, let us look first at the responses that called for public policy measures to ban human cloning. (shrink)
This article focuses on the access of people in developing countries to medications and medical services that are readily available to inhabitants of industrialized countries. There are, of course, other critical dimensions of public health that require action on a global scale. These include relief for large numbers of people who are starving or living at nearly subsistence levels; provision of a supply of clean, potable water for populations deprived of that essential resource; and the consequences for local agricultural production (...) in countries in which globalization has led to deforestation of vast portions of the land. The focus here on access to health services and needed medications is not intended to minimize the importance of these other areas of global health. (shrink)