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)
As the HIV epidemic continues unabated, among the people most at risk are women and girls in developing countries. Condom distribution, adopted as a public health measure early in the epidemic, has had only marginal success. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), “Young girls and women are regularly and repeatedly denied information about, and access to, condoms. Often they do not have the power to negotiate the use of condoms. In many social contexts, men are resistant (...) to the use of condoms” (Condoms and HIV Prevention 2011). Counseling and public campaigns to encourage people to reduce risky behavior have not worked to stem the tide of new infections. Abstinence is not an option .. (shrink)
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)
Empirical evidence confirms the existence of health inequalities between women and men in developing countries, with women experiencing poorer health status than men, as well as less access to vital health services. These disparities have different sources and take different forms, some of which result from cultural factors, others from discriminatory laws and practices, and still others from the biological fact that only women undergo pregnancy and childbirth, a major cause of maternal mortality. The injustice lies in the fact that (...) many of these disparities result from socially controllable factors, while others could be remedied, especially in cases of violations of human rights. Past and recent policies and practices of the United States Government can be faulted for both actions and omissions that have contributed to such inequalities. Different conceptions of global justice are explored, with implications for who owes what to whom regarding these disparities. (shrink)
Many preventive intervention studies with adolescents address high-risk behaviors such as drug and alcohol use, and unprotected sex. Randomized controlled trials (RCT) are the gold standard methodology used to test the effectiveness of these behavioral interventions. Interventions outside the rigidly described protocol are prohibited. However, there are ethical challenges to implementing inflexible intervention protocols, especially when the target population is young, experiences many stressful events, and lives in a resource-poor environment. Teens who are at high risk for substance use or (...) sexual risk behaviors tend to be at risk for other problems such as exposure to violence, sexual and physical abuse, depression, and homelessness. How should investigators deal with the psychological and social needs of teenagers in prevention programs in an ethically appropriate way and at the same time preserve the validity of RCT results? We have identified program characteristics, participant characteristics, interaction with parents, and problems with adolescents not in the study as sources of ethical dilemmas in RCT with at-risk adolescents. As a result of our experience, we recommend that every behavioral intervention study develop an ethics protocol, which should include rules for providing help to participants, has contact information for experts to provide guidance, and an emergency procedure for dealing with life threatening situations. In addition, studies should have a resource manual, train research staff in these ethical issues, and work with a data safety and monitoring board or ethics committee. (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)
: 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)
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)
: 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)
: The Advisory Committee on Human Radiation Experiments experienced some disagreements among its members in the course of its work. An epistemological controversy over the nature and degree of evidence required to draw ethical conclusions pervaded the committee's deliberations. Other disagreements involved the proper role of a governmental advisory committee and the question of when it is appropriate to notify people that they were unknowing subjects of radiation experiments. In the end, the Committee was able to reach consensus on almost (...) all of its findings and recommendations through a process that preserved the integrity of its members. (shrink)
A young man, terminally ill and in extreme suffering, asks to be removed from life support, requesting morphine first so he'll be asleep when the machine stops. His physician agrees, but the hospital's chief administrator intervenes, arguing that the morphine might itself cause death, leaving the physician open to criminal indictment for murder. To placate the administrator, the doctor and patient reach a grim compromise: life support will be disconnected first, and only after manifest signs of suffering appear will the (...) physician administer the morphine, to alleviate pain. The patient's request is ultimately respected, but many staff members feel he has been made to suffer needlessly. This is just one of many cases Ruth Macklin discusses in Enemies of Patients, an eye-opening look at the growing number of forces that are hostile to the interests of patients, including hospital administrators, lawyers who represent hospitals, insurance companies, government regulations, and even some well intentioned physicians. Macklin, a highly regarded medical ethicist, the author of Mortal Choices and the subject of a New York Times Magazine cover story, provides a behind-the-scenes look at how the patient's ethical rights are often violated. She describes, for instance, how a new breed of hospital administrator, the risk manager, acts consistently as an enemy of the patient, often urging physicians to continue aggressive, expensive treatments for critically ill patients--even when the patient and doctor agree the treatment should cease--for fear of lawsuits, bad publicity, or criminal indictment. (Macklin points out, for instance, that even though no physician has ever been convicted of a crime for withdrawing treatment from a patient in a permanent vegetative state, hospital lawyers and risk managers regularly assert that there is a danger of criminal liability in such cases.) The government also can become an enemy of patients. The most egregious case, according to Macklin, is the Federal government's "gag rule" which has prohibited health care facilities that receive Title X funds from discussing abortion with pregnant women, violating the patient's right to full information. And physicians themselves can become enemies of patients. Some, seeing themselves as fiscal gatekeepers, ration expensive health care procedures on financial rather than medical grounds. Some physicians refuse to treat patients who don't follow their advice (a cardiologist, for instance, who will not take care of patients who smoke) and others won't treat patients who pose a threat of lawsuit (such as a California woman in need of life-sustaining dialysis, who had previously sued another physician). Packed with numerous case histories drawn from the author's experience in a major urban medical center, Enemies of Patients will give readers a better understanding of their rights as patients and show them how to forge an alliance with their doctors against common enemies. (shrink)
The AIDS epidemic calls for an ethical analysis of conflicting obligations surrounding HIV-infected psychiatric patients and confidentiality, as well as issues that go beyond confidentiality. Although laws pertaining to HIV infection have been enacted in a number of states, these statutes leave much discretion to health professionals. The ethical principle known as "the harm principle" can permit disclosure of confidential information and detention or isolation of psychiatric patients who pose a threat of infecting other patients. From an ethical point of (...) view, however, the circumstances under which traditional protections may be weakened or abandoned remain limited. (shrink)
Psychiatrists are frequently called upon to make assessments of the rationality or irrationality of persons for a variety of medical-legal purposes. A key category is that of evaluations of a patient's capacity to grant informed consent for a medical procedure. A diagnosis of mental illness is neither a necessary nor a sufficient condition for a finding of incompetence. The notion of competency to grant consent, which is a mixed psychiatric-legal concept, shares some features with philosophical conceptions of rationality, but differs (...) from them in a number of important respects. This article describes the actual practice of psychiatrists when making such judgments, along with the standards of competency they employ. A comparison is made between those notions of competency and predominant philosophical conceptions of rationality. (shrink)
An examination is made of the dispute between the proponents of rational explanation of actions and of the deductive nomological pattern of explanation. A rapprochement between these two positions is suggested, with the aim of accounting for the normative character of reasons for acting. It is argued that the disputed area is an area of intersection between facts and values, and that far from it being the case that the normative and descriptive components can be separated or isolated, the underlying (...) precepts are to be viewed as both explanatory (descriptive) and normative. The discussion is divided into two general areas: (1) the normative force of reasons for acting; and (2) the normative character of rationality. (shrink)
