Public health ethics in the future will be distinguished from public health ethics in the past by this new subfield being labeled as such, acknowledged, and called upon for service. Ethical dilemmas have been present throughout the history of public health. The question of whether to force Henning Jacobson to be immunized in 1905 in accordance with the 1902 Massachusetts smallpox vaccination law was one of ethics as well as law. How Thomas Parran, Surgeon General in 1936, chose to respond (...) to a raging syphilis epidemic in the United States in the early part of the 2W century raised considerable moral debate in determining the appropriate public health response for a government? More recently, questions have arisen concerning the appropriate reach of government in controlling HIV banning smoking, or promoting healthy lifestyles. Debates over government infringement, morality, and justice recur throughout the history of public health. (shrink)

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. (...) A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)

Next SectionIntensification of poverty and degradation of health infrastructure over recent decades in countries most affected by HIV/AIDS present formidable challenges to clinical research. This paper addresses the overall standard of health care (SOC) that should be provided to research participants in developing countries, rather than the narrow definition of SOC that has characterised the international debate on standards of health care. It argues that contributing to sustainable improvements in health by progressively ratcheting the standard of care upwards for research (...) participants and their communities is an ethical obligation of those in resource-rich countries who sponsor and implement research in poorer ones. (shrink)

Clinical research has become a burgeoning activity in recent years, largely stimulated by the pharmaceutical industry's interest in new drugs with high marketing profiles. Several other forces fuel this thrust: the increasing dependence of academic medical institutions on research funding from industry; the need for large, efficient multicenter trials to obtain reliable and statistically significant results in the shortest possible time for drug registration purposes; and access to research subjects in countries. The intense interest in HIV/AIDS research and recent controversies (...) about revisions to the Helsinki Declaration, which have been seen by some to be motivated by the desire to facilitate exploitative research in countries, have stimulated renewed interest in the ethics of clinical research. (shrink)

A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

In this article I examine some proposals for modification of ethical documents regulating research, particularly, the problems that introducing certain economic clauses may pose. I evaluate suggestions that reject the notion of providing the ‘best proven diagnostic and therapeutic method’ in favor of ‘the highest attainable therapeutic method’ or ‘the proven effective prophylactic, diagnostic and therapeutic methods’. I analyze the plausibility and problems of introducing a double standard and the consequences it may have in developing countries. Finally I highlight the (...) impact these changes may imply for these countries. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

: Many bioethicists assume that morality is in a state of wide reflective equilibrium. According to this model of moral deliberation, public policymaking can build upon a core common morality that is pretheoretical and provides a basis for practical reasoning. Proponents of the common morality approach to moral deliberation make three assumptions that deserve to be viewed with skepticism. First, they commonly assume that there is a universal, transhistorical common morality that can serve as a normative baseline for judging various (...) actions and practices. Second, advocates of the common morality approach assume that the common morality is in a state of relatively stable, ordered, wide reflective equilibrium. Third, casuists, principlists, and other proponents of common morality approaches assume that the common morality can serve as a basis for the specification of particular policies and practical recommendations. These three claims fail to recognize the plural moral traditions that are found in multicultural, multiethnic, multifaith societies such as the United States and Canada. A more realistic recognition of multiple moral traditions in pluralist societies would be considerably more skeptical about the contributions that common morality approaches in bioethics can make to resolving contentious moral issues. (shrink)

Increasingly, the world seems to shrink due to our ever-expanding technological and communication capacities. Correspondingly, our awareness of other cultures increases. This is especially true in the field of bioethics because the technological progress of medicine throughout the world is causing dramatic and challenging intersections with traditionally held values. Think of the use of pregnancy monitoring technologies like ultrasound to abort fetuses of the “wrong” sex in India, the sale of human organs in and between countries, or the disjunction between (...) the haves and the have-nots in South America when it comes to bone marrow transplants, while thousands of other children die for want of fundamental goods and services like clean water, basic inoculations, and food itself. (shrink)

: The fifth edition of Beauchamp and Childress's Principles of Biomedical Ethics is distinguished by its emphatic embrace of common morality as the ultimate source of moral norms. This essay critically evaluates the fifth edition's discussion of common morality and, to a lesser extent, its treatment of coherence (both the model of ethical justification and the associated concept). It is argued that the book is overly accommodating of existing moral beliefs. The paper concludes with three suggestions for improving this leading (...) text. (shrink)

First, to what level of quality can medical ethics a spire, if it ignores callous discrimination in medrcal practice against large populations of the innocent poor? Second, how effective can such theories be in addressing the critical issues of medical and clinical ethics if they are unable to contribute to the closing of the gap of sociomedical disparity?Marcio Fabri dos Anjos, Medical Ethics in the Developing World: A Liberation Theology Perspective.

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)

: Phenomena of moral conflict and disagreement have led writers in ethics to two antithetical conclusions: Either valid moral distinctions hold universally or they hold relative to a particular and contingent moral framework, and so cannot be applied with universal validly. Responding to three articles in this issue of the Journal that criticize his previously published views on the common morality, the author maintains that one can consistently deny universality to some justified moral norms and claim universality for others. Universality (...) is located in the common morality and nonuniversality in other parts of the moral life, called "particular moralities." The existence of universal moral standards is defended in terms of: (1) a theory of the objectives of morality, (2) an account of the norms that achieve those objectives, and (3) an account of normative justification (both pragmatic and coherentist). (shrink)

As we look to the future in a world with porous borders and boundaries transgressed by technologies, an inevitable question is:Can there be a single, global bioethics? Intimately intertwined with this question is a second one: How might a global bioethics account for profound - and constantly transforming - sources of cultural difference? Can a uniform, global bioethics be relevant cross-culturally? These are not simple questions, rather, a multi-dimensional answer is required. It is important to distinguish between two meanings of (...) bioethics: the academic discipline of bioethics as opposed to bioethics as a set of practices governing clinical care and scientific research. There is growing evidence to support the notion of a shared global understanding of bioethics as a field of inquiry focused on the moral dimensions of science and biomedicine. (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)

In lieu of an abstract, here is a brief excerpt of the content:A Theory of International Bioethics: The Negotiable and the Non-NegotiableRobert Baker (bio)AbstractThe preceding article in this issue of the Kennedy Institute of Ethics Journal presents the argument that “moral fundamentalism,” the position that international bioethics rests on “basic” or “fundamental” moral principles that are universally accepted in all eras and cultures, collapses under a variety of multicultural and postmodern critiques. The present article looks to the contractarian tradition of (...) Hobbes and Locke—as reinterpreted by David Gauthier, Robert Nozick, and John Rawls—for an alternative justification for international bioethics. Drawing on the central themes of this tradition, it is argued that international bioethics can be rationally reconstructed as a negotiated moral order that respects culturally and individually defined areas of nonnegotiability. Further, the theory of a negotiated moral order is consistent with traditional ideals about human rights, is flexible enough to absorb the genuine insights of multiculturalism and postmodernism, and yet is strong enough to justify transcultural and transtemporal moral judgments, including the condemnation of the Nazi doctors at Nuremberg. This theory also is consistent with the history of the ethics of human subjects experimentation and offers insights into current controversies such as the controversy over changing the consent rule for experiments in emergency medicine and the controversy over exempting certain clinical trials of inexpensive treatments for preventing the perinatal transmission of AIDS from the ethical standards of the sponsoring country.The Preamble to the Council of Europe’s (1997) Convention on Human Rights and Biomedicine, the most recently ratified code of international bioethics, is noteworthy because it never mentions “principles,” the concept most frequently cited by the fundamentalists as basic to international bioethics. Instead it stresses rights, a concept that has been utterly ignored by the fundamentalist theorists of international bioethics. The Preamble exemplifies a conception of international [End Page 233] bioethics as an ethics of covenants and conventions grounded in human rights. In the full text of the Preamble, the term “rights” appears eight times and the expressions “convention” and “covenant” are used six times; the term “principle” does not appear at all. In this essay, I develop a theoretical framework for international bioethics based on conventions, covenants, and areas of “nonnegotiability”—a concept that serves as a functional analogue to the traditional notion of “human rights.” I also shall argue that, unlike the theory of basic principles central to moral fundamentalism, the theory of negotiated morality appears immune to the multicultural and postmodern critiques of international bioethics that were analyzed in the preceding article in this issue of the Kennedy Institute of Ethics Journal (Baker 1998).Negotiated Moral Order: A Model for International BioethicsReconsidering ContractarianismThe linkage of “conventions” and “covenants” with human rights that is evident in the Council of Europe’s Convention on Human Rights and Biomedicine traces back directly to the moral and political theories of Thomas Hobbes and John Locke. Such philosophers as David Gauthier (1986), Robert Nozick (1974), and John Rawls (1971, 1993) recently have reinvigorated this classic contractarian line of analysis. In this section, I shall reconsider classical contractarian theory from a perspective informed by these more recent analyses.The most riveting feature of all forms of contractarian theory is the metaphor of the contract itself, particularly the legitimating role it accords to assent. Because contractarians look to the assent of those who would be bound by a moral norm as ultimately the sole source of a norm’s legitimacy, the most important corollary of contractarian moral theory is that moral norms are illegitimate insofar as agents either in principle could not, hypothetically would not, or actually will not rationally assent to be bound by them. Contractarians also argue that because legal norms are legitimated by acceptance of the authority of those who promulgate them, the authority of such norms is bounded by the actual or hypothetical assent of the governed. These features of contractarian analysis generate the correlative concepts of human rights and civil rights.Less often remarked, but nonetheless integral to the metaphor of the social contract, is the contractarian recognition that the interests of the [End Page 234] parties who contract to form civil society are naturally in conflict (or, as Hobbes put... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 13.3 (2003) 189-192 [Access article in PDF] Is There a Common Morality? Robert M. VeatchSenior EditorOne of the most exciting and important developments in recent ethical theory—especially bioethical theory—is the emergence of the concept of "common morality." Some of the most influential theories in bioethics have endorsed the notion using it as the starting point of their systems. This issue of the Journal is (...) devoted to these developments.The core idea of a common morality is that all humans—at least all morally serious humans—have a pretheoretical awareness of certain moral norms. The claim is that normal humans intuit or in some other way know that there is something wrong with things like lying or breaking promises or killing people. These purportedly universally shared insights can provide the raw data from which ethical theories are constructed. As such, they are perhaps analogous to the raw sense data that are relied on in the natural sciences to launch the construction of scientific theories and accounts of the nature of reality. Some common morality theorists suggest an analogy between the natural and the moral sciences.In the natural sciences there is a widely shared belief that some raw sensory data are perceived by all normal humans and provide the basis for the construction of various scientific theories. For example, it is widely believed that all normal humans looking at the top light on a traffic signal perceive something that in English is called "red." Of course, different cultures will use different language to describe this experience. They may parse the boundaries differently (varying on the exact borderline between red and orange), provide widely differing accounts of why the experience of "red" occurs, and eventually generate significantly different theoretical formulations to explain the experience of redness. Moreover, some individuals may look at that top light of the traffic signal and not see color at all. One generally, however, does not account for this by denying there is any objective, generally shared basis for the experience that produces a sensation of redness in normal people. One simply explains the experience of the one who fails to see color by positing a defect in perception, called "color-blindness."Some moral theorists suggest that something analogous happens when humans look at the moral scene. The claim is that all normal humans in all places and cultures "see" certain moral requiredness. They see that some behaviors are, in some sense, generally wrong; that other behaviors are generally right; that [End Page 189] some character traits are generally praiseworthy, others blameworthy. No sophisticated common morality theorist denies that, as with color-blindness, there may be occasional outliers who for one reason or another fail to intuit or perceive these simple, abstract moral norms. Certainly, people in different cultures will define the terms differently, will recognize different limits on the norms, and will construct different theories to account for their experience. The primitive idea that there is something generally wrong with killing other humans will be articulated very differently in different cultures—some referring to the "sacredness of life;" others to a duty not to kill, a right to life, or a prohibition on killing the innocent. Some may extend the insight to a duty to prolong living, others limit it merely to a prohibition of direct, active killing. Some may endorse more exceptions—for killing of unjust aggressors, for killing in just war, for killing in self-defense; others, such as pacifists, will be much more stingy in doling out exceptions. Certainly, people at different times and places will articulate the norms in different language and embed them in different theories. The basic claim of common morality theorists, however, is that there is some primitive, pretheoretical insight that is shared by all normal, morally serious persons.Recently, the notion of a common morality has served as a starting point for bioethical theories as diverse as Bernard Gert, Charles Culver, and Danner Clouser's Bioethics: A Return to Fundamentals (1997) and the latest edition of Tom Beauchamp and James Childress's Principles of Biomedical Ethics... (shrink)

Interest in the ethics of research on human subjects, stimulated by atrocious human experimentation during WWII and the resultant Nuremberg Code, has been sustained by examples of unethical research in many countries and by proliferation of codes and guidelines. Such interest has intensified in recent years in association with expanding international collaborative research endeavors. The ongoing controversy in international research ethics takes place at two levels. At the practical level it is about the competing concerns of those predominantly interested in (...) doing research to advance knowledge and those who, while supporting the need for research, are more acutely aware of the potential to exploit vulnerable participants, especially in developing countries. At the level of theory the controversy pits ethical universalism against moral relativism.In her recent review of agreements and controversies in international research ethics, Ruth Macklin has concluded that, despite seeming agreement on several issues, many different viewpoints persist. In her view it is unlikely that these will be resolved easily. (shrink)

Current approaches in bioethics largely overlook the multicultural social environment within which most contemporary ethical issues unfold. For example, principlists argue that the common morality of society supports four basic ethical principles. These principles, and the common morality more generally, are supposed to be a matter of shared common sense. Defenders of case-based approaches to moral reasoning similarly assume that moral reasoning proceeds on the basis of common moral intuitions. Both of these approaches fail to recognize the existence of multiple (...) cultural and religious traditions in contemporary multicultural societies. In multicultural settings, patients and their families bring many different cultural models of morality, health, illness, healing, and kinship to clinical encounters. Religious convictions and cultural norms play significant roles in the framing of moral issues. At present, mainstream bioethics fails to attend to the particular moral worlds of patients and their family members. A more anthropologically informed understanding of the ethical issues that emerge within health care facilities will need to better recognize the role of culture and religion in shaping modes of moral deliberation. (shrink)