From its early origins to the present, the development of mainstream economic theory has taken a direction which has excluded the analysis of human needs as a basis for social policy. The problems associated with this orientation are increasingly recognized both by economists and non-economists. As Sen (1985) points out, it is indeed strange for a discipline concerned with the well-being of people to neglect the question of needs. Currently, some writers such as Doyal and Gough (1991), post-Keynesian (...) economists such as Lavoie (1994), and those such as Davis and O'Boyle (1994) who work in the newly emerging school of social economics have begun to address the question of human needs, especially in relation to problems of policy assessment and evaluation. The approaches of some development economists who have dealt with similar issues were also instrumental in drawing attention to the significance of the long-neglected concept of needs (Stewart, 1985; Cole and Miles, 1984). (shrink)
The various statements and declarations of the World Medical Association that address conflicts of interest on the part of physicians as (1) researchers, and (2) practitioners, are examined, with particular reference to the October 2000 revision of the Declaration of Helsinki. Recent contributions to the literature, notably on conflicts of interest in medical research, are noted. Finally, key provisions of the American Medical Association’s Code of Medical Ethics (2000–2001 Edition) that address the various forms of conflict of interest that can (...) arise in the practice of medicine are outlined. (shrink)
This paper considers how best to approach dilemmas posed to global health and biosecurity policy by increasing advances in practical applications of nanotechnology. The type of nano-technology policy dilemmas discussed include: expenditure of public funds, public-funded research priorities, public confidence in government and science and, finally, public safety. The article examines the value in this context of a legal obligation that the development of relevant public health law be calibrated against less corporate-infuenced norms issuing from bioethics and (...) international human rights. (shrink)
IRBs in action -- Everyone's an expert? Warrants for expertise -- Local precedents -- Documents and deliberations: an anticipatory perspective -- Setting IRBs in motion in Cold War America -- An ethics of place -- The many forms of consent -- Deflecting responsibility -- Conclusion: the making of ethical research.
There have been serious controversies in the latter part of the 20th century about the roles and functions of scientific and medical research. In whose interests are medical and biomedical experiments conducted and what are the ethical implications of experimentation on subjects unable to give competent consent? From the decades following the Second World War and calls for the global banning of medical research to the cautious return to the notion that in controlled circumstances, medical research on human (...) subjects is in the best interest of the given individual and the broader population, this book addresses the key implications of experimentation on humans. This volume covers major ethical themes within biomedical research providing historical, philosophical, legal and policy reflections on the literature and specific issues in the field of research on human subjects. Focusing on special populations (the elderly, children, prisoners and the cognitively impaired) it represents the most up-to-date review of the special ethical and legal conflicts that arise with relation to experimentation on subjects from these groups. In the light of current initiatives for law reform pertaining to research ethics the world over, this volume provides a timely, comprehensive and provocative exploration of the field. The volume has been carefully organized to present important philosophical perspectives on organizing principles that should underlie any practical application. A forward-looking historical review of the regulatory regimes of principal jurisdictions, including of the legal controls already in place, provides the backdrop for future policy initiatives. Additionally, in the light of global restructuring of health care systems, several chapters have been devoted to epidemiological research and related issues. (shrink)
Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may have significant bearing (...) on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest. (shrink)
Spectacular treatment disasters in recent years have made it clear that informal "let's-try-it-and-see" methods of testing new proposals are more risky now than ever before, and have led many to call for a halt to experimentation in clinical medicine. In this easy-tp-read, philosophical guide to humanexperimentation, William Silverman pleads for wider use of randomized clinical trials, citing many examples that show how careful trials can overturn preconceived or ill-conceived notions of a therapy's effectiveness and lead (...) to a clearer understanding of clinical anomalies. Because it gives careful guidance on setting up trials and avoiding conceptual pitfalls, this book will be of great interest to all epidemiologists and clinical statisticians, and to a wide varitey of clinicians, pharmacologists, and nurses. Since it requires no medical or statistical knowledge, it will also appeal to ethicists, lawyers, and the general public. (shrink)
Current developments in biomedicine are presenting us with difficult ethical decisions and raising complex policy questions about how to regulate these new developments. Particularly vexing for governments have been issues related to human embryo experimentation. Because some of the most promising biomedical developments, such as stem cell research and nuclear somatic transfer, involve such experimentation, several international bodies have drafted documents aimed to provide guidance to governments when developing biomedical science policy. Here I focus on (...) two such documents: the Council of Europe's Convention for the Protection of Human Rights and Dignity of the Human Being and the Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being.I argue that by using human dignity as a criterion to determine the permissibility of particular human embryo research practices, these documents cannot aid in identifying research that would be contrary to human dignity. Thus, they fail to guide public policy on embryo experimentation. Their use of human dignity as a criterion makes their task of offering guidance unfeasible because the concept as used in these documents is too vague and is applied in contradictory ways. I discuss the main goals of these documents and their claims in relation to human embryo research. I then discuss how they have influenced public policy in several countries. Finally, I show that although these Council of Europe treaties attempt to serve as public policy guides in the area of embryo research, they fail to do so. (shrink)
This book focuses on experimentation that is carried out on human beings, including medical research, drug research and research undertaken in the social sciences. It discusses the ethics of such experimentation and asks the question: who defends the interests of these human subjects and ensures that they are not harmed? The author finds that ethical research depends on the adequacy of review by committee. Indeed most countries now rely on research ethics committees for the protection of (...) the interests of the human participants in research. Dr McNeill analyses how successful these committees are in balancing the interests of science with the interests of human subjects. (shrink)
This essay explores some moral problems raised by experimentation involving the human fetus. In the first part of the essay three examples of fetal experimentation from the medical literature are described in some detail. Next, the ethical and legal arguments employed in the two major existing public policy-documents on fetal experimentation are analyzed. Finally, the author seeks to identify four fundamental presuppositions which underlie divergent normative positions on the problem of fetal experimentation.
Contemporary notions of what constitutes tribal self government for Indigenous Peoples in the legal systems of the nation-states Canada, New Zealand and the United States of America have their origins in philosophies and theories developed by European nation-states generally, in relation to their colonial expansion into what is now called the Americas. This thesis examines the nature of these theories, and how they have formed the basis for legal precedent and public policy in the three nation-states. A representative (...) analysis of three contemporary issues will serve to illustrate the outcome of this legal/political history. I look at three sites. These are the British Columbia Treaty Process in Canada, the Waka Umanga legislation in New Zealand, and legal developments arising from the Indian Reorganization Act in the United States. Full sovereignty from an Indigenous Peoples worldview existed for Indigenous nations, and with it, self government. The notion of self government as a viable and contemporary public policy initiative is well grounded in law and history. It would seem that current initiatives to acknowledge this inherent right are more about preserving colonial hegemony rather then engaging in honest negotiation. Current initiatives are converging into a single public policy goal; namely the corporatisation of Indigenous Peoples legal personality and self governing capacity. What used to be distinct nation-state development now seems to be a four nation-state (CANZUS) unified plan being implemented on four different fronts. Clearly, from the legal history, self government is something fundamentally different from self-management. The advent of Legal Positivism has played a significant role in assumptions that inherent sovereignty and self government never existed under European legal systems. The framework of tribal self governance must be viewed in the context of the values of the specific People to be a true expression of an Indigenous Nation exercising self government. This fundamental distinction can be traced back to the legal history. The foundational laws regarding interactions with Indigenous Peoples were developed under theories of natural law. The contemporary state practice is conducted under positivist law, with a nod toward developing human rights standards. Only through continued advocacy for the legal recognition of inherent rights will the nation-states be challenged on their self management agenda. (shrink)
This article offers an integrated account of two strands of global health justice: health-related human rights and health-related common goods. After sketching a general understanding of the nature of human rights, it proceeds to explain both how individual human rights are to be individuated and the content of their associated obligations specified. With respect to both issues, the human right to health is taken as the primary illustration. It is argued that the individuation of the right (...) to health is fixed by reference to the subject matter of its corresponding obligations, and not by the interests it serves, and the specification of the content of that right must be properly responsive to thresholds of possibility and burden. The article concludes by insisting that human rights cannot constitute the whole of global health justice and that, in addition, other considerations—including the promotion of health-related global public goods—should also shape such policy. Moreover, the relationship between human rights and common goods should not be conceived as mutually exclusive. On the contrary, there sometimes exists an individual right to some aspect of a common good, including a right to benefit from health-related common goods such as programmes for securing herd immunity from diphtheria. (shrink)
Indigenous Zuni farming, including cultural values, ecological and biological diversity, and land distribution and tenure, appears to have been quite productive and sustainable for at least 2000 before United States influence began in the later half of the 18th century. United States Government Indian agriculture policy has been based on assimilation of Indians and taking of their resources, and continues in more subtle ways today. At Zuni this policy has resulted in the degradation and loss of natural (...) resources for farming, reduction in the number of Zuni farmers and their control over farming resources, individualization of rights in farmland, consolidation of farm fields, and declining biological diversity in agriculture. The Zuni Sustainable Agriculture Project with the Zuni Irrigation Association and the Zuni community, are now working to revitalize sustainable Zuni farming, based on traditional values, knowledge, and technology, combined with modern knowledge and technology where appropriate. The United States government can support these efforts through appreciation of the need for Zuni control and the potential value of cultural and biological diversity. (shrink)
American history has been rife with human subjects research scandals, particularly those that involve “vulnerable” populations. State and federal laws and regulations often do not provide any special oversight mechanisms or protections to ensure the ethical and safe inclusion of cognitively impaired adults in research. At the New York State level, repeated efforts have been made to regulate research involving individuals who lack consent capacity. In January 2014, the New York State Task Force on Life and the Law released (...) its Report and Recommendations for Research with Human Subjects Who Lack Consent Capacity, which represents the most recent step in a decades-long process in the state to develop oversight mechanisms that are appropriately sensitive to the fine line between protecting a vulnerable population and impeding the advancement of research. These recommendations may serve as a model for research policy in other states and at the federal level, particularly in light of shifting societal concerns and changing political winds. (shrink)
For ten years, 1971–1981, the Institute onHuman Values in Medicine (IHVM) played a keyrole in the development of Bioethics as afield. We have written this history andanalysis to bring to new generations ofBioethicists information about the developmentof their field within both the humanitiesdisciplines and the health professions. Thepioneers in medical humanities and ethics cametogether with medical professionals in thedecade of the 1960s. By the 1980s Bioethics wasa fully recognized discipline. We show the rolethat IHVM programs played in defining thefield, (...) training faculty and helping schools todevelop programs. We review the beginnings ofthe IHVM in the crucible of social andtechnological change that led to theestablishment of the IHVM's parentorganization, the Society for Health and HumanValues. We then turn to the IHVM programsthrough which Faculty members receivedfellowships to explore new crossovers betweenthe humanities and the health professions. Wehave not only described the Fellows Program asit existed in 1973–1980, but have completed asurvey of the fellows a quarter of a centuryafter they held their fellowships. We describeother IHVM programs designed to facilitate theinitiation and development of new humanitiesprograms, to explore conceptual issues betweenmedicine and five humanities fields, to conductissue driven or educational method conferencesand to advance humanities programs intograduate education through the Directors ofMedical Education. (shrink)
In this paper, we provide as accurate a picture as possible of transnational trade in human eggs involving Canadians. We explain the legal status in Canada, and call for reform in the regulation, of such trade.
Recommandations have been formulated in 1985 with reference to socialist morality and law and as a result of interdisciplinary discussion by the IAME (Interdisciplinary Working Party on Medical Ethics at the GDR Academy of Postgraduate Medical Education) for clinical application of in vitro fertilization and for the use of human oocytes and early embryonic stages.
This essay examines the risks of racialized science as revealed in the American mustard gas experiments of World War II. In a climate of contested beliefs over the existence and meanings of racial differences, medical researchers examined the bodies of Japanese American, African American, and Puerto Rican soldiers for evidence of how they differed from whites.
This article argues that hunger in Canada, while being an outcome of unemployment, low incomes, and inadequate welfare, springs also from the failure to recognize and implement the human right to food. Food security has, however, largely been ignored by progressive social policy analysis. Barriers standing in the way of achieving food security include the increasing commodification of welfare and the corporatization of food, the depoliticization of hunger by governments and the voluntary sector, and, most particularly, the neglect (...) by the federal and provincial governments of their obligations to guarantee the domestic right to food as expressed in international human rights law. The interconnectedness of hunger, welfare, and food security issues in a first world society are explored from the perspective of progressive social policy and food security analysis and the development of alternative strategies. In terms of advancing the human right to food in Canada, particular emphasis is placed on the role of the state and civil society, and the social and economic rights of citizenship built on an inclusive social policy analysis and politics of welfare, food security and human rights. (shrink)
This article addresses three questions: How can we define and measure what constitutes a foreign policy in human rights? How is it possible to explain both the activism of a state and its ideological orientation in the international promotion of human rights? What is the empirical evidence found when we try to answer these questions in intermediate states? Research done on four cases (Argentina, Australia, Brazil and South Africa) suggests a correlation between domestic efforts in the promotion (...) of human rights and international advocacy. It also shows that the greater the power of intermediate states, the greater their activism in human rights. Further, as development grows states show less support for economic, social and cultural rights. Last, the strategic relation with the USA shapes how states vote regarding human rights violators states. (shrink)
Scientific research and ethics -- Ethical theory and decision making -- Data acquisition and management -- Mentoring and professional relationship -- Collaboration in research -- Authorship -- Publication and peer review -- Misconduct in research -- Intellectual property -- Conflicts of interest and scientific objectivity -- The use of animals in research -- The use of human subjects in research -- The use of vulnerable subjects in research -- Genetics, cloning, and stem cell research -- International research.
Health policy frameworks usually construe environmental protection and human health as harmonious values. Policies that protect the environment, such as pollution control and pesticide regulation, also benefit human health. In recent years, however, it has become apparent that promoting human health sometimes undermines environmental protection. Some actions, policies, or technologies that reduce human morbidity, mortality, and disease can have detrimental effects on the environment. Since human health and environmental protection are sometimes at odds, political (...) leaders, citizens, and government officials need a way to mediate and resolve conflicts between these values. Unfortunately, few approaches to applied bioethics have the conceptual tools to do accomplish this task. Theories of health care ethics have little to say about the environment, and theories of environmental ethics don’t say much about human health. In this essay, I defend an approach to ethical decision-making that gives policy-makers some tools for balancing promotion of human health and protection of the environment. (shrink)
Debate about legal and policy reform has been haunted by a pernicious confusion about human nature, the idea that it is a set of rigid dispositions, today generally conceived as genetic, that is manifested the same way in all circumstances. Opponents of egalitarian alternatives argue that we cannot depart far from the status quo because human nature stands in the way. Advocates of such reforms too often deny the existence of human nature because, sharing this conception, (...) they think it would prevent changes they deem desirable. Both views rest on deep errors about what it is to have a nature and how genetics works. Human nature, like the nature of anything else, is a set of potentials to behave certain ways in given environments, not a nonsocial genetic something that inevitably produces the same result in any environment. To say that existing inequalities, are due to our genes, inalterable because heritable, ignores that genetic propensities may be differently manifested in different environments. Heritability has meaning only relative to an environment and a population and implies nothing about inevitability. A better sort of inegalitarian argument is that a proposed reform, given our nature, would be too costly even if possible. However, this sort of argument is too rarely supported by evidence and generally ignores the costs of existing inequalities. But egalitarians err in supposing that, if behavior is unconstrained by biology, the status quo is easily alterable. The environment may be extremely hard to change. Legal and policy debate should adopt a correct understanding of human nature as a set of propensities and ask of any proposed reform agreed to be otherwise desirable what and how alterable are its causes, genetic, environmental, or more accurately both. (shrink)
All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing (...) the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested. (shrink)