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)
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)
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)
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)
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.
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)
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.
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)
The relation and collaboration of human and animal medicine had its ups and downs throughout history. The interaction between these two disciplines has been especially fruitful in the broad areas of patho-physiology and of epidemiology. An exploration of the interaction between the two disciplines, using historical and contemporary examples in comparative medicine, zoonoses, zooprophylaxis, and human-animal bond, reveals that a better understanding of animal and human disease, as well as societal changes such as interest in (...) non-conventional medicine, are leading to a broader concept of one medicine that includes animal and humanmedicine as well as social and other sciences. (shrink)
The first IVF baby was born in the 1970s. Less than 20 years later, we had cloning and GM food, and information and communication technologies had transformed everyday life. In 2000, the human genome was sequenced. More recently, there has been much discussion of the economic and social benefits of nanotechnology, and synthetic biology has also been generating controversy. This important volume is a timely contribution to increasing calls for regulation - or better regulation - of these and other (...) new technologies. Drawing on an international team of legal scholars, it reviews and develops the role of human rights in the regulation of new technologies. Three controversies at the intersection between human rights and new technology are given particular attention. First, how the expansive application of human rights could contribute to the creation of a brave new world of choice, where human dignity is fundamentally compromised; second, how new technologies, and our regulatory responses to them, could be a threat to human rights; and, third, how human rights could be used to create better regulation of these technologies. (shrink)
Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the unique concerns that (...) arise in specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that arise when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging issues in human subjects research, namely financial conflicts of interest and the interpretation of scientific data. (shrink)
Introduction The Brazilian national curriculum guidelines for undergraduate medicine courses inspired and influenced the groundwork for knowledge acquisition, skills development and the perception of ethical values in the context of professional conduct. Objective The evaluation of ethics education in research involving human beings in undergraduate medicine curriculum in Brazil, both in courses with active learning processes and in those with traditional lecture learning methodologies. Methods Curricula and teaching projects of 175 Brazilian medical schools were analyzed using a (...) retrospective historical and descriptive exploratory cohort study. Thirty one medical schools were excluded from the study because of incomplete information or a refusal to participate. Active research for information from institutional sites and documents was guided by terms based on 69 DeCS/MeSH descriptors. Curriculum information was correlated with educational models of learning such as active learning methodologies, tutorial discussions with integrated curriculum into core modules, and traditional lecture learning methodologies for large classes organized by disciplines and reviewed by occurrence frequency of ethical themes and average hourly load per semester. Results Ninety-five medical schools used traditional learning methodologies. The ten most frequent ethical themes were: 1 – ethics in research (26); 2 – ethical procedures and advanced technology (46); 3 – ethic-professional conduct (413). Over 80% of schools using active learning methodologies had between 50 and 100 hours of scheduled curriculum time devoted to ethical themes whereas more than 60% of traditional learning methodology schools devoted less than 50 hours in curriculum time to ethical themes. Conclusion The data indicates that medical schools that employ more active learning methodologies provide more attention and time to ethical themes than schools with traditional discipline-based methodologies. Given the importance of ethical issues in contemporary medical education, these findings are significant for curriculum change and modification plans in the future of Brazilian medical education. (shrink)
On the 50th anniversary of the Willowbrook experiment's inception, in which Dr. Saul Krugman intentionally infected cognitively disabled children with hepatitis, it is worth reflecting on how our attitude toward research ethics of the past informs our current practices. In examining ethical violations in postwar medicine, we frequently turn to examples that shock and appall, thereby offering concomitant comfort as we measure their safe distance from our own medical context. And yet, which modern medical student has not heard a (...) variation of the phrase "This study would never have passed an ethics committee today" in reference to a classic experiment or a professor's very own work? Even with Nuremburg fresh in the .. (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.
Critically exploring medical thought in a cultural milieu with no discernible influence from the European Enlightenment, _Being Human_ reveals an otherwise unnoticed intersection of early modern sensibilities and religious values in traditional Tibetan medicine. It further studies the adaptation of Buddhist concepts and values to medical concerns and suggests important dimensions of Buddhism's role in the development of Asian and global civilization. Through its unique focus and sophisticated reading of source materials,_ Being Human_ adds a crucial chapter in the (...) larger historiography of science and religion. The book opens with the bold achievements in Tibetan medical illustration, commentary, and institution building during the period of the Fifth Dalai Lama and his regent, Desi Sangye Gyatso, then looks back to the work of earlier thinkers, tracing a strategically astute dialectic between scriptural and empirical authority on questions of history and the nature of human anatomy. It follows key differences between medicine and Buddhism in attitudes toward gender and sex and the moral character of the physician, who had to serve both the patient's and the practitioner's well-being. _Being Human_ ultimately finds that Tibetan medical scholars absorbed ethical and epistemological categories from Buddhism yet shied away from ideal systems and absolutes, instead embracing the imperfectability of the human condition. (shrink)
This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, and suggests procedures (...) in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethics committees. (shrink)
The puzzling case of the broken arm -- Hernias, diets, and drugs -- Why physicians cannot know what will benefit patients -- Sacrificing patient benefit to protect patient rights -- Societal interests and duties to others -- The new, limited, twenty-first-century role for physicians as patient assistants -- Abandoning modern medical concepts: doctor's "orders" and hospital "discharge" -- Medicine can't "indicate": so why do we talk that way? --"Treatments of choice" and "medical necessity": who is fooling whom? -- Abandoning (...) informed consent -- Why physicians get it wrong and the alternatives to consent: patient choice and deep value pairing -- The end of prescribing: why prescription writing is irrational -- The alternatives to prescribing -- Are fat people overweight? -- Beyond prettiness: death, disease, and being fat -- Universal but varied health insurance: only separate is equal -- Health insurance: the case for multiple lists -- Why hospice care should not be a part of ideal health care I: the history of the hospice -- Why hospice care should not be a part of ideal health care II: hospice in a postmodern era -- Randomized humanexperimentation: the modern dilemma -- Randomized humanexperimentation: a proposal for the new medicine -- Clinical practice guidelines and why they are wrong -- Outcomes research and how values sneak into finding of fact -- The consensus of medical experts and why it is wrong so often. (shrink)
Justice at Nuremberg traces the history of the Nuremberg Doctors' Trial held in 1946-47, as seen through the eyes of the Austrian bliogemigrbliogé psychiatrist Leo Alexander. His investigations helped the United States to prosecute twenty German doctors and three administrators for war crimes and crimes against humanity. The legacy of Nuremberg was profound. In the Nuremberg code--a landmark in the history of modern medical ethics--the judges laid down, for the first time, international guidelines for permissible experiments on humans. One of (...) those who helped to formulate the code was Alexander. Justice at Nuremberg provides a detailed insight into the origins of human rights in medical science and into the changing role of international law, ethics and politics. (shrink)