Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not been (...) inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (shrink)

Thus, Meyers provides a valuable account, not only of current medical attitudes, but also of relevant case and statute law as it stands at present.

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)

How should the law deal with the challenges of advancing biotechnology? This book is a philosophical and legal re-analysis.

Bioethics; medical ethics; human experimentation in medicine; law and legislation.

Topics discussed in this work are abortion, euthanasia, medical negligence and human experimentation.

This book examines the field of bioethics from an international and regional legal perspective. It focuses on major international law documents such as the United Nations Universal Declaration on Bioethics and Human Rights and UNESCO declarations on human cloning and the human genome. Coverage of regional legal instruments includes the Council of Europe Convention on Human Rights and Biomedicine (the Oviedo Convention) and its Protocols on cloning, transplantation, and research with human beings. Work on surrogacy (...) issues by the Hague Conference on Private International Law is also discussed, as are some African regional legal instruments on biosafety, and stem cell research. (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)

The originality of this volume lies in the interdisciplinary synergies that emerge through the issues it explores and the approaches it adopts. It offers legal and ethical reflections on the criminal qualification of a series of conducts ranging from human experimentation and non-consensual medical interventions to organ transplant trafficking and marketing of human body parts. It also considers procedural matters, notably related to psychiatric and medical evidence. In so doing, it combines legal and other types of conceptualizations (...) to examine such contemporary issues as rights of the LGBTIQ population, access to medical care, corporate criminal liability, rights of children and Islamic jurisprudence. (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)

The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject.

This book contains lectures from the International Conference on Human Rights and Biomedicine, held in Rotterdam, the Netherlands, December 10-12, 2008. The conference was organized by the Institute of Health Policy and Management, Erasmus University Rotterdam and the Erasmus Observatory on Health Law. Eminent scholars from a variety of disciplines - medicine, law, ethics, and philosophy - discuss the meaning of underlying principles of the Convention on Human Rights and Biomedicine (1997) and the fundamental rights in healthcare, (...) contemporary dilemmas in healthcare (policy), and the Convention's impact on national health legislation and daily practice. In particular, the contributions discuss the following topics: human rights and health ethics, equitable access to health care, medical research, human genetics, and organ transplants. (shrink)

Aujourd'hui, des malades atteints de pathologies graves pour lesquelles les alternatives therapeutiques sont limitees ou inexistantes reclament, non plus tant une protection contre les essais cliniques, qu'un droit d'y participer. Cette nouvelle revendication est le point de depart de la presente enquete, a la fois historique, juridique et sociologique, qui montre comment s'est formee, dans les normes et dans les pratiques, du XVIIIe au XXe siecle, la distinction entre l'animal de laboratoire et le sujet humain. Entre les cobayes et les (...) hommes. La premiere partie de l'ouvrage decrit la formation, de part et d'autre du proces des medecins de Nuremberg, d'un consensus normatif international en reponse aux crises sanitaires, accidents et scandales qui emaillent l'histoire des essais medicaux sur l'etre humain. La seconde partie detaille la situation en France, l'emergence d'une legislation sur les recherches biomedicales, les paradoxes qui persistent dans la loi et les realites nouvelles, sociologiques et scientifiques, qu'elle doit affronter. L'ouvrage montre l'urgence d'un nouveau contrat social en matiere de recherche biomedicale, articulant respect de l'autonomie, equite d'acces et protection des personnes. Et il propose des solutions. (shrink)

Executive Summary There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given ...

In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.

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)

Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.

This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.

A collection of first-person case studies that detail serious ethical problems in medical practice and research.

Written by one of Ireland's leading medical law academics, this practical book comprehensively covers case law and regulations regarding the healthcare system, the law relating to human reproduction, and the key issues of consent and treatment. Designed to be used by lawyers and healthcare professionals, Medicine, Ethics and the Law in Ireland provides an invaluable reference tool for anybody who requires accurate information and guidance on this area of Irish law. This new edition includes: Medical research and clinical (...) trials; Organ donation and transportation; Patient safety and QA; and Biobanking. (shrink)

Die Textsammlung bietet eine Zusammenstellung aller wichtigen Rechtstexte völkerrechtlicher, gemeinschaftsrechtlicher und nationaler Natur aus dem Bereich der humanen Biomedizin.

This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and ...

" La science avance plus vite que l'homme ". La formule de François Mitterrand se révèle, chaque jour davantage en matière de bioéthique, d'une étonnante actualité! Alors qu'il est encore bien malaisé de porter un jugement éthique et juridique sur le développement des biotechnologies, chacun s'interroge sur la justification et les risques des techniques les plus récentes, les perspectives qu'elles ouvrent à l'homme, mais également leur compatibilité avec la dignité de la personne. Lors d'un colloque pluridisciplinaire et international organisé par (...) la Faculté de droit de Nancy, le Centre Juridique Franco-Allemand et le Groupe de recherche de droit médical de l'Université de la Sarre, juristes, philosophes et médecins se sont penchés ensemble sur ces questions essentielles. Leurs réflexions et les discussions qu'elles ont engendrées, à la lumière des sensibilités française et allemande, font l'objet du présent ouvrage. En langue française, les diverses contributions sont suivies d'un résumé en allemand. Les fulgurants progrès des biotechnologies offrent incontestablement à l'humanité des chances nouvelles. Mais face à des biologistes dont certains se prennent déjà pour Dieu, il devient d'une urgente nécessité de réaffirmer les Droits de l'Homme. Qu'il s'agisse de procréation médicalement assistée, de thérapie génique ou d'expérimentation sur l'homme, une conclusion s'impose : lorsqu'elle menace la dignité de la personne, la liberté de la Science doit être limitée. L'avenir de l'espèce humaine est peut-être à ce prix... (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.

These essays, first presented at a conference, “Coping with Sickness,” held in Italy in 1997, address ethical and regulatory medical issues within a historical context. Many of the essays, while addressing interesting topics, combine policy analysis and critical cultural theory. Critical cultural theory can be intellectually engaging at times but is generally irrelevant to public officials concerned with specific policy issues.Coping with Sickness is the third and final volume derived from a series of conferences cosponsored by the European Science Foundation (...) and the Euroconferences Activity of the European Union. The eight essays are organized chronologically and cover a range of disparate topics: medical practitioners and the Spanish Inquisition , the history of autopsy legislation in German since 1800 , the history of “sadism” as a medical term in the nineteenth century , folk medicine in Holland in the late nineteenth century , abortion in Weimar Germany , drug testing in Africa in the early twentieth century , comparative policies toward STDs , and the debate over brain death in Germany . As might be expected in an anthology of this sort, the quality varies considerably. Nonetheless, the subjects addressed in this volume are engaging—much to the credit of the editors.Two pieces in particular represent the range of these collected essays. In “Vacher the Ripper and the Construction of the Nineteenth‐Century Sadist,” Angus McLaren, one of the best historians writing on the history of sexuality today, explores the “discovery” of sadism in the late nineteenth century by focusing on the dramatic trial of Joseph Vacher, who was charged in 1895 for the brutal sexual murder of a woman in Champuis. He later confessed to the murder and the sexual violation of another seven females and four males. Vacher had a long history of mental illness; indeed, he had been institutionalized in July 1893 following a failed attempt at suicide that left a bullet lodged in his head. At the trial the criminologist Alexandre Lacassagne was brought in as an expert witness to testify that Vacher was not insane but an antisocial sadist, as revealed by his dabbling in anarchism, vagabondism, and homosexuality. As a consequence, Vacher was found guilty and given a death sentence.McLaren finds in this trial an example of the social construction of a new medical concept, “sadism.” The emergence of the concept of sadism, he argues, reflected a “gendered notion” of defining appropriate male and female behavior; physicians at the turn of the century believed that “civilized men were most threatened, not by excess passion, but by the enervation spawned by urban life” . The concept of sadism was also employed by doctors to enhance their own authority and to alert the public to the dangers of a male manifesting “feminine traits” and to “beat back” homosexuality.There is much interesting conjecture to McLaren's study, but what policy lessons should be drawn from this remains unclear. If every concept is actually a social construction, reflecting the social anxieties of the age, then is the fashionable concept of social construction itself socially constructed to enhance the authority of the medical historian?More interesting methodologically is Claudia Wiesemann's absorbing essay on the historical debate in Germany over “brain death.” Relying on Ulrich Beck's social theory of simple and reflexive modernization, she shows that, when confronted with complex scientific questions, the public has to decide between competing plausible scientific claims; as a result, political groups make use of scientific expertise and counterexpertise to push their favorite practical and legal solutions. (shrink)

This paper surveys the conceptions of law and of legislation to be found in the philosophy of Julian the Emperor. A hierarchy of levels of law is described, going from transcendent divine orders and paradigmatic laws down to the laws of nature, laws innate in human souls and regional laws. Julian’s ideal legislator is discussed, as inspired by transcendent, paradigmatic laws and as subordinate to law and its protector. An example of Julian’s legislation is discussed. Attention is paid to (...) Julian’s use of Plato’s Republic, Statesman, and Laws. (shrink)

Medical ethics and medical practice -- Public health and the state-patient relationship -- Health rights and obligations in the European Union -- Consent to treatment -- Liability for medical injury -- Medical confidentiality -- Genetic information and the law -- The management of infertility and childlessness -- The control of fertility -- Civil and criminal liability in reproductive medicine -- Health resources and dilemmas in treatment -- Treatment of the aged -- Mental health and human rights -- The (...) body as property -- Medical futility -- The diagnosis of death -- The donation of organs and transplantation -- Euthanasia and assistance in dying -- Biomedical human research and experimentation -- Research on children, fetuses and embryos. (shrink)