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

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)

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.

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)

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

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)

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

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)

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)

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)

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)

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.

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

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 ...

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)

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)

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

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.

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

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

" 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)

La autora de esta obra desarrolla un estudio en el que se analizan los derechos del individuo en contraposición con los del profesional de las ciencias de la vida, parte de los preceptos de la bioética, que ofrece el sustento ético-teórico, y el Derecho, que constituye el sistema normativo. Contempla temas referentes a cuestiones bioéticas y jurídicas relacionadas con el tratamiento y manipulación del embrión, apropiación indebida de material genético, responsabilidad civil en la transmisión de enfermedades congénitas y genéticas derivadas (...) de la reproducción asistida, anencefalia, clonación, entre otros aspectos relacionados con el genoma humano. (shrink)

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