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)
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)
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)
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 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.
Most people know precious little about the risks and benefits of participating in a clinical trial--a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway. Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole surgery at leading (...) cancer centersnever -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more. Patients at Risk written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatmenthormone replacement therapy, drugs such as Vioxx or Celebrexmay now be much riskier than we thought. The latest book in a surge of recent books criticizing the medical establishment (but the first to look at clinical trials specifically), Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform. (shrink)
La obra recoge, desde una perspectiva interdisciplinar, las aportaciones de un grupo de investigadores españoles e italianos que han trabajado conjuntamente durante varios años en distintas cuestiones en torno a las posibilidades y riesgos de los avances biotecnológicos y su incidencia en el campo de los derechos humanos. Los estudios y debates se han realizado en el marco del programa de doctorado internacional sobre "Derechos humanos: Problemas actuales" encabezado por las Universidades de Valencia y Palermo. El Profesor Jesús Ballesteros, Catedrático (...) de Filosofía del Derecho en la Universidad de Valencia, ha sido el encargado de dirigir y coordinar este proyecto. (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)
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 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 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)
The concept of reproductive health promises to play a crucial role in improving health care provision and legal protection for women around the world. This is an authoritative and much-needed introduction to and defence of the concept of reproductive health, which though internationally endorsed, is still contested. The authors are leading authorities on reproductive medicine, women's health, human rights, medical law, and bioethics. They integrate their disciplines to provide an accessible but comprehensive picture. They analyse 15 cases from (...) different countries and cultures, and explore options for resolution. The aim is to equip readers to fashion solutions in their own health care circumstances, compatibly with ethical, legal and human rights principles. (shrink)
It is a common feature of debates on the regulation of reproductive medicine to find law portrayed as a crude form of intervention consisting in the imposition of inflexible rules on doctors and medical researchers. This paper argues that this view must be replaced by a more accurate assessment of the law's potential role in the regulation of reproductive medicine. From an analysis of the White Paper on human fertilisation and embryology, and in particular the proposed Statutory (...) Licensing Authority, the author contends that far from being an inflexible method of regulation law can foster discussion and compromise. (shrink)
Up to the present, there have not been any specific norms regarding medically assisted human reproduction in Romanian legislation. Due to this situation the general legislation regarding medical assistance, the Penal and Civil law and the provisions of the Code of Deontology of the Romanian College of Physicians are applied to the field of medically assisted human reproduction. By analysing the ethical and legal conflicts regarding medically assisted human reproduction in Romania, some characteristics cannot be (...) set apart because they derive from religious, cultural and socio-economic aspects. In this article the authors identify the development stages of medically assisted human reproduction in Romania, beginning from these characteristics and insisting upon the failure of the legal system in this specific field. The authors consider that the law regarding medically assisted human reproduction cannot be effective because it did not take into account the ethical and cultural aspects that might appear. Furthermore, in this framework of the legal process, no public debate involving the representatives of civil society was undertaken although the Council of Europe Oviedo Convention approved by our country according to law no. 17/2001 stipulated exactly this working method. Content Type Journal Article Pages 4-13 Authors Beatrice Ioan, PHD, MD, MA IN BIOETHICS, University of Medicine and Pharmacy, Iasi, Romania Vasile Astarastoae, PHD, MD, JD, University of Medicine and Pharmacy, Iasi, Romania Journal Human Reproduction & Genetic Ethics Online ISSN 2043-0469 Print ISSN 1028-7825 Journal Volume Volume 14 Journal Issue Volume 14, Number 2 / 2008. (shrink)
Disabled/“differently abled” persons by virtue of being human have the right to enjoy human rights to life, liberty, equality, security, and dignity. However, due to social indifference, psychological barriers, a limited definition of “disability” entitling protection of law, and a lack of proper data, disabled persons in India remain an invisible category. Although several laws exit to ensure their full and effective participation in society, they remain insufficient as they are primarily based on the government's discretion. At the (...) same time, whenever the judiciary finds an opportunity, it acts as a real protector of disabled persons, but it is not feasible to knock on the door of the judiciary for every request. Interestingly, various civil societies and human rights activists have occasionally asserted the rights of the disabled. However, unless the foundation stones of law are fortified, disabled persons cannot fully realize their rights. It is high time to enact effective laws, with timely implementation, to protect their interests and empower their capabilities that are based on a “rights-based approach” rather than on the charity, medical, or social approaches. Thus, the horizons of law must be expanded to provide a “human friendly environment” for all of the disabled to overcome the barriers that impair their development. (shrink)
The proposed article provides an overview of European and North American states’ legislation, which regulates the procedure for pre-clinical research, clinical trials and state registration of medicinal products, as well as responsibility for its violation, analysis of the problems and prospects of adaptation of the national legislation to European legal space, particularly in the field of criminal and legal regulation of relations in the sphere of pre-clinical trials, clinical trials and state registration of medicine. The emphasis is (...) put on the matter that inclusion of Article 321-2 into the Criminal Code of Ukraine leads to a false concurrence with other provisions of the Code. The author proposes to introduce recent EU legislation (Acquis Communautaire) on legal regulation of clinical trials and circulation of medicine into the law of Ukraine, clarify terminology related to Fundamentals of Ukrainian Legislation on Health Protection and the Special Part of criminal law, introduce criminal liability for legal entities that will provide effective control over negative effects of research centers’ activity. It is suggested to develop legislative proposals to improve the provisions of the Criminal Code of Ukraine, which provide legal protection of relations arising in connection with pre-clinical research, clinical trials and state registration of medicinal products. (shrink)
In this article, Gostin and Archer explore the varied lenses through which governments are obligated to address humanitarian needs. States’responsibilities to help others derive from domestic law, political commitments, ethical values, national interests, and international law. What is needed, however, is clarity and detailed standards so that States can operationalize this responsibility, making it real for developing countries. Transnational cooperation needs to be more effective and consistent to provide assistance for the world's poorest and least healthy people.
Right to life is an essential natural right protected and defended by law. The aim of this publication is to discuss the main issues regarding human right to life and its protection in the Roman law. Article deals with the problems of beginning and end of the human life and legal capacity in Rome, elements of legal protection of slaves and family members subject to pater familias life as well as the principle crimes attempting to human life. (...) First of all, the right to life as well as the right to liberty were held to be the institutes of natural law (ius naturale) meanwhile institutes that provided possibility to withdraw those rights (e. g. patria potestas that in the most ancient époque included right to decide on subject person’s right to life) are derived from the branches of positive law—civil (ius civile) and law of nations (ius gentium). Such attitude of the Roman jurisprudence had a solid impact on recognizing right of life to be an inherent law of every person, deriving immediately from the human nature and not conferred by the society and the state. (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)
Research technologies can now produce so much information that there is signifcant potential for incidental fndings . These are fndings generated in research that are beyond the aims of the study. Current law and federal regulations ofer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defned set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. (...) This article traces the underlying ethical and legal theories supporting researcher duties to manage IFs, including duties to develop a plan for management in the research protocol, to discuss the possibility of and management plan for IFs in the informed consent process, and to address, evaluate, and ultimately ofer to disclose IFs of potential clinical or reproductive signifcance to research participants when they arise. (shrink)