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)

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)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause (...) the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (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)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December (...) 1948;Bearing in mind the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (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 human experimentation, 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 important new work surveys the source and ramifications of the famed Nuremburg Code -- recognized around the world as one of the cornerstones of modern bioethics.

In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more (...) extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges. (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)

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)

Human experimentation can have different meanings: indeed, with the development of medical research, therapeutic acts have to be distinguished from acts of cognitive values. For each kind of acts, specific conditions of acceptability and specific protections of human beings have to be defined.Human experimentation must be envisaged at different levels to evaluate ethical aspects: its scientific value, the risks, benefits envisaged, the populations implicated, etc…The individual consent must be present too in the relationship between the (...) subject and the doctors. In fact, is a real consent possible?Instead to insist on problems in terms of medical research, one would have to insist perhaps more on the fact that the medical practice in general would have to answer more to ethical grounds and to scientific rules. It is the non scientific medicine which is immoral and dangerous, as well the medicine with financial interests, or also the medecine without experimentation.The main arguments must remain at the level of the dignity of the persons, autonomy and freedom of choice must remain the fundamental values. (shrink)

Mit Beitragen von: Wolfgang U. Eckart, Christian Bonah, Wolfgang U. Eckart / Andreas Reuland, Alexander Neumann, Peter Steinkamp, Volker Roelcke, Anne ...

This chapter contains sections titled: Introduction History of Experimentation on Human Beings Regulation of Human Experimentation Guidelines, Regulations and Directives to Regulate Human Experimentation Regulation of Experimentation in Surgery and Clinical Medicine Discussion References.

Ethical questions in medicine have become common topics of discussion during the past twenty years. Bitter disputes have arisen regarding abortion, suicide, human experimentation, as well as the management of the dying patient and the severely disabled newborn. These issues are loaded with such emotion that it is sometimes difficult to look at them in a rational manner. Noted neurosurgeon and author Milton D. Heifetz has made the tough decisions in tragic, often anguishing situations. As a member (...) of hospital ethics committees for many years, Dr. Heifetz found that discussions of complex issuesmany involving urgent matters of life and deathwere all too often clouded by tradition, dogma, and gut reactions. A comprehensive moral foundation with the flexibility to respond to often rapidly changing circumstances is desperately needed if health-care professionals are to confront head-on the daily questions of medical ethics. Dr. Heifetz offers this moral grounding to help all who must make difficult medical choices: physicians, nurses, patients, families, and policy makers struggling to develop substantive rules for medical conduct. (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)

Inclusion of the humanities in undergraduate medicine curricula remains controversial. Skeptics have placed the burden of proof of effectiveness upon the shoulders of advocates, but this may lead to pursuing measurement of the immeasurable, deflecting attention away from the more pressing task of defining what we mean by the humanities in medicine. While humanities input can offer a fundamental critical counterweight to a potentially reductive biomedical science education, a new wave of thinking suggests that the kinds of arts (...) and humanities currently used in medical education are neither radical nor critical enough to have a deep effect on students’ learning and may need to be reformulated. The humanities can certainly educate for tolerance of ambiguity as a basis to learning democratic habits for contemporary team-based clinical work. William Empson’s ‘seven types of ambiguity’ model for analyzing poetry is transposed to medical education to: (a) formulate seven values proffered by the humanities for improving medical education; (b) offer seven ways of measuring impact of medical humanities provision, thereby reducing ambiguity; and (c) --as a counterweight to (b) – celebrate seven types of ambiguity in contemporary medical humanities that critically reconsider issues of proof of impact. (shrink)

This chapter contains sections titled: Scandalous Research in the Twentieth Century Basic Principles of Research Ethics Respect for Persons Beneficence Justice Conclusion.

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)

For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social–psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices :168–175, 2001). Institutions such as Institutional Review Boards and Ethics (...) Committees oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki. Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants. The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2 years ago we launched a pilot ethics committee at our technical university and began soliciting our colleagues to submit their studies for review. In the past year, we have become officially recognized as a human subjects ethics committee for our university and we are beginning the process of requiring all studies using human subjects to apply for our approval. In this article, we consider some of the special problems relating to protecting human participants in a technology context, and discuss some of our experiences and insights about reviewing human subjects research at a technical university, concluding: that not less than in medical studies, human participants used in technology research benefit from ethical committees’ reviews, practical requirements for publications, grants, and avoiding legal liability are also served by such committees, and ethics committees in such contexts have many similarities to, but certain other special foci than medical ethics committees. We believe that this experience, and these observations, are helpful for those seeking to establish such committees in technology research contexts, and for framing the particular issues that may arise in such contexts for the benefit of researchers, and nascent committees seeking to establish their own procedures. (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)

This is the first re-publication and first English translation of regulations concerning Human Experimentation which were binding law prior to and during the Third Reich, 1931 to 1945. The introduction briefly describes the duties of the Reichsgesundheitsamt, which formulated these regulations. It then outlines the basic concept of the Richtlinien for protecting subjects and patients on the one hand and for encouraging New Therapy and Human Experimentation on the other hand. Major issues, like personal responsibility of (...) the physician or researcher, teaching of ethics of research and therapy, and research and therapy on vulnerable populations, are compared with the regulations in the Nuremberg Code and subsequent regulations influenced by the Nuremberg Code. CiteULike Connotea Del.icio.us What's this? (shrink)

The case of women radium dial painters — women who tipped their brushes while painting the dials of watches and instruments with radioactive paint — has been extensively discussed in the medical and historical literature. Their painful and abhorrent deaths have occupied the interest of physicians, lawyers, politicians, military agencies, and the public. Hardly any discussion has concerned, however, the use of those women as experimental subjects in a number of epidemiological studies that took place from 1920 to 1990. This (...) article addresses the neglected issue of human experimentation in relation to the radium dial painters. Although women’s medical examinations have been classified as simple, routine measurements of radiation burden on the body and presented as a great offer to humanity, for more than fifty years those women had been repeatedly used as experimental subjects without proper consent. I argue that through this case it becomes obvious that the issue of defining what counts as human experimentation shifts from an epistemological to a serious ethical and political question, concerning the making of scientific knowledge while issues of gender related to this process are also discussed. (shrink)

With the principle of tour de force, we refer to the use of the power of moral legality, the strength of statutes, and the fairness of judgments. A quantum force of moral legality and legal morality serves as an imperative force in the implementation of fair criminal justice, as well as in the prevention of future victims across the globe. Contrary to positivist ideas, the simple notion of morality contains within itself the very essence of international criminal norms. (...) If the source of morality did not exist in the structure of our criminal justice, we could no longer call it criminal justice and would instead have to call it criminal revenge. Beyond the moral essence of international criminal justice, we also challenge the hidden illegality and immorality of certain attitudes. This is done in order to prevent acts which violate human rights law and criminal justice provisions. The codes of international human rights law cannot properly function without the comprehensive nature of morality which elevates the moral virtue of international criminal justice and strengthens the tour de force. One may observe that the principle of the tour de force of the moral virtue within the system of international criminal justice loses its legal power when governments attempt to justify their unjust decisions. This is the main reason why the major potential value of the tour de force of the moral virtue of human rights law and international criminal justice is not as strong as it should be. In order to achieve a vision of the tour de force of moral virtue, we need to establish a devoted influential ethical vision of the truth beyond political tradition. An unparalleled philosophical piece of literature for libraries. (shrink)

Who should define what constitutes ethical and lawful medical practice? Judges? Doctors? Scientists? Or someone else entirely? This volume analyses how effectively criminal law operates as a forum for resolving ethical conflict in the delivery of health care. It addresses key questions such as: how does criminal law regulate controversial bioethical areas? What effect, positive or negative, does the use of criminal law have when regulating bioethical conflict? And can the law accommodate moral controversy? By exploring (...) class='Hi'>criminal law in theory and in practice and examining the broad field of bioethics as opposed to the narrower terrain of medical ethics, it offers balanced arguments that will help readers form reasoned views on the ethical legitimacy of the invocation and use of criminal law to regulate medical and scientific practice and bioethical issues. (shrink)

The discovery of the molecular structure of deoxyribonucleic acid and the science of molecular biology have profoundly changed medicine’s diagnostic capability and promise to transform the therapeutic realm. When some genetic disorders are diagnosed, physicians can intervene for prevention or treatment. While the basic structure of DNA is the same for all human beings, no two individuals, other than identical twins, have the same DNA sequence. This discovery has had important repercussions in the criminal justice system, where (...) DNA can serve as an identification tool.At the crossroads of these different uses of DNA, there are great concerns about potential misuses of genetic information. Preventing disease, curing illness, and convicting criminals are all seen as worthwhile uses of the technology, but concerns of potential misuse in medicine or in the criminal justice system are not unfounded. A 1998 American Medical Association study showed that 68 percent of patients had fears that their genetic test results would be used against them by their employers or insurers. Others, pointing to racial profiling, have suggested that we may now face genetic profiling. (shrink)

We live in an age of great scientific and technological innovation, and what seemed out of the question or at least very doubtful only a few years ago, today lies almost within our grasp. In no area is this more true than that of human health care, where lifesaving and life-enhancing technologies have given, or have the enormous potential in the not so distant future to give, relief from some of the most terrible human illnesses. On two fronts (...) in particular, xenograft or cross-species transplantation and genetic engineering of animals on behalf of gene therapy in humans, such relief appears very promising, if not actually on the horizon. Certainly, extensive research work on both fronts is underway both in the United States and abroad. (shrink)

In this article I explore the possibilities of experimentation as a non-foundational praxis for introducing novel ways of being into existence. Beginning with a discussion, following Bataille, of the excess of any thought, I argue that any action in the world is necessarily uncertain. Using the insights of Derridean deconstruction combined with Badiousian truth procedure I argue that experimentation offers a means for acting from this uncertain position. Experimentation takes advantage of the play and uncertainty of our (...) understanding of the world as a means of moving towards more progressive political positions. Normal 0 false false false EN-IE X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin-top:0cm; mso-para-margin-right:0cm; mso-para-margin-bottom:10.0pt; mso-para-margin-left:0cm; line-height:115%; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-fareast-language:EN-US;}. (shrink)

The discovery of the molecular structure of deoxyribonucleic acid and the science of molecular biology have profoundly changed medicine’s diagnostic capability and promise to transform the therapeutic realm. When some genetic disorders are diagnosed, physicians can intervene for prevention or treatment. While the basic structure of DNA is the same for all human beings, no two individuals, other than identical twins, have the same DNA sequence. This discovery has had important repercussions in the criminal justice system, where (...) DNA can serve as an identification tool.At the crossroads of these different uses of DNA, there are great concerns about potential misuses of genetic information. Preventing disease, curing illness, and convicting criminals are all seen as worthwhile uses of the technology, but concerns of potential misuse in medicine or in the criminal justice system are not unfounded. A 1998 American Medical Association study showed that 68 percent of patients had fears that their genetic test results would be used against them by their employers or insurers. Others, pointing to racial profiling, have suggested that we may now face genetic profiling. (shrink)

This is the first book in healthcare ethics addressing the moral issues regarding ownership of the human body. Modern medicine increasingly transforms the body and makes use of body parts for diagnostic, therapeutic and preventive purposes. The book analyzes the concept of body ownership. It also reviews the ownership issues arising in clinical care (for example, donation policies, autopsy) and biomedical research. Societies and legal systems also have to deal with issues of body ownership. A comparison is made (...) between specific legal arrangements in The Netherlands and France, as examples of legal approaches. In the final section of the book, different theoretical perspectives on the human body are analyzed: libertarian, personalist, deontological and utilitarian theories of body ownership. (shrink)

This paper explores the epistemology of extrapolation from model organisms to humans in molecular medicine. We take into account two common views on the issue, the homology view and the disanalogy view. In response to both interpretations, we argue that the foundational basis of extrapolations cannot simply be provided by homology and that relevant disanalogies can, thanks to the techniques of molecular biology, be experimentally controlled and exploited to allow useful and reliable extrapolations. The case of "humanised mice" in (...) the context of cancer stem cell research provides evidence of how animal models can be construed to approximate bona fide causal analogue models of human diseases. To supplement this view we show how the epistemology of model organisms needs to take into account the engineering side of molecular medicine. Model organisms are often manipulated to create analogies or remove disanalogies with the target system. We maintain that highlighting this feature is fundamental to explain what warrants extrapolation in the search for the molecular causes of disease. (shrink)

Background The justification for Nazi programs involving involuntary euthanasia, forced sterilisation, eugenics and human experimentation were strongly influenced by views about human dignity. The historical development of these views should be examined today because discussions of human worth and value are integral to medical ethics and bioethics. We should learn lessons from how human dignity came to be so distorted to avoid repetition of similar distortions. Discussion Social Darwinism was foremost amongst the philosophies impacting views (...) of human dignity in the decades leading up to Nazi power in Germany. Charles Darwin's evolutionary theory was quickly applied to human beings and social structure. The term 'survival of the fittest' was coined and seen to be applicable to humans. Belief in the inherent dignity of all humans was rejected by social Darwinists. Influential authors of the day proclaimed that an individual's worth and value were to be determined functionally and materialistically. The popularity of such views ideologically prepared German doctors and nurses to accept Nazi social policies promoting survival of only the fittest humans. A historical survey reveals five general presuppositions that strongly impacted medical ethics in the Nazi era. These same five beliefs are being promoted in different ways in contemporary bioethical discourse. Ethical controversies surrounding human embryos revolve around determinations of their moral status. Economic pressures force individuals and societies to examine whether some people's lives are no longer worth living. Human dignity is again being seen as a relative trait found in certain humans, not something inherent. These views strongly impact what is taken to be acceptable within medical ethics. Summary Five beliefs central to social Darwinism will be examined in light of their influence on current discussions in medical ethics and bioethics. Acceptance of these during the Nazi era proved destructive to many humans. Their widespread acceptance today would similarly lead to much human death and suffering. A different ethic in needed which views human dignity as inherent to all human individuals. (shrink)

Following decades of silence about the involvement of doctors, medical researchers and other health professionals in the Holocaust and other National Socialist (Nazi) crimes, scholars in recent years have produced a growing body of research that reveals the pervasive extent of that complicity. This interdisciplinary collection of studies presents documentation of the critical role medicine played in realizing the policies of Hitler's regime. It traces the history of Nazi medicine from its roots in the racial theories of the (...) 1920s, through its manifestations during the Nazi period, on to legacies and continuities from the postwar years to the present. (shrink)

Recent developments of three-dimensional printing of biomaterials in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more (...) particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article considers whether there is a limit as to what should be bioprinted in medicine; examines key risks of significant harm associated with testing 3D bioprinting for humans; investigates the clinical trial paradigm used to test 3D bioprinting; analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments. (shrink)

In this introduction, we address some of the complexities associated with the emergence of medicine’s bodies, not least as a means to ‘working with the body’ rather than simply producing a critique of medicine. We provide a brief review of some of the recent discussions on how to conceive of medicine and its bodies, noting the increasing attention now given to medicine as a technology or series of technologies active in constituting a multiplicity of entities – (...) bodies, diseases, experimental objects, the individualization of responsibility for health and even the precarity of life. We contrast what feminist theorists in the tradition of Judith Butler have referred to as the question of matter, and Science and Technology Studies with its focus on practice and the nature of emergence. As such we address tensions that exist in analyses of the ontological status of ‘the body’ – human and non-human – as it is enacted in the work of the laboratory, the randomized controlled trial, public health policy and, indeed, the market that is so frequently entangled with these spaces. In keeping with the recent turns toward ontology and affect, we suggest that we can regard medicine as concerned with the contraction and reconfiguration of the body’s capacities to affect and be affected, in order to allow for the subsequent proliferation of affects that, according to Bruno Latour, marks corporeal life. Treating both contraction and proliferation circumspectly, we focus on the patterns of affects wrought in particular by the abstractions of medicine that are described in the contributions to this special issue. Drawing on the work of A.N. Whitehead, we note how abstractions such as ‘medical evidence’, the ‘healthy human body’ or the ‘animal model’ are at once realized and undercut, mediated and resisted through the situated practices that eventuate medicine’s bodies. Along the way, we touch on the implications of this sort of perspective for addressing the distribution of agency and formulations of the ethical and the political in the medical eventuations of bodies. (shrink)

Human and veterinary medicine have many commonalities. The split into distinct disciplines occurred at different times in different places. In Europe, the establishment of the first veterinary universities towards the end of the 18th century was triggered by ravaging rinderpest epidemics and the increasing importance of livestock for draft, food supply, and war fare. Given this background, would it make sense to combine human, animal, traditional and modern medicine in healthcare provision, especially in less developed countries? (...) Such a “one-medicine” approach could enhance biomedical progress, improve the outreach of medical and veterinary services especially in remote areas, offer greater choices to patients, and make healthcare more culturally appropriate. On the other hand, it would require generalists rather than specialists and rare diseases may go unrecognized. The commonalities of human and veterinary medicine and the financial constraints many governments are presently facing are arguments in favor of a “one-medicine” approach, while status thinking, education systems, administrative structures, and legislations hinder its implementation. There are no instant recommendations for the application of one medicine but governments and development professionals need to generate fine-tuned, location-specific healthcare solutions. Advocacy, changes in education and training, the creation of institutional linkages, and the removal of legal barriers could help overcome obstacles. (shrink)