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)

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)

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)

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)

This review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed.

Rationale: In this article, I argue that we need a new perspective in the debate on autonomy in medicine, to understand many of the problems we face today – dilemmas that are situated at the intersection of autonomy and heteronomy, such as why well informed and autonomous people make unhealthy lifestyle choices. If people do not choose what they want, this is not simply caused by their lack of character or capability, but also by the fact that absolute autonomy (...) is impossible; autonomous individuals are ‘contaminated’ by heteronymous aspects, by influences from ‘outside’. Consequently, there are many good reasons to question the widely accepted hierarchical opposition of autonomy (progress) versus heteronomy (paternalism) in medicine. In an earlier article an analysis is made of the neologism ‘oughtonomy’ to support the thesis that when it comes down to human existence, autonomy and heteronomy are intertwined, rather than being merely opposites. Methods: In this article, I reflect upon how social conditions might improve our ‘choice architecture’, what Thaler & Sunstein have called ‘nudging’: how to change individual health choices without being paternalistic? I explore the extent to which both oughtonomy and nudging are able to challenge the question of autonomy in today’s medicine. Results and Conclusions: Autonomy may and should be a shared target in today’s medicine, but we should never forget that it is always intertwined with heteronomy. Starting from this perspective, progress in medicine demands far more than the increase of autonomy. (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)

Artificial Intelligence (AI) is transforming our world: today machines not only can mimic human actions but out-perform human agents in many activities, including learning and thinking. AI offers revolutionary solutions and new possibilities in transportation, business, communication, medicine, law, and other domains. While some welcome this brave new world, others fear the threats AI pose to people’s livelihoods, social relations, individuality, freedom, and perhaps even the very survival of the human species. No doubt some of (...) this existential angst is exaggerated, but AI does raise questions for our understanding of the world and ourselves that require serious reflection, including questions about adequacy of education in various aspects. This chapter offers, from the perspectives of John Dewey’s Pragmatism as well as Confucianism, some reflections on the role of the humanities in education in response to the opportunities and challenges of the development and widespread use of AI. It shows that Dewey and Confucius share similar views regarding the humanistic purpose of education and their philosophies of education offer arguments for why humanities education will be relevant, if not more important, when many jobs we are familiar with become obsolete. Their attitudes toward the economic motive in education will help us rethink the meaning of work in a “world without work.” At the same time, they offer a critical evaluation of contemporary humanities education, which have failed to realize their visions of personal cultivation and growth. Among its failings is the continued dichotomy between the humanities and the sciences. In the age of AI, it has become even more vital to integrate them to avoid science and technology from becoming materialistic and anti-human while the humanities become merely literary and without any means to transform the world. (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)

The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, and with (...) inadequate experimental methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen. (shrink)

The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, and with (...) inadequate experimental methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen. (shrink)

All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing (...) the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested. (shrink)

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)

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)

For ten years, 1971–1981, the Institute onHuman Values in Medicine (IHVM) played a keyrole in the development of Bioethics as afield. We have written this history andanalysis to bring to new generations ofBioethicists information about the developmentof their field within both the humanitiesdisciplines and the health professions. Thepioneers in medical humanities and ethics cametogether with medical professionals in thedecade of the 1960s. By the 1980s Bioethics wasa fully recognized discipline. We show the rolethat IHVM programs played in defining thefield, (...) training faculty and helping schools todevelop programs. We review the beginnings ofthe IHVM in the crucible of social andtechnological change that led to theestablishment of the IHVM's parentorganization, the Society for Health and HumanValues. We then turn to the IHVM programsthrough which Faculty members receivedfellowships to explore new crossovers betweenthe humanities and the health professions. Wehave not only described the Fellows Program asit existed in 1973–1980, but have completed asurvey of the fellows a quarter of a centuryafter they held their fellowships. We describeother IHVM programs designed to facilitate theinitiation and development of new humanitiesprograms, to explore conceptual issues betweenmedicine and five humanities fields, to conductissue driven or educational method conferencesand to advance humanities programs intograduate education through the Directors ofMedical Education. (shrink)

This new edition of Charles Fried's 'Medical Experimentation' includes a general introduction by Franklin Miller and the late Alan Wertheimer, a reprint of the 1974 text, an in-depth analysis by Harvard Law School scholars I. Glenn Cohen and D. James Greiner, and a new essay by Fried reflecting on the original text and how it applies to the contemporary landscape of medicine and medical experimentation.

Ethics in scientific research has never been more important. Recent controversies over the integrity of data in federally funded science, the manipulation and distortion of privately sponsored research, cloning, stem cell research, and the patenting of DNA and cell lines, illustrate the need for a more thorough education in ethics for researchers at all levels. Now in its second edition, Responsible Conduct of Research provides an introduction to many of the social, ethical, and legal issues facing scientists today. The (...) fully updated volume includes three brand new chapters and additional cases for discussion, as well as analysis of the latest issues and problems in research ethics. Featuring chapters that treat such topics as ethical decision-making, research misconduct, and intellectual property, this new edition will be an indispensable resource for students and teachers, academics and industry professionals alike. (shrink)

Addresses the issues at the heart of international medicine and social responsibility. A number of international declarations have proclaimed that health care is a fundamental human right. But if we accept this broad commitment, how should we concretely define the state’s responsibility for the health of its citizens? Although there is growing debate over this issue, there are few books for general readers that provide engaging accounts of critical incidents, practices, and ideas in the field of (...) class='Hi'>human rights, health care, and medicine. Included in the book are case studies of such issues as AIDS among orphans in Romania, organ trafficking, prison conditions, health care rationing, medical research in the third world, and South Africa’s constitutionally guaranteed right of access to health care. It uses these topics to address themes of protection of vulnerable populations, equity and fairness in delivering competent medical care, informed consent and the free flow of information, and state responsibility for ensuring physical, mental, and social well-being. (shrink)

The invocation of moral rights in moral/social debate today is a recipe for deadlock in our consideration of substantive issues. How we treat animals and humans in part should derive from the value of their lives, which is a function of the quality of their lives, which in turn is a function of the richness of their lives. Consistency in argument requires that humans with a low quality of life should be chosen as experimental subjects over animals with a (...) higher quality of life. (shrink)

Men often make riskier decisions than women across a wide range of real-life behaviors. Whether this sex difference is accentuated, diminished, or stable under stressful conditions is, however, contested in the scientific literature. A critical blind spot lies amid this contestation: Most studies use standardized, laboratory-based, cognitive measures of decision making rather than complex real-life social simulation tasks to assess risk-related behavior. To address this blind spot, we investigated the effects of acute psychosocial stress on risk decision making in (...) men and women using a standardized cognitive measure and a novel task that simulated a real-life social situation. Participants were exposed to either an acute psychosocial stressor or an equivalent control condition. Stressor-exposed participants were further characterized as high- or low-cortisol responders. Results confirmed that the experimental manipulation was effective. On the IGT, participants characterized as low-cortisol responders made significantly riskier decisions than those characterized as high-cortisol responders. Similarly, in the online chatroom, participants characterized as low-cortisol responders were, relative to those in the Non-Stress group, significantly more likely to make risky decisions. Together, these results suggest that at lower levels of cortisol both men and women tend to make riskier decisions in both economic and social spheres. (shrink)

What are the limits of the use of artificial intelligence (AI) in the relational aspects of medical and nursing care? There has been a lot of recent work and applications showing the promise and efficiency of AI in clinical medicine, both at the research and treatment levels. Many of the obstacles discussed in the literature are technical in character, regarding how to improve and optimize current practices in clinical medicine and also how to develop better data bases for (...) optimal parameter adjustments and predictive algorithms. This paper argues that there are also in principle obstacles to the application of AI in clinical medicine and care where empathy is important, and that these problems cannot be solved with any of the technical and theoretical approaches that shape the current application of AI in specific areas of clinical medicine in which care for patients is fundamental. This is important, because it generates specific risks that may be overlooked otherwise, and it justifies the necessity of human monitoring and emotional intervention in clinical medicine. Consequently, difficult issues concerning moral and legal responsibility may ensue if these in principle problems are ignored. (shrink)

Winner of the Los Angeles Times Book Prize With a new preface by the author In his most powerful and important book, renowned psychiatrist Robert Jay Lifton presents a brilliant analysis of the crucial role that German doctors played in the Nazi genocide. Now updated with a new preface, The Nazi Doctors remains the definitive work on the Nazi medical atrocities, a chilling exposé of the banality of evil at its epitome, and a sobering reminder of the darkest side of (...) human nature. (shrink)

As a continuation of this author’s previous cosmological neuroscience papers on the hypothesized Soul of Multiverse and its possible laws, the present work examined the social aspects of four of these laws. The following key aspects were recognized: (1) Knowing about the cosmic Law of Coexistence in Diversity can let our mind respect not only the endless diversity of human beings but also the cohesive force of space-time in which all are connected. This may help realizing the superiority (...) of cooperation for shared goals over competition for gaining by harming others. (2) Knowing about the cosmic Law of Truth in Complexity can ready our mind to confront the problems of societies with the understanding that these problems are much more complex than generally thought. This may help initiating the needed intellectual renaissance of the 21st century. (3) Knowing about the cosmic Law of Divine - Evil Asymmetry can make our mind appreciate the slight yet sufficient supremacy of divine over evil. This may help restoring faith in the eventual creation of a just society, where social justice is defined as an administrative mechanism providing the right conditions for every human being to accomplish his or her Conscience-led Mission throughout life, while allowing each of these accomplishments to be reciprocated with the gratitude it induced in the involved social systems, small or large, to let equal opportunities in life coexist with due diversity in welcomed, not abused, social recognitions. And (4) knowing about the cosmic Law of Lives to Transcend can empower our mind to build on these advances. This may help moving evolution towards the human species worthy of its origin and destination. (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)

In this paper our aim is to examine whether research conducted on human participants with LSD-25 raises unique research ethical questions or demands particular concerns with regard to the design, conduct and follow-up of these studies, and should this be the case, explore and describe those issues. Our analysis is based on reviewing publications up to date which examine the clinical, research and other uses of LSD and those addressing ethical and methodological concerns of these applications, just as some (...) historical examinations of this subject. The first chapters of the paper give an overview regarding the history of LSD-research with human participants, healthy volunteers and patients alike. The remaining chapters have a focus on questions regarding the potential ethical issues of such human trials in the contemporary research ethics framework. We also consider briefly political and regulatory issues regarding this substance that possibly affect its clinical and research applications. (shrink)

This feels like a time of environmental and moral crisis without parallel.... Not only do human beings seem not to believe in anything but, despite exponential advances in information production, we do not appear to know much either. This book is a guide for everyone who feels understandably perplexed. The book considers issues as diverse as: the lure of alternative religions and belief systems; the use of the rhetoric of economics to justify amoral decisionmaking; green politics and genetically-modified crops; (...) new technology's power to preserve the status quo; and the true impetus behind the Human Genome Project. Presenting an explanation of recent findings in science and their relationship with society and politics, the book seeks to give guidance towards responsible political action. Starting from themes developed in the companion volume The Search for Mind, the author attempts to provide intellectual roots for the 'anti-capitalist' or 'anti-globalization' movement and, in particular, treats social protest as a form of knowledge-seeking. The author brings to very topical and controversial concerns some much-needed clarity. Complete with reader-friendly summaries of current thought in the biological, physical, and social sciences, this book is designed primarily for the popular market but will also appeal to those working or studying in these fields. (shrink)

The article presents specific recommendations for the examination of AI systems in medicine developed by the authors. The recommendations based on the problems, risks and limitations of the use of AI identified in scientific and philosophical publications of 2019-2022. It is proposed to carry out ethical expertise of projects of medical AI, by analogy with the review of projects of experimental activities in biomedicine; to conduct an ethical review of AI systems at the stage of preparation for their development (...) followed by monitoring the testing of the created system; to focus on bioethical principles during the examination of AI systems for medical purposes. (shrink)

Public goods, as well as commercial commodities, are affected by exclusive arrangements secured by intellectual property (IP) rights. These rights serve as an incentive to invest human and material capital in research and development. Particularly in the life sciences, IP rights regulate objects such as food and medicines that are key to securing human rights, especially the right to adequate food and the right to health. Consequently, IP serves private (economic) and public interests. Part of this charge claims (...) that the current IP regime is privatizing the very building blocks of research and development – that used to be part of the commons. The public domain, in contrast to the private domain, may be the locus of much more diverse forms of creativity that at the same time ensures a wider plurality of productive traditions. An IP regime must support a sense of public morality because it is dependent upon civil support. This inevitably prompts questions of what are “good” exclusive rights and what are “bad” exclusive rights, and how shall such IP rights be developed. We argue that the democratization of the current IP regimes is an important first step to respond to these issues. (shrink)

Ethics boards have become obligatory passage points in today's medical science, and we forget how novel they really are. The use of humans in experiments is an age-old practice that records show goes back to at least the third century BC and, since the early modern period, as a practice it has become increasingly popular. Yet, in most countries around the world, hardly any formal checks and balances existed to govern the communal oversight of experiments involving human subjects until (...) at least the 1960s. Ethics by Committee traces the rise of ethics boards for human experimentation in the second half of the twentieth century. Using the Netherlands as a case-study, Noortje Jacobs shows how the authority of physicians to make decisions about clinical research gave way in most developed nations to formal mechanisms of communal decision-making that served to regiment the behavior of individual researchers. This historically unprecedented change in scientific governance came out of a growing international wariness of medical research in the decades after World War II. Research ethics committees were originally intended not only to make human experimentation more ethical but also to raise its epistemic quality. By examining complex negotiations over the appropriate governance of human subjects research, Ethics by Committee advances our understanding not only of the history of research ethics and the randomized controlled trial but also, more broadly, of how liberal democracies in the late twentieth century have sought to resolve public concerns over charged issues in medicine and science. (shrink)

Given the sordid history of injustices linking genetics to race and ethnicity, considerations of justice are central to ensuring the responsible development of precision medicine programmes around the world. While considerations of justice may be in tension with other areas of concern, such as scientific value or privacy, there are also tensions between different aspects of justice. This paper focuses on three particular aspects of justice relevant to this precision medicine: social justice, distributive justice and human (...) rights. We describe the implications of each for the use of race and ethnicity in precision medicine, and also how they intersect and potentially conflict with each another. By attending to these intersections, we aim to enrich and add nuance to debates over how best to proceed with precision medicine initiatives. (shrink)

This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, and suggests procedures (...) in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethics committees. (shrink)

In this book, author John Lynch shows how three controversial experiments--the Tuskegee Syphilis Study, the Willowbrook Hepatitis Study, and the Cincinnati Total Body Irradiation Study--have been remembered and forgotten, and why their memorialization or their erasure matters today.

Biomedical research on humans is an important part of medical progress. But, when lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. IRB members face difficult decisions every day. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues (...) involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the lives of human participants. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process. (shrink)

This book presents an interpretation of pharmaceutical, surgical and psychotherapeutic interventions based on a univalent metalanguage: biosemiotics. It proposes that a metalanguage for the physical, mental, social, and cultural aspects of health and medicine could bring all parts and aspects of human life together and thus shape a picture of the human being as a whole, made up from the heterogeneous images of the vast variety of sciences and technologies in medicine discourse. The book adopts (...) a biosemiotics clinical model of thinking because, similar to the ancient principle of alchemy, tam ethice quam physice, everything in this model is physical as much as it is mental. Signs in the forms of vibrations, molecules, cells, words, images, reflections and rites conform cultural, mental, physical, and social phenomena. The book decodes healing, dealing with health, illness and therapy by emphasizing the first-person experience as well as objective events. It allows readers to follow the energy-information flows through and between embodied minds and to see how they form physiological functions such as our emotions and narratives. (shrink)

This is the first book to examine behavioral theories on social preference from institutional and philosophical perspectives using economic experiments. The experimental method in economics has challenged central behavioral assumptions based on rationality and selfishness, proposing empirical evidence that not only profit seeking but also social preferences matter in individuals' decision making. By performing distribution experiments in institutional contexts, the author extends assumptions about human behavior to understand actual social economy. The book also aims to enrich (...) behavioral theories of economics directed toward institutional evolution. The author scrutinizes how specific institutional conditions enhance or mute individuals' selfish incentives or their fairness ideals such as egalitarian, performance-based, labor-value radicalism or libertarianism. From experimental results and their analysis, implications for actual problems in social economy and institutional change are derived: why performance-based pay often fails to promote workers' productivity; why labor wages decline whereas shareholder's values increase after financialization; and whether socially responsible investment can be a social institution for corporate governance. The book is also addressed to philosophers of social sciences interested in how experimental methods can contribute to developing cognition of human behaviors and be extended to social theories. Referring to behavioral theorists in the history of economic thought, the author discusses the meanings of experiments in the methodology of social sciences. She also proposes new ways of interpreting experimental results by reviving historic social theories and applying them to actual social problems. (shrink)

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)

What motives underlie the ways humans interact socially? Are these the same for all societies? Are these part of our nature, or influenced by our environments?Over the last decade, research in experimental economics has emphatically falsified the textbook representation of Homo economicus. Literally hundreds of experiments suggest that people care not only about their own material payoffs, but also about such things as fairness, equity and reciprocity. However, this research left fundamental questions unanswered: Are such social preferences stable components (...) of human nature; or, are they modulated by economic, social and cultural environments? Until now, experimental research could not address this question because virtually all subjects had been university students, and while there are cultural differences among student populations throughout the world, these differences are small compared to the full range of human social and cultural environments. A vast amount of ethnographic and historical research suggests that people's motives are influenced by economic, social, and cultural environments, yet such methods can only yield circumstantial evidence about human motives. Combining ethnographic and experimental approaches to fill this gap, this book breaks new ground in reporting the results of a large cross-cultural study aimed at determining the sources of social preferences that underlie the diversity of human sociality. The same experiments which provided evidence for social preferences among university students were performed in fifteen small-scale societies exhibiting a wide variety of social, economic and cultural conditions by experienced field researchers who had also done long-term ethnographic field work in these societies. The findings of these experiments demonstrated that no society in which experimental behaviour is consistent with the canonical model of self-interest. Indeed, results showed that the variation in behaviour is far greater than previously thought, and that the differences between societies in market integration and the importance of cooperation explain a substantial portion of this variation, which individual-level economic and demographic variables could not. Finally, the extent to which experimental play mirrors patterns of interaction found in everyday life is traced.The book starts with a succinct but substantive introduction to the use of game theory as an analytical tool and its use in the social sciences for the rigorous testing of hypotheses about fundamental aspects of social behaviour outside artificially constructed laboratories. The results of the fifteen case studies are summarized in a suggestive chapter about the scope of the project. (shrink)

Given the sordid history of injustices linking genetics to race and ethnicity, considerations of justice are central to ensuring the responsible development of precision medicine programmes around the world. While considerations of justice may be in tension with other areas of concern, such as scientific value or privacy, there are also tensions between different aspects of justice. This paper focuses on three particular aspects of justice relevant to this precision medicine: social justice, distributive justice and human (...) rights. We describe the implications of each for the use of race and ethnicity in precision medicine, and also how they intersect and potentially conflict with each another. By attending to these intersections, we aim to enrich and add nuance to debates over how best to proceed with precision medicine initiatives. (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)

In lieu of an abstract, here is a brief excerpt of the content:Research Ethics after World War II: The Insular Culture of BiomedicineAllan M. Brandt (bio) and Lara Freidenfelds (bio)Human subjects research in the United States has only recently emerged as an important area of historical investigation. Over the last quarter century, scholars have begun the process of grounding within an historical context both the complex relationship between researchers and subjects and the processes by which biomedical knowledge is produced. (...) Their studies examine topics ranging from the impact of the anti-vivisectionist movement on human experimentation in the early twentieth century (Lederer 1995) to the development of the discipline of bioethics in the 1960s and 1970s (Rothman 1991) and the emergence of the legal concept of informed consent for human research (Katz, Glass, and Capron 1972). Many of the discussions focus on isolated incidents of scandal, such as the Tuskegee Syphilis Study (Jones 1993; Brandt 1978) and the Willowbrook School hepatitis study (Rothman and Rothman 1984). In doing so, they attempt to explain how such clearly unethical research could have been initiated and what consequences have resulted from public knowledge of such research.Nonetheless, the broader historical contexts and implications of human subjects research have yet to be fully delineated. This project will be of crucial importance, not only for historians, but also for those concerned with research policy and medical ethics. The historical examination of human subjects research will provide further insight into the details of research methods, the construction of protocols, and the historically specific interest in certain diseases. In addition, scholars will better understand the relationships of power and authority between researcher and subject, as well as the social and scientific mechanisms for the production of new biomedical knowledge. The process of enlisting research subjects illuminates the significance of class, gender, ethnicity, and race in science, in biomedicine, and in society. The fact that, historically, much research has employed research subjects from vulnerable populations, who participated in coercive contexts, has exposed powerful social assumptions embedded in the research enterprise. [End Page 239]The revelation of new documents indicating past abuses has sparked much of the investigation into human subjects research and the recent investigation of human radiation experiments during the Cold War era. One of the most important achievements of the Advisory Committee on Human Radiation Experiments was the uncovering of thousands of documents, a remarkable mine of archival data, that had been previously inaccessible to researchers. Jonathan Moreno and Susan Lederer’s article on the history of Cold War research ethics in this issue of the Kennedy Institute ofEthics Journal represents the first attempt since the publication of the Committee’s Final Report to analyze the Committee’s findings in a serious historical context.Historical accounts of the emergence of bioethics traditionally have left a great void in their discussions of human experimentation, generally ignoring the period between the writing of the Nuremberg Code in 1947 and the publication of Henry Beecher’s 1966 New England Journal ofMedicine article condemning systematic, unethical practices in human experimentation (Rothman 1991). The period from 1946 to 1966, however, was a time of vigorous research characterized by a fragmented community of medical researchers who applied inconsistent ethical standards and employed highly variable research practices. Both military and civilian medical researchers were intensely interested in radiation and thus conducted human subjects research along those lines, including examinations of the effects of plutonium injections and of total body irradiation, the use of trace radioisotopes to study various body processes, and observations of the effects of radiation intentionally released into the environment. The U.S. Government sponsored several thousand such studies (ACHRE 1995 [GPO, pp. 227–31; Oxford, pp. 135–38]), some of which were conducted on hospital patients, institutionalized children, military personnel, and prisoners. The Cold War scientific culture that produced this research must be examined from an historical ethical perspective.A central aspect of the culture of biomedical science after World War II was its insularity. Increasingly high standards of admission and challenging training had come to ensure that only a select group of individuals was admitted to the professions of medicine and research science. In this culture of experts, trustworthiness and ethical judgment were considered to be dependent upon expertise... (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)

BackgroundDuring a commercial surrogacy arrangement, the event of embryo transfer can be seen as the formal starting point of the arrangement. However, it is common for surrogates to undergo a failed attempt at pregnancy conception or missed conception after an embryo transfer. This paper attempts to argue that such failed attempts can be understood as a loss. It aims to reconstruct the experiences of loss and grief of the surrogates and the intended parents as a consequence of their collective failure (...) to conceive a surrogate pregnancy.MethodsDrawing on a qualitative study conducted over a period of eight months between 2014 and 2015 at two fertility clinics in Delhi and two in Kolkata, India, this paper examines the experiences of the surrogates and the intended parents when faced with missed conceptions or failed conceptions during a surrogacy arrangement.ResultsWe argue that while the surrogate grieves the non-arrival of a ‘good news’ as an uncertain loss, the intended parents experience yet another, failure in addition to the losses they might have incurred during their previous fertility treatments. The body of the surrogate becomes a site of ‘a lost opportunity’. The surrogate embodies a loss in her quest to achieve social mobility and the intended parents experience a disembodied pregnancy loss. This very emotional experience stands in stark contrast to the conceptualisation of such failed attempts as non-events within the discourse of the surrogacy industry. The experience of loss of the intended parents is recognised but their grief is given no space. We argue that such ambiguity around the nature of losses resulting out of a missed or failed conception during surrogacy is an outcome of lack of interpersonal relationship between the surrogate and the intended parents.ConclusionsSince commercial surrogacy is a relational process, the only way in which the experiences of losses and failures of the actors at the preconception stage can be better addressed is through developing close sharing and understanding between each other through an ethics of care. Therefore, to nurture caring relationships, surrogacy needs to be understood as a moral commitment by –the surrogates and intended parents. To enable such a commitment, there is a need to reconsider the pre-defined and legally regulated professional duty of the doctors, agents and agencies. It cannot be a one-sided commitment, but has to have elements of mutuality. (shrink)

Introduction. The article raises the problem of eugenics as a direction of scientific thought and practice of improving the human species. The modern advances in reproductive medicine, the development of biology, the emergence of methods for editing the human genome have updated the debate around eugenics. The aim of the work is a comprehensive study of the discourse and practice of eugenics in the period of the 19th — 21st centuries. This aim involves solving a number of (...) tasks: 1) analysis of the historical context and prerequisites for the eugenics emergence; 2) the study of the institutionalization and practical implementation of its ideas in Western countries in the period until the end of World War II; 3) research on the position of eugenics after the war and the transition of discussions to the mainstream of genetics, bioethics, transhumanism; 4) study of the modern discourse of eugenics, ethical issues and the degree of government intervention in population reproduction. Methods. The author uses the historical-retrospective method, which makes it possible to comprehensively consider the context of the emergence and development of eugenics, the comparative method (when comparing the characteristic features of the «old» (authoritarian, forced) and «new» (democratic, based on personal choice) eugenics), the institutional approach ( when identifying the main institutions involved in the development, dissemination, implementation of the ideas of eugenics) and a discursive approach (to study modern discussions about the «new» eugenics and related ethical problems). Scientific novelty of the research. A comprehensive study of eugenics has been carried out, a connection has been established between the «old» and «new» eugenics, and their similarities and differences have been investigated. Results. The need to distinguish eugenics as a theory of human selection and as a practice has been proven, and the latter, depending on the political, cultural and socio-economic situation in the country, can take a variety of forms: from counseling and preventive measures to racial cleansing. It was found that population growth, urbanization, mass migration, instability in society, combined with the ideas of modernism about social order by the forces of science and technology, contributed to the spread of eugenics ideas in the late 19th - early 20th centuries. After the Nuremberg trials, the concept under study temporarily dropped out of scientific discourse. The article examines in detail the socio-economic and other preconditions that contributed to the revival of interest in eugenics in the 60s of XX century and at the present stage. It is shown that today part of the discussion has shifted to the mainstream of genetics, bioethics and transhumanism. Conclusions. It has been established that discussions about eugenics run up against the problem of breeding control, which means that they raise the question of who should perform selection, how, what are its criteria. The ethical aspects of introducing control are complicated by the fact that perceptions of the «norm» and the degree of permitted interference depend on the particular society. (shrink)

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

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.