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)

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)

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.

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)

Research regulation is a timely topic for discussions in bioethics and public health policy. This response to articles in the previous special issue of the Monash Bioethics Review emphasises the importance of having both internal and external controls of human experimentation. Unless both elements are incorporated into research ethics governance frameworks, they will ultimately fail to achieve what should be their primary goal: human subject protection.

The 3Rs, or the replacement, reduction, and refinement of animal research, are widely accepted as the best approach to maximizing high-quality science while ensuring the highest standard of ethical consideration is applied in regulating the use of animals in scientific procedures. This contrasts with the muted scientific interest in the 3Rs when they were first proposed in The Principles of Humane Experimental Technique. Indeed, the relative success of the 3Rs has done little to encourage engagement with their original text, which (...) remains little read and out of print. By adopting a historical perspective, this article argues that one explanation for this disjunction may be found in another, more celebrated, event of 1959: C. P. Snow’s Rede lecture on The Two Cultures. The moral outlook of The Principles of Humane Experimental Technique derived from an earlier ethos wherein humanistic and scientific values occupied a shared culture. While the synthetic style of The Principles has hindered its readership, this article concludes that there is value to recovering the notion that the humanities and social sciences can contribute to the improvement of animal research. (shrink)

Ethical conduct is a maxim in scholarly research as well as scholarly endeavour generally. In the case of research involving humans, few if any question the necessity for ethics approval of procedures by ethics boards or committees. However, concerns have been raised about the appropriateness of ethics approval processes for social science research arguing that the orientation of ethics boards and committees to biomedical and experimental scientific research, institutional risk aversion, and other factors lead to over-protection (...) of research participants and overly restrictive processes that delay and sometimes prevent important social science research. This is particularly significant when social science research is required to respond to social, environmental, or health emergencies and in contract research projects for the reasons explained. This analysis of an ethics approval case study adds to increasing concerns that ethics approval processes can have perverse effects in the social sciences. While a single case study does not provide generalizable findings, in-depth analysis of a significant case can identify issues that need to be further explored. Recommendations offer pathways for facilitating social science research including in emergency situations in which timeliness is important and in collaborative approaches such as participatory action research, while maintaining high ethical standards. (shrink)

Offers a vision of wholeness for approaching human ethical responses to what science is telling us about the crises facing our environment and climate.

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)

Subject perspectives : the missing element in research ethics -- Personal knowledge and study participation -- The everyday ethics of human research -- The hidden world of subjects : rule-breaking in clinical trials -- Participants as partners in genetic research -- Terminally ill patients and the right to try experimental drugs -- Embedded ethics in developing country research -- Research subjects as literary subjects -- How to hear subjects.

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)

There is the world of ideas and the world of practice; the French are often for sup pressing the one and the English the other; but neither is to be suppressed. -Matthew Arnold The Function of Criticism at the Present Time From its inception, bioethics has confronted the need to reconcile theory and practice. At first the confrontation was purely intellectual, as writers on ethical theory (within phi losophy, theology, or other humanistic disciplines) turned their attention to topics from the (...) world of medical practice. Recently the confrontation has grown more intense. The ap pointment of clinical ethicists in hospitals and other health care settings is an accelerating trend in North America. Concomitantly, those institutions involved in training peo ple in clinical ethics have added organized exposure to the world of practice, in the form of placement requirements, to the normal academic course load. In common with other dis ciplines, bioethics has begun to see clinical training as a con dition of didactic theory and apprenticeship. (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)

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.

This essay explores some moral problems raised by experimentation involving the human fetus. In the first part of the essay three examples of fetal experimentation from the medical literature are described in some detail. Next, the ethical and legal arguments employed in the two major existing public policy-documents on fetal experimentation are analyzed. Finally, the author seeks to identify four fundamental presuppositions which underlie divergent normative positions on the problem of fetal experimentation.

Protecting the people we experiment on --"Inside the black box" : becoming and being IRB members -- Weighing risks and benefits and undue inducement -- Defining research and how good it needs to be -- What to tell subjects : battles over consent forms -- From "nitpicky" to "user-friendly" : inter-IRB variations and their causes -- Federal agencies vs. local IRBs -- The roles of industry -- The local ecologies of institutions -- Trusting vs. policing researchers -- Bad behavior: research (...) integrity -- Researchers abroad : studies in the developing world -- Changing national policies -- Conclusions : other changes. (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)

In his essay, Philosophical Reflections on Experimenting with Human Subjects, Hans Jonas contends that except in cases of widespread medical emergencies, people do not have a moral or social obligation to volunteer to be subjects in medical experiments. He further argues that any appeal for volunteer subjects in medical experiments should whenever possible give priority to those who can identify with the project and offer a strong sense of commitment to its goals. The first of these claims is given (...) support against some recent criticisms, but argument is offered to show that the second claim not only does little to enhance the stature of the standard requirement of free and informed consent but may even weaken the moral validity of the consent. (shrink)

The prelims comprise: Introduction A (re)Defmition of what Human Gene Therapy is About Neurological Gene Therapy Ethics and Gene Therapy Acknowledgments Notes.

Instead of another federal advisory panel to identify ethical principles governing human subjects research, it is time we had a national board with authority to regulate and review such research.

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.

Tremendous development in recent medical science and the consequent discoveries resulting in successful prevention and also cure of different diseases are shared by clinical research involving the human volunteers. Preceding the trials in the human subjects, and to ensure safety, the proposed drug and other interventions are either tested in animals (vivo) or in laboratory (vitro) to evaluate initial safe starting dose for the human beings and to key out the benchmarks for the clinical monitoring for the (...) potential unfavorable effects. These pre human trials might not necessarily protect against the untoward effects in the human beings as happened in the case of thalidomide tragedy, which caused disability and killed thousands of babies born to the mothers, those who took this medicine. Use of healthy human volunteers in the preliminary experiments or phase I clinical trials either reduces or excludes risks of subsequent undesirable effects in the future trails (1). Phase-1 trials are conducted in order to test the safety, reactions and immunogenicity of vaccines in volunteers. Novel treatments for the cancer are first tested in phase 1 trials enrolling the patients with advanced disease, who have exhausted the standard treatment options. Phase-1 oncology trials are the pivot point in the translation of new cancer therapies from bench to bedside. Nevertheless, these trials remain ethically controversial. The controversy stems from the fact that, classically, phase-1 oncology clinical trials involve first-in-human testing of experimental treatment candidates in patients with a terminal diagnosis, who typically have exhausted standard treatment options. Commentators on the ethics of phase-1 clinical trials make diametrically opposed claims about the prospect of direct medical benefit from participation in these trials-benefits that can be attributed to receiving the experimental treatment intervention. One camp of benefit skeptics, inhabited mainly by bioethicists, characterizes this form of research as lacking any reasonable prospect of direct medical benefit. They see an ethical cloud hovering over phase-1 trials, because the vast majority of patients volunteer for phase-1 trials out of a motivation to receive medical benefit. In the view of these skeptics, such patients therefore harbor a ‘therapeutic misconception’ about research participation. This misconception calls into question the validity of informed consent and thereby undercuts the ethical basis of these trials (2). In this paper, I will discuss the ethical justification of the participation of human volunteers in phase-1 trials. (shrink)

A generation ago, we adopted a national system for the protection of human subjects in research. Today, that system is facing new challenges. Many argue that the system has failed to evolve in concert with dramatic changes in the research environment. Accordingly, efforts are underway to reform the existing process to make it both more efficient and more effective. At the same time, many are also reexamining the system in more fundamental ways — going well beyond considerations of policies (...) and compliance and raising questions that go to the very foundations of what constitutes an ethical conduct of human research.Experimentation involving human subjects is a necessary step in the process of translating scientific discovery and technological advancement into procedures and products that offer the prospect of better lives for all of us. It helps us to better understand why we do the things we do and believe what we believe. (shrink)