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)

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)

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)

This paper explores the possibility for a means of bringing about novelty which does not rely on kairological philosophies based on an event. In contrast to both common sense and contemporary philosophical understandings of the term where for novelty to arise there must be some break in the repetition of the structure, this paper argues that it is possible for novelty to come about through small-scale experimentation. This is done by relying on the philosophical notion of ‘economy’ in order (...) to understand how we think about the world. In this regard, our thinking about the world depends upon acknowledging certain possibilities at the expense of others. History can then be seen as the distribution of emphasis which allows for these past possibilities and the future potentiality they may hold. Novelty, defined here as a rereading of history, is precisely the disruption of these possibilities and a challenge to the memory of the system. The conclusion to this paper argues that experimentation is an important means by which we can bring novelty into the world. (shrink)

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.

Background: “Therapeutic misconception” arises when human subjects interpret a clinical trial as aimed primarily at therapy rather than producing knowledge. Therapeutic misconceptions may be more prevalent in trials enrolling gravely ill subjects or involving novel and well publicised investigational agents.Objective: To examine the extent to which investigators express therapeutic optimism in phase 1 human gene transfer consent documents, whether highly active gene transfer researchers are more prone to expressing therapeutic optimism, and whether consent forms (...) have grown more optimistic in their descriptions of personal benefit over the last decade.Design: Content analysis was performed on 277 consent documents to measure the number of sentences describing possibility of benefit, terminology used for experimental agents, the proportion of statements describing personal versus societal benefits, and whether investigators attempted to thwart therapeutic misconceptions.Results: Consent forms generally used therapeutic terminology to describe study agents, devoted more sentences to describing possible personal benefits than to describing benefits to society, and infrequently explained that a particular benefit was unlikely. Consent documents used by highly active gene transfer researchers tended to portray significantly greater optimism about personal benefit than less active investigators, though they were also significantly more cautious with agent terminology. Finally, therapeutic optimism expressed in consent forms has declined over the past decade.Conclusions: Consent documents used in phase 1 gene transfer trials, although increasingly attentive to possible therapeutic misconceptions, are inappropriately optimistic about direct benefits of trial participation. Such optimism is expressed more emphatically in trials involving highly active gene transfer researchers as principal investigators. (shrink)

The use of human brain tissue in neuroscience research is increasing. Recent developments include transplanting neural tissue, growing or maintaining neural tissue in laboratories and using surgically removed tissue for experimentation. Also, it is likely that in the future there will be attempts at partial or complete brain transplants. A discussion of the ethical issues of using human brain tissue for research and brain transplantation has been organized around nine broadly defined topic areas. Criteria for human (...) brain tissue transplantation and laboratory use of brain tissue are proposed. (shrink)

This paper aims to bring the epistemic dimensions of stem cell experiments out of the background, and show that they can be critically evaluated. After introducing some basic concepts of stem cell biology, I set out the current “gold standard” for experimental success in that field (§2). I then trace the origin of this standard to a 1988 controversy over blood stem cells (§3). Understanding the outcome of this controversy requires attention to the details of experimental techniques, the organization of (...) epistemic communities, and relations between the two (§4). With its resolution, a standard for experimental success was established for HSC research, which in turn serves as an exemplar for studies of other stem cells. This historical case study reveals a robust standard for experimental success in stem cell biology: to trace processes of development at the single-cell level, in the form of cell lineage hierarchies. Experiments conforming to this standard can be further critically assessed as means to the therapeutic end of stem cell research: use of stem cells to repair human organs and tissues. (shrink)

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)

The Therapeutic Misconception (TM) is a cognitive error with similarities to another cognitive error -- the Gambler's Fallacy (GF). This paper examines the similarities between TM and GF in an attempt to further illuminate the nature of TM, and to distinguish it from another cognitive error, Unrealistic Optimism (UO). Many cases of UO and mis-classified as TM.

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 article reformulates Stephan Helmreich´s the ¨microbiomisation of race¨ as the historiality of otherness in the foundations of human microbiome science. Through the lens of my ethnographic fieldwork of a transnational community of microbiome scientists that conducted a landmark human microbiome research on indigenous microbes and its affiliated and first personalised microbiome initiative, the American Gut Project, I follow and trace the key actors, experimental systems and onto-epistemic claims in the emergence of human microbiome science a decade (...) ago. In doing so, I show the links between the reinscription of race, comparative research on the microbial genetic variation of human populations and the remining of bioprospected data for personalised medicine. In these unpredictable research movements, the microbiome of non-Western peoples and territories is much more than a side project or a specific approach within the field: it constitutes the nucleus of its experimental system, opening towards subsequent and cumulative research processes and knowledge production in human microbiome science. The article demonstrates that while human microbiome science is articulated upon the microbial ‘makeup’ of non-wester(nised) communities, societies, and locales, its results and therapeutics are only applicable to medical conditions affecting rich nations (i.e., inflammatory, autoimmune, and metabolic diseases). My reformulation of ¨microbiomisation of race¨ as the condition of possibility of human microbiome science reveals that its individual dimension is sustained by microbial DNA data from human populations through bioprospecting practices and gains meaning through personalised medicine initiatives, informal online networks of pseudoscientific and commodified microbial-related evidence. (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)

The French philosopher, Gilles Deleuze, is emerging as one of the most important and influential philosophers of the 20th century, having published widely on philosophy, literature, language, psychoanalysis, art, politics, and cinema. However, because of the ‘experimental’ nature of certain works, combined with the manner in which he draws upon a variety of sources from various disciplines, his work can seem difficult, obscure, and even ‘willfully obstructive’. In an attempt to resist such impressions, this paper will seek to provide an (...) accessible introduction to Deleuze's work, and to begin to discuss how it can be employed to provide a significant critique and reconceptualization of the theoretical foundations and therapeutic practices of psychiatry, psychotherapy, and mental health nursing. In order to do this, the paper will focus upon Deleuze's masterwork, and the cornerstone to his philosophy as a whole, Difference and Repetition; in particular, it will discuss how his innovative and challenging account of time can be employed to provide a conception of human life as a ‘continuity’, rather than as a series of distinct ‘moments’ or ‘events’. As well as discussing the manner in which his work can provide us with an understanding of how life is different and significant for each human being, this paper will also highlight the potential importance of Deleuze's work for logotherapy, for the recent ‘turn’ to ‘narrative’ as a psychotherapeutic approach and for contemporary mental health care's growing interest in ‘social constructionism’. As such, this paper also seeks to stimulate further discussion and research into the importance and the relevance of Deleuze's work for the theory and practice of psychiatry, psychotherapy, and mental health nursing. (shrink)

Research on children raises major ethical issues, the most important being the inability of the subjects to provide freely given informed consent. Committees in Canada and the United States charged with formulating recommendations for the protection of human subjects in research came to some fundamentally different conclusions. Two of these are discussed as they apply to children: first the distinction between therapeutic and non-therapeutic research, recognized implicitly by the National Commission and deliberately avoided by the Medical Research (...) Council Working Group ; and second, the looser relation between local committees and Council as defined by guidelines in Canada and the tighter relation between the institutional review committees and the Department of Health, Education and Welfare defined by regulations in the United States. (shrink)

Both experimental and therapeutic uses of the new reproductive technologies have been governed not by the medical ideology of the best interests of patients and their children, but by the market ideology of profit maximization under the guise of "reproductive liberty." Government in our constitutional, democratic society has the authority and obligation to make and enforce reasonable regulations to manage the new reproductive market in order to protect the interests of the public, prospective parents, and their future children. The (...) "cloning" debate provides a useful opportunity to compare and contrast the competing regulatory models of the free market, professional guidelines, and government restrictions. (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.

Interactive robots are used increasingly not only in entertainment and service robotics, but also in rehabilitation, therapy and education. The work presented in this paper is part of the Aurora project, rooted in assistive technology and robot-human interaction research. Our primary aim is to study if robots can potentially be used as therapeutically or educationally useful ‘toys’. In this paper we outline the aims of the project that this study belongs to, as well as the specific qualitative contextual perspective (...) that is being used. We then provide an in-depth evaluation, in part using Conversation Analysis, of segments of trials where three children with autism interacted with a robot as well as an adult. We focus our analysis primarily on joint attention which plays a fundamental role in human development and social understanding. Joint attention skills of children with autism have been studied extensively in autism research and therefore this behaviour provides a relevant focus for our study. In the setting used, joint attention emerges from natural and spontaneous interactions between a child and an adult. We present the data in the form of transcripts and photo stills. The examples were selected from extensive video footage for illustrative purposes, i.e. demonstrating how children with autism can respond to the changing behaviour of their co-participant, i.e. the experimenter. Furthermore, our data shows that the robot provides a salient object, or mediator for joint attention. The paper concludes with a discussion of implications of this work in the context of further studies with robots and children with autism within the Aurora project, as well as the potential contribution of robots to research into the nature of autism. (shrink)

Occupational therapy often uses craft activities as therapeutic tools, but their therapeutic effectiveness has not yet been adequately demonstrated. The aim of this study was to examine changes in frontal midline theta rhythm and autonomic nervous responses during craft activities, and to explore the physiological mechanisms underlying the therapeutic effectiveness of occupational therapy. To achieve this, we employed a simple craft activity as a task to induce Fmθ and performed simultaneous EEG and ECG recordings. For participants in (...) which Fmθ activities were provoked, parasympathetic and sympathetic activities were evaluated during the appearance of Fmθ and rest periods using the Lorenz plot analysis. Both parasympathetic and sympathetic indices increased with the appearance of Fmθ compared to during resting periods. This suggests that a relaxed-concentration state is achieved by concentrating on craft activities. Furthermore, the appearance of Fmθ positively correlated with parasympathetic activity, and theta band activity in the frontal area were associated with sympathetic activity. This suggests that there is a close relationship between cardiac autonomic function and Fmθ activity. (shrink)

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)

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)

Developing World Bioethics, Volume 21, Issue 4, Page 211-226, December 2021.

Definition of the problem: The differentiation between ”therapeutic” and ”non-therapeutic” research has found broad acceptance within clinical research, law and medical ethics and is part of national law and international declarations. However, this terminology is problematic on the medical (descriptive) as well as on the ethical (normative) level. Arguments: On theoretical grounds and with an example from clinical practice it is argued that e.g. the terms ”therapeutic research” and ”experimental treatment” are rather manipulative to the patient. Conclusion: (...) In obtaining informed consent from human subjects in medical research the individual risk-benefit-assessment should be pointed out clearly rather than arguing in the category of ”therapeutic” versus ”non-therapeutic” research. (shrink)

Book reviewed in this article: Subjected to Science: Human Experimentation in America before the Second World War. By Susan E. Lederer.

Several years ago, the University of Minnesota hosted a lecture by Alan Milstein, a Philadelphia attorney specializing in clinical trial litigation. Milstein, who does not mince words, insisted on calling research studies “experiments.” “Don't call it a study,” Milstein said. “Don't call it a clinical trial. Call it what it is. It's an experiment.” Milstein's comments made me wonder: when was the last time I heard an ongoing research study described as a “human experiment”? The phrase is now almost (...) always associated with abuses. Asking a prospective subject to sign up for a medical experiment would probably get roughly the same response as asking him or her to sign up for a police interrogation. It wasn't always this way. In the early days of American bioethics, scholars used the word “experimentation” in the same neutral way that they later began to use “research study” and “clinical trial.”. (shrink)

Most people know precious little about the risks and benefits of participating in a clinical trial--a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway. Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole surgery at leading (...) cancer centersnever -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more. Patients at Risk written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatmenthormone replacement therapy, drugs such as Vioxx or Celebrexmay now be much riskier than we thought. The latest book in a surge of recent books criticizing the medical establishment (but the first to look at clinical trials specifically), Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform. (shrink)