Chapter One: Introduction “The ethical basis of all [medical] research is that information gained from one patient's experience should, where feasible, ...

Introduction TEMPE (Teaching Ethics: Material for Practitioner Education) is a two-year research project (2000-2002) funded by the European Commission ...

In this paper the permissibility of stem cell research on early human embryos is defended. It is argued that, in order to have moral status, an individual must have an interest in its own wellbeing. Sentience is a prerequisite for having an interest in avoiding pain, and personhood is a prerequisite for having an interest in the continuation of one's own existence. Early human embryos are not sentient and therefore they are not recipients of direct moral consideration. Early human embryos (...) do not satisfy the requirements for personhood, but there are arguments to the effect that they should be treated as persons nonetheless. These are the arguments from potentiality, symbolic value and the principle of human dignity. These arguments are challenged in this paper and it is claimed that they offer us no good reason to believe that early human embryos should be treated as persons. (shrink)

A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

We report on the deliberations of an interdisciplinary group of experts in science, law, and philosophy who convened to discuss novel ethical and policy challenges in stem cell research. In this report we discuss the ethical and policy implications of safety concerns in the transition from basic laboratory research to clinical applications of cell-based therapies derived from stem cells. Although many features of this transition from lab to clinic are common to other therapies, three aspects of stem cell biology pose (...) unique challenges. First, tension regarding the use of human embryos may complicate the scientific development of safe and effective cell lines. Second, because human stem cells were not developed in the laboratory until 1998, few safety questions relating to human applications have been addressed in animal research. Third, preclinical and clinical testing of biologic agents, particularly those as inherently complex as mammalian cells, present formidable challenges, such as the need to develop suitable standardized assays and the difficulty of selecting appropriate patient populations for early phase trials. We recommend that scientists, policy makers, and the public discuss these issues responsibly, and further, that a national advisory committee to oversee human trials of cell therapies be established. **NB we did not reccommend a NAC, we think it might be appropriate**. (shrink)

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

Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.

Since the Nuremberg trials (1947–1949), informed consent has become central for ethical practice in patient care and biomedical research. Codes of ethics emanating from the Nuremberg Code (1947) recognize the importance of protecting patients and research subjects from abuses, manipulation and deception. Informed consent empowers individuals to autonomously and voluntarily accept or reject participation in either clinical treatment or research. In some cases, however, the underlying mental or physical condition of the individual may alter his or her cognitive abilities and (...) compromise the informed consent process. This is particularly true in chronic psychiatric conditions such as Treatment-Resistant Depression (TRD), where individuals may fail to respond to traditional antidepressant treatments (e.g., psychotherapy, pharmacotherapy). Moreover, it may raise further concerns for an individual’s motivation to consent and the level of understanding of the treatment or research procedure. This paper focuses on the informed consent process for Vagus Nerve Stimulation (VNS) in the treatment of individuals diagnosed with TRD. Specifically, the paper addresses how depression may affect the decision-making capacity of an individual and the potential ethical and legal impact of failure to appreciate the seven elements of the consenting process (competence, voluntariness, disclosure, recommendation, understanding, decision, and authorization). To ensure the protection of vulnerable individuals with psychiatric disorders such as TRD and promote ethical behavior in biomedical research and patient care while avoiding potential legal pitfalls, we propose a paradigm that requires a stringent evaluation process of decision-making capacity for informed consent. (shrink)

This paper discusses the use of deep brain stimulation for the treatment of neurological and psychiatric disorders in children. At present, deep brain stimulation is used to treat movement disorders in children and a few cases of deep brain stimulation for psychiatric disorders in adolescents have been reported. Ethical guidelines on the use of deep brain stimulation in children are therefore urgently needed. This paper focuses on the decision-making process, and provides an ethical framework for (future) treatment decisions in pediatric (...) deep brain stimulation. I defend a shared decision-making model in case of deep brain stimulation for neurological and psychiatric disorders in children. To protect the vulnerable child patient, a dual consent process is needed where parents or parental guardians give their consent, and the child gives his/her assent. (shrink)

Psychogenic non epileptic seizures (PNES) are clinical events of psychological nature. Video-electroencephalography monitoring (V-EEGM) is a valuable method for the diagnosis of PNES and may be combined with provocative tests to induce seizures. The use of placebo in provocative tests for the diagnosis of PNES is controversial because of associated deception, and contrasts with the use of truly decreasing epileptogenic threshold techniques such as hyperventilation and photo stimulation. We present a clinical case of a pregnant woman with a past history (...) of refractory epilepsy, admitted in the obstetric department due to unremitting seizures. In this clinical context, non-deceiving provocative tests such as hyperventilation and photo stimulation could be potentially harmful, nevertheless, the use of intravenous saline injection presented as a safer alternative to diagnose PNES and hence obviate an urgent caesarean. This case illustrates a disproportionate risk of causing harm when telling the truth, in comparison with the benefit of avoiding such risk, although deceiving the patient. This is a clinical example of how considerations concerning the use of placebo must be evaluated in an individual basis. (shrink)

Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the unique concerns that arise in (...) specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that arise when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging issues in human subjects research, namely financial conflicts of interest and the interpretation of scientific data. (shrink)

In this paper, we defend the ethics of clinical research against the charge of paternalism. We do so not by denying that the ethics of clinical research is paternalistic, but rather by defending the legitimacy of paternalism in this context. Our aim is not to defend any particular set of paternalistic restrictions, but rather to make a general case for the permissibility of paternalistic restrictions in this context. Specifically, we argue that there is no basic liberty-right to participate in clinical (...) research and that considerations of distributive fairness justify some paternalistic protections of research subjects. (shrink)

The review system on research with human participants in the Netherlands is characterised as a decentralised controlled and integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research Ethics Committees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review system is a decentralised arrangement since most research proposal are (...) reviewed by the 30 accredited MRECs in the country. It is a controlled system in which the Central Committee is responsible for the accreditation and oversight of the MRECs and can make legally binding directives for these committees. The assessment of research proposals is an integrated peer review process in which all documents of the research file are reviewed by experts in one committee only. A small number of research proposals are assessed by the Central Committee and not by accredited MRECs. These proposals are on specific research categories such as gene therapy, cell therapy and embryo research. The review of research with surplus human embryos is regulated separately in the Embryos Act. The Central Committee provides support to the accredited MRECs and to researchers and sponsors. It is currently developing an internet portal to reduce the bureaucracy and make the review process more efficient and transparent. The Central Committee stimulates confidence on medical research in society by providing a public trial registry with core data on reviewed research proposals. (shrink)

Ethical Issues in International Biomedical Research is the definitive book on the ethics of research involving human subjects in developing countries. Using 21 actual case studies, it covers the most controversial topics, including the ethics of placebo research in Africa, what benefits should be provided to the community after completion of a research trial, how to address conflicts between IRBs in developed and developing countries, and undue inducement of poor people in developing countries. Each case is accompanied by two expert (...) commentaries, written by many of the worlds leading experts in bioethics as well as new voices with research experience in developing countries. No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful. (shrink)

Federal efforts beginning in the 1990's have successfully increased pediatric research to improve medical care for all children. Since 1997, the FDA has requested 800 pediatric studies involving 45,000 children. Much of this research is "non-beneficial"; that is, it exposes pediatric subjects to risk even though these children will not benefit from participating in the research. Non-beneficial pediatric research (NBPR) seems, by definition, contrary to the best interests of pediatric subjects, which is why one state supreme court has essentially prohibited (...) it. It also appears that the only plausible rationale for this research is utilitarian, as it risks some children for the good of all. But that rationale is troubling. This Article answers two related questions: (1) What is the appropriate legal relationship between NBPR and the "best interests of the child" standard? (2) What is the ethical justification for this research? I argue that courts should hold that the "best interests" standard governs pediatric research. But, contrary to existing case law, courts must consider the benefits to each child, including pediatric subjects, from a policy that permits NBPR, and not simply consider that a non-beneficial protocol presents more risk than potential benefit to a child. Moreover, I argue that the justification for the practice need not be utilitarian. There is no need to appeal to the greater good to justify the research because each child has reason to endorse a policy permitting NBPR where there is a very low ceiling on acceptable risk, and each child has reason to participate in a practice from which she benefits. More controversially, I argue that each child, like other persons, has reason to help others when she can do so at little to no cost to herself. The Article then highlights practical implications of the offered justifications. (shrink)

As the_number of clinical trials continues to grow, there is an increasing need for education and training in the field. The clinical research climate is less forgiving of errors and oversights and therefore requires more knowledge of regulations and requirements. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled. Includes a manual (...) for investigators, research nurses and study coordinators with minimal experience or who are new to clinical research An easy-to-read and open text design using ‘sidebars’ of examples and information boxes related to the main text Includes a list of Frequently Asked Questions and Glossary Duke Clinical Research Institute is the world’s largest academic clinical research organisation and is well known and respected within the clinical research community. (shrink)

Various commentaries on the use of animals in biomedical research and related.

Executive Summary There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given ...

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)

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)

In this humane and graceful book, philosopher Timothy Murphy offers insight into our attempts--popular and academic, American and non-American, scientific and ...

This volume assesses the ethical, quantitative, and qualitative questions posed by the current financing of biomedical research.

Journalist Alex O’Meara is one of the more than twenty million Americans enrolled in a clinical trial—three times as many people as a decade ago. Indeed, clinical trials have become a $24 billion industry that is reshaping every aspect of health-care development and delivery in the United States and around the world. As O’Meara chronicles, twentieth-century medical trials have led to epic advances in health care, from asthma inhalers and insulin pumps to heart valves and pacemakers. And yet, although regulations (...) safeguard against grossly unethical tests, significant problems are still associated with how clinical trials are carried out and reported. For example, despite eight clinical trials for Vioxx before the FDA approved it in 1998 for use as a painkiller, Merck took it off the market in 2004, too late for the eighty-eight thousand Americans who suffered heart attacks while taking Vioxx and the thirty-eight thousand who died. _ Chasing Medical Miracles is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment. Whether you are participating in a clinical trial, considering that option, or interested in our medical system, Alex O’Meara’s ground-breaking_book is essential reading. Alex O’Meara is a freelance journalist who has worked for the City News Bureau of Chicago, Newsday , the Baltimore Sun , and many other media organizations. In an effort to cure his type-1 diabetes, he participated in a risky and groundbreaking clinical trial to receive a transplant of islet cells from several cadaver pancreases. This is his first book. He lives in Bisbee, Arizona. Journalist Alex O’Meara is one of the more than twenty million Americans enrolled in a clinical trial—three times as many people as there were a decade ago. Indeed, clinical trials have become a $24 billion industry that is reshaping every aspect of health-care development and delivery in the United States and around the world. As O’Meara chronicles, twentieth-century medical trials have led to epic advances in health care, from asthma inhalers and insulin pumps to heart valves and pacemakers. And yet, although regulations safeguard against grossly unethical tests, significant problems are still associated with how clinical trials are carried out and reported. For example, despite eight clinical trials for Vioxx before the FDA approved it in 1998 for use as a painkiller, Merck took it off the market in 2004, too late for the eighty-eight thousand Americans who suffered heart attacks while taking Vioxx and the thirty-eight thousand who died. Chasing Medical Miracles is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment. Whether you are participating in a clinical trial, considering that option, or interested in our medical system, Alex O’Meara’s book is essential reading. “Americans have long_been mystified about how new drugs are developed. Though the term ‘clinical trial’ has entered the popular lexicon, most people still don’t know what goes on behind the scenes._ Chasing Medical Miracles tells the truth about the byzantine world of clinical trials. O’Meara exposes the ethics of medical research both in the U.S. and abroad. Essential reading for anyone who wants to understand how new medicines are developed.”—Joe Graedon, M.S., and Teresa Graedon, Ph.D., authors of The People’s Pharmacy “This travelogue of ‘the most dangerous part of medical discovery’ moves from O’Meara’s own experience as a research subject—ranging from terror to euphoria—to a broader exploration of the ethics and economics of clinical trials._He describes a landscape populated by brave and often desperate patients, whose heroism is integral to finding tomorrow’s cures.”— Robin Marantz Henig , author of Pandora’s Baby: How the First Test Tube Babies Sparked the Reproductive Revolution “In the ethically murky world of clinical trials, Alex O’Meara’s book is an illumination. Whether probing the use of_Third World people to test U.S. drugs, or revealing that the goal of clinical trials is not to cure anyone but to obtain data, Chasing Medical Miracles is educational in a valuable and troubling way.”—Stephen P. Kiernan, author of Last Rights: Rescuing the End of Life from the Medical System “Readers who assume that the trials only occur at academic medical centers will be surprised by the author’s findings. As they multiply and grow wildly expensive—up to $500 million for a single drug—pharmaceutical companies are hiring clinical-research organizations, profit-making enterprises that recruit subjects, pay them and perform studies in their own facilities. These organizations continue to migrate overseas to save money and escape FDA oversight . . ._[O’Meara] does a capable job of revealing alarming problems that must be addressed.” — Kirkus Reviews “Enjoy this bracing tour through the history, horror, and headaches of clinical trials, described by a guide with both a detached delivery and knowledgeable perspective. Former Newsday and Baltimore Sun reporter O'Meara, a Type I diabetic, signed up for a trial offering a possible cure, so he may be more than a little invested in how trials work. But his self-interest is a compelling element as he surveys a $24-billion-a-year industry that affects the lives of 20 million Americans. His investigation briskly sails through the interests that spark clinical trials, the money that pays for them and the bonanza of cash and/or equipment and medications for developing countries where researchers find it cheaper to recruit trial subjects. Best and most sweetly, however, the book delves into the human guinea pigs, such as gene therapy trial participant whose death raised questions about government oversight and the self-interest of the lead researcher. O'Meara presents lessons from a medical front that offers something more important than success or failure—hope. 'I'm still able to say, "At least I tried,"' O'Meara notes.”— Publishers Weekly. (shrink)

This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and ...

Bernard Rollin historically and conceptually examines the ideology that denies the relevance of ethics to science. Providing an introduction to basic ethical concepts, he discusses a variety of ethical issues relevant to science and how they are ignored, to the detriment of both science and society. These issues include research on human subjects, animal research, genetic engineering, biotechnology, cloning, xenotransplantation, and stem cell research. Rollin also explores the ideological agnosticism that scientists have displayed regarding subjective experience in humans and animals, (...) and its pernicious effect on pain management. (shrink)

Kenneth F. Schaffner compares the practice of biological and medical research and shows how traditional topics in philosophy of science--such as the nature of theories and of explanation--can illuminate the life sciences. While Schaffner pays some attention to the conceptual questions of evolutionary biology, his chief focus is on the examples that immunology, human genetics, neuroscience, and internal medicine provide for examinations of the way scientists develop, examine, test, and apply theories. Although traditional philosophy of science has regarded scientific discovery--the (...) questions of creativity in science--as a subject for psychological rather than philosophical study, Schaffner argues that recent work in cognitive science and artificial intelligence enables researchers to rationally analyze the nature of discovery. As a philosopher of science who holds an M.D., he has examined biomedical work from the inside and uses detailed examples from the entire range of the life sciences to support the semantic approach to scientific theories, addressing whether there are "laws" in the life sciences as there are in the physical sciences. Schaffner's novel use of philosophical tools to deal with scientific research in all of its complexity provides a distinctive angle on basic questions of scientific evaluation and explanation. (shrink)

Scientific research and ethics -- Ethical theory and decision making -- Data acquisition and management -- Mentoring and professional relationship -- Collaboration in research -- Authorship -- Publication and peer review -- Misconduct in research -- Intellectual property -- Conflicts of interest and scientific objectivity -- The use of animals in research -- The use of human subjects in research -- The use of vulnerable subjects in research -- Genetics, cloning, and stem cell research -- International research.

Ethics committees have a bad reputation for impeding, rather than facilitating research. Here, I argue that many committees actually improve the quality of the research proposal to such an extent that they deserve credit as authors in any resulting publications, or at least an acknowledgement of the contribution made.

Kihlbom has recently argued that a system of seeking negatively informed consent might be preferable in some cases to the ubiquitous informed consent model. Although this theory is perhaps not powerful enough to supplant informed consent in most settings, it lends strength to Evans’ and Hungin’s proposal that it can be ethical to prescribe placebos rather than "active" drugs. This paper presents an argument for using negatively informed consent for the specific purpose of authorising the use of placebos in clinical (...) contexts. (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)

Inferences like these are known as extrapolations.

Biomedical Research and Beyond: Expanding the Ethics of Inquiry investigates the ethics of biomedical and scientific inquiry, including embryonic research, animal research, genetic enhancement, and fairness in research in the developing world. Core concerns of biomedical and scientific research ethics are then shown also to be key in humanistic areas of inquiry. Biomedical Research and Beyond concludes with a discussion of the virtues that all inquirers, scientific, medical, and humanistic, should possess.

This book concludes by considering whether growing counter calls to reduce our consumption of meat/dairy products in the face of climate change threats are in ...

The methodology of the IDEFICS (Identification and prevention of dietary- and lifestyle-induced health effects in children and infants) study raises a number of important ethical questions. Many of these are already well recognised in ethical guidelines that uphold principles of individual and parental consent, confidentiality and scientific review. There are, however, wider issues that require ethical reflection. In this paper, we focus on a set of problems surrounding the evaluation of complex social interventions, and argue that comprehensive and objective evaluation (...) is a much more ethically charged aim than it may first appear. In particular, we contend that standard scientific measures - of body size and biomarkers - convey only part of the story. This is partly because, when we intervene in communities, we are also concerned with complex social effects. These effects are made even more complex by contemporary social anxieties about fat and physical appearance, as well as about the safety and security of children. Such anxieties increase the risk of undesirable side effects that are themselves difficult to gauge. In the face of these and other complexities, we argue that the evaluation of interventions should involve a strong ethical dimension. First, it must include - as does the IDEFICS study - consideration of the opinions of the people affected, who are subjected to interventions in ways that necessarily go beyond individual consent. Second, we suggest that interventions might also be assessed by how much they empower people - and especially those persons, such as children, who are otherwise often disempowered. (shrink)