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

This paper highlights a number of ethical dilemmas encountered in a pilot study with a hard-to-reach group of research participants with harmful childhood histories. Drawing on a project exploring black teenage mothers? understandings of their own childhood experiences of abuse, it is argued that in asking young mothers to talk about such an emotionally sensitive topic as their own harmful childhood, a number of challenges are posed about how to deal with number of key ethical principles. The paper begins by (...) outlining the context of the pilot study, including the research literature on this subject. It then discusses three key ethical principles that were considered during the process of the research: issues of gaining consent; and when the principle of confidentiality ought to be breached when a duty of care prerogative emerges. The paper explores these tensions in operationalising these principles when dealing with the competing needs and rights of gatekeepers, the young women and their carers, using occasional extracts from research findings to illustrate these tensions. The paper concludes with a discussion of the ethical challenges in accessing marginal voices in social research. (shrink)

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

The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process of international guidelines for biomedical research (...) involving human subjects. I focus in particular upon the issue of a standard of care. In the second section, I draw upon philosophers John Rawls, Claudia Card, and Allen Buchanan to discuss concerns regarding the 'least advantaged members of society' in the context of global inequality. The paper includes reflections upon pedagogy in courses focused upon international health research involving human subjects. (shrink)

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)

Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a safety trial, subacute (...) incomplete SCI patients for an efficacy trial, and perhaps primary progressive multiple sclerosis (MS) patients for a combined safety and efficacy trial. (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)

Bettina Schöne-Seifert and Marco Stier present a host of detailed and intriguing arguments to the effect that potentiality arguments have to be viewed as outdated due to developments in stem cell research, in particular the possibility of re-setting the development potential of differentiated cells, such as skin cells. However, their argument leaves them without an explanation of the intuitive difference between skin cells and human beings, which seems to be based on the assumption that a skin cell is merely part (...) of a human organism, while an embryo is at some point a human organism. An appropriately designed concept of the human organism can explain the difference, but also has the potential of re-dividing the argumentative landscape along familiar lines. (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.

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)

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)

In her article, Pascale Hess raises the issue of whether her proposed model may be extrapolated and applied to clinical research fields other than stem cell-based interventions in the brain (SCBI-B) (Hess 2012). Broadly summarized, Hess’s model suggests prioritizing efficacy over safety in phase 1 trials involving irreversible interventions in the brain, when clinical criteria meet the appropriate population suffering from “degenerative brain diseases” (Hess 2012). Although there is a need to reconsider the traditional phase 1 model, especially with respect (...) to first-in-human clinical trials involving novel technologies, the question arises as to whether it is appropriate to advocate for a new model that prioritizes efficacy over safety across all phase 1 clinical research trials involving irreversible interventions in the brain. -/- . (shrink)

Because few would object to evidence-based medicine’s (EBM) principal task of basing medical decisionmaking on the most judicious and up-to-date evidence, the debate over this prolific movement may seem puzzling. Who, one may ask, could be against evidence (Carr-Hill, 2006)? Yet this question belies the sophistication of the evidence-based movement. This chapter presents the evidence-based approach as a socio-medical phenomenon and seeks to explain and negotiate the points of disagreement between supporters and detractors. This is done by casting EBM as (...) more than the simple application of research findings to clinical care and improved health outcomes, but rather an umbrella term that harnesses a specific set of pedagogical objectives (some rather radical) under a name that makes it difficult to argue against. (shrink)

We live in an age of evidence-based healthcare, where the concept of evidence has been avidly and often uncritically embraced as a symbol of legitimacy, truth, and justice. By letting the evidence dictate healthcare decision making from the bedside to the policy level, the normative claims that inform decision making appear to be negotiated fairly—without subjectivity, prejudice, or bias. Thus, the term ‘‘evidence-based’’ is typically read in the health sciences as the empirically adequate standard of reasonable practice and a means (...) for increasing certainty. Supporters believe that evidence-based medicine (EBM) can introduce rational order to the deliberative processes of healthcare decision making. It is perhaps puzzling, then, to come across critical perspectives (typically arising from the humanities and the more theory-driven social sciences) raising concerns about a seeming technogovernance being introduced by this deferral to the evidence where power interests can be obfuscated by way of technical resolve. The critics holding this minority view argue that technological solutions to problems of knowledge and practice cannot replace medicine’s normative content. Against EBM’s democratic leanings toward transparency and accountability, medical criteria alone cannot decide valueladen ethically charged decisions. This paper attempts to explain and evaluate this important debate in the philosophy of medicine, focusing specifically on the dispute over 'evidence-based women's health'. (shrink)

Scientists, clinicians, and bioethicists are worried about how so-called personhood measures would limit access to certain types of contraception, research involving stem cells, and access to fertility treatments. While these measures have been struck down in Colorado, South Dakota, California, and Mississippi, the bill signed into law in Oklahoma in February deserves critical scrutiny, particularly into the ways these legal measures influence eligibility for clinical research. Oklahoma's bill states that the laws of the state “shall be interpreted and construed to (...) acknowledge on behalf of the unborn child at every stage of development all the rights, privileges, and immunities available to other persons, citizens, and residents of this state.”. (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)

This article is concerned about what may be happening to race and medicine in the “meantime” between today's clinical realities and the promised land of pharmacogenomics where the need for using race in medicine is supposed to fade away. It argues that previous debates over the use of race in medicine are being side-stepped as race is being reconfigured from a “crude surrogate” for genetic variation into a purportedly viable placeholder for variable drug response — to be used here and (...) now until the specific genetic underpinnings of drug response are more fully understood. Embracing the trope of “promise” in pharmacogenomics alongside the idea of using race as a useful interim proxy for genetic variation raises concerns that new diagnostic and therapeutic interventions may reflect or be mapped upon existing social categories of race, class, gender, and ethnicity in a harmful or dangerous manner. At the most basic level, the politics of the meantime in pharmacogenomics may be promoting the scientifically unjustified and socially dangerous recasting of race as a social and historical construct into a reified genetic category. (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)

Introduction -- Need for a research and evaluation capability : becoming a high-performing organization -- Need for a research and evaluation capability : accreditation requirements -- Structure and scope of an office of institutional research : findings from interviews -- Lessons learned from organizations with training missions similar to that of METC -- Conclusions and recommendations.

No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful.

In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.

Ethical issues surrounding research are complex and multifaceted. There are issues concerning: the methods used, the intended purpose, the foreseen and unforeseen effects, the use and dissemination of findings, and, not least, what is and what fails to be researched. - In this article we break down the issues into two main categories: (I) how the research itself is done; and (II) how it is determined by and in turn affects a wider context. In the first section we discuss familiar (...) issues such as the need for methodologically sound investigation, appropriate protections for the human subjects of research, as well as issues arising in collaborative research. The second set of issues is less well investigated and, indeed, particularly difficult to address; these are issues that extend well beyond the control of the researcher(s) or, quite often, any one individual or organization. We discuss the selection of research topics, research funding, publication and, finally, the role of external ethical guidelines and their institutional setting. (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)

It is common to argue that animal experimentation is justified by its essential contribution to the advancement of medical science. But note that this argument actually contains two premises: an empirical claim that animal experimentation is essential to the advancement of medical science and an ethical claim that if research is essential to the advancement of medical science, then it is justified. Both claims are open to challenge, but in the logic of the case, only one of them needs to (...) be shown false or moot in order to refute the argument. I argue that the ethical claim does not withstand scrutiny. In addition, the main so-called “alternatives” to animal research do not merit that label since they still involve the use of nonhuman animals. (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 ...

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 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)

What sex is permissible, if any, in non-clinical research relationships? In reply to my call for a code of conduct for non-clinical research, some commentators have called for more training in such matters, but this kind of training will not go very far without some kind of governing standards yet to be determined. It is not enough to assume that unarticulated opinions will suffice. Neither will approaches that involve even greater scrutiny over research, as if to divide research into two (...) categories: one in which sex with subjects is permissible and the other in which sex is impermissible. No practical solution to exploitation will be more important than having a code of ethics that guides decision-makers where institutional review bodies do not tread. (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 ...

"The Ethics of Fetal Research" distinguishes between the legal and ethical questions raised by experimentation on still-living human fetuses.

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)