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)
IRBs in action -- Everyone's an expert? Warrants for expertise -- Local precedents -- Documents and deliberations: an anticipatory perspective -- Setting IRBs in motion in Cold War America -- An ethics of place -- The many forms of consent -- Deflecting responsibility -- Conclusion: the making of ethicalresearch.
New and Emerging Science and Technology (NEST) based innovations, e.g. in the field of Life Sciences or Nanotechnology, frequently raise societal and political concerns. To address these concerns NEST researchers are expected to deploy socially responsible R&D practices. This requires researchers to integrate social and ethicalaspects (SEAs) in their daily work. Many methods can facilitate such integration. Still, why and how researchers should and could use SEAs remains largely unclear. In this paper we aim to relate motivations (...) for NEST researchers to include SEAs in their work, and the requirements to establish such integration from their perspectives, to existing approaches that can be used to establish integration of SEAs in the daily work of these NEST researchers. Based on our analyses, we argue that for the successful integration of SEAs in R&D practice, collaborative approaches between researchers and scholars from the social sciences and humanities seem the most successful. The only way to explore whether that is in fact the case, is by embarking on collaborative research endeavours. (shrink)
Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous (...)research participant may have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest. (shrink)
Recent advances in reprogramming technology do not bypass the ethical challenge of embryo sacrifice. Induced pluripotent stem cell (iPS) research has been and almost certainly will continue to be conducted within the context of embryo sacrifice. If human embryos have moral status as human beings, then participation in iPS research renders one morally complicit in their destruction; if human embryos have moral status as mere precursors of human beings, then advocacy of iPS research policy (...) that is inhibited by embryo sacrifice concerns renders one morally complicit in avoidable harms to persons. Steps may be taken to address these complicity concerns, but in the final analysis there is no alternative to achieving clarity with respect to the moral status of the human embryo. (shrink)
This book is the result of a three-year study undertaken by a multidisciplinary working party of the Institute of Medical Ethic (UK). The group was chaired by a moral theologian, and its members included biological and ethological scientists, toxicologists, physicians, veterinary surgeons, an expert in alternatives to animal use, officers of animal welfare organizations, a Home Office Inspector, philosophers, and a lawyer. Coming from these different backgrounds, and holding a diversity of moral views, the members produced the agreed (...) report as a result of detailed and rigorous discussions. The book sets out facts about animal experiments and about animal abilities to experience pain, distress and anxiety. There is a detailed examination of the moral claims related to the benefits likely to accrue from animal research, and of strategies for weighing these benefits against the harm caused to animals, in order to decide whether particular research projects ought or ought not to proceed. This leads to consideration of the statutory and non-statutory controls which safeguard standards in such research. The final section explores a variety of philosophical arguments about the use of animals in research, and offers a philosophical justification for the Working Party's more practical conclusions. Written in clear, nontechnical language, this book is accessible to lay people as well as to scientists. It is the first such document to emerge from a meeting of people with such widely differing views on this highly controversial subject, and represents a major contribution towards informing and raising the quality of contemporary debate. The book is unique in drawing together material and ideas never before found in one volume. It will interest a broad spectrum of readers, from ethicists and animal rights advocates to scientific researchers and laboratory administrators, along with general readers concerned about this compelling issue. (shrink)
In this paper, the results of a pilot interview study with 19 subjects participating in an EEG-based non-invasive brain–computer interface (BCI) research study on stroke rehabilitation and assistive technology and of a survey among 17 BCI professionals are presented and discussed in the light of ethical, legal, and social issues in research with human subjects. Most of the users were content with study participation and felt well informed. Negative aspects reported include the long and cumbersome preparation (...) procedure, discomfort with the cap and the wet electrodes, problems concerning BCI control, and strains during the training sessions. In addition, some users reflected on issues concerning system security. When asked for morally problematic issues in this field of non-invasive BCI research, the BCI professionals stressed the need for correct information transfer, the obligation to avoid unrealistic expectations in study participants, the selection of study participants, benefits and strains of participation, BCI illiteracy, the possibility of detrimental brain modifications induced by BCI use, and problems that may arise at the end of the trials. Furthermore, privacy issues were raised. Based on the results obtained, psychosocial and ethicalaspects of EEG-based non-invasive BCI research are discussed and possible implications for future research addressed. (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)
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)
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)
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 timely and topical look at the role of ethics in fieldwork takes into account some of the major issues confronting qualitative researchers. The main purposes of this book are twofold: to promote an understanding of the harmful possibilities of fieldwork; and to provide ways of dealing with ethical problems and dilemmas. To these ends, examples of actual fieldwork are provided that address ethical problems and dilemmas, and posit ways of dealing with them.
Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethicalaspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethicalaspects of their own studies.
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. (shrink)
Machine generated contents note: Preface; Acknowledgements; 1. Why medicine needs moral leaders; 2. Creating an organizational narrative; 3. Understanding normative expectations in medical moral leadership; Prologue to chapters four and five; 4. Expressing fiduciary, bureaucratic and collegial propriety; 5. Expressing inquisitorial and restorative propriety; Epilogue to chapters four and five; 6. Understanding organizational moral narrative; 7. Moral leadership for ethical organizations; Appendix 1. How the research was done; Appendix 2. Accountability for clinical performance: individuals (...) and organisations; Appendix 3. A brief guide to commonly used ethical frameworks; Index. (shrink)
Psychological theory and research in ethical decision making and ethical professional practice are presently hampered by a failure to take appropriate account of an extensive background in moral philosophy. As a result, attempts to develop models of ethical decision making are left vulnerable to a number of criticisms: that they neglect the problems of meta-ethics and the variety of meta-ethical perspectives; that they fail clearly and consistently to differentiate between descriptive and prescriptive accounts; that (...) they leave unexplicated the theoretical assumptions derived from the underlying moral theories; and that they fail to accommodate the complexity and comprehensiveness of the processes involved in the making and implementing of ethical decisions. Many of these problems also have implications for the methodological domain. This paper offers an analysis of the difficulties, and makes a number of recommendations for future theory, research and practical applications, including: the need for training in moral philosophy; clarification of the status of Professional Codes in decisional models; the development of theoretically comprehensive prescriptive models; and the testing of these models in ways that do justice to their dimensional scope and theoretical complexity. (shrink)
In spite of the growing interest in nursing ethics, few studies have focused on ethical dilemmas experienced by nurses working with clinical studies as ‘research nurses’. The aim of the present study was to describe and explore ethical dilemmas that Swedish research nurses experience in their day-to-day work. In a qualitative study a purposeful sample of six research nurses from five wards of differing disciplines in four Swedish hospitals was interviewed. The analysis displayed several examples (...) of ethical dilemmas, primarily tensions between the nurses’ obligations to the study and to the patients involved. A guiding moral principle for the nurses was patient-centeredness, where the interest of research must not override the interest of the patient. In situations where tensions between research and patient interests occurred, and doctors and nurses disagreed upon the judgement, the nurses sometimes chose to follow the doctors’ advice, and thus acted against their own moral judgment. Such situations seemed to create feelings of moral distress among the nurses. They described their profession as being ‘invisible’ and as lacking opportunities for ethical competence building. The conclusion is that research nurses frequently experience severe and difficult ethical dilemmas in their daily work. They need to be acknowledged as a particular profession in the health care organisation and encouraged to develop their specific ethical competence. (shrink)
This is an edited collection that is intended both as a primer for core concepts and principles in research ethics and as an in-depth exploration of the contextualisation of these principles in practice across key disciplines.
This paper discusses some of the ethicalaspects in research in Adapted Physical Activity (APA). It indicates some of the ethical challenges related to the choice of research problem to be investigated, and the treatment of participants, not least when working with people who are in some ways in a more vulnerable life situation. Drawing also on experiences as a researcher with a disability, the challenges and potential benefits of involving people with disabilities in APA (...)research is critically discussed. (shrink)
This study aimed to examine the thoughts and expectations of patients receiving healthcare from their physicians and evaluate the ethicalaspects of these thoughts and expectations. To determine the ethicalaspects of the thoughts and expectations of patients, an open-ended question was asked on the web page of the Turkish Armed Forces (TAF) Health Care Command, which is accessible to the users of the TAF intranet system (the internet system used within TAF institutions). The participants were (...) asked to express their thoughts in their own words. A total of 804 participants answered the question by providing their input. The statements of the participants were classified separately by two public health specialists. The classification was made in accordance with the basic principles of patient rights, and they were collected under various headings including expectations about respect and care, good communication, informed consent, and fair and non-privileged distribution of healthcare services. The results show that patients tend to consider the physicians they see as solely responsible for all the negative issues that they encounter during their healthcare. This indicates that there is a need for extensive research on the underlying factors involved in the negative thoughts and feelings toward healthcare professionals in both TAF and Turkey in general. (shrink)
Background: Although genetic research into Alzheimer disease (AD) is increasing, the ethicalaspects of this kind of research and the differences between ethical issues related to genetic and non-genetic research into AD have not yet received much attention. Objectives: (1) To identify and compare the five ethical issues considered most important by surveyed expert panellists in non-genetic and genetic AD research and (2) to compare our empirical findings with ethical issues in (...) genetic research in general as described in the literature. Method: A modified Delphi study in two rounds Results: Genetic and non-genetic research into AD generated an approximately equal number of topics with a considerable overlap. Different priorities in the ethics of both types of research were found. Genetic research raised new topics such as “confidentiality of genetic information” and “implications of research for relatives” which changes the impact and application of existing ethical topics such as “informed consent” and is judged to have more impact on both individuals and society. A difference with the results of more theoretical approaches on ethicalaspects related to AD research was also found. Conclusions: Different priorities are given to ethical issues in genetic and non-genetic research. These arise partly because genetic research causes unique and new questions, mostly related to the position of family members and the status of and access to genetic information. Differences found between the results of our empirical study and the more theoretical literature, suggest an additional value for empirical research in medical ethics. (shrink)
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)
During the past decade scientists, public policy analysts, politicians, and laypeople, have become increasingly aware of the importance of ethical conduct in scientific research. In this timely book, David B. Resnik introduces the reader to the ethical dilemmas and questions that arise in scientific research. Some of the issues addressed in the book include ethical decision-making, the goals and methods of science, and misconduct in science. The Ethics of Science also discusses significant case studies such (...) as human and animal cloning, the Challenger accident and Tobacco research. This is essential reading for anyone who wishes to understand the importance of ethics in science. (shrink)
Is it permissible to use a human embryo in stem cell research, or in general as a means for benefit of others? Acknowledging each embryo as an object of moral concern, Louis M.Guenin argues that it is morally permissible to decline intrauterine transfer of an embryo formed outside the body, and that from this permission and the duty of beneficence, there follows a consensus justification for using donated embryos in service of humanitarian ends. He then proceeds to show (...) how this justification commands assent even within moral and religious views commonly thought to oppose embryo use. Beneath his moral reasoning lies a carefully constructed metaphysical foundation incorporating accounts of the ontology of development, embryos, and species. He also incisively discusses nonreprocloning, reprocloning, ectogenesis, and related scientific frontiers. This compelling philosophical study will interest all concerned to understand virtue and obligation in the relief of suffering. (shrink)
In the last decade, fierce controversy has arisen over the nature of sexual orientation. Scientific research, religious views, increasingly ambiguous gender roles, and the growing visibility of sexual minorities have sparked impassioned arguments about whether our sexual desires are hard-wired in our genes or shaped by the changing forces of society. In recent years scientific research and popular opinion have favored the idea that sexual orientations are determined at birth, but philosopher and educator Edward Stein argues that much (...) of what we think we know about the origins of sexual desire is probably wrong. Stein provides a comprehensive overview of such research on sexual orientation and shows that it is deeply flawed. Stein argues that this research assumes a picture of sexual desire that reflects unquestioned cultural stereotypes rather than cross-cultural scientific facts, and that it suffers from serious methodological problems. He considers whether sexual orientation is even amenable to empirical study and asks if it is useful for our understanding of human nature to categorize people based on their sexual desires. Perhaps most importantly, Stein examines some of the ethical issues surrounding such research, including gay and lesbian civil rights and the implications of parents trying to select or change the sexual orientation of their children. The Mismeasure of Desire offers a reasoned, accessible, and incisive examination of contemporary thinking about one of the most hotly debated issues of our time and adds a compelling voice of dissent to prevailing--and largely unexamined--assumptions about human sexuality. (shrink)
The purpose of the present paper is: (1) to outline a conceptual framework useful for the analysis of ethical issues raised by goal-directed activities, (2) to apply this framework to nanoscale research, (3) identify some of the main challenges in the evaluation of such research, and (4) exemplify what is needed for a positive answer to the question “How can nanoscale research improve the quality of life?” A basic idea of the paper is that nanoscale (...) class='Hi'>research can improve the conditions and quality of life of large groups in society, provided that: (a) this research is directed at certain generally accepted goals, (b) at least some of the opportunities are exploited for the good of mankind, (c) the key obstacles on the road are eliminated, reduced or circumvented, and (d) this is done in ethically acceptable ways. (shrink)
Ethics and the University brings together the practice of ethics in the university (academic ethics) and the teaching of practical or applied ethics in the university. The book offers an explanation of practical ethics' recent emergence as a university subject, discusses research ethics, and explores the teaching of practical ethics, including sexual ethics. Michael Davis situates the subject of ethics within the university into a wider social and historical context that will be helpful in sorting out the complex issues.
Research that involves the creation of animals with human-derived parts opens the door to potentially valuable scientific and therapeutic advances, yet invokes unsettling moral questions. Critics and champions alike stand to gain from clear identification and careful consideration of the strongest ethical objections to this research. A prevailing objection argues that crossing the human/nonhuman species boundary introduces inexorable moral confusion (IMC) that warrants a restriction to this research on precautionary grounds. Though this objection may (...) capture the intuitions of many who find this research unsettling, it relies on mistaken views of both biology and moral standing, ultimately distorting the morally relevant facts. We critically examine IMC, identify mistaken essentialist assumptions, and reframe ethical concerns. The upshot is a stronger line of objection that encourages a more inclusive and productive ethical discourse. (shrink)
In the article, we analyse ethical and moral issues of public administration in region of Eastern Slovakia through some cases of the last years. We focused on self-governing regions, namely the Košice and Prešov self-governing regions. We identified two fundamental situations where failures on the side of public administrators occur: selection processes for vacant positions, be it directly in public administration or institutions that fall under its domain, and public procurement with regard to the acquisition of goods and (...) services. The year 2009 was the year of elections to self-governing regions which is why a great number of negative cases dealt with the election campaign. Further, we stated that negative cases dealt with failures of bodies of self-governing regions from both the legal (breaking the law) and moral viewpoint. By claiming that public administrators failed morally, we meant breaking moral norms and rules. Contradictions, which were identified (from the ethical viewpoint), predominantly result from the conflict between public and private interests. In many cases, private interests of public administrators are preferred at the expense of public interests. And it is exactly this preference (a conflict of interests) that is sensitively perceived by the public. (shrink)
The goal of the Human Genome Diversity Project (HGDP) was to reconstruct the history of human evolution and the historical and geographical distribution of populations with the help of scientific research. Through this kind of research, the entire spectrum of genetic diversity to be found in the human species was to be explored with the hope of generating a better understanding of the history of humankind. An important part of this genome diversity research consists in taking blood (...) and tissue samples from indigenous populations. For various reasons, it has not been possible to execute this project in the planned scope and form to date. Nevertheless, genomic diversity research addresses complex issues which prove to be highly relevant from the perspective of research ethics, transcultural medical ethics, and cultural philosophy. In the article at hand, we discuss these ethical issues as illustrated by the HGDP. This investigation focuses on the confrontation of culturally diverse images of humans and their cosmologies within the framework of genome diversity research and the ethical questions it raises. We argue that in addition to complex questions pertaining to research ethics such as informed consent and autonomy of probands, genome diversity research also has a cultural–philosophical, meta-ethical, and phenomenological dimension which must be taken into account in ethical discourses. Acknowledging this fact, we attempt to show the limits of current guidelines used in international genome diversity studies, following this up by a formulation of theses designed to facilitate an appropriate inquiry and ethical evaluation of intercultural dimensions of genome research. (shrink)
In the US, stem cell research is at a moral impasse—many see this research as ethically mandated due to its potential for ameliorating major diseases, while others see this research as ethically impermissible because it typically involves the destruction of embryos and use of ova from women. Because their creation does not require embryos or ova, induced pluripotent stem cells offer the most promising path for addressing the main ethical objections to stem cell research; (...) however, this technology is still in development. In order for scientists to advance induced pluripotent stem cell research to a point of translational readiness, they must continue to use ova and embryos in the interim. How then are we to ethically move forward with stem cell research? We argue that there is personal integrity and value in adopting a ‘moral compromise’ as a means for moving past the moral impasse in stem cell research. In a moral compromise, each party concedes part of their desired outcome in order to engage in a process that respects the values and desires of all parties equitably. Whereas some contend that moral compromise in stem cell research necessarily involves self-contradiction or loss of personal integrity, we argue that in the US context, stem cell research satisfies many of the key pre-conditions of an effective moral compromise. To illustrate our point, we offer a model solution wherein eggs and embryos are temporarily used until non-egg and non-embryonic sources of pluripotent stem cells are developed to a state of translational readiness. (shrink)