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.

Bioethics represents a dramatic revision of the centuries-old professional ethics that governed the behavior of physicians and their relationships with patients. This venerable ethics code was challenged in the years after World War II by the remarkable advances in the biomedical sciences and medicine that raised questions about the definition of death, the use of life-support systems, organ transplantation, and reproductive interventions. In response, philosophers and theologians, lawyers and social scientists joined together with physicians and scientists to rethink and revise (...) the old standards. Governments established commissions to recommend policies. Courts heard arguments and legislatures passed laws. This book is the first broad history of the growing field of bioethics. Covering the period 1947-1987, it examines the origin and evolution of the debates over human experimentation, genetic engineering, organ transplantation, termination of life-sustaining treatment, and new reproductive technologies. It assesses the contributions of philosophy, theology, law and the social sciences to the expanding discourse of bioethics. Written by one of the field's founders, The Birth of Bioethics is based on extensive archival research into sources that are difficult to obtain and on interviews with many of the leading figures in the moral debates in medicine. A very readable and comprehensive account of the evolution of bioethics, this book stresses the history of ideas but does not neglect the social and cultural context and the people involved. It will serve the information needs of philosophers, ethicists, social historians, and everyone interested in the origins of some of today's most hotly debated issues. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

ABSTRACT Publications are primarily a means of communicating scientific information to colleagues, but they are much more than that. Publications in peer reviewed journals are proof of academic competence, are used as a crucial component in evaluation criteria for academic promotion and fundraising and increase the prestige of research centres and universities. The urgent need for publications has also led to abuses in authorship. In the past the single‐author article was the rule, but over the past decades, the average number (...) of authors on scientific manuscripts has drastically increased. In the field of bioethics, however, no research has been undertaken to study whether the percentage of single‐author articles is decreasing, the proportion of multi‐author articles is increasing or the average number of authors per article is increasing. The objective of this research is to analyze these trends in authorship for the period 1990–2003 in peer reviewed journals in the field of bioethics. In the nine peer reviewed journals from the field of bioethics we studied, we observed a significant increase of the multi‐author article and of the average number of authors. This is mainly due to the increase in the number of publications with an empirical design. This growing trend is a challenge for the editors of journals in the field of bioethics to enhance awareness about the value and definition of authorship. (shrink)

This essay discusses some of the problems with current authorship practices and puts forward a proposal for a new system of credit allocation: in published works, scientists should more clearly define the responsibilities and contributions of members of research teams and should distinguish between different roles, such as author, statistican, technician, grant writer, data collector, and so forth.

This essay reviews six different approaches to intellectual property. It and argues that none of these accounts provide an adequate justification of intellectual property laws and policies because (1) there are many different types of intellectual property, and (2) a variety of incommensurable values play a role in the justification of intellectual property. The best approach to intellectual property is to assess and balance competing moral values in light of the particular facts and circumstances.

If stem cell-based therapies are developed, we will likely confront a difficult problem of justice: for biological reasons alone, the new therapies might benefit only a limited range of patients. In fact, they might benefit primarily white Americans, thereby exacerbating long-standing differences in health and health care.

There has long been tension between bioethicists whose work focuses on classical philosophical inquiry and those who perform empirical studies on bioethical issues. While many have argued that empirical research merely illuminates current practices and cannot inform normative ethics, others assert that research-based work has significant implications for refining our ethical norms. In this essay, I present a novel construct for classifying empirical research in bioethics into four hierarchical categories: Lay of the Land, Ideal Versus Reality, Improving Care, and Changing (...) Ethical Norms. Through explaining these four categories and providing examples of publications in each stratum, I define how empirical research informs normative ethics. I conclude by demonstrating how philosophical inquiry and empirical research can work cooperatively to further normative ethics. (shrink)

The prospect of using cell-based interventions to treat neurological conditions raises several important ethical and policy questions. In this target article, we focus on issues related to the unique constellation of traits that characterize CBIs targeted at the central nervous system. In particular, there is at least a theoretical prospect that these cells will alter the recipients' cognition, mood, and behavior—brain functions that are central to our concept of the self. The potential for such changes, although perhaps remote, is cause (...) for concern and careful ethical analysis. Both to enable better informed consent in the future and as an end in itself, we argue that early human trials of CBIs for neurological conditions must monitor subjects for changes in cognition, mood, and behavior; further, we recommend concrete steps for that monitoring. Such steps will help better characterize the potential risks and benefits of CBIs as they are tested and potentially used for treatment. (shrink)

Analytic moral philosophy's strong divide between empirical and normative restricts facts to providing information for the application of norms and does not allow them to confront or challenge norms. So any genuine attempt to incorporate experience and empirical research into bioethics – to give the empirical more than the status of mere 'descriptive ethics'– must make a sharp break with the kind of analytic moral philosophy that has dominated contemporary bioethics. Examples from bioethics and science are used to illustrate the (...) problems with the method of application that philosophically prevails in both domains and with the conception of rationality that underlies this method. Cues from how these problems can be handled in science then introduce summaries of richer, more productive naturalist and constructivist accounts of reason and normative knowledge. Liberated by a naturalist approach to ethics and an enlarged conception of rationality, empirical work can be recognized not just as essential to bioethics but also as contributing to normative knowledge. (shrink)

Publication in the biomedical literature is important because it is the major pathway by which new concepts and discoveries are disseminated amongst scientists. In the last 30 years there has been a dramatic increase, not only in the volume of publications but in the number of authors per article as well. This paper summarizes the current literature on authorship and its proliferation in medicine. From the literature it becomes clear that for biomedical articles, the mean number of authors increased from (...) 1.7 in 1960 to 3.1 in 1990, and there are indications that this trend is even greater in clinical medicine such that single authorship almost has disappeared. Formal guidelines of who should be considered an author have been set by the International Committee of Medical Journal Editors. There are studies suggesting that not all authors on multiauthor papers fulfill these criteria. Inappropriate multiple authorship leads to dilution of authorship responsibility and unjustified citation in curriculum vitae. Recommendations regarding the prevention of inappropriate authorship are given in this paper. (shrink)

This article discusses the relation between empirical and normative approaches in bioethics. The issue of dwarf tossing, while admittedly unusual, is chosen as a point of departure because it challenges the reader to look with fresh eyes upon several central bioethical themes, including human dignity, autonomy, and the protection of vulnerable people. After an overview of current approaches to the integration of empirical and normative ethics, we consider five ways that the empirical and normative can be brought together to speak (...) to the problem of dwarf tossing: prescriptive applied ethics, theoretical ethics, critical applied ethics, particularist ethics and integrated empirical ethics. We defend a position of critical applied ethics that allows for a two-way relation between empirical and normative theories. Against efforts fully to integrate the normative and the empirical into one synthesis, we propose that the two should stand in tension and relation to one another. The approach we endorse acknowledges that a social practice can and should be judged both by the gathering of empirical data and by normative ethics. Critical applied ethics uses a five stage process that includes: (a) determination of the problem, (b) description of the problem, (c) empirical study of effects and alternatives, (d) normative weighing and (e) evaluation of the effects of a decision. In each stage, we explore the perspective from both the empirical (sociological) and the normative ethical point of view. We conclude by applying our five-stage critical applied ethics to the example of dwarf tossing. (shrink)

Inappropriate authorship is a common problem in biomedical research and may be becoming one in bioethics, due to the increase in multiple authorship. This paper investigates the authorship policies of bioethics journals to determine whether they provide adequate guidance for researchers who submit articles for publication, which can help deter inappropriate authorship. It was found that 63.3% of bioethics journals provide no guidance on authorship; 36.7% provide guidance on which contributions merit authorship, 23.3% provide guidance on which contributions do not (...) merit authorship, 23.3% require authors to take responsibility for their contributions or for the article as a whole, 20% provide guidance on which contributions merit an acknowledgement but not authorship, 6.7% require authors to describe their contributions, and only 3.3% distinguish between authorship in empirical and conceptual research. To provide authors with effective guidance and promote integrity in bioethics research, bioethics journals should adopt authorship policies that address several important topics, such as the qualifications for authorship, describing authorship contributions, taking responsibility for the research and the difference between authorship in empirical and conceptual research. (shrink)