The discovery of induced pluripotent stem (iPS) cells in 2006 was heralded as a major breakthrough in stem cell research. Since then, progress in iPS cell technology has paved the way towards clinical application, particularly cell replacement therapy, which has refueled debate on the ethics of stem cell research. However, much of the discourse has focused on questions of moral status and potentiality, overlooking the ethical issues which are introduced by the clinical testing of iPS cell replacement therapy. First-in-human (...) trials, in particular, raise a number of ethical concerns including informed consent, subject recruitment and harm minimisation as well as the inherent uncertainty and risks which are involved in testing medical procedures on humans for the first time. These issues, while a feature of any human research, become more complex in the case of iPS cell therapy, given the seriousness of the potential risks, the unreliability of available animal models, the vulnerability of the target patient group, and the high stakes of such an intensely public area of science. Our paper will present a detailed case study of iPS cell replacement therapy for Parkinson's disease to highlight these broader ethical and epistemological concerns. If we accept that iPS cell technology is fraught with challenges which go far beyond merely refuting the potentiality of the stem cell line, we conclude that iPS cell research should not replace, but proceed alongside embryonic and adult somatic stem cell research to promote cross-fertilisation of knowledge and better clinical outcomes. (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)
The 21st-century translational science campaign could lead to an increase in first-in-human trials. As tests of investigational interventions move from the laboratory to human research, scientists, officials, and review committees should address ongoing concerns about the ethics of FIH trials. In this article, I describe three ethical considerations relevant to all FIH trials: the requirement for adequate preclinical research; study design safeguards; and choice of subject population. I also examine specific ethical considerations relevant to the three subject populations involved (...) in FIH research. I recommend a variety of actions that could increase subject protection and the value of the information generated in FIH trials. (shrink)
Risks of harm, translational uncertainty, ambiguities in potential direct benefit, and long-term follow-up merit consideration in first-in-human research. Some nanomedical technologies have additional characteristics that should be addressed, including: defining and describing nanomedical interventions; bystander risks; the therapeutic misconception; and a decision-making context that includes both common use of nanomaterials outside medicine and persistent unknowns about the effects of nanosize. This paper considers how to address these issues in informed consent to first-in-human nanomedicine research.
The aims of this article are to consider whether there are medical and societal differences among diseases regarding which patient groups should be asked to participate in first-in-human trials of stem-cell-based therapies; any differences in the light of values generally endorsed by different types of ethical theories, since the question in the title of this article is value laden, and its answer depends on which values one wants to promote and protect, and how they are ranked in importance; whether (...) the answer to that question is disease-specific, or whether it depends on factors common to several diseases. To illustrate these problems, we use Parkinson’s disease and Huntington’s disease , between which there are important medical and societal differences. Moreover, research on stem-cell-based therapies for these diseases is being translated from research to practice. This approach to the problem can be applied to decision making about similar problems raised by other diseases that exhibit the same types of differences. (shrink)
The transition of novel and potentially promising medical therapies into their initial human clinical trials can engender conflicting pressures. On the one side, because Phase I trials raise greater ethical and human protection challenges than later stage clinical trials, there is a need to proceed cautiously. This is particularly the case for Phase I trials with a novel therapy being tested in humans for the first time, usually termed first-in-human (FIH) trials, especially if the FIH trial involves significant risks. (...) On the other side, scientists interested in having their research validated, corporations with a financial interest in the field, and potential patients and patient support groups desirous of having .. (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)
The decision to initiate invasive, first-in-human trials involving Parkinson’s disease presents a vexing ethical challenge. Such studies present significant surgical risks, and high degrees of uncertainty about intervention risks and biological effects. We argue that maintaining a favorable riskbenefit balance in such circumstances requires a higher than usual degree of confidence that protocols will lead to significant direct and/or social benefits. One critical way of promoting such confidence is through the application of stringent evidentiary standards for preclinical studies. We (...) close with a series of recommendations for strengthening the internal and external validity of preclinical studies, reducing their tendency toward optimism and publication biases, and improving the knowledge base used to design and evaluate preclinical studies. (shrink)
Novel nanomedical interventions require human testing to evaluate their safety and effectiveness. To establish a proper evidentiary basis for human trials, nanomedical innovations must first be subjected to animal and other laboratory testing. But it is uncertain whether the traditional laboratory approaches to safety evaluation will supply adequate information on nanotechnology risks to humans. This uncertainty, together with other features of nanomedical innovation, heightens the ethical challenges in conducting FIH nanotrials.
This chapter suggests a new interpretation of Spinoza’s concept of mind claiming that the goal of the equation of the human mind with the idea of the body is not to solve the mind-body problem, but rather to show how we can, within the framework of Spinoza’s rationalism, conceive of finite minds as irreducibly distinguishable individuals. To support this view, the chapter discusses the passage from E2p11 to E2p13 against the background of three preliminaries, i.e. the notion of a union (...) between mind and body as it appears in Thomas Aquinas’ refutation of Averroism, Spinoza’s views on knowledge of actually existing things in E2p8c, and the phenomenological character of E2a2-4. It argues that while this view on the human mind does not undermine radical rationalism, it does require its amendment by some irreducibly empirical concessions. (shrink)
In 1999, the Journal of Business Ethics published its 1 500th article. This article commemorates the journal's quest "to improve the human condition" (Michalos, 1988, p. 1) with a summary and assessment of the first eighteen volumes. The first part provides an overview of JBE, highlighting the journal's growth, types of methodologies published, and the breadth of the field. The second part provides a detailed account of the quantitative research findings. Major research topics include (1) prevalence of ethical behavior, (2) (...) ethical sensitivities, (3) ethics codes and programs, (4) corporate social performance and policies, (5) human resource practices and policies, and (6) professions – accounting, marketing/sales, and finance/strategy. Much remains to be done. (shrink)
Human flourishing is the topic of an increasing number of books and articles in educational philosophy. Flourishing should be regarded as an ideal aim of education. If this is defended, the first step should be to elucidate what is meant by flourishing, and what exactly the concept entails. Listing formal criteria can facilitate reflection on the ideal of flourishing as an aim of education. We took Aristotelian eudaimonia as a prototype to construct two criteria for the concept of human flourishing: (...) human flourishing is regarded as intrinsically worthwhile and flourishing means ‘actualisation of human potential’. The second criterion has three sub-criteria: flourishing is about a whole life, it is a ‘dynamic state’ and flourishing presupposes there being objective goods. (shrink)
With neuroscience and psychology making significant advances in contemporary brain research, fundamental questions concerning the nature of human life and activity will become evermore critical as we proceed further into the twenty-first century. Put simply, are we creatures who exercise some genuine degree of freedom and agency in the world or are we creatures whose actions are largely if not wholly determined by biological, neurological, and psychological factors far below the radar of our conscious awareness? This article explores this important (...) and timely question by examining the views of Paul Sheldon Davies, Reinhold Niebuhr, and Alfred North Whitehead. Drawing on contemporary science, Davies dismisses Niebuhr’s existential analysis of human existence and any meaningful conception of human agency. Succinctly stated, can one take both the results of contemporary neuroscience seriously, as Davies does, and the affirmation of human agency seriously, as Niebuhr does? The thesis of this essay is that Whitehead offers a constructive bridge between Davies’ affirmation of science and Niebuhr’s existential account of human existence. In sum, it is argued that Whitehead’s process philosophy enables us to affirm the genuine influence of nonconscious factors in experience as well as the authenticity of human agency and subjectivity in the world. (shrink)
The causes of asymmetries for handedness and cerebral speech are of scientific interest, but is it sensible to try to determine which of these came first? I argue that (1) first causes belong to mythology, not science; (2) much of the cited evidence is weak; and (3) the treatment of individual differences is inadequate in comparison with the right shift theory.
Recent studies with human infants and nonhuman primates reveal that posture interacts with the expression and stability of handedness. Converging results demonstrate that quadrupedal locomotion hinders the expression of handedness, whereas bipedal posture enhances preferred hand use. From an evolutionary perspective, these findings suggest that right-handedness may have emerged first, following the adoption of bipedal locomotion, with speech emerging later.
This paper aims to show how recent cinematic representations reveal a far more pessimistic and essentialised vision of Human/Cyborg hybridity in comparison with the more enunciative and optimistic ones seen at the end of the twentieth century. Donna Haraway’s still influential 1985 essay “A Cyborg Manifesto” saw the combination of the organic and the technological as offering new and exciting ways beyond the normalised culturally constructed categories of gender and identity formation. However, more recently critics see her later writings as (...) embodying a Faustian deal between the individual and hegemony, where technology does not enhance but merely returns the subject to a level of normalisation. As such cybernetics is only configured as a form of prosthetic rehabilitation, to ‘re’-able the ‘dis’-abled, that ultimately re-establishes earlier essentialised subject positions through that same evolutionary process. The Six Million Dollar Man, which ran from 1974 to 1978, exampled a symbiosis between the organic and the technological where the broken human body is not just re-made via mechanical prosthesis but through a process of Cyborg hybridity which actually makes it better, faster, stronger than before. In contrast, contemporary films such as Avatar (Cameron 2009), Transformers II: Revenge of the Fallen (Bay 2009) and Iron Man II (Faveraeu 2010) portray an inherent anxiety toward the cyborg body disavowing of any human/cyborg interaction beyond re-establishing their own discrete and separate subject positions. Although human/cyborg symbiosis constructs the possibility for potentialised bodies beyond those previously imagined, contemporary, popular, film represents them as separated and essentialised. This article looks at what cultural anxieties might produce such an about turn in such representations how this positions human identity in a time of increasing technology and, as a result, asks “whatever happened to The Six Million Dollar Man?”. (shrink)
Examining the concepts of ' security ' and 'sustainability', as they are employed in contemporary environmental discourses, the paper argues that, although the importance of the environment has been increasingly acknowledged since the 1970s, there has been a failure to incorporate other discourses surrounding 'nature'. The implications of the 'new genetics', prompted by research into recombinant DNA, suggest that future approaches to sustainability need to be more cognisant of changes in 'our' nature, as well as those of 'external' nature, the (...) environment. This broadening of the compass of ' security ' and 'sustainability' discourses would help provide greater insight into human security, from an environmental perspective. (shrink)