On one view, limb transplants cross technological frontiers but not ethical ones; the only issues to be resolved concern professional competence, under the assumption of patient autonomy. Given that the benefits of limb transplant do not outweigh the risks, however, the autonomy and rationality of the patient are not necessarily self‐evident. In addition to questions of resource allocation and informed consent, limb, and particularly hand, allograft also raises important issues of personal identity and bodily integrity. We present two linked schemas (...) for exploring ethical issues in limb transplants. The first, relying on conventional concepts in biomedical ethics, asks whether the procedure is research or therapy, whether the costs outweigh the benefits, and whether it should be up to the patient to decide. The second introduces more speculative and theoretically challenging questions, including bodily integrity, the argument from unnaturalness, and the function of the hand in expressing personal identity and intimacy. We conclude that limb transplants are not ruled out a priori, unlike some procedures that are prima facie wrong to perform, such as amputation of healthy limbs to relieve body dysmorphic disorders. However, their legitimacy is not proven by appeals to the interests of scientific research, cost‐benefit, or patient autonomy. (shrink)

Fecal microbiota transplantation has demonstrated efficacy and is increasingly being used in the treatment of patients with recurrent Clostridium difficile infection. Despite a lack of high-quality trials to provide more information on the long-term effects of FMT, there has been great enthusiasm about the potential for expanding its applications. However, FMT presents many serious ethical and social challenges that must be addressed as part of a successful regulatory policy response. In this article, we draw on a sample of the scientific (...) and bioethics literatures to examine clusters of ethical and social issues arising in five main areas: informed consent and the vulnerability of patients; determining what a “suitable healthy donor” is; safety and risk; commercialization and potential exploitation of vulnerable patients; and public health implications. We find that these issues are complex and worthy of careful consideration by health care professionals. Desperation of a patient should not be the basis for selecting treatment with FMT, and the patient's interests should always be of paramount concern. Authorities must prioritize development of appropriate and effective regulation of FMT to safeguard patients and donors, promote further research into safety and efficacy, and avoid abuse of the treatment. (shrink)

BackgroundBiobanks are considered to be key infrastructures for research development and have generated a lot of debate about their ethical, legal and social implications. While the focus has been on human genomic research, rapid advances in human microbiome research further complicate the debate.DiscussionWe draw on two cystic fibrosis biobanks in Toronto, Canada, to illustrate our points. The biobanks have been established to facilitate sample and data sharing for research into the link between disease progression and microbial dynamics in the lungs (...) of pediatric and adult patients. We begin by providing an overview of some of the ELSI associated with human microbiome research, particularly on the implications for the broader society. We then discuss ethical considerations regarding the identifiability of samples biobanked for human microbiome research, and examine the issue of return of results and incidental findings. We argue that, for the purposes of research ethics oversight, human microbiome research samples should be treated with the same privacy considerations as human tissues samples. We also suggest that returning individual microbiome-related findings could provide a powerful clinical tool for care management, but highlight the need for a more grounded understanding of contextual factors that may be unique to human microbiome research.ConclusionsWe revisit the ELSI of biobanking and consider the impact that human microbiome research might have. Our discussion focuses on identifiability of human microbiome research samples, and return of research results and incidental findings for clinical management. (shrink)

As the international genomic research community moves from the tool-making efforts of the Human Genome Project into biomedical applications of those tools, new metaphors are being suggested as useful to understanding how our genes work - and for understanding who we are as biological organisms. In this essay we focus on the Human Microbiome Project as one such translational initiative. The HMP is a new 'metagenomic' research effort to sequence the genomes of human microbiological flora, in order to pursue the (...) interesting hypothesis that our 'microbiome' plays a vital and interactive role with our human genome in normal human physiology. Rather than describing the human genome as the 'blueprint' for human nature, the promoters of the HMP stress the ways in which our primate lineage DNA is interdependent with the genomes of our microbiological flora. They argue that the human body should be understood as an ecosystem with multiple ecological niches and habitats in which a variety of cellular species collaborate and compete, and that human beings should be understood as 'superorganisms' that incorporate multiple symbiotic cell species into a single individual with very blurry boundaries. These metaphors carry interesting philosophical messages, but their inspiration is not entirely ideological. Instead, part of their cachet within genome science stems from the ways in which they are rooted in genomic research techniques, in what philosophers of science have called a 'tools-to-theory' heuristic. Their emergence within genome science illustrates the complexity of conceptual change in translational research, by showing how it reflects both aspirational and methodological influences. (shrink)