Medical technologies, including nanomedicine products, are intended to improve health but in many cases may also create their own health risks. Medical products that create their own health risks differ from most other risk-creating technologies in that the very purpose of the medical technology is to prevent or treat health risks. This paradox of technologies intended to reduce existing risks that may have the effect of creating new risks has two conflicting implications. On one hand, we may be more tolerant (...) of health risks from medical technologies because these products are intended to, and often do, reduce overall health risks and improve our health. The health benefits of a medical technology may outweigh the unavoidable adverse effects of that same technology in an individual patient or in the overall treated population. (shrink)

Clinical trials of nanotechnology medical products present complex risk management challenges that involve many uncertainties and important risk-risk trade-offs. This paper inquires whether the precautionary principle can help to inform risk management approaches to nanomedicine clinical trials. It concludes that prudent precaution may be appropriate for ensuring the safety of such trials, but that the precautionary principle itself, especially in its more extreme forms, does not provide useful guidance for specific safety measures.

This paper aims to identify the key characteristics of model organisms that make them a specific type of model within the contemporary life sciences: in particular, we argue that the term “model organism” does not apply to all organisms used for the purposes of experimental research. We explore the differences between experimental and model organisms in terms of their material and epistemic features, and argue that it is essential to distinguish between their representational scope and representational target. We also examine (...) the characteristics of the communities who use these two types of models, including their research goals, disciplinary affiliations, and preferred practices to show how these have contributed to the conceptualization of a model organism. We conclude that model organisms are a specific subgroup of organisms that have been standardized to fit an integrative and comparative mode of research, and that it must be clearly distinguished from the broader class of experimental organisms. In addition, we argue that model organisms are the key components of a unique and distinctively biological way of doing research using models.Keywords: Experimental organism; Genetics; Model organism; Modeling; Philosophy of biology; Representation. (shrink)

In this paper, we explore the recent creation of “iBlastoids,” which are 3-D structures that resemble early human embryos prior to implantation which formed via self-organization of reprogrammed ad...

The biological sciences have become increasingly reliant on so-called 'model organisms'. I argue that in this domain, the concept of a descriptive model is essential for understanding scientific practice. Using a case study, I show how such a model was formulated in a preexplanatory context for subsequent use as a prototype from which explanations ultimately may be generated both within the immediate domain of the original model and in additional, related domains. To develop this concept of a descriptive model, I (...) focus on use of the nematode worm Caenorhabditis elegans and the wiring diagrams that were developed as models of its neural structure. In addition, implications of the concept of a descriptive model, particularly its relevance for the data-phenomena distinction as well as its relation to long-standing debates on realism, are briefly examined. (shrink)

Through an examination of the actual research strategies and assumptions underlying the Human Genome Project (HGP), it is argued that the epistemic basis of the initial model organism programs is not best understood as reasoning via causal analog models (CAMs). In order to answer a series of questions about what is being modeled and what claims about the models are warranted, a descriptive epistemological method is employed that uses historical techniques to develop detailed accounts which, in turn, help to reveal (...) forms of reasoning that are explicit, or more often implicit, in the practice of a particular field of scientific study. It is suggested that a more valid characterization of the reasoning structure at work here is a form of case-based reasoning. This conceptualization of the role of model organisms can guide our understanding and assessment of these research programs, their knowledge claims and progress, and their limitations, as well as how we educate the public about this type of biomedical research. (shrink)

Through an examination of the actual research strategies and assumptions underlying the Human Genome Project, it is argued that the epistemic basis of the initial model organism programs is not best understood as reasoning via causal analog models. In order to answer a series of questions about what is being modeled and what claims about the models are warranted, a descriptive epistemological method is employed that uses historical techniques to develop detailed accounts which, in turn, help to reveal forms of (...) reasoning that are explicit, or more often implicit, in the practice of a particular field of scientific study. It is suggested that a more valid characterization of the reasoning structure at work here is a form of case-based reasoning. This conceptualization of the role of model organisms can guide our understanding and assessment of these research programs, their knowledge claims and progress, and their limitations, as well as how we educate the public about this type of biomedical research. (shrink)

Although cases are central to the epistemic practices utilized within clinical medicine, they appear to be limited in their ability to provide evidence about causal relations because they provide detailed accounts of particular patients without explicit filtering of those attributes most likely to be relevant for explaining the phenomena observed. This paper uses a series of recent case reports to explore the role of cases in casual attribution in medical diagnosis. It is argued that cases are brought together by practitioners (...) to generate causal attributions and testable predictions using a manipulability view of causation. (shrink)

ArgumentWe examine the criteria used to validate the use of nonhuman organisms in North-American alcohol addiction research from the 1950s to the present day. We argue that this field, where the similarities between behaviors in humans and non-humans are particularly difficult to assess, has addressed questions of model validity by transforming the situatedness of non-human organisms into an experimental tool. We demonstrate that model validity does not hinge on the standardization of one type of organism in isolation, as often the (...) case with genetic model organisms. Rather, organisms are viewed as necessarily situated: they cannot be understood as a model for human behavior in isolation from their environmental conditions. Hence the environment itself is standardized as part of the modeling process; and model validity is assessed with reference to the environmental conditions under which organisms are studied. (shrink)

What consciousness exactly is remains an unsettled issue among both philosophers and biologists. Three aspects of consciousness are generally recognized: awareness consciousness (through connection...

Many consumers are motivated to attend Farmers’ Markets because of the opportunity to purchase fresh and local products. The subsequent interactions at FMs provide an important pathway for the direct exchange of information. While previous research suggests that people value local food and the FM shopping experience and that purchasing directly from producers can lead to transformative learning, little is known about exactly how the shopping experience at FMs can influence consumer purchasing behavior. This study examines the extent of and (...) mechanism for such “influencing.” Using data from surveys, observations, and interviews gathered at six FMs, we analyze the interactions between consumers and vendors, including the motivations and values of both parties. We explore the question, “How do farmers’ markets facilitate change in consumer purchasing behavior?” We propose that the dynamic of change in consumer purchasing behavior at FMs takes root in the exchange of information between consumers and vendors during interactions. Our results suggest that there are three specific characteristics shared by FM consumers and vendors that lead to these meaningful interactions at FMs: symmetry of motivations to attend FMs, shared values, and mutual dependence on interactions. Then, when a consumer learns new information from a FM vendor during an interaction, the consumer is more likely to make a change in their immediate purchase. Information about the products for sale and the modes of production of those items can especially impact consumers’ immediate purchases at FMs. We found that FM interactions can also impact long-term purchasing behavior, such as purchasing more organic or locally produced foods. Our results suggest that FM interactions may have significant implications for consumer health, local economies, and the environment. (shrink)

The so-called "biometric-Mendelian controversy" has received much attention from science studies scholars. This paper focuses on one scientist involved in this debate, Arthur Dukinfield Darbishire, who performed a series of hybridization experiments with mice beginning in 1901. Previous historical work on Darbishire's experiments and his later attempt to reconcile Mendelian and biometric views describe Darbishire as eventually being "converted" to Mendelism. I provide a new analysis of this episode in the context of Darbishire's experimental results, his underlying epistemology, and his (...) influence on the broader debate surrounding the rediscovery and acceptance of Mendelism. I investigate various historiographical issues raised by this episode in order to reflect on the idea of "conversion" to a scientific theory. Darbishire was an influential figure who resisted strong forces compelling him to convert prematurely due to his requirements that the new theory account for particularly important anomalous facts and answer the most pressing questions in the field. (shrink)

Bioethics has entered a new era: as many commentators have noted, the familiar mantra of autonomy, beneficence, nonmaleficence, and justice has proven to be an overly simplistic framework for understanding problems that arise in modern medicine, particularly at the intersection of public policy and individual preferences. A tradition of liberal pluralism grounds respect for individual preferences and affirmation of competing conceptions of the good. But we struggle to maintain (or at times explicitly reject) this tradition in the face of individual (...) preferences that we find distasteful, suspect, or even repugnant, especially where the broader social good or respect for equality is at stake. Directed donation presents us with such a dilemma: can we uphold the right of self-determination through respect of individual preferences regarding disposition of transplantable organs while at the same time maintaining an allocation system that reflects values of equity and justice claimed to underlie the socially negotiated practice of transplantation? Or are some preferences simply to be deemed unethical and not respected, even if that leads to a reduction in the number of transplantable organs available and to an apparent disregard for the autonomous decisions of the recently deceased? (shrink)

Objective: Even when critically ill patients are almost certain to die from their illnesses, there is generally an element of prognostic uncertainty. Little is known about how physicians handle this uncertainty in conversations with surrogate decision makers. We sought to evaluate whether and how physicians discuss prognostic uncertainty with surrogate decision makers of patients who are highly likely, but not certain, to die. Design: We audiotaped and transcribed discussions between clinicians and surrogate decision makers at two major California teaching hospitals (...) from 2006 through 2008. Physicians completed a questionnaire addressing their prognostic estimates for patients' survival to hospital discharge. Participants: We included physicians and surrogates of 12 incapacitated, critically ill patients. Measurements: We analyzed transcripts of discussions in which physicians' estimates of patients' chances of hospital survival were 1% to 5%; we coded whether physicians disclosed the prognostic uncertainty and, if so, how they conveyed that death was highly likely but not certain. Results: Physicians' estimates of short-term survival were 1% to 5% for 12 of the 70 patients enrolled in the original study. In 8 of 12 cases, physicians conveyed prognostic uncertainty by using probabilistic language or by an explicit mention of uncertainty. In four cases, physicians made at least one statement that either implied or was ambiguous about whether death was certain. Conclusion: We observed variability in how physicians handle prognostic uncertainty in their discussions with surrogates of patients who are highly likely, but not certain, to die, including some circumstances in which physicians stated or implied that death was certain. (shrink)

This article unpacks a particular use of ‘cases’ within developmental biology, namely as a means of describing the typical or canonical patterns of phenomena. The article explores how certain cases have come to be established within the field and argues that although they were initially selected for reasons of convenience or ease of experimental manipulation, these cases come to serve as key reference points within the field because of the epistemological structures imposed on them by the scientists using them and, (...) hence, become usable in a wider variety of circumstances including future theory development. (shrink)

Background: Falls in older adults are a major public health problem. White matter hyperintensities are highly prevalent in older adults and are a risk factor for falls. In the absence of a cure for WMHs, identifying potential strategies to counteract the risk of WMHs on falls are of great importance. Physical activity is a promising countermeasure to reduce both WMHs and falls risk. However, no study has yet investigated whether PA attenuates the association of WMHs with falls risk. We hypothesized (...) that PA moderates the association between WMHs and falls risk.Methods: Seventy-six community-dwelling older adults aged 70–80 years old were included in this cross-sectional study. We indexed PA using the Physical Activity Score for the Elderly Questionnaire. Falls risk was assessed using the Physiological Profile Assessment, and WMH volume was determined by an experienced radiologist on T2-weighted and PD-weighted MRI scans. We first examined the independent associations of WMH volume and PASE score with PPA. Subsequently, we examined whether PASE moderated the relationship between WMH volume and PPA. We plotted simple slopes to interpret the interaction effects. Age, sex, and Montreal Cognitive Assessment score were included as covariates in all models.Results: Participants had a mean age of 74 years and 54 were female. Forty-nine participants had a Fazekas score of 1, 19 had a score of 2, and 6 a score of 3. Both PASE and WMH volume were each independently associated with PPA score. The interaction model indicated that PASE score moderated the association between WMH volume and PPA, whereby higher PASE score attenuated the association between WMHs and falls risk.Conclusion: PA is an important moderator of falls risk. Importantly, older adults with WMH can reduce their risk of falls by increasing their PA. (shrink)

Prior to the genomic sequencing era, the bible for those working in clinical genetics was McKusick’s Mendelian Inheritance in Man, which appeared in multiple editions between the 1960s and the late 1990s. This catalogue was organized according to general patterns of inheritance and focused on phenotypes. Beginning in the mid-1980s, it was replaced by Online Mendelian Inheritance in Man, a continuously updated catalogue documenting molecular relationships between genetic variation and phenotypic expression. This paper explores this resource’s evolution with attention to (...) how disease is distinguished from clinically irrelevant variation and how phenotypic similarities are captured in cases where there is no obvious genotypic association. It is argued that hybrid compromises are encoded into OMIM®; in addition to serving its key original purpose of being a diagnostic catalogue, it also began to record detectable variations in the genome even if they were not known to be associated with phenotypically visible disorders or even phenotypic variations. Although the impacts of geneticization have been well recognized, particularly in popular media, this example allows exploration of some of the historic, epistemic, and methodological causes that underlie tendencies toward disease geneticization in contemporary medicine, while highlighting that such gene-focused strategies may in fact be warranted in some contexts. (shrink)

There has been growing global interest in livestock animal welfare. Previous research into attitudes towards animal welfare has focused on Europe and the United States, with comparatively little focus on Australia, which is an important location due to the prominent position of agriculture economically and culturally. In this article, we present results from qualitative research on how Australian meat consumers conceptualise sheep and beef cattle welfare. The study was conducted in two capital cities (Melbourne, Victoria and Adelaide, South Australia) and (...) a much smaller rural centre (Toowoomba, Queensland) using focus groups (involving 40.9% of participants) and mall-intercept interviews (59.1% of participants), totalling 66 participants. Qualitative analysis highlights that participants had clear ideas of what it means for an animal to live a ‘good life’ and experience a ‘good death,’ with their beliefs strongly tied to their expectations and cultural understandings of what Australian agriculture ‘should be.’ In response to open-ended questions, participants expressed attitudes that relied on romanticised visions of the ‘rural idyll’ as seen in frequent discussions about what is ‘normal’ for sheep meat and beef production, and relatedly, what count as ‘natural behaviours.’ Many participants rejected anything associated with the ‘other,’ classifying it as not ‘normal’: we argue that which is not considered normal, including intensive production, foreign ownership, and halal slaughter practices, appear to place participants’ conceptualizations of an animal’s ‘good death,’ and in turn the potential for a ‘good life,’ at risk. (shrink)

Debates continue to surround the system in the United States for allocating transplantable cadaveric organs, due in large part to the scarcity of such organs in relation to the number of individuals waiting to undergo transplantation. Candidates awaiting transplantation gain access to cadaveric organs by being placed by individual transplant programs on the national list of the Organ Procurement and Transplantation Network, overseen by the United Network for Organ Sharing. In recent years, the UNOS board has visited the issue of (...) multiple listing, that is, allowing one candidate to be registered on the waiting lists of two or more transplant programs, and has continued to permit multiple listing. (shrink)

The prelims comprise: Why Is Reproductive Choice Important? Is There a Right to Reproduce? Is There a Duty to Reproduce? Are There Duties Not to Reproduce? Responsibilities in Reproductive Decisions Are There Rights to Rear Children? Conclusions References.

The past year in bioethics in Australia has been relatively predictable. We continue to struggle with rising healthcare costs, though thankfully not on par with numerous other countries due to a relatively positive economic outlook. We are still fighting difficulties associated with higher medical indemnity costs, which have again caused many physicians to leave private practice, particularly in high-risk and specialty practice areas. In response, the federal government delayed the imposition of the medical indemnity levy for physicians until mid 2005. (...) In May, the Australian Law Reform Commission and the Australian Health Ethics Commission issued their final joint report on genetic testing entitled “Essentially Yours” and endorsed use of genetic tests by insurance companies, despite the concerns of some geneticists and many members of the public about their scientific reliability. However, they also advocated the establishment of the Human Genetics Commission of Australia to oversee such uses of genetic tests in terms of both scientific and actuarial reliability, and debates continue over the implementation of this and a number of their other recommendations. And state governments continue to phase in smoking bans in public places, with most implementing full bans in enclosed restaurants and cafes and planning to require provision of nonsmoking areas in all pubs within the next year. a. (shrink)

The majority of midwives in the UK are employed within the NHS. They are legally bound to fulfil their contractual obligations to their employers. At the same time they are professionally mandated to interpret and act on the UKCC's Code of professional conduct. Midwives have always maintained that they are autonomous practitioners, and the Code is written in a way that endorses this belief. Underlying the Code is the assumption that midwives have moral and professional freedom to act on its (...) imperatives. However, midwives' claim to autonomy is flawed, and therefore the Code's claim to be a source of empowerment is also flawed. Underlying the difficulties is a conflict derived from the imposition of a deontologically-based professional Code on to a workforce that is constrained within and employed by the utilitarian-based NHS. (shrink)

I’m sick of being treated like a dumb Mum who doesn’t understand the science. As far as I’m concerned, my family’s health is just too important. … If the government can’t protect the safety of my family, then I will.Recent Greenpeace activism in Australia resulted in the destruction of a field trial of a line of wheat “designed” to improve human nutrition. This incident demonstrates that, while there is significant ongoing public and private investment in genetically modified crop research and (...) development in Australia, many people continue to oppose GM foods strongly. We noted with interest that Greenpeace described this activism with language that explicitly connected the actions to the gender.. (shrink)

In recent years, there has been a distinct shift in the relationship between science and society. We have moved away from the classic unidirectional “deficit” model (Simis et al. 2016) focused on t...

The American Journal of Bioethics, Volume 11, Issue 10, Page 22-24, October 2011.

Community databases have become crucial to the collection, ordering and retrieval of data gathered on model organisms, as well as to the ways in which these data are interpreted and used across a range of research contexts. This paper analyses the impact of community databases on research practices in model organism biology by focusing on the history and current use of four community databases: FlyBase, Mouse Genome Informatics, WormBase and The Arabidopsis Information Resource. We discuss the standards used by the (...) curators of these databases for what counts as reliable evidence, acceptable terminology, appropriate experimental set-ups and adequate materials (e.g., specimens). On the one hand, these choices are informed by the collaborative research ethos characterising most model organism communities. On the other hand, the deployment of these standards in databases reinforces this ethos and gives it concrete and precise instantiations by shaping the skills, practices, values and background knowledge required of the database users. We conclude that the increasing reliance on community databases as vehicles to circulate data is having a major impact on how researchers conduct and communicate their research, which affects how they understand the biology of model organisms and its relation to the biology of other species. (shrink)

The Bermuda Principles for DNA sequence data sharing are an enduring legacy of the Human Genome Project. They were adopted by the HGP at a strategy meeting in Bermuda in February of 1996 and implemented in formal policies by early 1998, mandating daily release of HGP-funded DNA sequences into the public domain. The idea of daily sharing, we argue, emanated directly from strategies for large, goal-directed molecular biology projects first tested within the “community” of C. elegans researchers, and were introduced (...) and defended for the HGP by the nematode biologists John Sulston and Robert Waterston. In the C. elegans community, and subsequently in the HGP, daily sharing served the pragmatic goals of quality control and project coordination. Yet in the HGP human genome, we also argue, the Bermuda Principles addressed concerns about gene patents impeding scientific advancement, and were aspirational and flexible in implementation and justification. They endured as an archetype for how rapid data sharing could be realized and rationalized, and permitted adaptation to the needs of various scientific communities. Yet in addition to the support of Sulston and Waterston, their adoption also depended on the clout of administrators at the US National Institutes of Health and the UK nonprofit charity the Wellcome Trust, which together funded 90% of the HGP human sequencing effort. The other nations wishing to remain in the HGP consortium had to accommodate to the Bermuda Principles, requiring exceptions from incompatible existing or pending data access policies for publicly funded research in Germany, Japan, and France. We begin this story in 1963, with the biologist Sydney Brenner’s proposal for a nematode research program at the Laboratory of Molecular Biology at the University of Cambridge. We continue through 2003, with the completion of the HGP human reference genome, and conclude with observations about policy and the historiography of molecular biology. (shrink)

The biological sciences have become increasingly reliant on so-called ‘model organisms’. I argue that in this domain, the concept of a descriptive model is essential for understanding scientific practice. Using a case study, I show how such a model was formulated in a preexplanatory context for subsequent use as a prototype from which explanations ultimately may be generated both within the immediate domain of the original model and in additional, related domains. To develop this concept of a descriptive model, I (...) focus on use of the nematode worm Caenorhabditis elegans and the wiring diagrams that were developed as models of its neural structure. In addition, implications of the concept of a descriptive model, particularly its relevance for the data-phenomena distinction as well as its relation to long-standing debates on realism, are briefly examined. (shrink)