Objective: To audit doctors’ knowledge of informed consent.Design: 10 consent scenarios with “true”, “false”, or “don’t know” answers were completed by doctors who care for children at a large district general hospital. These questions tested clinicians’ knowledge of who could give consent in different clinical situations.Setting: Royal United Hospital, Bath, UK.Results: 51 doctors participated . Paediatricians scored higher than other clinicians . Only 36% of paediatricians and 8% of other clinicians realised that the biological father of a child born before (...) 1 December 2003 needed a court order or a parental responsibility agreement to acquire parental responsibility, and thus be able to consent on behalf of his child, if he was not married to the child’s mother. Non-paediatric clinicians were unsure or incorrect when tested on situations where people with parental responsibility do not agree, or where young people , who are Fraser competent do not want to consult their parents. Most clinicians did not know that the parents of a 20-year-old man with severe learning difficulties are unable to consent to surgery on his behalf, and many non-paediatricians were unclear on who could give consent when a child lived with foster parents.Conclusion: Clinicians who obtain consent for the treatment of children need to increase their knowledge on who is able to give informed consent to ensure best practice. (shrink)

As children and adolescents receive increased research attention, ethical issues related to obtaining informed consent for pediatric intervention research have come into greater focus. In this article, we conceptualize parent permission and child assent within a goodness-of-fit framework that encourages investigators to create consent procedures “fitted” to the research context, the child's cognitive and emotional maturity, and the family system. Drawing on relevant literature and a hypothetical case example, we highlight four factors investigators may consider when constructing consent procedures that (...) best reflect participants' rights, concerns, and well-being: (a) the child's current assent capacity and the likely impact of study information on the child's mental and physical development, (b) parents' understanding of their child's treatment needs and distinctions between treatment and clinical trials research, (c) the family's history of shared decision making, and (d) the child's strivings for autonomy within the context of their parents' duty to make decisions in the child's best interest. (shrink)

Current advances in connectivity, sensor technology, computing power and the development of complex algorithms for processing health-related data are paving the way for the delivery of innovative long-term health care services in the future. Such technological developments will, in particular, assist the elderly and infirm to live independently, at home, for much longer periods. The home is, in fact, becoming a locus for health care innovation that may in the future compete with the hospital. However, along with these advances come (...) valid privacy and security questions arising from the fact that the data collected and transmitted through these technologies could also allow for individual monitoring as well as unauthorized access to critical diagnostic and other health data. (shrink)

I take 'informal logic' to be the (descriptive and normative) study of 'real arguments'-arguments which are or have been used with the aim of convincing others of a point of view. I argue that the informal logic tradition thus conceived (i) lends strong support to something like Quine's view that our beliefs really support one another like the filaments in a spider's web--and thus that the traditional view that implication is an asymmetric relation is false; (ii) suggests that the classic (...) division of arguments into deductive and inductive has distorted our thinking about the evaluation of real arguments; and (iii) implies that naturalised epistemology is on the right track. (shrink)

Religion, defined as ‘the idea of a state that transcends ourselves and our world and the working out of the consequences of that idea’, may influence the ethical thinking of scientists and engineers in two ways. The first is at the level of the individual and how personal beliefs affect the choice of research, design or development projects, relationships with other researchers and the understandings of the consequences of research on other aspects of life. The second level is that of (...) the social and cultural setting in which scientists and engineers work; how society decides which research to sponsor, how to apply the results of scientific discovery and which technology it chooses to develop and for what purposes. In neither of these areas is religious belief a necessary condition for scientists and engineers to pursue one course of action rather than another. The existence of religious belief within the individual and society is, though, part of the ethical framework in which scientist and engineers work and therefore something to which attention should be paid. Religion provides a particular perspective on what should be. Conversely science and technology provide information on the nature of the person and the universe in which we live, which must be taken into account when theologians and religious moralists apply their ethical norms and principles. (shrink)

Taking up the notion of engineering as social experimentation, this paper argues that engineering research laboratory directors have a responsibility to inform graduate engineering students who participate in their research projects of the potential broader social dimensions of those projects. Informing engineers-in-the-making of the broader social dimensions of the research they are learning to conduct would help ensure their future capacity to act as ethically responsible social experimenters. The paper also argues that graduate engineers have a right to be informed (...) participants in activities that may have broader social dimensions than are recognized by formal research evaluation or educational processes. The process of obtaining the informed consent of graduate engineering students, if implemented effectively, would thus help ensure both their capacity to act as moral agents and their own moral integrity. Since the eventual outcomes of research can be uncertain, complex, and contested, most traditional institutional frameworks—such as principle-based codes of conduct and risk-benefit frameworks—provide an insufficient basis to inform engineers and citizens. Rather, we recommend an ongoing discursive process that explores a number of different actors, contexts, and scenarios, and that evolves with the social context of the engineering research in question. While this may seem burdensome to the engineering research process, it can be integrated directly into the group research meetings and mentorship activities that typically already go on. Moreover, it can actually be seen to benefit engineering practices. (shrink)

La Oroya, Peru, and Herculaneum, Missouri, USA, are two cities 4,000 miles apart but beset with common health and environmental risk: high levels of lead contamination. A key participant in this unfolding tale of environmental disaster has been The Renco Group, a privately held investment holding company based in New York. This case study sheds light on The Renco Group’s Corporate Social Responsibility (CSR) in a developing country (Peru) as distinct from CSR in a developed country (USA) by presenting the (...) distinctive set of formal and informal forces that shape the ethical outcome. The question – one which animates much of this case – is what mechanisms exist that work either collectively or individually to encourage or even require a privately-owned firm to act in a socially responsible manner or, more modestly, to cease activities that are deemed to harm society or the general welfare in a multi-country context? (shrink)

Drawing on a conception of scientists and community members as partners in the construction of ethically responsible research practices, this article urges investigators to seek the perspectives of teenagers and parents in evaluating the personal and political costs and benefits of research on adolescent risk behaviors. Content analysis of focus group discussions involving over 100 parents and teenagers from diverse ethnic and socioeconomic backgrounds revealed community opinions regarding the scientific merit, social value, racial bias, and participant and group harms and (...) benefits associated with surveys, informant reports, intervention studies, blood sampling, and genetic research on youth problems. Participant comments highlight new directions for socially responsible research. (shrink)

A generation before Beardsley, legal scholar John Henry Wigmore invented a scheme for representing arguments in a tree diagram, aimed to help advocates analyze the proof of facts at trial. In this essay, I describe Wigmore's "Chart Method" and trace its origin and influence. Wigmore, I argue, contributes to contemporary theory in two ways. His rhetorical approach to diagramming provides a novel perspective on problems about the theory of reasoning, premise adequacy, and dialectical obligations. Further, he advances a novel solution (...) to the problem of assessing argument quality by representing the strength of argument in meeting objections. (shrink)

Whether intended or not, conceptions of informed consent are often rooted in archetypal notions of the researcher and prospective study participant. The former is assumed problematically to be a disinterested yet humanitarian individual who is well trained to conduct robust science. The latter is often characterized as being motivated by some altruistic notions about the contribution to science and society they are making even as they seek some personal benefit from the research. Cast in a dyad, the researcher has the (...) responsibility to inform the participant thoroughly about the purpose of the research, the risks and benefits of participation, and any alternatives to research available, as well as the .. (shrink)

Human judgements are affected by the words in which information is presented —or ‘framed’. According to the standard gloss, ‘framing effects’ reveal counter-normative reasoning, unduly affected by positive/negative language. One challenge to this view suggests that number expressions in alternative framing conditions are interpreted as denoting lower-bounded (minimum) quantities. However, it is unclear whether the resulting explanation is a rationalising one. I argue that a number expression should only be interpreted lower-boundedly if this is what it actually means. I (...) survey how number expressions might be assigned lower-bounded meanings, due to their conventional semantics or pragmatic enrichment in context. I argue that deciding between these possibilities requires foundational philosophical input. (shrink)

IntroductionCerebral visual impairment results from damage to cerebral visual processing structures. It is the most common cause of pediatric visual impairment in developed countries and rising in prevalence in developing nations. There is currently limited understanding on how neurologic, developmental, and ophthalmic factors predict outcome for pediatric CVI.MethodA retrospective manual chart review of pediatric CVI patients seen at the tertiary pediatric hospital neurology and neuro-ophthalmology service between 2010 and 2019 was conducted. Patients were stratified into severity groups, and followed over (...) time to identify outcome predictors. Collected baseline characteristics included perinatal, genetic, developmental, and neurologic history, along with neuroimaging and fundoscopic findings on examination. Longitudinal data collected included age, seizure control, and type of therapy received. Linear mixed-effect models were used for longitudinal CVI grade outcome analysis.ResultsA total of 249 individuals spanning 779 patient visits were identified. Mean age at diagnosis was 18.8 ± 16.8 months. About 64.3% were born at term age. Perinatal history revealed hypoxic ischemic encephalopathy in 16.5%, intraventricular hemorrhage in 11.6%, and seizures in 21.7%. At presentation, 60.3% had a diagnosis of cerebral palsy and 84.7% had developmental delay. Among all subjects, 78.6% had epilepsy; 33.8% had an epileptic encephalopathy, with spasms/hypsarrhythmia being most common. Abnormal neuroimaging was present in 93.8%. Genetic anomalies were present in 26.9%. Baseline visual examination revealed no blink-to-light in 24.5%; only BTL in 34.5%, fixation/tracking in 26.5%, and optokinetic drum follow in 14.4%. Longitudinal data analysis showed that perinatal history of HIE, a positive epilepsy history, using multiple epilepsy medications, cerebral palsy, and abnormal fundoscopic findings were all negatively associated with CVI grade change over time. After controlling for significant confounders, receiving any type of therapy [early childhood intervention, physical and occupational therapy, refractive error correction or glasses] was significantly associated with longitudinal improvement in CVI grade compared to patients who did not receive any therapy, with glasses yielding the largest benefit.ConclusionThis study offers extensive insights into neurologic, developmental and ophthalmologic features in patients with moderate to severe CVI. In concordance with previous findings, aspects of perinatal history and epilepsy/seizure control may help inform severity and prognosis in the general neurology or ophthalmology clinic. Conversely, these aspects, as well as genetic and specific epilepsy traits may alert vision health care providers in the clinic to pursue visual evaluation in at-risk individuals. Longitudinal follow-up of CVI patients showed that interventional therapies demonstrated vision function improvement greater than no therapy and maturational development. (shrink)

We present experimental evidence that people's modes of social interaction influence their construal of truth. Participants who engaged in cooperative interactions were less inclined to agree that there was an objective truth about that topic than were those who engaged in a competitive interaction. Follow-up experiments ruled out alternative explanations and indicated that the changes in objectivity are explained by argumentative mindsets: When people are in cooperative arguments, they see the truth as more subjective. These findings can help inform research (...) on moral objectivism and, more broadly, on the distinctive cognitive consequences of different types of social interaction. (shrink)

Beyond belief change and meme adoption, both genetics and infection have been spoken of in terms of information transfer. What we examine here, concentrating on the specific case of transfer between sub-networks, are the differences in network dynamics in these cases: the different network dynamics of germs, genes, and memes. Germs and memes, it turns out, exhibit a very different dynamics across networks. For infection, measured in terms of time to total infection, it is network type rather than degree (...) of linkage between sub-networks that is of primary importance. For belief transfer, measured in terms of time to consensus, it is degree of linkage rather than network type that is crucial. Genes model each of these other dynamics in part, but match neither in full. For genetics, like belief transfer and unlike infection, network type makes little difference. Like infection and unlike belief, on the other hand, the dynamics of genetic information transfer within single and between linked networks are much the same. In ways both surprising and intriguing, transfer of genetic information seems to be robust across network differences crucial for the other two. (shrink)

: This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function (...) as root causes of therapeutic misconceptions. (shrink)

Fisher, Jin, and Scott push a central assumption of syntactic bootstrapping: that learners have a universal bias to map each noun in a sentence onto a participant role (i.e., argument of the verb). They propose two enrichments: First, that children use both semantic and syntactic information in representing nouns that accompany a verb; second, that children expect continuity across a discourse. They provide evidence for both learning mechanisms among young children, further spelling out the precise mechanisms underlying syntactic (...) bootstrapping. (shrink)

In this paper we make a simple theoretical point using a practical issue as an example. The simple theoretical point is that robustness is not 'all or nothing': in asking whether a system is robust one has to ask 'robust with respect to what property?' and 'robust over what set of changes in the system?' The practical issue used to illustrate the point is an examination of degrees of linkage between sub-networks and a pointed contrast in robustness and fragility between (...) the dynamics of (1) contact infection and (2) information transfer or belief change. Time to infection across linked sub-networks, it turns out, is fairly robust with regard to the degree of linkage between them. Time to infection is fragile and sensitive, however, with regard to the type of sub-network involved: total, ring, small world, random, or scale-free. Aspects of robustness and fragility are reversed where it is belief updating with reinforcement rather than infection that is at issue. In information dynamics, the pattern of time to consensus is robust across changes in network type but remarkably fragile with respect to degree of linkage between sub-networks. These results have important implications for public health interventions in realistic social networks, particularly with an eye to ethnic and socio-economic sub-communities, and in social networks with sub-communities changing in structure or linkage. (shrink)

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" (§ 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have (...) helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria. (shrink)

This article surveys the latest research on risky-choice framing effects, focusing on the implications for rational decision-making. An influential program of psychological research suggests that people's judgements and decisions depend on the way in which information is presented, or ‘framed’. In a central choice paradigm, decision-makers seem to adopt different preferences, and different attitudes to risk, depending on whether the options specify the number of people who will be saved or the corresponding number who will die. It is standardly (...) assumed that such responses violate a foundational tenet of rational decision-making, known as the principle of description invariance. We discuss recent theoretical and empirical research that challenges the dominant ‘irrationalist’ narrative. These approaches typically pay close attention to how decision-makers represent decision problems (including their interpretation of numerical quantifiers or predicate choice) and they highlight the need for a more robust characterization of the description invariance principle. We conclude by indicating avenues for future research that could bring us closer to a complete—and potentially rationalizing—explanation of framing effects. (shrink)

It is widely accepted that the way information transfers across networks depends importantly on the structure of the network. Here, we show that the mechanism of information transfer is crucial: in many respects the effect of the specific transfer mechanism swamps network effects. Results are demonstrated in terms of three different types of transfer mechanism: germs, genes, and memes. With an emphasis on the specific case of transfer between sub-networks, we explore both the dynamics of each of these (...) across networks and a measure of their comparative fitness. Germ and meme transfer exhibit very different dynamics across linked networks. For germs, measured in terms of time to total infection, network type rather than degree of linkage between sub-networks is the primary factor. For memes or belief transfer, measured in terms of time to consensus, it is the opposite: degree of linkage trumps network type in importance. The dynamics of genetic information transfer is unlike either germs or memes. Transfer of genetic information is robust across network differences to which both germs and memes prove sensitive. We also consider function: how well germ, gene, and meme transfer mechanisms can meet their respective objectives of infecting the population, mixing and transferring genetic information, and spreading a message. A shared formal measure of fitness is introduced for purposes of comparison, again with an emphasis on linked sub-networks. Meme transfer proves superior to transfer by genetic reproduction on that measure, with both memes and genes superior to infection dynamics across all networks types. What kinds of network structure optimize fitness also differ among the three. Both germs and genes show fairly stable fitness with added links between sub-networks, but genes show greater sensitivity to the structure of sub-networks at issue. Belief transfer, in contrast to the other two, shows a clear decline in fitness with increasingly connected networks. When it comes to understanding how information moves on networks, our results indicate that questions of information dynamics on networks cannot be answered in terms of networks alone. A primary role is played by the specific mechanism of information transfer at issue. We must first ask about how a particular type of information moves. (shrink)

I use the psychological phenomenon of ‘attribute framing’ as a case study for exploring philosophical conceptions of semantics and the semantics-pragmatics divide. Attribute frames are pairs of sentences that use contradictory expressions to predicate the same property of an individual or object. Despite their equivalence, pairs of attribute frames have been observed to induce systematic variability in hearers’ responses. One explanation of such framing effects appeals to the distinct ‘reference point information’ conveyed by alternative frames. Although this information (...) is taken to be pragmatic, a live debate in the philosophy of language concerns the extent to which pragmatic information can really be held apart from semantics. Therefore, in this article I examine whether – and how – reference point information might be thought to intrude on the semantics of an attribute frame. I describe two ways in which the information might be considered broadly semantic, due to its being directly communicated or conventional. However, I argue that the framing data in fact support a narrower conception of semantics, and a semantics-pragmatics distinction that separates standing sentence meaning from enriched communicated meaning. (shrink)

Understanding the dynamics of information is crucial to many areas of research, both inside and outside of philosophy. Using computer simulations of three kinds of information, germs, genes, and memes, we show that the mechanism of information transfer often swamps network structure in terms of its effects on both the dynamics and the fitness of the information. This insight has both obvious and subtle implications for a number of questions in philosophy, including questions about the nature (...) of information, whether there is genetic information, and how to arrange scientific communities. (shrink)

Does expertise within a domain of knowledge predict accurate self-assessment of the ability to explain topics in that domain? We find that expertise increases confidence in the ability to explain a wide variety of phenomena. However, this confidence is unwarranted; after actually offering full explanations, people are surprised by the limitations in their understanding. For passive expertise, miscalibration is moderated by education; those with more education are accurate in their self-assessments. But when those with more education consider topics related to (...) their area of concentrated study, they also display an illusion of understanding. This “curse of expertise” is explained by a failure to recognize the amount of detailed information that had been forgotten. While expertise can sometimes lead to accurate self-knowledge, it can also create illusions of competence. (shrink)

Background: Many people participating in dementia research may lack capacity to give informed consent and the relationship between cognitive function and capacity remains unclear. Recent changes in the law reinforce the need for robust and reproducible methods of assessing capacity when recruiting people for research.Aims: To identify numbers of capacitous participants in a pragmatic randomised trial of dementia treatment; to assess characteristics associated with capacity; to describe a legally acceptable consent process for research.Methods: As part of a pragmatic randomised controlled (...) trial of Ginkgo biloba for mild-moderate dementia, we used a consenting algorithm that met the requirements of existing case law and the exigencies of the new Mental Capacity Act. We decided who had capacity to give informed consent for participation in the trial using this algorithm and sought predictors of capacity.Results: Most participants with mild-moderate dementia in this trial were unable to give informed consent according to the legal criteria. When adjusted for confounding, the Mini Mental State examination did not predict the presence of capacity.Conclusion: Cognitive testing alone is insufficient to assess the presence of capacity. Researchers and clinicians need to be aware of the challenging processes regarding capacity assessment. We outline a procedure which we believe meets the ethical and legal requirements. (shrink)

Three widely accepted principles – autonomy, beneficence and justice – provide a useful analytic framework for considering controversies and conflicts in bioethics. Since these principles capture key concepts found in diverse normative theories they provide a starting point from which consistent ethical analysis and comparison can begin. While justice is commonly discussed in the business ethics literature, the other two principles are not widely discussed. This paper investigates whether the principles of autonomy and beneficence provide a framework that is equally (...) useful for framing issues in business ethics. It is argued that they do. First, the principle of autonomy, with its associated notions of informed consent, privacy, confidentiality, voluntariness, self-mastery, and so on, provides a consistent approach to the analysis of diverse issues that arise in business ethics from market research to recruitment practices. Second, it is argued that the relationships between a business and its stakeholders ground duties of beneficence. The principle of beneficence provides a framework for considering the issues that arise in these relationships. (shrink)

This paper poses questions regarding the ethical prioritisation in qualitative research studies on assessing a person's or a group's fitness to provide informed consent, arguing that this may have unwanted as well as desirable consequences, particularly in relation to rights of citizenship for socially marginalised populations who tend to be labelled vulnerable. Drawing on three theoretical perspectives (Arendt, Honneth and Bourdieu), it is suggested that the emphasis placed on a research participant's capacity to provide informed consent cannot be regarded solely (...) as a protective measure for ?vulnerable? groups, but is also bound up with their social positioning as socially ?deficient? according to liberal (classical and neo-liberal) models of citizenship. Participation in a qualitative study can be seen as a dimension of the civil and human right to freedom of expression, and this can be particularly important for those labelled vulnerable as freedom of expression is a precondition for recognition and parity of status. Nevertheless, the importance of informed consent is not rejected; instead, it is posited that the protective rights accorded to vulnerable groups in qualitative research need to be considered alongside other human goods, such as the promotion of voice, agency and active citizenship. (shrink)

Framing effects occur when people respond differently to the same information, just because it is conveyed in different words. For example, in the classic ‘Disease Problem’ introduced by Amos Tversky and Daniel Kahneman, people’s choices between alternative interventions depend on whether these are described positively, in terms of the number of people who will be saved, or negatively in terms of the corresponding number who will die. In this paper, I discuss an account of framing effects based on ‘fuzzy-trace (...) theory’. The central claim of this account is that people represent the numbers in framing problems in a ‘gist-like’ way, as ‘some’; and that this creates a categorical contrast between ‘some’ people being saved (or dying) and ‘no’ people being saved (or dying). I argue that fuzzy-trace theory’s gist-like representation, ‘some’, must have the semantics of ‘some and possibly all’, not ‘some but not all’. I show how this commits fuzzy-trace theory to a modest version of a rival ‘lower bounding hypothesis’, according to which lower-bounded interpretations of quantities contribute to framing effects by rendering the alternative descriptions extensionally inequivalent. As a result, fuzzy-trace theory is incoherent as it stands. Making sense of it requires dropping, or refining, the claim that decision-makers perceive alternatively framed options as extensionally equivalent; and the related claim that framing effects are irrational. I end by suggesting that, whereas the modest lower bounding hypothesis is well supported, there is currently less evidence for the core element of the fuzzy trace account. (shrink)

Although there is clearly a need for evidenced‐based behavioral or biomedical prevention or treatment programs for suicide, substance abuse, and sexual health targeted to members of the LGBT population under the age of eighteen, few such programs exist, due in substantial part to limited research knowledge. Ambiguities in regulations that govern human subjects protections and the related inconsistencies in institutional review board (IRB) interpretations of regulatory language are the key reason for the lack of rigorous clinical trial evidence to support (...) treatment choices and prevention approaches to reducing health disparities for this population. Given the socially sensitive nature of suicide, substance abuse, and HIV and STI research in general and LGBT research specifically, in the absence of empirical data to guide their decisions, IRBs must often rely on subjective judgments of minimal risk, which can lead to overestimation of the magnitude and probability of psychological, social, and informational harms that might arise from LGBT youth participation in clinical trials. In addition, more than other youth, LGBT adolescents whose families are unaware of their sexual orientation or gender identity or whose families have victimized them on account of it may be reluctant to participate in studies that require guardian permission. This, in turn, intensifies problems of recruitment and unbiased sampling. However, many IRBs are reluctant to apply federal regulations permitting waiver of guardian permission under conditions in which such permission is clearly not “feasible” or “reasonable” to require. Consequently, many investigators have excluded LGBT individuals under eighteen years of age in health intervention research proposals because of anticipated or actual difficulties obtaining IRB approval. This situation is in conflict with current ethical discourse focusing on the right of youths to participate in trials that will protect them from receiving developmentally untested, inappropriate, and unsafe treatments. In this article, we describe these barriers and recommendations for providing LGBT youth safe and fair access to health research. (shrink)

A public good has two defining properties: It is non-rivalrous: consumption of the good by one party does not reduce the ability of any other party to consume that good. It is non-excludable: it is not possible to prevent anyone from consuming it. The opposite of a public good is a private good. A private good has the following properties: Consumption of it is rivalrous: in as much as one person uses or consumes it, another person cannot use or consume (...) it. It is excludable: it is possible to exclude people from using it. The difference between private and public goods has implications for making decisions about who pays for them. The rivalrous property of a private good makes it desirable that the consumer of the good should be the one to pay for it; the excludable property of a private good makes it possible to charge the consumer for consuming it – if you don't pay then you will be excluded from having or using it. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

Taking up the notion of engineering as social experimentation, this paper argues that engineering research laboratory directors have a responsibility to inform graduate engineering students who participate in their research projects of the potential broader social dimensions of those projects. Informing engineers-in-the-making of the broader social dimensions of the research they are learning to conduct would help ensure their future capacity to act as ethically responsible social experimenters. The paper also argues that graduate engineers have a right to be informed (...) participants in activities that may have broader social dimensions than are recognized by formal research evaluation or educational processes. The process of obtaining the informed consent of graduate engineering students, if implemented effectively, would thus help ensure both their capacity to act as moral agents and their own moral integrity. Since the eventual outcomes of research can be uncertain, complex, and contested, most traditional institutional frameworks—such as principle-based codes of conduct and risk-benefit frameworks—provide an insufficient basis to inform engineers and citizens. Rather, we recommend an ongoing discursive process that explores a number of different actors, contexts, and scenarios, and that evolves with the social context of the engineering research in question. While this may seem burdensome to the engineering research process, it can be integrated directly into the group research meetings and mentorship activities that typically already go on. Moreover, it can actually be seen to benefit engineering practices. (shrink)

This paper poses questions regarding the ethical prioritisation in qualitative research studies on assessing a person's or a group's fitness to provide informed consent, arguing that this may have unwanted as well as desirable consequences, particularly in relation to rights of citizenship for socially marginalised populations who tend to be labelled vulnerable. Drawing on three theoretical perspectives (Arendt, Honneth and Bourdieu), it is suggested that the emphasis placed on a research participant's capacity to provide informed consent cannot be regarded solely (...) as a protective measure for ‘vulnerable’ groups, but is also bound up with their social positioning as socially ‘deficient’ according to liberal (classical and neo-liberal) models of citizenship. Participation in a qualitative study can be seen as a dimension of the civil and human right to freedom of expression, and this can be particularly important for those labelled vulnerable as freedom of expression is a precondition for recognition and parity of status. Nevertheless, the importance of informed consent is not rejected; instead, it is posited that the protective rights accorded to vulnerable groups in qualitative research need to be considered alongside other human goods, such as the promotion of voice, agency and active citizenship. (shrink)

Generation and heredity theories before early modern mechanist accounts might be faulted for numerous deficits. One might cite in this regard the failure to even attempt to explain how the inheritance of traits could occur, given what is known about the generation of new individuals. On the other hand, it would be hard to allow this as a true failure against the backdrop of a generation theory that poses form, and not matter, as the key to understanding the emergence of (...) new structures in the offspring of two organisms. Hence the signal contribution of the mechanist accounts in this sphere was simply the suggestion that theories of generation and heredity might look to matter and its behavior in order to explain how new individuals are created and retain or discard features of the individuals whence they sprung. Among these accounts, one early important set of views was presented by Pierre Gassendi, eventually as a full-blown atomist conjecture but even beforehand, and early on, as a thoroughgoing materialist theory. Gassendi's materialist mechanism for the transmission of traits is imperfect (and by the common sense of our day, implausible), not always or exclusively deployed in generation, and not clearly the physical bearer of information, as conformity to a materialist model would suggest. Nonetheless, his proposed mechanism represents a valuable attempt to provide an account of inheritance phenomena in materialist and ultimately atomist terms and rooted in an account of generation. (shrink)

In order to understand the transmission of a disease across a population we will have to understand not only the dynamics of contact infection but the transfer of health-care beliefs and resulting health-care behaviors across that population. This paper is a first step in that direction, focusing on the contrasting role of linkage or isolation between sub-networks in (a) contact infection and (b) belief transfer. Using both analytical tools and agent-based simulations we show that it is the structure of a (...) network that is primary for predicting contact infection—whether the networks or sub-networks at issue are distributed ring networks or total networks (hubs, wheels, small world, random, or scale-free for example). Measured in terms of time to total infection, degree of linkage between sub-networks plays a minor role. The case of belief is importantly different. Using a simplified model of belief reinforcement, and measuring belief transfer in terms of time to community consensus, we show that degree of linkage between sub-networks plays a major role in social communication of beliefs. Here, in contrast to the case of contract infection, network type turns out to be of relatively minor importance. What you believe travels differently. In a final section we show that the pattern of belief transfer exhibits a classic power law regardless of the type of network involved. (shrink)

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects’ compliance to study protocols. Concern with these two critical issues leads drug companies to approach (...) clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. (shrink)

The aim of this paper is to engage with the interplay between representational content and design in chemistry and to explore some of its epistemological consequences. Constraints on representational content arising from the aspectual structure of representation can be manipulated by design. Designs are epistemologically important because representational content, hence our knowledge of target systems in chemistry, can change with design. The significance of this claim is that while it has been recognised that the way one conveys information makes (...) a difference to the inferences one can draw from representations in spite of the invariance of informational content, the present paper argues that in chemistry and biochemistry it is often the case that designs have cognitive priority relative to informational content. (shrink)

Although therapist sexual attraction to clients is common, and therapist self-disclosure is an often-used intervention, therapist self-disclosure of sexual feelings to clients is an understudied phenomenon. In this article, I critically review the small base of literature on therapist self-disclosure of sexual feelings, including information on prevalence rates, empirical research, and case studies. By incorporating these findings with information from relevant sections of the American Psychological Association (2002) Ethics Code, my intent is to evaluate different aspects of therapist (...) self-disclosure of sexual feelings and arrive at conclusions regarding therapists' use of these disclosures. It appears that direct, explicit disclosures of sexual feelings can run the risk of harming clients and may therefore be unethical. Therefore, the use of this technique is discouraged. I discuss the issue of using less explicit interventions. (shrink)

Researchers studying at-risk and socially disenfranchised child and adolescent populations are facing ethical dilemmas not previously encountered in the laboratory or the clinic. One such set of ethical challenges involves whether to: (a) share with guardians research derived information regarding participant risk, (b) provide participants with service referrals, or (c) report to local authorities problems uncovered during the course of investigation. The articles assembled for this special section address the complex issues of deciding if, when, and how to report (...) or provide referrals for research participants who are minors (referred to hereafter as minor research participants). This paper focuses on two factors underlying these decisions: the validity of risk estimates and meta-ethical positions on scientific responsibility. It is suggested that, before sharing information about minor research participants investigators should do the following: critically examine the diagnostic validity of developmental measures, include the scope and limitations of information sharing in informed consent procedures, and become familiar with state reporting laws. I discuss the impact of the traditionally accepted act utilitarian meta-ethical position on the investigator-participant relationship, and I recommend consideration of alternative positions as a step toward developing a research ethic of scientific responsibility and care. (shrink)

This editorial introduces a revised set of publication requirements for papers, submitted to Homeopathy, that involve animal experimentation. Journals that publish studies involving animal experimentation have a major role to play in the maintenance of ethical standards because researchers are reliant upon them for publication of their findings. With an increasing global trend towards greater transparency and accountability in animal experimentation, many academic journals, such as the British Journal of Pharmacology, 1 and 2 are taking action to improve reporting standards. (...) In recognition of this need, members of Homeopathy's Editorial Board have been working together to examine the scientific rationale and the most relevant ethical guidelines for the use of animals in research. In addition, they have examined existing published studies in homeopathy research and current practice within the broad domain of medical research. Each of these aspects has informed the revised publication policy, whose overarching objectives are to maximise the ethical standards and scientific quality of animal research in homeopathy, and thereby ultimately to avoid any unnecessary suffering of animals used in such research. The following description details the background that was considered, the rationale for this development, and the steps that will be taken. (shrink)

This provocative book paved the way for nursing research informed by f eminist scholarship, critical theory, and post-modern thought. Controv ersial then, relevant today.

Objective Recent legislation mandating the inclusion of children in clinical trials has resulted in an increase in the number of children participating in research. We reviewed the literature regarding the reasons parents chose to accept or decline an invitation to enrol their children in clinical research. Methods We searched for qualitative studies, written in the English language that considered the experiences of parents who had been invited to enrol their children in research. SCOPUS and Web of Knowledge electronic databases and (...) reference lists of retrieved articles and review papers were searched. Retrieved articles were synthesised using the narrative synthesis method. Results 16 qualitative studies exploring the experiences of parents living in five countries whose children had a range of health conditions of varying severity were included. The health status of the child appeared to influence parents' reasons for participation. Parents whose children had life threatening conditions often considered they had no choice but to participate and many welcomed the innovation offered through research participation. Such parents also viewed the risks of research less negatively than those whose children were healthy or in the stable stage of a chronic condition. This raises questions regarding the voluntariness of informed consent by such parents. Conclusions A tailored approach is needed when discussing research participation with parents of eligible children. While parents of healthy children may be more open to discussions of altruism, those whose children have life threatening illnesses should be given adequate information about the alternatives to, and risks of, research participation. (shrink)