In a recent paper in this journal, John Worrall (2008) used the example of a series of trials involving extracorporeal membrane oxygenation (ECMO), a technology for the treatment of respiratory failure in newborns, to illustrate the relationship between ethics and epistemology in medical research. One of the issues considered was whether or not it was ethical to perform a particular clinical trial at all, and he showed clearly that the answer was intimately related to epistemological judgments about the weight to (...) be given existing evidence concerning treatment effectiveness. In the case of ECMO, a trial was initiated at the University of Michigan (Bartlett et al. 1985), despite the fact that the researchers had .. (shrink)

Rationale Despite their inherently pervasive limitations, data from observational studies are increasingly relied upon by health car.

Background: Waiving parent permission can be an option in some epidemiological and social research with adolescents. However, exemptions have not been uniformly considered or applied. Our aim is to critically assess the different factors that could be taken into account when making decisions about waiving active parental permission in observational research with adolescents.DiscussionIn some cases alternatives to parental permission could be applied to protect the rights of both adolescents and parents and also to assure the benefits to adolescents as (...) a group that can come from appropriately conducted studies. However, the criteria of ensuring minimal risk can be difficult to define and apply and a distinction between harm and discomfort is reviewed. Waiving active parental permission could be acceptable when the risk of harm is minimal; when the research questions are related to an activity for which adolescents are not legally considered to be children; when the risk of harm or discomfort may increase if parental permission is required; and when risk of discomfort is low because the questionnaire is not potentially offensive for some adolescents and/or for some parents.SummaryStringent rules concerning parental permission in some studies could be detrimental to adolescents. A framework and a decision tree guide are proposed to help researchers and Research Ethics Committees in their decisions on whether active parental permission must be obtained. (shrink)

In the following dialogue between TT - a foundationalist - and WdeV - a Sellarsian, we offer our differing assessments of the principle for observational knowledge proposed in Wilfrid Sellars's 'Empiricism and the Philosophy of Mind'. Sellars writes: 'For a Konstatierung "This is green" to "express observational knowledge", not only must it be a symptom or sign of the presence of a green object in standard conditions, but the perceiver must know that tokens of "This is green" are (...) symptoms of the presence of green objects in conditions which are standard for visual perception.' In the ensuing dialogue, TT argues that it sets the bar too high when knowledge about perceptual conditions is required for ordinary observational knowledge - that young children, for example, are implausibly excluded as knowers given Sellars's principle. WdeV defends Sellars's metaknowledge requirement against these charges. Results from developmental psychology are surveyed for what they show about the actual capabilities of young children. The implications of these results for the success of Sellars's principle are debated. (shrink)

Exploiting the skills of others enables individuals to reduce the risks and costs of resource innovation. Social corvids are known to possess sophisticated social and physical cognitive abilities. However, their capacity for imitative learning and its inter-individual transmission pattern remains mostly unexamined. Here we demonstrate the large-billed crows' ability to learn problem-solving techniques by observation and the dominance-dependent pattern in which this technique is transmitted. Crows were allowed to observe one of two box-opening behaviours performed by a dominant or subordinate (...) demonstrator and then tested regarding action and technique. The observers successfully opened the box on their first attempts by using non-matching actions but matching techniques to those observed, suggesting emulation. In the subsequent test sessions, dominant observers (i.e. those dominant to the bird acting as demonstrator) consistently used the learned technique, whereas subordinates (i.e. those subordinate to the bird acting as demonstrator) learned alternative techniques by explorative trial and error. Our findings demonstrate crows' capacity to learn by observing behaviours and the effect of dominance on transmission patterns of behavioural skills. Keywords: social learning; imitation; emulation; affordance; culture; innovation. (shrink)

Evidence-based medicine (EBM) ranks different medical research methods on a hierarchy, at the top of which are randomized controlled trials (RCTs) and systematic reviews or meta-analyses of RCTs. Any study that does not randomly assign patients to a treatment or a control group is automatically placed at a lower level on the hierarchy. This article argues that what matters is whether the treatment and control groups are similar with respect to potential confounding factors, not whether they got that way through (...) randomization. Moreover, nonrandomized studies tend to have other characteristics that make them useful sources of evidence, in that they tend to last longer and to enroll more patients than do randomized trials. Replacing the sharp dichotomy between randomized and nonrandomized studies with a continuum from "clean" studies (which have high internal validity but whose results do not readily generalize to clinical practice) to pragmatic studies (which are designed to more closely reflect clinical practice) would also make a place for outcomes research and research using clinical databases, which are not included in the current hierarchy of evidence but which can provide important information about the safety and efficacy of treatments. (shrink)

Based on observations and interviews collected during a yearlong ethnography of two anatomy laboratory courses at a large Midwestern university, this article argues that students learn anatomy through the formation of an observational-embodied look. All of the visual texts and material objects of the lab—from atlas illustrations, to photographs, to 3D models, to human bodies—are involved in this look that takes the form of anatomical demonstration and dissection. The student of anatomy, then, brings together observation, visual evidence, haptic experience, (...) and anatomical-medical knowledge to identity as anatomy those objects on display. Through an interrogation of and reflection on the bodies of the course, the participants must learn to recognize and appreciate the descriptive and relational values of anatomical evidence, and in the process develop the habitus of anatomists. Drawing from the work of Maurice Merleau-Ponty, Pierre Bourdieu, and Herbert Dreyfus, the author seeks to both uncover how students learn anatomy as well as articulate a theory of embodied learning. (shrink)

In this article I examine two mathematical definitions of observational equivalence, one proposed by Charlotte Werndl and based on manifest isomorphism, and the other based on Ornstein and Weiss’s ε-congruence. I argue, for two related reasons, that neither can function as a purely mathematical definition of observational equivalence. First, each definition permits of counterexamples; second, overcoming these counterexamples will introduce non-mathematical premises about the systems in question. Accordingly, the prospects for a broadly applicable and purely mathematical definition of (...) observational equivalence are unpromising. Despite this critique, I suggest that Werndl’s proposals are valuable because they clarify the distinction between provable and unprovable elements in arguments for observational equivalence. (shrink)

The Energy-Time Uncertainty (ETU) has always been a problem-ridden relation, its problems stemming uniquely from the perplexing question of how to understand this mysterious Δ t . On the face of it (and, indeed, far deeper than that), we always know what time it is. Few theorists were ignorant of the fact that time in quantum mechanics is exogenously defined, in no ways intrinsically related to the system. Time in quantum theory is an independent parameter, which simply means independently known (...) . In the early 1960s Aharonov (1961-64) and Bohm (1961-64) mounted a spirited attack against the ETU, which sealed its fate to the present date. By emphasising that time is always “well-defined” in quantum theory, they were led to the conclusion that no ETU should exist, a view shared by many in the 1990s, if Busch (1990) is to be believed. In a similar vein, I emphasize that (a) physical systems occupy a particular energy state at a particular instant of time, if at all; (b) even in absence of all time-measuring instruments, it is still trivially warranted that one can measure a system's energy as accurately as one pleases, and simply announce “The system's energy is exactly E NOW!”, a possibility which no quantum mechanics of any sort, or any physical theory whatsoever, can afford to tamper with or change, except circularly. One never loses one's own perception of time, when one measures the energy, a fact which no measurement conceivable can interfere with or affect. Both (a) and (b) uniquely entail that energy and time are compatible, if not indeed intimately interconnected, contrary to what the relevant uncertainty seems to affirm. In response to Aharonov's and Bohm's initial problem, I reinterpret ΔEΔt ≥ h , as directly derived from authentic quantum principles, without however having to assume a direct incompatibility between its related concepts, attributing their complementarity to conditions other than ordinarily assumed. (shrink)

We review the observational foundations of the ΛCDMΛCDM model, considered by most cosmologists as the standard model of cosmology. The Cosmological Principle, a key assumption of the model is shown to be verified with increasing accuracy. The fact that the Universe seems to have expanded from a hot and dense past is supported by many independent probes . The explosion of detailed observations in the last few decades has allowed for precise measurements of the cosmological parameters within Friedman–Lemaître–Robertson–Walker cosmologies (...) leading to the ΛCDMΛCDM model: an apparently flat Universe, dominated by a cosmological constant, whose matter component is dominantly dark. We describe and discuss the various observational probes that led to this conclusion and conclude that the ΛCDMΛCDM model, although leaving a number of open questions concerning the deep nature of the constituents of the Universe, provides the best theoretical framework to explain the observations. (shrink)

Gender based sociological and linguistic studies show that differences exist in communication style of men and women, boys and girls. Although many gender stereotypes have changed with modernization and awareness about gender issues however common assumption is that ‘girls are talkative’ and boys are ‘less emotional’. In the context of transitions in culture and society, this study explored verbal and nonverbal communication differences among male and female university students. Using purposive sampling method, male and female students were observed in (...) three types of groups sitting at different social spots in University of Karachi. In total 30 male and 30 female students were observed for verbal and nonverbal communication. The units of observations were Paralanguage for verbal communication and gestures, facial expressions, eye contact, distance and space when sitting and standing. Results showed that overall both boys and girls were talkative and used slang language within same sex groups. However, the topic of discussion was personal for girls and politics for boys. Females kept a space and distance while sitting and standing as compared to boys. Within groups, male and female student’s body language showed superiority. The study has limitations therefore generalization of results for other gender-typed situations are not promising. Future studies could examine in other situations where status and power difference exist within relationships. (shrink)

Exploiting the skills of others enables individuals to reduce the risks and costs of resource innovation. Social corvids are known to possess sophisticated social and physical cognitive abilities. However, their capacity for imitative learning and its inter-individual transmission pattern remains mostly unexamined. Here we demonstrate the large-billed crows' ability to learn problem-solving techniques by observation and the dominance-dependent pattern in which this technique is transmitted. Crows were allowed to observe one of two box-opening behaviours performed by a dominant or subordinate (...) demonstrator and then tested regarding action and technique. The observers successfully opened the box on their first attempts by using non-matching actions but matching techniques to those observed, suggesting emulation. In the subsequent test sessions, dominant observers consistently used the learned technique, whereas subordinates learned alternative techniques by explorative trial and error. Our findings demonstrate crows' capacity to learn by observing behaviours and the effect of dominance on transmission patterns of behavioural skills. Keywords: social learning; imitation; emulation; affordance; culture; innovation. (shrink)

ABSTRACTThe aim of this observational study is to explore how history teachers promote historical contextualisation in their lessons. Historical contextualisation is the ability to situate phenomen...

Informed consent represents a cornerstone of the endeavours to make health care research ethically acceptable. Based on experience of qualitative research on power dynamics in nursing care in acute psychiatry, we show that the requirement for informed consent may be practised in formalistic ways that legitimize the researcher's activities without taking the patient's changing perception of the situation sufficiently into account. The presentation of three patient case studies illustrates a diversity of issues that the researcher must consider in each (...) situation. We argue for the necessity of researchers to base their judgement on a complex set of competencies. Consciousness of research ethics must be combined with knowledge of the challenges involved in research methodology in qualitative research and familiarity with the therapeutic arena in which the research is being conducted. The article shows that the alternative solution is not simple but must emphasize the researcher's ability to doubt and be based on an awareness of the researcher's fallibility. (shrink)

BackgroundWinning funding for health and medical research usually involves a lengthy application process. With success rates under 20%, much of the time spent by 80% of applicants could have been better used on actual research. An alternative funding system that could save time is using democracy to award the most deserving researchers based on votes from the research community. We aimed to pilot how such a system could work and examine some potential biases.MethodsWe used an online survey with a convenience (...) sample of Australian researchers. Researchers were asked to name the 10 scientists currently working in Australia that they thought most deserved funding for future research. For comparison, we used recent winners from large national fellowship schemes that used traditional peer review.ResultsVoting took a median of 5 min. Extrapolating to a national voting scheme, we estimate 599 working days of voting time, compared with 827 working days for the current peer review system for fellowships. The gender ratio in the votes was a more equal 45:55 compared with 34:66 in recent fellowship winners, although this could be explained by Simpson’s paradox. Voters were biased towards their own institution, with an additional 1.6 votes per ballot above the expected number. Respondents raised many concerns about the idea of using democracy to fund research, including vote rigging, lobbying and it becoming a popularity contest.ConclusionsThis is a preliminary study of using voting that does not investigate many of the concerns about how a voting system would work. We were able to show that voting would take less time than traditional peer review and would spread the workload over many more reviewers. Further studies of alternative funding systems are needed as well as a wide discussion with the research community about potential changes. (shrink)

Research into robotic social learning, especially that concerned with imitation, often focuses at differing ends of a spectrum from observational learning at one end to following or matched-dependent behaviour at the other. We study the implications and differences that arise when carrying out experiments both at the extremes and within this spectrum. Physical Khepera robots with minimal sensory capabilities are used, and after training, experiments are carried out where an imitating robot perceives the dynamic movement behaviours of another model (...) robot carrying a light source. It learns the movement behaviour of the model by either statically observing the model, dynamically observing the model or by following the model. It finally re-enacts the learnt behaviour. We compare the results of these re-enactments and illustrate the differences and trade-offs that arise between static observational and reactive following learning methods. We also consider circumstances where, for this robotic embodiment, dynamic observation has both advantages and disadvantages when compared to static observation. We conclude by discussing the implications that arise from using and combining these types of social learning. (shrink)

A number of arguments have shown that randomization is not essential in experimental design. Scientific conclusions can be drawn on data from experimental designs that do not involve randomization. John Worrall has recently taken proponents of randomized studies to task for suggesting otherwise. In doing so, however, Worrall makes an additional claim: randomized interventional studies are epistemologically equivalent to observational studies, providing the experimental groups are comparable according to background knowledge. I argue against this claim. In (...) the context of testing the efficacy of drug therapies, well-designed interventional studies are epistemologically superior to well-designed observational studies because they have the capacity to avoid a type of selection bias. Although arguments for interventional studies are present in the medical literature, these arguments are too often presented as an argument for randomization. Randomization in interventional studies is defended on Bayesian grounds. (shrink)

Ethical approval must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study. Sixteen European national coordinators of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA. N = 8/16 of the NCs could apply at one single national ethical committee, while the others had to apply to various regional ECs and/or individual hospital institutional research boards. The time between applying (...) for EA and the first decision varied between 7 days and 300 days. In 9/16 informed consent from the patient was not deemed necessary; in 7/16 informed consent was required from the patient or relatives. The upload of coded data to a central database required additional information in 14/16. In 4/16 the NCs had to ask separate approval to keep a subject identification code list to de-pseudonymize the patients if questions would occur. Only 2/16 of the NCs agreed that informed consent was necessary for this observational study. Overall, 6/16 of the NCs were satisfied with the entire process and 8/16 were unsatisfied. 11/16 would welcome a European central EC that would judge observational studies for all European countries. Variations in the process and prolonged time needed to get EA for observational studies hampers inclusion of patients in some European countries. This might have a negative influence on the external validity. Further harmonization of ethical approval process across Europe is welcomed for low-risk observational studies. Getting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries. (shrink)

Background Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals. Methods This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI (...) Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. Results A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies discussed informed consent. Only half of those reported that written informed consent had been obtained; few reported oral consent, and few used other methods such as online consent or completion and return of data collection to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received. Conclusion The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required. (shrink)

In this paper I examine two mathematical definitions of observational equivalence, one proposed by Charlotte Werndl and based on manifest isomorphism, and the other based on Ornstein and Weiss's ε-congruenceε-congruence. I argue, for two related reasons, that neither can function as a purely mathematical definition of observational equivalence. First, each definition permits of counterexamples; second, overcoming these counterexamples will introduce non-mathematical premises about the systems in question. Accordingly, the prospects for a broadly applicable and purely mathematical definition of (...) observational equivalence are unpromising. Despite this critique, I suggest that Werndl's proposals are valuable because they clarify the distinction between provable and unprovable elements in arguments for observational equivalence. (shrink)

23 pages, no figure. Proceedings of "Philosophical Aspects of Modern Cosmology" held in Granada, Spain, 22-23 Sept. 2011. Studies in History and Philosophy of Modern Physics ; doi:10.1016/j.shpsb.2013.02.002.

Background: Black, Asian and minority ethnic groups have a high need for organ transplantation but deceased donation is low. This restricts the availability of well-matched organs and results in relatively long waiting times for transplantation, with increased mortality risks. Objective: To identify barriers to organ donor registration and family consent among the BAME population, and to develop and evaluate a training intervention to enhance communication with ethnic minority families and identify impacts on family consent. Methods: Three-phase programme comprising community-based research (...) involving two systematic reviews examining attitudes and barriers to organ donation and effective interventions followed by 22 focus groups with minority ethnic groups; hospital-based research examining staff practices and influences on family consent through ethics discussion groups with staff, a study on intensive care units and interviews with bereaved ethnic minority families; and development and evaluation of a training package to enhance cultural competence among ICU staff. Setting: Community focus group study in eight London boroughs with high prevalence of ethnic minority populations. Hospital studies at five NHS hospital trusts. Participants: Community studies: 228 focus group participants; hospital studies: 35 nurses, 28 clinicians, 19 hospital chaplains, 25 members of local Organ Donation Committees, 17 bereaved family members; and evaluation: 66 health professionals. Data sources: Focus groups with community residents, systematic reviews, qualitative interviews and observation in ICUs, EDGs with ICU staff, bereaved family interviews and questionnaires for trial evaluation. Review methods: Systematic review and narrative synthesis. Results: Community studies: Organ Donor Register – different ethnic/faith and age groups were at varying points on the ‘pathway’ to organ donor registration, with large numbers lacking knowledge and remaining at a pre-contemplation stage. Key attitudinal barriers were uncertainties regarding religious permissibility, bodily concerns, lack of trust in health professionals and little priority given to registration, with the varying significance of these factors varying by ethnicity/faith and age. National campaigns focusing on ethnic minorities have had limited impact, whereas characteristics of effective educational interventions are being conducted in a familiar environment; addressing the groups’ particular concerns; delivery by trained members of the lay community; and providing immediate access to registration. Interventions are also required to target those at specific stages of the donation pathway. Hospital studies: family consent to donation – many ICU staff, especially junior nurses, described a lack of confidence in communication and supporting ethnic minority families, often reflecting differences in emotional expression, faith and cultural beliefs, and language difficulties. The continuing high proportion of family donation discussions that take place without the collaboration of a specialist nurse for organ donation reflected consultants’ views of their own role in family consent to donation, a lack of trust in SNODs and uncertainties surrounding controlled donations after circulatory death. Hospital chaplains differed in their involvement in ICUs, reflecting their availability/employment status, personal interests and the practices of ICU staff. Evaluation: professional development package – a digital versatile disk-based training package was developed to promote confidence and skills in cross-cultural communication. Initial evaluation produced positive feedback and significant affirmative attitudinal change but no significant difference in consent rate over the short follow-up period with requirements for longer-term evaluation. Limitations: Participants in the focus group study were mainly first-generation migrants of manual socioeconomic groups. It was not permitted to identify non-consenting families for interview with data regarding the consent process were therefore limited to consenting families. Conclusions: The research presents guidance for the effective targeting of donation campaigns focusing on minority ethnic groups and provides the first training package in cultural competence in the NHS. Future work: Greater evaluation is required of community interventions in the UK to enhance knowledge of effective practice and analysis of the experiences of non-consenting ethnic minority families. Funding: The National Institute for Health Research Programme Grants for Applied Research programme. (shrink)

Background Individual physicians and physician-associated factors may influence patients’/surrogates’ autonomous decision-making, thus influencing the practice of do-not-resuscitate orders. The objective of this study was to examine the influence of individual attending physicians on signing a DNR order. Methods This study was conducted in closed model, surgical intensive care units in a university-affiliated teaching hospital located in Northern Taiwan. The medical records of patients, admitted to the surgical intensive care units for the first time between June 1, 2011 and December 31, (...) 2013 were reviewed and data collected. We used Kaplan–Meier survival curves with log-rank test and multivariate Cox proportional hazards models to compare the time from surgical intensive care unit admission to do-not-resuscitate orders written for patients for each individual physician. The outcome variable was the time from surgical ICU admission to signing a DNR order. Results We found that each individual attending physician’s likelihood of signing do-not-resuscitate orders for their patients was significantly different from each other. Some attending physicians were more likely to write do-not-resuscitate orders for their patients, and other attending physicians were less likely to do so. Conclusion Our study reported that individual attending physicians had influence on patients’/surrogates’ do-not-resuscitate decision-making. Future studies may be focused on examining the reasons associated with the difference of each individual physician in the likelihood of signing a do-not-resuscitate order. (shrink)

Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including (...) interventional and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues are presented. To accelerate study approval in future public health emergencies, we recommend: internally consistent and complete submissions with information documents in language participants are likely to understand, close collaboration between local and international researchers from research inception, generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, direct information exchange between the chairs of advisory, safety review and ethics committees, more Ethics Committee support for investigators than is standard and a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care. (shrink)

For nearly as long as the word “correlation” has been part of statistical parlance, students have been warned that correlation does not prove causation, and that only experimental studies, e.g., randomized clinical trials, can establish the existence of a causal relationship. Over the last few decades, somewhat of a consensus has emerged between statisticians, computer scientists, and philosophers on how to represent causal claims and connect them to probabilistic relations. One strand of this work studies the conditions under (...) which evidence accumulated from non-experimental (observational) studies can be used to infer a causal relationship. In this paper, I compare the typical conditions required to infer that one variable is a direct cause of another in observational and experimental studies. I argue that they are essentially the same. (shrink)

H. B. D. Kettlewell's field experiments on industrial melanism in the peppered moth, Biston betularia, have become the best known demonstration of natural selection in action. I argue that textbook accounts routinely portray this research as an example of controlled experimentation, even though this is historically misleading. I examine how idealized accounts of Kettlewell's research have been used by professional biologists and biology teachers. I also respond to some criticisms of David Rudge to my earlier discussions of this case study, (...) and I question Rudge's claims about the importance of purely observational studies for the eventual acceptance and popularization of Kettlewell's explanation for the evolution of industrial melanism. (shrink)

_This paper deals with the interrelationship between causal explanation and methodology in a relatively young discipline in biology: epigenetics. Based on cases from molecular and ecological epigenetics, I show that James Woodward’s interventionist account of causation captures essential features about how epigeneticists using highly diverse methods, i.e. laboratory experiments and purely observational studies, think about causal explanation. I argue that interventionism thus qualifies as a useful unifying explanatory approach when it comes to cross-methodological research efforts: It can act (...) as a guiding rationale to link causal models in molecular biology with statistical models derived from observational data analysis and to identify test-criteria for reciprocal transparent studies in different fields of research, which is a shared issue across the sciences.___. (shrink)

The study of low penetrance gene variants in a complex genetic disorder such as stroke does not pose the same risks and benefits as a study of highly penetrant mutations.1 Because of the nature of their disease, however, stroke patients may not understand the information given when they are asked for consent to participate in research and are potentially vulnerable subjects. In a systematic review of publications on ischaemic stroke genetics, we assessed the way in which informed consent and ethics (...) committee approval are reported.MethodsWe searched the MEDLINE database for stroke genetics studies published in English between January 2000 and January 2002, using the medical subject heading term “cerebrovascular disorders, genetics of” plus the text words “ischaemic” and “stroke.”2 We included only original clinical trials and observational studies of human genetic risk factors for ischaemic stroke.Both authors independently reviewed every article. We used standardised forms to record whether an explicit statement described informed consent and institutional review board procedures. We also recorded whether …. (shrink)

The recent debate around scientific realism has taken an epistemic turn. The issue is no longer whether theoretical discourse is or is not assertoric (truth-valuable), nor whether theoretical discourse can be reduced to observational discourse. All sides of the present debate have left behind traditional instrumentalism and reductive empiricism. Instead, they endorse semantic realism which suggests that theoretical discourse (that is, statements about theoretical entities) should be understood literally and be taken to be assertoric and irreducible. In this setting, (...) the philosophical reaction to realism challenges the grounds for the realists’ belief in the existence of the unobservable entities posited by theories and in the truth of the assertions made about them. This reaction can take different shapes. But the dominant one, coming from van Fraassen’s constructive empiricism, is that an empiricist cannot be rationally forced to be a scientific realist. In his view, an empiricist can understand scientific theories literally but remain agnostic as to the truth (or falsity) of their theoretical assertions. Besides, if an empiricist decides to accept a theory he accepts it not as true but as empirically adequate. (shrink)

This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The second paper compares the alleged (...) methodological benefits of randomised trials over observational studies for investigating treatment benefits. It suggests that claims about the superiority of well-conducted randomised controlled trials over well-conducted observational studies are justified, especially when results from the two methods are contradictory. The third paper argues that postulating the unpredictability paradox in systematic reviews when no detectable empirical differences can be found requires further justification. The fourth paper examines the problem of absence causation in the context of explaining causal mechanisms and argues that a recent solution is incomplete and requires further justification. Solving the problem by describing absences as causes of 'mechanism failure' fails to take into account the effects of absences that lead to vacillating levels of mechanism functionality . The fifth paper criticises literature that has emphasised functioning versus 'broken' or 'non-functioning' mechanisms emphasising that many diseases result from increased or decreased mechanism function, rather than complete loss of function. Mechanistic explanations must account for differences in the effectiveness of performed functions, yet current philosophical mechanistic explanations do not achieve this. The last paper argues that the standard of evidence embodied in the ICE theory of technological function is too permissive for evaluating whether the proposed functions of medical technologies have been adequately assessed and correctly ascribed. It argues that high-quality evidence from clinical studies is necessary to justify functional ascriptions to health care technologies. (shrink)

Much attention has been devoted to ethical issues related to randomized controlled trials for HIV treatment and prevention. However, there has been less discussion of ethical issues surrounding families involved in observational studies of HIV transmission. This paper describes the process of ethical deliberation about how best to obtain informed consent from sex partners of injection drug users (IDUs) tested for HIV, within a recent HIV study in Eastern Europe. The study aimed to assess the amount of HIV (...) serodiscordance among IDUs and their sexual partners, identify barriers to harm reduction, and explore ways to optimize intervention programs. Including IDUs, either HIV-positive or at high risk for HIV, and their sexual partners would help to gain a more complete understanding of barriers to and opportunities for intervention. (shrink)

Part I is concerned with the tenet of modern Emperical Realism that while the theoretical concepts employed in science obtain their meanings entirely from the connections their usage establishes with the data language, the referents of such terms may be "unobservables," that is, entities which cannot be discussed within the data language alone. Such a view avoids both the restrictive excesses of logical positivism and the epistemic laxity of transcendentalism; however, it also necessitates a break with classical semantics, for it (...) follows from the empirical realistic position that a theoretical term must in principle be capable of simultaneously designating not just one entity, but indefinitely many. Drawing upon the Carnapian explication of "analytic truth," Part II examines a possible axiomatic basis for the empiricist theory of scientific meaningfulness to demonstrate that even if theoretical terms are able to designate entities inaccessible to the observation language, as held by Empirical Realism, so long as the meanings of theoretical terms derive from their connections with the observation language, the meaning content of a theory is exhausted by its observational consequences. (shrink)

In response to Petitmengin and Bitbol's recent account of first-person methodologies in the study of consciousness, I provide a revised model of our introspective knowledge of our own conscious experience. This model, which I call the existential constitution model of phenomenal knowledge, avoids the problems that Petitmengin and Bitbol identify with standard observational models of introspection while also avoiding an underlying metaphorical misconception in their own proximity model, which misconstrues first-person knowledge of consciousness in terms of a dichotomous epistemic (...) relationship. The end result is a clearer understanding of the unique nature and epistemic properties of our knowledge of consciousness, as well as the epistemic status of subsequent first-person reports on conscious experience. (shrink)