Objectives To evaluate whether the requirement of “minimal risk and burden” for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk. Design and setting Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO). Review methods The analysis included 165 proposals for paediatric research without direct benefit (...) that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit. Results 11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved. Conclusions The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent. (shrink)

There are two views of the ad hominem argument found in the textbooks and other traditional treatments of this argument, the Lockean or ex concessis view and the view of ad hominem as personal attack. This article addresses problems posed by this ambiguity. In particular, it discusses the problem of whether Aristotle's description of the ex concessis type of argument should count as evidence that he had identified the circumstantial ad hominem argument. Argumentation schemes are used as the basis (...) for drawing a distinction between this latter form of argument and another called argument from commitment, corresponding to the ex concessis argument. (shrink)

Medical ethicists debate whether or not the moral assessment of cases of euthanasia should depend on whether the patient is 'killed' or 'allowed to die'. The usual presupposition is that a clear distinction between killing and letting die can be drawn so that this substantive question is not begged. I contend that the categorisation of cases of instances of killing rather than as instances of letting die depends in part on a prior moral assessment of the case. Hence is (...) it trivially rather than substantively true that the distinction has moral significance. But even if a morally neutral (ie non-question begging) distinction could be drawn, its application to the euthanasia controversy is problematic. I illustrate the difficulties of employing this distinction to reach moral conclusions by critically discussing Philippa Foot's recent treatment of euthanasia. I conclude that even if an act of euthanasia is an instance of killing, and there exists a prima facie moral duty not to kill, and no more stringent duty overrides this duty, one still cannot determine such an act to be morally impermissible. (shrink)

Introduction Stored human samples and the establishment of biobanks are increasing in the world. Along with this there are the questions of ethics that arise such as the correct method of obtaining informed consent for research on stored samples and the policies involved in collaborative research using collected samples. This study is an attempt to evaluate the researchers, academics and policy makers' views on these ethical aspects. Methods This was an anonymised study involving a Sri Lankan population of researchers, ethics (...) committee members, and policy makers. A self administered questionnaire was utilised as the study instrument. The questionnaire captured four major areas of interest: demographic characteristics of respondents, their attitudes on informed consent policy, their opinion on rights of collaborating researchers, their attitudes on dealing with international differences in regulatory frameworks. Results The study included 55 responders with 40/55 agreeing that donors should receive the option of giving informed consent for future research, with 31/55 considering multiple- type consent options most appropriate. Regarding the issue of shared samples in collaborative research majority agreed that source country ethics review committee approval was necessary 53/55. Conclusion The study concludes that sample donors should be given the option of giving advance consent to unspecified future research provided that future research is approved by an ethics committee. In collaborative research, it is necessary to involve ethics committees from donor countries in the research approval process. (shrink)

Training in scientific integrity continues to be an important topic in universities and other research institutions. Its main goal is to prevent scientific misconduct and promote good scientific practice. However, there is still no consensus on how scientific integrity should be taught. Moreover, the perspective of those who receive such training is often underrepresented. Yet it is precisely their interests and needs that must be considered when developing educational programs. Against this backdrop, we conducted a mixed-methods study with the (...) goal of capturing students’ perspectives on the teaching of scientific integrity. Using our online Scientific Integrity course, we explore what specific aspects of digital teaching on scientific integrity are valued, and explore other topics of interest from students’ perspectives on scientific integrity. The article presents (1) students’ self-assessment before (Q1) and after (Q2) taking the online Scientific Integrity course at the RWTH Aachen University in Germany (2) students’ feedback on the course format, video, exam, organization, and support (Q2) (3) a list of other topics of interest in the area of scientific integrity (Q2). The research outcomes demonstrate an improvement in the study participants’ self-assessment after following the online course and there is a general satisfaction among the students in regard to the course digital format and its components although a desire to have more exchange and discussion was expressed. Further topics of interest in the area of scientific integrity that study participants would like to learn about have a practical appeal and among others include research pressure, examples of applications, preventive measures, theory of science, citation rules, funding of university research. Although the results relate to our course, they provide insight into students’ perspectives on online teaching of scientific integrity. Thus, they may be helpful to higher education institutions developing online courses on scientific integrity that are tailored to university students. (shrink)

Background: More and more quantitative information is becoming available about the risks of complications arising from medical treatment. In everyday practice, this raises the question whether each and every risk, however low, should be disclosed to patients. What could be good reasons for doing or not doing so? This will increasingly become a dilemma for practitioners.Objective: To report doctors’ views on whether to disclose or withhold information on low risks of complications.Methods: In a qualitative study design, 37 respondents were (...) included. Focus group interviews were held with 22 respondents and individual in-depth interviews with 15.Results: Doctors have doubts about disclosing or withholding information on complication risk, especially in a risk range of 1 in 200 to 1 in 10 000. Their considerations on whether to disclose or to withhold information depend on a complicated mix of patient and doctor-associated reasons; on medical and personal considerations; and on the kind and purpose of intervention.Discussion: Even though the degree of a risk is important in a doctor’s considerations, the severity of the possible complications and patients’ wishes and competencies have an important role as well. Respondents said that low risks should always be communicated when there are alternatives for the intervention or when the patient may prevent or mitigate the risk. When the appropriateness of disclosing risks is doubtful, doctors should always tell their patients that no intervention is without risk, give them the opportunity to gather all the information they need or want, and enable them to detect a complication at an early stage. (shrink)

Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial (...) drug, if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists. Conclusion: Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a “fair” price; these views were less demanding than those of non-US subjects in other studies. However, our participants’ views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results. (shrink)

This paper argues that professionals who make boundary-related decisions should be guided by relationship-based practice. In our roles as service users and professionals, drawing from our lived experiences of professional relationships, we argue we need to move away from distance-based practice. This includes understanding the boundary stories and narratives that exist for all of us – including the people we support, other professionals, as well as the organisations and systems within which we work. When we are dealing with professional (...) boundary issues, we should centre relationship-building skills that are central to many other aspects of our work. Skills that foster relationships at all levels – between professionals, service users, and services – need to be revalued. Our final recommendation is to create, develop, and foster safer spaces within and outside of organisations, as well as inter-professionally, for the discussion and exploration of boundary-related issues and practice. We are interested in hearing from those with experiences of being marginalised by boundaries so that they can inform a reshaping of our collective ideas around boundary related practices. To foster relationship-based practices in organisations, we have outlined several recommendations here; however, we recognize that these do not go far enough, and that collective action is needed to inform systemic change. (shrink)

Tacitus writes that, by insisting that legionary legates who had not so far held the praetorship should immediately proceed to that office, Asinius Gallus ‘altius penetrare et arcana imperii temptari’. In C.Q. N.S. xvi , 327, I suggested that this demand of Gallus’ was probably probing dangerously deeply into and perhaps threatening to wreck the carefully worked-out imperial promotions system, the working of which has been examined by Birley. It is the purpose of this note to look at a (...) number of examples of such irregularity, which, though not as early as the debate during the course of which Gallus made his suggestion, do at least illustrate the process later in the Julio-Claudian era. (shrink)

Background : researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the (...) trial drug and the uses of such reasons. Data sources: databases in science/medicine, law and ethics, thesis databases, bibliographies, research ethics books and included publications’ notes/bibliographies. Publication selection: a publication was included if it included a reason as above. See article for detailed inclusion conditions. Data extraction and analysis: two reviewers extracted and analyzed data on publications and reasons. Results: of 2060 publications identified, 75 were included. These mentioned reasons based on morality, legality, interests/incentives, or practicality, comprising 36 broad (235 narrow) types of reason. None of the included publications, which included informal reviews and reports by official bodies, mentioned more than 22 broad (59 narrow) types. For many reasons, publications differed about the reason’s interpretation, implications and/or persuasiveness. Publications differed also regarding costs, feasibility and legality of PTA. Limitations: reason types could be applied differently. The quality of reasons was not measured. Conclusion: this review captured a greater variety of reasons and of their uses than any included publication. Decisions based on informal reviews or sub-sets of literature are likely to be biased. Research is needed on PTA ethics, costs, feasibility and legality and on assessing the quality of reason-based literature. (shrink)

Background: Funding organisations and research ethics committees should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union , funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs.Objective: To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: Do existing procedures promote representation of women and gender expertise in the (...) committee? How are sex and gender issues dealt with in protocol evaluation?Methods: Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents .Results: All countries have rules to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender-specific risk–benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools.Conclusions: The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs. (shrink)

This makes his book especially valuable." -- Yuri Gurevich, Professor of Computer Science, University of Michigan Computability and complexity theory should be of central concern to practitioners as well as theorists.

In this paper, I criticize the pairing of irreducible thickness with the traditional view of evaluation which says evaluation is a matter of encoding good or bad in some way. To do this, I first explicate the determination view, which holds that irreducibly thick concepts are to thin concepts as determinates are to determinables. I then show that, even if the determination view did establish irreducible thickness, it would not have proven that the evaluative is well understood as being an (...) instance of the determination relation; in order to do that, the determination view needs to show how the evaluative fit a general analysis of the determination relation. However, when the determination view attempts to fill in the analysis, we get implausible results—so implausible, I claim, that we should see the results as a reductio to the view. To generalize the criticism to any view like the determination view, I show that the same results ensue when we model the evaluative on mereology. Finally, I diagnose the general failure by claiming that the evaluative domain, as conceived by the defender of irreducible thickness, just does not have the structure to secure the tight connection between thick and thin concepts while also carving up our conceptual economy in a plausible way. (shrink)

Fins and colleagues rightly note that “clinical ethics consultation is a high-stakes endeavor with an increasing prominence in health care systems” for which “progress in developing standards for q...

Background: We were finding volunteers for functional magnetic resonance imaging studies with abnormalities requiring referral surprisingly frequently. The bioethics surrounding the incidental findings are not straightforward and every imaging institution will encounter this situation in their normal volunteers. Yet the implications for the individuals involved may be profound. Should all participants have review of their imaging by an expert and who should be informed? Methods: The normal volunteers that were imaged with magnetic resonance (MR) which were reviewed by (...) a consultant neuroradiologist. All participants completed a volunteer consent form in addition to a standard departmental MR safety screening form. The volunteer screening form requires the general practitioner details to be completed and asks the participant to consider closely the possibility and implications of finding an unexpected but potentially serious abnormality before signing. Results: 525 different individuals were scanned as normal volunteers, the mean age was 35-years and 330 were males. Of these 525, 46 had definite significant abnormalities (8.8%), mean age 50-years. Conclusion: We have found a high rate of incidental abnormalities amongst individuals participating in imaging studies at our institution. It is our current practice to inform the research study participant of the findings, counsel them and inform their primary care physician. We think that it is advisable for researchers utilising MR imaging of the brain to have access to trained neuroradiologists, a protocol in place to deal with this problem and take consent in a way that allows the participant to realise the possibility of an abnormal finding. (shrink)

In recent years, the genetic testing and selection of IVF embryos, known as preimplantation genetic testing (PGT), has gained much traction in clinical assisted reproduction for preventing transmission of genetic defects. However, a more recent ethically and morally controversial development in PGT is its possible use in selecting IVF embryos for optimal intelligence quotient (IQ) and other non–disease-related socially desirable traits, such as tallness, fair complexion, athletic ability, and eye and hair colour, based on polygenic risk scores (PRS), in what (...) is referred to as PGT-P. Artificial intelligence (AI) and machine learning–based analysis of big data sets collated from genome sequencing of specific human ethnic populations can be used to estimate an individual embryo’s likelihood of developing such multifactorial traits by analysing the combination of specific genetic variants within its genome. Superficially, this technique appears compliant with Islamic principles and ethics. Because there is no modification of the human genome, there is no tampering with Allah’s creation (taghyīr khalq Allah). Nevertheless, a more critical analysis based on the five maxims of Islamic jurisprudence (qawa'id fiqhiyyah) that are often utilized in discourses on Islamic bioethics, namely qaṣd (intention), yaqın̄ (certainty), ḍarar (injury), ḍarūra (necessity), and `urf (custom), would instead reveal some major ethical and moral flaws of this new medical technology in the selection of non–disease-related socially desirable traits, and its non-compliance with the spirit and essence of Islamic law (shariah). Muslim scholars, jurists, doctors, and biomedical scientists should debate this further and issue a fatwa on this new medical technology platform. (shrink)

From the first months of life, human infants produce “protophones,” speech-like, non-cry sounds, presumed absent, or only minimally present in other apes. But there have been no direct quantitative comparisons to support this presumption. In addition, by 2 months, human infants show sustained face-to-face interaction using protophones, a pattern thought also absent or very limited in other apes, but again, without quantitative comparison. Such comparison should provide evidence relevant to determining foundations of language, since substantially flexible vocalization, the inclination (...) to explore vocalization, and the ability to interact socially by means of vocalization are foundations for language. Here we quantitatively compare data on vocalization rates in three captive bonobo (Pan paniscus) mother–infant pairs with various sources of data from our laboratories on human infant vocalization. Both humans and bonobos produced distress sounds (cries/screams) and laughter. The bonobo infants also produced sounds that were neither screams nor laughs and that showed acoustic similarities to the human protophones. These protophone-like sounds confirm that bonobo infants share with humans the capacity to produce vocalizations that appear foundational for language. Still, there were dramatic differences between the species in both quantity and function of the protophone and protophone-like sounds. The bonobo protophone-like sounds were far less frequent than the human protophones, and the human protophones were far less likely to be interpreted as complaints and more likely as vocal play. Moreover, we found extensive vocal interaction between human infants and mothers, but no vocal interaction in the bonobo mother–infant pairs—while bonobo mothers were physically responsive to their infants, we observed no case of a bonobo mother vocalization directed to her infant. Our cross-species comparison focuses on low- and moderate-arousal circumstances because we reason the roots of language entail vocalization not triggered by excitement, for example, during fighting or intense play. Language appears to be founded in flexible vocalization, used to regulate comfortable social interaction, to share variable affective states at various levels of arousal, and to explore vocalization itself. (shrink)

Case-based instruction has been regarded by many as a viable alternative to traditional lecture-based education and training. However, little is known about how case-based training techniques impact training effectiveness. This study examined the effects of two such techniques: (a) presentation of alternative outcome scenarios to a case, and (b) conducting a structured outcome evaluation. Consistent with the hypotheses, results indicate that presentation of alternative outcome scenarios reduced knowledge acquisition, reduced sensemaking and ethical decision-making strategy use, and reduced decision ethicality. Conducting (...) a structured outcome evaluation had no impact on these outcomes. Results indicate that those who use case-based instruction should take care to use clear, less complex cases with only a singular outcome if they are seeking these types of outcomes. (shrink)

As clinical ethics consultants move toward professionalization, the process of certifying individual consultants or accrediting programs will be discussed and debated. With certification, some entity must be established or ordained to oversee the standards and procedures. If the process evolves like other professions, it seems plausible that it will eventually include a written examination to evaluate the core knowledge competencies that individual practitioners should possess to meet peer practice standards. The American Society for Bioethics and Humanities has published core (...) knowledge competencies for many years that are accepted by experts as the prevailing standard. Probably any written examination will be based upon the ASBH core knowledge competencies. However, much remains to be done before any examination may be offered. In particular, it seems likely that a recognized examining board must create and validate examination questions and structure the examination so as to establish meaningful, defensible parameters after dealing with such challenging questions as: Should the certifying examination be multiple choice or short-answer essay? How should the test be graded? What should the pass rate be? How may the examination be best administered? To advance the field of health care ethics consultation, thought leaders should start to focus on the written examination possibilities, to date unaddressed carefully in the literature. Examination models—both objective and written—must be explored as a viable strategy about how the field of health care ethics consultations can grow toward professionalization. (shrink)

In this paper I want to examine a view of the Darwinian theory of evolution which was put forward fairly recently by A. R. Manser. His approach is of interest not only in itself, but also because it may be expanded to raise some fundamental questions about the nature of the science of biology in general. I shall not consider these further implications here, but shall concentrate on an examination of his thesis in the context in which it is raised. (...) My paper falls into two sections. In the first I shall state Manser's thesis and some of the arguments with which he supports it, and shall try to show how a series of objections raised by A. G. N. Flew and K. Connolly may be answered. In the second I shall offer on my own account a positive argument to provide a possible basis for his point of view, with the aim of indicating why the theory should be of the kind he suggests, and what form the study of evolution must take. (shrink)

Inverting a face impairs perception of its features and recognition of its identity. Whether faces are special in this regard is a current topic of research and debate. Kanizsa studied the role of facial features and environmental context in perceiving the emotion and identity of upright and inverted faces. He found that observers are biased to interpret faces in a retinal coordinate frame, and that this bias is readily overruled by increased realism of facial features, but not easily overruled by (...) environmental context. An additional factor contributing to a retinal coordinate-frame interpretation may be the ambiguous nature of the face stimuli. Since his facial expressions are interpretable both upright and inverted, they may in both orientations activate an endogenous attentional process for faces. We present visual search and change-blindness experiments that explore how inversion, negation, and facial emotion affect visual attention to static faces. We find that attention to faces is impaired by inversion and negation. We also find that the parts of the face that receive greater attention can be influenced by the emotional expression of the face. We propose to extend these experiments to dynamic faces. To this end, we develop a theory of the visual representation of dynamic faces, in which faces are represented by classes of `spacetime fragments'-moving regions of the face with high informational content. We then present ideas for future experiments which are motivated by the spacetime fragment theory, and which should serve to constrain its further development. (shrink)

Firearm injury in the United States is a public health crisis in which physicians are uniquely situated to intervene. However, their ability to mitigate harm is limited by a complex array of laws and regulations that shape their role in firearm injury prevention. This piece uses four clinical scenarios to illustrate how these laws and regulations impact physician practice, including patient counseling, injury reporting, and the use of court orders and involuntary holds. Unintended consequences on clinical practice of laws intended (...) to reduce firearm injury are also discussed. Lessons drawn from these cases suggest that physicians require more nuanced education on this topic, and that policymakers should consult front-line healthcare providers when designing firearm policies. (shrink)

Objectives: To gather information about the practices and attitudes of providers of maternity care with respect to informed consent for newborn screening .Methods: A questionnaire concerning information provision and parental consent for NBS was sent to all 1036 registered lead maternity carers in New Zealand.Results: 93% of LMC in New Zealand report giving parents information concerning NBS, most frequently after delivery and in the third trimester . The majority of LMC currently obtain some form of consent for NBS from parents (...) and consider this to be the ideal approach . Despite this a significant minority of LMC reported considering that NBS should be mandatory. Of those in our survey who believed that NBS should be mandatory, paradoxically most still believed that some form of parental consent should be obtained; of those who believed testing should not be mandatory, only a small proportion would accept parental refusal without question.Conclusions: When the results of this survey are considered in conjunction with existing evidence there appears to be a consensus that good quality information in the prenatal period should be an integral part of any NBS programme. The issue of consent is more complex and there is less agreement on the preferred degree of parental involvement in decisions to allow babies to undergo NBS. A policy that both strongly recommends NBS but also allows parental choice appears to be most consistent with the views of LMC in this survey. (shrink)

Avoiding whinges from various and potentially conflicting stakeholders is a major challenge for sustainable development and for the identification of sustainability scenarios or policies for biodiversity and ecosystem services. It turns out that independently complying with whinge thresholds and constraints of these stakeholders is not sufficient because dynamic ecological-economic interactions and uncertainties occur. Thus more demanding no whinge standards are needed. In this paper, we first argue that these new boundaries can be endogenously exhibited with the mathematical concepts of viability (...) kernel and viable controls. Second, it is shown how these no whinge kernels have components, such as harvesting of resources, that should remain within safe corridor while some other components, in particular biodiversity, have only lower conservation limits. Thus, using radar charts, we show how this no whinge kernels can take the shape of a tree that we name viability tree. These trees of viability capture the idea that the unbounded renewal potential of biodiversity combined with a bounded use of the different ecosystem services are crucial ingredients for the sustainability of socio-ecosystems and the design of no whinge policies reconciling the different stakeholders involved. (shrink)

BackgroundInternationally, patient access to notes is increasing. This has been driven by respect for patient autonomy, often recognised as a primary tenet of medical ethics: patients should be able to access their records to be fully engaged with their care. While research has been conducted on the impact of patient access to outpatient and primary care records and to patient portals, there is no such review looking at access to hospital medical records in real time, nor an ethical analysis (...) of the issues involved in such a change in process.MethodsThis study employed a systematic review framework in two stems, to integrate literature identified from two searches: Medline, CINAHL and Scopus databases were conducted, (for (1) hospitalised patients, patient access to records and its effects on communication and trust within the doctor-patient relationship; and (2) patient access to medical records and the ethical implications identified). The qualitative and quantitative results of both searches were integrated and critically analysed.Results3954 empirical and 4929 ethical studies were identified; 18 papers representing 16 studies were identified for review (12 empirical and 6 ethical). The review reveals a consensus that our current approach to giving information to patients – almost exclusively verbally – is insufficient; that patient access to notes is a welcome next step for patient-centred care, but that simply allowing full access, without explanation or summary, is also insufficient. Several ethical implications need to be considered: increased information could improve patient trust and knowledge but might transfer an (unwelcome) sense of responsibility to patients; doctors and patients have conflicting views on how much information should be shared and when; sharing written information might increase the already significant disparity in access to health care, and have unforeseen opportunity costs. The impact on medical practice of sharing notes in real time will also need to be evaluated.ConclusionsThe review presents encouraging data to support patient access to medical notes. However, sharing information is a critical part of clinical practice; changing how it is done could have significant empirical and ethical impacts; any changes should be carefully evaluated. (shrink)

Increasing ethical attention and debate is focusing on whether individuals who take part in clinical trials should be given access to post-trial care. However, the main focus of this debate has been upon drug trials undertaken in low-income settings. To broaden this debate, we report findings from interviews with individuals (n = 24) who participated in a clinical trial of a closed-loop system, which is a medical device under development for people with type 1 diabetes that automatically adjusts blood (...) glucose to help keep it within clinically recommended ranges. Individuals were recruited from UK sites and interviewed following trial close-out, at which point the closed-loop had been withdrawn. While individuals were stoical and accepting of the requirement to return the closed-loop, they also conveyed varying degrees of distress. Many described having relaxed diabetes management practices while using the closed-loop and having become deskilled as a consequence, which made reverting back to pre-trial regimens challenging. Participants also described unanticipated consequences arising from using a closed-loop. As well as deskilling, these included experiencing psychological and emotional benefits that could not be sustained after the closed-loop had been withdrawn and participants reevaluating their pre- and post-trial life in light of having used a closed-loop and now perceiving this life much more negatively. Participants also voiced frustrations about experiencing better blood glucose control using a closed-loop and then having to revert to using what they now saw as antiquated and imprecise self-management tools. We use these findings to argue that ethical debates about post-trial provisioning need to be broadened to consider potential psychological and emotional harms, and not just clinical harms, that may result from withdrawal of investigated treatments. We also suggest that individuals may benefit from information about potential nonclinical harms to help make informed decisions about trial participation. (shrink)

Background: The Declaration of Helsinki, the World Medical Association’s statement of ethical guidelines regarding medical research, is published in the three official languages of the WMA: English, French and Spanish.Methods: A detailed comparison of the three official language versions was carried out to determine ways in which they differed and ways in which the wording of the three versions might illuminate the interpretation of the document.Results: There were many minor linguistic differences between the three versions. However, in paragraphs 1, 6, (...) 29, 30 and in the note of clarification to paragraph 29, there were differences that could be considered potentially significant in their ethical relevance.Interpretation: Given the global status of the Declaration of Helsinki and the fact that it is translated from its official versions into many other languages for application to the ethical conduct of research, the differences identified are of concern. It would be best if such differences could be eliminated but, at the very least, a commentary to explain any differences that are unavoidable on the basis of language or culture should accompany the Declaration of Helsinki. This evidence further strengthens the case for international surveillance of medical research ethics as has been proposed by the WMA. (shrink)

Law is an essential tool for public health practice, and the use of a systematic legal framework can assist with preventing chronic diseases and addressing the growing epidemic of obesity.The action options available to government at the federal, state, local, and tribal levels and its partners can help make the population healthier by preventing obesity and decreasing the growing burden of associated chronic diseases such as cardiovascular disease and Type 2 diabetes. The Centers for Disease Control and Prevention uses the (...) four-part systematic legal framework commonly referred to as “public health legal preparedness” to demonstrate the essential role law can play for any public health issue. This paper uses the “laws and legal authorities” component of the framework and should be considered in combination with the competencies, coordination, and information-best practices components of the framework. (shrink)

Inverting a face impairs perception of its features and recognition of its identity. Whether faces are special in this regard is a current topic of research and debate. Kanizsa studied the role of facial features and environmental context in perceiving the emotion and identity of upright and inverted faces. He found that observers are biased to interpret faces in a retinal coordinate frame, and that this bias is readily overruled by increased realism of facial features, but not easily overruled by (...) environmental context. An additional factor contributing to a retinal coordinate-frame interpretation may be the ambiguous nature of the face stimuli. Since his facial expressions are interpretable both upright and inverted, they may in both orientations activate an endogenous attentional process for faces. We present visual search and change-blindness experiments that explore how inversion, negation, and facial emotion affect visual attention to static faces. We find that attention to faces is impaired by inversion and negation. We also find that the parts of the face that receive greater attention can be influenced by the emotional expression of the face. We propose to extend these experiments to dynamic faces. To this end, we develop a theory of the visual representation of dynamic faces, in which faces are represented by classes of `spacetime fragments'-moving regions of the face with high informational content. We then present ideas for future experiments which are motivated by the spacetime fragment theory, and which should serve to constrain its further development. (shrink)

In the first of these two lectures Professor Hart is concerned with certain controversies and changes of attitude towards the question of moral guilt—mens rea,’ the guilty mind’—in criminal proceedings according to English law. There is, on the one hand and at one extreme, the attitude of the McNaughten Rules which excludes guilt only in the case of a ‘defect of reason’; at the other extreme there is the modern position, represented by Lady Wootton according to which the conception of (...) metis rea should be dropped altogether—criminal proceedings are concerned with ‘social hygiene’ and have nothing to do with responsibility: the question of responsibility comes up only after a verdict has been reached in estimating what steps are likely to have the best consequences for the ‘criminal’ and for society. Between these extremes Professor Hart takes a kind of middle course, what he calls ‘a moderate form of the new doctrine’: ‘Under this scheme mens rea would continue to be a necessary condition of liability to be investigated and settled before conviction except so far as it relates to mental abnormality. The innovation would be that the accused person would not be able to adduce any form of mental abnormality as a bar to conviction. The question of his mental abnormality would under this scheme be investigated only after conviction and would primarily be concerned with his present rather than his past mental state’. He admits that there are some practical difficulties against this view, but he does not consider the theoretical difficulty that the theory does away with the principle that criminal conviction must be based on guilt and responsibility. (shrink)

Welfare-friendly outdoor poultry husbandry systems are associated with potentially higher public health risks for certain hazards, which results in a dilemma: whether to choose a system that improves chicken welfare or a system that reduces these public health risks. We studied the views of citizens and poultry farmers on judging the dilemma, relevant moral convictions and moral arguments in a practical context. By means of an online questionnaire, citizens and poultry farmers judged three practical cases, which illustrate the dilemma of (...) improving chicken welfare or reducing public health risks for Campylobacter, avian influenza and dioxin. Furthermore, they scored the importance of moral arguments and to what extend they agreed with moral convictions related to humans and chickens. Citizens were more likely than farmers to choose a system that benefits chicken welfare at the expense of public health. These different judgments could be explained by differing moral convictions and valuations of moral arguments. Judgments of citizens and farmers were associated with moral arguments and convictions, predominantly with those regarding the value of chickens and naturalness. Citizens agreed stronger with moral convictions regarding the intrinsic value of chickens and regarding naturalness than farmers did, while farmers agreed stronger with conviction regarding fairness. We argue that opinions of citizens and farmers are context-dependent, which may explain the differences between these groups. It implies that opinions of different stakeholder groups should be considered in order to achieve successful innovations in poultry husbandry, which are supported by society. (shrink)

В монографии представлена систематизация современных западных и отечественных подходов в исследовании качеств современного человека, таких как креативность и информативность. Для читателей, интересующихся проблемами социальной философии.

Volume 1 presents the texts in new translations by the authors, and these are accompanied by a philosophical and historical commentary designed for use by all readers, including those with no background in the classical world. With its glossary and indexes, this volume can stand alone as an independent tool of study.

We attempt to clarify the main conceptual issues in approaches to ‘objectification’ or ‘measurement’ in quantum mechanics which are based on superselection rules. Such approaches venture to derive the emergence of classical ‘reality’ relative to a class of observers; those believing that the classical world exists intrinsically and absolutely are advised against reading this paper. The prototype approach (K. Hepp, Helv. Phys. Acta45 (1972), 237–248) where superselection sectors are assumed in the state space of the apparatus is shown to be (...) untenable. Instead, one should couple system and apparatus to an environment, and postulate superselection rules for the latter. These are motivated by the locality of any observer or other (actual or virtual) monitoring system. In this way ‘environmental’ solutions to the measurement problem (H.D. Zeh, Found. Phys.1 (1970), 69–76; W. H. Zurek, Phys. Rev.D26 (1982), 1862–1880 and Progr. Theor. Phys.89 (1993), 281–312) become consistent and acceptable, too. Points of contact with the modal interpretation are briefly discussed. We propose a minimal value attribution to observables in theories with superselection rules, in which only central observables have properties. In particular, the eigenvector-eigenvalue link is dropped. This is mainly motivated by Ockham's razor. (shrink)

Inc.Q,., N.S. v , i76ff., Mr. A. E. Harvey discusses the problem presented by the first ten lines of the first column of the Berlin Papyrus of Corinna, and finds the solution in the region of erroneous colometry. So far as I can judge, he is justified in claiming that he has offered ‘the most concise and satisfactory explanation of the irregularities’; but, if so, there is one further step which should be taken, and there is one obscurity in (...) his account which should be clarified. (shrink)

Robert Brandom argues for a “pragmatic phenomenalist account” of knowledge. On this account, we should understand our notion of justification in accordance with a Sellarsian social practice model, and there is nothing more to the phenomenon of knowledge than the proprieties of takings-as-knowing. I agree with these two claims. But Brandom's proposal is so sketchy that it is unclear how it can deal with a number of much-discussed problems in contemporary epistemology. The main purpose of this article is to (...) develop and defend a pragmatic phenomenalist account of knowledge by resolving those problems. I argue, in particular, that this account can accommodate both the lesson of the Gettier problem and the lesson of reliabilism simultaneously. -/- RÉSUMÉ: Robert Brandom soutient une «théorie pragmatique et phénomenaliste» de la connaissance. Selon cette théorie, nous devons comprendre notre notion de justification d'après un modèle sellarsien de la pratique sociale, et il n'y a rien d'autre dans phénomène de connaissance que la pertinence de «prendre-pour-connaître». Je suis tout à fait d'accord avec ces deux opinions. Mais la thèse de Brandom est si sommaire qu'il n'est pas évident de savoir comment elle peut trailer les nombreux problèmes discutés en épistémologie contemporaine. Le but principal de cet article est de développer et défendre une théorie pragmatique et phénomenaliste de la connaissance en résolvant ces problèmes. Je soutiens, en particulier, que cette théorie peut s'accorder en même temps à lerçon du problème de Gettier et au «fiabilisme». (shrink)

On the ethics of extending human life: healthy people have a right to carry on livingHumanity has long demonstrated a paradoxical ambivalence concerning the extension of a healthy human lifespan. Modest health extension has been universally sought, whereas extreme health extension has been regarded as a snare and delusion—a dream beyond all others at first blush, but actually something we are better off without. The prevailing pace of biotechnological progress is bringing ever closer the day when humanity will be able (...) to act on the latter view by rejecting a clear and present opportunity for much longer healthy lives. Indeed, some biogerontologists contend that that day has already arrived, to the extent that our hesitation in embarking on a vigorous “war on ageing” is already delaying the point at which a cure for ageing will be developed. Here I consider whether our present caution concerning the wisdom of truly curing ageing is likely to survive the increased scrutiny that it will receive in coming years as a result of these technical advances. I conclude that it will not, because of its irreconcilability with values that are more deeply held by the large majority of humanity than any values that argue against the quest for a cure. I further conclude that all the major current reasons given for not curing ageing are mere crutches to help us cope with the immutability of ageing that we have been brought up to accept. Our failure to set aside such irrationality is already shortening potential longevity—quite probably of those already alive today—to a staggering degree. Once we realise this, our determination to consign human ageing to history will be second …. (shrink)

IN a letter to the Editor of MIND, Mr. G. T. Bennett of Emmanuel College, Cambridge, points out a stupid slip which I made on page 499 of MIND, N.S., No. 124. In illustrating Mr. Johnson's analysis of the subsumptive syllogism in my review of his Logic, Part II., I took as a major premise the proposition “Everything with sides and angles is equiangular, if equilateral”. This is, of course, ridiculously false, as Mr. Bennett points out. A figure made of (...) four equal jointed rods could be pushed into many different shapes. I want to make it quite clear that this is a slip.of my own, and that nothing of the kind occurs in Mr. Johnson's book. Of course, for purposes of illustration, it is a matter of indifference whether we choose false propositions or true ones, so that no injustice has been done to Mr. Johnson's theory. But I am not going to pretend that I did not think this proposition to be true at the moment when I wrote it down. I am sorry to have been so careless, and I should be still more sorry if anyone should have ascribed the carelessness to Mr. Johnson himself and not to his reviewer. I must thank Mr. Bennett for pointing out the mistake. (shrink)

This comprehensive sourcebook makes available in the original Latin and Greek the principal extant texts required for the study of the Stoic, Epicurean and sceptical schools of philosophy. The material is organised by schools, and within each school topics are treated thematically. The volume presents the same texts as are translated in The Hellenistic Philosophers, Volume 1. The authors provide their own critical apparatus, and also supply detailed notes on the more difficult texts. This volume is equipped with a large (...) annotated bibliography. (shrink)

The article presents the results of research activities which were undertaken in Volgograd Medical University to celebrate the World Bioethics Day. The theme of scientific events organized on the basis of the Department of Bioethics, Philosophy and Medical Law with a course of the sociology of medicine with the participation of the Department of Ethical, Legal and Sociological Expertise in Medicine of Volgograd Medical Scientific Center is “Benefit and Harm”. The article presents the Program of holding a scientific online conference (...) with international participation and the results of the essay competition among students and young scientists. (shrink)