BackgroundIn the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.MethodsBetween 2013 and 2019, 8252 participants (...) (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.ResultsSevere structural abnormalities occurred in 8.3% (95% confidence interval 7.7–8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.ConclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/nct02220582. (shrink)

We report specific heat and μSR measurements on Th and/or B substituted UBe13. The specific heat data show that either Th or B substitution reduces the Kondo temperature TK and increases the entropy at the superconducting transition by almost 20%, indicating an enhanced density of states. However, whereas μSR shows clear evidence for magnetic correlations for Th substitutions, no magnetism is observed for B substitutions. The enhanced specific heat jump in the B-substituted material is associated with a change in the (...) superconducting properties as TK is reduced. (shrink)

In recent times, daily, ordinary medical practices have incontrovertibly been developing under the condition of complexity. Complexity jeopardizes the moral core of practicing medicine: helping people, with their illnesses and suffering, in a medically competent way. Practical wisdom has been proposed as part of the solution to navigate complexity, aiming at the provision of morally good care. Practical wisdom should help practitioners to maneuver in complexity, where the presupposed linear ways of operating prove to be insufficient. However, this solution is (...) unsatisfactory, because the proposed versions of practical wisdom are too individualistic of nature, while physicians are continuously operating in varying teams, and dealing with complicated technologies and pressing structures. A second point of critique is, that these versions are theory based, and thus insufficiently attuned to the actual context of everyday medical practices. Now, our proposal is to use an approach of practical wisdom that enables medical practices to counter the complexity issue and to re-invent the moral core of medical practicing as well. This implies a practice oriented approach, as thematized by practice theory, qualitative empirical research from the inside, and abduction from actual performed practical wisdom towards an apt understanding of phronèsis. (shrink)

By closely examining the sources, movements, and persons of the Renaissance and the Reformation, Voegelin reveals the roots of today's political ideologies in this fourth volume of his _History of Political Ideas._ This insightful study lays the groundwork for Voegelin's critique of the modern period and is essential to an understanding of his later analysis. Voegelin identifies not one but two distinct beginnings of the movement toward modern political consciousness: the Renaissance and the Reformation. Historically, however, the powerful effects of (...) the second have overshadowed the first. In this book, Voegelin carefully examines both periods and their presence in modern thought. The Renaissance, represented by the works of Niccolò Machiavelli, Desiderius Erasmus, and Thomas More, is characterized by a struggle for balance. Machiavelli and Erasmus both looked to a virtuous prince to achieve order, one calling for brute force and the other for Christian spirituality to reach their goal. Also a participant in the first beginning of modernity, More was a complex thinker identified as a saint both of the church and of the communist movement. The issues he explored in _Utopia,_ as Voegelin demonstrates, indirectly gave rise to concepts that have profoundly affected Western history: colonization, imperialism, national socialism, and communism. Exploring the transition from the Renaissance to the Reformation is a brilliant chapter, "The People of God," which examines the sectarian movement. These pages contain the rich historical background that led to Voegelin's later conclusions about Gnosticism and its modern influences. Voegelin offers a controversial view of the Reformation as well as the political and religious situation directly preceding it. Yet he sheds light on the strengths and inadequacies of its key figures, Martin Luther and John Calvin. The driving force behind the Reformation stemmed solely from the powerful personality of Luther. What began as an abstract, purely technical discussion developed into a full-blown revolt. Later in the period, Calvin confronted the problems left behind by Luther and endeavored to create his own universal church to supplant the Catholic Church. His theory of a new elite would have a distinct impact on history. By examining the political ideas that first emerged during the Renaissance and Reformation, this fascinating volume provides a foundation for understanding the events of centuries to follow. (shrink)

Context: The dominant approach to the study of perception is representational/computational, with an emphasis on the achievements of the brain and the nervous system, which are taken to construct internal models of the world. Alternatives include ecological, embedded, embodied, and enactivist approaches, all of which emphasize the centrality of action in understanding perception. Problem: Despite sharing many theoretical commitments that lead to a rejection of the classical approach, the alternatives are characterized by important contrasts and points of divergence. Here we (...) focus on the enactive and ecological approaches, in particular, on how they construe the status of the environment and the content of perception. Method: We begin with a review of James Gibson’s ecological psychology, highlighting it as a psychology for all organisms not just humans. Against this backdrop, we consider enactivist arguments against direct perception - a central assertion of the ecological approach - and in favor of interpreting the activity of perceptual agents as a kind of construction of a perceptually meaningful world. Results: We assess the merits of this interpretation and we conclude that it cannot be grounded on fundamental principles such as thermodynamics and organism-environment mutuality. Implications: As a consequence, enactivism remains close to representationalism and entails a form of dualism. Constructivist content: We advance a criticism of the constructivist foundations of the enactive approach to perception. Perception-action mutuality at the heart of enactivism does not require mental construction; indeed, perception-action mutuality obviates construction. (shrink)

definitions and explanations frequently come together and permeate almost all fields of knowledge. This does not exclude mathematics, even when these definitions hold clear links and close connections with our physical world. Here we propose a rather different perspective. Making operational physical assumptions, we show how it is possible to rigorously reconstruct some features of both geometry and topology. Broadly speaking, assuming this operational and more concrete philosophy we not only are capable of defining primitive concepts like points, straight lines, (...) planes, angles and spaces, but we also go all the way up to more complex constructions. We show that within our method it is also possible to come up with what we call a compass-based topology as well as a normed and a metric space. We hope this operationalist point-of-view can assist other researchers and students to have a clearer understanding of these quite abstract concepts. (shrink)

BackgroundWhen conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations.MethodsA systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review.ResultsOf 1447 articles found 1391 were excluded (...) ; 56 were relevant and included. Articles were categorised into original research that evaluated the consent process or publications detailing the process of seeking consent and guidelines for ethical research. Guidelines were categorised into international ; national and state/regional/local guidelines. In five studies based in Australia, Canada and The United States of America the consent process with Indigenous people was objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and “plain language” forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous organisations provide examples of community-designed resources for seeking consent and describe methods of community engagement, but none are evaluated. International, national and local ethical guidelines stress the importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining individual consent. In the ‘Grey literature’ concerns about the consent process are identified but no solutions are offered.ConclusionConsultation with Indigenous communities is needed to determine how consent should be sought from the community and the individual, and how to evaluate this process. (shrink)

Researchers are required to seek consent from Indigenous communities prior to conducting research but there is inadequate information about how Indigenous people understand and become fully engaged with this consent process. Few studies evaluate the preference or understanding of the consent process for research with Indigenous populations. Lack of informed consent can impact on research findings. The Picture Talk Project was initiated with senior Aboriginal leaders of the Fitzroy Valley community situated in the far north of Western Australia. Aboriginal people (...) were interviewed about their understanding and experiences of research and consent processes. Transcripts were analysed using NVivo10 software with an integrated method of inductive and deductive coding and based in grounded theory. Local Aboriginal interpreters validated coding. Major themes were defined and supporting quotes sourced. Interviews with Aboriginal leaders were facilitated by a local Aboriginal Community Navigator who could interpret if necessary and provide cultural guidance. Participants were from all four major local language groups of the Fitzroy Valley; aged 31 years and above; and half were male. Themes emerging from these discussions included Research—finding knowledge; Being respectful of Aboriginal people, Working on country, and Being flexible with time; Working together with good communication; Reciprocity—two-way learning; and Reaching consent. The project revealed how much more there is to be learned about how research with remote Aboriginal communities should be conducted such that it is both culturally respectful and, importantly, meaningful for participants. We identify important elements in community consultation about research and seeking consent. (shrink)

In this very readable and interesting book Mr. Weatherby explores the thesis that Newman, while remaining true to Catholic doctrinal orthodoxy, nevertheless, compromised philosophically with the subjectivism, relativism, and individualism inherent in modern thought. Mr. Weatherby further claims that Newman treated these premises of modern thought as though "they were capable of synthesis with Catholic dogma." In coming to this position, Newman rejected the fifteen hundred-year old idea of a unified Christian society and accepted instead the fragmentation on which modern (...) culture is based. To develop his main point, Weatherby divides his book into four parts. Part One, "Newman and the Old Orthodoxy," reveals Newman’s divergence philosophically from the Caroline theological tradition and the Metaphysical poets. Newman did not deny that the Creation reflects the mind of God, but he personally could not find it. He was forced, therefore, to look for the "Paradise within" since he was unable to find God’s Paradise without. In Part Two, "The Spirit Afloat," after examining Newman’s Idealism and his relation to the Alexandrian Fathers, who were essentially mystic and idealist, Weatherby shows that Newman was a man of his times in that he had a much greater affinity with the Romantic poets than with the Metaphysical poets or those of the Middle Ages and Renaissance. These latter expressed metaphorically their full accord with the Thomist and Caroline outlook that God’s operations were visible in every detail of nature and that man by reason can proceed from the order and beauty of the visible world to a knowledge of God. The Romantics, on the other hand, with their more subjective view of life and nature, stressed not so much the external reality as man’s individual apprehension of it. The Romantics’ dominant impulse was their search for the "Paradise within." In Part Three, "Newman’s Modernism: A Theology of Safeguards," a study of Newman’s orthodox subjectivism, individualism, and relativism is presented, and Weatherby uses William R. Ingel’s words on Newman to point out that "one side of religion was based on principles which, when logically drawn out, must lead away from Catholicism in the direction of an individualistic religion of experience, and a substitution of history for dogma which makes all truth relative and all values fluid." Weatherby in Part Four, "The Consequences," articulates his criticism of Newman’s stand. It is, he claims, too radical one. Although Weatherby takes care not to call Newman a revolutionary—only a radical in his thinking—he points out that had Newman followed his anti-traditional mode of thought to its logical conclusion, political and social revolution could have resulted. Weatherby claims that Newman attempts to escape from the revolutionary consequences of his philosophy in that his "radicalism is never translated into religious or political activism." One of the strengths of Mr. Weatherby’s book is the great thoroughness with which he supports his stand. He gives specific and numerous examples and quotations from Newman’s works and from those of the other writers and philosophers he is using to make his point. This method, while admirable on the whole, occasionally results in repetition since Weatherby makes certain to give a summary after each comparison that is made.—M. L. F. (shrink)

The consent and community engagement process for research with Indigenous communities is rarely evaluated. Research protocols are not always collaborative, inclusive or culturally respectful. If participants do not trust or understand the research, selection bias may occur in recruitment, affecting study results potentially denying participants the opportunity to provide more knowledge and greater understanding about their community. Poorly informed consent can also harm the individual participant and the community as a whole. Invited by local Aboriginal community leaders of the Fitzroy (...) Valley, the Kimberley, Western Australia, The Picture Talk project explores the consent process for research. Focus groups of Aboriginal community members were conducted to establish preferences for methods of seeking individual consent. Transcripts were analysed through NVivo10 Qualitative software using grounded theory with inductive and deductive coding. Themes were synthesised with quotes highlighted. Focus groups with Aboriginal community members were facilitated by a Community Navigator as a cultural guide and interpreter and a researcher. Participants were recruited from all main language groups of the Fitzroy Valley – Gooniyandi, Walmajarri, Wangkatjungka, Bunuba and Nikinya. Participants were aged ≥18 years, with 5 female groups and one male group. Themes identified include: Reputation and trust is essential; The Community Navigator is key; Pictures give the words meaning – milli milli versus Pictures; Achieving consensus in circles; Signing for consent; and Research is needed in the Valley. Aboriginal communities of the Fitzroy Valley recommend that researchers collaborate with local leaders, develop trust and foster a good reputation in the community prior to research. Local Aboriginal researchers should be employed to provide cultural guidance throughout the research process and interpret local languages especially for elders. Pictures are preferred to written text to explain research information and most prefer to sign for consent. The Fitzroy Valley welcomes research when collaborative and for the benefit of the community. Future research could include exploring how to support young people, promote health screening and improve understanding of medical knowledge. (shrink)

Objective The UK Human Papillomavirus (HPV) vaccine programme commenced in the autumn of 2008 for year 8 (age 12–13 years) schoolgirls. We examine whether the vaccine should be given when there is a difference of opinion between daughters and parents or guardians. Design Qualitative study using semi-structured interviews. Participants A sample of 25 stakeholders: 14 professionals involved in the development of the HPV vaccination programme and 11 professionals involved in its implementation. Results Overriding the parents' wishes was perceived as problematic (...) and could damage the relationship between school and parents. A number of practical problems were raised in relation to establishing whether parents were genuinely against their daughter receiving the vaccine. Although many respondents recognised that the Gillick guidelines were relevant in establishing whether a girl could provide consent herself, they still felt that there were significant problems in establishing whether girls could be assessed as Gillick competent. In some areas school nurses had been advised not to give the vaccine in the absence of parental consent. None of the respondents suggested that a girl should be vaccinated against her consent even if her parents wanted her to have the vaccine. Conclusions While the Gillick guidelines provide a legal framework to help professionals make judgements about adolescents consenting to medical treatment, in practice there appears to be variable and confused interpretation of this guidance. Improved legal structures, management procedures and professional advice are needed to support those who are assessing competence and establishing consent to vaccinate adolescents in a school setting. (shrink)

Light effects on the activity of several genes have recently been exploited in studies of plant gene expression. We discuss here some examples involving nuclear genes of higher plants, with emphasis on responses mediated by the phytochrome system. Recent work has revealed considerable diversity in the responses of different genes, indicating that several different regulatory programs are probably involved. A start has been made in studies of nuclear events associated with the changes in expression. Transcriptional regulation almost certainly occurs, although (...) many details remain to be studied and effects on mRNA processing and turnover have not been ruled out. Recent in vitro mutagenesis and gene transfer experiments with the gene for the small subunit of RuBP carboxylase indicate that sequences involved in regulating the level of expression in the light are located 5′ to the gene within about 1 kb of the start of transcription. (shrink)

Hooglands commentaar op mijn ‘Pluralisme’ komt hierop neer dat levensbeschouwelijke neutraliteit niet mogelijk is, noch voor de overheid, noch voor de individuele burger. We kunnen geen radicale buitenstaanderspositie innemen tegenover de levensbeschouwing die we erop nahouden. Dat zou een vorm van hybris zijn. Wie niettemin levensbeschouwelijke neutraliteit bepleit en deze identificeert met tolerantie voor de levensbeschouwingen van anderen, pretendeert in feite dat het eigen tolerante standpunt moreel superieur is aan het standpunt van al diegenen die aan hun levensbeschouwing vastgeklonken zitten. (...) Dat is moreel verwerpelijk. (shrink)

Upshot: Gibsonian and enactivist thinkers appear to diverge primarily with respect to the emphasis placed on the contributions of the organism to perception-action. Enactivists claim that a fundamental asymmetry in the organism-environment relationship should be credited for the existence of meaning in the world. Gibsonians counter that theory must reckon with both the asymmetry and symmetry between organism and environment as well as with the role of specificational information in underwriting their coordination.

Although Next Generation Sequencing (NGS) has increased our ability to test and diagnose, its results are often not clear-cut and require a complex interpretation and negotiation process by both healthcare professionals and patients involved. In this paper, we explore how diagnoses identified through NGS are socially shaped under influence of the broader social context. Using an analytical framework stemming from the sociology of health and illness and science and technology studies, with a focus on the construction of diagnosis and the (...) role of uncertainty in medicine, we analyze the existing corpus of literature on NGS diagnostic practices. We show how in this early implementation phase of NGS, in which standardization efforts are not yet solidified, the boundary struggles around diagnoses obtained through NGS are particularly visible. We discuss the different steps in the diagnosis shaping process and what it subsequently entails to give and a receive a diagnosis using NGS. (shrink)

Transplantation research on samples and organs from deceased donors in England, Wales and Northern Ireland is under threat. The key problems relate to difficulties encountered in gaining consent for research projects, as distinct from consent to donation for clinical transplantation. They are due partly to the terms of the Human Tissue Act 2004 (the 2004 Act), and partly to its interpretation by the Human Tissue Authority (HTA). They include excessive interaction with donor representatives regarding ‘informed consent’ to research projects, uncertainty (...) as to the scope and duration of a donor's ‘authority’ over an organ, and restrictions caused by the apparent need for licensing of transplantation research under the 2004 Act, combined with lack of certainty, or guidance, as to the distinction between ‘research’, which requires a licence, and ‘service development’, which does not. In our view this confusion hinders and deters Specialist Nurses for Organ Donation in approaching donor representatives and discussing possible research projects with them. It has also, as we have reported elsewhere, led to abandonment of research projects for fear of liability, despite both Research Ethics Committee (REC) approval and donor consent. Such problems do not seem to occur under the transplant laws of most other comparable jurisdictions. The Transplantation Ethics Symposium, ‘The ethics of organ retrieval: goals, rights and responsibilities’, hosted by the MRC Centre for Transplantation at King's College London in December 2010, revealed that many senior clinicians and researchers, administrators, and lawyers are both unclear and in disagreement concerning the effects of the 2004 Act and the extent to which it is adhered to or ignored in practice. In this paper we examine the difficulties encountered and suggest solutions based on a less restrictive interpretation of the 2004 Act, or, more probably, a regulatory change under its authority. We propose that, in the long term, a law which includes consent for REC-approved research within the general consent for organ donation and transplantation seems preferable to the present system, both ethically and in practical terms. (shrink)

The data produced by the scientific community impacts on academia, clinicians, and the general public; therefore, the scientific community and other regulatory bodies have been focussing on ethical codes of conduct. Despite the measures taken by several research councils, unethical research, publishing and/or reviewing behaviours still take place. This exploratory study considers some of the current unethical practices and the reasons behind them and explores the ways to discourage these within research and other professional disciplinary bodies. These interviews/discussions with PhD (...) students, technicians, and academics/principal investigators were conducted mostly in European higher education institutions including UK, Italy, Ireland, Portugal, Czech Republic and Netherlands.Through collegiate discussions, sharing experiences and by examining previously published/reported information, authors have identified several less reported behaviours. Some of these practices are mainly influenced either by the undue institutional expectations of research esteem or by changes in the journal review process. These malpractices can be divided in two categories relating to methodological malpractices including data management, and those that contravene publishing ethics. The former is mostly related to “committed bias”, by which the author selectively uses the data to suit their own hypothesis, methodological malpractice relates to selection of out-dated protocols that are not suited to the intended work. Although these are usually unintentional, incidences of intentional manipulations have been reported to authors of this study. For example, carrying out investigations without positive controls; but including these from a previous study. Other methodological malpractices include unfair repetitions to gain statistical significance, or retrospective ethical approvals. In contrast, the publication related malpractices such as authorship malpractices, ethical clearance irregularities have also been reported. The findings also suggest a globalised approach with clear punitive measures for offenders is needed to tackle this problem. (shrink)