Background 300 million operations and procedures are performed annually across the world, all of which require a patient’s informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy. Methods The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars (...) to ratify outcomes for inclusion in the final core outcome set.. Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers. Results 36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the ‘consensus in’ criteria. 6 met ‘consensus in’ all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting ‘consensus in’ were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions. Conclusion This international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research. (shrink)

This paper provides a glimpse of some different theoretical frameworks and empirical methods in the author's search for theories and practices that might improve the utility and usability of computer artifacts. The essay touches on some problematic aspects of currently accepted theories and techniques in the cognitive sciences, especially in their application to the field of human-computer interaction, and mentions some alternative conceptions based on a cultural-historical approach. The intent is to widen the nature of the debate about appropriate frameworks (...) for discussing human activities especially when we discuss design activities in the context of computer systems development. The paper concludes with some suggestions for more fruitful research directions that involve the active participation of those for whom the research is ostensibly being done, and a greater emphasis on understanding how artifact design and use are inextricably intertwined. (shrink)

This article reports the findings from a study that investigates the relationship between ethical climates and police whistle-blowing on five forms of misconduct in the State of Georgia. The results indicate that a friendship or team climate generally explains willingness to blow the whistle, but not the actual frequency of blowing the whistle. Instead, supervisory status, a control variable investigated in previous studies, is the most consistent predictor of both willingness to blow the whistle and frequency of blowing the whistle. (...) Contrary to popular belief, the results also generally indicate that police are more inclined than civilian employees to blow the whistle in Georgia - in other words, they are less inclined to maintain a code of silence. (shrink)

PTEN‐induced kinase 1 (PINK1) is a Parkinson's disease gene that acts as a sensor for mitochondrial damage. Its best understood role involves phosphorylating ubiquitin and the E3 ligase Parkin (PRKN) to trigger a ubiquitylation cascade that results in selective clearance of damaged mitochondria through mitophagy. Here we focus on other physiological roles of PINK1. Some of these also lie upstream of Parkin but others represent autonomous functions, for which alternative substrates have been identified. We argue that PINK1 orchestrates a multi‐arm (...) response to mitochondrial damage that impacts on mitochondrial architecture and biogenesis, calcium handling, transcription and translation. We further discuss a role for PINK1 in immune signalling co‐ordinated at mitochondria and consider the significance of a freely diffusible cleavage product, that is constitutively generated and degraded under basal conditions. (shrink)

Chapter i The study of moral judgement The contemporary scene We are witnessing today a dramatic growth of interest in the processes of giving moral ...

Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women’s and staff views about the consent procedures used during the internal pilot of a trial, where the protocol permitted staff to gain verbal consent at recruitment. Interviews with staff (...) and participating women. Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants’ views about the consent procedures used. Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for obtaining written consent at recruitment. While alternative consent pathways have an important role to play in advancing emergency medicine research, and may be appreciated by potential recruits, they may give rise to unintended ethical and logistical challenges for staff. Staff would benefit from training and support to increase their confidence and willingness to recruit into trials using alternative consent pathways. This qualitative research was undertaken as part of the GOT-IT Trial. Date of registration 26/03/2014. (shrink)

Book reviewed in this article: Just Doctoring: Medical Ethics in the Liberal State. By Troyen A. Brennan. The Ends of Human Life: Medical Ethics in a Liberal Polity. By Ezekiel J. Emanuel.

In lieu of an abstract, here is a brief excerpt of the content:Objective Reality of Ideas in Descartes, Caterus, and Su irez NORMAN j. WELLS IT HAS LONG BEEN ACKNOWLEDGEDthat Francisco Sufirez's distinction between a formal and an objective concept exercised some influence upon Descartes's teaching on 'idea'.' It would appear, however, that not enough attention has been given to that distinction of Sufirez (and especially to another to be mentioned shordy) to aid in dispelling what I take to (...) be a widespread confusion and misunderstanding with regard to 'idea' in Descartes, especially with respect to 'idea' taken 'objectively'. Much, if not all, of the confusion in question has to do with Descartes's admittedly equivocal use of the term 'idea'. For he had allowed that 'idea' could be taken 'materially' (materialiter), on the one hand, for the knowing activity of the intellect. On the other hand, it could be taken 'objectively' (objective) for the thing (res) represented by that knowing activity.' At this point, the contemporary reader can only be brought up short, See E. Gilson, Index scolastico-cart~sien (New York: Burt Franklin Reprint, 1912), 48-49; Discours de la m~thode: Texte et commentazre (Paris: J. Vrin, 1947), 321; G. Rodis-Lewisin her edition of Meditationes de Prima PhRosoph.m (Paris: J. Vrin, 1953), 41 n. 1; L'oeuure de Descartes (Paris: J. Vrin, 1971), 53~ n. 8; J. Collins, Modern European Philosophy (Milwaukee: Bruce, 1954), 165;T.J. Cronin, S.J., Objecttve Being m Descartes and SuArez (Rome: Gregorian University Press, 1966); "Objective Reality of Ideas in Human Thought: Descartes and Su~rez," Wisdom in Depth: Essays in Honor of Henri Renard, SJ., eds. V. F. Daues, S.J., M. R. Holloway, S.J., L. Sweeney, S.J. (Milwaukee : Bruce, 1966), 68-79; L. Gilen, S.J., "Uber die Beziehungen Descartes zur zeitgenossischen Scholastik," Scholastik 32 (1957): 41-66; R. Dalbiez, "Les sources scolastiques de la th~orie cart6sienne de l'&re objectif," Revue d'histoire de la philosophic 3 (1929): 464-72;J. Owens, C.S.S.R., in The Cambridge HtstoU of Later Medu,val Philosophy, eds. N. Kretzmann, A. Kenny, J. Pinborg (Cambridge University Press, 1982), 459; G. Nuchelmans,Judgment and Propositwnfrom Descartesto Kant (Amsterdam: North Holland Publishing Co., 1983), 36-54. " Oeuvres de Descartes, ed. C. Adam et P. Tannery, 11 vols. (Paris: J. Vrin, 1897-19o9; hereafter cited according to volume, page and line), Praefatio ad Lectorem, 7: 8. 19-251 "Sed respondeo hic subesse aequivocationem in voce ideae: sumi enim potest vel materialiter, pro operatione intellectus, quo sensu me perfectior dici nequit, vel objective, pro re per istam operationem repraesentata, quae res, etsi non supponatur extra intellectum existere, potest tamen me esse perfectior ratione suae essentiae." It is clear that two realities are to be causally accounted for. The [33] 34 JOURNAL OF THE HISTORY OF PHILOSOPHY 28"1 JANUARY 1990 conditioned as we are by an appreciation of 'objectivity' altogether extramental! It makes for a considerable wrench of perspective to do justice to Descartes's acknowledged doctrine of intramental objectivity and an intramental 'thing represented' (resrepraesentata). 'Idea', then, in traditional Cartesian fashion, designates the act of representing as well as the 'thing represented '. S Yet, for all this, and despite repeated expressions of the same doctrine, there is a persistent tendency in the history of Cartesianism and its scholarship to interpret 'idea' taken 'objectively' as in some way representative. Contrary to what I take to be Descartes's constant position, such a rendering unwittingly transfers that function which is proper to the cognitive activity, mind is the efficient cause of its cognitive activity. With respect to ideas taken 'objectively', such as the ideas of God and the triangle on the levels of metaphysical and mathematical intelligibility, an efficient cause, extrinsic to the mind, is certainly at issue. For here we are in the presence of what is independent of the mind, however intramental it may be. On the triangle, see Medit. 5; 7: 64. ]4s7 : "...est tamen profecto determinata quaedam ejus natura, sire essentia, sive forma, immutabUis et aeterna, quae a me non efficta est, nec a mente mea dependet." For the idea of God, see Medit. 5; 7: 68. l o-12: "Nam sane multis modis inteUigo illam [ideam... (shrink)

The policy changes governing the relations between the pharmaceutical, medical device and service industries and academic clinical research physicians, recommended by the Institute of Medicine,1 the American Academy of Medical Colleges,2 and much discussed in the media and on our campuses, aim to create some protective ethical firewalls. However, some potentially critical consequences of these steps are missed if we do not acknowledge what else is on the table, and who is sitting at it. By only reacting defensively to the (...) juggernaut of righteous indignation over the loss of purity in a faculty physician's approach to medical problem solving, we are allowing the process to blind us to the difficulties in establishing fair and equitable management of all of the potential conflicts of commitment and conflicts of interest we incur, not only as faculty members, but also as departments and academic medical centres . Critically, this involves all sources of revenue—private, commercial and public—that support our professional and institutional commitments as well as our personal finances.i To counter the present crackdown on inappropriate financial relationships effectively, we will need to reframe the questions, and convince all stakeholders to the process that there is more to this crisis than can be resolved through our public confessions of commercial largesse obliged. The Phrma Code guidelines3 have resulted in what is believed to be a defensible, if as yet legally untested, compartmentalisation of the commercial sector's marketing, medical education and research sponsorship activities. We at the AMC are a long way from understanding how those same missions, as they emanate from our multifarious commitments, can be isolated and individually managed. Defining the parameters for establishing institutional conflicts of interest and commitment are beyond our essay's scope, but with the very public emphasis on capitalist subversion of …. (shrink)

Arnauld's criticisms as "a model of confusion confounded.” In a review of Wilson's book, R. McRae refers to "the difficult and not too coherent subject of material falsity. '' J. Cottingham describes the Descartes-Arnauld debate on the material falsity of adventitious ideas as "an involved and rather inconclusive exchange " and claims that the example of the material falsity of such ideas espoused by Descartes in Meditation III is "needlessly complicated. " A. Kenny, in turn, notes that several things are (...) "confusing in Descartes' account of false ideas. " Later reference is made to the fact that "Descartes appears confused. [...] and that "Descartes, it seems, cannot give a consistent answer. '' As will become clear, I take issue with each of these assessments. When Descartes' position on material falsity is understood in the light of late Scholastic sources, especially Suarez, whence it draws its strength and inspiration, the alleged confusion and incoherency vanishes. .. (shrink)

The precise relationship between the autonomic nervous system and emotion has been a topic of intense debate and research throughout the history of modern psychology. The present article considers some of the more influential theoretical frameworks that continue to drive contemporary research on the relationship between emotion and physiological processes. In particular, we highlight the multiple routes through which somatovisceral afference influences emotion and how this relates to the topic of emotion-specific patterns of autonomic nervous system activity.

Relevance logics came of age with the one and only International Conference on relevant logics in 1974. They did not however become accepted, or easy to promulgate. In March 1981 we received most of the typescript of IN MEMORIAM: ALAN ROSS ANDERSON Proceedings of the International Conference of Relevant Logic from the original editors, Kenneth W. Collier, Ann Gasper and Robert G. Wolf of Southern Illinois University. 1 They had, most unfortunately, failed to find a publisher - not, it appears, (...) because of overall lack of merit of the essays, but because of the expense of producing the collection, lack of institutional subsidization, and doubts of publishers as to whether an expensive collection of essays on such an esoteric, not to say deviant, subject would sell. We thought that the collection of essays was still (even after more than six years in the publishing trade limbo) well worth publishing, that the subject would remain undeservedly esoteric in North America while work on it could not find publishers (it is not so esoteric in academic circles in Continental Europe, Latin America and the Antipodes) and, quite important, that we could get the collection published, and furthermore, by resorting to local means, published comparatively cheaply. It is indeed no ordinary collection. It contains work by pioneers of the main types of broadly relevant systems, and by several of the most innovative non-classical logicians of the present flourishing logical period. We have slowly re-edited and reorganised the collection and made it camera-ready. (shrink)

Systems thinking has emerged as a means of conceptualizing and addressing complex public health problems, thereby challenging more commonplace understanding of problems and corresponding solutions as straightforward explanations of cause and effect. Systems thinking tries to address the complexity of problems through qualitative and quantitative modeling based on a variety of systems theories, each with their own assumptions and, more importantly, implicit and unexamined values. To date, however, there has been little engagement between systems scientists and those working in bioethics (...) and public health ethics. The goal of this paper is to begin to consider what it might mean to combine systems thinking with public health ethics to solve public health challenges. We argue that there is a role for ethics in systems thinking in public health as a means of elucidating implicit assumptions and facilitating ethics debate and dialogue with key stakeholders. (shrink)

In this article we examine the changing relationship to risk as revealed by the covid-19 pandemic and the ways this has, and may in future, alter sacramental practice, considering the radical effects this could have on traditional Christian practice. We consider the cultural trends that may lie behind this developing approach to risk, examining this in the context of an emergent transhuman identity that is technologically moderated and seeks to overcome risks of human mortality.

Evaluative processes have their roots in early evolutionary history, as survival is dependent on an organism’s ability to identify and respond appropriately to positive, rewarding or otherwise salubrious stimuli as well as to negative, noxious, or injurious stimuli. Consequently, evaluative processes are ubiquitous in the animal kingdom and are represented at multiple levels of the nervous system, including the lowest levels of the neuraxis. While evolution has sculpted higher level evaluative systems into complex and sophisticated information-processing networks, they do not (...) come to replace, but rather to interact with more primitive lower level representations. Indeed, there are basic features of the underlying neuroarchitectural plan for evaluative processes that are common across levels of organization—including that of evaluative bivalence. (shrink)