Nurse clinician‐scientists are increasingly expected to show leadership aimed at transforming healthcare. However, research on nurse clinician‐scientists' leadership (integrating researcher and practitioner roles) is scarce and hardly embedded in sociohistorical contexts. This study introduces leadership moments, that is, concrete events in practices that are perceived as acts of empowerment, in order to understand leadership in the daily work of newly appointed nurse clinician‐scientists. Following the learning history method we gathered data using multiple (qualitative) methods to get close (...) to their daily practices. A document analysis provided us with insight into the history of nursing science to illustrate how leadership moments in the everyday work of nurse clinician‐scientists in the “here and now” can be related to the particular histories from which they emerged. A qualitative analysis led to three acts of empowerment: (1) becoming visible, (2) building networks, and (3) getting wired in. These acts are illustrated with three series of events in which nurse clinician‐scientists' leadership becomes visible. This study contributes to a more socially embedded understanding of nursing leadership, enables us to get a grip on crucial leadership moments, and provides academic and practical starting points for strengthening nurse clinician‐scientists' leadership practices. Transformations in healthcare call for transformed notions of leadership. (shrink)

Clinician scientists have gained institutional support in the era of translational research, as the key solution to closing the ‘translational gap’ between biomedical research and medical practice. However, clinician scientists remain an ‘endangered species’ in search of a secure niche, while new grants and training programs attempt to counteract their measurable decline in numbers over the past decades. Our study asks how an occupational space for clinician scientists is currently situated between the politics of translation, professional dynamics, (...) and the specialization of academic disciplines. We interviewed clinician scientists, their adjacent professions—clinicians and biomedical researchers—, and contrast their views with expectations from the discourse on clinician scientists in the biomedical and policy literature. We identify professionalizable work and tasks that relate to, first, being able to speak the two languages of both clinic and research, second, translating patients’ needs and clinical experience for further research, and third, counteracting the trends towards specialization by providing an inclusive point of view. We find that clinician scientists are overburdened with fulfilling a hybrid role of simultaneously being clinicians and scientists. Based on these findings, we suggest a path for the future professional development of clinician scientists towards the role of a translator. (shrink)

Reasons for the limited uptake of the clinician–scientist role within nursing are examined, specifically: the lack of consensus about the nature of nursing science; the varying approaches to epistemology; and the influence of post-modern thought on knowledge development in nursing. It is suggested that under-development of this role may be remedied by achieving agreement that science is a necessary, worthy pursuit for nursing, and that rigorous science conducted from a clinical perspective serves nursing well. Straddling practice and research (...) is a powerful strategy for ensuring relevant research while forging strong links with practice. The clinician–scientist role, typically requiring a 75:25 ratio between research and clinical activities, is well established in medicine. Nursing, however, has been slow to institute the role; it is rare within North America, Australia, and western European countries, and almost non-existent outside those areas. Beyond structural obstacles, philosophical issues may explain nursing's reluctance to implement the role. Following a survey of clinician–scientist roles throughout the world, the nature of nursing science and epistemology, and the influence of post-modern thought on nursing attitudes to research are examined with respect to their influence on this role. The nurse clinician–scientist role holds promise for making strides in clinically relevant research, and for accelerating the knowledge cycle from clinical problem to research question to change in clinical practice. (shrink)

Clinician-scientists play a valuable role in bridging the gap between patient care and clinical research. However, there are no clear guidelines that describe how to handle the day-to-day ethical and methodological questions that arise when navigating the competing responsibilities of practitioner and researcher—a situation that can easily leave the clinician-scientist confused and frustrated. This article outlines common ethical and methodological concerns for the clinician-scientist when developing, implementing, and analyzing research in practice, and offers practical suggestions (...) to address these issues. This paper will outline the role that reflexivity can play throughout the research process to assist the clinician-scientist in maintaining ethical and methodological rigor, as well as upholding the moral obligations of both practitioner and researcher. (shrink)

Funding agencies in Canada are attempting to break down the organizational boundaries between disciplines to promote interdisciplinary research and foster the integration of the social sciences into the health research field. This paper explores the extent to which biomedical and clinician scientists’ perceptions of social science research operate as a cultural boundary to the inclusion of social scientists into this field. Results indicated that cultural boundaries may impede social scientists’ entry into the health research field through three modalities: (1) (...) biomedical and clinician scientists’ unfavourable and ambivalent posture towards social science research; (2) their opposition to a resource increase for the social sciences; and (3) clinician scientists procedural assessment criteria for social science. The paper also discusses the merits and limitations of Tom Gieryn’s concept of boundary-work for studying social dynamics within the field of science. (shrink)

In Nigeria, as in other developing countries, access to training in research ethics is limited, due to weak social, economic, and health infrastructure. The project described in this article was designed to develop the capacity of academic staff of the College of Medicine, University of Ibadan, Nigeria to conduct ethically acceptable research involving human participants.

In lieu of an abstract, here is a brief excerpt of the content:Should Clinicians’ Views of Mental Illness Influence the DSM?Elizabeth H. Flanagan (bio) and Roger K. Blashfield (bio)Keywordsclinicians, DSM, values, psychopathology, scienceThe relationship between clinicians and the DSM is complex. Clinicians are the primary intended audience of the DSM. However, as Widiger (2007) pointed out in his commentary, there is a tension associated with trying to meet the clinical goals of the DSM and also trying to optimize the scientific (...) goals of the DSM. Most commentators would agree that the recent editions of the DSM (from the DSM-III onward) have favored scientific values (e.g., Sadler 2005). Some commentators have taken sides and aligned themselves with either clinicians or with the science of classification. For instance, Garb (2005) has argued that clinicians should receive incentives to align themselves more closely with the science of the DSM. In contrast, Westen and Shedler (1999) have favored a clinician-based approach to the DSM and have argued that an ideal classification should be based on the prototypes that clinicians use to conceptualize diagnostic categories. Perhaps an extreme suggestion on how to deal with this tension between the values of clinicians and the values of scientists is to adopt the ICD-10 solution and create two versions of the next DSM. One version would be written for clinicians and another for researchers (Phillips et al. 2003).Widiger (2007) wondered whether the two of us as authors are on the fence about how the views of clinicians should affect the DSM. As clinical psychologists who are both clinicians and researchers, we understand his comment, especially in light of our attempt in our article not to overgeneralize from the time-consuming, labor-intensive, yet methodologically limited study we reported in our major paper.Nonetheless, our answer to the question asked in the title of this response, “Should clinicians’ views of mental illness influence the diagnostic manual?” is a clear and unequivocal yes. In our view, too much of the research literature stimulated by the recent DSMs has primarily used the diagnostic criteria in these DSMs to specify patient samples and then perform various experiments to study the DSM categories. We favor a different approach to research which is consistent with a comment once made by the philosopher of science, Karl Popper: “scientific theories originate from myths, and... a myth may contain important anticipations of scientific theories” (1963, 39). We believe that clinicians, with their years [End Page 285] of experience dealing with the ambiguities, the emotionality, and the chaos of psychopathology, have formed complex conceptual systems to try to understand the mysteries of abnormal behavior. We strongly support increased research attempts that will use clinicians as subjects and that will attempt to understand how clinicians use diagnostic concepts to understand patients.Although research on clinicians has not attracted a large amount of attention in the field, there is a long history of such research studies. For instance, in the 1970s, Overall used multivariate techniques to create graphical maps of how clinicians represented relationships among diagnoses (Overall et al. 1977). Widiger has used a similar strategy in some of his research (Widiger et al. 1987). In the early 1980s, a view of concept formation from cognitive psychology was used by Cantor et al. (1980) to look at psychiatric diagnoses as representing prototypes. Horowitz and colleagues extended this research. Blashfield and his colleagues had a grant to use the prototype model to study personality disorders and performed research investigating both case histories (Blashfield et al. 1985) and analyses of diagnostic criteria (Blashfield and Breen 1989; Davis, Blashfield, and McElroy 1993). Westen and colleagues have attempted to reconceptualize DSM personality disorder categories using the prototype model (Westen and Shedler 1999). Ahn and her colleagues (Ahn et al. 2006; Kim and Ahn 2002) have taken more recent applications of ideas from cognitive psychology to study how clinicians use and understand diagnostic categories. Finally, Flanagan and colleagues (Flanagan and Blashfield 2006; Flanagan, Keeley, and Blashfield, in press; Flanagan, Miller, and Davidson, submitted) have used qualitative and quantitative data analysis techniques to try to understand the diagnostic concepts held by experienced clinicians.Besides empirical studies of how clinicians use diagnostic concepts, we also support the increased interest in... (shrink)

Physicians, nurses, and other clinicians readily acknowledge being troubled by encounters with patients who trigger moral judgments. For decades social scientists have noted that moral judgment of patients is pervasive, occurring not only in egregious and criminal cases but also in everyday situations in which appraisals of patients' social worth and culpability are routine. There is scant literature, however, on the actual prevalence and dynamics of moral judgment in healthcare. The indirect evidence available suggests that moral appraisals function via a (...) complex calculus that reflects variation in patient characteristics, clinician characteristics, task, and organizational factors. The full impact of moral judgment on healthcare relationships, patient outcomes, and clinicians' own well-being is yet unknown. The paucity of attention to moral judgment, despite its significance for patient-centered care, communication, empathy, professionalism, healthcare education, stereotyping, and outcome disparities, represents a blind spot that merits explanation and repair. New methodologies in social psychology and neuroscience have yielded models for how moral judgment operates in healthcare and how research in this area should proceed. Clinicians, educators, and researchers would do well to recognize both the legitimate and illegitimate moral appraisals that are apt to occur in healthcare settings. (shrink)

Notwithstanding fundamental methodological advancements, scientific information about disorders of consciousness (DOCs)—e.g. Vegetative State/Unresponsive Wakefulness Syndrome (VS/UWS) and Minimally Conscious State (MCS)—is incomplete. The possibility to discriminate between different levels of consciousness in DOC states entails treatment strategies and ethical concerns. Here we attempted to investigate Italian clinicians’ and basic scientists’ opinions regarding some issues emerging from the care and the research on patients with DOCs. From our survey emerged that Italian physicians working with patients with DOCs give a central role (...) to ethics. Current Italian regulation regarding basic research conducted in patients with DOCs apparently risks to be inadequate to support scientific advancement, and would deserve a different assessment compared to ordinary treatments. We think the results of our survey deserve attention from an international audience because they exemplify the difficulty to define a shared approach to the issues related to patients with DOCs and the necessity to better assess both the ordinary and experimental treatment of patients with DOCs at the ethical and legal level. (shrink)

The Smart Home designed to extend older adults independence is emerging as a clinical solution to the growing ageing population. Nurses will and should play a key role in the development and application of Smart Home technology. Accordingly, conceptual frameworks are needed for nurse scientists who are collaborating with multidisciplinary research teams in developing an intelligent Smart Home that assists with managing older adults’ health. We present a conceptual framework that is grounded in critical realism and pragmatism, informing a unique (...) mixed methodological approach to generating, analyzing, and contextualizing sensor data for clinician‐based machine learning. This framework can guide nurse scientists in knowledge construction as they participate in multidisciplinary health‐assistive Smart Home and artificial intelligence research. In this paper, we review philosophical underpinnings and explicate how this framework can guide nurse scientists collaborating with engineers to develop intelligent health‐assistive Smart Homes. It is critical that clinical nursing knowledge is integrated into Smart Home and artificial intelligence features. A conceptual framework and practical method will provide needed structure for knowledge construction by nurse scientists. (shrink)

Morality, ethics, and the law : an overview of the foundations of contemporary clinical ethical analysis -- Case studies : ethical and legal challenges in the care of the neurologically injured critically ill patient -- Civil law and liability : the law of medical malpractice -- Legal reasoning, legal process, legal proof, and why it is confusing to clinician scientists -- Regulatory law and the clinical practice of the neurosciences -- Digital medicine and the data revolution managing digital distraction (...) and EMR : liability while leveraging opportunities in teleneurology and telecritical care -- Developing and leading a sustainable high reliability high performing unit : theories of quality, teamwork, medical error, and patient safety -- Neurolaw and the integration of neuroscience, ethics, and the law : the new frontiers. (shrink)

Much has been published about the ethical issues encountered by clinicians in genetics/genomics, but those experienced by clinical laboratory scientists are less well described. Clinical laboratory scientists now frequently face navigating ethical problems in their work, but how they should be best supported to do this is underexplored. This lack of attention is also reflected in the ethics tools available to clinical laboratory scientists such as guidance and deliberative ethics forums, developed primarily to manage issues arising within the clinic.We explore (...) what ethical issues are being experienced by clinical scientists, how they think such issues could be best analysed and managed, and whether their practice might be enhanced by more situated approaches to ethics deliberation and practice such as ethical preparedness. From thematic analysis of cases presented by clinical scientists at a specially convened meeting of the UK Genethics Forum, we derived three main ethical themes: (1) the redistribution of labour and responsibilities resulting from the practice of genomic medicine; (2) the interpretation and certainty of results and (3) the proposal that better standardisation and consistency of ethical approaches (for example, more guidelines and policy) could resolve some of the challenges arising.We argue that although standardisation is important for promoting shared understandings of good (including ethical) practice, supplementary approaches to enhance and sustain ethical preparedness will be important to help clinical scientists and others in the recently expanded genetic/genomic medicine environment foster quality ethical thinking. (shrink)

Healers: Extraordinary Clinicians at Work, by David Schenck and Larry R. Churchill, and What Patients Teach: The Everyday Ethics of Health Care, by Churchill, Joseph B. Fanning, and Schenck are both important and thought‐inspiring books. For the first, Schenck and Churchill recruited fifty practitioners, mostly physicians but some clinicians who practice alternative therapies, “identified by their peers as excellent healers,” and interviewed them to find out what they did to establish a good relationship with their patients. The results of their (...) interviews and how they wrote their book makes this the best and most concrete understanding of a necessary step to healing that I have read. What Patients Teach examines the patients’ perspective about forming relationships with their clinicians. The patients’ clinicians were asked to nominate patients to be interviewed to help answer the question. This volume, while important, is less extraordinary than the first because we hear less what the patients want to say and more what the authors want to tell us. That aside, taken together, these two books are a major advance in the literature of healing. (shrink)

Our think tank tasked by the Dutch Health Council, consisting of Radboud University Nijmegen Honours Academy students with various backgrounds, investigated the implications of Deep Brain Stimulation for psychiatric patients. During this investigation, a number of methodological, ethical and societal difficulties were identified. We consider these difficulties to be a reflection of a still fragmented field of research that can be overcome with improved organization and communication. To this effect, we suggest that it would be useful to found a centralized (...) DBS organization. Such an organization makes it possible to 1) set up and maintain a repository, 2) facilitate DBS studies with a larger sample size, 3) improve communication amongst researchers, clinicians and ethical committees, and 4) improve communication between DBS experts and the public at large. (shrink)

Our think tank tasked by the Dutch Health Council, consisting of Radboud University Nijmegen Honours Academy students with various backgrounds, investigated the implications of Deep Brain Stimulation for psychiatric patients. During this investigation, a number of methodological, ethical and societal difficulties were identified. We consider these difficulties to be a reflection of a still fragmented field of research that can be overcome with improved organization and communication. To this effect, we suggest that it would be useful to found a centralized (...) DBS organization. Such an organization makes it possible to 1) set up and maintain a repository, 2) facilitate DBS studies with a larger sample size, 3) improve communication amongst researchers, clinicians and ethical committees, and 4) improve communication between DBS experts and the public at large. (shrink)

In a recent discussion about how scientific knowledge might potentially change our understanding of the nature and extent of human genetic, cultural, or biological variation, the sociologist David Skinner identified two competing visions of the future: one that was decidedly dystopian, which conjured up a “re-racialized” future, and an opposing utopian future in which the potential for racialized thinking might be finally overcome. We can situate the ongoing debates about the congestive heart failure drug BiDil, approved by the Food and (...) Drug Administration for use only by African Americans, in relation to these differing future prospects.When the FDA announced its approval of BiDil in June 2005, it located the drug, and perhaps the future of pharmaceutical development, within a particular vision of the future, heralding BiDil as “representing a step toward the promise of personalized medicine.” The discourse of “personalized medicine” can be characterized as part of a utopian future, one in which clinicians will be able to make increasingly individualized decisions based on each patient’s genetic makeup so that the drugs they take will be those that work best for them. (shrink)

In this article two inter-related issues concerning the ongoing commercialisation of biomedical research are analyzed. One aim is to explain how scientists and clinicians at Swedish public institutions can make profits, both commercially and scientifically, by controlling rare human biological material, like embryos and embryonic stem cell lines. This control in no way presupposes legal ownership or other property rights as an initial condition. We show how ethically sensitive material (embryos and stem cell lines) have been used in Sweden as (...) a foundation for a commercial stem cell enterprise—despite all official Swedish strictures against commercialisation in this area. We also show how political decisions may amplify the value of controlling this kind of biological material. Another aim of the article is to analyze and discuss the meaning of this kind of academic commercial enterprise in a wider context of research funding strategies. A conclusion that is drawn is that the academic turn to commercial funding sources is dependent on the decline of public funding. (shrink)

Following recent debate on the relations between philosophy of science and the sciences, we wish to draw attention to some actual ways of training both young philosophers of science and young life scientists and clinicians. First, we recall a successful case of training philosophers of the life sciences in a strictly scientific environment. Second, after a brief review of the reasons why life scientists and clinicians are currently asking for more ethics, more methodology of science, and more philosophy of science (...) in the training of life scientists and clinicians, we present two training models that could spur the discussion on how to meet the requests coming from the scientific community. We argue that in order to reflect on mutual relations between philosophy of science and the sciences and to foster proper interactions, issues regarding the topics considered, the features of educational curricula, and the institutional organizations should be addressed jointly. (shrink)

Gilbert and colleagues point out the discrepancy between the limited empirical data illustrating changes in personality following implantation of deep brain stimulating electrodes and the vast number of conceptual neuroethics papers implying that these changes are widespread, deleterious, and clinically significant. Their findings are reminiscent of C. P. Snow’s essay on the divide between the two cultures of the humanities and the sciences. This division in the literature raises significant ethical concerns surrounding unjustified fear of personality changes in the context (...) of DBS and negative perceptions of clinician-scientists engaged in DBS. These concerns have real world implications for funding future innovative, DBS trials aimed to reduce suffering as well as hampering true interdisciplinary scholarship. We argue that the philosophical tradition of pragmatism and the value it places on empirical inquiry, experiential knowledge, and inter-disciplinary scholarship – reflecting diverse ways of knowing – provides a framework to start to address the important questions Gilbert and colleagues raise. In particular, we highlight the importance of expert clinician knowledge in contributing to the neuroethical questions raised by Gilbert and colleagues. Finally, we provide illustrative examples of some of our interdisciplinary empirical research that demonstrate the iterative cycle of inquiry characteristic of pragmatism in which conceptual neuroethics questions have led to empirical studies whose results then raise additional conceptual questions that give rise to new empirical studies in a way that highlights the contributions of the humanities and the sciences. (shrink)

Gilbert and colleagues point out the discrepancy between the limited empirical data illustrating changes in personality following implantation of deep brain stimulating electrodes and the vast number of conceptual neuroethics papers implying that these changes are widespread, deleterious, and clinically significant. Their findings are reminiscent of C. P. Snow’s essay on the divide between the two cultures of the humanities and the sciences. This division in the literature raises significant ethical concerns surrounding unjustified fear of personality changes in the context (...) of DBS and negative perceptions of clinician-scientists engaged in DBS. These concerns have real world implications for funding future innovative, DBS trials aimed to reduce suffering as well as hampering true interdisciplinary scholarship. We argue that the philosophical tradition of pragmatism and the value it places on empirical inquiry, experiential knowledge, and inter-disciplinary scholarship – reflecting diverse ways of knowing – provides a framework to start to address the important questions Gilbert and colleagues raise. In particular, we highlight the importance of expert clinician knowledge in contributing to the neuroethical questions raised by Gilbert and colleagues. Finally, we provide illustrative examples of some of our interdisciplinary empirical research that demonstrate the iterative cycle of inquiry characteristic of pragmatism in which conceptual neuroethics questions have led to empirical studies whose results then raise additional conceptual questions that give rise to new empirical studies in a way that highlights the contributions of the humanities and the sciences. (shrink)

Gilbert and colleagues point out the discrepancy between the limited empirical data illustrating changes in personality following implantation of deep brain stimulating electrodes and the vast number of conceptual neuroethics papers implying that these changes are widespread, deleterious, and clinically significant. Their findings are reminiscent of C. P. Snow’s essay on the divide between the two cultures of the humanities and the sciences. This division in the literature raises significant ethical concerns surrounding unjustified fear of personality changes in the context (...) of DBS and negative perceptions of clinician-scientists engaged in DBS. These concerns have real world implications for funding future innovative, DBS trials aimed to reduce suffering as well as hampering true interdisciplinary scholarship. We argue that the philosophical tradition of pragmatism and the value it places on empirical inquiry, experiential knowledge, and inter-disciplinary scholarship – reflecting diverse ways of knowing – provides a framework to start to address the important questions Gilbert and colleagues raise. In particular, we highlight the importance of expert clinician knowledge in contributing to the neuroethical questions raised by Gilbert and colleagues. Finally, we provide illustrative examples of some of our interdisciplinary empirical research that demonstrate the iterative cycle of inquiry characteristic of pragmatism in which conceptual neuroethics questions have led to empirical studies whose results then raise additional conceptual questions that give rise to new empirical studies in a way that highlights the contributions of the humanities and the sciences. (shrink)

Sex is a fundamentally important biological variable. Recent years have seen significant progress in the integration of sex in many aspects of basic and clinical research, including analyses of sex differences in brain function. Significant advances in the technology available for studying the endocrine and nervous systems are now coupled with a more sophisticated awareness of the interconnections of these two communication systems of the body. A thorough understanding of the current knowledge, conceptual approaches, methodological capabilities, and challenges is a (...) prerequisite to continued progress in research and therapeutics in this interdisciplinary area. Sex Differences in the Brain provides scientists with the basic tools for investigating sex differences in brain and behavior and insight into areas where important progress in understanding physiologically relevant sex differences has already been made. This book was edited and co-authored by members of the Isis Fund Network on Sex, Gender, Drugs and the Brain, sponsored by the Society for Womens Health Research. The book is arranged in three parts. The first part of the book introduces the study of sex differences in the brain, with an overview of how the brain, stress systems, and pharmacogenetics differ in males and females and how this information is important for the study of behavior and neurobiology of both genders. The second part presents examples of sex differences in neurobiology and behavior from both basic and clinical research perspectives, covering both humans and nonhuman animals. The final part discusses sex differences in the neurobiology of disease and neurological disorders. For interested individuals as well as those who are considering conducting research at the intersections of endocrinology, neuroscience, and other areas of biomedicine, the study of sex differences offers exciting and challenging questions and perspectives. This book is intended as a guide and resource for clinicians, scientists, and students. (shrink)

To be both a clinician and a scientist—what is usually called a clinician scientist or clinical investigator—is easy neither from an ethical nor from a methodological standpoint. On the one hand, it requires care, cure of the patients, and good ethical practice. On the other, excellent skills in experimental design and data analysis are necessary. In addition, the correct choice of a disease as a model to be studied is very often hampered by the obvious ethical (...) constraints of working with human beings, thus limiting the experimental armamentarium in the hands of the clinician scientist. Yet, Henry Beecher succeeded in both. He was an excellent clinician and scientist and put forward ideas and concepts that today... (shrink)

This paper gives an overview of the placebo effect in popular culture, especially as it pertains to the work of authors Patrick O’Brian and Sinclair Lewis. The beloved physician as placebo, and the clinician scientist as villain are themes that respectively inform the novels, The Hundred Days and Arrowsmith. Excerpts from the novels, and from film show how the placebo effect, and the randomized clinical trial, have emerged into popular culture, and evolved over time.

The nascent for-profit psychedelic industry has begun to engage in corporate practices like funding scientific research and research programs. There is substantial evidence that such practices from other industries like tobacco, alcohol, pharmaceuticals and food create conflicts of interest and can negatively influence population health. However, in a context of funding pressures, low publicly funded success rates and precarious academic labor, there is limited ethics guidance for researchers working at the intersection of clinical practice and population health as to how (...) they should approach potential financial sponsorship from for-profit entities, such as the psychedelic industry. This article reports on a reflective exercise among a group of clinician scientists working in psychedelic science, where we applied Adams’ (2016) PERIL (Purpose, Extent, Relevant harm, Identifiers, Link) ethical decision-making framework to a fictionalized case of corporate psychedelic financial sponsorship. Our analysis suggests financial relationships with the corporate psychedelic sector may create varying degrees of risk to a research program’s purpose, autonomy and integrity. We argue that the commercial determinants of health provide a useful framework for understanding the ethics of industry-healthcare entanglements and can provide an important population health ethics lens to examine nascent industries such as psychedelics, and work toward potential solutions. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Bioethics Inside the BeltwayNHGRI’s Intramural Ethics ExperimentRonald M. Green (bio)Early in 1995, the National Human Genome Research Institute (then known as the National Center for Human Genome Research) began a novel experiment. It established the Office of Genome Ethics in its Division of Intramural Research (DIR). An extramural “ELSI” funding program for research on the ethical, legal, and social implications of the Human Genome Project had been in existence (...) since 1990, and a joint Department of Energy, NIH Working Group to consider larger policy issues raised by the genome project had also been in existence since that date. But the establishment of the Office of Genome Ethics was the first effort to provide an in-house ethics service for the several hundred NHGRI genetic researchers working on the NIH campus.The experiment was also novel by NIH standards. The Clinical Center, which serves all NIH research institutes as a patient-care facility, has long had a bioethics program, but, to my knowledge, none of the 23 other institutes, centers, or divisions of the NIH had ever developed an ethics program to assist its on-campus researchers in identifying and addressing the ethical issues arising from their research. Behind this initiative lay the commitment to ethics in genetic research shared by Francis Collins, Director of NHGRI, Jeff Trent, Scientific Director of the Division of Intramural Research, and other senior scientists and administrators of the Institute.I was fortunate to be asked to serve as Director of this office. My previous experience in the federal context was limited. I had served on many NIH study sections and for a nine-month period had been a member of the Human Embryo Research Panel, but none of this amounted to an “insider’s view” of government bioethics. The preponderance of my bioethics career had transpired in the university and medical school/medical center environment.Because I had to continue to fulfill many Dartmouth commitments, I agreed to serve on an interim and half-time basis (one week in Bethesda; one week at home) for an 18-month period. I was assisted in maintaining this schedule by the appointment of a deputy, Mathew Thomas, a recent bioethics graduate of Duke University, who would serve on a full-time basis and provide continuity for our [End Page 181] work. Our objectives, established in consultation with NHGRI personnel, were to learn which functions would be most useful, to set up a program to provide them, and, eventually, to aid in the process of determining how an office like this might fit into NHGRI’s future.As this 18-month stint draws to a close, I can report that it has been an exhilarating experience. I am grateful for the opportunity to have worked with outstanding scientists in an area of growing importance and interest. I believe we have pioneered in the provision of bioethics education and counsel to a diverse group of genetic researchers. We have helped to “open the doors and windows” of the Genome Institute, facilitating two-way communication between NHGRI researchers and others interested in genetic and ethics. We have assisted with some knotty problems in genetic research while building a base of knowledge about highly specialized issues that is useful to researchers inside and outside NHGRI. What follows is an abbreviated overview and evaluation of our activities during this period.Main ActivitiesWorking with a core of interested supporters from every branch of the DIR, our office quickly established a roster of activities aimed at meeting identified needs. These included: (1) a consult service able to help investigators address urgent problems arising in their research or in the IRB review process; (2) a program of workshops and discussion groups dealing with challenging ethical issues raised by genetic research; (3) a program of public seminars bringing together NHGRI researchers and other clinicians, scientists, and scholars in the greater Washington area who are interested in genetic ethics; (4) a course on science research ethics to be offered to all NHGRI personnel; and (5) an ongoing program of research activities in genetics and ethics designed to provide depth and substance to the office’s work.ConsultationsIn an institute with scores of... (shrink)

BackgroundThe highly sensitive nature of genomic and associated clinical data, coupled with the consent-related vulnerabilities of children together accentuate ethical, legal and social issues (ELSI) concerning data sharing. The Key Implications of Data Sharing (KIDS) framework was therefore developed to address a need for institutional guidance on genomic data governance but has yet to be validated among data sharing practitioners in practice settings. This study qualitatively explored areas of consensus and dissensus of the KIDS Framework from the perspectives of Canadian (...) clinician-scientists, genomic researchers, IRB members, and pediatric ethicists.MethodsTwelve panelists participated in a three-round online policy Delphi to determine the desirability, feasibility, relative importance and confidence of twelve individual statements of the KIDS Framework. Mean and IQR were calculated from panelists’ ratings to determine the strength of consensus and polarity. Qualitative content analysis of panelists’ written responses was used to assess degree of support. Statements were validated when their combined ratings and qualitative rationales indicated high-moderate consensus (at least 70% agreement across two contiguous categories), low to no polarity (IQR at least 1.0) and strong support.ResultsNine original, and one new statement reached consensus. These statements outlined essential elements of the informed consent process, including a realistic evaluation of benefits and risks and assurance of future ethics oversight for secondary data use. Discrepant views on appropriate protections for anonymized and coded i.e. de-identified genomic data were primary sources of dissensus.ConclusionsThe validated statements provide institutions with empirically supported best practices for sharing genomic and associated clinical data involving children from the perspectives of key stakeholders. Concerted efforts to quantify informational risks that can be conveyed to patients and families are further needed to align data sharing policy with stakeholder priorities. (shrink)

Clinicians and cognitive scientists typically conceive of delusions as doxastic—they view delusions as beliefs. But some philosophers have countered with anti-doxastic objections: delusions cannot be beliefs because they fail the necessary conditions of belief. A common response involves meeting these objections on their own terms by accepting necessary conditions on belief but trying to blunt their force. I take a different approach by invoking a cognitive-phenomenal view of belief and jettisoning the rational/behavioural conditions. On this view, the anti-doxastic claims can (...) be rejected outright, and doxasticism can be defended. I call this the cognitive phenomenological defence of doxasticism. (shrink)

Social scientists have drawn attention to the role of hype and optimistic visions of the future in providing momentum to biomedical innovation projects by encouraging innovation alliances. In this article, we show how less optimistic, uncertain, and modest visions of the future can also provide innovation projects with momentum. Scholars have highlighted the need for clinicians to carefully manage the expectations of their prospective patients. Using the example of a pioneering clinical team providing deep brain stimulation to children and young (...) people with movement disorders, we show how clinicians confront this requirement by drawing on their professional knowledge and clinical expertise to construct visions of the future with their prospective patients; visions which are personalized, modest, and tainted with uncertainty. We refer to this vision-constructing work as recalibration, and we argue that recalibration enables clinicians to manage the tension between the highly optimistic and hyped visions of the future that surround novel biomedical interventions, and the exigencies of delivering those interventions in a clinical setting. Drawing on work from science and technology studies, we suggest that recalibration enrolls patients in an innovation alliance by creating a shared understanding of how the “effectiveness” of an innovation shall be judged. (shrink)

Scientists have the ability to influence policy in important ways through how they present their results. Surprisingly, existing codes of scientific ethics have little to say about such choices. I propose that we can arrive at a set of ethical guidelines to govern scientists’ presentation of information to policymakers by looking to bioethics: roughly, just as a clinician should aim to promote informed decision-making by patients, a scientist should aim to promote informed decision-making by policymakers. Though this may (...) sound like a natural proposal, I show it offers guidance that conflicts with standard scientific practices. I conclude by considering one cost of the proposal: that it would prevent scientists from acting as advocates in a way that is currently common in certain fields. I accept that the proposal would restrict scientists’ political advocacy rights, but argue that the benefits of adopting it — promoting democratic governance — justify the restriction. (shrink)

Many scientists and doctors hope that affordable genome sequencing will lead to more personalized medical care and improve public health in ways that will benefit children, families, and society more broadly. One hope in particular is that all newborns could be sequenced at birth, thereby setting the stage for a lifetime of medical care and self‐directed preventive actions tailored to each child's genome. Indeed, commentators often suggest that universal genome sequencing is inevitable. Such optimism can come with the presumption that (...) discussing the potential limits, cost, and downsides of widespread application of genomic technologies is pointless, excessively pessimistic, or overly cautious. We disagree. Given the pragmatic challenges associated with determining what sequencing data mean for the health of individuals, the economic costs associated with interpreting and acting on such data, and the psychosocial costs of predicting one's own or one's child's future life plans based on uncertain testing results, we think this hope and optimism deserve to be tempered.In the analysis that follows, we distinguish between two reasons for using sequencing: to diagnose individual infants who have been identified as sick and to screen populations of infants who appear to be healthy. We also distinguish among three contexts in which sequencing for either diagnosis or screening could be deployed: in clinical medicine, in public health programs, and as a direct‐to‐consumer service. Each of these contexts comes with different professional norms, policy considerations, and public expectations. Finally, we distinguish between two main types of genome sequencing: targeted sequencing, where only specific genes are sequenced or analyzed, and whole‐exome or whole‐genome sequencing, where all the DNA or all the coding segments of all genes are sequenced and analyzed.In a symptomatic newborn, targeted or genome‐wide sequencing can help guide other tests for diagnosis or for specific treatment that is urgently needed. Clinicians use the infant's symptoms (or phenotype) to interrogate the sequencing data. These same complexities and uncertainties, however, limit the usefulness of genome‐wide sequencing as a population screening tool. While we recognize considerable benefit in using targeted sequencing to screen for or detect specific conditions that meet the criteria for inclusion in newborn screening panels, use of genome‐wide sequencing as a sole screening tool for newborns is at best premature. We conclude that sequencing technology can be beneficially used in newborns when that use is nuanced and attentive to context. (shrink)

What clinicians, biomedical scientists, and other health care professionals know as individuals or as groups and how they come to know and use knowledge are central concerns of medical epistemology. Activities associated with knowledge production and use are called epistemic practices. Such practices are considered in biomedical and clinical literatures, social sciences of medicine, philosophy of science and philosophy of medicine, and also in other nonmedical literatures. A host of different kinds of knowledge claims have been identified, each with different (...) uses and logics of justification. A general framework is needed to situate these diverse contributions in medical epistemology, so we can see how they fit together. But developing such a framework turns out to be quite tricky. In this survey, three possible frameworks are considered along with the difficulties associated with each of them. The essay concludes with a fourth framework, which considers any epistemology as part of a practice that is oriented toward overcoming errors that emerge in antecedently given practices where knowledge is developed and used. As medicine indirectly advances health by directly mitigating disease, so epistemology indirectly advances knowledge by directly mitigating error. (shrink)

Scientists and clinicians are starting to translate genomic discoveries from research labs to the clinical setting. In the process, big data genomic technologies are both a risk to individual privacy and a benefit to personalized medicine. There is an opportunity to address the social and ethical demands of various stakeholders and shape the adoption of diagnostic genome technologies. We discuss ethical and practical issues associated with the networking of genomics by comparing how the European Union and North America understand and (...) practice notions of privacy and consent in research. An overview of international policy suggests the embedding of genomics within digital networks and the Internet creates conditions that challenge the management of privacy and consent in the age of big data. The risks of re-identification, informational harms, and data security vulnerabilities are issues that need to be better addressed in the clinical setting to reconcile the unpredictable pathway of research and practice in the networked information society. (shrink)

Scientists, clinicians, and bioethicists are worried about how so‐called personhood measures would limit access to certain types of contraception, research involving stem cells, and access to fertility treatments. While these measures have been struck down in Colorado, South Dakota, California, and Mississippi, the bill signed into law in Oklahoma in February deserves critical scrutiny, particularly into the ways these legal measures influence eligibility for clinical research. Oklahoma's bill states that the laws of the state “shall be interpreted and construed to (...) acknowledge on behalf of the unborn child at every stage of development all the rights, privileges, and immunities available to other persons, citizens, and residents of this state.”. (shrink)

Diagnosable individuals, caregivers, and clinicians typically embrace a biological conception of attention-deficit/hyperactivity disorder (ADHD), finding that medical treatment is beneficial. Scientists study ADHD phenomenology, interventions to ease symptoms, and underlying mechanisms, often with an aim of helping diagnosed people. Yet current understanding of ADHD, jointly influenced by science and society, has an unintended downside. Scientific and social influences have embedded negative values in the ADHD concept, and have simultaneously dichotomized ADHD diagnosable from non-diagnosable individuals. In social settings insistent on certain (...) types of success, the negative values associated with the diagnostic category are attributed to people in the dichotomized "ADHD" group. Devaluation, institutional restrictions on "success" definitions and endpoints, and limited options for achieving success jointly constitute institutionalized intolerance of ADHD. (shrink)

Although typically implicit, clinicians face an inherent conflict between their roles as medical healers and as providers of technical biomedicine (Scott et al. in Philos Ethics Humanit Med 4:11, 2009). This conflict arises from the tension between the physicalist model which still predominates in medical training and practice and the extra-physicalist dimensions of medical practice as epitomised in the concept of patient-centred care. More specifically, the problem is that, as grounded in a "borrowed" physicalist philosophy, the dominant "applied scientist" (...) model exhibits a number of limitations which severely restrict its ability to underwrite the effective practice of care. Moreover, being structural in character, these problems cannot be resolved by piecemeal modifications of the existing model, nor by an appeal to evidence-based medicine (Miles in J Eval Clin Pract 15(6):887-890, 2009; Miles in Folia Med 55(1):5-24, 2013; Miles et al. in J Eval Clin Pract 14(5):621-649, 2008). Hence, the need for medical theorists to "partner with experts in the humanities to build a sui generis philosophy of medicine" (Whatley in J Eval Clin Pract 20(6):961-964, 2014, p. 961). In response, the present paper seeks to vindicate the merits of hermeneutically-informed template in providing the requisite grounding. While capable of correcting for the limitations of the applied scientist model, a hermeneutically-informed template is a "both/and" approach, which seeks to complement rather than exclude the physicalist dimension, and thereby aspires to reconcile technical mastery with patient-centred care, rather than eschew one in favour of the other. As such, it can provide a cogent philosophical template for current best practice, which does justice to the art as well as the science of medical care. (shrink)

Despite claims from prominent scientists that SARS‐CoV‐2 indubitably emerged naturally, the etiology of this novel coronavirus remains a pressing and open question: Without knowing the true nature of a disease, it is impossible for clinicians to appropriately shape their care, for policy‐makers to correctly gauge the nature and extent of the threat, and for the public to appropriately modify their behavior. Unless the intermediate host necessary for completing a natural zoonotic jump is identified, the dual‐use gain‐of‐function research practice of viral (...) serial passage should be considered a viable route by which the novel coronavirus arose. The practice of serial passage mimics a natural zoonotic jump, and offers explanations for SARS‐CoV‐2's distinctive spike‐protein region and its unexpectedly high affinity for angiotensin converting enzyme (ACE2), as well as the notable polybasic furin cleavage site within it. Additional molecular clues raise further questions, all of which warrant full investigation into the novel coronavirus's origins and a re‐examination of the risks and rewards of dual‐use gain‐of‐function research. (shrink)

For over a century, scientists have sought to see through the protective shield of the human skull and into the living brain. Today, an array of technologies allows researchers and clinicians to create astonishingly detailed images of our brain's structure as well as colorful depictions of the electrical and physiological changes that occur within it when we see, hear, think and feel. These technologies—and the images they generate—are an increasingly important tool in medicine and science.Given the role that neuroimaging technologies (...) now play in biomedical research, both neuroscientists and nonexperts should aim to be as clear as possible about how neuroimages are made and what they can—and cannot—tell us. Add to this that neuroimages have begun to be used in courtrooms at both the determination of guilt and sentencing stages, that they are being employed by marketers to refine advertisements and develop new products, that they are being sold to consumers for the diagnosis of mental disorders and for the detection of lies, and that they are being employed in arguments about the nature (or absence) of powerful concepts like free will and personhood, and the need for citizens to have a basic understanding of how this technology works and what it can and cannot tell us becomes even more pressing. (shrink)

The publication of this book is an event in the making. All over the world scientists, psychologists, and philosophers are waiting to read Antonio Damasio's new theory of the nature of consciousness and the construction of the self. A renowned and revered scientist and clinician, Damasio has spent decades following amnesiacs down hospital corridors, waiting for comatose patients to awaken, and devising ingenious research using PET scans to piece together the great puzzle of consciousness. In his bestselling Descartes' (...) Error, Damasio revealed the critical importance of emotion in the making of reason. Building on this foundation, he now shows how consciousness is created. Consciousness is the feeling of what happens-our mind noticing the body's reaction to the world and responding to that experience. Without our bodies there can be no consciousness, which is at heart a mechanism for survival that engages body, emotion, and mind in the glorious spiral of human life. A hymn to the possibilities of human existence, a magnificent work of ingenious science, a gorgeously written book, The Feeling of What Happens is already being hailed as a classic. (shrink)

In his new book, eminent psychologist - Daniel Stern, explores the hitherto neglected topic of 'vitality'. Truly a tour de force from a brilliant clinician and scientist, Forms of Vitality is a profound and absorbing book - one that will be essential reading for psychologists, psychotherapists, and those in the creative arts.

In a devastating critique Raymond Tallis exposes the exaggerated claims made for the ability of neuroscience and evolutionary theory to explain human consciousness, behaviour, culture and society. While readily acknowledging the astounding progress neuroscience has made in helping us understand how the brain works, Tallis directs his guns at neuroscience’s dark companion – "Neuromania" as he describes it – the belief that brain activity is not merely a necessary but a sufficient condition for human consciousness and that consequently our everyday (...) behaviour can be entirely understood in neural terms. With the formidable acuity and precision of both clinician and philosopher, Tallis dismantles the idea that "we are our brains", which has given rise to a plethora of neuro-prefixed pseudo-disciplines laying claim to explain everything from art and literature to criminality and religious belief, and shows it to be confused and fallacious, and an abuse of the prestige of science, one that sidesteps a whole range of mind–body problems. The belief that human beings can be understood essentially in biological terms is a serious obstacle, argues Tallis, to clear thinking about what human beings are and what they might become. To explain everyday behaviour in Darwinian terms and to identify human consciousness with the activity of the evolved brain denies human uniqueness, and by minimising the differences between us and our nearest animal kin, misrepresents what we are, offering a grotesquely simplified and degrading account of humanity. We are, shows Tallis, infinitely more interesting and complex than we appear in the mirror of biologism. Combative, fearless and always thought-provoking, _Aping Mankind _is an important book, one that scientists, cultural commentators and policy-makers cannot ignore. (shrink)

As clinical-psychological scientists and practitioners increasingly work with diverse populations of traumatized people, it becomes increasingly important to attend to cultural models that influence the ways in which people understand and describe their responses to trauma. This paper focuses on potential uses of the concept of cultural script in this domain. Originally described by cognitive psychologists in the 1980s, scripts refer to specific behavioral and experiential sequences of elements such as thoughts, memories, attention patterns, bodily sensations, sleep abnormalities, emotions and (...) affective expressions, motivation, coping attempts and ritualized behaviors that are relevant to posttraumatic adjustment. We differentiate between experiences of traumatic stress that are scripted (e.g., cultural explanations are available) versus unscripted. Further characteristics such as script tracks, the effect of script interruptions, and contextual fit of scripts with other cultural models are also described. We consider examples of traumatic stress associated with war and organized, sexualized violence from ‘Western’ and ‘non-Western’ world regions. The concluding part of this review describes a number of possibilities for methodological approaches to assessment of cultural scripts. Capturing central elements of the script(s) of trauma would aid psychological researchers and clinicians in understanding the experiences of trauma in cultural context, which could ultimately lead to better clinical service opportunities worldwide. (shrink)