This article defends a version of the Westermarck Effect, integrating existing clinical, biological, and philosophical dimensions to incest avoidance. By focusing on care-based attachment in primates, my formulation of the effect suggests the power of a phylogenetic argument widely accepted by primatologists but not by cultural anthropologists. Identifying postadoption incest as a phenomenon with underexplored evidential value, the article sketches an explanatory strategy for reconciling the effect with the clinical reality of incest, concluding with an (...) explicit argument against culture-first or conventionalist accounts of incest avoidance prevalent in anthropology. (shrink)

In recent years, memories and reconstructions of incestuous child abuse have become common features of psychoanalytic treatment. Among some clinicians, such abuse is suspected even when there is little evidence. How does the analyst distinguish between incest real and imagined, and how do recovered memories of incest affect the analyst? In this poignant and beautifully written study, Elaine Siegel brings new insights to bear on these timely questions. An inveterate note taker, she discloses the countertransferential ruminations and associations (...) to the occurrence of incest at various stages during the treatment process over the course of 30 years of clinical work. The manner in which her "analytic instrument" evolved and was shaped by her analysands' stories makes for a fascinating subtext in a book that addresses itself to the differences and similarities during treatment of real and imagined incestuous abuse. Among the powrfully disturbing clinical cases at the heart of this study are two reports detailing the lengthy analyses of women who found corroboration for multigenerational incest. Siegel also presents two cases in which patients retracted their claims of incest toward the end of their treatments. Through the medium of these and other reports, Siegel explores how psychoanalysts are struggling both to understand incestuous abuse and to accomodate their treatment techniques to shifting societal perspectives. (shrink)

In recent years, memories and reconstructions of incestuous child abuse have become common features of psychoanalytic treatment. Among some clinicians, such abuse is suspected even when there is little evidence. How does the analyst distinguish between incest real and imagined, and how do recovered memories of incest affect the analyst? In this poignant and beautifully written study, Elaine Siegel brings new insights to bear on these timely questions. An inveterate note taker, she discloses the countertransferential ruminations and associations (...) to the occurrence of incest at various stages during the treatment process over the course of 30 years of clinical work. The manner in which her "analytic instrument" evolved and was shaped by her analysands' stories makes for a fascinating subtext in a book that addresses itself to the differences and similarities during treatment of real and imagined incestuous abuse. Among the powrfully disturbing clinical cases at the heart of this study are two reports detailing the lengthy analyses of women who found corroboration for multigenerational incest. Siegel also presents two cases in which patients retracted their claims of incest toward the end of their treatments. Through the medium of these and other reports, Siegel explores how psychoanalysts are struggling both to understand incestuous abuse and to accomodate their treatment techniques to shifting societal perspectives. (shrink)

Ernest Gellner's final book, first published in 1998, is a synoptic interpretation of the thought of Wittgenstein and Malinowski.

Assessment of decision-making capacity (DMC) can be difficult in acquired brain injury (ABI) particularly with the syndrome of organic personality disorder (OPD) (the “frontal lobe syndrome”). Clinical neuroscience may help but there are challenges translating its constructs to the decision-making abilities considered relevant by law and ethics. An in-depth interview study of DMC in OPD was undertaken. Six patients were purposefully sampled and rich interview data were acquired for scrutiny using interpretative phenomenological analysis. Interview data revealed that awareness of (...) deficit and thinking about psychological states can be present. However, the awareness of deficit may not be “online” and effectively integrated into decision-making. Without this online awareness of deficit the ability to appreciate or use and weigh information in the process of deciding some matters appeared absent. We argue that the decision-making abilities discussed are: (1) necessary for DMC, (2) threatened by ABI, and (3) assessable at interview. Some advice for practically incorporating these abilities within assessments of DMC in patients with OPD is outlined. (shrink)

A study of clinical medical ethicists was conducted to determine the various philosophical positions they hold with respect to ethical decision making in medicine and their various positions' relationship to the subjective-objective controversy in value theory. The study consisted of analyzing and interpreting data gathered from questionnaires from 52 clinical medical ethicists at 28 major health care centers in the United States. The study revealed that most clinical medical ethicists tend to be objectivists in value theory, i.e., (...) believe that value judgments are knowledge claims capable of being true or false and therefore expressions of moral requirements and normative imperatives emanating from an external value structure or moral order in the world. In addition, the study revealed that most clinical medical ethicists are consistent in the philosophical foundations of their ethical decision making, i.e., in decision making regarding values they tend not to hold beliefs which are incompatible with other beliefs they hold about values. (shrink)

Objective: Caloric vestibular stimulation has traditionally been used as a tool for neurological diagnosis. More recently, however, it has been applied to a range of phenomena within the cognitive neurosciences. Here, we provide an overview of such studies and review our work using CVS to investigate the neural mechanisms of a visual phenomenon - binocular rivalry. We outline the interhemispheric switch model of rivalry supported by this work and its extension to a metarivalry model of interocular-grouping phenomena. In addition, (...) studies showing a slow rate of binocular rivalry in bipolar disorder are discussed, and the relationship between this finding and the interhemispheric switch model is described. We also review the effects of CVS in various clinical contexts, explain how the technique is performed and discuss methodological issues in its application. (shrink)

A stock divestment campaign is a common strategy used by social activists to pressure corporations to abandon undesirable practices. However, evidence on the effectiveness of the strategy remains mixed. In this paper, we examine the effectiveness of an international stock boycott by studying a large sample of institutional investor transactions in four emerging market stocks targeted by the Sudan divestment campaign from 2001 to 2012. We find evidence of a negative relationship between the intensity of the campaign and the ownership (...) breadth of the stocks, suggesting the effectiveness of the campaign in encouraging investors to divest from targeted companies. Additional analysis indicates that investors in countries that are sympathetic towards CSR activities are more responsive to the divestment campaign. Further, we find evidence consistent with higher campaign intensity being associated with more depressed stock prices. Finally, when performing qualitative content analyses of the annual reports and CSR reports, we find evidence about the effects of the campaign on the targeted companies’ corporate policies and activities in Sudan. In sum, our results support the effectiveness of the stock boycott. (shrink)

Doctoral programs at U.S. universities play a critical role in the development of human resources both in the United States and abroad. This volume reports the results of an extensive study of U.S. research-doctorate programs in five broad fields: physical sciences and mathematics, engineering, social and behavioral sciences, biological sciences, and the humanities. Research-Doctorate Programs in the United States documents changes that have taken place in the size, structure, and quality of doctoral education since the widely used 1982 editions. This (...) update provides selected information on nearly 4,000 doctoral programs in 41 subdisciplines at 274 doctorate-granting institutions. This volume also reports the results of the National Survey of Graduate Faculty, which polled a sample of faculty for their views on the scholarly quality of program faculty and the effectiveness of doctoral programs in preparing research scholars/scientists. This much-anticipated update of such an essential reference will be useful to education administrators, university faculty, and students seeking authoritative information on doctoral programs. (shrink)

Cultural messages promote putting forward one’s best effort, and yet any level of success, or the effort itself, can lead to being regarded as a threat. People forming everyday social comparisons may feel threatened by those attempting to do their best, and may react to neutralize the perceived threat. The urge to undermine someone regarded as a threat can result in direct reprisal, social strain, or other repercussions that can range from unpleasantness to life-changing trauma. Given the potential for negative (...) outcomes, the experience of being regarded as a threat while attempting to do one’s best merits close examination. (shrink)

Clinical Study Agreements can have profound effects both on the protection of human subjects and on the independence of investigators to conduct research with scientific integrity. Sponsors, institutions, and even investigators may fail to give adequate attention to these issues in the negotiation of CSAs. Despite the key role of CSAs in structuring ethically important aspects of research, they remain largely unregulated and unreviewed for adherence to ethical norms. Academic institutions routinely enter into research contracts that fail to meet (...) adequate ethical standards. This is a failing that can have serious consequences.Accordingly, it is necessary that some independent body have the authority both to review research contracts for compliance with norms of subject protection and ethical integrity, and to reject studies that fail to meet ethical standards. Such review should take place prior to the start of research, not later. Because of its expertise and authority, the institutional ethics review board is the appropriate body to undertake such review. Much recent commentary has focused on contractual restrictions on the investigator’s freedom to publish research findings. The Olivieri experience, and that of other investigators, has brought freedom of publication issues into sharp focus. Clinical study agreements also raise a number of other ethical issues relating to human subjects and research integrity, however, including disclosures relating to patient safety, data analysis and reporting, budget, confidentiality, and premature termination of the study. This paper describes the ethical issues at stake in structuring such agreements and suggests ethical standards to guide institutional ethics review. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an (...) understanding of how clinicians view clinical studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

While certain substantial moral dilemmas in health care have been given much attention, like abortion, euthanasia or gene testing, doctors rarely reflect on the moral implications of their daily clinical work. Yet, with its aim to help patients and relieve suffering, medicine is replete with moral decisions. In this qualitative study we analyse how doctors handle the moral aspects of everyday clinical practice. About one hundred consultations were observed, and interviews conducted with fifteen clinical doctors from different (...) practices. It turned out that the doctors’ approach to clinical cases followed a rather strict pattern across specialities, which implied transforming patients’ diverse concerns into specific medical questions through a process of ‘essentialising’: Doctors broke the patient’s story down, concretised the patient’s complaints and categorised the symptoms into a medical sense. Patients’ existential meanings were removed, and the focus placed on the patients’ functioning. By essentialising, doctors were able to handle a complex and ambiguous reality, and establish a medically relevant problem. However, the process involved a moral as well as a practical simplification. Overlooking existential meanings and focusing on purely functional aspects of patients was an integral part of clinical practice and not an individual flaw. The study thus questions the value of addressing doctors’ conscious moral evaluations. Yet doctors should be aware that their daily clinical work systematically emphasises beneficence at the expense of others—that might be more important to the patient. (shrink)

In the last two centuries, our world would have been a safer place if philosophers such as Rousseau, Marx, and Nietzsche had not given intellectual encouragement to the radical ideologies of Jacobins, Stalinists, and fascists. Maybe the world would have been better off, from the standpoint of sound practice, if philosophers had engaged in only modest, decent theory, as did John Stuart Mill. Yet, as Ronald Beiner contends, the point of theory is not to think safe thoughts; the point is (...) to open intellectual horizons. In Philosophy in a Time of Lost Spirit, Beiner reflects on the dualism of theory and practice. The purpose of the theorist is not to offer sensible guidance on the conduct of social life but to test the boundaries of our vision of social order. Whereas the liberal citizen should embody the practical virtues of prudence and moderation, the theorist should be radical, probing, and immoderate. Looking back at the liberal-communitarian debate of the 1980s, Beiner recognizes that the antidote to our spiritless times lies neither in the embrace of community over individualism nor of individualism over community: both individual and community need to be submitted to radical questioning. It is by exposing ourselves to the challenge of fearless thinking encountered at the philosophical extremities that we are most likely to understand our own world at a deeper level. In this collection of essays and reviews, Ronald Beiner helps us to think critically about the thought-worlds of our foremost contemporary thinkers, including Hannah Arendt, Allan Bloom, Michel Foucault, Hans-Georg Gadamer, J¦rgen Habermas, Will Kymlicka, Christopher Lasch, Richard Rorty, Judith Shklar, Leo Strauss, Charles Taylor, and Michael Walzer. (shrink)

Discrimination and inequalities in healthcare can be experienced by many patients due to many characteristics ranging from the obviously visible to the more subtly noticeable, such as race and ethnicity, legal status, social class, linguistic fluency, health literacy, age, gender and weight. Discrimination can take a number of forms including overt racist statement, stereotyping or explicit and implicit attitudes and biases. This paper presents the case study of a complex transcultural clinical encounter between the mother of a young infant (...) in a highly vulnerable social situation and a hospital healthcare team. In this clinical setting, both parties experienced difficulties, generating explicit and implicit negative attitudes that heightened into reciprocal mistrust, conflict and distress. The different factors influencing their conscious and unconscious biases will be analysed and discussed to offer understanding of the complicated nature of human interactions when faced with vulnerability in clinical practice. This case vignette also illustrates how, even in institutions with long-standing experience and many internal resources to address diversity and vulnerability, cultural competence remains a constant challenge. (shrink)

This qualitative social scientific interview study delves into the ways in which professional vision is constructed in clinical ethics consultation (CEC). The data consist of 11 semi-structured interviews that were conducted with clinical ethics consultants currently working in hospitals in one major urban area in the U.S. The interviews were analyzed with the qualitative research method of critical discourse analysis, with a focus on identifying the cultural structures of knowledge that shape CEC as a professional practice. The discourses (...) were first identified as belonging to two higher discourse categories, order and agency. Order was divided into three lower categories, emotional, managerial, and rational order, and discourses of agency into the lower categories of exploration, technique, deliberation, and distancing. An additional discourse of neutral interaction was identified as a bridging discourse, activated to level tensions emerging out of conflicting goals and agencies embedded in CEC practice. This analysis brings out as its main observation that clinical ethics consultants draw on and shift between potentially ideologically conflicting social positions that can create built-in tensions within the professional domain. The study calls attention to these tensions and suggests for the professional group to discuss the possibility of defining priorities between different kinds of order, identified in this study, that shape the CEC domain. (shrink)

Objective: To pilot informed consent materials developed for Aboriginal parents in a vaccine trial, and evaluate their design and the informed consent process.Methods: Cross sectional quantitative and qualitative survey of 20 Aboriginal and 20 non-Aboriginal women in Alice Springs. Information about the proposed research was presented to Aboriginal participants by an Aboriginal researcher, using purpose designed verbal, visual, and written materials. Non-Aboriginal participants received standard materials developed by the sponsor. Questionnaires were used to evaluate recall and understanding immediately and five (...) days later. Qualitative analysis of Aboriginal participants’ interviews was performed.Results: There were no differences between the groups in understanding of diseases prevented by the vaccine, the potential risks of participating, or the voluntary nature of participation. Most Aboriginal participants had difficulty with the concept of a “licensed” versus “unlicensed” vaccine. The non-Aboriginal group had a good understanding of this. Aboriginal participants identified the use of the flipchart, along with a presentation by a doctor and Aboriginal health worker, as preferred delivery modes. Group presentations were preferred rather than one-on-one discussions. The use of the questionnaire posed considerable methodological difficulties.Conclusions: A one-off oral presentation to Aboriginal participants is unlikely to produce “informed consent”. Key but unfamiliar concepts require identification and particularly considered presentation. (shrink)

With disagreement, doubts, or ambiguous grounds in end–of-life decisions, doctors are advised to involve a clinical ethics committee. However, little has been published on doctors’ experiences with discussing an end-of-life decision in a CEC. As part of the quality assurance of this work, we wanted to find out if clinicians have benefited from discussing end-of-life decisions in CECs and why. We will disseminate some Norwegian doctors’ experiences when discussing end-of-life decisions in CECs, based on semi-structured interviews with fifteen Norwegian (...) physicians who had brought an end-of-life decision case to a CEC. Almost half of the cases involved conflicts with the patients’ relatives. In a majority of the cases, there was uncertainty about what would be the ethically preferable solution. Reasons for referring the case to the CEC were to get broader illumination of the case, to get perspective from people outside the team, to get advice, or to get moral backing on a decision already made. A great majority of the clinicians reported an overall positive experience with the CECs’ discussions. In cases where there was conflict, the clinicians reported less satisfaction with the CECs’ discussions. The study shows that most doctors who have used a CEC in an end-of-life decision find it useful to have ethical and/or legal aspects illuminated, and to have the dilemma scrutinized from a new perspective. A systematic discussion seems to be significant to the clinicians. (shrink)

Federal regulations are the minimum requirements for conducting clinical studies. Some innovation would improve the situation of many involved in these studies, including: study subjects, those who monitor studies, and clinical investigators as well as Institutional Review Boards. Respecting patient and whistle-blower input; appreciating research staff contributions; and implementing a systems and partnership approach would foster quality and advance clinical research.

We have begun work on two separate but related ontologies for the study of neurological diseases. The first, the Neurological Disease Ontology (ND), is intended to provide a set of controlled, logically connected classes to describe the range of neurological diseases and their associated signs and symptoms, assessments, diagnoses, and interventions that are encountered in the course of clinical practice. ND is built as an extension of the Ontology for General Medical Sciences — a high-level candidate OBO Foundry ontology (...) that provides a set of general classes that can be used to describe general aspects of medical science. ND is being built with classes utilizing both textual and axiomatized definitions that describe and formalize the relations between instances of other classes within the ontology itself as well as to external ontologies such as the Gene Ontology, Cell Ontology, Protein Ontology, and Chemical Entities of Biological Interest. In addition, references to similar or associated terms in external ontologies, vocabularies and terminologies are included when possible. Initial work on ND is focused on the areas of Alzheimer’s and other diseases associated with dementia, multiple sclerosis, and stroke and cerebrovascular disease. Extensions to additional groups of neurological diseases are planned. The second ontology, the Neuro-Psychological Testing Ontology (NPT), is intended to provide a set of classes for the annotation of neuropsychological testing data. The intention of this ontology is to allow for the integration of results from a variety of neuropsychological tests that assay similar measures of cognitive functioning. Neuro-psychological testing is an important component in developing the clinical picture used in the diagnosis of patients with a range of neurological diseases, such as Alzheimer’s disease and multiple sclerosis, and following stroke or traumatic brain injury. NPT is being developed as an extension to the Ontology for Biomedical Investigations. (shrink)

Background: Therapeutic misconception, the misunderstanding of differences between research and clinical care, is widely prevalent among non-incarcerated trial participants. However, little attention has been paid to its presence among individuals who participate in research while incarcerated. Methods: This study examined the extent to which 72 incarcerated individuals may experience therapeutic misconception about their participation in one of six clinical trials, and its correlation with participant characteristics and potential influences on research participation. Results: On average, participants endorsed 70% of (...) items suggestive of therapeutic misconception. The tendency toward therapeutic misconception was significantly higher among African Americans and Latinos compared to Whites, among older and less educated participants, and among enrollment in a substance-abuse-related trial; it was also correlated with a belief that the trial was the only way to obtain needed treatment. Conclusions: Therapeutic misconception may be particularly high among select incarcerated individuals and is associated with a perceived lack of treatment options. Further examination of therapeutic misconception among incarcerated research participants is needed. (shrink)

OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number (...) of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. (shrink)

Federal regulations are the minimum requirements for conducting clinical studies. Some innovation would improve the situation of many involved in these studies, including: study subjects, those who monitor studies, and clinical investigators as well as Institutional Review Boards. Respecting patient and whistle-blower input; appreciating research staff contributions; and implementing a systems and partnership approach would foster quality and advance clinical research.

Negotiating clinical knowledge: a field study of psychiatric nurses’ everyday communication Nursing practices at psychiatric hospitals have changed significantly over the last decades. In this paper, everyday nursing practices were interpreted in light of these institutional changes. The objective was to examine how mental health nurses’ production of clinical knowledge was influenced by the particular social relations on hospital wards. Empirical data stemming from an extended fieldwork at two Danish psychiatric hospital wards were interpreted using interactionistic theory and (...) the metaphor: ‘the game of clinical knowledge’. The results indicated that the nurses’ production of clinical knowledge was highly dependent on the individual nurses’ practical ability to participate in the game. Furthermore, the nurses colluded in their mutual communication to enable the collective display and sense of knowing that protected them against explicit signs of uncertainty about the clinic. The game of clinical knowledge influenced processes of clinical decision‐making among the nurses as the game added to a distorted widening of a ‘fictional distance’ between patients and the representations produced by the nurses. (shrink)

To assess the effectiveness of Visual Thinking Strategies in medical education curricula, a pretest–posttest experimental study design was used to evaluate the impact of participating in VTS workshops on first-year medical students. A total of forty-one intervention and sixty comparative students completed the study which included the analysis of clinical images followed by a measurement of word count, length of time analyzing images, and quality of written observations of clinical images. VTS training increased the total number of words (...) used to describe clinical images, the time spent analyzing the images, and the number of clinically relevant observations. (shrink)

Psychological assessment has long been reported as a key component of clinical psychology. This paper examined and shed light on the complexities surrounding the clinical significance of therapeutic approach to treatment Planning. To achieve this objective, the paper searched and used the PsycINFO and PubMed databases and the reference sections of chapters and journal articles to analysed the underlying themes: 1) a strong basis for the usage of therapeutic approach to psychological assessment in treatment plans, 2) explained the (...) conceptual meaning of clinical significant change in therapeutic assessment, 3) used initial theory to explain the therapeutic mechanisms of change in clinical practice, 4) analysed the empirically documenting clinically significant change in therapeutic assessment. Finally, the study suggested that though therapeutic assessment is not sufficient for the systematic study of psychotherapy outcome and process, it is still consistent with both the lay-man and professional expectations regarding treatment outcome and also provides a precise method for classifying clients as “changed” or “unchanged” on the basis of clinical significance criteria. (shrink)

A study was undertaken of the views of users of two genitourinary medicine (GUM) clinics in England on unlinked anonymous testing (UAT) for HIV. The UAT programme measures the prevalence of HIV in the population, including undiagnosed prevalence, by testing residual blood (from samples taken for clinical purposes) which is anonymised and irreversibly unlinked from the source. 424 clinic users completed an anonymous questionnaire about their knowledge of, and attitudes towards, UAT. Only 1/7 (14%) were aware that blood left (...) over from clinical testing may be tested anonymously for HIV. A large majority (89%) said they would agree to their blood being tested, although 74% wanted the opportunity to consent. These findings indicate broad support for UAT of blood in a group of patients whose samples are included in the HIV surveillance programme. The findings suggest the need for greater attention to be given to the provision of information and, if replicated in a larger survey, may justify a reappraisal of UK policy on UAT. (shrink)

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose (...) a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

BackgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.MethodsAn adaptation of the RAND/ucla Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, (...) regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.ResultsFifty-three recommendations were evaluated. After the first round, 34 recommendations were judged “appropriate”; 19 were judged “uncertain”; and none was judged “inappropriate”. After the second round, 9 “uncertains” changed to “appropriate”. All recommendations rated medians of 6.5–9 on a 1–9 scale (1 = “extremely inappropriate”, 5 = “uncertain”, 9 = “extremely appropriate”). The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest “uncertainty” rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.ConclusionsThe RAND/ucla method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged “appropriate” by all stakeholders involved in the informed consent process. (shrink)

BackgroundCase consultation performed by clinical ethics committees (CECs) is a complex activity which should be evaluated. Several evaluation studies have reported stakeholder satisfaction in single institutions. The present study was conducted nationwide and compares clinicians’ evaluations on a range of aspects with the CEC’s own evaluation.MethodsProspective questionnaire study involving case consultations at 19 Norwegian CECs for 1 year, where consultations were evaluated by CECs and clinicians who had participated.ResultsEvaluations of 64 case consultations were received. Cases were complex with (...) multiple ethical problems intertwined. Clinicians rated the average CEC consult highly, being both satisfied with the process and perceiving it to be useful across a number of aspects. CEC evaluations corresponded well with those of clinicians in a large majority of cases. Having next of kin/patients present was experienced as predominantly positive, though practised by only half of the CECs. The educational function of the consult was evaluated more positively when the CEC used a systematic deliberation method.ConclusionsCEC case consultation was found to be a useful service. The study is also a favourable evaluation of the Norwegian CEC system, implying that it is feasible to implement well-functioning CECs on a large scale. There are good reasons to involve the stakeholders in the consultations as a main rule. (shrink)

Our society's practice of inadequately representing women as subjects of clinical research is unjust, not only because it results in inequalities in the quality and availability of care that have a detrimental impact on women's health, but also because it is linked to women's oppression. Although recent policy changes help to resolve the problems, more must be done. Additional remedies for the injustices of our society's research practices are proposed.

Clinical next generation sequencing is a term that refers to a variety of technologies that permit rapid sequencing of large numbers of DNA segments, up to and including entire genomes. As an approach that is playing an increasingly important role in obtaining genetic information from patients, it may be viewed by public and private payers either positively, as an enabler of the promised benefits of personalized medicine, or as “the perfect storm” resulting from the confluence of high market demand, (...) an uproven technology, and an unprepared delivery system. A number of recent studies have noted that coverage and reimbursement will be critical for clinical integration of NGS, yet the evidentiary pathway for payer decision-making is unclear. Although there are multiple reasons for this uncertain reimbursement environment, the situation stems in large part from a long-standing lack of alignment between the information needs of regulators and post-regulatory decision-makers such as payers. (shrink)

Discrimination and inequalities in healthcare can be experienced by many patients due to many characteristics ranging from the obviously visible to the more subtly noticeable, such as race and ethnicity, legal status, social class, linguistic fluency, health literacy, age, gender and weight. Discrimination can take a number of forms including overt racist statement, stereotyping or explicit and implicit attitudes and biases. This paper presents the case study of a complex transcultural clinical encounter between the mother of a young infant (...) in a highly vulnerable social situation and a hospital healthcare team. In this clinical setting, both parties experienced difficulties, generating explicit and implicit negative attitudes that heightened into reciprocal mistrust, conflict and distress. The different factors influencing their conscious and unconscious biases will be analysed and discussed to offer understanding of the complicated nature of human interactions when faced with vulnerability in clinical practice. This case vignette also illustrates how, even in institutions with long-standing experience and many internal resources to address diversity and vulnerability, cultural competence remains a constant challenge. (shrink)