Novel immune therapies are increasingly based on the molecular differentiation of disease patterns. The related clinical studies are thus more often characterized by the so-called adaptive study designs (umbrella or basket studies including platform studies), which are continuously adjusted based on novel results. This paper analyses new study designs beyond the often-postulated need for regulation in order to identify ethical problems based on typical structural features and to—whenever possible—suggest solutions. To do so, it addresses the following (...) topics: the relationship between social and scientific values of a study as well as aspects of the scientific validity of new forms of evidence; the inclusion of study subjects under the condition of relative uncertainty; specific challenges in the process of ethical approval, and ethical and practical challenges in the process of informing patients and receiving informed consent. Additionally, the topic of a potential risk–benefit assessment of such therapies is addressed. (shrink)

Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all (...) medical specialties. (shrink)

BackgroundInformed consent forms for clinical research are several and variable at international, national and local levels. According to the literature, they are often unclear and poorly understood by participants. Within the H2020 project CORBEL—Coordinated Research Infrastructures Building Enduring Life-science Services—clinical researchers, researchers in ethical, social, and legal issues, experts in planning and management of clinical studies, clinicians, researchers in citizen involvement and public engagement worked together to provide a minimum set of requirements for informed consent in (...) clinical studies.MethodsThe template was based on a literature review including systematic reviews and guidelines searched on PubMed, Embase, Cochrane Library, NICE, SIGN, GIN, and Clearinghouse databases, and on comparison of templates gathered through an extensive search on the websites of research institutes, national and international agencies, and international initiatives. We discussed the draft versions step-by-step and then we referred to it as the “matrix” to underline its modular character and indicate that it allows adaptation to the context in which it will be used. The matrix was revised by representatives of two international patient groups.ResultsThe matrix covers the process of ensuring that the appropriate information, context and setting are provided so that the participant can give truly informed consent. It addresses the key topics and proposes wording on how to clarify the meaning of placebo and of non-inferiority studies, the importance of individual participants’ data sharing, and the impossibility of knowing in advance how the data might be used in future studies. Finally, it presents general suggestions on wording, format, and length of the information sheet.ConclusionsThe matrix underlines the importance of improving the process of communication, its proper conditions (space, time, setting), and addresses the participants’ lack of knowledge on how clinical research is conducted. It can be easily applied to a specific setting and could be a useful tool to identify the appropriate informed consent format for any study. The matrix is mainly intended to support multicentre interventional randomized clinical studies, but several suggestions also apply to non-interventional research. (shrink)

As the_number of clinical trials continues to grow, there is an increasing need for education and training in the field. The clinical research climate is less forgiving of errors and oversights and therefore requires more knowledge of regulations and requirements. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled. (...) Includes a manual for investigators, research nurses and study coordinators with minimal experience or who are new to clinical research An easy-to-read and open text design using ‘sidebars’ of examples and information boxes related to the main text Includes a list of Frequently Asked Questions and Glossary Duke Clinical Research Institute is the world’s largest academic clinical research organisation and is well known and respected within the clinical research community. (shrink)

Anger is probably one of the mostly debated basic emotions, owing to difficulties in detecting its appearance during development, its functional and affective meaning (is it a positive or a negative emotion?), especially in human beings. Behaviors accompanied by anger and rage serve many different purposes and the nuances of aggressive behaviors are often defined by the symbolic and cultural framework and social contexts. Nonetheless, recent advances in neuroscientific and developmental research, as well as clinical psychodynamic investigation, afford a (...) new view on the role of anger in informing and guiding many aspects of human conducts. Developmental studies have confirmed the psychophysiological, cognitive and social acquisition that hesitate in the pre-determined sequence appearance of anger and rage in the first two years of life. The so-called affective neurosciences have shown the phylogenetic origin of the two circuits underlying the emergence of anger along with its evolutionary role for promoting survival. This view has been integrated by the psychodynamic theory of motivational systems that attribute a double role to anger: on the one hand, this affect works as an inwardly directed signal concerning a pressure to overcome an obstacle or an aversive situation; on the other hand, anger is also an outwardly directed communicative signal establishing differentiation and conflict within interpersonal relationships and affective bonds. Of course, human peculiar mental functioning requires the appraisal of such signals by higher cortical functions and, there is little doubt that the meaning that orientates individual behaviors is, eventually, construed on a social and cultural level. At the same time, everyday life experiences as well as clinical insights into psychopathic, narcissistic and borderline personality pathology clearly illustrate the necessity to correctly interpret and give answers to the basic questions raised around the topic of anger as a basic emotion. (shrink)

Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of (...) the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (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)

Bioethics: Legal and Clinical Case Studies is a case-based introduction to ethical issues in health care. Through seventy-eight compelling scenarios, the authors demonstrate the practical importance of ethics, showing how the concerns at issue bear on the lives of patients, health care providers, and others. A range of central topics are covered, including informed consent, medical futility, reproductive ethics, privacy, cultural competence, and clinical trials. Each chapter includes a selection of important legal cases as well as (...) class='Hi'>clinical case studies for critical analysis. The case studies are often presented as moral dilemmas, and are conducive to rich discussion. A companion website offers a curated collection of relevant legal precedents as well as additional case studies and other resources. (shrink)

Our society has long sanctioned, at least tacitly, a degree of conflict of interest in medical practice and clinical research as an unavoidable consequence of the different interests of the physician or clinical investigator, the patient or clinical research subject, third party payers or research sponsors, the government, and society as a whole, to name a few. In the past, resolution of these conflicts has been left to the conscience of the individual physician or clinical investigator (...) and to professional organizations. The public is no longer willing to allow health care providers to wholly govern their own conflicts of interest for several reasons. These include: new forms of health care financing and delivery that provide innovative and lucrative opportunities for physician or insurer enrichment at patient expense; the increased importance of commercial research support as peer-reviewed governmental research support has decreased; evidence that physicians and clinical investigators too frequently resolve conflicts of interest in their own favor; and a general societal mistrust of authority. This volume represents a multidisciplinary effort, drawing from philosophy, medicine, law, economics and public policy to identify and categorize conflicts of interest in medical practice and clinical research, and, where possible, to offer a mechanism for resolving them. Part I addresses conflicts of interest from a theoretical perspective, offering basic concepts and analytical frameworks. The second part discusses two topics prominent in current health care policy debates--self-referral and financial incentives to limit care. Part III examines conflicts of interest generated by pharmaceutical industry involvement in clinical practice and research. The final section deals with conflicts of interest in clinical research in several contexts, including institutional reviews boards, clinical trials, Cooperative Research and Development Agreements between government and private researchers, brokerage of research subjects by Contract Research Organizations, and cost-effectiveness studies. (shrink)

Clinical trials and other forms of evaluation of medical treatment are held to give an objective assessment of the ‘clinical effectiveness’ of the medical treatments under evaluation. This kind of evaluation is central to the evidence-based medicine movement, as it provides a basis for the rational selection of treatment. The ethical status of randomised clinical trials is widely agreed to depend crucially upon the state of equipoise regarding which of two (or more) treatments is more (or most) (...) effective in a defined population. However, the meaning and nature of ‘clinical effectiveness’ are unclear. in this paper, I discuss the proposals to define clinical effectiveness as a relational property and as an intrinsic property, and the way effectiveness may supervene upon more fundamental physical properties of treatments. I discuss whether effectiveness is a single property or a family of properties; the types of outcome which can be explained by effectiveness properties; and the relationship between ‘objective’ and ‘preference’ outcomes. This paper suggests that while it may be possible to put clinical effectiveness on a proper metaphysical footing, in practice the language of clinical effectiveness is more properly a topic of the human sciences than of the natural sciences. (shrink)

The paper is a record of a debate which took place between a group of clinicians and the author concerning a clinical trial of a drug supposed to postpone the time when HIV-patients develop AIDS. A problem with the trial was that on available (inconclusive) evidence it appeared that one patient out of 500 was killed by the drug. The question raised was whether, in view of this evidence, it was morally defensible to go on with the trial. The (...) discussion came to involve general topics such as the appropriate role of the ideal of autonomy as well as more particular topics of quantitative and qualitative risk assessments. The main thrust of the argument is that different conceptions of rationality may provide rationales of conflicting clinical decisions. Philosophy matters to medicine. Keywords: autonomy, equipoise, hazards, the Helsinki Declaration, maximizing expected utility, potential benefits, rationality, risk assessment CiteULike Connotea Del.icio.us What's this? (shrink)

BackgroundMedical education is currently more considerate about the human dimension. The present qualitative study aimed to explain the experiences of clinical professors with regard to humanism in clinical education in Iran.MethodsThis mixed methods study had two phases, a quanitative phase of scientometrics and a qualitative phase of a content analysis. In the scientometrics phase, Ravar PreMap and VOSviewer software programs were utilized for plotting the conceptual networks. The networks were analyzed at the micro-level based on centrality indices. The (...) conceptual network was plotted and the prominent topics in clinical education were identified using co-word analysis. In the second qualitative phase on the topic, based on the scientometrics phase, semi-structured interviews were conducted with clinical professors. The interviews were transcribed verbatim and analyzed.ResultsOn the basis of the analysis of titles, abstracts, and keywords of the retrieved articles on clinical education from ISI Web of Science, Scopus, and PubMed, 1412 keywords were extracted. After the refining process, 356 keywords with 6741 relations remained. Upon plotting the conceptual network, 19 conceptual clusters related to clinical education were obtained. Then, micro-level network analysis indicated that the keyword humanism with the frequency of 137 had the highest rate, closeness, and betweenness. Moreover, from the interview data analysis, two themes of “intertwined nature of the human spirit in clinical education” and “humanistic behavior of professors in clinical education” were extracted.ConclusionAs a part of the educational culture, humanistic values must be intertwined with the medical education curriculum. In this regard, humanism and clinical reasoning are the two major clusters of clinical teaching; moreover, altruism and adherence to humanistic values, and scientific qualification are other main pillars that should be considered as the criteria for the selection of clinical professors and medical students. (shrink)

BackgroundPrevious empirical work among physicians has led us to propose that clinical practice is experienced by clinicians as an engagement-in-the-clinical-situation. In this study, we pursue our exploration of clinical practice ‘on its own terms’ by turning to the experience of patients.MethodsPhenomenological analysis of in-depth individual interviews with 8 patients.ResultsWe describe the patient experience as a set of three motifs: the shock on the realization of the illness, the chaos of the health care environment, and the anchor point (...) provided by an engaged physician. We draw on Heidegger’s notion of solicitude to show that patients are actively ascertaining the physician’s engagement in their care.ConclusionsThese findings lead us to question the classical “dual discourse” of medicine that offers a dichotomous account of clinical practice as the addition of care to cure, art to science, humanism to technique, and person to medical case. We found no such distinctions in our empirical investigation of clinical practice. Rather, in our synthesis, practice appears as a unitary experience. The physician’s solicitude for the patient entrains engagement in the clinical situation. Moreover, the solicitous, engaged physician constitutes an anchor point for the patient. (shrink)

Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan Africa (...) as an initial step to a comprehensive capacity-strengthening programme. The number of members per committee ranged from 3 to 21, with an average of 11. Members of 10 institutional committees were all from the institution where the committees were based, raising prima facie questions as to whether independence and objectivity could be guaranteed in the review work of such committees. Results: The majority of the committees (92%) cited scientific design of clinical trials as the area needing the most attention in terms of training, followed by determination of risks and benefits and monitoring of research. The survey showed that 38% of the ERC members did not receive any form of training. In the light of the increasing complexity and numbers of health research studies being conducted in Africa, this deficit requires immediate attention. Outcome: The survey identified areas of weakness in the operations of ERCs in Africa. Consequently, AMANET is addressing the identified needs and weaknesses through a 4-year capacity-building project. (shrink)

Clinical ethics consultation has developed from local pioneer projects into a field of growing interest among both clinicians and ethicists. What is needed are more systematic studies on the ethical challenges faced in clinical practice and problem solving through ethics consultation from interdisciplinary perspectives. The Thematic Issue covers a range of topics and includes five recent studies from various European countries and the USA, focusing on issues such as the ethical difficulties of end of life decisions, (...) experiences with newly developed or well established ethics consultation services, and the expectations of physicians in various clinical fields who are still unfamiliar with clinical ethics consultation. The papers included illustrate the interface between different socio-cultural contexts and their ways of dealing with clinical ethics consultation. They deepen the dialogue on clinical ethics consultation that has emerged at the European and International level. (shrink)

Background Studying the contribution of individual countries to leading journals in a specific discipline can highlight which countries have the most impact on that discipline and whether a geographic bias exists. This article aims to examine the international distribution of publications in the field of bioethics. Methods Retrospective quantitative study of nine peer reviewed journals in the field of bioethics and medical ethics (Bioethics, Cambridge Quarterly of Healthcare Ethics, Hastings Center Report, Journal of Clinical Ethics, Journal of Medical Ethics, (...) Kennedy Institute of Ethics Journal, Nursing Ethics, Christian Bioethics, and Theoretical Medicine and Bioethics). Results In total, 4,029 articles published between 1990 and 2003 were retrieved from the nine bioethical journals under study. The United States (59.3%, n = 2390), the United Kingdom (13.5%, n = 544), Canada (4%, n = 160) and Australia (3.8%, n = 154) had the highest number of publications in terms of absolute number of publications. When normalized to population size, smaller affluent countries, such as New Zealand, Finland and Sweden were more productive than the United States. The number of studies originating from the USA was decreasing in the period between 1990 and 2003. Conclusion While a lot of peer reviewed journals in the field of bioethics profile themselves as international journals, they certainly do not live up to what one would expect from an "international" journal. The fact that English speaking countries, and to a larger extent American authors, dominate the international journals in the field of bioethics is a clear geographic bias towards the bioethical discussions that are going on in these journals. (shrink)

Clinical trials and other forms of evaluation of medical treatment are held to give an objective assessment of the 'clinical effectiveness' of the medical treatments under evaluation. This kind of evaluation is central to the evidence-based medicine movement, as it provides a basis for the rational selection of treatment. The ethical status of randomised clinical trials is widely agreed to depend crucially upon the state of equipoise regarding which of two treatments is more effective in a defined (...) population. However, the meaning and nature of 'clinical effectiveness' are unclear. in this paper, I discuss the proposals to define clinical effectiveness as a relational property and as an intrinsic property, and the way effectiveness may supervene upon more fundamental physical properties of treatments. I discuss whether effectiveness is a single property or a family of properties; the types of outcome which can be explained by effectiveness properties; and the relationship between 'objective' and 'preference' outcomes. This paper suggests that while it may be possible to put clinical effectiveness on a proper metaphysical footing, in practice the language of clinical effectiveness is more properly a topic of the human sciences than of the natural sciences. (shrink)

Evidence, as viewed through the lens of statistical significance, is not always as it appears! In the investigation of clinical research findings arising from statistical analyses, a fundamental initial step for the emerging fraud detective is to retrieve the source data for cross-examination with the study data. Recognizing that source data are not always forthcoming and that, realistically speaking, the investigator may be uninitiated in fraud detection and investigation, this paper will highlight some key methodological procedures for providing a (...) sounder evidence base for withdrawing from a study on grounds of integrity. The promotion of patient safety is paramount. However, there is a broader rationale for disseminating these ideas. This includes empowering researchers to optimize their personal integrity, make informed choices regarding membership of future research collaborations and successfully voice their concerns to journal editors, particularly where a conflict of interests can render such dialogues particularly difficult. Recommendations will be supported by topical case studies and practical steps involving data exploration, testing of baseline data and application of Benford’s Law. While this paper has a clinical focus, the advice provided is transferrable to a wide range of multidisciplinary research settings outside of Medicine. (shrink)

Background Given that AI-driven decision support systems (AI-DSS) are intended to assist in medical decision making, it is essential that clinicians are willing to incorporate AI-DSS into their practice. This study takes as a case study the use of AI-driven cardiotography (CTG), a type of AI-DSS, in the context of intrapartum care. Focusing on the perspectives of obstetricians and midwives regarding the ethical and trust-related issues of incorporating AI-driven tools in their practice, this paper explores the conditions that AI-driven CTG (...) must fulfill for clinicians to feel justified in incorporating this assistive technology into their decision-making processes regarding interventions in labor. Methods This study is based on semi-structured interviews conducted online with eight obstetricians and five midwives based in England. Participants were asked about their current decision-making processes about when to intervene in labor, how AI-driven CTG might enhance or disrupt this process, and what it would take for them to trust this kind of technology. Interviews were transcribed verbatim and analyzed with thematic analysis. NVivo software was used to organize thematic codes that recurred in interviews to identify the issues that mattered most to participants. Topics and themes that were repeated across interviews were identified to form the basis of the analysis and conclusions of this paper. Results There were four major themes that emerged from our interviews with obstetricians and midwives regarding the conditions that AI-driven CTG must fulfill: (1) the importance of accurate and efficient risk assessments; (2) the capacity for personalization and individualized medicine; (3) the lack of significance regarding the type of institution that develops technology; and (4) the need for transparency in the development process. Conclusions Accuracy, efficiency, personalization abilities, transparency, and clear evidence that it can improve outcomes are conditions that clinicians deem necessary for AI-DSS to meet in order to be considered reliable and therefore worthy of being incorporated into the decision-making process. Importantly, healthcare professionals considered themselves as the epistemic authorities in the clinical context and the bearers of responsibility for delivering appropriate care. Therefore, what mattered to them was being able to evaluate the reliability of AI-DSS on their own terms, and have confidence in implementing them in their practice. (shrink)

Background: Clinical research nurses experience unique challenges in the context of their role that can lead to conflict and moral distress. Although examined in many areas, moral distress has not been studied in clinical research nurses. Research aim: The aim of this study was to examine moral distress in clinical research nurses and the relationship between moral distress scores and demographic characteristics of clinical research nurses. Research design: This was a descriptive quantitative study to measure moral (...) distress in clinical research nurses using the Measure of Moral Distress – Healthcare Professionals (MMD-HP) administered electronically. Demographic data were also collected. Participants and research context: Registered nurses working in the clinical research nurse role ( N = 322) were recruited through use of social media, emails, digital flyers, and snowball recruitment. Data was analyzed using SPSS. Pearson’s correlation, independent t-test, and one-way ANOVA were performed to explore differences among the demographic variables. Ethical considerations: This study was approved by the Institutional Review Board at Texas Woman’s University. A consent statement was included, and completion of the questionnaire was construed as consent. Findings/results: Analysis revealed a mean overall moral distress score of 79.58 (SD = 64.27) and median of 67, with a range of 0–354. Moral distress scores were negatively correlated with clinical research nurse age ( r = 0-.156, p < 0.05). Reliability of the MMD-HP was demonstrated with a Cronbach’s alpha of 0.93. Conclusions: The findings demonstrate that clinical research nurses do experience moral distress and revealed a wide range of scores. Further research is necessary to determine potential patient impact due to moral distress and to develop processes to minimize moral distress in the clinical research setting. This study was conducted during the COVID-19 pandemic, and the digital recruitment methods proved effective in recruiting a wide range of clinical research nurses, both nationally and internationally. (shrink)

Outsourcing clinical trials sponsored by pharmaceutical companies from industrialized countries to low- -income countries – summarized as transnational biomedical research – has lead to many concerns about ethical standards. Whether study participants are particularly vulnerable is one of those concerns. However, the concept of vulnerability is still vague and varies in its definition. Despite the fact that important international ethical guidelines such as the Declaration of Helsinki by the World Medical Association or the Ethical Guidelines for Biomedical Research Involving (...) Human Subjects by the Council of International Organizations of Medical Sciences refer to vulnerability as ethical principle, each of their approaches are different. To overcome these shortcomings, we analyze and unite different approaches of vulnerability and develop practical criteria in order to operationalize the concept especially for the context of TBR. These criteria refer to the context of a study as well as the characteristics and the current living situation of study participants. Based on a case study of an HIV-vaccine-trial conducted in India we demonstrate how those criteria can be applied in a retrospective way to identify potential ethical conflicts. The criteria can also indicate a prospective function for ethical pre-assessment. For this, we provide an outlook for three major topics: 1. Vulnerability as a normative concept: Different ways of protection; 2. The relevance of transparency and 3. Vulnerability as an instrument to increase decision participation of human subjects. (shrink)

Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Descriptions of activities involving priority setting in annual reports from Norwegian CECs were studied and categorized through qualitative content analysis. Three hundred thirty-nine reports from 38 CECs (...) were studied. We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs’ work further. The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests. (shrink)

Background Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Method Descriptions of activities involving priority setting in annual reports from Norwegian CECs were studied and categorized through qualitative content analysis. Results Three hundred thirty-nine reports (...) from 38 CECs were studied. We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. Discussion In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs’ work further. Conclusions The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests. (shrink)

This paper discusses a study examining how mentors in nurse education make professional judgments about the clinical competence of their pre‐registration nursing students. Interviews were undertaken with nine UK students and 15 mentors, using critical incidents in practice settings as a focus. The study was undertaken for the English National Practice‐Based Professional Learning Centre for Excellence in Teaching and Learning. This paper reports on the conversation analytic thread of the work. The mentor role with pre‐registration nursing students is not (...) only supportive but involves formal assessment. Central to the relationship is communication. In professional education, communication is seen as a skill to be applied and assessed in practice settings but is also the medium mentors and mentees use to talk about the relationship. Analysis of excerpts of conversation in the interviews shows that episodes of communication are used as topics of conversation to establish professional identity. It also reveals that judgments about the extent of professional capacity of both students and mentors are grounded in everyday behaviours (for example, enthusiasm, indifference and confidence) as well as professional competence. In addition to focusing on clinical issues, mentors can and do use mundane communication as a resource for judgments about competence. (shrink)

Now in its fourth edition, Rational Diagnosis and Treatment: Evidence-Based Clinical Decision - Making is a unique book to look at evidence-based medicine and the difficulty of applying evidence from group studies to individual patients._ The book analyses the successive stages of the decision process and deals with topics such as the examination of the patient,_the reliability of clinical data, the logic of diagnosis, the fallacies of uncontrolled therapeutic experience and the need for randomised clinical trials (...) and meta-analyses. It is the main theme of the book that, whenever possible, clinical decisions must be based on the evidence from clinical research, but the authors also explain the pitfalls of such research and the problems involved in applying evidence from groups of patients to the individual patient._ For this new edition, the sections on placebo and meta-analysis and on alternative medicine have been thoroughly updated, and there is more focus on insufficient reporting of harms of interventions. The sections on different research designs describe advantages and limitations, and the increased medicalisation and the effects of cancer screening on health people are noted. A section on academic freedom when clinicians collaborate with industry and ghost authors is added._ This essential reference work integrates the science and statistical approach of evidence-based medicine with the art and humanism of medical practice; distinguishing between data, sets of data, knowledge and wisdom, and their application. Such an intellectually challenging book is ideal for both medical students and doctors who require theoretical and practical clinical skills to help ensure that they apply theory in practice. (shrink)

In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records (...) enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges. (shrink)

Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated in a (...) trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Results Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. Conclusion This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent. (shrink)

In many research studies, tumor biopsies are an unavoidable requirement for achieving key scientific aims. Yet some commentators view mandatory research biopsies as coercive and suggest they should be optional, or at least optional until further data are obtained regarding their scientific usefulness. Further complicating the ethical picture is the fact that some research biopsies offer a potential for clinical benefit to trial participants. We interviewed and surveyed a convenience sample of participants in phase I clinical trials (...) at a single institution. Our primary aim was to describe phase I participants’ understanding of whether a research biopsy offered them the prospect of medical benefit. We also endeavored to describe participants’ views about biopsies—specifically, the benefits of biopsies, if any, and whether biopsies were acceptable, risky, or discouraged trial participation. Finally, we collected data on demographics and attitudes to see if any strong correlations with misunderstanding, acceptability, or riskiness existed. Overall, the respondents tended to view research biopsies as acceptable, though they did not succeed in identifying the lack of benefit of a research biopsy. These findings call for renewed efforts in consent conversations and documents to carefully describe the benefits, or lack thereof, of research biopsies. (shrink)

ObjectivePhysical and mental well-being are threatened by climate change. Since hospitals in high-income countries contribute significantly to climate change through their greenhouse gas (GHG) emissions, the medical ethics imperative of ‘do no harm’ imposes a responsibility on hospitals to decarbonise. We investigated hospital stakeholders’ perceptions of hospitals’ GHG emissions sources and the sense of responsibility for reducing GHG emissions in a hospital.MethodsWe conducted 29 semistructured qualitative expert interviews at one of Germany’s largest hospitals, Heidelberg University Hospital. Five patients, 12 (...) class='Hi'>clinical and 12 administrative employees on different levels were selected using purposive maximum variation sampling. Interviews were transcribed verbatim and analysed using the framework approach.ResultsConcerning GHG emissions, hospital stakeholders perceived energy and waste as most relevant emission sources followed by mobility. Climate change mitigation in general was considered as important. However, in their role as patients or employees, hospital stakeholders felt less responsible for climate change mitigation. They saw providing best possible medical care to be the top priority in hospitals and were often concerned that patients’ health could be jeopardised by climate change mitigation measures.ConclusionPerceptions of most important emission sources did not coincide with those in literature, highlighting the need to inform stakeholders, for instance, about pharmaceuticals as important emission source. A frequently perceived conflict between reducing emissions and providing high-quality medical care could be eased, if reducing emissions would not only be justified as a contribution to mitigation, but also as a contribution to preventing ill health—a basic principle of medical ethics. (shrink)

The chapters published in this volume developed from presentations, and their associated discussions at a conference organised by the Scottish Branch of the British Psychological Society, held at Rothesay, Isle of Bute, Scotland in September 1987. The goal of the conference was to bring together workers across a wide area of neuropsychological research to discuss recent technological advances, developments in assessment and rehabilitation, and to address theoretical issues of current interest. Thus, the chapters in this book include contributions on the (...) use of Magnetic Resonance Imaging and Single Photon Emission Computed Tomography in neuropsychological research, studies of hemi spheric specialisation and cooperation, alcoholic and Alzheimer type dementia, prosopagnosia and facial processing, the assessment, management and rehabilitation of memory problems, the assessment of premorbid intellectual status and issues in developmental neuropsychology. Many of those engaged in research and clinical practice in neuropsychology encounter a range of topic at least as wide as this in their professional lives. The opportunity for researchers and clinicians to discuss some of the key issues in the field was invaluable and we hope that readers gain as much from the material presented here as the participants did from the meeting itself. (shrink)

Movies can serve valuable didactic purposes teaching clinical ethics to medical students. However, using film sequences as means to develop critical thinking is not a straightforward task. There is a significant gap in the literature regarding how to analyse the ethical content embedded in these clips systematically, in a way that facilitates the students’ transition from anecdotal reflections to abstract thinking. This article offers a pedagogical proposal to approach the ethical analysis of film sequences in a systematic fashion. This (...) structured stepwise method encourages students to identify the main ethical problem of a selected scene and to reflect on the theoretical principles involved, emphasizing the application of these norms and values in a contextually situated analysis. We believe this method in film studies both reinforces the students’ comprehension of the theoretical framework of an ethical topic, and casts light on its pertinence and limitations under the circumstances of the scene, thus proving a constructive tool to strengthen the bridge between the theoretical teaching of clinical ethics and clinical practice. (shrink)

As an important professional value, dignity has always been an ethical concern in nursing education and practice. However, the dignity of nursing students in clinical environments has remained a little-discussed topic. This study aims to explore and describe nursing students’ dignity in clinical learning environments. This study is a qualitative descriptive work in which data were collected via semi-structured, in-depth, individual interviews and subsequently analyzed according to conventional content analysis. Based on the inclusion criteria of the study, (...) nursing students were selected from different departments of university hospitals in the south of Iran from October 2019 to December 2020. Sampling continued to the point of data saturation. This study has been approved by the institutional review board of the university. Two themes emerged from the data collected in the interviews: trust-based relationships and formation of professional identity. The findings of the study show that nursing students need to be supported by their instructors and perceive that the personnel and patients believe in their ability. In an effectively supportive, trust-based atmosphere, these factors can contribute to maintaining nursing students dignity. Also, showing respect for their personal identity, projecting a positive image of nursing, and giving them authority to perform executive and clinical tasks in hospital departments play a major role in the formation of nursing students’ professional identity and development of their dignity. Accordingly, it is recommended that in cultural contexts and clinical learning environments, more attention should be given to nursing students’ dignity. (shrink)

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision‐making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss it with (...) partners or relatives; and perceived benefits such as quality of care, non‐cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk‐benefit balance was strongly influenced by women’s needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision‐making process enhances women’s ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process. (shrink)

ObjectiveTo assess the scientific and ethical basis for clinical innovation in psychopharmacology.MethodsWe conducted a literature review, utilizing MEDLINE search and bibliographic cross-referencing, and historical evidence regarding the discovery and development of new medications in psychiatry. Clinical innovation was defined as use of treatments in a clinical setting which have not been well-proven in a research setting.ResultsEmpirical data regarding the impact of clinical innovation in psychopharmacology are lacking. A conceptual and historical assessment of this topic highlights (...) the ethical and scientific importance of clinical innovation. Ethically, it touches a borderline that, in our judgment, is not adequately framed in contemporary mainstream bioethics. Currently, research is viewed as not at all benefiting the patients who participate in it, while clinical care is viewed as being solely for the benefit of patients. Clinical innovation straddles these two worlds, uncomfortably at times. While many argue that clinical innovation should either be avoided or folded into research projects, we argue that clinical innovation is necessary for progress in psychopharmacology research, and that it can prosper best when guided by the following ethical principles: 1.) The treatment should be based on a viable hypothesis. 2.) Whenever possible, one's clinical observations should be reported so they can be evaluated by the scientific community. 3.) One should be willing to report unexpected observations of drug effects. 4.) A high standard of informed consent should be maintained. Again, this proposal goes against the standard view among bioethicists that research and clinical care are categorically opposed activities, as made clear by the either-or dichotomy of the Belmont Report on bioethics. This approach has so polarized our profession into clinicians versus researchers, that many clinicians will not apply new knowledge produced by clinical research until it eventually gets incorporated into formal treatment guidelines, while researchers have little to guide them as to what kind of new knowledge it is most important to provide.SummaryClinical innovation brings out the ambiguities in our current ethical conceptions of research versus clinical care. Yet, historically, clinical innovation has been an important contributor to progress in psychopharmacology. We argue that clinical innovation should not be discouraged, but rather it should occur under certain ethical conditions."Almost everyone can and should do research...because almost everyone has a unique observational opportunity at some time in his life which he has an obligation to record....If one considers the fundamental operations or methods of research, one immediately realizes that most people do research at some time or another, except that they do not call their activity by that name. There are seven operations....In simple language they are counting, sorting, measuring, comparing, nature-study, guess testing, and reappraisal....Guess testing is of course what most people think of when the word research is mentioned; except that it is bad manners to call a guess a guess. It should be called an hypothesis. Let us make one plea. Guessing becomes merely a game unless it is done in the context of a plan for action. It is a waste of time elaborating untestable hypotheses [1]."John Cade. (shrink)

Cortisone, initially known as ‘compound E’ was the medical sensation of the late 1940s and early 1950s. As early as April 1949, only a week after Philip Hench and colleagues first described the potential of ‘compound E’ at a Mayo Clinic seminar, the New York Times reported the drug’s promise as a ‘modern miracle’ in the treatment of rheumatoid arthritis. Given its high profile, it is unsurprising that historians of medicine have been attracted to study the innovation of cortisone. It (...) arrived at the end of a decade of ‘therapeutic revolutions’, kicked off by penicillin transforming the treatment of bacterial infections and ending with hopes of a revolution in the treatment of non-infectious, chronic inflammatory diseases. Despite these studies of cortisone’s introduction, few historians have taken the story forward and considered how cortisone was adopted and adapted into clinical practice. This article tells the longer of how the drug and its derivatives were taken from research laboratories and integrated into clinical practice; what has in recent decades become known as translational medicine. In exploring cortisone’s first decade in Britain, we focus specifically on its role in the treatment of RA. Our approach is always to consider cortisone’s use in the context of other treatments available to clinicians, and at local and national institutional settings. We do not discuss the many other therapeutic uses of cortisone, which ranged for topical applications for skin diseases to the management of cancers, especially childhood leukaemia, nor do we discuss its close analogue ACTH—AdenoCorticoTropic Hormone. We think there are lessons in our study for TM policies today. (shrink)

Cortisone, initially known as ‘compound E’ was the medical sensation of the late 1940s and early 1950s. As early as April 1949, only a week after Philip Hench and colleagues first described the potential of ‘compound E’ at a Mayo Clinic seminar, the New York Times reported the drug’s promise as a ‘modern miracle’ in the treatment of rheumatoid arthritis. Given its high profile, it is unsurprising that historians of medicine have been attracted to study the innovation of cortisone. It (...) arrived at the end of a decade of ‘therapeutic revolutions’, kicked off by penicillin transforming the treatment of bacterial infections and ending with hopes of a revolution in the treatment of non-infectious, chronic inflammatory diseases. Despite these studies of cortisone’s introduction, few historians have taken the story forward and considered how cortisone was adopted and adapted into clinical practice. This article tells the longer of how the drug and its derivatives were taken from research laboratories and integrated into clinical practice; what has in recent decades become known as translational medicine. In exploring cortisone’s first decade in Britain, we focus specifically on its role in the treatment of RA. Our approach is always to consider cortisone’s use in the context of other treatments available to clinicians, and at local and national institutional settings. We do not discuss the many other therapeutic uses of cortisone, which ranged for topical applications for skin diseases to the management of cancers, especially childhood leukaemia, nor do we discuss its close analogue ACTH—AdenoCorticoTropic Hormone. We think there are lessons in our study for TM policies today. (shrink)

Cortisone, initially known as ‘compound E’ was the medical sensation of the late 1940s and early 1950s. As early as April 1949, only a week after Philip Hench and colleagues first described the potential of ‘compound E’ at a Mayo Clinic seminar, the New York Times reported the drug’s promise as a ‘modern miracle’ in the treatment of rheumatoid arthritis. Given its high profile, it is unsurprising that historians of medicine have been attracted to study the innovation of cortisone. It (...) arrived at the end of a decade of ‘therapeutic revolutions’, kicked off by penicillin transforming the treatment of bacterial infections and ending with hopes of a revolution in the treatment of non-infectious, chronic inflammatory diseases. Despite these studies of cortisone’s introduction, few historians have taken the story forward and considered how cortisone was adopted and adapted into clinical practice. This article tells the longer of how the drug and its derivatives were taken from research laboratories and integrated into clinical practice; what has in recent decades become known as translational medicine. In exploring cortisone’s first decade in Britain, we focus specifically on its role in the treatment of RA. Our approach is always to consider cortisone’s use in the context of other treatments available to clinicians, and at local and national institutional settings. We do not discuss the many other therapeutic uses of cortisone, which ranged for topical applications for skin diseases to the management of cancers, especially childhood leukaemia, nor do we discuss its close analogue ACTH—AdenoCorticoTropic Hormone. We think there are lessons in our study for TM policies today. (shrink)

Despite technological innovations, clinical expertise remains the cornerstone of psychiatry. A clinical expert does not only have general textbook knowledge, but is sensitive to what is demanded for the individual patient in a particular situation. A method that can do justice to the subjective and situation-specific nature of clinical expertise is ethnography. Effective deep brain stimulation (DBS) for obsessive-compulsive disorder (OCD) involves an interpretive, evaluative process of optimizing stimulation parameters, which makes it an interesting case to study (...) clinical expertise. The aim of this study is to explore the role of clinical expertise through an ethnography of the particular case of DBS optimization in OCD. In line with the topic of the special issue this article is a part of, we will also use our findings to reflect on ethnography as a method to study complex phenomena like clinical expertise. This ethnography of DBS optimization is based on 18 months of participant observation and nine in-depth interviews with a team of expert clinicians who have been treating over 80 OCD patients since 2005. By repeatedly observing particular situations for an extended period of time, we found that there are recurrent patterns in the ways clinicians interact with patients. These patterns of clinical practice shape the possibilities clinicians have for making sense of DBS-induced changes in patients’ lived experience and behavior. Collective established patterns of clinical practice are dynamic and change under the influence of individual learning experiences in particular situations, opening up new possibilities and challenges. We conclude that patterns of clinical practice and particular situations are mutually constitutive. Ethnography is ideally suited to bring this relation into view thanks to its broad temporal scope and focus on the life-world. Based on our findings, we argue that clinical expertise not only implies skillful engagement with a concrete situation but also with the patterns of clinical practice that shape what is possible in this specific situation. Given this constraining and enabling role of practices, it is important to investigate them in order to find ways to improve diagnostic and therapeutic possibilities. (shrink)

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021.

Title in English: Psychology of Nationality as A New Studies Umbrella in Indonesia. Abstract: The role of psychology in dealing with issues of and improving the welfare of the nation has often been raised into topics of psychology seminars and conferences, both in subdisciplines of social psychology, clinical-macro psychology, and other subdisciplines. Psychology, as a science that deals with human dimensions, tries to contribute from formulating the definition of "nation" to doing research and social intervention on the nation's (...) problems. This phenomenon is very encouraging because it shows that we are continually questioning ourselves as a nation, a precondition for healthy development, as well as seeing and trying to reach the possibilities of how our nation will "become". Every psychology (assumed that psychology is not singular) that indicates and prescribes adherence of feelings and commitments of citizens with the imagined community of the nation deserve to be called as Psychology of Nationality. (shrink)

In the introduction to hisAllgemeine Psychopathologie, published in 1913, Karl Jaspers stated that psychology has little value for the psychopathologist because it focuses on all kinds of interesting matters, but not on normal psychic life. In this article we argue that today, in the year 2013, little has changed in this respect. During the past century, normal psychic life (non-pathological psychic life) has rarely been a topic of research. Clinical psychology has focused primarily on studying three other topics: (...) the mind-body problem (does the mind actually exist, or are we exclusively the result of brain function?), the methodological debate (should psychology use quantitative or qualitative research results as a basis for its expertise?) and the psychotherapy debate (Is psychotherapy effective? If so, which form is the most effective?). Due to this focus, our knowledge in the above-mentioned areas has increased significantly, but the issue raised by Karl Jaspers about normal psychic life has still not been addressed. In this article, we propose that normal psychic life should indeed become the new focus of clinical psychology. We illustrate the importance of this new focus with three examples from clinical psychology: the Global Assessment of Functioning scale, empathy and the emergence of positive psychology during the past decade. We then explore the efficacy of phenomenology for studying this normal psychic life, thereby discovering a useful epistemological basis in Husserl’s systematic phenomenology. Various phenomenological research methods are evaluated in the light of this systematic phenomenology. (shrink)

Background Teaching ethical competencies is an essential component of professional and postgraduate curricula. Developing practical–ethical problem-solving competencies as well as appraising program-specific studies and related research ethics are topics typically addressed. However, assessment of these ethical competencies poses a challenge. Written or oral assessment formats addressing relevant learning objectives is mainly limited to knowledge testing alone, often not capturing relevant skills or attitudes pertinent to those competencies. Aim During the reaccreditation of the masters of science program in Nursing Science (...) at Witten/Herdecke University, this challenge was addressed by implementation of an innovative examination format for postgraduate education. Procedure For the module “Ethics in nursing practice and research” a format based on the Objective Structured Clinical Examination format was developed. This assessment method incorporates evaluation of acquired skills and attitudes of nursing students. Conclusion The article demonstrates development and adaption of the OSCE format for this purpose. (shrink)

The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and decision-making. The (...) key finding was that ethics committees received and processed the applications variably, reflecting individual factors and local problems. To improve consensus and facilitate multicentre studies, standard forms and instructions are suggested and the establishment of a national committee or advisory group advocated. (shrink)

Involvement of industry in academic research is widespread and associated with favorable outcomes for industry. The objective of this study was to review empirical data on the attitudes of researchers toward industry involvement and financial ties in research. A review of the literature for quantitative data from surveys on the attitudes of researchers to financial ties in research, reported in English, resulted in the 17 studies included. Review of these studies revealed that investigators are concerned about the impact (...) of financial ties on choice of research topic, research conduct and publication, but this concern is less among investigators already involved with industry. Researchers approve of industry collaboration and financial ties when the ties are indirectly related to the research, disclosure is upfront, and results and ideas are freely publicized. However, their trust in disclosure as a way to manage conflicts may reveal a lack of awareness of the actual impact of financial incentives on themselves and other researchers. (shrink)

The use of placebo in clinical practice has been the topic of extensive debate in the bioethics literature, with much scholarship focusing on concerns regarding deception. While considerations of placebo without deception have largely centred on open-label placebo, this paper considers a different kind of ethical quandary regarding placebo without an intent to deceive—one where the provider believes a treatment is effective due to a direct physiological mechanism, even though that belief may not be supported by rigorous scientific (...) evidence. This is often the case with complementary and alternative medicine (CAM) techniques and also with some mainstream therapies that have not proven to be better than sham. Using one such CAM technique as a case study—electroencephalography (EEG) neurofeedback for attention-deficit/hyperactivity disorder (ADHD)—this paper explores the ethics of providing therapies that may have some beneficial effect, although one that is likely due to placebo effect. First, we provide background on EEG neurofeedback for ADHD and its evidence base, showing how it has proven to be equivalent to—but not better than—sham neurofeedback. Subsequently, we explore whether offering therapies that are claimed to work via specific physical pathways, but may actually work due to the placebo effect, constitute deception. We suggest that this practice may constitute unintentional deception regarding mechanism of action. Ultimately, we argue that providers have increased information provision obligations when offering treatments that diverge from standard of care and we make recommendations for mitigating unintentional deception. (shrink)

Determining what constitutes an anticipatable incidental finding from clinical research and defining whether, and when, this IF should be returned to the participant have been topics of discussion in the field of human subject protections for the last 10 years. It has been debated that implementing a comprehensive IF-approach that addresses both the responsibility of researchers to return IFs and the expectation of participants to receive them can be logistically challenging. IFs have been debated at different levels, such as (...) the ethical reasoning for considering their disclosure or the need for planning for them during the development of the research study. Some authors have discussed the methods for re-contacting participants for disclosing IFs, as well as the relevance of considering the clinical importance of the IFs. Similarly, other authors have debated about when IFs should be disclosed to participants. However, no author has addressed how the “actionability” of the IFs should be considered, evaluated, or characterized at the participant's research setting level. This paper defines the concept of “Actionability at the Participant's Research Setting Level” for anticipatable IFs from clinical research, discusses some related ethical concepts to justify the APRSL concept, proposes a strategy to incorporate APRSL into the planning and management of IFs, and suggests a strategy for integrating APRSL at each local research setting. (shrink)

Psychoanalysis has traditionally had difficulty in accounting for the existence of evil. Freud saw it as a direct expression of unconscious forces, whereas more recent theorists have examined the links between early traumatic experiences and later ‘evil’ behaviour. _Humanizing Evil: Psychoanalytic, Philosophical and Clinical Perspectives _explores the controversies surrounding definitions of evil, and examines its various forms, from the destructive forces contained within the normal mind to the most horrific expressions observed in contemporary life. Ronald Naso and _Jon Mills_ (...) bring together an international group of experts to explore how more subtle factors can play a part, such as conformity pressures, or the morally destabilizing effects of anonymity, and show how analysts can understand and work with such factors in clinical practice._ _Each chapter is unified by the view that evil is intrinsically linked to human freedom, regardless of the gap experienced by perpetrators between their intentions and consequences. While some forms of evil follow seamlessly from psychopathology, others call this relationship into question. Rape, murder, serial killing, and psychopathy show very clear links to psychopathology and character whereas the horrors of war, religious fundamentalism, and political extremism resist such reductionism. Humanizing _Evil_ is unique in the diversity of perspectives it brings to bear on the problem of evil. It will be essential reading for psychoanalysts, psychotherapists, philosophers, and Jungians. Because it is an integrative depth-psychological effort, it will interest general readers as well as scholars from a variety of disciplines including the humanities, philosophy, religion, mental health, criminal justice, political science, sociology, and interdisciplinary studies. Ronald Naso, Ph.D., ABPP is psychoanalyst and clinical psychologist in independent practice in Stamford, CT. The author of numerous papers on psychoanalytic topics, he is an associate editor of _Contemporary Psychoanalytic Studies_, and contributing editor of _Division/Review _and _Journal of Psychology and Clinical Psychiatry_. His book, _Hypocrisy Unmasked: Dissociation, Shame, and the Ethics of Inauthenticity_, was published by Aronson in 2010. Jon Mills, Psy.D., Ph.D., ABPP is a philosopher, psychoanalyst, and clinical psychologist. He is Professor of Psychology & Psychoanalysis at Adler Graduate Professional School, Toronto. A 2006, 2011, and 2013 Gradiva Award winner, he is Editor of two book series in psychoanalysis, on the Editorial Board for _Psychoanalytic Psychology_, and is the author and/or editor of thirteen books including his most recent works, _Underworlds: Philosophies of the Unconscious from Psychoanalysis to Metaphysics_, and _Conundrums: A Critique of Contemporary Psychoanalysis_, which won the Goethe Award for best book in 2013. (shrink)

This book integrates philosophy of science, data acquisition methods, and statistical modeling techniques to present readers with a forward-thinking perspective on clinical science. It reviews modern research practices in clinical psychology that support the goals of psychological science, study designs that promote good research, and quantitative methods that can test specific scientific questions. It covers new themes in research including intensive longitudinal designs, neurobiology, developmental psychopathology, and advanced computational methods such as machine learning. Core chapters examine significant statistical (...) topics, for example missing data, causality, meta-analysis, latent variable analysis, and dyadic data analysis. A balanced overview of observational and experimental designs is also supplied, including preclinical research and intervention science. This is a foundational resource that supports the methodological training of the current and future generations of clinical psychological scientists. (shrink)