German medical schools have not yet sufficiently introduced students to the field of good scientific practice. In order to prevent scientific misconduct and to foster scientific integrity, courses on GSP must be an integral part of the curriculum of medical students. Based on a review of the literature, teaching units and materials for two courses on GSP were developed and tested in a pilot course. The pilot course was accompanied by a pre-post evaluation that assessed students’ knowledge and (...) attitudes towards scientific integrity and scientific misconduct. A syllabus was designed that comprised the following six topics: theoretical foundations of GSP; scientific publishing; empirical data; scientific supervision and teamwork; clinical research; personal interests. The comparison pre versus post-intervention yielded statistically significant changes in regard to the participants’ knowledge and attitude toward all forms of scientific misconduct treated in the course. As the majority of participants was not familiar with the fundamental regulations or guidelines of GSP, it seems crucial to train students in actively applying such norms to real-world conflicts. Students’ unfamiliarity with the fundamentals of GSP can be linked to the fact that many students have already experienced forms of scientific misconduct. Thus, GSP syllabi should be closely adjusted to a student’s realm of experience. All in all, courses on GSP can be seen as a potential means to increase the number of young scholars. (shrink)

This paper reports a European Forum for Good Clinical Practice workshop held in 2011 to consider a research ethics committee training syllabus, subsequent training needs and resources. The syllabus that was developed was divided into four competencies: committee working; scientific method; ethical analysis and the regulatory framework. Appropriate training needs for each, with possible resources, were discussed. Lack of funding for training was reported as a major problem but affordable alternatives were debated. Strengths and weaknesses of (...) this approach were discussed and the resultant proposal will be disseminated through the European Forum for Good Clinical Practice and the research ethics committees of member states. (shrink)

Training for members of research ethics committees varies from state to state in Europe. To follow this up, the European Forum for Good Clinical Practice organised a workshop in March 2007 to explore these issues and look for solutions. This article summarises the discussion, providing ways forward to develop REC training.

The scope of this essay is to introduce and explain the methodology underlying the Lanza Foundation Protocol for the analysis of clinical cases. The essay is divided in three parts. Part one examines the Protocol's methodology within the whole evolutionary framework of argumentation in bioethics. Particular attention is given to the most significant methodologies developed in European bioethics. Part two describes the system of argumentation which serves as a frame for both approaches, namely, the normative and the (...) hermeneutical. Finally, the third part presents in an analytic fashion the operations which define the Protocol itself. The Protocol is the result of an interdisciplinary effort and it provides a detailed grid for analyzing and tackling the ethical components of clinical cases. The Protocol is primarily directed toward Ethics Committees in their consulting activity, yet it has been proven of considerable importance at an educational level also, particular in continuing education programs for health care professionals. (shrink)

This paper joins the debate over changes in the role of health professionals when applying advance directives to manage the decision-making process at the end of life care. Issues in relation to advance directives occur in clinical units in Lithuania; however, it remains one of the few countries in the European Union where the discussion on advance directives is not included in the health-care policy-making agenda. To encourage the discussion of advance directives, a study was designed to examine (...) health professionals’ understanding and preferences related to advance directives. In addition, the study sought to explore the views of health care professionals of the application of Advance Directives in clinical practice in Lithuania. A cross-sectional survey was conducted by interviewing 478 health professionals based at major health care centers in Kaunas district, Lithuania. The design of the study included the use of a questionnaire developed for this study and validated by a pilot study. The collected data were analyzed using standard descriptive statistical methods. The analysis of knowledge about AD revealed some statistically significant differences when comparing the respondents’ profession and gender. The analysis also indicated key emerging themes among respondents including tranquility of mind, the longest possible life expectancy and freedom of choice. Further, the study findings revealed that more than half of the study participants preferred to express their will while alive by using advance directives. The study findings revealed a low level of knowledge on advance directives among health professionals. Most health professionals agreed that AD’s improved end-of-life decision making while the majority of physicians appreciated AD as the best tool for sharing responsibilities in clinical practice in Lithuania. More physicians than nurses preferred the presence of advance directives to support their decision making in end-of-life situations. (shrink)

Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, (...) Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants’ consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant’s consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities. (shrink)

Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are “fit for purpose” by meeting acknowledged standards of process, debate and outcome. This paper reports a workshop in Warsaw in April 2008, organised by the European Forum for Good Clinical Practice, on the problems of setting standards for RECs in the European Union. Representatives from 27 countries were invited; 16 were represented. Problems identified were the limited and (...) variable resources, difficulties of setting standards for ethical debate and its outcomes and that REC members, as volunteers, may resent the imposition of standards. Other ways to set standards were discussed, including analysis of current multicentre review, collecting REC member reports for review, learning from appeals and feedback from applicants, and use of other regional and national meetings. The place of a central, national board or ethics committee was debated as was the need for collaborating with partners in other fields. (shrink)

Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data (...) obtained. (shrink)

Nursing as a profession has a social mandate to contribute to the good of society through knowledge-based practice. Knowledge is built upon theories, and theories, together with their philosophical bases and disciplinary goals, are the guiding frameworks for practice. This article explores a philosophical perspective of nursing's social mandate, the disciplinary goals for the good of the individual and society, and one approach for translating knowledge into practice through the use of a middle-range theory. It (...) is anticipated that the integration of the philosophical perspective and model into nursing practice will strengthen the philosophy, disciplinary goal, theory, and practice links and expand knowledge within the discipline. With the focus on humanization, we propose that nursing knowledge for social good will embrace a synthesis of the individual and the common good. This approach converges vital and agency needs described by Hamilton and the primacy of maintaining the heritage of the good within the human species as outlined by Maritain. Further, by embedding knowledge development in a changing social and health care context, nursing focuses on the goals of clinical reasoning and action. McCubbin and Patterson's Double ABCX Model of Family Adaptation was used as an example of a theory that can guide practice at the community and global level. Using the theory-practice link as a foundation, the Double ABCX model provides practising nurses with one approach to meet the needs of individuals and society. The integration of theory into nursing practice provides a guide to achieve nursing's disciplinary goals of promoting health and preventing illness across the globe. When nursing goals are directed at the synthesis of the good of the individual and society, nursing's social and moral mandate may be achieved. (shrink)

ABSTRACT This article presents an overview of the Portuguese transposition of the European Directive on Good Clinical Practice (2001/20/e) concerning scientific and academic debates on bioethics and clinical investigation. Since the Directive was transposed into Portuguese law by its National Assembly, the bureaucracy of clinical trials has been ever more complex. Despite demands for swift application processes by the Pharmaceutical industry, supported by the European Parliament, the Directive's transcription to the national law has (...) not always delivered the expected outcome. However, this has led to an increased number of applications for clinical trials in Portuguese hospitals. In this article I revise bioethical publications and decree‐laws enabling an informed appraisal of the anxieties and prospects for the implementation of the clinical trials Directive in Portugal. This article also places the European Directive in the field of sociology of bioethics, arguing that Portuguese bioethical institutions differ from those of the US, and also from Northern European counterparts. The main divergence is that those people in Portugal who claim expertise in ‘legal’ bioethics do not dominate either the bureaucratic structure of research or ethics committees for health. Even experts in the applied ethics field now claim that ‘professional bioethicists do not exist’. The recent creation of a national Ethics Committee for Clinical Investigation (CEIC) in line with the European Directive on Good Clinical Practice (GCP) will not change the present imbalance between different professional jurisdictions in the national bioethical debate in Portugal. (shrink)

This project is a philosophical analysis of the practice of bioethics consultation---what might be called the philosophy of bioethics. It assesses claims made about the purposes and appropriate aims of the field, in order to establish whether an identifiable conceptual unity underlies the practice. The conclusion is that no such unity exists. ;The project begins by assessing the history of the field, in the hope that a historical analysis will explain why the field arose at all, which reason (...) could then be used as a basis for claiming a particular purpose for bioethics consultation. However, it becomes clear that history has bequeathed diverse and sometimes conflicting goals to bioethics consultation. History suggests that the field exists both as a service to physicians and as a service to patients, though the interests of these two parties may be in tension. ;This work also assesses contemporary accounts of bioethics consultation and shows that they are radically divergent and incommensurable, in addition to often being too vague to guide the practice. An investigation of possible philosophical arguments regarding bioethics consultation also fails to disclose a single coherent foundation for the field. The project ends with a conceptual geography of twelve possible roles a bioethics consultant may play, and finds that though some are in tension, none may be ruled out of court on independent grounds in the absence of an overarching account of the appropriate aims of the field. ;What this project demonstrates is that there is no conceptual unity underlying the practice of bioethics consultation. Instead, the enterprise must be understood as comprised of a plurality of roles serving a diversity of purposes and a heterogeneity of goods with no single uniting purpose. (shrink)

This paper presents a review, conducted by the ethics working party of the European Forum for Good Clinical Practice, of the structures and functions of research ethics committees across the member states of the EU. The findings demonstrate widespread differences, and further working groups have been established to develop thinking across Europe, in respect of the training of REC members, ethics committee quality assurance and the involvement of vulnerable subjects in research. In practical terms the differences (...) do not matter, but they should be recognized. The review itself is considered a dynamic document and will be updated every six months. (shrink)

With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed (...) a simple auditing process and evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital’s Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. Investigator reply rates gradually increased, except for the first year. The studies were graded as “critical,” “major,” “minor,” and “not a finding”, based on findings and number of deficiencies. The auditors’ decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being “major” or “critical”. Inappropriateness of documents, failure to obtain informed consent, inappropriateness of informed consent process, and failure to protect participants’ personal information were associated with higher audit grade. We were able to observe critical GCP violations in the routine internal audit results of post-screening audit compliance checks in “non-responding” and “critical” studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to ensure medical ethics. The tool also provides useful selection criteria for conducting routine audits. (shrink)

Table of contentsI1 Proceedings of the 4th World Conference on Research IntegrityConcurrent Sessions:1. Countries' systems and policies to foster research integrityCS01.1 Second time around: Implementing and embedding a review of responsible conduct of research policy and practice in an Australian research-intensive universitySusan Patricia O'BrienCS01.2 Measures to promote research integrity in a university: the case of an Asian universityDanny Chan, Frederick Leung2. Examples of research integrity education programmes in different countriesCS02.1 Development of a state-run “cyber education program of research ethics” (...) in KoreaEun Jung Ko, Jin Sun Kwak, TaeHwan Gwon, Ji Min Lee, Min-Ho LeeCS02.3 Responsible conduct of research teachers’ training courses in Germany: keeping on drilling through hard boards for more RCR teachersHelga Nolte, Michael Gommel, Gerlinde Sponholz3. The research environment and policies to encourage research integrityCS03.1 Challenges and best practices in research integrity: bridging the gap between policy and practiceYordanka Krastev, Yamini Sandiran, Julia Connell, Nicky SolomonCS03.2 The Slovenian initiative for better research: from national activities to global reflectionsUrsa Opara Krasovec, Renata SribarCS03.3 Organizational climate assessments to support research integrity: background of the Survey of Organizational Research Climate and the experience with its use at Michigan State UniversityBrian C. Martinson, Carol R. Thrush, C.K. Gunsalus4. Expressions of concern and retractionsCS04.1 Proposed guidelines for retraction notices and their disseminationIvan Oransky, Adam MarcusCS04.2 Watching retractions: analysis of process and practice, with data from the Wiley retraction archivesChris Graf, Verity Warne, Edward Wates, Sue JoshuaCS04.3 An exploratory content analysis of Expressions of ConcernMiguel RoigCS04.4 An ethics researcher in the retraction processMichael Mumford5. Funders' role in fostering research integrityCS05.1 The Fonds de Recherche du Québec’s institutional rules on the responsible conduct of research: introspection in the funding agency activitiesMylène Deschênes, Catherine Olivier, Raphaëlle Dupras-LeducCS05.2 U.S. Public Health Service funds in an international setting: research integrity and complianceZoë Hammatt, Raju Tamot, Robin Parker, Cynthia Ricard, Loc Nguyen-Khoa, Sandra TitusCS05.3 Analyzing decision making of funders of public research as a case of information asymmetryKarsten Klint JensenCS05.4 Research integrity management: Empirical investigation of academia versus industrySimon Godecharle, Ben Nemery, Kris Dierickx5A: Education: For whom, how, and what?CS05A.1 Research integrity or responsible conduct of research? What do we aim for?Mickey Gjerris, Maud Marion Laird Eriksen, Jeppe Berggren HoejCS05A.2 Teaching and learning about RCR at the same time: a report on Epigeum’s RCR poll questions and other assessment activitiesNicholas H. SteneckCS05A.4 Minding the gap in research ethics education: strategies to assess and improve research competencies in community health workers/promoteresCamille Nebeker, Michael Kalichman, Elizabeth Mejia Booen, Blanca Azucena Pacheco, Rebeca Espinosa Giacinto, Sheila Castaneda6. Country examples of research reward systems and integrityCS06.1 Improving systems to promote responsible research in the Chinese Academy of SciencesDing Li, Qiong Chen, Guoli Zhu, Zhonghe SunCS06.4 Exploring the perception of research integrity amongst public health researchers in IndiaParthasarathi Ganguly, Barna Ganguly7. Education and guidance on research integrity: country differencesCS07.1 From integrity to unity: how research integrity guidance differs across universities in Europe.Noémie Aubert Bonn, Kris Dierickx, Simon GodecharleCS07.2 Can education and training develop research integrity? The spirit of the UNESCO 1974 recommendation and its updatingDaniele Bourcier, Jacques Bordé, Michèle LeducCS07.3 The education and implementation mechanisms of research ethics in Taiwan's higher education: an experience in Chinese web-based curriculum development for responsible conduct of researchChien Chou, Sophia Jui-An PanCS07.4 Educating principal investigators in Swiss research institutions: present and future perspectivesLouis Xaver Tiefenauer8. Measuring and rewarding research productivityCS08.1 Altimpact: how research integrity underpins research impactDaniel Barr, Paul TaylorCS08.2 Publication incentives: just reward or misdirection of funds?Lyn Margaret HornCS08.3 Why Socrates never charged a fee: factors contributing to challenges for research integrity and publication ethicsDeborah Poff9. Plagiarism and falsification: Behaviour and detectionCS09.1 Personality traits predict attitude towards plagiarism of self and others in biomedicine: plagiarism, yes we can?Martina Mavrinac, Gordana Brumini, Mladen PetrovečkiCS09.2 Investigating the concept of and attitudes toward plagiarism for science teachers in Brazil: any challenges for research integrity and policy?Christiane Coelho Santos, Sonia VasconcelosCS09.3 What have we learnt?: The CrossCheck Service from CrossRefRachael LammeyCS09.4 High p-values as a sign of data fabrication/falsificationChris Hartgerink, Marcel van Assen, Jelte Wicherts10. Codes for research integrity and collaborationsCS10.1 Research integrity in cross-border cooperation: a Nordic exampleHanne Silje HaugeCS10.3 Research integrity, research misconduct, and the National Science Foundation's requirement for the responsible conduct of researchAaron MankaCS10.4 A code of conduct for international scientific cooperation: human rights and research integrity in scientific collaborations with international academic and industry partnersRaffael Iturrizaga11. Countries' efforts to establish mentoring and networksCS11.1 ENRIO : a network facilitating common approaches on research integrity in EuropeNicole FoegerCS11.2 Helping junior investigators develop in a resource-limited country: a mentoring program in PeruA. Roxana Lescano, Claudio Lanata, Gissella Vasquez, Leguia Mariana, Marita Silva, Mathew Kasper, Claudia Montero, Daniel Bausch, Andres G LescanoCS11.3 Netherlands Research Integrity Network: the first six monthsFenneke Blom, Lex BouterCS11.4 A South African framework for research ethics and integrity for researchers, postgraduate students, research managers and administratorsLaetus OK Lategan12. Training and education in research integrity at an early career stageCS12.1 Research integrity in curricula for medical studentsGustavo Fitas ManaiaCS12.2 Team-based learning for training in the responsible conduct of research supports ethical decision-makingWayne T. McCormack, William L. Allen, Shane Connelly, Joshua Crites, Jeffrey Engler, Victoria Freedman, Cynthia W. Garvan, Paul Haidet, Joel Hockensmith, William McElroy, Erik Sander, Rebecca Volpe, Michael F. VerderameCS12.4 Research integrity and career prospects of junior researchersSnezana Krstic13. Systems and research environments in institutionsCS13.1 Implementing systems in research institutions to improve quality and reduce riskLouise HandyCS13.2 Creating an institutional environment that supports research integrityDebra Schaller-DemersCS13.3 Ethics and Integrity Development Grants: a mechanism to foster cultures of ethics and integrityPaul Taylor, Daniel BarrCS13.4 A culture of integrity at KU LeuvenInge Lerouge, Gerard Cielen, Liliane Schoofs14. Peer review and its role in research integrityCS14.1 Peer review research across disciplines: transdomain action in the European Cooperation in Science and Technology “New Frontiers of Peer Review ”Ana Marusic, Flaminio SquazzoniCS14.2 Using blinding to reduce bias in peer reviewDavid VauxCS14.3 How to intensify the role of reviewers to promote research integrityKhalid Al-Wazzan, Ibrahim AlorainyCS14.4 Credit where credit’s due: professionalizing and rewarding the role of peer reviewerChris Graf, Verity Warne15. Research ethics and oversight for research integrity: Does it work?CS15.1 The psychology of decision-making in research ethics governance structures: a theory of bounded rationalityNolan O'Brien, Suzanne Guerin, Philip DoddCS15.2 Investigator irregularities: iniquity, ignorance or incompetence?Frank Wells, Catherine BlewettCS15.3 Academic plagiarismFredric M. Litto16. Research integrity in EuropeCS16.1 Whose responsibility is it anyway?: A comparative analysis of core concepts and practice at European research-intensive universities to identify and develop good practices in research integrityItziar De Lecuona, Erika Löfstrom, Katrien MaesCS16.2 Research integrity guidance in European research universitiesKris Dierickx, Noémie Bonn, Simon GodecharleCS16.3 Research Integrity: processes and initiatives in Science Europe member organisationsTony Peatfield, Olivier Boehme, Science Europe Working Group on Research IntegrityCS16.4 Promoting research integrity in Italy: the experience of the Research Ethics and Bioethics Advisory Committee of the Consiglio Nazionale delle Ricerche Cinzia Caporale, Daniele Fanelli17. Training programs for research integrity at different levels of experience and seniorityCS17.1 Meaningful ways to incorporate research integrity and the responsible conduct of research into undergraduate, graduate, postdoctoral and faculty training programsJohn Carfora, Eric Strauss, William LynnCS17.2 "Recognize, respond, champion": Developing a one-day interactive workshop to increase confidence in research integrity issuesDieter De Bruyn, Bracke Nele, Katrien De Gelder, Stefanie Van der BurghtCS17.4 “Train the trainer” on cultural challenges imposed by international research integrity conversations: lessons from a projectJosé Roberto Lapa e Silva, Sonia M. R. Vasconcelos18. Research and societal responsibilityCS18.1 Promoting the societal responsibility of research as an integral part of research integrityHelene IngierdCS18.2 Social responsibility as an ethical imperative for scientists: research, education and service to societyMark FrankelCS18.3 The intertwined nature of social responsibility and hope in scienceDaniel Vasgird, Stephanie BirdCS18.4 Common barriers that impede our ability to create a culture of trustworthiness in the research communityMark Yarborough19. Publication ethicsCS19.1 The authors' forum: A proposed tool to improve practices of journal editors and promote a responsible research environmentIbrahim Alorainy, Khalid Al-WazzanCS19.2 Quantifying research integrity and its impact with text analyticsHarold GarnerCS19.3 A closer look at authorship and publication ethics of multi- and interdisciplinary teamsLisa Campo-Engelstein, Zubin Master, Elise Smith, David Resnik, Bryn Williams-JonesCS19.4 Invisibility of duplicate publications in biomedicineMario Malicki, Ana Utrobicic, Ana Marusic20. The causes of bad and wasteful research: What can we do?CS20.1 From countries to individuals: unravelling the causes of bias and misconduct with multilevel meta-meta-analysisDaniele Fanelli, John PA IoannidisCS20.2 Reducing research waste by integrating systems of oversight and regulationGerben ter Riet, Tom Walley, Lex Marius BouterCS20.3 What are the determinants of selective reporting?: The example of palliative care for non-cancer conditionsJenny van der Steen, Lex BouterCS20.4 Perceptions of plagiarism, self-plagiarism and redundancy in research: preliminary results from a national survey of Brazilian PhDsSonia Vasconcelos, Martha Sorenson, Francisco Prosdocimi, Hatisaburo Masuda, Edson Watanabe, José Carlos Pinto, Marisa Palácios, José Lapa e Silva, Jacqueline Leta, Adalberto Vieyra, André Pinto, Mauricio Sant’Ana, Rosemary Shinkai21. Are there country-specific elements of misconduct?CS21.1 The battle with plagiarism in Russian science: latest developmentsBoris YudinCS21.2 Researchers between ethics and misconduct: A French survey on social representations of misconduct and ethical standards within the scientific communityEtienne Vergès, Anne-Sophie Brun-Wauthier, Géraldine VialCS21.3 Experience from different ways of dealing with research misconduct and promoting research integrity in some Nordic countriesTorkild VintherCS21.4 Are there specifics in German research misconduct and the ways to cope with it?Volker Bähr, Charité22. Research integrity teaching programmes and their challengesCS22.1 Faculty mentors and research integrityMichael Kalichman, Dena PlemmonsCS22.2 Training the next generation of scientists to use principles of research quality assurance to improve data integrity and reliabilityRebecca Lynn Davies, Katrina LaubeCS22.3 Fostering research integrity in a culturally-diverse environmentCynthia Scheopner, John GallandCS22.4 Towards a standard retraction formHervé Maisonneuve, Evelyne Decullier23. Commercial research and integrityCS23.1 The will to commercialize: matters of concern in the cultural economy of return-on-investment researchBrian NobleCS23.2 Quality in drug discovery data reporting: a mission impossible?Anja Gilis, David J. Gallacher, Tom Lavrijssen, Malwitz David, Malini Dasgupta, Hans MolsCS23.3 Instituting a research integrity policy in the context of semi-private-sector funding: an example in the field of occupational health and safetyPaul-Emile Boileau24. The interface of publication ethics and institutional policiesCS24.1 The open access ethical paradox in an open government effortTony SavardCS24.2 How journals and institutions can work together to promote responsible conductEric MahCS24.3 Improving cooperation between journals and research institutions in research integrity casesElizabeth Wager, Sabine Kleinert25. Reproducibility of research and retractionsCS25.1 Promoting transparency in publications to reduce irreproducibilityVeronique Kiermer, Andrew Hufton, Melanie ClyneCS25.2 Retraction notices issued for publications by Latin American authors: what lessons can we learn?Sonia Vasconcelos, Renan Moritz Almeida, Aldo Fontes-Pereira, Fernanda Catelani, Karina RochaCS25.3 A preliminary report of the findings from the Reproducibility Project: Cancer biologyElizabeth Iorns, William Gunn26. Research integrity and specific country initiativesCS26.1 Promoting research integrity at CNRS, FranceMichèle Leduc, Lucienne LetellierCS26.2 In pursuit of compliance: is the tail wagging the dog?Cornelia MalherbeCS26.3 Newly established research integrity policies and practices: oversight systems of Japanese research universitiesTakehito Kamata27. Responsible conduct of research and country guidelinesCS27.1 Incentives or guidelines? Promoting responsible research communication through economic incentives or ethical guidelines?Vidar EnebakkCS27.3 Responsible conduct of research: a view from CanadaLynn PenrodCS27.4 The Danish Code of Conduct for Research Integrity: a national initiative to promote research integrity in DenmarkThomas Nørgaard, Charlotte Elverdam28. Behaviour, trust and honestyCS28.1 The reasons behind non-ethical behaviour in academiaYves FassinCS28.2 The psychological profile of the dishonest scholarCynthia FekkenCS28.3 Considering the implications of Dan Ariely’s keynote speech at the 3rd World Conference on Research Integrity in MontréalJamal Adam, Melissa S. AndersonCS28.4 Two large surveys on psychologists’ views on peer review and replicationJelte WichertsBrett Buttliere29. Reporting and publication bias and how to overcome itCS29.1 Data sharing: Experience at two open-access general medical journalsTrish GrovesCS29.2 Overcoming publication bias and selective reporting: completing the published recordDaniel ShanahanCS29.3 The EQUATOR Network: promoting responsible reporting of health research studiesIveta Simera, Shona Kirtley, Eleana Villanueva, Caroline Struthers, Angela MacCarthy, Douglas Altman30. The research environment and its implications for integrityCS30.1 Ranking of scientists: the Russian experienceElena GrebenshchikovaCS30.4 From cradle to grave: research integrity, research misconduct and cultural shiftsBronwyn Greene, Ted RohrPARTNER SYMPOSIAPartner Symposium AOrganized by EQUATOR Network, Enhancing the Quality and Transparency of Health ResearchP1 Can we trust the medical research literature?: Poor reporting and its consequencesIveta SimeraP2 What can BioMed Central do to improve published research?Daniel Shanahan, Stephanie HarrimanP3 What can a "traditional" journal do to improve published research?Trish GrovesP4 Promoting good reporting practice for reliable and usable research papers: EQUATOR Network, reporting guidelines and other initiativesCaroline StruthersPartner Symposium COrganized by ENRIO, the European Network of Research Integrity OfficersP5 Transparency and independence in research integrity investigations in EuropeKrista Varantola, Helga Nolte, Ursa Opara, Torkild Vinther, Elizabeth Wager, Thomas NørgaardPartner Symposium DOrganized by IEEE, the Institute of Electrical and Electronics EngineersRe-educating our author community: IEEE's approach to bibliometric manipulation, plagiarism, and other inappropriate practicesP6 Dealing with plagiarism in the connected world: An Institute of Electrical and Electronics Engineers perspectiveJon RokneP7 Should evaluation of raises, promotion, and research proposals be tied to bibliometric indictors? What the Institute of Electrical and Electronics Engineers is doing to answer this questionGianluca SettiP8 Recommended practices to ensure conference content qualityGordon MacPhersonPartner Symposium EOrganized by the Committee on Freedom and Responsibility in the Conduct of Science of ICSU, the International Council for ScienceResearch assessment and quality in science: perspectives from international science and policy organisationsP9 Challenges for science and the problems of assessing researchEllen HazelkornP10 Research assessment and science policy developmentCarthage SmithP11 Research integrity in South Africa: the value of procedures and processes to global positioningRobert H. McLaughlinP12 Rewards, careers and integrity: perspectives of young scientists from around the worldTatiana Duque MartinsPartner Symposium FOrganized by the Online Resource Center for Ethics Education in Engineering and Science / Center for Engineering, Ethics, and Society of the National Academy of EngineeringP13 Research misconduct: conceptions and policy solutionsTetsuya Tanimoto, Nicholas Steneck, Daniele Fanelli, Ragnvald Kalleberg, Tajammul HusseinPartner Symposium HOrganized by ORI, the Office of Research Integrity; Universitas 21; and the Asia Pacific Research Integrity NetworkP14 International integrity networks: working together to ensure research integrityPing Sun, Ovid Tzeng, Krista Varantola, Susan ZimmermanPartner Symposium IOrganized by COPE, the Committee on Publication EthicsPublication without borders: Ethical challenges in a globalized worldP15 Authorship: credit and responsibility, including issues in large and interdisciplinary studiesRosemary ShinkaiPartner Symposium JOrganized by CITI, the Cooperative Institutional Training InitiativeExperiences on research integrity educational programs in Colombia, Costa Rica and PeruP16 Experiences in PeruRoxana LescanoP17 Experiences in Costa RicaElizabeth HeitmanP18 Experiences in ColumbiaMaria Andrea Rocio del Pilar Contreras NietoPoster Session B: Education, training, promotion and policyPT.01 The missing role of journal editors in promoting responsible researchIbrahim Alorainy, Khalid Al-WazzanPT.02 Honorary authorship in Taiwan: why and who should be in charge?Chien Chou, Sophia Jui-An PanPT.03 Authorship and citation manipulation in academic researchEric Fong, Al WilhitePT.04 Open peer review of research submission at medical journals: experience at BMJ Open and The BMJTrish GrovesPT.05 Exercising authorship: claiming rewards, practicing integrityDésirée Motta-RothPT.07 Medical scientists' views on publication culture: a focus group studyJoeri Tijdink, Yvo SmuldersPoster Session B: Education, training, promotion and policyPT.09 Ethical challenges in post-graduate supervisionLaetus OK LateganPT.10 The effects of viable ethics instruction on international studentsMichael Mumford, Logan Steele, Logan Watts, James Johnson, Shane Connelly, Lee WilliamsPT.11 Does language reflect the quality of research?Gerben ter Riet, Sufia Amini, Lotty Hooft, Halil KilicogluPT.12 Integrity complaints as a strategic tool in policy decision conflictsJanneke van Seters, Herman Eijsackers, Fons Voragen, Akke van der Zijpp and Frans BromPoster Session C: Ethics and integrity intersectionsPT.14 Regulations of informed consent: university-supported research processes and pitfalls in implementationBadaruddin Abbasi, Naif Nasser AlmasoudPT.15 A review of equipoise as a requirement in clinical trialsAdri LabuschagnePT.16 The Research Ethics Library: online resource for research ethics educationJohanne Severinsen, Espen EnghPT.17 Research integrity: the view from King Abdulaziz City for Science and TechnologyDaham Ismail AlaniPT. 18 Meeting global challenges in high-impact publications and research integrity: the case of the Malaysian Palm Oil BoardHJ. Kamaruzaman JusoffPT.19 University faculty perceptions of research practices and misconductAnita Gordon, Helen C. HartonPoster Session D: International perspectivesPT.21 The Commission for Scientific Integrity as a response to research fraudDieter De Bruyn, Stefanie Van der BurghtPT. 22 Are notions of the responsible conduct of research associated with compliance with requirements for research on humans in different disciplinary traditions in Brazil?Karina de Albuquerque Rocha, Sonia Maria Ramos de VasconcelosPT.23 Creating an environment that promotes research integrity: an institutional model of Malawi Liverpool Welcome TrustLimbanazo MatandikaPT.24 How do science policies in Brazil influence user-engaged ecological research?Aline Carolina de Oliveira Machado Prata, Mark William NeffPoster Session E: Perspectives on misconductPT.26 What “causes” scientific misconduct?: Testing major hypotheses by comparing corrected and retracted papersDaniele Fanelli, Rodrigo Costas, Vincent LarivièrePT.27 Perception of academic plagiarism among dentistry studentsDouglas Leonardo Gomes Filho, Diego Oliveira GuedesPT. 28 a few bad apples?: Prevalence, patterns and attitudes towards scientific misconduct among doctoral students at a German university hospitalVolker Bähr, Niklas Keller, Markus Feufel, Nikolas OffenhauserPT. 29 Analysis of retraction notices published by BioMed CentralMaria K. Kowalczuk, Elizabeth C. MoylanPT.31 "He did it" doesn't work: data security, incidents and partnersKatie SpeanburgPoster Session F: Views from the disciplinesPT.32 Robust procedures: a key to generating quality results in drug discoveryMalini Dasgupta, Mariusz Lubomirski, Tom Lavrijssen, David Malwitz, David Gallacher, Anja GillisPT.33 Health promotion: criteria for the design and the integrity of a research projectMaria Betânia de Freitas Marques, Laressa Lima Amâncio, Raphaela Dias Fernandes, Oliveira Patrocínio, and Cláudia Maria Correia Borges RechPT.34 Integrity of academic work from the perspective of students graduating in pharmacy: a brief research studyMaria Betânia de Freitas Marques, Cláudia Maria Correia Borges Rech, Adriana Nascimento SousaPT.35 Research integrity promotion in the Epidemiology and Health Services, the journal of the Brazilian Unified Health SystemLeila Posenato GarciaPT.36 When are clinical trials registered? An analysis of prospective versus retrospective registration of clinical trials published in the BioMed Central series, UKStephanie Harriman, Jigisha PatelPT.37 Maximizing welfare while promoting innovation in drug developmentFarida LadaOther posters that will be displayed but not presented orally:PT.38 Geoethics and the debate on research integrity in geosciencesGiuseppe Di Capua, Silvia PeppoloniPT.39 Introducing the Professionalism and Integrity in Research Program James M. DuBois, John Chibnall, Jillon Van der WallPT.40 Validation of the professional decision-making in research measureJames M. DuBois, John Chibnall, Jillon Van der Wall, Raymond TaitPT.41 General guidelines for research ethicsJacob HolenPT. 42 A national forum for research ethicsAdele Flakke Johannessen, Torunn EllefsenPT.43 Evaluation of integrity in coursework: an approach from the perspective of the higher education professorClaudia Rech, Adriana Sousa, Maria Betânia de Freitas MarquesPT.44 Principles of geoethics and research integrity applied to the European Multidisciplinary Seafloor and Water Column Observatory, a large-scale European environmental research infrastructureSilvia Peppoloni, Giuseppe Di Capua, Laura BeranzoliF1 Focus track on improving research systems: the role of fundersPaulo S.L. Beirão, Susan ZimmermanF2 Focus track on improving research systems: the role of countriesSabine Kleinert, Ana MarusicF3 Focus track on improving research systems: the role of institutionsMelissa S. Anderson, Lex Bouter. (shrink)

Adherence to good ethical practices is fundamental to psychologists as they navigate the multitude of ethical issues that arise in their daily professional activities. Foundational ethical principl...

Research ethics is a very exciting field at the moment. Important public debate is continuing at national and international levels, concerning the proposed revisions to the Declaration of Helsinki and the Council for the International Organisation of Medical Sciences (CIOMS) guidelines, the proposed European clinical trials directive and the recent Good Clinical Practice guidelines. There is also debate about obtaining, using and storing genetic, and tissue, samples. This ferment has resulted in a wealth of guidelines (...) and learned articles, but as yet there are few useful and up-to-date book-length discussions of the field. This is partly due to the increasing diversity of types of research (including research design), and the variety of the contexts of research (the hospital-based clinical trial is arguably no longer typical of medical research). However, it is also to do with what such a book is supposed to do. Recent works like Baruch Brody's Ethics of Biomedical Research (OUP, 1998) give, in effect, an …. (shrink)

This book shows that global population ageing is an opportunity to improve the quality of human life rather than a threat to economic competitiveness and stability. It describes the concept of the creative ageing policy as a mix of the silver economy, the creative economy, and the social and solidarity economy for older people. The second volume of Economic Foundations for Creative Ageing Policy focuses on the public policy and management concepts related to the use of the opportunities that are (...) created by population ageing. Klimczuk covers theoretical analyses and case study descriptions of good practices to suggest strategies that could be internationally popularized. Each chapter includes exercises and assignments for both students and those who are likely to apply the presented concepts in practice. Contents: Foreword by Richard Adler Foreword by Dominic Campbell Introduction 1 The Politics of Ageing and the Challenges of Ageing Populations 2 Understanding Public Policy on Ageing 3 Sociological and Gerontological Perspectives on Ageing, Creativity, and the Third Age 4 Diversity of Ageing Policy Concepts 5 The Emergence of the Creative Ageing Movement 6 Aims and Challenges of the Creative Ageing Policy 7 Principles, Governance, and Coproduction of the Creative Ageing Policy 8 Organizational Forms and Management for the Building of Creative Capital of Older People Conclusion Afterword by Andreas Hoff and Kurt Lüscher Afterword by Suchandrima Chakraborty Afterword by Jorge Felix. (shrink)

Industrialization laid the foundation for contemporary civilization but also begot environmental problems, which have been building up and remained unsolved to this day. There is widespread belief that, if industrial manufacturing lies at the root of environment degradation through endless spewing of residual waste, trade among nations is to blame for scattering residual waste the world over. Yet paradoxically, it is the very international trade that might be the ground for major remedies thereto. The 20th century witnessed the shift (...) from free trade to fair trade; it is about time to shift from fair trade to clean trade. Nevertheless, such serious problems had barely been dealt with until the post-World War II period. An awareness-raising effort in this line was made by the European Union which, since the early 1970s, has been dealing with environmental and social issues, especially the ones deriving from international trade, in a decisive and responsible manner. Still, EU’s new policy in the field of environment protection has a downside in that it affects trade relations with partners from outside the Union, both developing and developed countries, thereby drawing fierce international reaction. The good part is that EU’s actions will most likely prompt other nations to follow suit. (shrink)

Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on (...) work done since 1990 at the Institute of Medicine and focuses on five questions. First, what are guidelines, and who develops them? Second, what criteria or principles should be used to create good guidelines? Third, what problems or pitfalls exist in developing and disseminating guidelines? Fourth, in what ways can guidelines help improve medical care, and in what ways will they not be as practical or useful, particularly with respect to quality of care? Finally, what ethical context might guide deliberations on this topic? (shrink)

The goal of this article is to present a first list of ethical concerns that may arise from research and personal use of virtual reality (VR) and related technology, and to offer concrete recommendations for minimizing those risks. Many of the recommendations call for focused research initiatives. In the first part of the article, we discuss the relevant evidence from psychology that motivates our concerns. In Section “Plasticity in the Human Mind,” we cover some of the main results suggesting that (...) one’s environment can influence one’s psychological states, as well as recent work on inducing illusions of embodiment. Then, in Section “Illusions of Embodiment and Their Lasting Effect,” we go on to discuss recent evidence indicating that immersion in VR can have psychological effects that last after leaving the virtual environment. In the second part of the article, we turn to the risks and recommendations. We begin, in Section “The Research Ethics of VR,” with the research ethics of VR, covering six main topics: the limits of experimental environments, informed consent, clinical risks, dual-use, online research, and a general point about the limitations of a code of conduct for research. Then, in Section “Risks for Individuals and Society,” we turn to the risks of VR for the general public, covering four main topics: long-term immersion, neglect of the social and physical environment, risky content, and privacy. We offer concrete recommendations for each of these 10 topics, summarized in Table 1. (shrink)

Background: Ethics support services are growing in Europe to help doctors in dealing with ethical difficulties. Currently, insufficient attention has been focused on the experiences of doctors who have faced ethical difficulties in these countries to provide an evidence base for the development of these services.Methods: A survey instrument was adapted to explore the types of ethical dilemma faced by European doctors, how they ranked the difficulty of these dilemmas, their satisfaction with the resolution of a recent ethically difficult (...) case and the types of help they would consider useful. The questionnaire was translated and given to general internists in Norway, Switzerland, Italy and the UK.Results: Survey respondents ranged in age from 28 to 82 years, and averaged 25 years in practice. Only a minority reported having access to ethics consultation in individual cases. The ethical difficulties most often reported as being encountered were uncertain or impaired decision-making capacity , disagreement among caregivers and limitation of treatment at the end of life . The frequency of most ethical difficulties varied among countries, as did the type of issue considered most difficult. The types of help most often identified as potentially useful were professional reassurance about the decision being correct , someone capable of providing specific advice , help in weighing outcomes and clarification of the issues . Few of the types of help expected to be useful varied among countries.Conclusion: Cultural differences may indeed influence how doctors perceive ethical difficulties. The type of help needed, however, did not vary markedly. The general structure of ethics support services would not have to be radically altered to suit cultural variations among the surveyed countries. (shrink)

Background: Clinical education is an essential part of the Bachelor’s program in Nursing and a keystone of professional nursing education. Through clinical experiences, the student nurses acquire nursing knowledge and essential skills for professional practice. The preceptor plays a vital role in the development of student nurses becoming professional nurses. Aim: The aim of this Nordic qualitative study was to explore the experiences of good preceptorship in relation to undergraduate student nurses in clinical education from (...) the perspective of the preceptors themselves. Method: Data were collected by narrative interviews with 27 preceptors in Finland and Sweden and analyzed using a hermeneutical approach. Findings: A caring relationship, based on caring ethics, is seen as the foundation for learning and development. Moreover, a mutual respect is a prerequisite for fellowship and a good atmosphere. As such, encounters are characterized by reciprocity and mutuality. The preceptors have a deep sense of responsibility toward the students and the profession. Furthermore, the preceptors have an inner responsibility to guide the students into working life and to share their knowledge by acting as role models. Conclusion: The findings suggest that preceptorship should be examined through new lenses. Moreover, preceptorship is an ethical issue that should be recognized by all stakeholders. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Clinical Ethics: Balancing Praxis and TheoryEdmund D. Pellegrino (bio)When André Hellegers founded the Kennedy Institute, he envisioned a close collaboration between ethics and clinical practice. He even called for physician specialists whose expertise would be in both fields (Reich 1994, p. 324). A quarter of a century later, his vision and prediction have become realities. Clinical ethics is today a thriving entity with its own (...) literature, practitioners, and methodology.This clinical turn has, on the whole, been salutary. The abstractness of ethical theory has been tempered by the concreteness of clinical realities; clinicians have been helped to make bedside decisions even in the face of theoretical uncertainty and dissonance; and a variety of disciplines besides theology and philosophy have entered ethical discourse and enriched it.These advantages notwithstanding, clinical ethics has certain inherent traits that make it problematical. Some seek its norms in what “works” in practice or in paradigm cases (Jonsen and Toulmin 1988); others shape it to achieve consensus or satisfy the needs of public policy (Meilaender 1995); still others reduce bioethics to merely a method for the resolution of moral conflict. Rather than simply modulating theory by practice, clinical ethics can end up by repudiating theory entirely (Toulmin, in press). Taken to their logical conclusion, these tendencies make clinical ethics a species of the antifoundationalism that has strongly influenced moral philosophy in the last decade (Tollefsen 1995, pp. 3–18; Rockmore and Singer 1992). But antifoundationalism itself is a theory of ethics even though it supposedly denies the validity of any overarching theories.Antifoundationalism presents its own difficulties. For one thing it begs important questions that will not go away: for example, how do we know that a decision is a good one? what does it mean to say that a decision “works”? is the [End Page 347] outcome of a good decisional procedure itself a good decision? and to what extent are compromise and exigency admissible in moral decisions? Theoretical and “foundational” questions of this sort will not evaporate because they are ignored. They inevitably will be answered by begging the essential questions or grounding them solely in prelogical presuppositions.To avoid these difficulties, the advantages of clinical ethics must be retained without capitulation to the anti-theory bias of contemporary philosophy. This means that theory and practice must both be retained and be conceptually related to each other. To effect this we must take account of the long intellectual history of the relationship between the speculative and the practical intellect—i.e., between knowledge sought for its own sake and knowledge sought for some use beyond simply the possession of it (Lobkowicz 1967, pp. 78–81). Suffice it to say that medicine has long been the paradigm case for the union of theory and praxis. Relating them conceptually is an essential propaedeutic to any theory of moral praxis in medicine.The rest of this essay examines the inextricability of theory and practice in two of the three major branches of clinical ethics—the substantive and the professional. The third branch, procedural ethics—i.e., the ethics of the process of decision making—deals with informed consent, with respect for persons, professional colleagues, and families, and with the ethics of conflict resolution. Obviously, there are theoretical issues here as well. For want of space, procedural ethics will not be discussed, but it presents the same conjunction of theory and practice encountered in professional and substantive ethics.Substantive EthicsSubstantive ethics refers to the moral content rather than the process of moral decisions, to the moral status and permissibility of the specific clinical medical acts themselves—e.g., abortion, euthanasia, pre-implantation diagnosis, surrogate motherhood, withholding and withdrawing treatment, the physician as gatekeeper, and the like—the whole range of moral questions clinicians face in treating patients. Moral diversity and plurality on these issues is the most powerful force behind the dominance of procedural ethics. But, unfortunately, a morally valid decision-making procedure does not confer normative validity on the decision itself. Moral validity rests on questions that go beyond prevailing practices, on what we take to be the nature and moral status of persons, fetuses, and brain-damaged humans, the value or disvalue of... (shrink)

The Human Fertilization and Embryology Authority policy on permitting ova provision for research purposes breaches good regulatory practice in being inconsistent, unaccountable and untargeted. This article will illustrate how these breaches have resulted in a policy which is unfair to ova providers who wish to contribute to stem cell research and undermines the intentions behind the policy's very inception. (This article is based on a paper entitled Appropriate Recompense for Oocytes in Stem Cell Research presented at the Stem (...) Cells: Hope or Hype debate, North West Genetics Knowledge Park, Manchester in May 2007.). (shrink)

Ageing populations are a major consideration for socio-economic development in the early twenty first century. This demographic change is mainly seen as a threat rather than as an opportunity to improve the quality of human life, especially in Europe, where ageing has resulted in a reduction in economic competitiveness. Economic Foundations for Creative Ageing Policy mixes the silver economy, the creative economy, and the social economy to construct positive solutions for an ageing population. Klimczuk covers theoretical analyses and case study (...) descriptions of good practices to suggest strategies that could be internationally popularized. Contents: Foreword by Harry R. Moody Foreword by Kathrin Komp Introduction 1. Old Age as a Stage in the Life Course and the Life Cycle 2. Forms of Older People’s Capital 3. Creativity and Ageing: Concepts and Controversies 4. Mixed Economy and Multisectoral Approach to Population Ageing 5. Silver, Creative, and Social Economies as Positive Responses to Population Ageing 6. Benefits at the Interface Between Economic Systems Conclusion Afterword by Lukasz Tomczyk. (shrink)

In general, most, but not necessarily all, patients want truthfulness about their health. Available evidence indicates that truth-telling practices and preferences are, to an extent, a cultural artefact. It is the case that practices among nurses and doctors have moved towards more honest and truthful disclosure to their patients. It is interesting that arguments both for and against truth-telling are established in terms of autonomy and physical and psychological harm. In the literature reviewed here, there is also the view that (...) truth-telling is essential because it is an intrinsic good, while it is argued against on the grounds of the uncertainty principle. Based on this review, it is recommended that practitioners ought to ask patients and patients' families what informational requirements are preferred, and research should continue into truth-telling in clinical practice, particularly to discover its very nature as a cultural artefact, and the other conditions and contexts in which truth-telling may not be preferred. (shrink)

Background‘The Clinical Ethics Advisory Group’ (CEAG) is the clinical ethics support body for Newcastle upon Tyne Hospitals National Health Service Foundation Trust. A significant change in CEAG’s way of working occurred over the past 5 years as a result of Court decisions, increasing public expectations and an increase in CEAG’s paediatric case flow.PurposeReview historical data: (a) as a useful benchmark to look for the early impact of significant service changes and (b) to seek possible reference (‘sentinel’) cases (...) for use with a posited practical (casuistic) case-based reasoning model.MethodsAudit of the minutes of the first 22 years’ meetings was undertaken by the two chairs of CEAG over that period of time.Results223 matters discussed: 86 Trust policy issues; 117 clinical cases (84 adult (32 urgent), 33 child (8 urgent)); 12 CEAG procedural issues and 8 UK Clinical Ethics Network ‘round robin’ cases. The range of topic areas was wide. A broad range of ethical structures were deployed, principlism predominated. Quality was subjectively assessed by each reviewer, but different methods were used. This proved highly concordant between the two reviewers. 47% (105/223) of discussions were ‘excellent’ (*A4C4–A4C4) and 70% (156.5/223) ‘good’ or better (*A4C4–A3C3). By meeting the criteria of ‘excellent’ and ‘prospective’, 92/223 (41%) of matters were deemed potentially suitable as sentinel cases.ConclusionsThe audit provides a rich vein of information. There is demand for CEAG’s services, workload is becoming more complex. Formal funding for such services seems justified. (shrink)

The biopsychosocial model is characterized by the systematic consideration of biological, psychological, and social factors and their complex interactions in understanding health, illness, and health care delivery. This model opposes the biomedical model, which is the foundation of most current clinical practice. In the biomedical model, quest for evidence based medicine, the patient is reduced to molecules, genes, organelles, systems, diseases, etc. This reduction has brought great advances in medicine, but it lacks a holistic view of the (...) person. To solve the problem, we propose an early team based approach where the primary care physician leads a group of people that can help her/him address the psychosocial issues while she/he attends to the biomedical issues. This article addresses one case where the clinical ethicist facilitating a team based biopsychosocial model for the care of a patient worked as a bridge between the primary team, the critical care team, and the psychosocial team to advance the argument that good communication among the groups can lead to a true biopsychosocial model where the collaboration of the social worker, psychologist, chaplain, ethicist and the different medical teams can improve the overall patient experience. (shrink)

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals (...) who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only.. Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject’s life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject’s participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject’s consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject’s autonomy and rights it is necessary to add to them two other conditions: the emergency research could not be conducted using other research participants capable of giving informed consent; and informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible. A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible. (shrink)

This book is an anthology with the following themes. Non-European Tradition: Bussanich interprets main themes of Hindu ethics, including its roots in ritual sacrifice, its relationship to religious duty, society, individual human well-being, and psychic liberation. To best assess the truth of Hindu ethics, he argues for dialogue with premodern Western thought. Pfister takes up the question of human nature as a case study in Chinese ethics. Is our nature inherently good (as Mengzi argued) or bad (Xunzi’s view)? (...) Pfister ob- serves their underlying agreement, that human beings are capable of becoming good, and makes precise the disagreement: whether we achieve goodness by cultivating autonomous feelings or by accepting external precepts. There are political consequences: whether government should aim to respect and em- power individual choices or to be a controlling authority. Early Greek Thinking: Collobert examines the bases of Homeric ethics in fame, prudence, and shame, and how these guide the deliberations of heroes. She observes how, by depending upon the poet’s words, the hero gains a quasi- immortality, although in truth there is no consolation for each person’s inevi- table death. Plato: Santas examines Socratic Method and ethics in Republic 1. There Socrates examines definitions of justice and tests them by comparison to the arts and sciences. Santas shows the similarities of Socrates’ method to John Rawls’ method of considered judgments in reflective equilibrium. McPherran interprets Plato’s religious dimension as like that of his teacher Socrates. McPherran shows how Plato appropriates, reshapes, and extends the religious conventions of his own time in the service of establishing the new enterprise of philosophy. Ac- cording to Taylor, Socrates believes that humans in general have the task of helping the gods by making their own souls as good as possible, and Socrates’ unique ability to cross-examine imposes on him the special task of helping others to become as good as possible. This conception of Socrates’ mission is Plato’s own, consisting in an extension of the traditional conception of piety as helping the gods. Brickhouse and Smith propose a new understanding of Socratic moral psychology—one that retains the standard view of Socrates as an intellectualist, but also recognizes roles in human agency for appetites and passions. They compare and contrast the Socratic view to the picture of moral psychology we get in other dialogues of Plato. Hardy also proposes a new, non-reductive understanding of Socratic eudaimonism—he argues that Socrates invokes a very rich and complex notion of the “Knowledge of the Good and Bad”, which is associated with the motivating forces of the virtues. Rudebusch defends Socrates’ argument that knowledge can never be impotent in the face of psychic passions. He considers the standard objections: that knowledge cannot weigh incom- mensurable human values, and that brute desire, all by itself, is capable of moving the soul to action. Aristotle: Anagnostopoulos interprets Aristotle on the nature and acquisition of virtue. Though virtue of character, aiming at human happiness, requires a complex awareness of multiple dimensions of one’s experience, it is not properly a cognitive capacity. Thus it requires habituation, not education, according to Aristotle, in order to align the unruly elements of the soul with reason’s knowledge of what promotes happiness. Shields explains Aristotle’s doctrine that goodness is meant in many ways as the doctrine that there are different analyses of goodness for different types of circumstance, just as for being. He finds Aristotle to argue for this conclusion, against Plato’s doctrine of the unity of the Good, by applying the tests for homonymy and as an immediate cons- equence of the doctrine of categories. Shields evaluates the issue as unresolved at present. Russell discusses Aristotle’s account of practical deliberation and its virtue, intelligence (phronesis). He relates the account to contemporary philo- sophical controversies surrounding Aristotle’s view that intelligence is neces- sary for moral virtue, including the objections that in some cases it is unnecessary or even impedes human goodness. Frede examines the advantages and disadvantages of Aristotle’s virtue ethics. She explains the general Greek con- ceptions of happiness and virtue, Aristotle’s conception of phronesis and compares the Aristotle’s ethics with modern accounts. Liske discusses the question of whether the Aristotelian account of virtue entails an ethical-psy- chological determinism. He argues that Aristotle’s understanding of hexis allows for free action and ethical responsibility : By making decisions for good actions we are able to stabilize our character (hexis). Hellenistic and Roman: Annas defends an account of stoic ethics, according to which the three parts of Stoicism—logic, physics, and ethics—are integrated as the parts of an egg, not as the parts of a building. Since by this analogy no one part is a foundation for the rest, pedagogical decisions may govern the choice of numerous, equally valid, presentations of Stoic ethics. Piering interprets the Cynic way of life as a distinctive philosophy. In their ethics, Cynics value neither pleasure nor tradition but personal liberty, which they achieve by self-suffi- ciency and display in speech that is frank to the point of insult. Plotinus and Neoplatonism: Gerson outlines the place of ordinary civic virtue as well as philosophically contemplative excellence in Neoplatonism. In doing so he attempts to show how one and the same good can be both action-guiding in human life and be the absolute simple One that grounds the explanation of everything in the universe. Delcomminette follows Plotinus’s path to the Good as the foundation of free will, first in the freedom of Intellect and then in the “more than freedom” of the One. Plotinus postulates these divinities as not outside but within each self, saving him from the contradiction of an external foundation for a truly free will. General Topics: Halbig discusses the thesis on the unity of virtues. He dis- tinguishes the thesis of the identity of virtues and the thesis of a reciprocity of virtues and argues that the various virtues form a unity (in terms of reciprocity) since virtues cannot bring about any bad action. Detel examines Plato’s and Aristotle’s conceptions of normativity : Plato and Aristotle (i) entertained hybrid theories of normativity by distinguishing functional, semantic and ethical normativity, (ii) located the ultimate source of normativity in standards of a good life, and thus (iii) took semantic normativity to be a derived form of normativity. Detel argues that hybrid theories of normativity are—from a mo- dern point of view—still promising. Ho ̈ffe defends the Ancient conception of an art of living against Modern objections. Whereas many Modern philosophers think that we have to replace Ancient eudaimonism by the idea of moral obligation (Pflicht), Ho ̈ffe argues that Eudaimonism and autonomy-based ethics can be reconciled and integrated into a comprehensive and promising theory of a good life, if we enrich the idea of autonomy by the central elements of Ancient eudaimonism. Some common themes: The topics in Chinese and Hindu ethics are perhaps more familiar to modern western sensibilities than Homeric and even Socratic. Anagnostopoulos, Brickhouse and Smith, Frede, Liske, Rudebusch, and Russell all consider in contrasting ways the role of moral character, apart from intellect, in ethics. Brickhouse / Smith, Hardy, and Rudebusch discuss the Socratic con- ception of moral knowledge. Brickhouse / Smith and Hardy retain the standard view of the so called Socratic Intellectualism. Shields and Gerson both consider the question whether there is a single genus of goodness, or if the term is a homonym. Bussanich, McPherran, Taylor, and Delcomminette all consider the relation between religion and ethics. Pfister, Piering, Delcomminette, and Liske all consider what sort of freedom is appropriate to human well-being. Halbig, Detel, and Ho ̈ffe propose interpretations of main themes of Ancient ethics. (shrink)

This paper raises questions about the epistemological foundations of evidence-based medicine . We argue that EBM is based upon reliabilist epistemological assumptions, and that this is appropriate - we should focus on identifying the most reliable processes for generating and collecting medical knowledge. However, we note that this should not be reduced to narrow questions about which research methodologies are the best for gathering evidence. Reliable processes for generating medical evidence might lie outside of formal research methods. We also question (...) the notion of the knower that is assumed by EBM. We argue that EBM assumes an enlightenment conception of knowers as autonomous, substitutable individuals. This conception is troubled by the way that clinicians learn the role of anecdote in health care and the role of patient choice, all of which bring into play features of clinicians and patients as situated individuals with particular backgrounds and experiences. EBM's enlightenment conception of the knower is also troubled by aspects of the way evidence is produced. Given these limitations, we argue that EBM should retain its reliabilist bent, but should look beyond formal research methodologies in identifying processes that yield reliable evidence for clinical practice. We suggest looking to feminist epistemology, with its focus on the standpoints of individual situated knowers, and the role of social context in determining what counts as knowledge. (shrink)

Critical thinking is a complex, dynamic process formed by attitudes and strategic skills, with the aim of achieving a specific goal or objective. The attitudes, including the critical thinking attitudes, constitute an important part of the idea of good care, of the good professional. It could be said that they become a virtue of the nursing profession. In this context, the ethics of virtue is a theoretical framework that becomes essential for analyse the critical thinking concept in nursing (...) care and nursing science. Because the ethics of virtue consider how cultivating virtues are necessary to understand and justify the decisions and guide the actions. Based on selective analysis of the descriptive and empirical literature that addresses conceptual review of critical thinking, we conducted an analysis of this topic in the settings of clinical practice, training and research from the virtue ethical framework. Following JBI critical appraisal checklist for text and opinion papers, we argue the need for critical thinking as an essential element for true excellence in care and that it should be encouraged among professionals. The importance of developing critical thinking skills in education is well substantiated; however, greater efforts are required to implement educational strategies directed at developing critical thinking in students and professionals undergoing training, along with measures that demonstrate their success. Lastly, we show that critical thinking constitutes a fundamental component in the research process, and can improve research competencies in nursing. We conclude that future research and actions must go further in the search for new evidence and open new horizons, to ensure a positive effect on clinical practice, patient health, student education and the growth of nursing science. (shrink)

Local review of research by ethics committees in the UK has long been held to be an important right of the local research ethics committee and, even with the introduction of the European Clinical Trials Directive, the governance arrangements for research ethics committees continue to allow for local review of multicentre studies. There is no requirement for local review in either the European Union directive or in the guidelines on good clinical practice, and there (...) is little evidence of it anywhere else in Europe. The idea that there can be “local”, as opposed to “central” ethical issues in research is an interesting one, which raises important issues about the nature of research ethics and ethical review. The aim of this paper is to argue that there are no such things as local issues in research ethics, and suggest that those questions currently addressed as local issues properly belong within the research governance framework. (shrink)

While the story of Stanislav Petrov – the Soviet Lieutenant Colonel who likely saved the world from nuclear holocaust in 1983 – is often trotted out to advocate for the view that human beings ought to be kept “in the loop” of automated weapons’ responses, I argue that the episode in fact belies this reading. By attending more closely to the features of this event – to Petrov’s professional background, to his familiarity with the warning system, and to his decisions (...) to defy his protocol – it becomes clear that Petrov was not seamlessly working “in his loop,” but reassessing it entirely. I claim that this exhibits a paradox intrinsic to all automated loops: namely, that their optimum function in fact rests on unforeseen human interventions that cannot be reliably codified ex ante, that is, that good judgment cannot simply be “programmed into” their protocols. This dependence, moreover, reveals automation’s ineluctable need for virtue ethics – not in the usual sense (whereby ethics deliberates about, say, possible damages and loss of life), but in the sense that ethical judgment, rightly understood, entails the reassessment of all of the conditions surrounding a decision, including whether a protocol should be followed at all. (shrink)

Hans Blumenberg is celebrated for demonstrating that metaphors have had a more foundational influence than concepts on European intellectual history. Many acknowledge that his insights might have achieved even greater impact if he had articulated a more explicit theory of metaphor. In 1960 Blumenberg discusses the historical formation of metaphors that have given rise to meaningful discourses on metaphysical abstractions, like God, existence, or Being, but he does not develop a general model of metaphoric language, and his work rarely (...) engages with other contemporary theories of metaphor. During Blumenberg’s lifetime, French and German postwar philosophers rarely cited one another. Yet French hermeneutics, and the work of philosopher Paul Ricoeur in particular, may have strongly influenced Blumenberg’s research group, Poetik und Hermeneutik. This paper is an attempt to recuperate intellectual affinities between Blumenberg and Ricoeur, in order to demonstrate that Ricoeur’s claims about metaphor provide the theoretical background for a fuller appreciation of Blumenberg’s metaphor analyses. (shrink)

Medical school curricula and postgraduate education programmes expend considerable resources teaching medical ethics. Simultaneously, whistleblowers’ agitation continues, at great personal cost, to prompt major intrainstitutional and public inquiries that reveal problems with the application of medical ethics at particular clinical “coalfaces”.Virtue ethics, emphasising techniques promoting an agent’s character and instructing their conscience, has become a significant mode of discourse in modern medical ethics. Healthcare whistleblowers, whose complaints are reasonable, made in good faith, in the public interest, and not (...) vexatious, we argue, are practising those obligations of professional conscience foundational to virtue based medical ethics. Yet, little extant virtue ethics scholarship seriously considers the theoretical foundations of healthcare whistleblowing.The authors examine whether healthcare whistleblowing should be considered central to any medical ethics emphasising professional virtues and conscience. They consider possible causes for the paucity of professional or academic interest in this area and examine the counterinfluence of a continuing historical tradition of guild mentality professionalism that routinely places relationships with colleagues ahead of patient safety.Finally, it is proposed that a virtue based ethos of medical professionalism, exhibiting transparency and sincerity with regard to achieving uniform quality and safety of health care, may be facilitated by introducing a technological imperative using portable computing devices. Their use by trainees, focused on ethical competence, provides the practical face of virtue ethics in medical education and practice. Indeed, it assists in transforming the professional conscience of whistleblowing into a practical, virtue based culture of self reporting and personal development. (shrink)

The multitude of training models and curricula for the specialty of clinical neuropsychology around the world has led to organized activities to develop a framework of core competencies to ensure sufficient expertise among entry-level professionals in the field. The Standing Committee on Clinical Neuropsychology of the European Federation of Psychologists’ Associations is currently working toward developing a specialty certification in clinical neuropsychology to establish a cross-national standard against which to measure levels of equivalency and uniformity in (...) competence and service provision among professionals in the field. Through structured interviews with experts from 28 European countries, we explored potential areas of core competency. Specifically, questions pertained to the perceived importance of a series of foundational, functional, and other competencies, as well as current training standards and practices, and optimal standards. Our findings revealed considerable agreement on academic and clinical training, despite varied actual training requirements currently, with fewer respondents relegating importance to training in teaching, supervision, and research, and even fewer to skills related to management, administration, and advocacy. European expert clinical neuropsychologists were in agreement with previous studies regarding the importance of sound theoretical and clinical training but management, administrative, and advocacy skills were not central to their perspective of a competent specialist in clinical neuropsychology. Establishing a specialty certificate in clinical neuropsychology based on core competencies may enable mobility of clinical neuropsychologists across Europe, and, perhaps, provide an impetus for countries with limited criteria to reconsider their training requirements and harmonize their standards with others. (shrink)

It has become fashionable to question attempts to derive internationally agreed duties of clinical care from more general theories of human rights. For example, some argue that such attempts risk moral abstraction through their neglect for the importance of culture and community in shaping moral consciousness and are thus often unhelpful in the resolution of concrete moral dilemmas within medicine. Others denounce the importance of general moral principles altogether in bioethics and attempt to articulate what are claimed to be (...) more practical approaches to resolving moral conflict. This paper challenges such arguments. It does so through arguing that: i) all humans everywhere have the same basic human needs; ii) the satisfaction of these needs varies with culture; iii) the imputation of moral duties on others entails respect for their right to basic need satisfaction, including the right to choose between cultures; iv) internationally accepted clinical duties of care embrace presumptions about the duties and rights of patients which follow from these more general principles and v) problems of moral indeterminacy that arise from putting these principles into practice can be resolved through associated procedural policies of rational negotiation and compromise. The moral importance and practicality of respect for individual human rights within the practice of medicine is thus defended. Indeed, the paper concludes by arguing that without belief in human rights linked to a theory of basic human needs, communitarian theories of morality are incoherent. (shrink)

EurepGAP is a pioneering field level food safety protocol called ‘good agricultural practices’ currently exercising influence over the global food quality assurance system. Developed by a consortium of major European retailers, this private standard enforces codes of conduct that address issues of health and safety for producers and consumers, as well as working conditions and environmental management on the farmland. Despite various merits and benefits that the standard is premised to offer, the institutional design gives a financial edge (...) to powerful large farms and exporters while diminishing opportunities for smaller growers and exporters to remain in the profitable agricultural export sector of the Global South. This paper explores the institutional origin and evolution of EurepGAP, discusses entry barriers and risks that EurepGAP imposes on the global value chain stakeholders, as well as the ethical implications from broader theoretical perspectives. Subsequently, it examines the evolving nature of a new trend in the fresh fruit and vegetable sector, i.e., the rise of public GAP standards. Promoted by some governments in the Global South, these GAP standards emphasize support for horizontal partnerships among value chain stakeholders, farmer participation, and less capital-intensive agricultural innovations. The paper argues that, within certain limitations, these GAP standards have the potential to be the major alternative GAP approach by encouraging a much broader inclusion of small-scale producers towards the attainment of various social, economic, and environmental benefits. (shrink)

The prevalence and negative impact of brain disorders are increasing. Clinical Neuropsychology is a specialty dedicated to understanding brain-behavior relationships, applying such knowledge to the assessment of cognitive, affective, and behavioral functioning associated with brain disorders, and designing and implementing effective treatments. The need for services goes beyond neurological diseases and has increased in areas of neurodevelopmental and psychiatric conditions, among others. In Europe, a great deal of variability exists in the education and training of Clinical Neuropsychologists. Training (...) models include master’s programs, continuing education courses, doctoral programs, and/or post-doctoral specialization depending on the country, with no common framework of requirements, although patients’ needs demand equal competencies across Europe. In the past five years, the Standing Committee on Clinical Neuropsychology of the European Federation of Psychologists’ Association has conducted a series of surveys and interviews with experts in the field representing 30 European countries. The information, along with information from the existing literature, is used in presenting an overview of current and relevant topics related to policy and guidelines in the training and competencies in Clinical Neuropsychology. An option for the way forward is the EuroPsy Specialist Certificate which is currently offered in Work- and Organizational psychology and Psychotherapy. It builds upon the Basic Certificate and complements national standards without overriding them. General principles can be found that can set the basis for a common, solid, and comprehensive specialty education/training, sharpening the Neuropsychologists’ competencies across Europe. The requirements in Clinical Neuropsychology should be comparable to those for the existing specialty areas in the EuroPsy model. Despite the perceived challenges, developing a Specialist Certificate appears a step forward for the development of Clinical Neuropsychology. Recommendations are proposed towards a shared framework of competencies by the means of a common level of education/training for the professionals in Europe. Benchmarking training standards and competencies across Europe has the potential of providing protection against unqualified and ethically questionable practice, creating transparency, raising the general European standard, and promoting mobility of both Clinical Neuropsychologists and patients in Europe, for the benefit of the professional field and the population. (shrink)

Bioethics has begun to see the revaluation of affects in medical practice, but not all of them, and not necessarily in the sense of affects as we know them. Empathy has been accepted as important for good medical practice, but only in a way that strips it of its affectivity and thus prevents other affects, like sympathy, from being accepted. As part of a larger project that aims at revaluing the importance of affectivity in medical practice, (...) the purpose of this paper is to develop a clinical sympathy that can serve as a trainable skill for medical professionals. While everyday sympathy may be problematic as a professional skill for physicians, this does not imply that sympathy should be entirely rejected. As a natural part of our moral psychology, sympathy is an intersubjective affect that aids in our interactions with others and our decision-making abilities. I present here a theory of clinical sympathy as an affective response to patients, in which physicians are both attuned to their affective response and understand how their affects are influencing their beliefs and judgments. In this way, clinical sympathy serves as a trainable skill that can aid physicians in their interactions with their patients. (shrink)

Background There is little evidence of junior trainee perspectives in the design and implementation of medical ethics and law curriculum in UK medical schools.Aim To determine the ethical issues the foundation year 1 doctors encountered during clinical practice and the skills and knowledge of MEL, which were useful in informing MEL curriculum development.Method The National Research Ethics Service gave ethical approval. Eighteen one-to-one interviews were conducted in each school with FY1 doctors.Analysis Interviews were recorded and transcribed verbatim; (...) a thematic analysis was undertaken with the transcriptions and saturation of themes was achieved.Key findings Themes closely overlapped between the two study sites. Knowing my place as an FY1 ; Do not attempt resuscitation)/end-of-life pathway and its implications; ‘You have to be there’ ; and advanced interpersonal skills competency for ethical clinical practice.Conclusions The data provide a snapshot of the real challenges faced by MEL FY1 doctors in early clinical practice: they may feel ill-prepared and sometimes unsupported by senior members of the team. The key themes suggest areas for development of undergraduate and postgraduate MEL curricula. We will work to develop our own curriculum accordingly. We intend to further investigate the applicability of our findings to UK medical ethics and law curriculum. (shrink)

Good academic practice is more than the avoidance of clear-cut cheating. It also involves navigation of the gray zones between cheating and good practice. The existing literature has left students’ understanding of gray zone practices largely unexplored. To begin filling in this gap, we present results from a questionnaire study involving N = 1639 undergraduate students from seven European countries representing all major disciplines. We show that large numbers of these students are unable to identify (...) gray area issues and lack sensitivity to the context dependence of these. We also show that a considerable proportion of students have a poor understanding of concepts like plagiarism and falsification, not only in gray zone scenarios, but also in cases of relatively clear-cut cheating. Our results are similar across the faculties and countries of study, and even for students who have attended academic integrity training. We discuss the implications of this for academic integrity training. (shrink)

The aim of Language for those who have Nothing is to think psychiatry through the writings of Mikhail Bakhtin. Using the concepts of Dialogism and Polyphony, the Carnival and the Chronotope, a novel means of navigating the clinical landscape is developed. Bakhtin offers language as a social phenomenon and one that is fully embodied. Utterances are shown to be alive and enfleshed and their meanings realised in the context of given social dimensions. The organisation of this book corresponds with (...) carnival practices of taking the high down to the low before replenishing its meaning anew. Thus early discussions of official language and the chronotope become exposed to descending levels of analysis and emphasis. Patients and practitioners are shown to occupy an entirely different spatio-temporal topography. These chronotopes have powerful borders and it is necessary to use the Carnival powers of cunning and deception in order to enter and to leave them. The book provides an overview of practitioners who have attempted such transgression and the author records his own unnerving experience as a pseudopatient. By exploring the context of psychiatry's unofficial voices: its terminology, jokes, parodies, and everyday narratives, the clinical landscape is shown to rely heavily on unofficial dialogues in order to safeguard an official identity. (shrink)