In this paper we assume that ‘theory’ is important for Clinical Ethics Support Services (CESS). We will argue that the underlying implicit theory should be reflected. Moreover, we suggest that the theoretical components on which any clinical ethics support (CES) relies should be explicitly articulated in order to enhance the quality of CES.A theoretical framework appropriate for CES will be necessarily complex and should include ethical (both descriptive and normative), metaethical and (...) organizational components. The various forms of CES that exist in North-America and in Europe show their underlying theory more or less explicitly, with most of them referring to some kind of theoretical components including ‘how-to’ questions (methodology), organizational issues (implementation), problem analysis (phenomenology or typology of problems), and related ethical issues such as end-of-life decisions (major ethical topics).In order to illustrate and explain the theoretical framework that we are suggesting for our own CES project METAP, we will outline this project which has been established in a multi-centre context in several healthcare institutions. We conceptualize three ‘pillars’ as the major components of our theoretical framework: (1) evidence, (2) competence, and (3) discourse. As a whole, the framework is aimed at developing a foundation of our CES project METAP.We conclude that this specific integration of theoretical components is a promising model for the fruitful further development of CES. (shrink)

In this paper we assume that ‘theory’ is important for Clinical Ethics Support Services (CESS). We will argue that the underlying implicit theory should be reflected. Moreover, we suggest that the theoretical components on which any clinical ethics support (CES) relies should be explicitly articulated in order to enhance the quality of CES.A theoretical framework appropriate for CES will be necessarily complex and should include ethical (both descriptive and normative), metaethical and (...) organizational components. The various forms of CES that exist in North‐America and in Europe show their underlying theory more or less explicitly, with most of them referring to some kind of theoretical components including ‘how‐to’ questions (methodology), organizational issues (implementation), problem analysis (phenomenology or typology of problems), and related ethical issues such as end‐of‐life decisions (major ethical topics).In order to illustrate and explain the theoretical framework that we are suggesting for our own CES project METAP, we will outline this project which has been established in a multi‐centre context in several healthcare institutions. We conceptualize three ‘pillars’ as the major components of our theoretical framework: (1) evidence, (2) competence, and (3) discourse. As a whole, the framework is aimed at developing a foundation of our CES project METAP.We conclude that this specific integration of theoretical components is a promising model for the fruitful further development of CES. (shrink)

Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...

In today’s pluralistic society, clinical ethics consultation cannot count on a pre-given set of rules and principles to be applied to a specific situation, because such an approach would deny the existence of different and divergent backgrounds by imposing a dogmatic and transcultural morality. Clinical ethics support (CES) needs to overcome this lack of foundations and conjugate the respect for the difference at stake with the necessity to find shared and workable solutions for ethical issues (...) encountered in clinical practice. We argue that a pragmatist approach to CES, based on the philosophical theories of William James, John Dewey, and Charles Sanders Peirce, can help to achieve the goal of reaching practical solutions for moral problems in the context of today’s clinical environment, characterized by ethical pluralism. In this article, we outline a pragmatist theoretical framework for CES. Furthermore, we will show that moral case deliberation, making use of the dilemma method, can be regarded an example of a pragmatist approach to CES. (shrink)

Evaluating the impact of clinical ethics support services remains a challenging task. 1 Against this background, we applaud the authors for developing a theoretical framework that aims to explain how repeated moral case deliberations may promote ‘practical wisdom’ in healthcare professionals and improve the quality of care in health facilities. 2 In our view, it is of particular value to draw attention to the learning processes that may be induced by ethics support services. (...) Understanding such learning processes on the individual and organisational level is a prerequisite for longitudinal research designs that may be suitable to study the impact of specific ethics support services on criteria deemed relevant in patient care. 3 In our comment, we would like to focus on one aspect, which we deem necessary to be able to explain the possible impact of ethics support on the quality of healthcare. This is the... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause (...) the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

Objective: The field of clinical ethics is relatively new and expanding. Best practices in clinical ethics against which one can benchmark performance have not been clearly articulated. The first step in developing benchmarks of clinical ethics services is to identify and understand current practices.Design and setting: Using a retrospective case study approach, the structure, activities, and resources of nine clinical ethics services in a large metropolitan centre are described, compared, and contrasted.Results: The (...) data yielded a unique and detailed account of the nature and scope of clinical ethics services across a spectrum of facilities. General themes emerged in four areas—variability, visibility, accountability, and complexity. There was a high degree of variability in the structures, activities, and resources across the clinical ethics services. Increasing visibility was identified as a significant challenge within organisations and externally. Although each service had a formal system for maintaining accountability and measuring performance, differences in the type, frequency, and content of reporting impacted service delivery. One of the most salient findings was the complexity inherent in the provision of clinical ethics services, which requires of clinical ethicists a broad and varied skill set and knowledge base. Benchmarks including the average number of consults/ethicist per year and the hospital beds/ethicist ratio are presented.Conclusion: The findings will be of interest to clinical ethicists locally, nationally, and internationally as they provide a preliminary framework from which further benchmarking measures and best practices in clinical ethics can be identified, developed, and evaluated. (shrink)

Most donated organs in the United States come from brain dead donors, while a small percentage come from patients who die in “controlled,” or expected, circumstances, typically after the family or surrogate makes a decision to withdraw life support. The number of organs available for transplant could be substantially if donations were permitted in “uncontrolled” circumstances–that is, from people who die unexpectedly, often outside the hospital. According to projections from the Institute of Medicine, establishing programs permitting “uncontrolled donation after (...) circulatory determination of death,” or uDCDD, throughout the United States has the potential to provide 22,000 more donation opportunities annually. In contrast, U.S. controlled donation after circulatory determination of death, or cDCDD, cases have increased progressively over the past decade from 87 to 848 donors, but currently account for only 10.6 percent of all deceased donors. Following the IOM recommendations, several projects exploring the feasibility of uDCDD were funded by the federal government, including a grant from the Health Resources and Services Administration that supported a pilot project in New York City in which the authors of this article participated.A key feature of our protocol, and indeed of many uDCDD protocols, is the initiation of preservation methods such as chest compressions and extracorporeal membrane oxygenation shortly after death in order to perfuse and preserve the donor's organs. Critics of uDCDD argue that the means of determining death deviates from generally ascribed principles. They assert that reinstituting circulation in order to preserve organs has the effect of “undoing” the prior determination of death. The result is that cDCDD is widely accepted and practiced routinely even though it only marginally increases the number of organs available for transplantation, and uDCDD is widely considered unacceptable despite being ethically embraced and proven to significantly increase organ donation opportunities in other countries. This article explores the evolution of this counterintuitive state of affairs and calls for a policy that, in line with the IOM report, allows for both cDCDD and uDCDD protocols. (shrink)

Clinical ethics support, in particular Moral Case Deliberation, aims to support health care providers to manage ethically difficult situations. However, there is a lack of evaluation instruments regarding outcomes of clinical ethics support in general and regarding Moral Case Deliberation (MCD) in particular. There also is a lack of clarity and consensuses regarding which MCD outcomes are beneficial. In addition, MCD outcomes might be context-sensitive. Against this background, there is a need for a (...) standardised but flexible outcome evaluation instrument. The aim of this study was to develop a multi-contextual evaluation instrument measuring health care providers’ experiences and perceived importance of outcomes of Moral Case Deliberation. (shrink)

In this chapter, we explore the question of on what grounds reports of clinical ethics support in general, including especially clinical ethics consultation, can or should be evaluated when using a peer review system. It is our contention that to evaluate clinical ethics consultation within a peer review system aiming at transparency and fairness, a defined and shared criteria of evaluation, i.e. an evaluation standard is required. When evaluating a performed ethics consultation, (...) we can roughly distinguish between an internal standard, which refers to the conceptualization of clinical ethics consultation held by the respective consultant or by the assessed clinical ethics support service themselves, and external standards. Most important is the way how an external standard is being defined: Is it just the standard of another service or colleague? Or is it the result of a larger consensus-building process of a relevant body representing a larger group of colleagues, such as the ASBH? Or does it even rely on the “evidence” of related research? An external standard, however, may rest on criteria that are not – or not fully – accepted by the evaluated CESS or individual ethics consultant. Identifying the internal standard of an observed ethics consultant’s work may also be challenging. From the evaluator’s perspective the responsibility for making an internal standard known and unequivocal lies with the “author” of the material. The potential gap between internal and external standards marks a methodological difficulty that as such has to be addressed within peer review evaluation. (shrink)

A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results (...) show that (a) participants felt that they gained an increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded ‘grey zone articles’, in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients’ and caregivers’ views on ethical challenges, is presented. (shrink)

There is a claim that clinical ethics support services (CESS) improve healthcare quality within healthcare organisations. However, there is lack of strong evidence supporting this claim. Rather, the current focus is on the quality of CESS themselves or on individual learning outcomes. In response, this article proposes a theoretical framework leading to empirical hypotheses that describe the relationship between a specific type of CESS, moral case deliberation and the quality of care at the organisational level. (...) We combine insights from the literature on CESS, organisational learning and quality improvement and argue that moral case deliberation causes healthcare professionals to acquire practical wisdom. At the organisational level, where improving quality is a continuous and collective endeavour, this practical wisdom can be aggregated into morisprudence, which is an ongoing formulation of moral judgements across cases encountered within the organisation. Focusing on the development of morisprudence enables refined scrutinisation of CESS-related quality claims. (shrink)

Evaluating clinical ethics support services has been hailed as important research task. At the same time, there is considerable debate about how to evaluate CESS appropriately. The criticism, which has been aired, refers to normative as well as empirical aspects of evaluating CESS. In this paper, we argue that a first necessary step for progress is to better understand the intervention in CESS. Tools of complex intervention research methodology may provide relevant means in this respect. In a (...) first step, we introduce principles of “complex intervention research” and show how CESS fulfil the criteria of “complex interventions”. In a second step, we develop a generic “conceptual framework” for “ethics consultation on request” as standard for many forms of ethics consultation in clinical ethics practice. We apply this conceptual framework to the model of “bioethics mediation” to make explicit the specific structural and procedural elements of this form of ethics consultation on request. In a final step we conduct a comparative analysis of two different types of CESS, which have been subject to evaluation research: “proactive ethics consultation” and “moral case deliberation” and discuss implications for evaluating both types of CESS. To make explicit different premises of implemented CESS interventions by means of conceptual frameworks can inform the search for sound empirical evaluation of CESS. In addition, such work provides a starting point for further reflection about what it means to offer “good” CESS. (shrink)

In this paper we introduce narrative and hermeneutical perspectives to clinical ethics support services (CESS). We propose a threefold consideration of ‘theory’ and show how it is interwoven with ‘practice’ as we go along. First, we look at theory in its foundational role: in our case ‘narrative ethics’ and ‘philosophical hermeneutics’ provide a theoretical base for clinical ethics by focusing on human identities entangled in stories and on moral understanding as a dialogical process. (...) Second, we consider the role of theoretical notions in helping practitioners to understand their situation in clinical ethics practice, by using notions like ‘story’, ‘responsibility’, or ‘vulnerability’ to make explicit and explain their practical experience. Such theoretical notions help us to interpret clinical situations from an ethical perspective and to foster moral awareness of practitioners. And, thirdly, we examine how new theoretical concepts are developed by interpreting practice, using practice to form and improve our ethical theory. In this paper, we discuss this threefold use of theory in clinical ethics support services by reflecting on our own theoretical assumptions, methodological steps and practical experiences as ethicists, and by providing examples from our daily work. In doing so, we illustrate that theory and practice are interwoven, as theoretical understanding is dependent upon practical experience, and vice-versa. (shrink)

The prospect of using genome technologies to modify the human germline has raised profound moral disagreement but also emphasizes the need for wide-ranging discussion and a well-informed policy response. The Hinxton Group brought together scientists, ethicists, policymakers, and journal editors for an international, interdisciplinary meeting on this subject. This consensus statement formulated by the group calls for support of genome editing research and the development of a scientific roadmap for safety and efficacy; recognizes the ethical challenges involved in (...) class='Hi'>clinical reproductive applications of genome editing but, importantly, rejects the idea that human reproductive germline modification is necessarily morally unacceptable; and highlights the importance of meaningful engagement in discussions of genome editing and the development of regulation and oversight mechanisms to govern future uses of such technologies. (shrink)

Objectives During the COVID-19 pandemic, healthcare resources including staff were diverted from paediatric services to support COVID-positive adult patients. Hospital visiting restrictions and reductions in face-to-face paediatric care were also enforced. We investigated the impact of service changes during the first wave of the pandemic on children and young people (CYP), to inform recommendations for maintaining their care during future pandemics. Design A multi-centre service evaluation was performed through a survey of consultant paediatricians working within the North Thames Paediatric (...) Network, a group of paediatric services in London. We investigated six areas: redeployment, visiting restrictions, patient safety, vulnerable children, virtual care and ethical issues. Results Survey responses were received from 47 paediatricians across six National Health Service Trusts. Children's right to health was largely believed to be compromised by the prioritisation of adults during the pandemic (81%; n = 33). Sub-optimal paediatric care due to redeployment (61%; n = 28) and the impact of visiting restrictions on CYP's mental health (79%; n = 37) were reported. Decreased hospital attendances of CYP were associated with parental fear of COVID-19 infection-risks (96%; n = 45) and government ‘stay at home’ advice (89%; n = 42). Reductions in face-to-face care were noted to have disadvantaged those with complex needs, disabilities and safeguarding concerns. Conclusion Consultant paediatricians perceived that paediatric care was compromised during the first wave of the pandemic, resulting in harm to children. This harm must be minimised in subsequent pandemics. Recommendations for future practice which were developed from our findings are provided, including maintaining face-to-face care for vulnerable children. (shrink)

Background Although the importance of clinical ethics in contemporary clinical environments is established, development of formal clinical ethics services in the Australia health system has, to date, been ad hoc. This study was designed to systematically follow and reflect upon the first 18 months of activity by a newly established service, to examine key barriers and facilitators to establishing a new service in an Australian hospital setting. Methods: how the study was performed and statistical tests (...) used A qualitative case study approach was utilised. The study gathered and analysed data using observations of service committee meetings, document analysis of agendas and minutes, and semi-structured interviews with committee members to generate semantic themes. By interpreting the thematic findings in reference to national capacity building resources, this study also aimed to provide practice-based reflections for other health agencies. Results: the main findings An overarching theme identified in the data was a strong commitment to supporting clinicians facing difficult patient care decisions and navigating difficult discussions with patients and families. Another key theme was the role of the new clinical ethics support service in providing clinicians with a pathway to raise system-wide issues with the organisation Executive. While there was strong clinical engagement, consumer and community participation remained a challenge, as did unresolved governance issues and a need for clearer policy relationship between the service and the organisation. Conclusions: brief summary and potential implications Considering these themes in relation to the national capacity building resources, the study identifies three areas likely to require ongoing development and negotiation. These are: the role of the clinical ethics support service as a link between the workforce and the Executive; the incorporation of consumers and patients; and ethical reasoning. To improve the effectiveness of the service, it is necessary to increase clarity on the service’s role at the governance and policy level, as well as develop strategies for engaging consumers, patients and families. Finally, the capacity of the service to reflect on complex cases may be enhanced through explicit discussions of various different ethical frameworks and ways of deliberating. (shrink)

In their contribution, Kok et al raise a relevant, though often underestimated, issue: clinical ethics support services are often assumed to lead to an improvement of quality of care at the organisational level, but evidence in support of this claim is weak, if not completely lacking.1 Therefore, the authors propose a complex theoretical model connecting a specific kind of CESS, moral case deliberation, with mechanisms for quality of care improvement at the individual and the organisational (...) level. The proposal is original, and the topic discussed of great interest not only to practitioners and researchers dealing with CESS, but also to health policy-makers and managers of healthcare system, for all of whom it is indeed crucial to understand whether and how ethics support can positively impact quality of care. However, despite its undoubtful merits, we feel that some claims and model’s underlying assumptions might require in-depth scrutiny and more solid justification. i. First, the authors discuss two different approaches to understanding quality of care: the first approach, which they define as reductionist, interprets quality as an outcome-oriented, quantitative, and therefore, measurable function. The second approach defines quality …. (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)

This paper argues that professionals who make boundary-related decisions should be guided by relationship-based practice. In our roles as service users and professionals, drawing from our lived experiences of professional relationships, we argue we need to move away from distance-based practice. This includes understanding the boundary stories and narratives that exist for all of us – including the people we support, other professionals, as well as the organisations and systems within which we work. When we are dealing with professional (...) boundary issues, we should centre relationship-building skills that are central to many other aspects of our work. Skills that foster relationships at all levels – between professionals, service users, and services – need to be revalued. Our final recommendation is to create, develop, and foster safer spaces within and outside of organisations, as well as inter-professionally, for the discussion and exploration of boundary-related issues and practice. We are interested in hearing from those with experiences of being marginalised by boundaries so that they can inform a reshaping of our collective ideas around boundary related practices. To foster relationship-based practices in organisations, we have outlined several recommendations here; however, we recognize that these do not go far enough, and that collective action is needed to inform systemic change. (shrink)

This article describes a process of developing, implementing and evaluating a clinical ethics support service intervention with the goal of building up a context-sensitive structure of minimal clinical-ethics in an oncology department without prior clinical ethics structure. Scholars from different disciplines have called for an improvement in the evaluation of clinical ethics support services for different reasons over several decades. However, while a lot has been said about the concepts and (...) methodological challenges of evaluating CESS up to the present time, relatively few empirical studies have been carried out. The aim of this article is twofold. On the one hand, it describes a process of development, modifying and evaluating a CESS intervention as part of the ETHICO research project, using the approach of qualitative-formative evaluation. On the other hand, it provides a methodological analysis which specifies the contribution of qualitative empirical methods to the evaluation of CESS. We conclude with a consideration of the strengths and limitations of qualitative evaluation research with regards to the evaluation and development of context sensitive CESS. We further discuss our own approach in contrast to rather traditional consult or committee models. (shrink)

Clinical ethical support services (CESS) represent a multifaceted field of aims, consultancy models, and methodologies. Nevertheless, the overall aim of CESS can be summed up as contributing to healthcare of high ethical standards by improving ethically competent decision-making in clinical healthcare. In order to support clinical care adequately, CESS must pay systematic attention to all real-life ethical issues, including those which do not fall within the ‘favourite’ ethical issues of the day. In this paper we (...) attempt to capture a comprehensive overview of categories of ethical tensions in clinical care. We present an analytical exposition of ethical structural features in judgement-based clinical care predicated on the assumption of the moral equality of human beings and the assessment of where healthcare contexts pose a challenge to achieving moral equality. The account and the emerging overview is worked out so that it can be easily contextualized with regards to national healthcare systems and specific branches of healthcare, as well as local healthcare institutions. By considering how the account and the overview can be applied to i) improve the ethical competence of healthcare personnel and consultants by broadening their sensitivity to ethical tensions, ii) identify neglected areas for ethical research, and iii) clarify the ethical responsibility of healthcare institutions' leadership, as well as specifying required institutionalized administration, we conclude that the proposed account should be considered useful for CESS. (shrink)

Initiating clinical ethics support in psychiatry and maintaining its continuity appear to be easy. This is contradicted by the observed delay or lack of CESiP, e.g. ethics consultation. On the basis of a published literature search and the discussion of practical experiences over 2.5 years 10 tasks and relating challenges of initiating and maintaining CESiP are formulated and illustrated by examples. Referral to experiences is grounded on the systematic documentation of ca. 100 CESiP activities. The tasks (...) and challenges illustrate how CESiP was initiated and maintained in child and adolescent, adult and forensic psychiatry. Each example is followed by a “rule of thumb” that was found useful in our centre. Discussion: Suggestions I–III are of organisational nature, IV–X have explicit ethical content concerning the ethos or professionalism of the ethics consultant and CES practice. Their realisation requires a minimum of stability of CESiP and considerable consultancy experience. (shrink)

Clinical ethical support services (CESS) represent a multifaceted field of aims, consultancy models, and methodologies. Nevertheless, the overall aim of CESS can be summed up as contributing to healthcare of high ethical standards by improving ethically competent decision‐making in clinical healthcare. In order to support clinical care adequately, CESS must pay systematic attention to all real‐life ethical issues, including those which do not fall within the ‘favourite’ ethical issues of the day. In this paper we (...) attempt to capture a comprehensive overview of categories of ethical tensions in clinical care. We present an analytical exposition of ethical structural features in judgement‐based clinical care predicated on the assumption of the moral equality of human beings and the assessment of where healthcare contexts pose a challenge to achieving moral equality. The account and the emerging overview is worked out so that it can be easily contextualized with regards to national healthcare systems and specific branches of healthcare, as well as local healthcare institutions. By considering how the account and the overview can be applied to i) improve the ethical competence of healthcare personnel and consultants by broadening their sensitivity to ethical tensions, ii) identify neglected areas for ethical research, and iii) clarify the ethical responsibility of healthcare institutions' leadership, as well as specifying required institutionalized administration, we conclude that the proposed account should be considered useful for CESS. (shrink)

BackgroundMachine learning-based clinical decision support systems (ML_CDSS) are increasingly employed in various sectors of health care aiming at supporting clinicians’ practice by matching the characteristics of individual patients with a computerised clinical knowledge base. Some studies even indicate that ML_CDSS may surpass physicians’ competencies regarding specific isolated tasks. From an ethical perspective, however, the usage of ML_CDSS in medical practice touches on a range of fundamental normative issues. This article aims to add to the ethical discussion by (...) using professionalisation theory as an analytical lens for investigating how medical action at the micro level and the physician–patient relationship might be affected by the employment of ML_CDSS.Main textProfessionalisation theory, as a distinct sociological framework, provides an elaborated account of what constitutes client-related professional action, such as medical action, at its core and why it is more than pure expertise-based action. Professionalisation theory is introduced by presenting five general structural features of professionalised medical practice: (i) the patient has a concern; (ii) the physician deals with the patient’s concern; (iii) s/he gives assistance without patronising; (iv) s/he regards the patient in a holistic manner without building up a private relationship; and (v) s/he applies her/his general expertise to the particularities of the individual case. Each of these five key aspects are then analysed regarding the usage of ML_CDSS, thereby integrating the perspectives of professionalisation theory and medical ethics.ConclusionsUsing ML_CDSS in medical practice requires the physician to pay special attention to those facts of the individual case that cannot be comprehensively considered by ML_CDSS, for example, the patient’s personality, life situation or cultural background. Moreover, the more routinized the use of ML_CDSS becomes in clinical practice, the more that physicians need to focus on the patient’s concern and strengthen patient autonomy, for instance, by adequately integrating digital decision support in shared decision-making. (shrink)

In a clinic-wide approach to establish liberal policies, a closed psychiatric ward was planned to be opened. The leaders of the multi-professional team of this ward requested continuous ethics support during the first few months after the transition from their previously closed ward into an open one. During the process of accompanying the team through this ethically sensitive period of institutional change, several variations of ethics consultation were developed: the ‘context-adjusted’ clinical ethics support. Some (...) ethics consultations focused on a retrospective evaluation of a patient case, in other ethics consultations consolidation of a previous case discussion was worked out, and/or reflections on fundamental ethical issues were included. Based on our experiences and the feedback of the team, we consider this context-adjusted clinical ethics support as feasible and effective. (shrink)

BackgroundClinical Ethics Support Services have been established to support healthcare professionals in addressing ethically sensitive issues in clinical practice and, in many countries, they are under development. In the context of growing CESS, exploring how healthcare professionals experience and address clinical ethics issues in their daily practice represents a fundamental step to understand their potential needs. This is even more relevant in the context of extremely sensitive diseases, such as cancer. On this basis, we (...) carried out a qualitative study conducting in-depth semi-structured interviews with stakeholders of a major comprehensive cancer centre in Italy, with the twofold aim of investigating what ethical issues arise in the context of clinical oncology and how they are addressed, as well as stakeholders’ expectations about a potential CESS to be implemented within the Institution.MethodsThe study was conducted within the theoretical framework of Grounded Theory. Participants were healthcare professionals and other key stakeholders working within the cancer centre. The semi-structured interview aimed at exploring common ethical aspects of oncology, investigating stakeholders’ professional experience in dealing with clinical ethics issues, their expectations and requests regarding ethics support services. Transcripts of the interviews were coded and analysed according to the principles of Grounded Theory.ResultsTwenty-one stakeholders were interviewed. Our analysis showed a wide consensus on the identification of ethically relevant issues, above all those concerning communication, end-of-life, and resource allocation. The absence of institutional tools or strategies to address and manage ethical issues at the patient bedside emerged, and this is reflected in the widespread request for their development in the future. The ideal support service should be fast and flexible in order to adapt to different needs and clinical cases.ConclusionsThe interviewees showed a limited degree of ‘ethical awareness’: despite having reported many issues in clinical practice, they could hardly identify and describe the ethical aspects, while complaining about a lack of ethical resources in their management. To build a truly effective support service, it therefore seems appropriate to take such context into consideration and address the emerged needs. Ethical sensitivity seems to be key and it becomes even more relevant in critical clinical areas, such as the therapeutic pathways of terminally ill patients. (shrink)

BackgroundVarious forms of Clinical Ethics Support (CES) have been developed in health care organizations. Over the past years, increasing attention has been paid to the question of how to foster the quality of ethics support. In the Netherlands, a CES quality assessment project based on a responsive evaluation design has been implemented. CES practitioners themselves reflected upon the quality of ethics support within each other’s health care organizations. This study presents a qualitative (...) evaluation of this Responsive Quality Assessment (RQA) project.MethodsCES practitioners’ experiences with and perspectives on the RQA project were collected by means of ten semi-structured interviews. Both the data collection and the qualitative data analysis followed a stepwise approach, including continuous peer review and careful documentation of the decisions.ResultsThe main findings illustrate the relevance of the RQA with regard to fostering the quality of CES by connecting to context specific issues, such as gaining support from upper management and to solidify CES services within health care organizations. Based on their participation in the RQA, CES practitioners perceived a number of changes regarding CES in Dutch health care organizations after the RQA: acknowledgement of the relevance of CES for the quality of care; CES practices being more formalized; inspiration for developing new CES-related activities and more self-reflection on existing CES practices.ConclusionsThe evaluation of the RQA shows that this method facilitates an open learning process by actively involving CES practitioners and their concrete practices. Lessons learned include that “servant leadership” and more intensive guidance of RQA participants may help to further enhance both the critical dimension and the learning process within RQA. (shrink)

BackgroundClinical ethics support aims to support health care professionals in dealing with ethical issues in clinical practice. Although the prevalence of CES is increasing, it does meet challenges and pressing questions regarding implementation and organization. In this paper we present a specific way of organizing CES, which we have called integrative CES, and argue that this approach meets some of the challenges regarding implementation and organization.MethodsThis integrative approach was developed in an iterative process, combining actual experiences (...) in a case study in which we offered CES to a team that provides transgender health care and reflecting on the theoretical underpinnings of our work stemming from pragmatism, hermeneutics and organizational and educational sciences.ResultsIn this paper we describe five key characteristics of an integrative approach to CES; 1. Positioning CES more within care practices, 2. Involving new perspectives, 3. Creating co-ownership of CES, 4. Paying attention to follow up, and 5. Developing innovative CES activities through an emerging design.ConclusionsIn the discussion we compare this approach to the integrated approach to CES developed in the US and the hub and spokes strategy developed in Canada. Furthermore, we reflect on how an integrative approach to CES can help to handle some of the challenges of current CES. (shrink)

For decades a debate has played out in the literature about who bioethicists are, what they do, whether they can be considered professionals qua bioethicists, and, if so, what professional responsibilities they are called to uphold. Health care ethics consultants are bioethicists who work in health care settings. They have been seeking guidance documents that speak to their special relationships/duties toward those they serve. By approving a Code of Ethics and Professional Responsibilities for Health Care Ethics Consultants, (...) the American Society for Bioethics and Humanities (ASBH) has moved the professionalization debate forward in a significant way. This first code of ethics focuses on individuals who provide health care ethics consultation (HCEC) in clinical settings. The evolution of the code's development, implications for the field of HCEC and bioethics, and considerations for future directions are presented here. (shrink)

A traditional approach to teaching medical ethics aims to provide knowledge about ethics. This is in line with an epistemological view on ethics in which moral expertise is assumed to be located in theoretical knowledge and not in the moral experience of healthcare professionals. The aim of this paper is to present an alternative, contextual approach to teaching ethics, which is grounded in a pragmatic-hermeneutical and dialogical ethics. This approach is called moral case deliberation. (...) Within moral case deliberation, healthcare professionals bring in their actual moral questions during a structured dialogue. The ethicist facilitates the learning process by using various conversation methods in order to find answers to the case and to develop moral competencies. The case deliberations are not unique events, but are a structural part of the professional training on the work floor within healthcare institutions. This article presents the underlying theory on ethics and illustrates this approach with an example of a moral case deliberation project in a Dutch psychiatric hospital. The project was evaluated using the method of responsive evaluation. This method provided us with rich information about the implementation process and effects the research process itself also lent support to the process of implementation. (shrink)

While many have suggested that to withdraw medical interventions is ethically equivalent to withholding them, the moral complexity of actually withdrawing life supportive interventions from a patient cannot be ignored. Utilizing interplay between expository and narrative styles, and drawing upon our experiences with patients, families, nurses, and physicians when life supports have been withdrawn, we explore the changeable character of boundaries in end-of-life situations. We consider ways in which boundaries imply differences – for example, between cognition and performance – and (...) how the encounter with boundaries can generate altered meanings important for understanding decisions and actions in these contexts. We conclude that the reliance on mere roles to support the moral weight of withdrawing medical interventions is inadequate. Roles that lead us to such moments are exceeded by the responsibility encountered in such moments. And here, we suggest, is the momentous character of withdrawal: it presents the grave astonishment, the trembling awe, in the not-being-there of the other in death. (shrink)

We applaud the authors’ efforts to provide a theoretical basis for and more clearly link clinical ethics support services (CESS) to organisational-level quality improvement (QI). We agree that additional theorising and testing of the resultant theoretical frameworks is of benefit to the field of clinical ethics and that the outcome of a CESS is more valuable than the sum of the individual cases that it handles. We would suggest that the authors have emphasised (...) the output of the CESS without fully considering the process by which it happens. While moral case deliberation does provide an example pathway for QI, such improvements do not necessarily need to occur through the mechanism of moral case deliberation. Further engagement with QI literature could provide valuable insights to quality within the field of clinical ethics. For example, combining the QI concepts of organisational culture and high reliability organisations (HROs) with the clinical ethics... (shrink)

BackgroundWe describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions (...) were evaluated. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases.ResultThe authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries.ConclusionThis work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-European countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/cas. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort. (shrink)

We examined the ethical justification for a national policy governing public funding for the induced pluripotent stem cell stock project in Japan and argue that the initiation of the iPSC stock project in 2012, when no clinical trial using iPSC-derived products had yet succeeded, was premature and unethical. Our analysis considers a generally accepted justice criterion and shows it fails to justify public funding of the iPSC stock project. We also raise concerns related to the massive (...) amounts of public funding at stake and the absence of evidence supporting claimed success rates. We conclude that the iPSC stock project should be re-considered and deferred until a substantial number of clinical trials using iPSC-derived products are deemed successful. This analysis should benefit others worldwide as they consider their own public funding policies. (shrink)

This article discusses an approach to translational bioethics (TB) that is concerned with the adaptation—or ‘translation’—of concepts, theories and methods from bioethics to practical contexts, in order to support ‘non-bioethicists’, such as researchers and healthcare practitioners, in dealing with their ethical issues themselves. Specifically, it goes into the participatory development of clinical ethics support (CES) instruments that respond to the needs and wishes of healthcare practitioners and that are tailored to the specific care contexts in which (...) they are to be used. The theoretical underpinnings of this participatory approach to TB are found in hermeneutic ethics and pragmatism. As an example, the development of CURA, a low-threshold CES instrument for healthcare professionals in palliative care, is discussed. From this example, it becomes clear that TB is a two-way street. Practice may be improved by means of CES that is effectively tailored to specific end users and care contexts. The other way around, ethical theory may be enriched by means of the insights gained from engaging with practice in developing CES in a process of co-creation. TB is also a two-way street in the sense that it requires collaboration and commitment of both bioethicists and practitioners, who engage in a process of mutual learning. However, substantial challenges remain. For instance, is there a limit to the extent to which a method of moral reasoning can be adapted in order to meet the constraints of a given healthcare setting? Who is to decide, the bioethicist or the practitioners? (shrink)

Past research illustrated that leaders could restrict followers’ deviance by reinforcing social norms of appropriate behaviors. Nevertheless, we submit that this understanding is incomplete without considering the effects of leaders on followers’ self-sanctions given that most undesirable behaviors are controlled internally. This research argues that interactional justice is an effective strategy for leaders to enhance followers’ self-sanctions. Leaders’ interactional justice provides personalized information and dyadic treatment that indirectly reduce employees’ deviance by restraining followers’ moral disengagement. Besides, this study examines the (...) social sanction role of ethical leadership. Ethical leaders highlight the importance of adherence to collective norms, which influence the relationship between followers’ moral disengagement and deviance. By identifying the different pathways via which they influence followers’ moral disengagement, we integrate interactional justice and ethical leadership into one theoretical framework. Our predictions are supported by data analyses of 220 samples from a multi-wave and -source field study. This integrative framework contributes to a comprehensive understanding of how leaders restrict employees’ deviance. (shrink)

Objectives: To assess whether according to healthcare providers, the creation of an ethics service responds to a need; assess the importance of an ethics service for healthcare providers; determine what ethics services should be offered and the preferred formats of delivery; and identify key issues to be initially dealt with by the ethics service.Design: A survey of healthcare providers in Québec’s Centre Local de Services Communautaires , healthcare institutions dedicated to community health and social services.Findings: 96 (...) respondents agreed that an ethics service was needed, and on average the ethics service project was judged to be very important. Preferred formats for ethics consultation and education were identified, as well as key concerns such as the need of respect for the patient as a person, elder abuse and ethical issues in home care.Conclusion: This survey is helping in the implementation of an ethics service and can guide others in similar healthcare institutions. (shrink)

The European Clinical Trials Directive was issued in 2001 and aimed to simplify and harmonise the regulatory framework of clinical trials throughout Europe, thus stimulating European research. However, significant complexity and inconsistency remains due to disparate interpretation by EU member states. Critical care research has been particularly impacted due to variable and often restrictive consenting procedures for incapacitated subjects, with some countries requiring a court-appointed representative, while others recognise consent from family members and occasionally professional representatives. Furthermore, (...) the absence of a waiver of consent threatened to put an end to emergency research in Europe and was met with varied responses. Approval procedures by ethics committees are equally inconsistent, particularly those relating to provision of a single opinion for multi-centre trials. Although evidence is somewhat mixed, this complexity as well as a general increase in administrative and financial burden following the Directive has been shown to cause a reduction in clinical trial activity in Europe, particularly academic trials. We aim to clarify some of these inconsistent procedures, particularly those relating to informed consent of incapacitated subjects, as well as discussing some general weaknesses and possible improvements of the Directive ahead of its planned revision in 2011. (shrink)

BackgroundMulti-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals.MethodsWe collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.ResultsThe total costs of gaining approval were 38 % of the (...) budget for a study of 50 centres (mean cost AUD $6960 per site) and 2 % for a study of 11 centres (mean cost AUD $2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety.ConclusionsImprovements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked. (shrink)

Clinical ethics support mechanisms in healthcare are increasing but little is known about the specific developments in elderly care. The aim of this paper is to present a systematic literature review on the characteristics of existing ethics support mechanisms in institutional elderly care. A review was performed in three electronic databases . Sixty papers were included in the review. The ethics support mechanisms are classified in four categories: ‘institutional bodies’ ; ‘frameworks’ ; ‘educational (...) programmes and moral case deliberation’; and ‘written documents and policies’. For each category the goals, methods and ways of organising are described. Ethics support often serves several goals and can be targeted at various levels: case, professional or organisation. Over the past decades a number of changes have taken place in the development of ethics support in elderly care. Considering the goals, ethics support has become more outreaching and proactive, aiming to qualify professionals to integrate ethics in daily care processes. The approaches in clinical ethics support have become more diverse, more focused on everyday ethical issues and better adapted to the concrete learning style of the nursing staff. Ethics support has become less centrally organised and more connected to local contexts and primary process within the organisation. (shrink)

This Open Access book about the Zadeh Project demonstrates and explores a core question in clinical ethics: how can ethics consultants be accountable in the face of a robust plurality of ethical standpoints, especially those that underwrite practices and methods for doing ethics consultation as well as those viewpoints and values encountered in daily clinical ethics practice? Underscoring this question is the recognition that the field of clinical ethics consultation has arrived (...) at a crucial point in its maturation. Many efforts are underway to more formally “professionalize” the field, with most aimed toward stabilizing a specific set of institutional considerations. Stretched between these institutional and practical initiatives resides a crucial set of of ethical considerations, chief among them the meaning and scope of responsibility for clinical ethics consultants. Developed around a long-form case scenario, the Zadeh Project provides a multi-layered series of “peer-reviews”: critique of the actions of the case scenario’s ethics consultant; reflection on clinical ethics method; examination of the many ways that commitments to method and practice can, and do, intersect, overlap, and alter one another. The design and format of this book thus models a key element for clinical ethics practice: the need and ability to provide careful and thoughtful explanation of core moral considerations that emerge among diverse standpoints. Specifically designed for those studying to become and those who are ethics consultants, this book, with its innovative and multi-layered approach, allows readers to share a peer-review-like experience that shows accountability to be what it is, an ethical, not merely procedural or administrative, undertaking. (shrink)

BackgroundHow should clinical ethics support services such as clinical ethics committees (CECs) be implemented and evaluated? We argue that both the CEC itself and theimplementationof the CEC should be considered as ‘complex interventions’.Main textWe present a research project involving the implementation of CECs in community care in four Norwegian municipalities. We show that when both the CEC and its implementation are considered as complex interventions, important consequences follow – both for implementation and the study (...) thereof. Emphasizing four such sets of consequences, we argue, first, that the complexity of the intervention necessitates small-scale testing before larger-scale implementation and testing is attempted; second, that it is necessary to theorize the intervention in sufficient depth; third, that the identification of casual connections charted in so-called logic models allows the identification of factors that are vital for the intervention to succeed and which must therefore be studied; fourth, that an important part of a feasibility study must be to identify and chart as many as possible of the causally important contextual factors.ConclusionThe conceptualization of the implementation of a CEC as a complex intervention shapes the intervention and the way evaluation research should be performed, in several significant ways. We recommend that researchers consider whether a complex intervention approach is called for when studying CESS implementation and impact. (shrink)

Like other Arab countries, Jordan must find ways of responding to the rapid processes of change affecting many aspects of social life. This is particularly urgent in healthcare, where social and technical change is often manifested in tensions about ethical decision-making in the clinic. To explore the attitudes, beliefs and concerns relating to ethical decision-making among health professionals in Jordanian hospitals, a qualitative study was conducted involving face-to-face interviews with medical personnel in four hospitals in Amman, the capital of Jordan. (...) Data were analysed thematically in relation to a pre-existing set of ethical categories. Interviews were conducted with thirty-eight doctors covering most medical specialities. Five major themes emerged from the interviews: ethical awareness, ethical issues, the impact of religion on ethical decision-making, practical and theoretical resources for ethical decision-making, and challenges. While uncertainty was expressed about some aspects of Western approaches to ethics, participants strongly supported adoption of a range of Western bioethical principles, including cultural and ethical diversity, along with adherence to Islamic religious norms. A range of serious ethical challenges facing the Jordanian health system were identified, covering social, legal, managerial, and technical issues. Ethical decision-making in Jordan is complex, having to accommodate the needs of patients, the opinions of doctors and their families, the views of religious authorities, managerial considerations, and both local norms and international standards. Health professionals struggle with three sets of tensions that emerge out of the struggle between traditional, community-embedded forms of social organization and the demands generated by globalization and the influence of Western culture: the tensions between tradition and modernity, conservatism and pragmatism, and religion and secularism. Doctors in Jordan prefer approaches to ethical decision-making that realize a balance between the extremes, although the exact nature of where that balance should lie remains uncertain. (shrink)

This article argues that standard models of person-centred care (PCC) and shared decision making (SDM) rely on simplistic, often unrealistic assumptions of patient capacities that entail that PCC/SDM might have detrimental effects in many applications. We suggest a complementary PCC/SDM approach to ensure that patients are able to execute rational decisions taken jointly with care professionals when performing self-care. Illustrated by concrete examples from a study of adolescent diabetes care, we suggest a combination of moral and psychological considerations to (...) class='Hi'>support the claim that standard PCC/SDM threatens to systematically undermine its own goals. This threat is due to a tension between the ethical requirements of SDM in ideal circumstances and more long-term needs actualized by the context of self-care handled by patients with limited capacities for taking responsibility and adhere to their own rational decisions. To improve this situation, we suggest a counseling, self-care, adherence approach to PCC/SDM, where more attention is given to how treatment goals are internalized by patients, how patients perceive choice situations, and what emotional feedback patients are given. This focus may involve less of a concentration on autonomous and rational clinical decision making otherwise stressed in standard PCC/SDM advocacy. (shrink)

Bioethicists, medical professionals and lawyers who support Posthumous Assisted Reproduction as an ethical procedure in the case of the deceased’s spouse often oppose it in the case of the deceased’s parents. In addition, supporters of PAR usually rely on an individualistic version of liberalism, thus focusing on a personal rather than relational approach to autonomy. This article proposes an alternative and comprehensive theoretical framework for the practice of PAR, based on the concepts of solidarity and relational autonomy. (...) By analyzing empirical data on people’s attitudes towards PAR, we reveal an important distinction between the deceased’s wish and the deceased’s consent. In addition, we show that in the majority of cases individuals report that the well-being of their relatives is paramount once they are dead. This finding, as will be demonstrated in the article, is not fully in line with Tremellen and Savulescu’s position who allow PAR in the case of the deceased’s spouse but not in the case of his parents. We also suggest that a relational autonomy perspective can be used to evaluate the choices and actions of the deceased, and to justify the requests for PAR by his spouse or parents. Furthermore, the discussion leads us to analyze both Sandel’s account of solidarity and the more recent account of Prainsack and Buyx. We conclude that PAR can be considered as a solidarity-based practice, both at the familial and societal level, an aspect that should be given more emphasis in the discourse surrounding PAR. (shrink)

BackgroundInternationally, clinical ethics support has yet to be implemented systematically in community health and care services. A large-scale Norwegian project attempted to increase ethical competence in community services through facilitating the implementation of ethics support activities in 241 Norwegian municipalities. The article describes the ethics project and the ethics activities that ensued.MethodsThe article first gives an account of the Norwegian ethics project. Then the results of two online questionnaires are (...) reported, characterizing the scope, activities and organization of the ethics activities in the Norwegian municipalities and the ethical topics addressed.ResultsOne hundred and thirty-seven municipal contact persons answered the first survey, whereas 217 ethics facilitators from 48 municipalities responded to the second. The Norwegian ethics project is vast in scope, yet has focused on some institutions and professions whilst seldom reaching others. Patients and next of kin were very seldom involved. Through the ethics project employees discussed many important ethical challenges, in particular related to patient autonomy, competence to consent, and cooperation with next of kin. The “ethics reflection group” was the most common venue for ethics deliberation.ConclusionsThe Norwegian project is the first of its kind and scope, and other countries may learn from the Norwegian experiences. Professionals have discussed central ethical dilemmas, the handling of which arguably makes a difference for patients/users and service quality. The study indicates that large scale implementation of CES structures for the municipal health and care services is complex, yet feasible. (shrink)

Research on employees’ responses to corporate social responsibility has recently accelerated and begun appearing in top-tier academic journals. However, existing findings are still largely fragmented, and this stream of research lacks theoretical consolidation. This article integrates the diffuse and multi-disciplinary literature on CSR micro-level influences in a theoretically driven conceptual framework that contributes to explain and predict when, why, and how employees might react to CSR activity in a way that influences organizations’ economic and social performance. Drawing on (...) social identity theory and social exchange theory, we delineate the different but interdependent psychological mechanisms that explain how CSR can strengthen the employee–organization relationship and subsequently foster employee-related, micro-level outcomes. Contributions of our framework to extant literature and potential extensions for future research are then discussed. (shrink)

How could it happen that the very processes intended to assure ethical research in Australia might, themselves, undermine good research practice?This paper describes one PhD candidate’s recent experiences of multicentre review for a Human Research Ethics Committee approved, low/negligible risk, qualitative study, at the crossroad of health services research and organisational research.A retrospective review of international literature about multi-centre review processes revealed that many of these experiences were not unique and might have been expected, notwithstanding Australian efforts at harmonisation (...) of multi-centre review. This paper examines not only the burden of red-tape that was applied to a small doctoral study, but also the way in which the red-tape threatened the anonymity of potential study participants and risked exposing them to undue pressure and distress.These experiences support the view that harmonisation initiatives have not yet developed as the Australian National Health and Medical Research Council may have hoped and that further attention is needed to harmonise research governance processes. (shrink)