Name der Zeitschrift: Jahrbuch für Wissenschaft und Ethik Jahrgang: 20 Heft: 1 Seiten: 237-240.

Due to the variety of research ethics and integrity training formats it may be challenging to use a common instrument to monitor and evaluate the development of competencies and learning progress as well as determine the effectiveness of the training. The present study scrutinises the use of learning diaries as one possible measure to evaluate the development of ethics competencies. The aim of the study was to increase understanding about how learning diaries capture development of (...) class='Hi'>research ethics and integrity competencies of participants and explore the use of diaries as a measure of training effectiveness. In the evaluative case study, a micro-credential programme was used as the context of the study and data was analysed using deductive content analysis. As a result, we outline criteria for analysis to be used in ethics training programmes for learning diaries. Results indicated that learning diaries submitted in the forum format (compared to individual submissions) provide peer support, so learners display more content knowledge on high levels of reflection and understanding. Submitting learning diaries over a longer period and making submissions repeatedly can improve writing and reflection competencies. The quality of learning diary entries may also depend on learner characteristics, such as commitment and motivation. Keeping a learning diary can help retain obtained competencies over a longer period. The article ends with a set of recommendations for implementing learning diaries as one measure of evaluation. (shrink)

The new business opportunities and prospects emerging in Europe within the Common Market and other Western and European countries also raise important ethical challenges. This work comprises a collection of ethical insights to enhance the conduct of business in an evolving Europe.

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 research focuses on how research ethics committee and integrity board members discuss and decide on solutions to case scenarios that involve a dimension of research ethics or integrity in collaborative settings. The cases involved issues around authorship, conflict of interest, disregard of good scientific practice and ethics review, and research with vulnerable populations (children and neonates). The cases were set in a university, a hospital, or a research institute. In (...) the research, we used a deductive qualitative approach with thematic analysis. Twenty-seven research ethics committee and research integrity board members from 16 European countries and one country outside Europe participated. Participants represented natural and life sciences, social sciences, and humanities. They worked on cases involving ethical/integrity issues in six different constellations. Results show that experts apply key elements of ethical decision making, namely identification of ethical issues, stakeholders, guidelines, solutions, and own positionality, in dealing collaboratively with ethics/ integrity problems, and the nature of the application depends on the complexity of the case. Understanding how individuals knowledgeable in research ethics and integrity, in this case, individuals serving on research ethics committees and integrity boards, approach ethical/ moral issues can help to identify strategies that may be useful in the development of research ethics and integrity training for junior researchers who may benefit from learning professional strategies. (shrink)

BackgroundThe areas of Research Ethics (RE) and Research Integrity (RI) are rapidly evolving. Cases of research misconduct, other transgressions related to RE and RI, and forms of ethically questionable behaviors have been frequently published. The objective of this scoping review was to collect RE and RI cases, analyze their main characteristics, and discuss how these cases are represented in the scientific literature.MethodsThe search included cases involving a violation of, or misbehavior, poor judgment, or detrimental (...) class='Hi'>research practice in relation to a normative framework. A search was conducted in PubMed, Web of Science, SCOPUS, JSTOR, Ovid, and Science Direct in March 2018, without language or date restriction. Data relating to the articles and the cases were extracted from case descriptions.ResultsA total of 14,719 records were identified, and 388 items were included in the qualitative synthesis. The papers contained 500 case descriptions. After applying the eligibility criteria, 238 cases were included in the analysis. In the case analysis, fabrication and falsification were the most frequently tagged violations (44.9%). The non-adherence to pertinent laws and regulations, such as lack of informed consent and REC approval, was the second most frequently tagged violation (15.7%), followed by patient safety issues (11.1%) and plagiarism (6.9%). 80.8% of cases were from the Medical and Health Sciences, 11.5% from the Natural Sciences, 4.3% from Social Sciences, 2.1% from Engineering and Technology, and 1.3% from Humanities. Paper retraction was the most prevalent sanction (45.4%), followed by exclusion from funding applications (35.5%).ConclusionsCase descriptions found in academic journals are dominated by discussions regarding prominent cases and are mainly published in the news section of journals. Our results show that there is an overrepresentation of biomedical research cases over other scientific fields compared to its proportion in scientific publications. The cases mostly involve fabrication, falsification, and patient safety issues. This finding could have a significant impact on the academic representation of misbehaviors. The predominance of fabrication and falsification cases might diverge the attention of the academic community from relevant but less visible violations, and from recently emerging forms of misbehaviors. (shrink)

This article argues that lingering uncertainty about the normative foundations of research ethics is perpetuated by two unfounded dogmas of research ethics. The first dogma is that clinical research, as a social activity, is an inherently utilitarian endeavor. The second dogma is that an acceptable framework for research ethics must impose constraints on this endeavor whose moral force is grounded in role-related obligations of either physicians or researchers. This article argues that these dogmas (...) are common to traditional articulations of the equipoise requirement and to recently articulated alternatives, such as the non-exploitation approach. Moreover, important shortcomings of these approaches can be traced to their acceptance of these dogmas. After highlighting these shortcomings, this article illustrates the benefits of rejecting these dogmas by sketching the broad outlines of an alternative called the "integrative approach" to clinical research. (shrink)

The increasing need for innovative research driven by rapid global changes gives doctoral supervisors of early-stage researchers a significant role in facilitating the ethical conduct of qualitative research. In the context of European Commission funding, the demands of research ethics and integrity place a tremendous responsibility on the supervisors of early-stage researchers involved in cross-national projects. This document study seeks to illuminate the role of the supervisors in facilitating research ethics in these (...) projects. Specifically, we describe and discuss the supervisor role associated with five approaches to doctoral supervision of qualitative research, namely those described as ‘Functional’, ‘Enculturation’, ‘Critical thinking’, ‘Emancipation’ and ‘Developing a quality relationship’. The main challenges for supervisors of cross-national research projects are the cultural and linguistic mobilisation of ethical principles in qualitative research processes and the management of the future use of open data. The results from this study have implications for planning and conducting cross-national studies within research involving human participants. These results can guide supervisors in the codification and mobilisation of ethical qualitative research in practice. (shrink)

Background:Moral courage is defined as courage to act according to one’s own ethical values and principles even at the risk of negative consequences for the individual. In a complex nursing practice, ethical considerations are integral. Moral courage is needed throughout nurses’ career.Aim:To analyse graduating nursing students’ moral courage and the factors associated with it in six European countries.Research design:A cross-sectional design, using a structured questionnaire, as part of a larger international ProCompNurse study. In the questionnaire, moral courage was (...) assessed with a single question (visual analogue scale 0–100), the questionnaire also covered several background variables.Participants and research context:The sample comprised graduating nursing students (n = 1796) from all participating countries. To get a comprehensive view about graduating nursing students’ moral courage, the views of nurse managers (n = 538) and patients (n = 1327) from the same units in which the graduating nursing students practised were also explored, with parallel questionnaires.Ethical considerations:Ethical approvals and research permissions were obtained according to national standards in every country and all participants gave their informed consent.Results:The mean of graduating nursing students’ self-assessed moral courage was 77.8 (standard deviation 17.0; on a 0–100 scale), with statistically significant differences between countries. Higher moral courage was associated with many factors, especially the level of professional competence. The managers assessed the graduating nursing students’ moral courage lower (66.5; standard deviation 18.4) and the patients slightly higher (80.6; standard deviation 19.4) than the graduating nursing students themselves.Discussion and conclusions:In all countries, the graduating nursing students’ moral courage was assessed as rather high, with differences between countries and populations. These differences and associations between moral courage and ethics education require further research. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind (...) the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (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)

Ethics and integrity should be intertwined within the concept of Responsible Research. Integrity Officers should also be Ethics Officers, enforcing compliance with rules and norms, but also raising awareness on the meaning of ethics in researchers’ daily work. Paul Ricoeur’s definition of Ethics – “the aim of living a good life with and for others in just institutions” (Ricoeur in Oneself as Another. University of Chicago Press, 1994 ) –, points out the relational (...) dimension of Ethics that matters to all the stakeholders in scientific research. The dialogical interaction between Ethics and Integrity can help to prevent researchers from assuming self-regulation as the only possible path to be followed. In this paper, the challenges and the opportunities posed by this approach will be outlined and discussed, mainly, the challenges of building trust bottom up, while setting up restrictions to comply with rules and norms top down. Concerning the opportunities, the focus will be on making better science and building a solid network among the various stakeholders of the research system. (shrink)

With the proliferation of networked electronic communication came daunting capabilities to collect, process, combine and store data, resulting in hitherto unseen transformational pressure on the concepts of trust, security and privacy as we know them. The Future Internet will bring about a world where real life will integrate physical and digital life. Technology development for data linking and mining, together with unseen data collection, will lead to unwarranted access to personal data, and hence, privacy intrusion. Trust and identity lie at (...) the basis of many human interactions and transactions, and societies have developed legitimate concern for privacy being essential for freedom and creativity. The burgeoning development of the Information Society, particularly during the past fifteen years, transcended the societal readiness to respond to the transformational change evoked by ICT. We have reached the eleventh hour for the preservation of trust and privacy as elements that can be transposed into our digital future. Europe has been at the forefront in recognizing the importance of privacy protection in relation to digital data, witness the advanced European legislation in this domain. The European Commission recognizes that appropriate measures need to combine technology development with legal means, user awareness and tools supporting data controllers to comply with law in an accountable and transparent way, and that empower users with a controlling stake in managing their personal data. Activities are underway at many levels. European RTD programmes play their role in supporting research in trustworthy ICT, privacy enhancing technologies, privacy-by-design in service layers as well as in networks, enabling technologies such as cryptography, and in generalized frameworks for trust and privacy-protective identity management. (shrink)

With the proliferation of networked electronic communication came daunting capabilities to collect, process, combine and store data, resulting in hitherto unseen transformational pressure on the concepts of trust, security and privacy as we know them. The Future Internet will bring about a world where real life will integrate physical and digital life. Technology development for data linking and mining, together with unseen data collection, will lead to unwarranted access to personal data, and hence, privacy intrusion. Trust and identity lie at (...) the basis of many human interactions and transactions, and societies have developed legitimate concern for privacy being essential for freedom and creativity. The burgeoning development of the Information Society, particularly during the past fifteen years, transcended the societal readiness to respond to the transformational change evoked by ICT. We have reached the eleventh hour for the preservation of trust and privacy as elements that can be transposed into our digital future. Europe has been at the forefront in recognizing the importance of privacy protection in relation to digital data, witness the advanced European legislation in this domain. The European Commission recognizes that appropriate measures need to combine technology development with legal means, user awareness and tools supporting data controllers to comply with law in an accountable and transparent way, and that empower users with a controlling stake in managing their personal data. Activities are underway at many levels. European RTD programmes play their role in supporting research in trustworthy ICT, privacy enhancing technologies, privacy-by-design in service layers as well as in networks, enabling technologies such as cryptography, and in generalized frameworks for trust and privacy-protective identity management. (shrink)

Numerous researchers have examined the antecedents of trust between managers and subordinates. Recent studies conclude that their influence varies depending on whether what is being examined is a manager's trust in a subordinate or a subordinate's trust in a manager. However, the reasons given to justify this phenomenon present limitations. This article offers a new theoretical approach that relates the influence of each antecedent to Aristotelian forms of reasoning, ethical, and instrumental. The proposed approach shows that the influence of each (...) antecedent depends on which rationality prevails in the person who trusts. The contribution of this article is to better explain the phenomenon of interpersonal trust formation and its logic, while offering at the same time several practical implications for managers interested in developing an organizational culture based on trust. The article begins with a literature review of more relevant empirical studies analyzing superior–subordinate trust formation and presents some theoretical limitations of the arguments described in these works. Then, it offers a new theorerical approach based on Aristotelian thought to explain the influence of the antecedents of trust in management–subordinate relationships. The theoretical contribution is then confirmed in an empirical study of 163 mid-level managers in Spain. (shrink)

Name der Zeitschrift: Jahrbuch für Wissenschaft und Ethik Jahrgang: 20 Heft: 1 Seiten: 293-302.

Universities and other research institutions are increasingly providing additional training in research integrity to improve the quality and reliability of research. Various training courses have been developed, with diverse learning goals and content. Despite the importance of training that focuses on moral character and professional virtues, there remains a lack of training that adopts a virtue ethics approach. To address this, we, a European Commission-funded consortium, have designed a train-the-trainer programme for research (...) class='Hi'>integrity. The programme is based on (1) virtue ethics, (2) the ethos of science, (3) learning by doing and (4) learner-centred teaching. The blended learning programme combines e-learning modules with participatory group sessions. Trainers are taught how to guide researchers through a series of structured exercises for fostering reflection on scientific virtues, and how to promote understanding and application of the European Code of Conduct for Research Integrity. Trainers are provided with adaptable tools and resources that can be used and combined in different ways. The programme implementation began in Spring 2020 and 470 trainers have participated to date. When trainers were asked to grade – between 0 (very bad) and 10 (excellent) – the e-learning modules and the participatory exercises, 60% scored a grade 8 or higher (median = 8, IQR = 2) for the e-learning modules, whereas 80% scored a grade 8 or higher (median = 9, IQR = 1) for the participatory exercises. A majority felt that the training helped them as a trainer to learn about ways to organise and teach a research integrity course (82%) and would recommend the interactive exercises to others (92%). Trainers have educated over 3300 researchers in Europe using our virtue-based approach. The VIRT2UE train-the-trainer programme fosters research integrity by providing trainers with exercises and tools which enable them to stimulate the development of good researchers across Europe. (shrink)

Unavailability of published data and studies focused on young researchers in Europe and research integrity issues reveals that clear understanding and stance on this subject within European area is lacking. Our study provides information on attitudes and experiences of European researchers at early career stages, based on a limited sample of respondents. The study provides both quantitative and qualitative results for the examined issues. The data suggest that awareness and interest of the younger researchers surveyed in (...) research integrity issues is high, however, it is often based on self-initiatives, with many of the respondents not having adequate training or any possibility to obtain it. Our attitude survey conducted within the European Council of Doctoral Candidates and Junior Researchers indicates that only 22 % of respondents had an opportunity to obtain relevant training, and that only one third believed that institutions and supervisors regularly paid attention to it. Further, we noted certain differences between disciplines. The study also reveals that many younger researchers felt they faced problems due to the misconduct of their senior colleagues and the existing institutional culture. The results of the study indicate a need for better prevention mechanisms, training and raising awareness activities. Preferably, junior researchers should be given an active role in shaping the integrity culture. It should be noted that the presented results should be considered in the context of the limitations stemming from the small-scale survey. This paper encourages further research activities on research integrity practices to provide stronger evidence on the attitudes and experiences of young researchers in Europe and other parts of the world. (shrink)

To build a culture of integrity in a HE institution, innovative approaches are needed to enhance education of research ethics and integrity. In addition to educating students, understanding is needed on how to facilitate for those who lead others. The focus is on early-career researchers as future REI leaders. The current study sheds light on how learning and REI leadership competencies evolve during scaffolded collaborative research ethics training for this target group. The study combines (...) new instruments as part of holistic DBR. Data was collected from 3 groups of experienced researchers attending 3 training sessions in the form of written group reports and group discussion recordings. Qualitative deductive analysis was utilised for monitoring the learning process, scaffolding patterns, and display of REI leadership principles. Also, quantitative analysis was applied to group discussion data, displaying the nature of collaboration. Results imply that collaborative case-based role play format is effective in training future REI leaders. All groups displayed high levels of understanding. Combining ECRs and researchers with leadership experience supported knowledge building in the groups by bringing in various perspectives. Even though groups required different amounts of scaffolding, the nature was similar: maintaining goal orientation, highlighting critical features and redirecting learners. Learning analytics of collaboration indicated that the person with leadership experience was not necessarily the most active participant nor took the role of a ‘group leader’. Still, it was mostly that person who displayed leadership competencies thus supporting other group members to develop leadership aspects. (shrink)

Ethics and ethical behaviour are the fundamental pillars of a civilised society. The focus on ethical behaviour is indispensable in certain fields such as medicine, finance, or law. In fact, ethics gets precedence with anything that would include, affect, transform, or influence upon individuals, communities or any living creatures. Many institutions within Europe have set up their own committees to focus on or approve activities that have ethical impact. In contrast, lesser-developed countries are trying to set up these (...) committees to govern their academia and research. As the first European consortium established to assist academic integrity, European Network for Academic Integrity, we felt the importance of guiding those institutions and communities that are trying to conduct research with ethical principles. We have established an ethical advisory working group within ENAI with the aim to promote ethics within curriculum, research and institutional policies. We are constantly researching available data on this subject and committed to help the academia to convey and conduct ethical behaviour. Upon preliminary review and discussion, the group found a disparity in understanding, practice and teaching approaches to ethical applications of research projects among peers. Therefore, this short paper preliminarily aims to critically review the available information on ethics, the history behind establishing ethical principles and its international guidelines to govern research.The paper is based on the workshop conducted in the 5th International conference Plagiarism across Europe and Beyond, in Mykolas Romeris University, Lithuania in 2019. During the workshop, we have detailed a) basic needs of an ethical committee within an institution; b) a typical ethical approval process ; and c) the ways to obtain informed consent with some examples. These are summarised in this paper with some example comparisons of ethical approval processes from different universities. We believe this paper will provide guidelines on preparing and training both researchers and research students in appropriately upholding ethical practices through ethical approval processes. (shrink)

This article summarizes some of the results of the BIOMED II project “Basic Ethical Principles in European Bioethics and Biolaw” connected to a research project of the Danish Research Councils “Bioethics and Law”. The BIOMED project was based on cooperation between 22 partners in most EU countries. The aim of the project was to identify the ethical principles of respect for autonomy, dignity, integrity and vulnerability as four important ideas or values for a European bioethics (...) and biolaw. The research concluded that the basic ethical principles cannot be understood as universal everlasting ideas or transcendental truths but they rather function reflective guidelines and important values in European culture. The method of the research was conceptual, philosophical analysis of the cultural background of the four values or normative ideas that people use and find important in their existence. Moreover, this was combined with analysis of empirical legal material and policy documents. Also, a number of qualitative interviews with relevant experts were carried out. Another important result of the BIOMED project was the partner's Policy Proposals to the European Commission, the Barcelona Declaration, unique as a philosophical and political agreement between experts in bioethics and biolaw from many different countries. The Policy Proposals are reprinted here at the end of the article. (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)

Background: The Directive 2001/20/EC was an important first step towards consistency in the requirements and processes for clinical trials across Europe. However, by applying the same rules to all types of drug trials and transposing the Directive’s principles into pre-existing national legislations, the Directive somewhat failed to meet its facilitation and harmonisation targets. In the field of ethics, the Directive 2001/20/EC conditioned the way of understanding and transposing the “single opinion” process in each country. This led to a situation (...) in which two models of research ethics committees organisation systems exist, being the model in which the “single opinion” is considered to be the decision made by a single ethics committee more effective and simpler in terms of administrative and logistic workload. Method: A survey was conducted in 10 European countries. Members of the European Clinical Research Infrastructures Network working party number 1, with expertise in the field of ethics, responded. Results: There is a major heterogeneity in the composition of ethics committees among the surveyed countries based on the number of members, proportion of experts versus lay members and expertise of the scientific members. A harmonised education of the ethics committees’ membership based in common curricula is recommended by the majority of countries. Conclusions: Despite the efforts for harmonisation of the European Clinical Trial Directive, from an ethical point of view, there remains a plurality of ethics committees' systems in Europe. It is important to comprehend the individual national systems to understand the problems they are facing. (shrink)

The use of empirical research methods in bioethics has been increasing in the last decades. It has resulted in discussions about the ‘empirical turn of bioethics’ and raised questions related to the value of empirical work for this field, methodological questions about its quality and rigor, and how this integration of the normative and the empirical can be achieved. The aim of this paper is to describe the attitudes of bioethics researchers in this field towards the use of empirical (...) research, and examine their actual conduct: whether they use empirical research methods, and whether they have made attempts at integrating the empirical and the normative. An anonymous online survey was conducted to reach scholars working in bioethics/biomedical ethics/ethics institutes or centers in 12 European countries. A total of 225 bioethics researchers participated in the study. Of those, 200 questionnaires were fully completed, representing a response rate of 42.6%. The results were analysed using descriptive statistics. Most respondents indicated that they use or have used empirical methods in their work. A similar proportion of respondents reported having had at least some training in qualitative or quantitative methods, respectively. Among the ‘empirical researchers’, more than a fifth had not received any methodological training. It appears that only 6% or less of the ‘empirical researchers’ considered themselves experts in the methods that they have used. Only 35% of the scholars who have used empirical methods reported having integrated empirical data with normative analysis, whereas for their current projects, 59.8% plan to do so. There is a need to evaluate the current educational programs in bioethics and to implement rigorous training in empirical research methods to ensure that ‘empirical researchers’ have the necessary skills to conduct their empirical research in bioethics. Also imperative is clear guidance on the integration of the normative and the empirical so that researchers who plan to do so have necessary tools and competences to fulfil their goals. (shrink)

While the debate on values in science focuses on normative questions on the level of the individual (e.g. should researchers try to make their work as value free as possible?), comparatively little attention has been paid to the institutional and professional norms that researchers are expected to follow. To address this knowledge gap, we conduct a content analysis of leading national codes of conduct for research integrity of European countries, and structure our analysis around the question: do (...) these documents allow for researchers to be influenced by “non-epistemic” (moral, cultural, commercial, political, etc.) values or do they prohibit such influence in compliance with the value-free ideal (VFI) of science? Our results return a complex picture. On the one hand, codes of conduct consider many non-epistemic values to be a legitimate influence on the decision-making of researchers. On the other, most of these documents include what we call _VFI-like positions_: passages claiming that researchers should be free and independent from any external influence. This shows that while many research integrity documents do not fully endorse the VFI, they do not reject it and continue to be implicitly influenced by it. This results in internal tensions and underdetermined guidance on non-epistemic values that may limit some of the uses of research integrity codes, especially for purposes of ethical self-regulation. While codes of conduct cannot be expected to decide how researchers should act in every instance, we do suggest that they acknowledge the challenges of how to integrate non-epistemic values in research in a more explicit fashion. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Buddhist-Christian Studies 22 (2002) 195-197 [Access article in PDF] Fourth Conference of the European Network of Buddhist-Christian Studies John D'Arcy May Irish School of Ecumenics, Trinity College Dublin Hosted by the Department of Theology at the University of Lund, May 4-7, 2001, this conference reversed the perspective of the previous one, which studied Buddhist perceptions of Jesus. In the event, a strong Buddhist presence from Europe, Thailand, (...) and Japan ensured that distinctive, even conflicting Buddhist views of Christianity were represented at the Lund conference. But there were also some impressive attempts by Christians to come to terms with the history of the relationship and its implications for theology.A feature of the conference was personal testimonies to lives transformed by awareness of other traditions. Eshin Nishimura described his "Zen way—with Christians," starting with his contacts with Quakers in postwar Japan and America. In an extremely interesting and controversial session, Sulak Sivaraksa of Thailand and Reimyo Tierelinckx, a Belgian living the life of a Zen nun in Dortmund, Germany, disagreed about those aspects of Christianity that are actually relevant to Buddhism: social action or contemplation? In his Christian response, Jacques Scheuer emphasized the "always already, always now" character of grace and the eschatological perspective of "Christ ahead of us" as a fundamental contrast, while Asa Egner pointed out the difference between salvation without self-interest and the "god" of capitalism.There were also examples of how Buddhism is understood by Christians in specific contexts. Sulak Sivaraksa recalled the intolerance of the missionaries in Thailand, who assumed they had a monopoly on truth and morality and were "not comfortable with differences." On the other hand, they stimulated renewal in the Theravada sangha and forced Buddhists to confront structural violence. Kosuke Koyama, who was one of those missionaries, said he became more relaxed about living in space-time as the coordinates of divine-human encounter, but questioned whether dependent coorigination and the Buddhist emphasis on psychology leave enough room for a sense of history. Yet Buddhism too requires that we make an effort to "put out the fire," which in today's context should lead to a hermeneutic of ethical action. Eshin Nishimura told how Buddhism, even before it reached Japan, had begun to conceive of the Buddha as an absolute being transcending time and space who was to be worshipped as a savior. He startled participants by speaking of "the secret reason why [End Page 195] Japanese Buddhism is so degenerate," which he later clarified to some extent by illustrating how practice can have priority over charity.Though there was plenty of opportunity to practice at the conference, the personal side was complemented by a number of first-rate scholarly studies of both history and theology/buddhology. Elizabeth Harris drew on her firsthand knowledge of Sri Lanka to analyze the different phases the Christian understanding of Buddhism passed through there. In the period 1800-1830 there was puzzlement among the British as to whether the Buddha was a god or a man who proposed a "system of undisguised atheism." Between 1830 and 1870, though the realization was dawning that Buddhism represented a high degree of ethics and even holiness, the missionaries did everything in their power to undermine it and demonstrate its inferiority and inauthenticity. From 1870 to 1900 this trend continued, despite a growing sympathy for the Buddha and Buddhism on the part of humanists and scholars. The outcome was a "demythologizing" of the Buddha to a status below that of Jesus as the prelude to the growth of conservative evangelical Christianity in Sri Lanka.Hakan Eilert gave a reassessment of Karl Reichelt, the Norwegian Lutheran missionary to China, where he arrived in 1893 after having a healing experience of nature mysticism. This made him more open to Daoism, Confucianism, and Buddhism than might have been expected of a Lutheran from such a conservative background. Though his motto was "the light of the Buddha shines everywhere," in fact he seems to have read Christian ideas into Buddhism. Constrained by incipient Barthianism and a watchful home church, Reichelt... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Conversion and Religious Identity in Buddhism and ChristianityJohn D'Arcy MayA Benedictine abbey that has been involved in exchanges with Buddhist monks since 1979 was an appropriate setting for serious discussion of double identity and change of identity between Buddhists and Christians. The European Network holds its conferences every two years, and after experiencing the Benedictine hospitality of St.Ottilien once again it was decided that every second conference (...) should be held here in the future, with the intervening ones in different centers throughout Europe. Br.Josef Götz OSB introduced the conference by telling the story of the intermonastic encounters with monks of the Soto, Rinzai, and Shingon traditions over the last twenty-five years at St. Ottilien. Participants in these agreed that they had never learned so much about their own traditions as when they were engaged in dialogue at a spiritual and experiential level with their monastic "others." One Zen monk told the Benedictines, "Working with your carpenter, I understand Christianity," and another asked for baptism in order to participate more fully in the liturgy.The situation in the Buddhist countries of Asia, however, is not necessarily so harmonious, as reports by Fr. Thomas Timpte OSB from Korea and Dr. Elizabeth Harris from Sri Lanka made clear. Just to hear about the religious situation in South Korea, the "great unknown" of East Asian Buddhism, was worthwhile. Though four traditions—Shamanism, Buddhism with elements of Daoism, Confucianism, and Christianity—coexist largely peacefully, the advent of Christianity caused tensions arising from both persecutions and conversions. Though many Koreans would find no contradiction in being both Confucianist (at least in a cultural sense) and Christian, Buddhism itself is coming to be seen as a cultural phenomenon, and those earnestly seeking peace of heart turn to Christianity. Almost half the members of [End Page 189] parliament are either Catholic or Protestant, though there is little evidence of Christian ethics in political practice. Nevertheless, Buddhism is now the fastest-growing religion, as Catholics in particular find themselves attracted to the temple environment, which is experienced as "a kind of homecoming." "Christian in the head, Shamanist in the belly, Buddhist in the heart," though a simplification, sums up the situation.In Sri Lanka, on the other hand, things are considerably more fraught, and with the passage of anticonversion legislation the conference theme of conversion and identity is a charged topic. Elizabeth Harris illustrated the lengths to which certain Christians are prepared to go to win converts, such as working the camps of tsunami survivors. Though British evangelical missionaries had originally been afforded remarkable hospitality by the Buddhists—even being invited to preach in temples —their insistence that if Christianity is right, Buddhism must be wrong polarized relations, and the great public debate of 1815 still sets a precedent. Thus even for contemporary Christian inheritors of the fusion of the European Enlightenment with evangelical Christianity, both the conviction of sin and rational argument assure the superiority of Christianity. In the ethnic conflict presently raging, the religions are "not innocent," with Tamils and Christians being conflated into the "other" against which Sinhalese antipathy is directed. This is all the more tragic in that most Sri Lankan Buddhists accept the traditional ethic of tolerance.Jørgen Skov Sørensen and Kajsa Ahlstrand illuminated the religious situation in Scandinavia from different perspectives. Sørensen reflected on the "soft boundaries" that actually exist in many pluralistic societies, something that puzzled both civil servants and missionaries even in colonial India. There is a danger that contemporary Christians will try to impose the same unambiguous boundaries on postmodern Europe as they did in their former colonies. Ahlstrand's report on an empirical study done in Sweden showed how unrealistic this is. Dual identity as both Buddhist and Christian was more common than complete identification with either, and 42 percent of those who identified completely with Christianity said they did not believe in God!The centerpiece of the conference was a vigorous debate between Paul Williams, a prominent British Buddhist and professor of Indian and Tibetan philosophy who announced his conversion to Catholicism in a provocative book, The Unexpected Way, and two protagonists who disagreed with his reasoning from... (shrink)

Background: For many years, studies have shown that the results of clinical trials are often published or reported selectively with a statistically significant bias in favour of positive trial results. Trial registration as a precondition for publication had only limited effects on current practice. Results of trials which were approved by research ethics committees are often published only partially, with a substantial time lag or not at all. This study examined existing procedures of RECs in the European (...) Union to monitor and prevent incomplete registration of trials and selective reporting of trial results. It further investigated opinions of REC members about the need to update current legislation on this matter. Methods: Web-based survey on members of RECs in 22 European countries. Results: Over 90 percent of respondents agreed that the incomplete publication of trial results had a strong or somewhat negative impact on public health and on healthcare professionals’ trust in the validity of clinical research, yet only 30 percent reported that their REC had some mechanism in place to check that findings of approved studies are published in some form. Less than 10 percent stated that their REC has further specific procedures in place to prevent or minimize selective reporting of study results. Respondents stated variously that their REC did not have the resources to follow up on this matter. Conclusions: The existing legislation to regulate trial registration and encourage complete publication of trial results leaves room for improvement. REC members welcome guidelines to adequately address both problems. The new Regulation EU No. 536/2014 as well as the FDA Amendment Act from 2007 require the reporting of summary results within 1 year after study end. As recent reviews demonstrated, without any systematic approach to monitor the adherence to these regulations, publication rates remain rather low. (shrink)

This scoping review maps research ethics and integrity challenges and best practices encountered by research actors in the DACH countries (Germany, Austria, and Switzerland), including researchers, funders, publishers, research ethics committees, and policymakers, during the COVID-19 pandemic. The COVID-19 pandemic brought research and, in turn, research ethics and integrity, into public focus. This review identified challenges related to changing research environments, diversity in research, publication and dissemination trends, scientific (...) literacy and trust in science, recruitment, research redundancy and study termination, placebo and human challenge studies, data management, and informed consent. These challenges are linked to two crucial factors: first, actors in the DACH research ecosystem lacked a sound knowledge base to assess the risks and benefits of research during the COVID-19 pandemic. Second, researchers in the DACH region faced pressure from policymakers, funders, and the public to generate relevant, timely, and consistent findings to mitigate the impacts of the COVID-19 pandemic. In addition, this review highlights best practices to mitigate the effects of future crises on research ethics and integrity, including enhanced cooperation among actors, continuous ethics assessments, and support for public scientific literacy. (shrink)

The practice of assigning authorship for a scientific publication tends to raise two normative questions: 1) ‘who should be credited as an author?’; 2) ‘who should not be credited as an author but should still be acknowledged?’. With the publication of the revised version of The European Code of Conduct for Research Integrity (ECCRI), standard answers to these questions have been called into question. This article examines the ways in which the ECCRI approaches these two questions and (...) compares these approaches to standard definitions of ‘authorship’ and ‘acknowledgment’ in guidelines issued by the International Committee of Medical Journal Editors (ICMJE) and the World Association of Medical Editors (WAME). In light of two scenarios and the problems posed by these kinds of ‘real-world’ examples, we recommend specific revisions to the content of the ECCRI in order not only to provide a more detailed account of the tasks deserving of acknowledgment, but to improve the Code’s current definition of authorship. (shrink)

Research Integrity (RI) is high on the agenda of both institutions and science policy. The European Union as well as national ministries of science have launched ambitious initiatives to combat misconduct and breaches of research integrity. Often, such initiatives entail attempts to regulate scientific behavior through guidelines that institutions and academic communities can use to more easily identify and deal with cases of misconduct. Rather than framing misconduct as a result of an information deficit, we (...) instead conceptualize Questionable Research Practices (QRPs) as attempts by researchers to reconcile epistemic and social forms of uncertainty in knowledge production. Drawing on previous literature, we define epistemic uncertainty as the inherent intellectual unpredictability of scientific inquiry, while social uncertainty arises from the human-made conditions for scientific work. Our core argument—developed on the basis of 30 focus group interviews with researchers across different fields and European countries—is that breaches of research integrity can be understood as attempts to loosen overly tight coupling between the two forms of uncertainty. Our analytical approach is not meant to relativize or excuse misconduct, but rather to offer a more fine-grained perspective on what exactly it is that researchers want to accomplish by engaging in it. Based on the analysis, we conclude by proposing some concrete ways in which institutions and academic communities could try to reconcile epistemic and social uncertainties on a more collective level, thereby reducing incentives for researchers to engage in misconduct. (shrink)

Over the last decade, a plethora of international policies and guidelines on research integrity have been produced, and many countries have developed national codes of conduct. Recently, as a way of implementing these codes, institutions have begun offering mandatory training in research integrity for PhD fellows. This paper is based on a case study of a mandatory course in research integrity for PhD fellows at a faculty of medicine in Denmark. The study comprised a (...) small survey, participatory fieldwork, and interviews with six course participants, the course leader and a teacher. Based on this study, the paper shows that the PhD fellows perceived the integrity course as if it, to some extent, contributed to normalising the questionable research practice and grey zone behaviour that the course was conceived to prevent. The interviews, however, also show that this latent normalisation must be seen in the context of the PhD fellows’ position within a strongly competitive culture, which sometimes rewards questionable behaviour. For this reason, creating a culture of research integrity cannot be accomplished by integrity training alone, it demands a wider structural change in the incentives for career advancement that sustain the current asymmetries of power. (shrink)

The European Union approach to data protection consists of assessing the adequacy of the data protection offered by the laws of a particular jurisdiction against a set of principles that includes purpose limitation, transparency, quality, proportionality, security, access, and rectification. The EU's Data Protection Directive sets conditions on the transfer of data to third countries by prohibiting Member States from transferring to such countries as have been deemed inadequate in terms of the data protection regimes. In theory, each jurisdiction (...) is evaluated similarly and must be found fully compliant with the EU's data protection principles to be considered adequate. In practice, the inconsistency with which these evaluations are made presents a hurdle to international data-sharing and makes difficult the integration of different data-sharing approaches; in the 20 years since the Directive was first adopted, the laws of only five countries from outside of the EU, Economic Area, or the European Free Trade Agreement have been deemed adequate to engage in data transfers without the need for further administrative safeguards. (shrink)

The sheer impact of the recent global financial turmoil and scandals (such as Enron and WorldCom) has demonstrated that unbridled commercial entrepreneurs who are allowed to pursue their short-term opportunities regardless of the consequences has led to a massive depreciation of the wealth of nations, social livelihood and environmental degradation. This article suggests that the time has come for entrepreneurs to adopt a more integrative view of business that blends economic, social and environmental values. Social entrepreneurs present such a proposition (...) through their deep commitment towards the social vision, appreciation of sustainable practices, innovativeness, ability to build social networks and also generate viable financial returns. It could be expected that social entrepreneurs often possess certain distinct personality characteristics which define their behaviours/actions. Personality traits are partly developed by innate nurturing, socialization and education. These tacit traits are also formed values/beliefs held and play an important role in driving social entrepreneurial decision making. Thus, personality traits may influence the intentions and the manner in which the individual acts. We hold that if social entrepreneurship is to be effective and impactful, business and management education can facilitate the development of these critical personality traits. Thus, this study primes at determining the personality traits that influence social entrepreneurs’ start-up intentions. It also reinforces the findings that personality traits do influence entrepreneurship in general. This study examines the influence of the Big Five personality traits on social entrepreneurship dimensions. The findings reveal that agreeableness positively influences all dimensions of social entrepreneurship, whereas openness exerts a positive influence on social vision, innovation and financial returns. Methodologically, this study develops valid and reliable scales for social entrepreneurship and verifies the adopted Big Five personality measure of Schmit et al. (Pers Psychol 53:153–193, 2000) using the five-point Likert scale. The implication of this study is that element of appreciation of social responsibility, sustainability and character development needs to be integrated within the business education curriculum to support social entrepreneurs in realizing genuine value and impact to the causes and communities they serve. Future business leaders also need to be equipped with entrepreneurship skills, while exuding independent and reflective thinking in the pursuit life-long learning. The originality of this study lies in its focus on personality traits on social rather than commercial entrepreneurship. It is hoped that the findings will trigger a paradigm shift towards greater social entrepreneurship through education by nurturing sustainable development values in future business graduates. (shrink)

The Joint Research Centre (JRC) is the European Commission’s in-house science and knowledge service, employing a substantial staff of scientists devoted to conducting research to provide independent scientific advice for EU policy. Focussed on various research areas aligned with EU priorities, the JRC excels in delivering scientific evidence for policymaking and has published numerous science-for-policy reports and scientific articles. Drawing on a scientific integrity statement, surveys among JRC’s research staff, and thematic discussions with JRC’s (...) research leaders, the JRC has developed a comprehensive Scientific Integrity and Research Ethics (SIRE) framework, including instruments, procedures, and guidelines to ensure high standards and independence in its research. Key components of the SIRE framework include a Scientific Integrity Officer, an Editorial Review Board, a Research Ethics Board, and guidelines for responsible conduct of research. This article provides an overview of the JRC’s SIRE framework and how it was developed, emphasising the importance of maintaining independence, integrity, and ethics in scientific research that supports EU policy. The article also discusses potential gaps in the framework and where additional efforts may be needed, comparing with the recent U.S. National Science and Technology Council report on Protecting the Integrity of Government Science. (shrink)

Empirical-ethical research constitutes a relatively new field which integrates socio-empirical research and normative analysis. As direct inferences from descriptive data to normative conclusions are problematic, an ethical framework is needed to determine the relevance of the empirical data for normative argument. While issues of normative-empirical collaboration and questions of empirical methodology have been widely discussed in the literature, the normative methodology of empirical-ethical research has seldom been addressed. Based on our own research experience, we discuss one (...) aspect of this normative methodology, namely the selection of an ethical theory serving as a background for empirical-ethical research. (shrink)

The review of literature on stakeholders reveals that there is need to understand more about firm-stakeholder relationships especially from stakeholders’ point of view. Market integration in the European Union (EU) provides an excellent context for increasing such understanding since it is creating opportunities and threats for firms and their stakeholders. This research aims to make a contribution in this direction by analyzing strategic responses of primary stakeholders to selected threat events in the history of Volkswagen (VW) since 1960.

Institutions receiving federal funding for research from the U.S.Public Health Service need to have policies and procedures to both prevent research misconduct and to adjudicate it when it occurs. The person who is designated to handle research misconduct is typically referred to as the research integrity officer (RIO). In this interview study we report on 79 RIOs who describe how they would handle allegations of research misconduct. Their responses were compared to two expert RIOs. (...) The responses to the allegations in the scenarios demonstrated that RIOs are not uniformly well prepared to handle activities associated with reported allegations of research misconduct. We recommend greater preparation through directed training, use of check lists of possible behaviors necessary to consider when situations arise, being involved in a network of RIOs so one can discuss options, and the possible need to certify RIOs. (shrink)

Research integrity is fundamental to the validity and reliability of scientific findings, and for ethical conduct of research. As part of PRINTEGER (Promoting Integrity as an Integral Dimension of Excellence in Research), this study explores the views of researchers, research managers, administrators, and governance advisors in Estonia, Italy, Norway and UK, focusing specifically on their understanding of institutional and organisational influences on research integrity.A total of 16 focus groups were conducted. Thematic analysis (...) of the data revealed that competition is pervasive and appeared in most themes relating to integrity. The structural frameworks for research such as funding, evaluation and publication were thought to both protect and, more commonly, undermine integrity. In addition, institutional systems, including workload and research governance, shaped participants’ day-to-day work environment, also affecting research integrity. Participants also provided ideas for promoting research integrity, including training, and creating conditions that would be supportive of research integrity.These findings support a shift away from individual blame and towards the need for structural and institutional changes, including organisations in the wider research environment, for example funding bodies and publishing companies. (shrink)

This essay concerns the extent to which quantitative research in management and organizational studies is divorced from ethics, as alleged in a recent JBE editorial by Zyphur and Pierides. After carefully examining the criticisms set forth by Zyphur and Pierides and the merits of the alternative they propose, I conclude that the problems with QR and the researchers who conduct it are arguably much less extreme that Zyphur and Pierides claim. This conclusion is informed by a sampling of (...) QR studies recently published in management journals, which could be further corroborated by a more thorough review and evaluation of QR studies using principles drawn from the ethics literature. I believe this assessment would indicate that, despite room for improvement, QR and ethics can and do peacefully coexist, and quantitative researchers are largely aware of the problems and opportunities associated with integrating their work with ethics. (shrink)

Fostering research integrity (RI) increasingly focuses on normative guidance and supportive measures within institutions. To be successful, the implementation of support should be informed by stakeholders’ experiences of RI support. This study aims to explore experiences of RI support in Dutch, Spanish and Croatian universities. In total, 59 stakeholders (Netherlands n = 25, Spain n = 17, Croatia n = 17) participated in 16 focus groups in three European countries. Global themes on RI support experiences were identified (...) by thematic analysis. Themes identified were: ‘RI governance and institutional implementation’, ‘RI roles and structures’, ‘RI education and supervision’, and ‘Infrastructure, technology and tools supporting daily practice’. Experiences of support differed between countries in relation to: the efforts to translate norms into practice; the extent to which RI oversight was a responsibility of RE structures, or separate RI structures; and the availability of support close to research practice, such as training, responsible supervision, and adequate tools and infrastructure. The study reinforces the importance of a whole institutional approach to RI, embedded within local jurisdictions, rules, and practices. A whole institutional approach puts the emphasis of responsibility on institutions rather than individual researchers. When such an approach is lacking, some stakeholders look for intervention by authorities, such as funders, outside of the university. (shrink)

Since 2010, the European Journal of Anaesthesiology has required the reporting of five items concerning ethical approval in articles describing human research: ethics committee’s name and address, chairperson’s name, study’s protocol number and approval date. We aimed to assess whether this requirement has helped to identify and to contact the referenced ethics committees. In this cross-sectional study, we analysed articles requiring ethical approval, according to the Swiss federal law for human research and published in the (...) European Journal of Anaesthesiology in 2011. Ethics committees were searched through our institutional Internet access based on information provided in the articles. The last search was performed in November 2015. Numbers of items reported, of ethics committees identified, and of those that confirmed having provided ethical approval are reported. Of 76 articles requiring ethical approval, 74 declared it. Ethics committees’ names and addresses were mentioned in 63/74, protocol numbers in 51/74, approval dates in 48/74, and chairpersons’ names in 45/74. We could identify 44/74 committees; 36/74 answered our inquiry and 24/74 confirmed their role. Thirty-four of 74 articles reported all five items; in 25/34, we were able to identify an ethics committee, 18/34 answered our inquiry, and 15/34 confirmed their role. Forty of 74 articles reported ≤4 items; in 19/40, we were able to identify an ethics committee, 18/40 answered our inquiry, and 9/40 confirmed their role. Reporting five items significantly increased identification of ethics committees and their confirmation of ethical approval. Twelve of 74 ethics committees were unable to confirm their role in approving the study. Even when details concerning ethical approval were reported in these studies of human research, we were unable to identify almost half of the ethics committees concerned. The reporting of five items, compared with reporting ≤4, was associated with facilitated identification of ethics committees, and increased the likelihood that they would be able to confirm the study’s approval. Future research should identify which information facilitates identification of, and contact with, ethics committees. (shrink)

A clear understanding of terminology is crucial in any academic field. When it is clear that complex interdisciplinary concepts are interpreted differently depending on the academic field, geographical setting or cultural values, it is time to take action. Given this, the Glossary for Academic Integrity, newly developed by the European Network for Academic Integrity project, served as the basis for compiling a comprehensive taxonomy of terms related to academic integrity. Following a rigorous coding exercise, the (...) taxonomy was partitioned into three constituent components – Integrity, Misconduct and Neutral terms. A review of relevant literature sources is included, and the strengths and weaknesses of existing taxonomies are discussed in relation to this new offering. During the creation of these artefacts the authors identified and resolved many differences between their individual interpretative understandings of concepts/terms and the viewpoints of others. It is anticipated that the freely-available glossary and taxonomy will be explored and valued by researchers, teachers, students and the general public alike. (shrink)

Since 1989, clinical ethics consultation in form of hospital ethics committees was established in most of the transition countries of Central and Eastern Europe. Up to now, the similarities and differences between HECs in Central and Eastern Europe and their counterparts in the U.S. and Western Europe have not been determined. Through search in literature databases, we have identified studies that document the implementation of clinical ethics consultation in Central and Eastern Europe. These studies have been analyzed (...) under the following aspects: mode of establishment of HECs, character of consultation they provide, and their composition. The results show that HECs in the transition countries of Central and Eastern Europe differ from their western-European or U.S. counterparts with regard to these three aspects. HECs were established because of centrally imposed legal regulations. Little initiatives in this area were taken by medical professionals interested in resolving emerging ethical issues. HECs in the transition countries concentrate mostly on review of research protocols or resolution of administrative conflicts in healthcare institutions. Moreover, integration of non-professional third parties in the workings of HECs is often neglected. We argue that these differences can be attributed to the historical background and the role of medicine in these countries under the communist regime. Political and organizational structures of healthcare as well as education of healthcare staff during this period influenced current functioning of clinical ethics consultation in the transition countries. (shrink)

The European Union is strategically committed to the development of nanotechnology and its industrial exploitation. However, nanotechnology also has the potential to disrupt human health and the environment. The EU claims to be committed to the safe and responsible development of nanotechnology. In this sense, the EU has become the first governing body in the world to develop nanospecific regulations, largely due to legislative action taken by the European Parliament, which has compensated for the European Commission’s reluctance (...) to develop special regulations for nanomaterials. Nevertheless, divergences aside, political bodies in the EU assume that nanotechnology development is controllable and take for granted that both the massive industrial use of nanomaterials and a high level of environmental and health protection are compatible. However, experiences such as the European controversy over agri-food biotechnology, which somewhat delegitimized the regulatory authority of the EU over technological safety and acceptability, arguably show that controllability assumptions are contestable on the grounds of alternative socio-economic and cultural preferences and values. Recently developed inclusive governance models on safety and innovation, such as “Responsible Research and Innovation”, widely claim that a diversity of considerations and issues are integrated into R&D processes. Even so, the possibility of more radically alternative constitutions of socio-technical safety seems to be seriously limited by the current ideology of innovation and economic imperatives of the global, knowledge-based, capitalist economy. (shrink)

Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences (...) of the pediatric oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents. Due to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes. (shrink)

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict (...) or come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

The concept of vulnerability is widely used in research ethics to signal attention to participants who require special protections in research. However, this concept is vague and under‐theorized. There is also growing concern that the dominant categorical approach to vulnerability (as exemplified by research ethics regulations and guidelines delineating vulnerable groups) is ethically problematic because of its assumptions about groups of people and is, in fact, not very guiding. An agreed‐upon strategy is to move from (...) categorical towards analytical approaches (focused on analyzing types and sources of vulnerability) to vulnerability. Beyond this agreement, however, scholars have been advancing competing accounts of vulnerability without consensus about its appropriate operationalization in research ethics. Based on previous debates, we propose that a comprehensive account of vulnerability for research ethics must include four components: definition, normative justifications, application, and implications. Concluding that no existing accounts integrate these components in a functional (i.e., practically applicable) manner, we propose an integrative and functional account of vulnerability inspired by pragmatist theory and enriched by bioethics literature. Using an example of research on deep brain stimulation for treatment‐resistant depression, we illustrate how the integrative‐functional account can guide the analysis of vulnerability in research within a pragmatist, evidence‐based approach to research ethics. While ultimately there are concerns to be addressed in existing research ethics guidelines on vulnerability, the integrative‐functional account can serve as an analytic tool to help researchers, research ethics boards, and other relevant actors fill in the gaps in the current landscape of research ethics governance. (shrink)

Prior researches have highlighted challenges and variations arising from the requirements of research ethics committees and ethics governance systems across diverse research fields. This emphasizes the need to investigate how universities convey and implement research ethical practices. Research ethics plays a pivotal role in guiding the integration of ethical principles throughout all stages of research starting from its inception and planning to its completion and the dissemination of results. These practices encompass a (...) range of considerations, reviews, guidelines, and processes aimed at safeguarding the rights, dignity, health, safety, and privacy of research participants. Using the content analysis technique, this paper aims to analyse research ethical practices information on universities’ websites from three developed countries and developing countries respectively using the isomorphism conception. The findings suggest that the coercive, normative, and mimetic isomorphic pressures explain the research ethics governance practices. The ethical practices information was disclosed more on university websites of the developed countries. Suggestions to improve the university’s research ethics governance system for the post-COVID-19 era were provided in the paper. (shrink)